Very Short Dual Antiplatelet Therapy after Drug-Eluting Stent Implantation in Patients Who Underwent Complex Percutaneous Coronary Intervention: Insight from the STOPDAPT-2 Trial

Ko Yamamoto, Hirotoshi Watanabe, Takeshi Morimoto, Takenori Domei, Masanobu Ohya, Manabu Ogita, Kensuke Takagi, Hirohiko Suzuki, Akira Nikaido, Mitsuru Ishii, Shinya Fujii, Masahiro Natsuaki, Satoshi Yasuda, Takeo Kaneko, Takashi Tamura, Toshihiro Tamura, Mitsuru Abe, Kazuya Kawai, Koichi Nakao, Kenji AndoKengo Tanabe, Yuji Ikari, Keiichi Igarashi Hanaoka, Yoshihiro Morino, Ken Kozuma, Kazushige Kadota, Yutaka Furukawa, Yoshihisa Nakagawa, Takeshi Kimura

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

Background: Safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) is uncertain in patients undergoing complex percutaneous coronary intervention (PCI). Methods: We conducted a post hoc subgroup analysis based on the complexity of PCI in the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy-2), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT after cobalt-chromium everolimus-eluting stent implantation. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents, >60 mm total stent lengths, and target of chronic total occlusion. The primary end point was the composite of cardiovascular (cardiovascular death/myocardial infarction/definite stent thrombosis/stroke) and bleeding (TIMI [Thrombolysis in Myocardial Infarction] major/minor) end points. The major secondary end points were the cardiovascular and bleeding end points. Results: Among the 3009 study patients, there were 509 patients (16.9%) with complex PCI (1-month DAPT: N=245, and 12-month DAPT: N=264) and 2500 patients (83.1%) without complex PCI (1-month DAPT: N=1255, and 12-month DAPT: N=1245). There were no significant interactions between the complexity of PCI and the effects of 1-month DAPT versus 12-month DAPT on the primary end point (complex PCI: 1.67% versus 5.32%, hazard ratio, 0.30 [95% CI, 0.10-0.92], P=0.04, and noncomplex PCI: 2.50% versus 3.35%, hazard ratio, 0.75 [95% CI, 0.47-1.20], P=0.23; Pinteraction=0.14), and on the major secondary cardiovascular end point (complex PCI: 1.67% versus 3.04%, hazard ratio, 0.54 [95% CI, 0.16-1.79], P=0.31, and noncomplex PCI: 2.02% versus 2.39%, hazard ratio, 0.86 [95% CI, 0.50-1.47], P=0.58; Pinteraction=0.49). The cumulative 1-year incidence of the major secondary bleeding end point was significantly lower in the 1-month DAPT group than in the 12-month DAPT group regardless of the complexity of PCI (complex PCI: 0% versus 2.29%, log-rank P=0.02, and noncomplex PCI: 0.48% versus 1.38%, log-rank P=0.02). Conclusions: The effects of clopidogrel monotherapy after 1-month DAPT relative to 12-month DAPT for the primary and major secondary end points were comparable in complex PCI and noncomplex PCI without significant interactions. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02619760.

Original languageEnglish
Pages (from-to)469-479
Number of pages11
JournalCirculation: Cardiovascular Interventions
DOIs
Publication statusAccepted/In press - 2021

Keywords

  • clopidogrel
  • drug-eluting stent
  • percutaneous coronary intervention
  • stent
  • thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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