EuroPCR: Which TAVI vascular closure device is safest?

PARIS – The Perclose ProGlide vascular closure device resulted in significantly fewer major vascular complications than its chief competitor, the Prostar XL, in patients undergoing transcatheter aortic valve implantation by a percutaneous transfemoral approach in the multicenter CONTROL trial.

“ProGlide-based vascular closure is associated with significantly lower rates of arterial rupture and hematomas, lower rates of major vascular complications, bleeding, acute kidney injury, and shorter hospital stay,” Dr. Israel M. Barbash reported in presenting the CONTROL results at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Serious vascular complications remain a major concern when transcatheter aortic valve implantation (TAVI) is performed via a percutaneous transfemoral approach. The CONTROL study was conducted to determine whether the two closure devices most widely used for this purpose worldwide – the Prostar XL and Perclose ProGlide, both marketed by Abbott Vascular – differ in their adverse event rates.

CONTROL was a nine-center, international, retrospective, nonrandomized, matched-pairs comparison study. Starting with a pool of 3,138 percutaneous transfemoral TAVI patients, investigators used propensity score matching on nine variables to narrow the study population to 1,270 patients in 635 closely matched pairs.

The variables used in the matching process fell into three categories: comorbid conditions, including diabetes, coronary artery disease, and peripheral vascular disease; arterial factors such as tortuosity and calcification; and sheath type and size. Most patients underwent TAVI with a Cook Check-flo Performer or Edwards expandable eSheath and received a CoreValve or Sapien XT heart valve.

The major vascular complication rate was 2% in the ProGlide group, and more than threefold higher at roughly 7.5% in the Prostar group. Rates of life-threatening bleeding and major bleeding by the Valve Academic Research Consortium-2 (VARC-2) definitions also were significantly higher with the use of the Prostar device. In addition, rates of hematoma and femoral artery rupture were both threefold higher in the Prostar group.

Acute kidney injury occurred in 6.6% of the Prostar group, compared with 2.7% with ProGlide. The median hospital length of stay was a full day longer in the Prostar group: 6 days versus 5 days, according to Dr. Barbash of Sheba Medical Center in Tel Hashomer, Israel.

Despite the consistently higher adverse event rates documented in the Prostar group, in-hospital mortality rates didn’t differ between the two study arms. There was, however, a trend for lower in-hospital mortality in the ProGlide group by a margin of 3.5% versus 4.9% with Prostar; this difference might well have achieved statistical significance with larger patient numbers, the cardiologist continued.

A learning curve was evident for the ProGlide device: after an operator’s first 20 cases, the vascular complication rate dropped sharply. In contrast, the high adverse event rates associated with the Prostar device didn’t decrease significantly no matter how much experience with the device an operator gained.

“It looks like ‘Goodby Prostar, hello ProGlide.’ That’s what your data say to me,” said session cochair Dr. A. Pieter Kappetein, professor of cardiothoracic surgery at Erasmus University in Rotterdam, the Netherlands.

Asked if he thinks a randomized trial is warranted in light of the clear and consistent messages provided by the CONTROL study, Dr. Barbash replied, yes, but not yet.

“Sheath sizes are decreasing and new players will come into the vascular closure device market soon. When they do, that will be the time for a randomized trial comparing the new ones to the older ones,” he added.

CONTROL was an investigator-initiated study. Dr. Barbash reported having no financial conflicts.

bjancin@frontlinemedcom.com

PARIS – The Perclose ProGlide vascular closure device resulted in significantly fewer major vascular complications than its chief competitor, the Prostar XL, in patients undergoing transcatheter aortic valve implantation by a percutaneous transfemoral approach in the multicenter CONTROL trial.

“ProGlide-based vascular closure is associated with significantly lower rates of arterial rupture and hematomas, lower rates of major vascular complications, bleeding, acute kidney injury, and shorter hospital stay,” Dr. Israel M. Barbash reported in presenting the CONTROL results at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Serious vascular complications remain a major concern when transcatheter aortic valve implantation (TAVI) is performed via a percutaneous transfemoral approach. The CONTROL study was conducted to determine whether the two closure devices most widely used for this purpose worldwide – the Prostar XL and Perclose ProGlide, both marketed by Abbott Vascular – differ in their adverse event rates.

CONTROL was a nine-center, international, retrospective, nonrandomized, matched-pairs comparison study. Starting with a pool of 3,138 percutaneous transfemoral TAVI patients, investigators used propensity score matching on nine variables to narrow the study population to 1,270 patients in 635 closely matched pairs.

The variables used in the matching process fell into three categories: comorbid conditions, including diabetes, coronary artery disease, and peripheral vascular disease; arterial factors such as tortuosity and calcification; and sheath type and size. Most patients underwent TAVI with a Cook Check-flo Performer or Edwards expandable eSheath and received a CoreValve or Sapien XT heart valve.

The major vascular complication rate was 2% in the ProGlide group, and more than threefold higher at roughly 7.5% in the Prostar group. Rates of life-threatening bleeding and major bleeding by the Valve Academic Research Consortium-2 (VARC-2) definitions also were significantly higher with the use of the Prostar device. In addition, rates of hematoma and femoral artery rupture were both threefold higher in the Prostar group.

