Impact of Sex on 2-Year Clinical Outcomes in Patients Treated With 6-Month or 24-Month Dual-Antiplatelet Therapy Duration: A Pre-Specified Analysis From the PRODIGY Trial

详细信息    查看全文

• 作者：Giuseppe Gargiulo ; MD^a ; ^b ; Sara Ariotti ; MD^a ; ^c ; Andrea Santucci ; MD^a ; Raffaele Piccolo ; MD^a ; Andrea Baldo ; MD^a ; Anna Franzone ; MD^a ; Giulia Magnani ; MD^a ; Marcello Marino ; MD^a ; Giovanni Esposito ; MD ; PhD^b ; Stephan Windecker ; MD^a ; Marco Valgimigli ; MD ; PhD^a ; ^c ; ^{marco.valgimigli@insel.ch" class="auth_mail" title="E-mail the corresponding author}
• 关键词：bleeding ; clopidogrel ; DAPT ; ischemic events ; sex
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2016
• 出版时间：12 September 2016
• 年：2016
• 卷：9
• 期：17
• 页码：1780-1789
• 全文大小：953 K

文摘

The aim of this study was to assess the impact of sex on 2-year outcomes after percutaneous coronary intervention (PCI) in patients randomly allocated to 24-month versus 6-month dual-antiplatelet therapy (DAPT).

d="absSec_2">Background

d="abspara0015">The optimal duration of DAPT after PCI is highly debated. Whether sex per se should drive decision making on DAPT duration remains unclear.

d="absSec_3">Methods

d="abspara0020">The primary efficacy endpoint of PRODIGY (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study) was the composite of death, myocardial infarction, or cerebrovascular accident at 24-month follow-up. The key safety endpoint was type 2, 3, or 5 bleeding according to the Bleeding Academic Research Consortium criteria.

d="absSec_4">Results

d="abspara0025">Women (n = 459 [23.3%]) were older and more likely to have hypertension, lower creatinine clearance, and acute coronary syndrome but had a lower severity of coronary artery disease. After adjustment, prolonged DAPT, compared with 6-month treatment, did not reduce the primary endpoint in both men (adjusted hazard ratio: 1.080; 95% confidence interval: 0.766 to 1.522; p = 0.661) and women (adjusted hazard ratio: 1.013; 95% confidence interval: 0.588 to 1.748; p = 0.962) (interaction p = 0.785). No sex disparity was identified across multiple secondary ischemic endpoints, including overall or cardiovascular mortality, myocardial infarction, and stent thrombosis. There was also no clear sex-related effect on clinically relevant bleeding, including Bleeding Academic Research Consortium type 3 or 5, TIMI (Thrombolysis in Myocardial Infarction), and GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) scales.

d="absSec_5">Conclusions

d="abspara0030">The present findings suggest that men and women undergoing PCI have similar adjusted 2-year ischemic and bleeding outcomes, despite being characterized by different clinical presentation. Sex failed to emerge as a treatment modifier with respect to DAPT duration, suggesting that decision making on DAPT duration in female patients should weigh ischemic versus bleeding risks.