Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.
Shanghai Medical College, Fudan University, Shanghai, China.
Thromb Haemost. 2020 May;120(5):857-865. doi: 10.1055/s-0040-1709520. Epub 2020 May 5.
Cilostazol-based dual antiplatelet therapy (DAPT) is widely used in patients with aspirin intolerance after coronary drug-eluting stent (DES) implantation in China. However, this empirical strategy is not recommended or even mentioned in Chinese or international guidelines due to a lack of evidence from large-scale studies. We aimed to explore the efficacy and safety of cilostazol-based DAPT in this special population.
In this cohort study, patients were grouped according to the DAPT strategy that they received after coronary DES implantation. The primary efficacy endpoint was major adverse cardiovascular and cerebrovascular events (MACCEs). Angiographic follow-up and major bleeding events were also recorded.
A total of 918 patients receiving cilostazol-based DAPT due to aspirin intolerance were enrolled, matched with 918 patients receiving aspirin-based DAPT. After 15-month prospective follow-up, the cilostazol group had lower risk of MACCE (5.1% vs. 7.6%, propensity score adjusted hazard ratio = 0.671 [95% confidence interval 0.462-0.974], = 0.036) compared with the aspirin group. Lower rate of coronary lesion progression was also found through follow-up angiography in the cilostazol group (17.4% vs. 23.6%, = 0.022), especially in nontarget lesions (12.1% vs. 17.6%, = 0.019). The two groups had the same risk of major bleeding events (0.8% vs. 0.4%, = 0.364).
In the current study, cilostazol is a good substitute for aspirin in patients who have aspirin intolerance but need DAPT after coronary DES implantation in China. However, large-scale randomized controlled trials were still required to further confirm its efficacy and safety.
在中国，在冠状动脉药物洗脱支架（DES）植入后，由于对阿司匹林不耐受，广泛应用西洛他唑为基础的双联抗血小板治疗（DAPT）。然而，由于缺乏大规模研究的证据，这种经验性策略在中国或国际指南中既不被推荐，甚至都未被提及。我们旨在探讨在这一特殊人群中西洛他唑为基础的 DAPT 的疗效和安全性。
在这项队列研究中，患者根据 DES 植入后接受的 DAPT 策略进行分组。主要疗效终点是主要不良心脑血管事件（MACCEs）。还记录了血管造影随访和主要出血事件。
共纳入 918 例因对阿司匹林不耐受而接受西洛他唑为基础的 DAPT 的患者，与 918 例接受阿司匹林为基础的 DAPT 的患者相匹配。经过 15 个月的前瞻性随访，西洛他唑组 MACCE 的风险较低（5.1%比 7.6%，经倾向评分调整的风险比=0.671[95%置信区间 0.462-0.974]，=0.036）。西洛他唑组在随访造影时也发现冠状动脉病变进展率较低（17.4%比 23.6%，=0.022），特别是在非靶病变（12.1%比 17.6%，=0.019）。两组大出血事件的风险相同（0.8%比 0.4%，=0.364）。
在目前的研究中，西洛他唑是中国冠状动脉 DES 植入后因对阿司匹林不耐受但需要 DAPT 的患者中阿司匹林的良好替代品。然而，仍需要大规模的随机对照试验来进一步证实其疗效和安全性。
