The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.
The Department of Cardiology, Xijing Hospital, Air Force Military Medical University, Xi'an, Shanxi Province, China.
Adv Ther. 2020 Jul;37(7):3150-3161. doi: 10.1007/s12325-020-01376-0. Epub 2020 May 16.
Optimal dual antiplatelet therapy (DAPT) duration for medically managed acute coronary syndrome (ACS) (MMACS) patients is still unknown. We explored the efficacy and safety of ≥ 12-month DAPT among MMACS patients.
In this sub-analysis of the optimal antiplatelet therapy for Chinese Patients with Coronary Artery Disease study (NCT01735305), clinical outcomes among MMACS patients were compared between the < 12-month and ≥ 12-month DAPT groups. The primary efficacy endpoint was a composite of cardiac death, myocardial infarction, and stroke. Safety endpoints included the Bleeding Academic Research Consortium (BARC) 2-5, BARC 3-5, and all bleeding events. Propensity score matching (PSM) was used to compare baseline characteristics between the < 12-month and ≥ 12-month DAPT groups.
In this cohort of ACS patients (n = 10,016), MMACS patients (n = 2967) were less likely to use DAPT at 12 (31.64% vs. 67.47%, P < 0.0001) and 24 (13.82% vs. 18.71%, P < 0.0001) months and experienced more ischemic events at 12 (4.55% vs. 3.40%, P = 0.006) and 24 (6.88% vs. 5.08%, P = 0.0004) months than those treated with percutaneous coronary intervention (n = 7049). Among MMACS patients, the rate of primary efficacy endpoint occurring within the second year was significantly higher in the < 12-month DAPT group than in the ≥ 12-month group both before (2.88% vs. 1.60%, P = 0.040) and after (3.19% vs. 1.71%, P = 0.045) PSM. After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups.
MMACS patients with insufficient DAPT management experienced relatively more ischemic events. DAPT for at least 1 year may be beneficial to this special population without significantly increasing the bleeding risks.
ClinicalTrials.gov identifier, NCT01735305.
对于接受药物治疗的急性冠状动脉综合征(ACS)(MMACS)患者,最佳双联抗血小板治疗(DAPT)持续时间仍不清楚。我们探讨了 MMACS 患者接受≥12 个月 DAPT 的疗效和安全性。
在这项优化中国冠心病患者抗血小板治疗研究(NCT01735305)的亚分析中,比较了 MMACS 患者在 12 个月 DAPT 组和≥12 个月 DAPT 组之间的临床结局。主要疗效终点是心脏死亡、心肌梗死和卒中的复合终点。安全性终点包括出血学术研究联合会(BARC)2-5、BARC 3-5 和所有出血事件。采用倾向评分匹配(PSM)比较 12 个月和≥12 个月 DAPT 组之间的基线特征。
在这组 ACS 患者(n=10016)中,MMACS 患者(n=2967)不太可能在 12 个月(31.64%比 67.47%,P<0.0001)和 24 个月(13.82%比 18.71%,P<0.0001)使用 DAPT,并且在 12 个月(4.55%比 3.40%,P=0.006)和 24 个月(6.88%比 5.08%,P=0.0004)发生更多的缺血事件。与接受经皮冠状动脉介入治疗(n=7049)的患者相比,MMACS 患者在第二年发生主要疗效终点的发生率在 12 个月 DAPT 组明显高于≥12 个月 DAPT 组,无论在 PSM 前(2.88%比 1.60%,P=0.040)还是 PSM 后(3.19%比 1.71%,P=0.045)。在 PSM 后,两组之间的所有出血、BARC 2-5 和 BARC 3-5 出血均无显著差异。
接受药物治疗的急性冠状动脉综合征患者的双联抗血小板治疗管理不足,发生相对更多的缺血事件。至少 1 年的 DAPT 可能对这一特殊人群有益,而不会显著增加出血风险。
ClinicalTrials.gov 标识符,NCT01735305。