A supplement to Ob.Gyn. News. This supplement was sponsored by Ethicon Women's Health & Urology.

•Topics
•Faculty/Faculty Disclosure

To view the supplement, click the image above.

• Introduction
• Adhesiogenesis
• Adhesion Frequency in Cesarean Deliveries
• General and Obstetric Sequelae of Adhesions
• Where Are Adhesions Most Likely to Develop?
• Should We Do Peritoneal Closure?
• Adhesion Prevention
• Data on Clinical Effectiveness
• Using ORC at Cesarean Delivery

Faculty/Faculty Disclosure

Hector Chapa, MD, FACOG
Medical Director and Outreach Coordinator
Women's Specialty Center
Clinical Faculty
Obstetrics and Gynecology
Residency Program
Methodist Medical Center
Dallas, Texas
Dr Chapa has received clinical grant funding from Johnson & Johnson Medical Affairs for clinical trials of Interceed

A supplement to Ob.Gyn. News. This supplement was sponsored by Ethicon Women's Health & Urology.

•Topics
•Faculty/Faculty Disclosure

To view the supplement, click the image above.

• Introduction
• Adhesiogenesis
• Adhesion Frequency in Cesarean Deliveries
• General and Obstetric Sequelae of Adhesions
• Where Are Adhesions Most Likely to Develop?
• Should We Do Peritoneal Closure?
• Adhesion Prevention
• Data on Clinical Effectiveness
• Using ORC at Cesarean Delivery

Faculty/Faculty Disclosure

Hector Chapa, MD, FACOG
Medical Director and Outreach Coordinator
Women's Specialty Center
Clinical Faculty
Obstetrics and Gynecology
Residency Program
Methodist Medical Center
Dallas, Texas
Dr Chapa has received clinical grant funding from Johnson & Johnson Medical Affairs for clinical trials of Interceed

A supplement to Ob.Gyn. News. This supplement was sponsored by Ethicon Women's Health & Urology.

•Topics
•Faculty/Faculty Disclosure

To view the supplement, click the image above.

• Introduction
• Adhesiogenesis
• Adhesion Frequency in Cesarean Deliveries
• General and Obstetric Sequelae of Adhesions
• Where Are Adhesions Most Likely to Develop?
• Should We Do Peritoneal Closure?
• Adhesion Prevention
• Data on Clinical Effectiveness
• Using ORC at Cesarean Delivery

Faculty/Faculty Disclosure

Hector Chapa, MD, FACOG
Medical Director and Outreach Coordinator
Women's Specialty Center
Clinical Faculty
Obstetrics and Gynecology
Residency Program
Methodist Medical Center
Dallas, Texas
Dr Chapa has received clinical grant funding from Johnson & Johnson Medical Affairs for clinical trials of Interceed

Management of acute lymphoblastic leukemia should be driven in large part by patient age, according to new clinical practice guidelines issued by the National Comprehensive Cancer Network.

Adolescents and young adults between the ages of 15 and 39 years benefit from the intensive therapies used to treat children, while older adults are thought to be less tolerant of the high-dose pediatric regimens, explained Dr. Patrick A. Brown.

"At this point, multiple studies have indicated that young adults with acute lymphoblastic leukemia [ALL] benefit significantly from pediatric-inspired treatments, and the new guidelines reflect this," said Dr. Brown, cochair of the NCCN panel that wrote the guidelines.

The treatment of older adults, on the other hand, is compromised relative to their younger counterparts, not only by their diminished tolerance of high-dose therapies but also by the presence in many adults of cytogenic abnormalities, including the translocation that results in the Philadelphia (Ph) chromosome, said Dr. Brown, director of the Pediatric Leukemia Program at the Kimmel Comprehensive Cancer Canter, Johns Hopkins University, Baltimore.

The Ph chromosome, a common feature in adult ALL patients but rare in children, leads to formation of the BCR-ABL fusion gene that is associated with a poor prognosis independent of age, he noted in an interview.

The new guidelines were presented March 17 at the conference in Hollywood, Fla.

They call for initial patient stratification based on Ph status and treatment of Ph-positive ALL patients with regimens that incorporate BCR-ABL-targeting tyrosine kinase inhibitors, such as imatinib (Gleevec). Imatinib is FDA approved for the treatment of adult patients with relapsed or refractory Ph-positive ALL.

Regarding treatment decisions, the guidelines recommend risk stratification by age, with adolescent and young adult patients aged 15-39 years being considered separately from the adult population 40 years and older. The guidelines also advocate that those 65 years and older be considered separately as well, but caution that "chronological age alone is a poor surrogate for determining patient fitness for therapy."

Consideration of allogeneic stem cell transplantation as a consolidation option following induction therapy in ALL patients should be based on Ph status and age, Dr. Brown said, noting that the guidelines recommend it for Ph-positive patients as well as PH-negative patients younger than 65 years who have high-risk features. These include elevated white blood cell count, hypodiploidy, or rearrangements of the mixed-lineage leukemia gene, not including those adult patients with preclusive comorbidities, such as organ dysfunction.

The guidelines also recommend:

• Central nervous system prophylaxis and treatment, including cranial irradiation, intrathecal chemotherapy, or high-dose systemic chemotherapy, throughout the course of therapy, from induction through maintenance, to clear leukemic cells from CNS sites that cannot be accessed by systemic chemotherapy because of the blood-brain barrier.

• Postinduction consolidation comprising drug combinations similar to those used during the induction phase, such as high-dose methotrexate, cytarabine, mercaptopurine, and l-asparaginase.

• Extended maintenance therapy for all patients (except those with mature B-cell ALL in whom relapses rarely occur beyond 12 months), typically comprising daily mercaptopurine and weekly methotrexate, often with periodic vincristine and corticosteroids, for 2 years in adults and 2-3 years in children.

• The possible inclusion of novel, immune-based agents that target specific genetic abnormalities, such as the BCR-ABL selective tyrosine kinase inhibitors for Ph-positive ALL, the anti-CD20 monoclonal antibody rituximab (Rituxan) for CD20-expression B-cell lineage ALL, and the adenosine deaminase substrate nelarabine (Arranon) for T-cell lineage ALL.

The NCCN guidelines also incorporate recommendations for minimal residual disease evaluation, provision of supportive care, and management of treatment-associated toxicities.

While the survival outcomes associated with ALL have improved dramatically among children in recent years – the cure rate with current treatment regimens is approximately 80% – the long-term prognosis for adults with the disease is poor, with cure rates of 30-40%, according to NCCN ALL guidelines panel member Dr. Daniel J. DeAngelo.

"ALL is the rarest form of adult leukemia, and we still have a lot of unanswered questions," said Dr. DeAngelo of the Dana-Farber Cancer Institute, Boston. "For this reason, adult patients with the disease should be referred to specialized cancer treatment centers and should be enrolled in clinical trials whenever possible."

Dr. Brown disclosed no relevant conflicts of interest. Dr. DeAngelo disclosed relationships with Bristol-Myers Squibb, Novartis, and Sigma-Tau Pharmaceuticals. The full list of disclosures for the NCCN ALL Guidelines Panel members can be found at http://www.nccn.org.

Management of acute lymphoblastic leukemia should be driven in large part by patient age, according to new clinical practice guidelines issued by the National Comprehensive Cancer Network.

Adolescents and young adults between the ages of 15 and 39 years benefit from the intensive therapies used to treat children, while older adults are thought to be less tolerant of the high-dose pediatric regimens, explained Dr. Patrick A. Brown.

"At this point, multiple studies have indicated that young adults with acute lymphoblastic leukemia [ALL] benefit significantly from pediatric-inspired treatments, and the new guidelines reflect this," said Dr. Brown, cochair of the NCCN panel that wrote the guidelines.

The treatment of older adults, on the other hand, is compromised relative to their younger counterparts, not only by their diminished tolerance of high-dose therapies but also by the presence in many adults of cytogenic abnormalities, including the translocation that results in the Philadelphia (Ph) chromosome, said Dr. Brown, director of the Pediatric Leukemia Program at the Kimmel Comprehensive Cancer Canter, Johns Hopkins University, Baltimore.

The Ph chromosome, a common feature in adult ALL patients but rare in children, leads to formation of the BCR-ABL fusion gene that is associated with a poor prognosis independent of age, he noted in an interview.

The new guidelines were presented March 17 at the conference in Hollywood, Fla.

They call for initial patient stratification based on Ph status and treatment of Ph-positive ALL patients with regimens that incorporate BCR-ABL-targeting tyrosine kinase inhibitors, such as imatinib (Gleevec). Imatinib is FDA approved for the treatment of adult patients with relapsed or refractory Ph-positive ALL.

Regarding treatment decisions, the guidelines recommend risk stratification by age, with adolescent and young adult patients aged 15-39 years being considered separately from the adult population 40 years and older. The guidelines also advocate that those 65 years and older be considered separately as well, but caution that "chronological age alone is a poor surrogate for determining patient fitness for therapy."

