Favourable rates of ischaemic outcomes were observed among selected high bleeding risk patients who underwent percutaneous coronary intervention (PCI) with the Synergy everolimus-eluting stent (Boston Scientific) who received a three-month course of dual antiplatelet therapy (DAPT).
This is according to the primary results of the EVOLVE Short DAPT clinical trial, which were published online in the journal Circulation: Cardiovascular Interventions this week. Study authors Ajay Kirtane (Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, USA) et al write that the findings support the safety of abbreviated DAPT using the Synergy stent platform.
Prolonged DAPT after PCI is associated with increased bleeding, despite a reduction of ischaemic events, Kirtane et al note in the study. The Synergy everolimus-eluting stent is designed to facilitate rapid endothelialisation and enable shorter-duration DAPT by incorporating a thin-strut platinum-chromium stent that elutes everolimus from a thin abluminal layer of bioabsorbable polymer.
EVOVLE Short DAPT prospectively evaluated the safety of a three-month DAPT regime in high bleeding risk patients who were treated with the Synergy stent system, enrolled at 110 sites worldwide since 2009.
Excluding those with acute myocardial infarction or complex lesions, the study required patients to undergo DAPT—aspirin + P2Y12 inibitor—for three months, except those on chronic anticoagulation, in whom aspirin was optional. The analysis also includes patients free of events (stroke, myocardial infarction, revascularisation, and stent thrombosis) who discontinued P2Y12 inhibitor at three months, but continued aspirin, and had at least one year of follow-up or an endpoint event.
Primary endpoints include death or myocardial infarction compared with a historical control and study stent-related definite or probable stent thrombosis compared to a performance goal. In total 1,487 patients were included in the analysis.
Kirtane et al report that the adjusted rate of death/myocardial infraction between three and 15 months was 5.6% among patients receiving three-month DAPT, versus 5.7% in the 12-month DAPT control group, while the rate of study stent-related stent thrombosis between three‒15 months was 0.2% in the three-month DAPT group.
Summarising the findings, Kirtane et al write: “Favourable rates of ischaemic outcomes were observed among selected high bleeding risk patients undergoing percutaneous coronary intervention with the Synergy everolimus-eluting stent who tolerated three months of P2Y12 inhibitor and then discontinued it, supporting the safety of abbreviated DAPT with this stent platform.”