Acute kidney injury occurred in 6.6% of the Prostar group, compared with 2.7% with ProGlide. The median hospital length of stay was a full day longer in the Prostar group: 6 days versus 5 days, according to Dr. Barbash of Sheba Medical Center in Tel Hashomer, Israel.

Despite the consistently higher adverse event rates documented in the Prostar group, in-hospital mortality rates didn’t differ between the two study arms. There was, however, a trend for lower in-hospital mortality in the ProGlide group by a margin of 3.5% versus 4.9% with Prostar; this difference might well have achieved statistical significance with larger patient numbers, the cardiologist continued.

A learning curve was evident for the ProGlide device: after an operator’s first 20 cases, the vascular complication rate dropped sharply. In contrast, the high adverse event rates associated with the Prostar device didn’t decrease significantly no matter how much experience with the device an operator gained.

“It looks like ‘Goodby Prostar, hello ProGlide.’ That’s what your data say to me,” said session cochair Dr. A. Pieter Kappetein, professor of cardiothoracic surgery at Erasmus University in Rotterdam, the Netherlands.

Asked if he thinks a randomized trial is warranted in light of the clear and consistent messages provided by the CONTROL study, Dr. Barbash replied, yes, but not yet.

“Sheath sizes are decreasing and new players will come into the vascular closure device market soon. When they do, that will be the time for a randomized trial comparing the new ones to the older ones,” he added.

CONTROL was an investigator-initiated study. Dr. Barbash reported having no financial conflicts.

bjancin@frontlinemedcom.com

PARIS – The Perclose ProGlide vascular closure device resulted in significantly fewer major vascular complications than its chief competitor, the Prostar XL, in patients undergoing transcatheter aortic valve implantation by a percutaneous transfemoral approach in the multicenter CONTROL trial.

“ProGlide-based vascular closure is associated with significantly lower rates of arterial rupture and hematomas, lower rates of major vascular complications, bleeding, acute kidney injury, and shorter hospital stay,” Dr. Israel M. Barbash reported in presenting the CONTROL results at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Serious vascular complications remain a major concern when transcatheter aortic valve implantation (TAVI) is performed via a percutaneous transfemoral approach. The CONTROL study was conducted to determine whether the two closure devices most widely used for this purpose worldwide – the Prostar XL and Perclose ProGlide, both marketed by Abbott Vascular – differ in their adverse event rates.

CONTROL was a nine-center, international, retrospective, nonrandomized, matched-pairs comparison study. Starting with a pool of 3,138 percutaneous transfemoral TAVI patients, investigators used propensity score matching on nine variables to narrow the study population to 1,270 patients in 635 closely matched pairs.

The variables used in the matching process fell into three categories: comorbid conditions, including diabetes, coronary artery disease, and peripheral vascular disease; arterial factors such as tortuosity and calcification; and sheath type and size. Most patients underwent TAVI with a Cook Check-flo Performer or Edwards expandable eSheath and received a CoreValve or Sapien XT heart valve.

The major vascular complication rate was 2% in the ProGlide group, and more than threefold higher at roughly 7.5% in the Prostar group. Rates of life-threatening bleeding and major bleeding by the Valve Academic Research Consortium-2 (VARC-2) definitions also were significantly higher with the use of the Prostar device. In addition, rates of hematoma and femoral artery rupture were both threefold higher in the Prostar group.

Acute kidney injury occurred in 6.6% of the Prostar group, compared with 2.7% with ProGlide. The median hospital length of stay was a full day longer in the Prostar group: 6 days versus 5 days, according to Dr. Barbash of Sheba Medical Center in Tel Hashomer, Israel.

Despite the consistently higher adverse event rates documented in the Prostar group, in-hospital mortality rates didn’t differ between the two study arms. There was, however, a trend for lower in-hospital mortality in the ProGlide group by a margin of 3.5% versus 4.9% with Prostar; this difference might well have achieved statistical significance with larger patient numbers, the cardiologist continued.

A learning curve was evident for the ProGlide device: after an operator’s first 20 cases, the vascular complication rate dropped sharply. In contrast, the high adverse event rates associated with the Prostar device didn’t decrease significantly no matter how much experience with the device an operator gained.

“It looks like ‘Goodby Prostar, hello ProGlide.’ That’s what your data say to me,” said session cochair Dr. A. Pieter Kappetein, professor of cardiothoracic surgery at Erasmus University in Rotterdam, the Netherlands.

Asked if he thinks a randomized trial is warranted in light of the clear and consistent messages provided by the CONTROL study, Dr. Barbash replied, yes, but not yet.

“Sheath sizes are decreasing and new players will come into the vascular closure device market soon. When they do, that will be the time for a randomized trial comparing the new ones to the older ones,” he added.

CONTROL was an investigator-initiated study. Dr. Barbash reported having no financial conflicts.

bjancin@frontlinemedcom.com