Consideration of allogeneic stem cell transplantation as a consolidation option following induction therapy in ALL patients should be based on Ph status and age, Dr. Brown said, noting that the guidelines recommend it for Ph-positive patients as well as PH-negative patients younger than 65 years who have high-risk features. These include elevated white blood cell count, hypodiploidy, or rearrangements of the mixed-lineage leukemia gene, not including those adult patients with preclusive comorbidities, such as organ dysfunction.

The guidelines also recommend:

• Central nervous system prophylaxis and treatment, including cranial irradiation, intrathecal chemotherapy, or high-dose systemic chemotherapy, throughout the course of therapy, from induction through maintenance, to clear leukemic cells from CNS sites that cannot be accessed by systemic chemotherapy because of the blood-brain barrier.

• Postinduction consolidation comprising drug combinations similar to those used during the induction phase, such as high-dose methotrexate, cytarabine, mercaptopurine, and l-asparaginase.

• Extended maintenance therapy for all patients (except those with mature B-cell ALL in whom relapses rarely occur beyond 12 months), typically comprising daily mercaptopurine and weekly methotrexate, often with periodic vincristine and corticosteroids, for 2 years in adults and 2-3 years in children.

• The possible inclusion of novel, immune-based agents that target specific genetic abnormalities, such as the BCR-ABL selective tyrosine kinase inhibitors for Ph-positive ALL, the anti-CD20 monoclonal antibody rituximab (Rituxan) for CD20-expression B-cell lineage ALL, and the adenosine deaminase substrate nelarabine (Arranon) for T-cell lineage ALL.

The NCCN guidelines also incorporate recommendations for minimal residual disease evaluation, provision of supportive care, and management of treatment-associated toxicities.

While the survival outcomes associated with ALL have improved dramatically among children in recent years – the cure rate with current treatment regimens is approximately 80% – the long-term prognosis for adults with the disease is poor, with cure rates of 30-40%, according to NCCN ALL guidelines panel member Dr. Daniel J. DeAngelo.

"ALL is the rarest form of adult leukemia, and we still have a lot of unanswered questions," said Dr. DeAngelo of the Dana-Farber Cancer Institute, Boston. "For this reason, adult patients with the disease should be referred to specialized cancer treatment centers and should be enrolled in clinical trials whenever possible."

Dr. Brown disclosed no relevant conflicts of interest. Dr. DeAngelo disclosed relationships with Bristol-Myers Squibb, Novartis, and Sigma-Tau Pharmaceuticals. The full list of disclosures for the NCCN ALL Guidelines Panel members can be found at http://www.nccn.org.

Management of acute lymphoblastic leukemia should be driven in large part by patient age, according to new clinical practice guidelines issued by the National Comprehensive Cancer Network.

Adolescents and young adults between the ages of 15 and 39 years benefit from the intensive therapies used to treat children, while older adults are thought to be less tolerant of the high-dose pediatric regimens, explained Dr. Patrick A. Brown.

"At this point, multiple studies have indicated that young adults with acute lymphoblastic leukemia [ALL] benefit significantly from pediatric-inspired treatments, and the new guidelines reflect this," said Dr. Brown, cochair of the NCCN panel that wrote the guidelines.

The treatment of older adults, on the other hand, is compromised relative to their younger counterparts, not only by their diminished tolerance of high-dose therapies but also by the presence in many adults of cytogenic abnormalities, including the translocation that results in the Philadelphia (Ph) chromosome, said Dr. Brown, director of the Pediatric Leukemia Program at the Kimmel Comprehensive Cancer Canter, Johns Hopkins University, Baltimore.

The Ph chromosome, a common feature in adult ALL patients but rare in children, leads to formation of the BCR-ABL fusion gene that is associated with a poor prognosis independent of age, he noted in an interview.

The new guidelines were presented March 17 at the conference in Hollywood, Fla.

They call for initial patient stratification based on Ph status and treatment of Ph-positive ALL patients with regimens that incorporate BCR-ABL-targeting tyrosine kinase inhibitors, such as imatinib (Gleevec). Imatinib is FDA approved for the treatment of adult patients with relapsed or refractory Ph-positive ALL.

Regarding treatment decisions, the guidelines recommend risk stratification by age, with adolescent and young adult patients aged 15-39 years being considered separately from the adult population 40 years and older. The guidelines also advocate that those 65 years and older be considered separately as well, but caution that "chronological age alone is a poor surrogate for determining patient fitness for therapy."

Consideration of allogeneic stem cell transplantation as a consolidation option following induction therapy in ALL patients should be based on Ph status and age, Dr. Brown said, noting that the guidelines recommend it for Ph-positive patients as well as PH-negative patients younger than 65 years who have high-risk features. These include elevated white blood cell count, hypodiploidy, or rearrangements of the mixed-lineage leukemia gene, not including those adult patients with preclusive comorbidities, such as organ dysfunction.

The guidelines also recommend:

• Central nervous system prophylaxis and treatment, including cranial irradiation, intrathecal chemotherapy, or high-dose systemic chemotherapy, throughout the course of therapy, from induction through maintenance, to clear leukemic cells from CNS sites that cannot be accessed by systemic chemotherapy because of the blood-brain barrier.

• Postinduction consolidation comprising drug combinations similar to those used during the induction phase, such as high-dose methotrexate, cytarabine, mercaptopurine, and l-asparaginase.

• Extended maintenance therapy for all patients (except those with mature B-cell ALL in whom relapses rarely occur beyond 12 months), typically comprising daily mercaptopurine and weekly methotrexate, often with periodic vincristine and corticosteroids, for 2 years in adults and 2-3 years in children.

• The possible inclusion of novel, immune-based agents that target specific genetic abnormalities, such as the BCR-ABL selective tyrosine kinase inhibitors for Ph-positive ALL, the anti-CD20 monoclonal antibody rituximab (Rituxan) for CD20-expression B-cell lineage ALL, and the adenosine deaminase substrate nelarabine (Arranon) for T-cell lineage ALL.

The NCCN guidelines also incorporate recommendations for minimal residual disease evaluation, provision of supportive care, and management of treatment-associated toxicities.

While the survival outcomes associated with ALL have improved dramatically among children in recent years – the cure rate with current treatment regimens is approximately 80% – the long-term prognosis for adults with the disease is poor, with cure rates of 30-40%, according to NCCN ALL guidelines panel member Dr. Daniel J. DeAngelo.

"ALL is the rarest form of adult leukemia, and we still have a lot of unanswered questions," said Dr. DeAngelo of the Dana-Farber Cancer Institute, Boston. "For this reason, adult patients with the disease should be referred to specialized cancer treatment centers and should be enrolled in clinical trials whenever possible."

Dr. Brown disclosed no relevant conflicts of interest. Dr. DeAngelo disclosed relationships with Bristol-Myers Squibb, Novartis, and Sigma-Tau Pharmaceuticals. The full list of disclosures for the NCCN ALL Guidelines Panel members can be found at http://www.nccn.org.

A supplement to Ob.Gyn. News. This supplement was sponsored by TEVA Women's Health.

•Topics
•Faculty/Faculty Disclosure

To view the supplement, click the image above.

• Defining OC-Related Bleeding
• Differences Among OC Regimens
• Management of OC-Related Bleeding

Faculty/Faculty Disclosure

Christopher M. Estes, MD, MPH
Assistant Professor
Director, Clerkship in Obstetrics and Gynecology
Medical Director
Reproductive Health Services
University of Miami Miller, School of Medicine
Department of Obstetrics and Gynecology
Miami, FL

Mandy Gittler, MD
Medical Director
All Women's Health
Chicago, IL and Tacoma, WA

Dr Estes has nothing to disclose. Dr Gittler is a consultant to, and has received funding for clinical grants from TEVA Women's Health.

Copyright © 2011 by Elsevier Inc.

A supplement to Ob.Gyn. News. This supplement was sponsored by TEVA Women's Health.

•Topics
•Faculty/Faculty Disclosure

To view the supplement, click the image above.

• Defining OC-Related Bleeding
• Differences Among OC Regimens
• Management of OC-Related Bleeding

Faculty/Faculty Disclosure

Christopher M. Estes, MD, MPH
Assistant Professor
Director, Clerkship in Obstetrics and Gynecology
Medical Director
Reproductive Health Services
University of Miami Miller, School of Medicine
Department of Obstetrics and Gynecology
Miami, FL

Mandy Gittler, MD
Medical Director
All Women's Health
Chicago, IL and Tacoma, WA

Dr Estes has nothing to disclose. Dr Gittler is a consultant to, and has received funding for clinical grants from TEVA Women's Health.

Copyright © 2011 by Elsevier Inc.

A supplement to Ob.Gyn. News. This supplement was sponsored by TEVA Women's Health.

•Topics
•Faculty/Faculty Disclosure

To view the supplement, click the image above.

