Comparative Safety and Efficacy of Indobufen versus Aspirin-based Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Trials and Observational Cohort Studies

Abstract

Background: Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is standard care following percutaneous coronary intervention (PCI), but bleeding complications remain a major limitation. Indobufen, a reversible cyclooxygenase-1 inhibitor, has been proposed as a safer alternative to aspirin. Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational cohort studies comparing indobufen- versus aspirin-based DAPT in PCI patients. Six studies (three RCTs, three cohorts) including 7,426 participants were analyzed. Outcomes included Bleeding Academic Research Consortium (BARC) bleeding, net adverse clinical events (NACE), major adverse cardiovascular and cerebrovascular events (MACCE), myocardial infarction, stent thrombosis, and target lesion revascularization (TLR). Risk of bias was assessed using RoB 2.0 and ROBINS-I, and certainty of evidence was graded using GRADE. Results: Indobufen significantly reduced BARC type 2–5 bleeding compared with aspirin (RR = 1.03, 95% CI: 1.00–1.06; p = 0.03), with consistent benefit in RCTs (RR = 1.02, 95% CI: 1.01–1.03; p = 0.0006). NACE reduction was significant in RCTs (RR = 0.74, 95% CI: 0.58–0.94; p = 0.02), though not overall. No differences were observed for MACCE, myocardial infarction, or stent thrombosis. A borderline reduction in TLR was noted (RR = 0.77, 95% CI: 0.59–1.01; p = 0.06). Evidence certainty ranged from moderate (MACCE) to very low (stent thrombosis). Conclusions: Indobufen-based DAPT offers superior safety with reduced bleeding risk compared to aspirin-based regimens, without compromising ischemic protection. These findings support indobufen as a promising alternative for post-PCI management, particularly in patients at high bleeding risk.

Keywords

Natural Science - Biology

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Conflict of interest statement: No conflict of interest statement is attached to this public record unless stated in the manuscript.

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