| Institution: | 1. Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Caserta, Italy;2. Icahn School of Medicine at Mount Sinai, New York, New York, USA;3. Clinical Trials Unit, Bern, Switzerland;4. Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy;5. University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA;6. Department of Cardiology, CHA Bundang Medical Center, CHA University College of Medicine, Seongnam, South Korea;7. Kyoto University Graduate School of Medicine, Department of Cardiovascular Medicine, Kyoto, Japan;8. Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea;9. Department of Cardiovascular Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China;10. Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland;11. Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA;12. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Belgium;13. Faculty of Medicine and Life Sciences, University of Hasselt, Hasselt, Belgium;14. Department of Medicine, McMaster University, Hamilton, Ontario, Canada;15. Hamilton Health Sciences, Hamilton, Ontario, Canada;p. Kokura Memorial Hospital, Department of Cardiology, Kitakyushu, Japan;q. Department of Cardiology, National University of Ireland Galway, Galway, Ireland;r. NHLI, Imperial College London, London, United Kingdom;s. Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands;t. Department of Cardiology, Cork University Hospital, Cork, Ireland;u. Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, USA;v. Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland |
| Abstract: | BackgroundIt remains unclear whether P2Y12 inhibitor monotherapy preserves ischemic protection while limiting bleeding risk compared with dual antiplatelet therapy (DAPT) after complex percutaneous coronary intervention (PCI).ObjectivesWe sought to assess the effects of P2Y12 inhibitor monotherapy after 1-month to 3-month DAPT vs standard DAPT in relation to PCI complexity.MethodsWe pooled 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 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was all-cause mortality, myocardial infarction, and stroke. The key safety endpoint was Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding.ResultsOf 22,941 patients undergoing PCI from 5 trials, 4,685 (20.4%) with complex PCI had higher rates of ischemic events. The primary efficacy endpoint was similar between P2Y12 inhibitor monotherapy and DAPT among patients with complex PCI (HR: 0.87; 95% CI: 0.64-1.19) and noncomplex PCI (HR: 0.91; 95% CI: 0.76-1.09; Pinteraction = 0.770). The treatment effect was consistent across all the components of the complex PCI definition. Compared with DAPT, P2Y12 inhibitor monotherapy consistently reduced BARC 3 or 5 bleeding in complex PCI (HR: 0.51; 95% CI: 0.31-0.84) and noncomplex PCI patients (HR: 0.49; 95% CI: 0.37-0.64; Pinteraction = 0.920).ConclusionsP2Y12 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 compared with standard DAPT, irrespective of PCI complexity. (PROSPERO P2Y12 Inhibitor Monotherapy Versus Standard Dual Antiplatelet Therapy After Coronary Revascularization: Individual Patient Data Meta-Analysis of Randomized Trials]; CRD42020176853) |
