Article Impact Level: HIGH Data Quality: STRONG Summary of BMJ, 389, e082561. https://doi.org/10.1136/bmj-2024-082561 Dr. Daniele Giacoppo et al.
Points
- A meta-analysis of five trials, including 16,117 patients, compared P2Y12 inhibitor monotherapy against aspirin for secondary prevention in patients who had undergone percutaneous coronary intervention.
- P2Y12 inhibitor monotherapy significantly reduced the risk of major adverse cardiac and cerebrovascular events compared to aspirin, with a compelling hazard ratio of 0.77 during follow-up.
- The analysis demonstrated no statistically significant difference in the rates of major bleeding between the P2Y12 inhibitor group and the aspirin group over the long-term study period.
- This benefit in the primary outcome was driven primarily by a measurable reduction in the incidence of both myocardial infarction and stroke among patients receiving a P2Y12 inhibitor.
- These findings support preferentially prescribing P2Y12 inhibitor monotherapy over aspirin for patients after they have completed their initial course of dual antiplatelet therapy following a coronary procedure.
Summary
An individual participant data meta-analysis of five randomized trials sought to determine the long-term comparative effectiveness of P2Y12 inhibitor monotherapy versus aspirin monotherapy for patients who had undergone percutaneous coronary intervention (PCI). The analysis included 16,117 patients (average age 65; 24% women) who were assigned to receive either a P2Y12 inhibitor (clopidogrel or ticagrelor) or aspirin after completing a median of 12 months of dual antiplatelet therapy (DAPT). The study followed participants for a median of 1351 days (interquartile range 373-1791 days) to assess primary outcomes of major adverse cardiac and cerebrovascular events (MACCE) and significant bleeding.
The results demonstrated a significant benefit for P2Y12 inhibitor monotherapy. This treatment was associated with a lower risk of the primary composite outcome of MACCE compared to aspirin monotherapy (hazard ratio [HR] 0.77, 95% confidence interval [CI] 0.67 to 0.89; P<0.001). This finding, which remained robust across multiple statistical models, yielded a number needed to treat to the benefit of 45.5 (95% CI 31.4 to 93.6). Conversely, the analysis found no significant difference in the two groups’ co-primary outcome of major bleeding (HR 1.26, 95% CI 0.78 to 2.04; P=0.35).
Further analysis of secondary outcomes revealed that the reduction in MACCE was primarily driven by lower myocardial infarction and stroke rates in the P2Y12 inhibitor group. Net adverse cardiac and cerebrovascular events (NACCE) were also lower for patients receiving a P2Y12 inhibitor. However, rates of all-cause death, cardiovascular death, and stent thrombosis were similar between the treatment arms. The findings support the preferential use of P2Y12 inhibitor monotherapy over aspirin for secondary prevention in the medium term following PCI and cessation of DAPT, given its superior efficacy in reducing ischemic events without a concurrent increase in significant bleeding risk.
Link to the article: https://www.bmj.com/content/389/bmj-2024-082561
References Giacoppo, D., Gragnano, F., Watanabe, H., Kimura, T., Kang, J., Park, K.-W., Kim, H.-S., Pettersen, A.-Å., Bhatt, D. L., Pocock(, S., Mehran, R., & Valgimigli, M. (2025). P2Y12 inhibitor or aspirin after percutaneous coronary intervention: Individual patient data meta-analysis of randomised clinical trials. BMJ, 389, e082561. https://doi.org/10.1136/bmj-2024-082561