• Defining OC-Related Bleeding
• Differences Among OC Regimens
• Management of OC-Related Bleeding

Faculty/Faculty Disclosure

Christopher M. Estes, MD, MPH
Assistant Professor
Director, Clerkship in Obstetrics and Gynecology
Medical Director
Reproductive Health Services
University of Miami Miller, School of Medicine
Department of Obstetrics and Gynecology
Miami, FL

Mandy Gittler, MD
Medical Director
All Women's Health
Chicago, IL and Tacoma, WA

Dr Estes has nothing to disclose. Dr Gittler is a consultant to, and has received funding for clinical grants from TEVA Women's Health.

Copyright © 2011 by Elsevier Inc.

A supplement to Ob.Gyn. News. This supplement was sponsored by Ethicon Women's Health & Urology.

•Topics
•Faculty/Faculty Disclosure

To view the supplement, click the image above.

• Introduction
• Total Versus Subtotal Abdominal Hysterectomy
• A Retrospective Comparison of LSH and TAH
• Two Approaches to Hysterectomy for Management of Benign Pathology

Faculty/Faculty Disclosure

Andrew I. Brill, MD
Director of Minimally Invasive Gynecology at California Pacific Medical Center
San Francisco, CA
Dr. Brill has a consulting agreement with Cephalon, Inc., Ethicon, Inc., and Karl Storz GmbH & Co. KG.

Copyright © 2010 by Elsevier Inc.

A supplement to Ob.Gyn. News. This supplement was sponsored by Ethicon Women's Health & Urology.

•Topics
•Faculty/Faculty Disclosure

To view the supplement, click the image above.

• Introduction
• Total Versus Subtotal Abdominal Hysterectomy
• A Retrospective Comparison of LSH and TAH
• Two Approaches to Hysterectomy for Management of Benign Pathology

Faculty/Faculty Disclosure

Andrew I. Brill, MD
Director of Minimally Invasive Gynecology at California Pacific Medical Center
San Francisco, CA
Dr. Brill has a consulting agreement with Cephalon, Inc., Ethicon, Inc., and Karl Storz GmbH & Co. KG.

Copyright © 2010 by Elsevier Inc.

A supplement to Ob.Gyn. News. This supplement was sponsored by Ethicon Women's Health & Urology.

•Topics
•Faculty/Faculty Disclosure

To view the supplement, click the image above.

• Introduction
• Total Versus Subtotal Abdominal Hysterectomy
• A Retrospective Comparison of LSH and TAH
• Two Approaches to Hysterectomy for Management of Benign Pathology

Faculty/Faculty Disclosure

Andrew I. Brill, MD
Director of Minimally Invasive Gynecology at California Pacific Medical Center
San Francisco, CA
Dr. Brill has a consulting agreement with Cephalon, Inc., Ethicon, Inc., and Karl Storz GmbH & Co. KG.

Copyright © 2010 by Elsevier Inc.

CHICAGO – Bariatric surgery crushed intensive medical therapy for the management of hyperglycemia in a randomized trial involving obese patients with poorly controlled type 2 diabetes.

"The lesson of this study is that for those obese patients who also have uncontrolled diabetes, there is now another treatment option that may be very, very effective at getting them in good control," Dr. Philip R. Schauer declared in presenting the 1-year results of the STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial.

STAMPEDE was a single-center prospective study involving 150 randomized patients. The primary end point – hemoglobin A_1c of 6.0% or less at 1 year – was achieved in 42% of patients in the Roux-en-Y gastric bypass group, 37% in the sleeve gastrectomy group, and 12% of patients assigned to state-of-the-art intensive medical management based upon American Diabetes Association guidelines, including a weight loss program, reported Dr. Schauer, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic.

At enrollment the average HbA_1c was 9.2% even though most patients were on three or more diabetes medications, and about half were taking insulin. The average baseline body mass index was 37 kg/m². More than 60% of subjects had moderate to severe fatty liver disease.

Particularly noteworthy was the finding that all gastric bypass patients with an HbA_1c of 6.0% or less at 1 year achieved that target despite having discontinued all diabetes medications, including insulin. So did 13 of 18 patients in the sleeve gastrectomy group who reached the primary end point.

"That’s as close to a definition of remission of diabetes as you can get to," the surgeon commented.

Improvements in secondary study end points related to cardiovascular risk were also far more impressive in the surgery arms.

Three patients in the gastric bypass group and one in the sleeve gastrectomy arm required redo operations. There were other serious complications in the surgical groups as well, but no deaths.

Follow-up of STAMPEDE participants will continue through 4 years. Dr. Schauer predicted that on the basis of the highly positive STAMPEDE findings, future studies will look at bariatric surgery versus intensive medical management in obese type 2 diabetic patients with lesser degrees of uncontrolled type 2 diabetes – say, HbA_1cs between 7% and 9%.

Reaction to STAMPEDE was cautious.

"That’s a huge intervention in order to get control of diabetes. I’m just not sure it’s ready for prime time yet," former ACC President Dr. W. Douglas Weaver said in an interview.

"I would like to see some more outcomes data in patients who’ve been managed in this way. You’d like to see that it not only keeps the weight off and the glucose levels lower over the longer term, but that it actually improves outcomes in terms of cardiovascular events and diabetic complications. Then it becomes compelling. Right now, we just have these surrogate improvements," added Dr. Weaver, head of the division of cardiovascular medicine at the Henry Ford Health System, Detroit.

Cleveland Clinic endocrinologist Dr. Sangeeta Kashyap, who headed the STAMPEDE diabetology team, said medical therapy is not to be discounted. It’s titratable, even stoppable if need be. A surgical fix is not.

"Surgery works very well, but once it’s done, it’s done. If you want to eat an extra bite of food, you’re not going to be able to without getting violently ill," she observed in an interview.

"Even though our results strongly support bariatric surgery for diabetes, I don’t think it’s going to be right for everybody. I think more studies need to be done to figure out who the best candidates are, and for which procedures," Dr. Kashyap said.

The durability of surgery’s antidiabetic effect has yet to be established, she added.

Simultaneously with Dr. Schauer’s presentation of STAMPEDE in Chicago, the study was published online by the New England Journal of Medicine (N. Engl. J. Med. 2012 March 26 [10.1056/NEJMoa1200225]).

STAMPEDE was supported by Ethicon Endo-Surgery, the National Institutes of Health, and LifeScan. Dr. Schauer and Dr. Kashyap reported serving as consultants to Ethicon, and Dr. Schauer consults for other companies as well.

CHICAGO – Bariatric surgery crushed intensive medical therapy for the management of hyperglycemia in a randomized trial involving obese patients with poorly controlled type 2 diabetes.

"The lesson of this study is that for those obese patients who also have uncontrolled diabetes, there is now another treatment option that may be very, very effective at getting them in good control," Dr. Philip R. Schauer declared in presenting the 1-year results of the STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial.

STAMPEDE was a single-center prospective study involving 150 randomized patients. The primary end point – hemoglobin A_1c of 6.0% or less at 1 year – was achieved in 42% of patients in the Roux-en-Y gastric bypass group, 37% in the sleeve gastrectomy group, and 12% of patients assigned to state-of-the-art intensive medical management based upon American Diabetes Association guidelines, including a weight loss program, reported Dr. Schauer, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic.

At enrollment the average HbA_1c was 9.2% even though most patients were on three or more diabetes medications, and about half were taking insulin. The average baseline body mass index was 37 kg/m². More than 60% of subjects had moderate to severe fatty liver disease.

Particularly noteworthy was the finding that all gastric bypass patients with an HbA_1c of 6.0% or less at 1 year achieved that target despite having discontinued all diabetes medications, including insulin. So did 13 of 18 patients in the sleeve gastrectomy group who reached the primary end point.

"That’s as close to a definition of remission of diabetes as you can get to," the surgeon commented.

Improvements in secondary study end points related to cardiovascular risk were also far more impressive in the surgery arms.

Three patients in the gastric bypass group and one in the sleeve gastrectomy arm required redo operations. There were other serious complications in the surgical groups as well, but no deaths.

Follow-up of STAMPEDE participants will continue through 4 years. Dr. Schauer predicted that on the basis of the highly positive STAMPEDE findings, future studies will look at bariatric surgery versus intensive medical management in obese type 2 diabetic patients with lesser degrees of uncontrolled type 2 diabetes – say, HbA_1cs between 7% and 9%.

Reaction to STAMPEDE was cautious.

"That’s a huge intervention in order to get control of diabetes. I’m just not sure it’s ready for prime time yet," former ACC President Dr. W. Douglas Weaver said in an interview.

"I would like to see some more outcomes data in patients who’ve been managed in this way. You’d like to see that it not only keeps the weight off and the glucose levels lower over the longer term, but that it actually improves outcomes in terms of cardiovascular events and diabetic complications. Then it becomes compelling. Right now, we just have these surrogate improvements," added Dr. Weaver, head of the division of cardiovascular medicine at the Henry Ford Health System, Detroit.

Cleveland Clinic endocrinologist Dr. Sangeeta Kashyap, who headed the STAMPEDE diabetology team, said medical therapy is not to be discounted. It’s titratable, even stoppable if need be. A surgical fix is not.

