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Primary Endpoint Results of the EVOLVE Trial: A Randomized Evaluation of a Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Coronary Stent
Study Questions:
What is the safety and efficacy of two dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES), compared with the durable polymer PROMUS Element EES?
Methods:
A total of 291 patients with a de novo lesion ≤28 mm in length, in a coronary artery of ≥2.25 to ≤3.5 mm diameter, were enrolled in the EVOLVE study, a prospective, randomized, single-blind, noninferiority trial. Patients were randomly assigned in a 1:1:1 ratio to PROMUS Element, SYNERGY, or SYNERGY half dose. The primary clinical endpoint was the 30-day rate of target lesion failure, defined as cardiac death or myocardial infarction related to the target vessel, or target lesion revascularization. The primary angiographic endpoint was 6-month in-stent late loss measured by quantitative coronary angiography. This trial was powered for testing of noninferiority for the 6-month primary angiographic endpoint. The criterion for noninferiority was considered to have been met if the upper limit of the one-sided 95.2% confidence interval for the difference between groups was not >0.20 mm.
Results:
The 30-day primary clinical endpoint of target lesion failure occurred in 0%, 1.1%, and 3.1% of patients in the PROMUS Element, SYNERGY, and SYNERGY half-dose groups, respectively. The 6-month in-stent late loss was 0.15 ± 0.34 mm for PROMUS Element, 0.10 ± 0.25 mm for SYNERGY, and 0.13 ± 0.26 mm for SYNERGY half-dose (SYNERGY, difference -0.06, upper 95.2% confidence limit: 0.02, p for noninferiority < 0.001; SYNERGY half-dose, difference -0.03, upper 95.2% confidence limit: 0.05, p for noninferiority < 0.001). Clinical event rates remained low and comparable between groups, with no stent thromboses in any group at 6 months.
Conclusions:
The authors concluded that the EVOLVE trial confirms the effective delivery of everolimus by a unique directional bioabsorbable polymer system utilizing the SYNERGY stent.
Perspective:
In the EVOLVE trial, both dose formulations of the SYNERGY stent were noninferior compared with the PROMUS Element stent for the 6-month angiographic endpoint of in-stent late loss, confirming effective delivery of everolimus by a unique directional bioabsorbable polymer system. Six-month clinical event rates were low, and there were no significant differences among groups. These preliminary results support the safety and efficacy of the abluminal bioabsorbable polymer SYNERGY EES for the treatment of patients with de novo coronary artery disease, but need additional prospective testing in an adequately powered randomized clinical trial with hard clinical endpoints.
Keywords: Coronary Artery Disease, Myocardial Infarction, Coronary Angiography, Thrombosis, Polymers, Immunosuppressive Agents, Confidence Intervals, Sirolimus, Single-Blind Method
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