Impact of Bleeding and Bivalirudin Therapy on Mortality Risk in Women Undergoing Percutaneous Coronary Intervention (from the REPLACE-2, ACUITY, and HORIZONS-AMI Trials)
Randomized controlled trial published in Am J Cardiol (2015)
Abstract
Women have higher bleeding complication and mortality rates after percutaneous coronary interventions (PCI). The contribution of female gender to bleeding and mortality is poorly understood. We evaluated the effect of gender and bleeding on outcomes of patients treated with bivalirudin during PCI by performing a patient-level pooled analysis of 3 randomized controlled trials (the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events, Acute Catheterization and Urgent Intervention Triage strategY, and Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) comparing bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitor (GPI) treatment in patients undergoing PCI. Of 14,784 patients, 7,413 patients received bivalirudin (1,870 women) and 7,371 patients received heparin + GPI (1,910 women). Women had significantly higher 30-day non-coronary artery bypass grafting (CABG)-related major bleeding rates (7.6% vs 3.8%, p <0.0001). After multivariate adjustment, female gender increased the hazard of major bleeding by 80% (hazard ratio 1.80, 95% confidence interval 1.52 to 2.11, p <0.001). Furthermore, women had a higher 1-year mortality rate (3.7% vs 2.7%, p = 0.002) than men; 30-day major bleeding was the strongest independent predictor of 1-year mortality in women (hazard ratio 2.48, 95% confidence interval 1.57 to 3.91, p = 0.001). Bivalirudin therapy in women reduced 30-day non-CABG-related major bleeding (5.6% vs 9.7%, p <0.0001) and 1-year mortality (2.9% vs 4.4%, p = 0.02) compared to standard therapy. In conclusion, in this cohort of patients treated for acute coronary syndrome and ST-segment elevation myocardial infarction, women have a near 2-fold increase in bleeding complications compared to men after PCI. Bleeding complications rather than gender is the strongest independent predictor of 1-year mortality in patients undergoing PCI. Furthermore, we observed a more pronounced clinical benefit in women treated with bivalirudin including a 44% reduction in major bleeding and a significant reduction in mortality rates at 1 year.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Резюме
Women have higher bleeding complication and mortality rates after percutaneous coronary interventions (PCI).
Почему это важно для гирудотерапии
В данном объединенном анализе данных на уровне пациентов из трех рандомизированных контролируемых исследований (REPLACE-2, ACUITY, HORIZONS-AMI; 14 784 пациента) оценивалось влияние пола и кровотечений на исходы у пациентов, получавших бивалирудин по сравнению с гепарином плюс ингибитор гликопротеина IIb/IIIa во время чрескожного коронарного вмешательства. У женщин частота больших кровотечений в течение 30 дней была почти в два раза выше, а также была выше смертность через один год; терапия бивалирудином у женщин снижала частоту больших кровотечений (5,6% против 9,7%) и смертность через один год (2,9% против 4,4%) по сравнению со стандартной терапией. В аннотации не упоминаются пиявки, гирудотерапия, гирудин или компоненты секретома пиявок. ПРЕДУПРЕЖДЕНИЕ: Это объединенный анализ рандомизированных исследований, сфокусированный на гендерных различиях в исходах ЧКВ; его связь со сферой интересов ASH не может быть установлена только на основе аннотации.
Цитирование
Impact of Bleeding and Bivalirudin Therapy on Mortality Risk in Women Undergoing Percutaneous Coronary Intervention (from the REPLACE-2, ACUITY, and HORIZONS-AMI Trials).
Ng VG et al. · Am J Cardiol, 2015
Связанный клинический контекст
Узнайте, как это исследование связано с клинической практикой
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