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Benefit-risk profile of extended dual antiplatelet therapy beyond 1 year in patients with high risk of ischemic or bleeding events after PCI

机译：高于缺血性或PCI后缺血事件高风险患者延长双抗血小板治疗的损益风险概况

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The benefits and harms of dual antiplatelet therapy (DAPT) continuation with aspirin and clopidogrel beyond 1 year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation for high ischemic or bleeding risk patients remain unclear. All consecutive patients undergoing PCI were prospectively included in the Fuwai PCI Registry from January 2013 to December 2013. We evaluated 7521 patients who were at high risk for thrombotic or hemorrhagic complications and were events free at 1 year after the index procedure. "TWILIGHT-like" patients with high risk of bleeding or ischemic events were defined by clinical and angiographic criteria. The primary ischemic outcome was major adverse cardiac and cerebrovascular events [MACCE] (a composite of all-cause death, myocardial infarction, or stroke). Median follow-up duration was 2.4 years. The risk of MACCE was significantly lower in DAPT>1-year group (n = 5252) than DAPT <= 1-year group (n = 2269) (1.5% vs. 3.8%; hazard ratio [HR]: 0.37; 95% confidence interval [CI]: 0.27-0.50;P< .001). This difference was largely driven by a lower risk of all-cause death. In contrast, the risk of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding was statistically similar between the two groups (1.0% vs. 1.1%; HR: 0.80; 95% CI: 0.50-1.28;P= .346). Results were consistent after multivariable regression and propensity-score matching. Prolonged DAPT beyond 1 year after DES implantation resulted in a significantly lower rate of atherothrombotic events, including a mortality benefit, with no higher risk of clinically relevant bleeding in "TWILIGHT-like" patients who were at high-risk for ischemic or bleeding events.
机译：对于高缺血或出血风险患者，在经皮冠状动脉介入治疗（PCI）和药物洗脱支架（DES）植入术后1年后继续使用阿司匹林和氯吡格雷进行双重抗血小板治疗（DAPT）的利弊尚不清楚。从2013年1月到2013年12月，所有连续接受PCI的患者前瞻性地纳入阜外PCI登记册。我们评估了7521名血栓或出血并发症高危患者，这些患者在指数程序后1年无事件发生。根据临床和血管造影标准确定出血或缺血性事件高风险的“曙光样”患者。主要缺血性结局是严重的心脑血管不良事件[MACCE]（由全因死亡、心肌梗死或中风组成）。中位随访时间为2.4年。DAPT>1年组（n=5252）的MACCE风险显著低于DAPT<1年组（n=2269）（1.5%对3.8%；危险比[HR]：0.37；95%可信区间[CI]：0.27-0.50；P<0.001）。这种差异在很大程度上是由全因死亡的风险降低造成的。相比之下，学术研究联盟（BARC）2型、3型或5型出血的风险在两组之间具有统计学相似性（1.0%对1.1%；HR:0.80；95%可信区间：0.50-1.28；P=0.346）。多变量回归和倾向评分匹配后结果一致。DES植入后持续DAPT超过1年，导致动脉粥样硬化血栓形成事件的发生率显著降低，包括死亡率增加，在“曙光样”患者中，缺血性或出血事件的高风险患者没有更高的临床相关出血风险。

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