Background:The appropriate duration of dual antiplatelet therapy (DAPT) and risk-benefit ratio for long-term DAPT in patients with left main (LM) disease undergoing percutaneous coronary intervention remains uncertain.Methods:Four thousand five hundred sixty-one consecutive patients with stenting of LM disease at a single center from January 2004 to December 2016 were enrolled. Decision to discontinue or remain on DAPT after 12 months was left to an individualized decision-making based on treating physicians by weighing the patient’s risks of ischemia versus bleeding and considering patient preference. The primary outcome was a composite of death, myocardial infarction, stent thrombosis, or stroke at 3 years. Key safety outcome was 3-year rate of Bleeding Academic Research Consortium 2, 3, or 5 bleeding.Results:Of 3865 patients free of ischemic and bleeding events at 12 months, 1727 (44.7%) remained on DAPT (mostly clopidogrel based [97.7%]) beyond 12 months after LM percutaneous coronary intervention. DAPT>12-month versus ≤12-month DAPT was associated with a significant reduced risk of 3-year primary outcome (2.6% versus 4.6%; adjusted hazard ratio: 0.59 [95% CI, 0.41–0.84]). The same trend was found for other ischemic end points: death (0.9% versus 3.0%; P_log-rank<0.001), cardiovascular death (0.5% versus 1.7%; P_log-rank=0.001), myocardial infarction (0.8% versus 1.9%; P_log-rank=0.005), and stent thrombosis (0.4% versus 1.1%; P_log-rank=0.017). The key safety end point was not significantly different between 2 regimens (1.8% versus 1.6%; adjusted hazard ratio: 1.07 [95% CI, 0.65–1.74]). The effect of DAPT>12 month on primary and key safety outcomes was consistent across clinical presentations, high bleeding risk, P2Y₁₂ inhibitor, and LM bifurcation percutaneous coronary intervention approach.Conclusions:In a large cohort of patients free from clinical events during the first year after LM percutaneous coronary intervention and at low apparent future bleeding risk, an individualized patient-tailored approach to longer duration (>12 month) of DAPT with aspirin plus a P2Y₁₂ inhibitor (mostly clopidogrel) improved both composite and individual efficacy outcomes by reducing ischemic risk, without a concomitant increase in clinically relevant bleeding.

中文翻译：

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左冠状动脉疾病支架置入术后患者长期与短期双重抗血小板治疗持续时间的新见解：前瞻性观察研究的结果

背景：对于接受经皮冠状动脉介入治疗的左主干 (LM) 疾病患者，双重抗血小板治疗 (DAPT) 的适当持续时间和长期 DAPT 的风险效益比仍不确定。方法：4561 名连续患有纳入 2004 年 1 月至 2016 年 12 月在单中心进行的 LM 疾病支架置入术。12 个月后停止或继续使用 DAPT 的决定取决于治疗医生通过权衡患者缺血与出血风险并考虑患者偏好的个体化决策。主要结局是 3 年时死亡、心肌梗死、支架血栓形成或卒中的复合结局。主要安全性结果是出血学术研究联盟 2、3 或 5 次出血的 3 年发生率。结果：在 12 个月时未发生缺血和出血事件的 3865 名患者中，1727 名（44.7%）在 LM 经皮冠状动脉介入治疗后 12 个月后仍接受 DAPT（主要基于氯吡格雷 [97.7%]）。DAPT>12 个月 vs ≤12 个月 DAPT 与 3 年主要结局风险显着降低相关（2.6% vs 4.6%；调整后的风险比：0.59 [95% CI，0.41–0.84]）。其他缺血性终点也有同样的趋势：死亡（0.9% vs 3.0%；P _log-rank <0.001）、心血管死亡（0.5% vs 1.7%；P _log-rank = 0.001）、心肌梗死（0.8% vs 1.9%；P _log-rank = 0.005）和支架血栓形成（0.4% vs 1.1 %；P_对数秩= 0.017)。两种方案的关键安全终点没有显着差异（1.8% 对 1.6%；调整后的风险比：1.07 [95% CI，0.65–1.74]）。DAPT>12 个月对主要和关键安全性结果的影响在临床表现、高出血风险、P2Y _{12中是一致的}抑制剂和 LM 分叉经皮冠状动脉介入治疗方法。结论：在 LM 经皮冠状动脉介入治疗后第一年没有临床事件且未来明显出血风险低的大型患者队列中，个体化的患者定制方法可延长持续时间（> 12 个月）的 DAPT 联合阿司匹林加 P2Y ₁₂抑制剂（主要是氯吡格雷）通过降低缺血风险改善了复合和个体疗效结果，而没有伴随临床相关出血的增加。