Final five-year clinical outcomes in the EVOLVE trial: A randomised evaluation of a novel bioabsorbable polymer-coated everolimus-eluting stent.

Abstract

Aims: The SYNERGY stent has a unique design to enhance optimal intravascular healing. The EVOLVE study compared the performance of the bioabsorbable polymer SYNERGY everolimus-eluting stent (EES at 2 doses) to the permanent polymer PROMUS Element EES. Methods and Results: The EVOLVE trial was a prospective,multicentre, randomised, controlled first human use trial enrolling patients with a de novo lesion <=28 mm in length in a coronary artery >=2.25 and <=3.5 mm in diameter. Patients were randomised 1:1:1 to treatment with one of three stents: PROMUS Element (N=98), SYNERGY stents releasing everolimus at an equivalent dose to PROMUS Element ("SYNERGY" group; N=94) and SYNERGY stents releasing half-dose everolimus ("SYNERGY 1/2 Dose" group; N=99). The primary clinical endpoint was 30-day target lesion failure (defined as target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularisation). At 30 days, the rate of TLF was not significantly different among groups; 0% in the PROMUS Element arm, 1.1% with SYNERGY, and 3.1% in the SYNERGY 1/2 Dose group (PROMUS Element: vs SYNERGYP=0.49; vs SYNERGY 1/2 Dose P=0.25). The primary angiographic endpoint of 6-month in-stent late loss was non-inferior between the control and SYNERGY groups (0.15+/-0.34 mm for PROMUS Element, 0.10+/-0.25 mm for SYNERGY, and 0.13+/-0.26 mm for SYNERGY 1/2 Dose; PROMUS Element: vs SYNERGY P=0.19; vs SYNERGY 1/2 Dose P=0.56). Four-year clinical event rates including TLF, TVF, death, MI and revascularisation were low and not significantly different between groups. At 4 years, the rate of TLF was 8.4% in the PROMUS Element group, 5.5% in the SYNERGY group and 5.2% in the SYNERGY 1/2 Dose group (PROMUS Element: vs SYNERGY P=0.64; vs SYNERGY 1/2 Dose, P=0.59). No TLF events were reported between 2 to 4 years of follow-up in either SYNERGY cohort. TVF at 4 years was 12.4% in the PROMUS Element group, 7.7% in the SYNERGY group and 8.3% in the SYNERGY 1/2 Dose group (PROMUS Element: vs SYNERGY P=0.40; vs SYNERGY 1/2 Dose, P=0.53). No stent thromboses were found in any group at 4 years. Conclusion(s): Short-term comparisons of SYNERGY to permanent polymer DES in EVOLVE have shown non-inferiority for TLF but the ultimate goal of the SYNERGY design for optimal healing is a significant long-term benefit. Results to 4 years in the EVOLVE trial have demonstrated comparable clinical outcomes with the PROMUS Element and SYNERGY platforms. This will be the first presentation of any 5-year clinical results with the SYNERGY stent.