September 26, 2019
EVOLVE Short DAPT Study Shows Low Rate of Adverse Events in High-Bleeding Risk Patients
September 26, 2019—The Cardiovascular Research Foundation (CRF) announced that results from the EVOLVE Short DAPT study were presented by lead investigator Ajay J. Kirtane, MD, at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, which is sponsored by CRF and held September 25–29 in San Francisco, California.
According to CRF, data from the study demonstrated that shortened 3-month dual antiplatelet therapy (DAPT) did not increase myocardial infarction (MI) or stent thrombosis in high bleeding risk (HBR) patients treated with a contemporary drug-eluting stent (Synergy thin-strut platinum-chromium stent; Boston Scientific Corporation).
Synergy elutes everolimus from an ultrathin abluminal layer of a bioabsorbable polymer. The device's drug release and polymer degradation are complete within 4 months of implantation. These design elements may facilitate endothelialization and enable shorter duration DAPT than used in pivotal approval trials.
The study enrolled 2,009 HBR patients at 110 sites around the world. Patient characteristics included age ≥ 75 years, with bleeding risk outweighing benefit of DAPT > 3 months, chronic anticoagulation, major bleeding within 12 months, history of stroke, thrombocytopenia, or renal insufficiency/failure. Patients with acute MI or complex lesions were excluded.
After undergoing percutaneous coronary intervention, patients were required to take DAPT (aspirin + P2Y12 inhibitor) for 3 months, except those on chronic anticoagulant in whom aspirin was optional. Event-free patients (stroke, MI, revascularization, stent thrombosis) who discontinued the P2Y12 inhibitor at 3 months, but continued aspirin between 3 and 15 months, were included in the primary analysis.
Clinical follow-up at 3 months was 95.2% (n = 1,912). Of those, 77.7% (n = 1,487) were eligible to discontinue the P2Y12 inhibitor.
The analysis population for the secondary endpoint (bleeding academic research consortium [BARC] 2, 3, or 5 bleeding) was 1,032 because 455 patients were excluded because they were on anticoagulation.
One coprimary endpoint assessed death or MI between 3 and 15 months postprocedure compared for noninferiority to a propensity-adjusted historical limus-eluting stent control group receiving 12-month DAPT.
Dr. Kitane the reported the following results:
- The event rate for patients who received 3-month DAPT (n = 1,454) was 5.6% versus 5.7% in the historical control group receiving 12-month DAPT (n = 1,493; noninferiority P = .0016).
- The second coprimary endpoint of Academic Research Consortium definite/probable stent thrombosis in patients with 3-month DAPT between 3 and 15 months was also met with an incidence of 0.3% compared to a 1.0% performance goal (noninferiority P < .0001).
- The secondary endpoint was the rate of BARC 2/3/5 bleeding in patients compared for superiority to the propensity-adjusted historical control.
- The rate of BARC 2/3/5 bleeding in patients receiving 3-month DAPT (n = 974) was 6.26% compared to 4.17% in the 12-month DAPT group (n = 947) (2.1%; 95% CI, -0.10 to 4.29; P = .98).
Dr. Kirtane commented in the CRF press release, “These data prospectively demonstrate a low rate of adverse events for patients who are at high risk for bleeding and who then stop DAPT at 3 months. This is critically important information because the required duration of DAPT following implantation of current generation drug-eluting stent platforms was previously unknown. These data better inform physicians on how best to tailor the recommended duration of DAPT to the bleeding risk of the patients they treat.”