The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
Columbia University Medical Center, New York, New York.
JAMA Cardiol. 2017 Aug 1;2(8):855-862. doi: 10.1001/jamacardio.2017.1978.
Women with acute myocardial infarction (MI) undergoing mechanical reperfusion remain at increased risk of adverse cardiac events and mortality compared with their male counterparts. Whether the benefits of new-generation drug-eluting stents (DES) are preserved in women with acute MI remains unclear.
To investigate the long-term safety and efficacy of new-generation DES vs early-generation DES in women with acute MI.
DESIGN, SETTING, AND PARTICIPANTS: Collaborative, international, individual patient-level data of women enrolled in 26 randomized clinical trials of DES were analyzed between July and December 2016. Only women presenting with an acute coronary syndrome were included. Study population was categorized according to presentation with unstable angina (UA) vs acute MI. Acute MI included non-ST-segment elevation MI (NSTEMI) or ST-segment elevation MI (STEMI).
Randomization to early- (sirolimus- or paclitaxel-eluting stents) vs new-generation (everolimus-, zotarolimus-, or biolimus-eluting stents) DES.
Composite of death, MI or target lesion revascularization, and definite or probable stent thrombosis at 3-year follow-up.
Overall, the mean age of participants was 66.8 years. Of 11 577 women included in the pooled data set, 4373 (37.8%) had an acute coronary syndrome as clinical presentation. Of these 4373 women, 2176 (49.8%) presented with an acute MI. In women with acute MI, new-generation DES were associated with lower risk of death, MI or target lesion revascularization (14.9% vs 18.4%; absolute risk difference, -3.5%; number needed to treat [NNT], 29; adjusted hazard ratio, 0.78; 95% CI, 0.61-0.99), and definite or probable stent thrombosis (1.4% vs 4.0%; absolute risk difference, -2.6%; NNT, 46; adjusted hazard ratio, 0.36; 95% CI, 0.19-0.69) without evidence of interaction for both end points compared with women without acute MI (P for interaction = .59 and P for interaction = .31, respectively). A graded absolute benefit with use of new-generation DES was observed in the transition from UA, to NSTEMI, and to STEMI (for death, MI, or target lesion revascularization: UA, -0.5% [NNT, 222]; NSTEMI, -3.1% [NNT, 33]; STEMI, -4.0% [NNT, 25] and for definite or probable ST: UA, -0.4% [NNT, 278]; NSTEMI, -2.2% [NNT, 46]; STEMI, -4.0% [NNT, 25]).
New-generation DES are associated with consistent and durable benefits over 3 years in women presenting with acute MI. The magnitude of these benefits appeared to be greater per increase in severity of acute coronary syndrome.
与男性相比，接受机械再灌注的急性心肌梗死（MI）女性仍存在不良心脏事件和死亡率增加的风险。新代药物洗脱支架（DES）的益处是否在急性 MI 女性中得到保留仍不清楚。
研究新代 DES 与早期代 DES 在急性 MI 女性中的长期安全性和疗效。
设计、地点和参与者：2016 年 7 月至 12 月期间对 26 项 DES 随机临床试验中纳入的女性进行了合作性、国际性、个体患者水平数据的分析。仅纳入出现急性冠状动脉综合征的女性。根据不稳定型心绞痛（UA）与急性 MI 的表现对研究人群进行分类。急性 MI 包括非 ST 段抬高型 MI（NSTEMI）或 ST 段抬高型 MI（STEMI）。
随机分为早期（西罗莫司或紫杉醇洗脱支架）与新代（依维莫司、佐他莫司或生物可吸收支架）DES。
3 年随访时死亡、MI 或靶病变血运重建和明确或可能的支架血栓形成的综合终点。
总体而言，参与者的平均年龄为 66.8 岁。在纳入的汇总数据集中，共有 11577 名女性，其中 4373 名（37.8%）以急性冠状动脉综合征为临床表现。在这 4373 名女性中，2176 名（49.8%）表现为急性 MI。在急性 MI 女性中，新代 DES 与较低的死亡、MI 或靶病变血运重建风险相关（14.9%比 18.4%；绝对风险差异，-3.5%；需要治疗的人数[NNT]，29；调整后的危险比，0.78；95%置信区间，0.61-0.99），且明确或可能的支架血栓形成风险较低（1.4%比 4.0%；绝对风险差异，-2.6%；NNT，46；调整后的危险比，0.36；95%置信区间，0.19-0.69），与无急性 MI 的女性相比，无交互作用的证据（P 交互值=0.59 和 P 交互值=0.31）。在从 UA 到 NSTEMI 再到 STEMI 的过渡中，使用新代 DES 观察到了分级绝对获益（对于死亡、MI 或靶病变血运重建：UA，-0.5%[NNT，222]；NSTEMI，-3.1%[NNT，33]；STEMI，-4.0%[NNT，25]；对于明确或可能的 ST：UA，-0.4%[NNT，278]；NSTEMI，-2.2%[NNT，46]；STEMI，-4.0%[NNT，25]）。
新代 DES 在急性 MI 女性中，与 3 年时持续和持久的益处相关。这些益处的幅度似乎随着急性冠状动脉综合征严重程度的增加而增加。