"Surgery works very well, but once it’s done, it’s done. If you want to eat an extra bite of food, you’re not going to be able to without getting violently ill," she observed in an interview.

"Even though our results strongly support bariatric surgery for diabetes, I don’t think it’s going to be right for everybody. I think more studies need to be done to figure out who the best candidates are, and for which procedures," Dr. Kashyap said.

The durability of surgery’s antidiabetic effect has yet to be established, she added.

Simultaneously with Dr. Schauer’s presentation of STAMPEDE in Chicago, the study was published online by the New England Journal of Medicine (N. Engl. J. Med. 2012 March 26 [10.1056/NEJMoa1200225]).

STAMPEDE was supported by Ethicon Endo-Surgery, the National Institutes of Health, and LifeScan. Dr. Schauer and Dr. Kashyap reported serving as consultants to Ethicon, and Dr. Schauer consults for other companies as well.

CHICAGO – Bariatric surgery crushed intensive medical therapy for the management of hyperglycemia in a randomized trial involving obese patients with poorly controlled type 2 diabetes.

"The lesson of this study is that for those obese patients who also have uncontrolled diabetes, there is now another treatment option that may be very, very effective at getting them in good control," Dr. Philip R. Schauer declared in presenting the 1-year results of the STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial.

STAMPEDE was a single-center prospective study involving 150 randomized patients. The primary end point – hemoglobin A_1c of 6.0% or less at 1 year – was achieved in 42% of patients in the Roux-en-Y gastric bypass group, 37% in the sleeve gastrectomy group, and 12% of patients assigned to state-of-the-art intensive medical management based upon American Diabetes Association guidelines, including a weight loss program, reported Dr. Schauer, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic.

At enrollment the average HbA_1c was 9.2% even though most patients were on three or more diabetes medications, and about half were taking insulin. The average baseline body mass index was 37 kg/m². More than 60% of subjects had moderate to severe fatty liver disease.

Particularly noteworthy was the finding that all gastric bypass patients with an HbA_1c of 6.0% or less at 1 year achieved that target despite having discontinued all diabetes medications, including insulin. So did 13 of 18 patients in the sleeve gastrectomy group who reached the primary end point.

"That’s as close to a definition of remission of diabetes as you can get to," the surgeon commented.

Improvements in secondary study end points related to cardiovascular risk were also far more impressive in the surgery arms.

Three patients in the gastric bypass group and one in the sleeve gastrectomy arm required redo operations. There were other serious complications in the surgical groups as well, but no deaths.

Follow-up of STAMPEDE participants will continue through 4 years. Dr. Schauer predicted that on the basis of the highly positive STAMPEDE findings, future studies will look at bariatric surgery versus intensive medical management in obese type 2 diabetic patients with lesser degrees of uncontrolled type 2 diabetes – say, HbA_1cs between 7% and 9%.

Reaction to STAMPEDE was cautious.

"That’s a huge intervention in order to get control of diabetes. I’m just not sure it’s ready for prime time yet," former ACC President Dr. W. Douglas Weaver said in an interview.

"I would like to see some more outcomes data in patients who’ve been managed in this way. You’d like to see that it not only keeps the weight off and the glucose levels lower over the longer term, but that it actually improves outcomes in terms of cardiovascular events and diabetic complications. Then it becomes compelling. Right now, we just have these surrogate improvements," added Dr. Weaver, head of the division of cardiovascular medicine at the Henry Ford Health System, Detroit.

Cleveland Clinic endocrinologist Dr. Sangeeta Kashyap, who headed the STAMPEDE diabetology team, said medical therapy is not to be discounted. It’s titratable, even stoppable if need be. A surgical fix is not.

"Surgery works very well, but once it’s done, it’s done. If you want to eat an extra bite of food, you’re not going to be able to without getting violently ill," she observed in an interview.

"Even though our results strongly support bariatric surgery for diabetes, I don’t think it’s going to be right for everybody. I think more studies need to be done to figure out who the best candidates are, and for which procedures," Dr. Kashyap said.

The durability of surgery’s antidiabetic effect has yet to be established, she added.

Simultaneously with Dr. Schauer’s presentation of STAMPEDE in Chicago, the study was published online by the New England Journal of Medicine (N. Engl. J. Med. 2012 March 26 [10.1056/NEJMoa1200225]).

STAMPEDE was supported by Ethicon Endo-Surgery, the National Institutes of Health, and LifeScan. Dr. Schauer and Dr. Kashyap reported serving as consultants to Ethicon, and Dr. Schauer consults for other companies as well.

NEW YORK – Patients with gout who took colchicine had less than one-half the risk of having a myocardial infarction that was seen in patients who were untreated for their gout. But this protective effect was not seen for patients taking allopurinol, Dr. Michael Pillinger, a coauthor of the study, said at a rheumatology meeting sponsored by New York University.

In this retrospective analysis of data from 1,300 patients from the New York Veterans Affairs Gout Cohort, about 0.5% of those taking colchicine had an MI, compared with 3% of those not taking any antigout medication (P less than .05). The MI rate for those taking allopurinol was slightly more than 2%, which was not significantly different from the rate in the untreated group. A significant reduction was seen for those taking both colchicine and allopurinol. Death rates were comparable among the groups.

"When we stepped out of the database and read the charts, we found [that] several of the patients who were categorized as having MIs on colchicine actually had been put on colchicine after their MI, so when we corrected for this, the difference was even greater," said Dr. Pillinger, director of the rheumatology fellowship program at New York University and director of rheumatology at the Manhattan campus of the VA New York Harbor Healthcare System.

"These are very provocative findings," he added. His group is currently undertaking more rigorous retrospective analyses and hopes to begin a prospective study.

Dr. Pillinger postulated that the lack of significant effect of allopurinol was due to its inconsistency in lowering urate levels. "In our hands, allopurinol does not always reduce urate levels," he noted.

These data confirm findings from an earlier study by Dr. Pillinger and his associates that looked at 45,000 Taiwanese men with hyperuricemia or gout. Those findings showed that treating hyperuricemia and gout could help control comorbid cardiovascular disease.

Dr. Pillinger reported financial relationships with Takeda (the study site) and URL Pharma (an investigator-initiated grant).

NEW YORK – Patients with gout who took colchicine had less than one-half the risk of having a myocardial infarction that was seen in patients who were untreated for their gout. But this protective effect was not seen for patients taking allopurinol, Dr. Michael Pillinger, a coauthor of the study, said at a rheumatology meeting sponsored by New York University.

In this retrospective analysis of data from 1,300 patients from the New York Veterans Affairs Gout Cohort, about 0.5% of those taking colchicine had an MI, compared with 3% of those not taking any antigout medication (P less than .05). The MI rate for those taking allopurinol was slightly more than 2%, which was not significantly different from the rate in the untreated group. A significant reduction was seen for those taking both colchicine and allopurinol. Death rates were comparable among the groups.

"When we stepped out of the database and read the charts, we found [that] several of the patients who were categorized as having MIs on colchicine actually had been put on colchicine after their MI, so when we corrected for this, the difference was even greater," said Dr. Pillinger, director of the rheumatology fellowship program at New York University and director of rheumatology at the Manhattan campus of the VA New York Harbor Healthcare System.

"These are very provocative findings," he added. His group is currently undertaking more rigorous retrospective analyses and hopes to begin a prospective study.

Dr. Pillinger postulated that the lack of significant effect of allopurinol was due to its inconsistency in lowering urate levels. "In our hands, allopurinol does not always reduce urate levels," he noted.

These data confirm findings from an earlier study by Dr. Pillinger and his associates that looked at 45,000 Taiwanese men with hyperuricemia or gout. Those findings showed that treating hyperuricemia and gout could help control comorbid cardiovascular disease.

Dr. Pillinger reported financial relationships with Takeda (the study site) and URL Pharma (an investigator-initiated grant).

NEW YORK – Patients with gout who took colchicine had less than one-half the risk of having a myocardial infarction that was seen in patients who were untreated for their gout. But this protective effect was not seen for patients taking allopurinol, Dr. Michael Pillinger, a coauthor of the study, said at a rheumatology meeting sponsored by New York University.

In this retrospective analysis of data from 1,300 patients from the New York Veterans Affairs Gout Cohort, about 0.5% of those taking colchicine had an MI, compared with 3% of those not taking any antigout medication (P less than .05). The MI rate for those taking allopurinol was slightly more than 2%, which was not significantly different from the rate in the untreated group. A significant reduction was seen for those taking both colchicine and allopurinol. Death rates were comparable among the groups.

"When we stepped out of the database and read the charts, we found [that] several of the patients who were categorized as having MIs on colchicine actually had been put on colchicine after their MI, so when we corrected for this, the difference was even greater," said Dr. Pillinger, director of the rheumatology fellowship program at New York University and director of rheumatology at the Manhattan campus of the VA New York Harbor Healthcare System.

