TCT-473 A Randomized Comparison of Biodegradable Polymer- and Permanent Polymer-coated Platinum Chromium Everolimus-Eluting Coronary Stents in China: EVOLVE China Study

Aims: The EVOLVE China randomised study sought to evaluate the clinical safety and effectiveness of the SYNERGY bioabsorbable polymer-coated everolimus-eluting stent (EES) for the treatment of patients with coronary heart disease in China. Methods and results: Eligible patients with de novo native coronary artery lesions were randomised (1: 1) to receive the SYNERGY or PROMUS Element Plus stent. The primary endpoint was in-stent late loss at nine months. Secondary endpoints included death, MI, revascularisation, and stent thrombosis up to 12 months. A total of 412 subjects were randomised (205 SYNERGY; 207 PROMUS Element Plus) at 14 sites in China from October 2013 to July 2014. SYNERGY was non-inferior to PROMUS Element Plus for the primary endpoint of nine-month in-stent late loss: SYNERGY 0.20 +/- 0.33 mm vs. PROMUS Element Plus 0.17 +/- 0.38 mm with an upper one-sided 97.5% confidence interval of the difference (0.10 mm), significantly less than the non-inferiority margin (0.15 mm; pl0.0008). Clinical adverse event rates were low and not significantly different between groups at nine and 12 months (all pg0.05). Conclusions: In the EVOLVE China trial, the SYNERGY bioabsorbable polymer-coated EES was noninferior to the PROMUS Element Plus permanent polymer-coated EES for the primary endpoint of late loss at nine months.