Department of Cardiology, Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
State Key Laboratory of Cardiovascular Disease, Beijing, China.
Platelets. 2021 May 19;32(4):533-541. doi: 10.1080/09537104.2020.1774052. Epub 2020 Jun 5.
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; < .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; = .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.
对于经皮冠状动脉介入治疗（PCI）后使用药物洗脱支架（DES）植入的高缺血或出血风险患者，双抗血小板治疗（DAPT）继续使用阿司匹林和氯吡格雷超过 1 年的益处和危害尚不清楚。所有连续接受 PCI 的患者均前瞻性纳入 2013 年 1 月至 2013 年 12 月期间的阜外 PCI 注册中心。我们评估了 7521 例患者，这些患者在索引手术后 1 年内有血栓形成或出血并发症的高风险且无事件发生。通过临床和血管造影标准定义 TWILIGHT 样患者具有高出血或缺血事件风险。主要缺血性结局为主要不良心脑血管事件（MACCE）（全因死亡、心肌梗死或卒中的复合结局）。中位随访时间为 2.4 年。DAPT>1 年组（n=5252）的 MACCE 风险明显低于 DAPT≤1 年组（n=2269）（1.5%比 3.8%；风险比[HR]：0.37；95%置信区间[CI]：0.27-0.50；<0.001）。这种差异主要是由全因死亡风险降低引起的。相比之下，两组之间 BARC 类型 2、3 或 5 出血的风险无统计学差异（1.0%比 1.1%；HR：0.80；95%CI：0.50-1.28；=0.346）。多变量回归和倾向评分匹配后结果一致。在 TWILIGHT 样高缺血或出血风险患者中，DES 植入后 DAPT 延长超过 1 年可显著降低动脉血栓栓塞事件的发生率，包括死亡率降低，且无更高的临床相关出血风险。