"These are very provocative findings," he added. His group is currently undertaking more rigorous retrospective analyses and hopes to begin a prospective study.

Dr. Pillinger postulated that the lack of significant effect of allopurinol was due to its inconsistency in lowering urate levels. "In our hands, allopurinol does not always reduce urate levels," he noted.

These data confirm findings from an earlier study by Dr. Pillinger and his associates that looked at 45,000 Taiwanese men with hyperuricemia or gout. Those findings showed that treating hyperuricemia and gout could help control comorbid cardiovascular disease.

Dr. Pillinger reported financial relationships with Takeda (the study site) and URL Pharma (an investigator-initiated grant).

A supplement to Ob.Gyn. News. This supplement was sponsored by TEVA Women's Health.

•Topics
•Faculty/Faculty Disclosure

To view the supplement, click the image above.

• History of the Hormone-Free Interval
• Physiologic Effects of a Modified Hormone-Free Interval
• Safety and Efficacy of Extended-Regimen Oral Contraception

Faculty/Faculty Disclosure

David J. Portman, MD
Director and Principal Investigator
Columbus Center for Women's
Health Research
Columbus, Ohio
Dr. Portman is a consultant to Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim GmbH, GlaxoSmithKline plc, and TEVA Women's Health. He has received funding for clinical grants from Bayer, Boehringer Ingelheim, Depomed, Inc., Pfizer Inc., TEVA Women's Health, and Warner Chilcott.

A supplement to Ob.Gyn. News. This supplement was sponsored by TEVA Women's Health.

•Topics
•Faculty/Faculty Disclosure

To view the supplement, click the image above.

• History of the Hormone-Free Interval
• Physiologic Effects of a Modified Hormone-Free Interval
• Safety and Efficacy of Extended-Regimen Oral Contraception

Faculty/Faculty Disclosure

David J. Portman, MD
Director and Principal Investigator
Columbus Center for Women's
Health Research
Columbus, Ohio
Dr. Portman is a consultant to Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim GmbH, GlaxoSmithKline plc, and TEVA Women's Health. He has received funding for clinical grants from Bayer, Boehringer Ingelheim, Depomed, Inc., Pfizer Inc., TEVA Women's Health, and Warner Chilcott.

A supplement to Ob.Gyn. News. This supplement was sponsored by TEVA Women's Health.

•Topics
•Faculty/Faculty Disclosure

To view the supplement, click the image above.

• History of the Hormone-Free Interval
• Physiologic Effects of a Modified Hormone-Free Interval
• Safety and Efficacy of Extended-Regimen Oral Contraception

Faculty/Faculty Disclosure

David J. Portman, MD
Director and Principal Investigator
Columbus Center for Women's
Health Research
Columbus, Ohio
Dr. Portman is a consultant to Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim GmbH, GlaxoSmithKline plc, and TEVA Women's Health. He has received funding for clinical grants from Bayer, Boehringer Ingelheim, Depomed, Inc., Pfizer Inc., TEVA Women's Health, and Warner Chilcott.

A supplement to Ob.Gyn. News.
This supplement is based on physician interviews. It is supported by Kenwood Therapeutics, a division of Bradley Pharmaceuticals, Inc.

To view the supplement, click the image above.



Topic Highlights

• Menopause and Hormone Therapy

• The Cardiovascular Paradox

• Current Recommendations for Postmenopausal Hormone Therapy

• Effective Low-Dose Therapy

• Clinical Trial of Transdermal Estrogen

• Other Considerations of Transdermal Hormone Therapy

Faculty/Faculty Disclosures

Donna Shoupe, MD
Professor, Department of Obstetrics and Gynecology
Keck School of Medicine
University of Southern California
Dr. Shoupe is on the advisory board of Bradley Pharmaceuticals, Inc.
Steven R. Goldstein, MD
Professor of Obstetrics and Gynecology
New York University School of Medicine
Dr. Goldstein has disclosed that he is on the advisory boards of Bradley Pharmaceuticals, Inc., Eli Lilly and Company, GlaxoSmithKline, Merck & Co., Inc., Novogyne Pharmaceuticals, Novo Nordisk, and Pfizer Inc.

With Comments From:
Daniel R. Mishell, Jr., MD
Lyle G. McNiele Professor
Department of Obstetrics/Gynecology
Keck School of Medicine
University of Southern California
Dr. Mishell has disclosed that he is a consultant to Barr Pharmaceuticals, Inc., and Bayer Healthcare Pharmaceuticals Inc.
Alfred Moffett Jr., MD, FACOG
Clinical Assistant Professor, Obstetrics and Gynecology
University of South Florida College of Medicine
OB-GYN Associates of Mid-Florida, P.A.
Dr. Moffett is on the advisory board of Bradley Pharmaceuticals, Inc.
Lee P. Shulman, MD, FACOG, FACMG
Professor and Chief
Division of Reproductive Genetics
Department of Obstetrics and Gynecology
Feinberg School of Medicine
Northwestern University
Dr. Shulman is on the advisory board of Bradley Pharmaceuticals, Inc.

Copyright © 2007 by Elsevier Inc.

A supplement to Ob.Gyn. News.
This supplement is based on physician interviews. It is supported by Kenwood Therapeutics, a division of Bradley Pharmaceuticals, Inc.

To view the supplement, click the image above.



Topic Highlights

• Menopause and Hormone Therapy

• The Cardiovascular Paradox

• Current Recommendations for Postmenopausal Hormone Therapy

• Effective Low-Dose Therapy

• Clinical Trial of Transdermal Estrogen

• Other Considerations of Transdermal Hormone Therapy

Faculty/Faculty Disclosures

Donna Shoupe, MD
Professor, Department of Obstetrics and Gynecology
Keck School of Medicine
University of Southern California
Dr. Shoupe is on the advisory board of Bradley Pharmaceuticals, Inc.
Steven R. Goldstein, MD
Professor of Obstetrics and Gynecology
New York University School of Medicine
Dr. Goldstein has disclosed that he is on the advisory boards of Bradley Pharmaceuticals, Inc., Eli Lilly and Company, GlaxoSmithKline, Merck & Co., Inc., Novogyne Pharmaceuticals, Novo Nordisk, and Pfizer Inc.

With Comments From:
Daniel R. Mishell, Jr., MD
Lyle G. McNiele Professor
Department of Obstetrics/Gynecology
Keck School of Medicine
University of Southern California
Dr. Mishell has disclosed that he is a consultant to Barr Pharmaceuticals, Inc., and Bayer Healthcare Pharmaceuticals Inc.
Alfred Moffett Jr., MD, FACOG
Clinical Assistant Professor, Obstetrics and Gynecology
University of South Florida College of Medicine
OB-GYN Associates of Mid-Florida, P.A.
Dr. Moffett is on the advisory board of Bradley Pharmaceuticals, Inc.
Lee P. Shulman, MD, FACOG, FACMG
Professor and Chief
Division of Reproductive Genetics
Department of Obstetrics and Gynecology
Feinberg School of Medicine
Northwestern University
Dr. Shulman is on the advisory board of Bradley Pharmaceuticals, Inc.

Copyright © 2007 by Elsevier Inc.

A supplement to Ob.Gyn. News.
This supplement is based on physician interviews. It is supported by Kenwood Therapeutics, a division of Bradley Pharmaceuticals, Inc.

To view the supplement, click the image above.



Topic Highlights

• Menopause and Hormone Therapy

• The Cardiovascular Paradox

• Current Recommendations for Postmenopausal Hormone Therapy

• Effective Low-Dose Therapy

• Clinical Trial of Transdermal Estrogen

• Other Considerations of Transdermal Hormone Therapy

Faculty/Faculty Disclosures

Donna Shoupe, MD
Professor, Department of Obstetrics and Gynecology
Keck School of Medicine
University of Southern California
Dr. Shoupe is on the advisory board of Bradley Pharmaceuticals, Inc.
Steven R. Goldstein, MD
Professor of Obstetrics and Gynecology
New York University School of Medicine
Dr. Goldstein has disclosed that he is on the advisory boards of Bradley Pharmaceuticals, Inc., Eli Lilly and Company, GlaxoSmithKline, Merck & Co., Inc., Novogyne Pharmaceuticals, Novo Nordisk, and Pfizer Inc.

With Comments From:
Daniel R. Mishell, Jr., MD
Lyle G. McNiele Professor
Department of Obstetrics/Gynecology
Keck School of Medicine
University of Southern California
Dr. Mishell has disclosed that he is a consultant to Barr Pharmaceuticals, Inc., and Bayer Healthcare Pharmaceuticals Inc.
Alfred Moffett Jr., MD, FACOG
Clinical Assistant Professor, Obstetrics and Gynecology
University of South Florida College of Medicine
OB-GYN Associates of Mid-Florida, P.A.
Dr. Moffett is on the advisory board of Bradley Pharmaceuticals, Inc.
Lee P. Shulman, MD, FACOG, FACMG
Professor and Chief
Division of Reproductive Genetics
Department of Obstetrics and Gynecology
Feinberg School of Medicine
Northwestern University
Dr. Shulman is on the advisory board of Bradley Pharmaceuticals, Inc.

