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, Laura; Kirtane, Ajay J; Windecker, Stephan; Yeh, Robert W; Dauerman, Harold L; Price, Matthew J; Christen, Thomas; Allocco, Dominic J; Meredith, Ian T; Kereiakes, Dean J (2018). 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. American Heart Journal, 205, pp. 110-117. Elsevier 10.1016/j.ahj.2018.08.004

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BACKGROUND While extended dual antiplatelet therapy (DAPT) with aspirin and a platelet (P2Y) 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 P2Y 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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0002-8703

Publisher:

Elsevier

Language:

English

Submitter:

Nadia Biscozzo

Date Deposited:

18 Feb 2019 11:24

Last Modified:

05 Dec 2019 06:28

Publisher DOI:

10.1016/j.ahj.2018.08.004

PubMed ID:

30218844

BORIS DOI:

10.7892/boris.125205

URI:

https://boris.unibe.ch/id/eprint/125205

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