P2Y12 Inhibitor Monotherapy or Dual Antiplatelet Therapy After Complex Percutaneous Coronary Interventions

Felice Gragnano; Roxana Mehran; Mattia Branca; Anna Franzone; Usman Baber; Yangsoo Jang; Takeshi Kimura; Joo-Yong Hahn; Qiang Zhao; Stephan Windecker; Charles M Gibson; Byeong-Keuk Kim; Hirotoshi Watanabe; Young Bin Song; Yunpeng Zhu; Pascal Vranckx; Shamir Mehta; Sung-Jin Hong; Kenji Ando; Hyeon-Cheol Gwon; Paolo Calabrò; Patrick W Serruys; George D Dangas; Eùgene P McFadden; Dominick J Angiolillo; Dik Heg; Marco Valgimigli; Single Versus Dual Antiplatelet Therapy (Sidney-2) Collaboration

doi:10.1016/j.jacc.2022.11.041

P2Y₁₂ Inhibitor Monotherapy or Dual Antiplatelet Therapy After Complex Percutaneous Coronary Interventions

J Am Coll Cardiol. 2023 Feb 14;81(6):537-552. doi: 10.1016/j.jacc.2022.11.041.

Authors

Felice Gragnano¹, Roxana Mehran², Mattia Branca³, Anna Franzone⁴, Usman Baber⁵, Yangsoo Jang⁶, Takeshi Kimura⁷, Joo-Yong Hahn⁸, Qiang Zhao⁹, Stephan Windecker¹⁰, Charles M Gibson¹¹, Byeong-Keuk Kim⁶, Hirotoshi Watanabe⁷, Young Bin Song⁸, Yunpeng Zhu⁹, Pascal Vranckx¹², Shamir Mehta¹³, Sung-Jin Hong⁶, Kenji Ando¹⁴, Hyeon-Cheol Gwon⁸, Paolo Calabrò¹, Patrick W Serruys¹⁵, George D Dangas², Eùgene P McFadden¹⁶, Dominick J Angiolillo¹⁷, Dik Heg³, Marco Valgimigli¹⁸; Single Versus Dual Antiplatelet Therapy (Sidney-2) Collaboration

Affiliations

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; Faculty of Medicine and Life Sciences, University of Hasselt, Hasselt, Belgium.
¹³ Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada.
¹⁴ Kokura Memorial Hospital, Department of Cardiology, Kitakyushu, Japan.
¹⁵ Department of Cardiology, National University of Ireland Galway, Galway, Ireland; NHLI, Imperial College London, London, United Kingdom.
¹⁶ Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands; Department of Cardiology, Cork University Hospital, Cork, Ireland.
¹⁷ Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, USA.
¹⁸ Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland; Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland. Electronic address: marco.valgimigli@eoc.ch.

PMID: 36754514
DOI: 10.1016/j.jacc.2022.11.041

Abstract

Background: It 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).

Objectives: We sought to assess the effects of P2Y₁₂ inhibitor monotherapy after 1-month to 3-month DAPT vs standard DAPT in relation to PCI complexity.

Methods: We 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.

Results: Of 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; P_interaction = 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; P_interaction = 0.920).

Conclusions: 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 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).

Keywords: DAPT; P2Y(12) inhibitors; complex PCI; meta-analysis; percutaneous coronary intervention.

Publication types

Meta-Analysis
Research Support, Non-U.S. Gov't

MeSH terms

Aspirin
Drug Therapy, Combination
Dual Anti-Platelet Therapy
Hemorrhage / chemically induced
Hemorrhage / epidemiology
Humans
Percutaneous Coronary Intervention* / adverse effects
Platelet Aggregation Inhibitors*
Purinergic P2Y Receptor Antagonists
Treatment Outcome

Substances

Platelet Aggregation Inhibitors
Aspirin
Purinergic P2Y Receptor Antagonists