Boston Scientific has reported positive, long-term data from the EVOLVE Trial of the Synergy everolimus-eluting bioabsorbable polymer platinum chromium coronary stent system, with no new major adverse cardiac events reported between years three and four. The study results were presented for the first time at EuroPCR 2015 (19–22 May, Paris, France) by Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia.
Boston Scientific has reported positive, long-term data from the EVOLVE trial of the Synergy everolimus-eluting bioabsorbable polymer platinum chromium coronary stent system, with no new major adverse cardiac events reported between years three and four. The study results were presented for the first time at EuroPCR 2015 (19–22 May, Paris, France) by Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia.
Findings from year four of the EVOLVE trial include the following key performance measures:
- the target lesion revascularisation rate was 1.1% compared with 6.1% for the PROMUS element plus stent system (p=0.07); and
- no definite or probable stent thrombosis was observed.
“These long-term data from the EVOLVE trial are quite important as they highlight the sustained safety and performance of Synergy,” said Meredith. ”We continue to be encouraged by the consistently positive clinical data that point to the potential for improved healing with Synergy compared to durable polymer drug-eluting stents.”
The EVOLVE trial is the first human use, prospective, randomised, single-blind study evaluating the non-inferiority of the Synergy stent, which employs an ultrathin bioabsorbable polymer coating applied to the abluminal surface of the stent. The comparator, the Promus element plus stent system (Boston Scientific), utilises a durable polymer coating applied to the entire stent (inner and outer) surface. EVOLVE is the first in a continuing cadence of clinical trials evaluating the performance of the Synergy stent in a range of patients.
In addition to these long-term data from the EVOLVE trial, one-year findings from the EVOLVE II pivotal trial of 466 patients with diabetes treated with the Synergy stent were presented by Stephan Windecker chief of cardiology and head of invasive cardiology at the Swiss Cardiovascular Center in Bern, Switzerland. Patients with diabetes face an increased risk of heart disease, stroke and myocardial infarction. The data presented for patients with diabetes include the following:
- the target lesion revascularisation rate was 4.4%; and
- definite/probable stent thrombosis was 1.1% at one year, with no definite/probable stent thrombosis events after the first week post percutaneous coronary intervention.
The EVOLVE II trial includes a global, multicentre, randomised, single-blind, non-inferiority pivotal trial designed to evaluate the safety and performance of the Synergy stent system compared to the durable polymer PROMUS system. The trial enrolled 1,684 patients in 125 sites worldwide. The EVOLVE II trial is part of a rigorous clinical programme designed to support the submission for US Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the Synergy stent.
The trial also includes a non-randomised, single-arm diabetes study. The EVOLVE II Diabetes Substudy pooled patients with diabetes randomised to the Synergy arm in the EVOLVE II pivotal trial with patients enrolled in the non-randomised single-arm diabetes study as pre-specified in the study protocol.
Patients in the EVOLVE II trial demonstrated clinical and angiographic complexity to a degree not observed in prior US pivotal trials for drug-eluting stents. More than 25% of patients had non-ST elevation myocardial infarction (NSTEMI) and approximately 75% of patients had AHA/ACC class B2/C coronary lesions. As previously reported, EVOLVE II met its primary endpoint, demonstrating non-inferiority of Synergy versus Promus for 12-month target lesion failure in the overall patient population.
“These long-term data, combined with the data for a particularly challenging group of patients—those with co-morbid diabetes—reinforce our belief in the difference SYNERGY can make for physicians and their patients,” said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. “The Synergy stent is designed to provide early healing and freedom from long-term polymer exposure, and we are confident that clinical studies and experience will continue to demonstrate excellent long-term outcomes.”