Copyright © 2007 by Elsevier Inc.

MIAMI BEACH – An investigational, peripheral artery stent graft with heparin bonding showed excellent 1-year performance as long as its size matched the treated vessel, in a multicenter, single-arm study of 119 patients.

The Viabahn heparin-bonded stent graft placed in superficial femoral arteries (SFA) and oversized at the proximal edge by no more than 20%, produced a 91% primary patency rate at 12 months after the intervention, compared with a 70% primary patency rate among patients who received the graft in vessels where proximal edge oversizing exceeded 20%, Dr. Richard Saxon said at the International Symposium on Endovascular Therapy (ISET) 2012.

The overall 12-month primary patency rate for the 119 patients in the study was 74%, including a 79% rate in patients who received the 5-mm diameter stent graft, which was "a marked improvement" compared with prior 5-mm devices, said Dr. Saxon, an interventional radiologist and director of research at the San Diego Cardiac and Vascular Institute.

"If we treat the correct subset of patients with this newer stent graft, patency will be excellent and reinterventions low. We need to measure [vessel diameters] and do it correctly, and we’ll get excellent results. Oversizing will lead to occlusions," Dr. Saxon said.

Oversizing compared with not oversizing led to "dramatically" different results.

The investigational stent graft used in the Gore Viabahn Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER) trial appeared to perform substantially better than historical experience with the similar stent graft without a heparin-coated surface. The 12-month results in the pivotal study of the Viabahn stent graft without heparin showed a primary patency rate of 57%, suggesting that the heparin coating led to a 17% increase in primary patency, he reported.

In addition, the study achieved a 74% 1-year patency rate in patients with long, complex lesions that averaged 19 cm, and 60% of patients had stage III or IV disease based on classification by the Inter-Society Consensus Guidelines for the Management of PAD (TASC II). The heparin-coated stent graft also featured contoured edges, designed to minimize the stenoses at proximal edges that have posed a problem with prior models. But the results showed that the contoured edge failed to eliminate edge stenosis, Dr. Saxon said.

The new findings show that the Viabahn heparin-coated stent graft is comparable to the investigational Zilver PTX paclitaxel-eluting nitinol stent, said Dr. Gary M. Ansel, clinical director of peripheral vascular interventions at the Midwest Cardiology Research Foundation in Columbus, Ohio. who was a coinvestigator on the pivotal trials for both devices. He added that such stenting should become the new standard of treatment.

One-year patency data for the paclitaxel-coated nitinol stent, developed by Cook, were reported last year (Circ. Cardiovasc. Interv. 2011;4:495-504). Last October, a Food and Drug Administration advisory panel voted unanimously to recommend marketing approval of the paclitaxel-eluting nitinol stent, but as of late January, the FDA had not yet issued a decision. http://www.cookmedical.com/zilverptx/index.html

VIPER enrolled patients with SFA lesions greater than 5 cm long at 11 U.S. sites. Their average age was 66 years, 62% were men, one-third had diabetes, 87% had hypertension, and 47% had coronary artery disease.

Their average lesion length was 19 cm, and 61% of the SFA lesions had moderate or severe calcification. The study’s primary end point was primary patency in the treated SFA after 12 months, assessed by Doppler ultrasound.

The results showed no impact of lesion length on outcomes, with primary patency rates in patients with lesions 20 cm or longer similar to those of patients with shorter lesions.

Within 30 days of stenting treatment, one patient had a major adverse event, a need for bypass due to a target-lesion occlusion. The stent graft placed in this patient was considered "markedly oversized," according to Dr. Saxon.

A second patient had target lesion occlusion during follow-up to 1 year, again linked with stent graft oversizing compared with the vessel’s diameter.

Average ankle-brachial index was 0.61 at baseline and 0.9 at 12 months. At 12-month follow-up, 66 (74%) of the 89 patients assessed for their Rutherford-Becker class had class 0 disease, and 74 (83%) had experienced at least a two-class reduction in their Rutherford-Becker status.

Twelve patients had a stent graft thrombosis or occlusion, with 10 of these patients having a worsening of their baseline Rutherford-Becker class. Thirteen patients required revisions for stenoses detected by ultrasound; seven of these patients were asymptomatic at the time of stenosis detection.

"We can’t wait for patients to become symptomatic or have their ankle-brachial index drop. We have to follow patients closely with duplex ultrasound," after SFA revascularization, Dr. Saxon said.

The VIPER trial was sponsored by W.L. Gore. Dr. Saxon disclosed ties with W.L. Gore, Cook, Lutonix, Concentric Medical, Vascular Resources, Abbott Vascular, and Reva Medical. Dr. Ansel disclosed ties with Abbott Vascular, Boston Scientific, Access Closure, Angioslide, Arsenal Medical, Atheromed, Atrium Medical, Bard, and Biocardia.

MIAMI BEACH – An investigational, peripheral artery stent graft with heparin bonding showed excellent 1-year performance as long as its size matched the treated vessel, in a multicenter, single-arm study of 119 patients.

The Viabahn heparin-bonded stent graft placed in superficial femoral arteries (SFA) and oversized at the proximal edge by no more than 20%, produced a 91% primary patency rate at 12 months after the intervention, compared with a 70% primary patency rate among patients who received the graft in vessels where proximal edge oversizing exceeded 20%, Dr. Richard Saxon said at the International Symposium on Endovascular Therapy (ISET) 2012.

The overall 12-month primary patency rate for the 119 patients in the study was 74%, including a 79% rate in patients who received the 5-mm diameter stent graft, which was "a marked improvement" compared with prior 5-mm devices, said Dr. Saxon, an interventional radiologist and director of research at the San Diego Cardiac and Vascular Institute.

"If we treat the correct subset of patients with this newer stent graft, patency will be excellent and reinterventions low. We need to measure [vessel diameters] and do it correctly, and we’ll get excellent results. Oversizing will lead to occlusions," Dr. Saxon said.

Oversizing compared with not oversizing led to "dramatically" different results.

The investigational stent graft used in the Gore Viabahn Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER) trial appeared to perform substantially better than historical experience with the similar stent graft without a heparin-coated surface. The 12-month results in the pivotal study of the Viabahn stent graft without heparin showed a primary patency rate of 57%, suggesting that the heparin coating led to a 17% increase in primary patency, he reported.

In addition, the study achieved a 74% 1-year patency rate in patients with long, complex lesions that averaged 19 cm, and 60% of patients had stage III or IV disease based on classification by the Inter-Society Consensus Guidelines for the Management of PAD (TASC II). The heparin-coated stent graft also featured contoured edges, designed to minimize the stenoses at proximal edges that have posed a problem with prior models. But the results showed that the contoured edge failed to eliminate edge stenosis, Dr. Saxon said.

The new findings show that the Viabahn heparin-coated stent graft is comparable to the investigational Zilver PTX paclitaxel-eluting nitinol stent, said Dr. Gary M. Ansel, clinical director of peripheral vascular interventions at the Midwest Cardiology Research Foundation in Columbus, Ohio. who was a coinvestigator on the pivotal trials for both devices. He added that such stenting should become the new standard of treatment.

One-year patency data for the paclitaxel-coated nitinol stent, developed by Cook, were reported last year (Circ. Cardiovasc. Interv. 2011;4:495-504). Last October, a Food and Drug Administration advisory panel voted unanimously to recommend marketing approval of the paclitaxel-eluting nitinol stent, but as of late January, the FDA had not yet issued a decision. http://www.cookmedical.com/zilverptx/index.html

VIPER enrolled patients with SFA lesions greater than 5 cm long at 11 U.S. sites. Their average age was 66 years, 62% were men, one-third had diabetes, 87% had hypertension, and 47% had coronary artery disease.

Their average lesion length was 19 cm, and 61% of the SFA lesions had moderate or severe calcification. The study’s primary end point was primary patency in the treated SFA after 12 months, assessed by Doppler ultrasound.

The results showed no impact of lesion length on outcomes, with primary patency rates in patients with lesions 20 cm or longer similar to those of patients with shorter lesions.

Within 30 days of stenting treatment, one patient had a major adverse event, a need for bypass due to a target-lesion occlusion. The stent graft placed in this patient was considered "markedly oversized," according to Dr. Saxon.

A second patient had target lesion occlusion during follow-up to 1 year, again linked with stent graft oversizing compared with the vessel’s diameter.

Average ankle-brachial index was 0.61 at baseline and 0.9 at 12 months. At 12-month follow-up, 66 (74%) of the 89 patients assessed for their Rutherford-Becker class had class 0 disease, and 74 (83%) had experienced at least a two-class reduction in their Rutherford-Becker status.

Twelve patients had a stent graft thrombosis or occlusion, with 10 of these patients having a worsening of their baseline Rutherford-Becker class. Thirteen patients required revisions for stenoses detected by ultrasound; seven of these patients were asymptomatic at the time of stenosis detection.

