Rationale and design of the EVOLVE Short DAPT Study to assess 3-month dual antiplatelet therapy in subjects at high risk for bleeding undergoing percutaneous coronary intervention

Am Heart J. 2018 Nov;205:110-117. doi: 10.1016/j.ahj.2018.08.004. Epub 2018 Aug 17.

Abstract

Background: While extended dual antiplatelet therapy (DAPT) with aspirin and a platelet (P2Y12) inhibitor after percutaneous coronary intervention (PCI) reduces the risk of stent thrombosis (ST) and myocardial infarction (MI), it also increases bleeding. Newer generation drug-eluting stents with bioabsorbable polymer coatings may reduce thrombotic events and allow abbreviated DAPT in selected patients. The EVOLVE Short DAPT study is designed to evaluate the safety of 3-month DAPT in high bleeding risk subjects treated with the SYNERGY bioabsorbable polymer everolimus-eluting stent.

Trial design: EVOLVE Short DAPT is a prospective, single-arm, international study that enrolled 2009 high risk bleeding subjects (defined as age ≥75 years, chronic anticoagulation, major bleeding within 12 months, history of stroke, renal insufficiency/failure, or thrombocytopenia) who underwent PCI with the SYNERGY stent. Subjects presenting with acute MI or complex lesions were excluded. After 3 months treatment with DAPT (except those on anticoagulant in whom aspirin is optional), subjects free from stroke, MI, revascularization or ST will be eligible to discontinue P2Y12 inhibitor, but continue aspirin. Co-primary endpoints assessed between 3-15 months are: i) death/MI compared for non-inferiority with propensity-adjusted historical group receiving 12-month DAPT, and ii) definite/probable ST compared to a performance goal. The secondary endpoint is the rate of bleeding in subjects not receiving chronic anticoagulation compared for superiority against a propensity-adjusted historical control.

Conclusion: The EVOLVE Short DAPT study will prospectively define the safety of DAPT discontinuation at 3 months in high bleeding risk patients treated with the SYNERGY stent.

Trial registration: ClinicalTrials.gov NCT02605447.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aspirin / administration & dosage*
  • Brazil / epidemiology
  • Clopidogrel / administration & dosage*
  • Coronary Artery Disease / complications
  • Coronary Artery Disease / therapy*
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Drug-Eluting Stents*
  • Europe / epidemiology
  • Female
  • Hemorrhage / complications
  • Hemorrhage / epidemiology*
  • Humans
  • Incidence
  • Japan / epidemiology
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention*
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Prospective Studies
  • Risk Factors
  • Treatment Outcome
  • United States / epidemiology

Substances

  • Platelet Aggregation Inhibitors
  • Clopidogrel
  • Aspirin

Associated data

  • ClinicalTrials.gov/NCT02605447