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Fibrinolytic therapy with tenecteplase prevents hemodynamic decompensation in patients with intermediate-risk pulmonary embolism but raises the risk of major hemorrhage and stroke, so its use is likely to remain controversial in this patient population, according to a report published online April 9 in the New England Journal of Medicine.
Fibrinolysis is warranted for high-risk pulmonary embolism characterized by hemodynamic instability, but its risks may outweigh its benefits when normotensive patients have acute right ventricular dysfunction and myocardial injury but no overt hemodynamic compromise. The international PEITHO (Pulmonary Embolism Thrombolysis) trial was performed to examine the safety and efficacy of a single-bolus injection of tenecteplase, in addition to standard anticoagulation therapy, in such patients, who were deemed to be at intermediate risk of an adverse outcome, said Dr. Guy Meyer of Université Paris Descartes and his associates.
PEITHO involved 1,006 adults (median age, 70 years) treated at 76 sites in 13 countries; 506 were randomly assigned to receive a tenecteplase infusion plus unfractionated heparin and 500 to receive a matching placebo infusion plus unfractionated heparin, and all were followed for 30 days. The primary efficacy outcome – a composite of death from any cause or hemodynamic decompensation (including hemodynamic collapse) within 7 days – occurred in only 2.6% of the tenecteplase group, which was significantly lower than was the 5.6% rate in the placebo group.
Hemodynamic decompensation occurred in only 1.6% of the tenecteplase group, compared with 5.0% of the placebo group, the investigators wrote (N. Engl. J. Med. 2014 April 9;370:1402-11 [doi:101056/NEJMoa1302097]).
However, major bleeding developed in 11.5% of the tenecteplase group within 7 days, compared with only 2.4% of the placebo group. And the fibrinolytic treatment was associated with a 2.0% risk of hemorrhagic stroke and a 6.3% rate of major extracranial hemorrhage. "Therefore, great caution is warranted when considering fibrinolytic therapy for hemodynamically stable patients with PE," Dr. Meyer and his associates said.
PEITHO was supported by the Programme Hospitalier de Recherche Clinique in France, the Federal Ministry of Education and Research in Germany, and Boehringer Ingelheim. Dr. Meyer reported ties to Boehringer Ingelheim, Leo Pharma, Bayer Healthcare, and Sanofi-Aventis, and his associates reported ties to numerous industry sources.
For the practicing clinician, the results of the PEITHO trial "provide valuable insight but no definitive answer" because they confirm the risks as well as the benefits of fibrinolysis for intermediate-risk PE, said Dr. C. Gregory Elliott.
The findings show that it is relatively safe to withhold fibrinolysis unless hemodynamic decompensation occurs. Perhaps a strategy of initiating anticoagulation but reserving fibrinolysis for cases of hemodynamic decompensation would minimize overall risks for this patient population, he said.
Dr. Elliott is in the department of medicine at the Intermountain Medical Center in Murray (Utah) and at the University of Utah, Salt Lake City. He reported ties to Bayer, Bristol-Myers Squibb, Janssen, and Boehringer Ingelheim. These remarks were taken from his editorial accompanying Dr. Meyer’s report (N. Engl. J. Med. 2014 April 9;370:1457-8 [doi:10.1056/NEJMe1401025]).
For the practicing clinician, the results of the PEITHO trial "provide valuable insight but no definitive answer" because they confirm the risks as well as the benefits of fibrinolysis for intermediate-risk PE, said Dr. C. Gregory Elliott.
The findings show that it is relatively safe to withhold fibrinolysis unless hemodynamic decompensation occurs. Perhaps a strategy of initiating anticoagulation but reserving fibrinolysis for cases of hemodynamic decompensation would minimize overall risks for this patient population, he said.
Dr. Elliott is in the department of medicine at the Intermountain Medical Center in Murray (Utah) and at the University of Utah, Salt Lake City. He reported ties to Bayer, Bristol-Myers Squibb, Janssen, and Boehringer Ingelheim. These remarks were taken from his editorial accompanying Dr. Meyer’s report (N. Engl. J. Med. 2014 April 9;370:1457-8 [doi:10.1056/NEJMe1401025]).
For the practicing clinician, the results of the PEITHO trial "provide valuable insight but no definitive answer" because they confirm the risks as well as the benefits of fibrinolysis for intermediate-risk PE, said Dr. C. Gregory Elliott.
The findings show that it is relatively safe to withhold fibrinolysis unless hemodynamic decompensation occurs. Perhaps a strategy of initiating anticoagulation but reserving fibrinolysis for cases of hemodynamic decompensation would minimize overall risks for this patient population, he said.
Dr. Elliott is in the department of medicine at the Intermountain Medical Center in Murray (Utah) and at the University of Utah, Salt Lake City. He reported ties to Bayer, Bristol-Myers Squibb, Janssen, and Boehringer Ingelheim. These remarks were taken from his editorial accompanying Dr. Meyer’s report (N. Engl. J. Med. 2014 April 9;370:1457-8 [doi:10.1056/NEJMe1401025]).
Fibrinolytic therapy with tenecteplase prevents hemodynamic decompensation in patients with intermediate-risk pulmonary embolism but raises the risk of major hemorrhage and stroke, so its use is likely to remain controversial in this patient population, according to a report published online April 9 in the New England Journal of Medicine.
