Article Impact Level: HIGH Data Quality: STRONG Summary of Journal of the American College of Cardiology, 81(6), 537–552. https://doi.org/10.1016/j.jacc.2022.11.041 Dr. Felice Gragnano et al.
Points
- The study aimed to compare P2Y12 inhibitor monotherapy and dual antiplatelet therapy (DAPT) for patients undergoing complex percutaneous coronary intervention (PCI).
- The study analyzed patient-level data from 5 randomized controlled trials that included 22,941 patients undergoing PCI, of which 4,685 had complex PCI.
- P2Y12 inhibitor monotherapy had similar primary efficacy endpoints for complex and noncomplex PCI patients compared to DAPT.
- P2Y12 inhibitor monotherapy consistently reduced Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding in complex and noncomplex PCI patients compared to DAPT.
- These findings suggest that P2Y12 inhibitor monotherapy could be considered an alternative to DAPT after complex PCI without increasing the risk of ischemic events.
Summary
This study investigated whether P2Y12 inhibitor monotherapy could provide ischemic protection while minimizing bleeding risk compared to dual antiplatelet therapy (DAPT) after complex percutaneous coronary intervention (PCI). The researchers analyzed patient-level data from randomized controlled trials comparing P2Y12 inhibitor monotherapy and standard DAPT on centrally adjudicated outcomes after coronary revascularization. Complex PCI was defined as any of 6 criteria: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 implanted, total stent length >60 mm, or chronic total occlusion. The study included 22,941 patients undergoing PCI from 5 trials, and 4,685 (20.4%) had complex PCI, with higher rates of ischemic events.
The results showed that P2Y12 inhibitor monotherapy and DAPT had similar primary efficacy endpoints for complex and noncomplex PCI patients. The primary efficacy endpoint was all-cause mortality, myocardial infarction, and stroke. The treatment effect was consistent across all the components of the complex PCI definition. Among patients with complex PCI, the hazard ratio (HR) for P2Y12 inhibitor monotherapy compared to DAPT was 0.87 (95% CI: 0.64-1.19), while among patients with noncomplex PCI, the HR was 0.91 (95% CI: 0.76-1.09; Pinteraction = 0.770).
However, P2Y12 inhibitor monotherapy consistently reduced Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding in complex and noncomplex PCI patients, compared to DAPT. The critical safety endpoint was BARC 3 or 5 bleeding. Among patients with complex PCI, the HR for P2Y12 inhibitor monotherapy compared to DAPT was 0.51 (95% CI: 0.31-0.84), while among patients with noncomplex PCI, the HR was 0.49 (95% CI: 0.37-0.64; Pinteraction = 0.920). The treatment effect was consistent across all the components of the complex PCI definition.
Therefore, P2Y12 inhibitor monotherapy after 1-month to 3-month DAPT was associated with similar rates of fatal and ischemic events and lower risk of major bleeding than standard DAPT, irrespective of PCI complexity. These findings suggest that P2Y12 inhibitor monotherapy could be considered an alternative to DAPT after complex PCI without increasing the risk of ischemic events. These results are based on a PROSPERO (P2Y12 Inhibitor Monotherapy Versus Standard Dual Antiplatelet Therapy After Coronary Revascularization: Individual Patient Data Meta-Analysis of Randomized Trials) study, with registration number CRD42020176853.
Link to the article: https://www.jacc.org/doi/10.1016/j.jacc.2022.11.041
References Gragnano, F., Mehran, R., Branca, M., Franzone, A., Baber, U., Jang, Y., Kimura, T., Hahn, J.-Y., Zhao, Q., Windecker, S., Gibson, C. M., Kim, B.-K., Watanabe, H., Song, Y. B., Zhu, Y., Vranckx, P., Mehta, S., Hong, S.-J., Ando, K., … Valgimigli, M. (2023). P2y12 inhibitor monotherapy or dual antiplatelet therapy after complex percutaneous coronary interventions. Journal of the American College of Cardiology, 81(6), 537–552. https://doi.org/10.1016/j.jacc.2022.11.041
