Final 5-Year EVOLVE Data Presented for Boston Scientific's Synergy Stent

May 19, 2016—At the EuroPCR 2016 conference held May 17–20 in Paris, France, the final 5-year results of the EVOLVE trial were announced. The trial evaluated the long-term safety and efficacy of the Synergy bioabsorbable-polymer drug-eluting stent system (Boston Scientific Corporation) for the treatment of patients with de novo coronary artery disease.

Boston Scientific advised that the data, which were presented by Prof. Ian Meredith, MD, reinforce earlier findings of sustained performance of the device. The company noted that the EVOLVE trial is part of a rigorous clinical program, which also includes the global multicenter EVOLVE II pivotal trial and the EVOLVE Short Dual-Antiplatelet Therapy study, which is currently enrolling patients.

The EVOLVE trial evaluated the noninferiority of the Synergy stent compared to a durable-polymer control stent. The prospective, randomized, single-blind, first-in-human-use study evaluated 291 patients with de novo native coronary lesions. It was conducted at 29 sites in Europe, Australia, and New Zealand.

According to Boston Scientific, the data for Synergy showed no stent thrombosis, a very low rate of target lesion revascularization (1.1%), and no significant differences between the Synergy device and the control for the key endpoints of target lesion failure, cardiac death, or myocardial infarction.

Boston Scientific stated that the Synergy stent is designed to deliver more rapid and complete arterial healing and reduce the risk of complications associated with long-term polymer exposure. It features ultrathin stent struts with an abluminal bioabsorbable drug/polymer coating technology that is absorbed shortly after drug elution is complete at 3-months, thereby eliminating long-term polymer exposure.

The Synergy stent received US Food and Drug Administration approval in 2015, and it is commercially available in the United States. Synergy received European CE Mark approval in 2012. It was approved in Japan in early 2016.