Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, 180 Fenglin Road, Shanghai, 200032, China.
National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China.
BMC Med. 2024 Apr 2;22(1):148. doi: 10.1186/s12916-024-03374-3.
Indobufen is widely used in patients with aspirin intolerance in East Asia. The OPTION trial launched by our cardiac center examined the performance of indobufen based dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). However, the vast majority of patients with acute coronary syndrome (ACS) and aspirin intolerance were excluded. We aimed to explore this question in a real-world population.
Patients enrolled in the ASPIRATION registry were grouped according to the DAPT strategy that they received after PCI. The primary endpoints were major adverse cardiovascular and cerebrovascular events (MACCE) and Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. Propensity score matching (PSM) was adopted for confounder adjustment.
A total of 7135 patients were reviewed. After one-year follow-up, the indobufen group was associated with the same risk of MACCE versus the aspirin group after PSM (6.5% vs. 6.5%, hazard ratio [HR] = 0.99, 95% confidence interval [CI] = 0.65 to 1.52, P = 0.978). However, BARC type 2, 3, or 5 bleeding was significantly reduced (3.0% vs. 11.9%, HR = 0.24, 95% CI = 0.15 to 0.40, P < 0.001). These results were generally consistent across different subgroups including aspirin intolerance, except that indobufen appeared to increase the risk of MACCE in patients with ACS.
Indobufen shared the same risk of MACCE but a lower risk of bleeding after PCI versus aspirin from a real-world perspective. Due to the observational nature of the current analysis, future studies are still warranted to further evaluate the efficacy of indobufen based DAPT, especially in patients with ACS.
Chinese Clinical Trial Register ( https://www.chictr.org.cn ); Number: ChiCTR2300067274.
在东亚，吲哚布芬被广泛用于阿司匹林不耐受的患者。我们心脏中心开展的 OPTION 试验考察了经皮冠状动脉介入治疗（PCI）后吲哚布芬双联抗血小板治疗（DAPT）的效果。然而，绝大多数急性冠脉综合征（ACS）和阿司匹林不耐受的患者被排除在外。我们旨在真实人群中探讨这个问题。
根据 PCI 后接受的 DAPT 策略，将纳入 ASPIRATION 登记研究的患者进行分组。主要终点是主要不良心脑血管事件（MACCE）和出血学术研究联合会（BARC）2、3、5 型出血。采用倾向性评分匹配（PSM）进行混杂因素校正。
共纳入 7135 例患者。经过 1 年随访，PSM 后吲哚布芬组与阿司匹林组的 MACCE 风险相同（6.5%比 6.5%，风险比[HR] = 0.99，95%置信区间[CI] = 0.65 至 1.52，P = 0.978）。然而，BARC 2、3、5 型出血显著减少（3.0%比 11.9%，HR = 0.24，95% CI = 0.15 至 0.40，P < 0.001）。这些结果在包括阿司匹林不耐受在内的不同亚组中基本一致，只是吲哚布芬似乎会增加 ACS 患者的 MACCE 风险。
从真实世界的角度来看，与阿司匹林相比，吲哚布芬在 PCI 后具有相同的 MACCE 风险，但出血风险更低。由于本次分析为观察性研究，仍需要进一步的研究来评估吲哚布芬 DAPT 的疗效，尤其是在 ACS 患者中。
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