Primary Results of the EVOLVE Short DAPT Study Are Published

March 1, 2021—Findings were published from the EVOLVE Short DAPT trial, which prospectively evaluated the safety of 3-month dual antiplatelet therapy (DAPT) in patients at high bleeding risk treated with the Synergy everolimus-eluting stent (Boston Scientific Corporation). The study by Ajay J. Kirtane, MD, et al is available online ahead of print in Circulation: Cardiovascular Interventions.

Dr. Kirtane, the study’s lead investigator, presented the results at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium.

The investigators noted in Circulation: Cardiovascular Interventions that the design elements of the Synergy stent, which is a thin-strut platinum-chromium stent that elutes everolimus from a thin abluminal layer of bioabsorbable polymer, may facilitate rapid endothelialization and enable shorter-duration DAPT.

As summarized in Circulation: Cardiovascular Interventions, EVOLVE Short DAPT enrolled 2,009 patients at 110 global sites. Patients with acute myocardial infarction or complex lesions were excluded.

After percutaneous coronary intervention, patients were required to take DAPT (aspirin + P2Y12 inhibitor) for 3 months, except those on chronic anticoagulation in whom aspirin was optional. The primary analysis included patients free of events (stroke, myocardial infarction, revascularization, and stent thrombosis) who discontinued P2Y12 inhibitor at 3 months but continued aspirin and had at least 1 year of follow-up or an endpoint event.

Two powered coprimary endpoints were (1) death/myocardial infarction compared with a historical control and (2) study stent–related definite/probable stent thrombosis compared to a performance goal.

The findings were reported as follows:

• The analysis population consisted of 1,487 patients
• The adjusted rate of death/myocardial infarction between 3 and 15 months was 5.6% among patients receiving 3-month DAPT versus 5.7% in the 12-month DAPT control (propensity-adjusted difference = −0.12%; 97.5% upper bound = 1.63%, which was less than the prespecified margin of 2.52; P = .0016 for noninferiority)
• The rate of study stent–related stent thrombosis between 3 to 15 months was 0.2% in the 3-month DAPT group (97.5% upper bound, 0.63%; P = .0005 for comparison to 1% performance goal)

In Circulation: Cardiovascular Interventions, the investigators concluded, “Favorable rates of ischemic outcomes were observed among selected high bleeding risk patients undergoing percutaneous coronary intervention with the Synergy everolimus-eluting stent who tolerated 3 months of P2Y12 inhibitor and then discontinued it, supporting the safety of abbreviated DAPT with this stent platform.”