Journal article
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.
- Mauri L Division of Cardiovascular Medicine/Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: laura.mauri@gmail.com.
- Kirtane AJ Division of Cardiology, Columbia University/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA.
- Windecker S Bern University Hospital, Bern, Switzerland.
- Yeh RW Beth Israel Deaconess Medical Center, Boston, MA, USA.
- Dauerman HL University of Vermont Larner College of Medicine, Burlington, VT, USA.
- Price MJ Scripps Clinic, La Jolla, CA, USA.
- Christen T Boston Scientific Corporation, Marlborough, MA, USA.
- Allocco DJ Boston Scientific Corporation, Marlborough, MA, USA.
- Meredith IT Boston Scientific Corporation, Marlborough, MA, USA.
- Kereiakes DJ The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH, USA. Electronic address: lindner@thechristhospital.com.
- 2018-09-16
Published in:
- American heart journal. - 2018
Aged
Aspirin
Brazil
Clopidogrel
Coronary Artery Disease
Dose-Response Relationship, Drug
Drug Therapy, Combination
Drug-Eluting Stents
Europe
Female
Hemorrhage
Humans
Incidence
Japan
Male
Middle Aged
Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors
Prospective Studies
Risk Factors
Treatment Outcome
United States
English
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.
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.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1016/j.ahj.2018.08.004
- PMID 30218844
- Persistent URL
- https://folia.unifr.ch/global/documents/106934
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