Department of Cardiology, Coronary Heart Disease Center, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037, China.
State Key Laboratory of Cardiovascular Disease, Beijing, China.
Cardiovasc Drugs Ther. 2020 Oct;34(5):663-675. doi: 10.1007/s10557-020-07030-9. Epub 2020 Jun 29.
The ischemic/bleeding trade-off of continuing dual antiplatelet therapy (DAPT) beyond 1 year after PCI for patients with high thrombotic risk (HTR) as endorsed by 2018 ESC/EACTS myocardial revascularization guidelines remain unknown.
Patients undergoing coronary stenting between January 2013 and December 2013 from the prospective Fuwai registry were defined as HTR if they met at least 1 ESC/EACTS guideline-endorsed HTR criteria. A total of 4578 patients who were at HTR and were events free at 1 year after the index procedure were evaluated. The primary efficacy outcome was major adverse cardiac and cerebrovascular events (MACCE) (composite of all-cause death, myocardial infarction, or stroke).
Median follow-up period was 2.4 years. > 1-year DAPT with clopidogrel and aspirin significantly reduced the risk of MACCE compared with ≤ 1-year DAPT (1.9% vs. 4.6%; hazard ratio (HR): 0.38; 95% confidence interval (CI): 0.27-0.54; P < 0.001), driven by a reduction in all-cause death (0.2% vs. 3.0%; HR, 0.07; 95% CI, 0.03-0.15). Cardiac death and definite/probable stent thrombosis also occurred less frequently in prolonged DAPT group. Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding occurred similarly between both groups (1.1% vs. 0.9%; HR, 1.11; 95% CI, 0.58-2.13; P = 0.763). Similar results were found using multivariable Cox model, propensity score-matched, and inverse probability of treatment weighting analysis.
Among patients with ESC-endorsed HTR who were free from major ischemic or bleeding events 1 year after coronary stenting, continued DAPT beyond 1 year might offer better effectiveness in terms of atherothrombotic events and comparable safety in terms of clinically relevant bleeding compared with ≤ 1-year DAPT. ESC-HTR criteria is an important parameter to take into account in tailoring DAPT prolongation.
2018 年 ESC/EACTS 心肌血运重建指南推荐，高血栓风险（HTR）患者 PCI 后继续双联抗血小板治疗（DAPT）超过 1 年的缺血/出血权衡仍不清楚。
前瞻性阜外注册研究中，2013 年 1 月至 12 月接受冠状动脉支架置入术的患者，如果符合至少 1 项 ESC/EACTS 指南推荐的 HTR 标准，则定义为 HTR。对 4578 例 HTR 患者进行评估，这些患者在指数手术后 1 年内无事件。主要疗效终点为主要不良心脑血管事件（MACCE）（全因死亡、心肌梗死或卒中等复合终点）。
中位随访时间为 2.4 年。与≤1 年 DAPT 相比，>1 年 DAPT（氯吡格雷和阿司匹林）显著降低 MACCE 风险（1.9%比 4.6%；风险比（HR）：0.38；95%置信区间（CI）：0.27-0.54；P<0.001），这主要是由于全因死亡率降低（0.2%比 3.0%；HR，0.07；95%CI，0.03-0.15）。在延长 DAPT 组，心脏死亡和明确/可能的支架血栓形成也较少发生。BARC 2、3 或 5 型出血在两组间相似（1.1%比 0.9%；HR，1.11；95%CI，0.58-2.13；P=0.763）。多变量 Cox 模型、倾向评分匹配和逆概率治疗加权分析也得到了类似的结果。
在冠状动脉支架置入 1 年后无主要缺血或出血事件的 ESC 推荐的 HTR 患者中，与≤1 年 DAPT 相比，继续 DAPT 超过 1 年可能在动脉粥样硬化血栓形成事件方面更有效，而在临床相关出血方面更安全。ESC-HTR 标准是决定延长 DAPT 时间的重要参数。
