Boston Scientific Presents Data Supporting Promus Premier and Synergy DES

May 22, 2013—At EuroPCR 2013 in Paris, Boston Scientific Corporation (Natick, MA) reported positive results from the NG PROMUS and the EVOLVE trials, which are evaluating new drug-eluting stent (DES) technologies for the treatment of coronary heart disease.

According to Boston Scientific, the NG PROMUS trial is evaluating the safety and effectiveness in the first-in-human use of the Promus Premier everolimus-eluting platinum chromium coronary stent system. Primary Investigator John Ormiston, MD, of Mercy Angiography in Auckland City, New Zealand presented the 30-day clinical and angiographic outcomes in the NG PROMUS clinical trial.

“The Promus Premier stent demonstrated excellent safety and effectiveness with 0% target lesion revascularization (TLR) and stent thrombosis,” commented Dr. Ormiston in the company’s press release. “In addition, the rate of technical success, the primary endpoint of the trial, was very high at 99.2%. The Promus Premier stent system truly is a major step forward in stent technology.”

The company noted that the Promus Premier features unique stent architecture that provides strength without compromising flexibility. The new-generation Promus device includes an enhanced low-profile delivery system with a shorter, more visible tip, dual-layer balloon, and Bi-Segment inner lumen catheter designed to facilitate precise stent delivery across challenging lesions.

Professor Ian Meredith, MD, Director of MonashHeart, at Monash Medical Center in Melbourne, Australia, presented the 2-year follow-up data from the EVOLVE trial, which is evaluating the safety and effectiveness of the Synergy everolimus-eluting bioabsorbable polymer-coated platinum chromium coronary stent system compared with the company’s Promus Element stent system. The primary clinical and angiographic endpoints of this noninferiority study have already been published.

In the Boston Scientific press release, Prof. Meredith commented, “The clinical results of the Synergy stent in EVOLVE continue to impress with respect to safety and efficacy. At 2 years, we see no increase in the 1.1% TLR and 0% stent thrombosis rates that we observed in the full-dose Synergy stent at 1 year.” Prof. Meredith added, “Interestingly, the difference in TLR between the Promus Element stent at 6.1% and the Synergy stent at 1.1% is approaching statistical significance (P = .07). This is encouraging, as it supports our hypothesis that the bioabsorbable polymer coating could provide a long term benefit over durable polymer-coated DES.”

The Synergy stent features a bioabsorbable polylactic-co-glycolic acid (PLGA) polymer and everolimus drug combination to create a low initial weight, ultra-thin, uniform coating that is applied to the abluminal surface of the stent. The PLGA polymer completes absorption shortly after drug elution ends at 3 months, leaving only a bare platinum chromium stent. The company noted that this technology provides the same level of restenosis reduction as a conventional everolimus-eluting stent while potentially offering faster and more complete vessel healing after stent implantation, which could reduce the required duration of post-procedure dual antiplatelet therapy.

The Promus Premier and Synergy DES devices have CE Mark approval. In the United States and Japan, they are investigational devices and are limited by applicable law to investigational use only and are not available for sale, advised Boston Scientific.