"We can’t wait for patients to become symptomatic or have their ankle-brachial index drop. We have to follow patients closely with duplex ultrasound," after SFA revascularization, Dr. Saxon said.

The VIPER trial was sponsored by W.L. Gore. Dr. Saxon disclosed ties with W.L. Gore, Cook, Lutonix, Concentric Medical, Vascular Resources, Abbott Vascular, and Reva Medical. Dr. Ansel disclosed ties with Abbott Vascular, Boston Scientific, Access Closure, Angioslide, Arsenal Medical, Atheromed, Atrium Medical, Bard, and Biocardia.

MIAMI BEACH – An investigational, peripheral artery stent graft with heparin bonding showed excellent 1-year performance as long as its size matched the treated vessel, in a multicenter, single-arm study of 119 patients.

The Viabahn heparin-bonded stent graft placed in superficial femoral arteries (SFA) and oversized at the proximal edge by no more than 20%, produced a 91% primary patency rate at 12 months after the intervention, compared with a 70% primary patency rate among patients who received the graft in vessels where proximal edge oversizing exceeded 20%, Dr. Richard Saxon said at the International Symposium on Endovascular Therapy (ISET) 2012.

The overall 12-month primary patency rate for the 119 patients in the study was 74%, including a 79% rate in patients who received the 5-mm diameter stent graft, which was "a marked improvement" compared with prior 5-mm devices, said Dr. Saxon, an interventional radiologist and director of research at the San Diego Cardiac and Vascular Institute.

"If we treat the correct subset of patients with this newer stent graft, patency will be excellent and reinterventions low. We need to measure [vessel diameters] and do it correctly, and we’ll get excellent results. Oversizing will lead to occlusions," Dr. Saxon said.

Oversizing compared with not oversizing led to "dramatically" different results.

The investigational stent graft used in the Gore Viabahn Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER) trial appeared to perform substantially better than historical experience with the similar stent graft without a heparin-coated surface. The 12-month results in the pivotal study of the Viabahn stent graft without heparin showed a primary patency rate of 57%, suggesting that the heparin coating led to a 17% increase in primary patency, he reported.

In addition, the study achieved a 74% 1-year patency rate in patients with long, complex lesions that averaged 19 cm, and 60% of patients had stage III or IV disease based on classification by the Inter-Society Consensus Guidelines for the Management of PAD (TASC II). The heparin-coated stent graft also featured contoured edges, designed to minimize the stenoses at proximal edges that have posed a problem with prior models. But the results showed that the contoured edge failed to eliminate edge stenosis, Dr. Saxon said.

The new findings show that the Viabahn heparin-coated stent graft is comparable to the investigational Zilver PTX paclitaxel-eluting nitinol stent, said Dr. Gary M. Ansel, clinical director of peripheral vascular interventions at the Midwest Cardiology Research Foundation in Columbus, Ohio. who was a coinvestigator on the pivotal trials for both devices. He added that such stenting should become the new standard of treatment.

One-year patency data for the paclitaxel-coated nitinol stent, developed by Cook, were reported last year (Circ. Cardiovasc. Interv. 2011;4:495-504). Last October, a Food and Drug Administration advisory panel voted unanimously to recommend marketing approval of the paclitaxel-eluting nitinol stent, but as of late January, the FDA had not yet issued a decision. http://www.cookmedical.com/zilverptx/index.html

VIPER enrolled patients with SFA lesions greater than 5 cm long at 11 U.S. sites. Their average age was 66 years, 62% were men, one-third had diabetes, 87% had hypertension, and 47% had coronary artery disease.

Their average lesion length was 19 cm, and 61% of the SFA lesions had moderate or severe calcification. The study’s primary end point was primary patency in the treated SFA after 12 months, assessed by Doppler ultrasound.

The results showed no impact of lesion length on outcomes, with primary patency rates in patients with lesions 20 cm or longer similar to those of patients with shorter lesions.

Within 30 days of stenting treatment, one patient had a major adverse event, a need for bypass due to a target-lesion occlusion. The stent graft placed in this patient was considered "markedly oversized," according to Dr. Saxon.

A second patient had target lesion occlusion during follow-up to 1 year, again linked with stent graft oversizing compared with the vessel’s diameter.

Average ankle-brachial index was 0.61 at baseline and 0.9 at 12 months. At 12-month follow-up, 66 (74%) of the 89 patients assessed for their Rutherford-Becker class had class 0 disease, and 74 (83%) had experienced at least a two-class reduction in their Rutherford-Becker status.

Twelve patients had a stent graft thrombosis or occlusion, with 10 of these patients having a worsening of their baseline Rutherford-Becker class. Thirteen patients required revisions for stenoses detected by ultrasound; seven of these patients were asymptomatic at the time of stenosis detection.

"We can’t wait for patients to become symptomatic or have their ankle-brachial index drop. We have to follow patients closely with duplex ultrasound," after SFA revascularization, Dr. Saxon said.

The VIPER trial was sponsored by W.L. Gore. Dr. Saxon disclosed ties with W.L. Gore, Cook, Lutonix, Concentric Medical, Vascular Resources, Abbott Vascular, and Reva Medical. Dr. Ansel disclosed ties with Abbott Vascular, Boston Scientific, Access Closure, Angioslide, Arsenal Medical, Atheromed, Atrium Medical, Bard, and Biocardia.

Vascular patients who most need treatment are often difficult and risky to treat by open operation or an endovascular intervention. In contrast, patients who least need invasive treatment or need it not at all usually have lesions that are easy to treat with good results. Examples are patients with advanced gangrene versus those with intermittent claudication; symptomatic patients with carotid artery stenosis versus those who are asymptomatic; patients with large abdominal aortic aneurysms versus those with small lesions.

This paradoxical situation occurs because most vascular lesions, particularly those associated with atherosclerosis, are in their early phases benign, cause minimal or no symptoms, and are unassociated with widespread vascular disease.

Moreover, many of these lesions, particularly with statins and other good medical therapy, will remain stable for long periods. These early lesions are technically easy to treat invasively, although such treatment may provide little or no benefit to the patient.

In contrast, only when lesions advance, become more complex and are associated with a widely diseased arterial system do they become threatening to life, limb, and the brain. These latter lesions are usually much harder to treat both by transcatheter or open operative techniques. This situation gives rise to several consequences relating to physician judgment, procedural outcomes, physician and institutional incomes, health care costs and ethical considerations.

Everyone in the vascular field should recognize and face these issues.

To help do so, let us examine some of these issues as they relate to the common problem of carotid bifurcation stenosis. High grade stenosis at this site, even when asymptomatic, can cause some strokes. Level 1 evidence from the so-called landmark asymptomatic trials (ACAS, ACST), which randomized patients from 1990-2003, showed significant stroke prevention from carotid endarterectomy (CEA) compared to medical treatment.

However, the benefit was slight (stroke rates were reduced from about 2% per year to about 1% per year), and there have been substantial improvements in medical treatments over the last decade to prevent strokes with statins and other measures. Carotid artery stenting (CAS) has also become a commonly used treatment to prevent strokes in asymptomatic carotid stenosis patients, although there is no convincing evidence that such treatment is more effective than current medical treatment in most if not all of these patients.

In addition, there is no solid evidence that CEA in asymptomatic patients prevents strokes more effectively than current medical treatment. Yet in the United States, 70%-90% of CEAs and 70%-96% of CAS procedures are performed on asymptomatic patients.

Should this be and how does the vascular disease paradox relate to this situation?

Vascular surgeons and interventionalists from all specialties want to continue to intervene on most of these asymptomatic carotid stenosis patients for several reasons. These include gratifyingly good outcomes from treating these usually simple, low-risk asymptomatic lesions and provision of income to physicians and hospitals.

These good outcomes also provide many accessory benefits to the treating physicians and surgeons by improving their overall results, a desirable goal in view of looming audits and pay-for-performance incentives. Also, increasing case numbers help practitioners to meet credentialing requirements.

However, there are negatives to continuing to perform large numbers of invasive treatments on asymptomatic carotid stenosis patients. One is the high cost to our health care system of providing these large numbers of invasive treatments largely to a group of patients who will derive little or no benefit. Another is the possibility that more patients will be harmed than helped.

Clearly what is needed are better ways to detect the asymptomatic patient at high risk for having a stroke so only those patients can be treated invasively. Although no such method is universally accepted, there are glimmers of hope that one or more will be proven effective.

Also needed are trials to establish the effectiveness of current medical therapy for stroke prevention in patients with asymptomatic carotid stenosis. However, such trials will not be simple to design because of the benign nature of most asymptomatic lesions. Thus, such trials will have to be conducted in patients selected to have more risky lesions.

Until such information is available, all practitioners should exercise restraint in treating patients with asymptomatic carotid stenosis invasively. They should not be seduced into treating simply because of the ease of treatment or the good outcomes – the vascular disease paradox. It is risk-benefit ratio that is more important. Physicians and surgeons should recognize that the landmark trials on this subject are now outdated, and should restrict such invasive treatment in some way to fewer patients than in the past – perhaps those with an increasing or very high grade (pinhole) stenosis or a contralateral occlusion.