Fibrinolysis is warranted for high-risk pulmonary embolism characterized by hemodynamic instability, but its risks may outweigh its benefits when normotensive patients have acute right ventricular dysfunction and myocardial injury but no overt hemodynamic compromise. The international PEITHO (Pulmonary Embolism Thrombolysis) trial was performed to examine the safety and efficacy of a single-bolus injection of tenecteplase, in addition to standard anticoagulation therapy, in such patients, who were deemed to be at intermediate risk of an adverse outcome, said Dr. Guy Meyer of Université Paris Descartes and his associates.
PEITHO involved 1,006 adults (median age, 70 years) treated at 76 sites in 13 countries; 506 were randomly assigned to receive a tenecteplase infusion plus unfractionated heparin and 500 to receive a matching placebo infusion plus unfractionated heparin, and all were followed for 30 days. The primary efficacy outcome – a composite of death from any cause or hemodynamic decompensation (including hemodynamic collapse) within 7 days – occurred in only 2.6% of the tenecteplase group, which was significantly lower than was the 5.6% rate in the placebo group.
Hemodynamic decompensation occurred in only 1.6% of the tenecteplase group, compared with 5.0% of the placebo group, the investigators wrote (N. Engl. J. Med. 2014 April 9;370:1402-11 [doi:101056/NEJMoa1302097]).
However, major bleeding developed in 11.5% of the tenecteplase group within 7 days, compared with only 2.4% of the placebo group. And the fibrinolytic treatment was associated with a 2.0% risk of hemorrhagic stroke and a 6.3% rate of major extracranial hemorrhage. "Therefore, great caution is warranted when considering fibrinolytic therapy for hemodynamically stable patients with PE," Dr. Meyer and his associates said.
PEITHO was supported by the Programme Hospitalier de Recherche Clinique in France, the Federal Ministry of Education and Research in Germany, and Boehringer Ingelheim. Dr. Meyer reported ties to Boehringer Ingelheim, Leo Pharma, Bayer Healthcare, and Sanofi-Aventis, and his associates reported ties to numerous industry sources.
Fibrinolytic therapy with tenecteplase prevents hemodynamic decompensation in patients with intermediate-risk pulmonary embolism but raises the risk of major hemorrhage and stroke, so its use is likely to remain controversial in this patient population, according to a report published online April 9 in the New England Journal of Medicine.
Fibrinolysis is warranted for high-risk pulmonary embolism characterized by hemodynamic instability, but its risks may outweigh its benefits when normotensive patients have acute right ventricular dysfunction and myocardial injury but no overt hemodynamic compromise. The international PEITHO (Pulmonary Embolism Thrombolysis) trial was performed to examine the safety and efficacy of a single-bolus injection of tenecteplase, in addition to standard anticoagulation therapy, in such patients, who were deemed to be at intermediate risk of an adverse outcome, said Dr. Guy Meyer of Université Paris Descartes and his associates.
PEITHO involved 1,006 adults (median age, 70 years) treated at 76 sites in 13 countries; 506 were randomly assigned to receive a tenecteplase infusion plus unfractionated heparin and 500 to receive a matching placebo infusion plus unfractionated heparin, and all were followed for 30 days. The primary efficacy outcome – a composite of death from any cause or hemodynamic decompensation (including hemodynamic collapse) within 7 days – occurred in only 2.6% of the tenecteplase group, which was significantly lower than was the 5.6% rate in the placebo group.
Hemodynamic decompensation occurred in only 1.6% of the tenecteplase group, compared with 5.0% of the placebo group, the investigators wrote (N. Engl. J. Med. 2014 April 9;370:1402-11 [doi:101056/NEJMoa1302097]).
However, major bleeding developed in 11.5% of the tenecteplase group within 7 days, compared with only 2.4% of the placebo group. And the fibrinolytic treatment was associated with a 2.0% risk of hemorrhagic stroke and a 6.3% rate of major extracranial hemorrhage. "Therefore, great caution is warranted when considering fibrinolytic therapy for hemodynamically stable patients with PE," Dr. Meyer and his associates said.
PEITHO was supported by the Programme Hospitalier de Recherche Clinique in France, the Federal Ministry of Education and Research in Germany, and Boehringer Ingelheim. Dr. Meyer reported ties to Boehringer Ingelheim, Leo Pharma, Bayer Healthcare, and Sanofi-Aventis, and his associates reported ties to numerous industry sources.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Major finding: The primary efficacy outcome – a composite of death from any cause or hemodynamic (including hemodynamic collapse) within 7 days – occurred in only 2.6% of the tenecteplase group, which was significantly lower than the 5.6% rate was in the placebo group.
Data source: An international randomized controlled trial involving 1,006 patients with intermediate-risk PE who received either tenecteplase (506 subjects) or a matching placebo infusion (500 subjects) and were followed for 30 days for death, hemodynamic decompensation, bleeding, stroke, recurrent PE, and serious adverse events.
Disclosures: PEITHO was supported by the Programme Hospitalier de Recherche Clinique in France, the Federal Ministry of Education and Research in Germany, and Boehringer Ingelheim. Dr. Meyer reported ties to Boehringer Ingelheim, Leo Pharma, Bayer Healthcare, and Sanofi-Aventis, and his associates reported ties to numerous industry sources.