Finally, it should be noted that a proposal to provide reimbursement for performing CAS on standard and low-risk carotid stenosis patients, including asymptomatic patients, is currently being considered by Medicare.

It is likely that some support for this proposal stems from the facts that lesions in such patients are easy to treat and the results of treatment are excellent. This is the vascular disease paradox which should be recognized and dealt with by all in the field.n

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

Vascular patients who most need treatment are often difficult and risky to treat by open operation or an endovascular intervention. In contrast, patients who least need invasive treatment or need it not at all usually have lesions that are easy to treat with good results. Examples are patients with advanced gangrene versus those with intermittent claudication; symptomatic patients with carotid artery stenosis versus those who are asymptomatic; patients with large abdominal aortic aneurysms versus those with small lesions.

This paradoxical situation occurs because most vascular lesions, particularly those associated with atherosclerosis, are in their early phases benign, cause minimal or no symptoms, and are unassociated with widespread vascular disease.

Moreover, many of these lesions, particularly with statins and other good medical therapy, will remain stable for long periods. These early lesions are technically easy to treat invasively, although such treatment may provide little or no benefit to the patient.

In contrast, only when lesions advance, become more complex and are associated with a widely diseased arterial system do they become threatening to life, limb, and the brain. These latter lesions are usually much harder to treat both by transcatheter or open operative techniques. This situation gives rise to several consequences relating to physician judgment, procedural outcomes, physician and institutional incomes, health care costs and ethical considerations.

Everyone in the vascular field should recognize and face these issues.

To help do so, let us examine some of these issues as they relate to the common problem of carotid bifurcation stenosis. High grade stenosis at this site, even when asymptomatic, can cause some strokes. Level 1 evidence from the so-called landmark asymptomatic trials (ACAS, ACST), which randomized patients from 1990-2003, showed significant stroke prevention from carotid endarterectomy (CEA) compared to medical treatment.

However, the benefit was slight (stroke rates were reduced from about 2% per year to about 1% per year), and there have been substantial improvements in medical treatments over the last decade to prevent strokes with statins and other measures. Carotid artery stenting (CAS) has also become a commonly used treatment to prevent strokes in asymptomatic carotid stenosis patients, although there is no convincing evidence that such treatment is more effective than current medical treatment in most if not all of these patients.

In addition, there is no solid evidence that CEA in asymptomatic patients prevents strokes more effectively than current medical treatment. Yet in the United States, 70%-90% of CEAs and 70%-96% of CAS procedures are performed on asymptomatic patients.

Should this be and how does the vascular disease paradox relate to this situation?

Vascular surgeons and interventionalists from all specialties want to continue to intervene on most of these asymptomatic carotid stenosis patients for several reasons. These include gratifyingly good outcomes from treating these usually simple, low-risk asymptomatic lesions and provision of income to physicians and hospitals.

These good outcomes also provide many accessory benefits to the treating physicians and surgeons by improving their overall results, a desirable goal in view of looming audits and pay-for-performance incentives. Also, increasing case numbers help practitioners to meet credentialing requirements.

However, there are negatives to continuing to perform large numbers of invasive treatments on asymptomatic carotid stenosis patients. One is the high cost to our health care system of providing these large numbers of invasive treatments largely to a group of patients who will derive little or no benefit. Another is the possibility that more patients will be harmed than helped.

Clearly what is needed are better ways to detect the asymptomatic patient at high risk for having a stroke so only those patients can be treated invasively. Although no such method is universally accepted, there are glimmers of hope that one or more will be proven effective.

Also needed are trials to establish the effectiveness of current medical therapy for stroke prevention in patients with asymptomatic carotid stenosis. However, such trials will not be simple to design because of the benign nature of most asymptomatic lesions. Thus, such trials will have to be conducted in patients selected to have more risky lesions.

Until such information is available, all practitioners should exercise restraint in treating patients with asymptomatic carotid stenosis invasively. They should not be seduced into treating simply because of the ease of treatment or the good outcomes – the vascular disease paradox. It is risk-benefit ratio that is more important. Physicians and surgeons should recognize that the landmark trials on this subject are now outdated, and should restrict such invasive treatment in some way to fewer patients than in the past – perhaps those with an increasing or very high grade (pinhole) stenosis or a contralateral occlusion.

Finally, it should be noted that a proposal to provide reimbursement for performing CAS on standard and low-risk carotid stenosis patients, including asymptomatic patients, is currently being considered by Medicare.

It is likely that some support for this proposal stems from the facts that lesions in such patients are easy to treat and the results of treatment are excellent. This is the vascular disease paradox which should be recognized and dealt with by all in the field.n

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

Vascular patients who most need treatment are often difficult and risky to treat by open operation or an endovascular intervention. In contrast, patients who least need invasive treatment or need it not at all usually have lesions that are easy to treat with good results. Examples are patients with advanced gangrene versus those with intermittent claudication; symptomatic patients with carotid artery stenosis versus those who are asymptomatic; patients with large abdominal aortic aneurysms versus those with small lesions.

This paradoxical situation occurs because most vascular lesions, particularly those associated with atherosclerosis, are in their early phases benign, cause minimal or no symptoms, and are unassociated with widespread vascular disease.

Moreover, many of these lesions, particularly with statins and other good medical therapy, will remain stable for long periods. These early lesions are technically easy to treat invasively, although such treatment may provide little or no benefit to the patient.

In contrast, only when lesions advance, become more complex and are associated with a widely diseased arterial system do they become threatening to life, limb, and the brain. These latter lesions are usually much harder to treat both by transcatheter or open operative techniques. This situation gives rise to several consequences relating to physician judgment, procedural outcomes, physician and institutional incomes, health care costs and ethical considerations.

Everyone in the vascular field should recognize and face these issues.

To help do so, let us examine some of these issues as they relate to the common problem of carotid bifurcation stenosis. High grade stenosis at this site, even when asymptomatic, can cause some strokes. Level 1 evidence from the so-called landmark asymptomatic trials (ACAS, ACST), which randomized patients from 1990-2003, showed significant stroke prevention from carotid endarterectomy (CEA) compared to medical treatment.

However, the benefit was slight (stroke rates were reduced from about 2% per year to about 1% per year), and there have been substantial improvements in medical treatments over the last decade to prevent strokes with statins and other measures. Carotid artery stenting (CAS) has also become a commonly used treatment to prevent strokes in asymptomatic carotid stenosis patients, although there is no convincing evidence that such treatment is more effective than current medical treatment in most if not all of these patients.

In addition, there is no solid evidence that CEA in asymptomatic patients prevents strokes more effectively than current medical treatment. Yet in the United States, 70%-90% of CEAs and 70%-96% of CAS procedures are performed on asymptomatic patients.

Should this be and how does the vascular disease paradox relate to this situation?

Vascular surgeons and interventionalists from all specialties want to continue to intervene on most of these asymptomatic carotid stenosis patients for several reasons. These include gratifyingly good outcomes from treating these usually simple, low-risk asymptomatic lesions and provision of income to physicians and hospitals.

These good outcomes also provide many accessory benefits to the treating physicians and surgeons by improving their overall results, a desirable goal in view of looming audits and pay-for-performance incentives. Also, increasing case numbers help practitioners to meet credentialing requirements.

However, there are negatives to continuing to perform large numbers of invasive treatments on asymptomatic carotid stenosis patients. One is the high cost to our health care system of providing these large numbers of invasive treatments largely to a group of patients who will derive little or no benefit. Another is the possibility that more patients will be harmed than helped.

Clearly what is needed are better ways to detect the asymptomatic patient at high risk for having a stroke so only those patients can be treated invasively. Although no such method is universally accepted, there are glimmers of hope that one or more will be proven effective.

Also needed are trials to establish the effectiveness of current medical therapy for stroke prevention in patients with asymptomatic carotid stenosis. However, such trials will not be simple to design because of the benign nature of most asymptomatic lesions. Thus, such trials will have to be conducted in patients selected to have more risky lesions.

Until such information is available, all practitioners should exercise restraint in treating patients with asymptomatic carotid stenosis invasively. They should not be seduced into treating simply because of the ease of treatment or the good outcomes – the vascular disease paradox. It is risk-benefit ratio that is more important. Physicians and surgeons should recognize that the landmark trials on this subject are now outdated, and should restrict such invasive treatment in some way to fewer patients than in the past – perhaps those with an increasing or very high grade (pinhole) stenosis or a contralateral occlusion.

Finally, it should be noted that a proposal to provide reimbursement for performing CAS on standard and low-risk carotid stenosis patients, including asymptomatic patients, is currently being considered by Medicare.

It is likely that some support for this proposal stems from the facts that lesions in such patients are easy to treat and the results of treatment are excellent. This is the vascular disease paradox which should be recognized and dealt with by all in the field.n

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.