Boston Scientific Corporation has reported positive results from two trials evaluating new, innovative drug-eluting stent (DES) technologies, which are emerging treatment options for coronary heart disease. The data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, and two-year follow-up data from the EVOLVE Trial comparing the safety and effectiveness of the SYNERGY Everolimus-Eluting Bioabsorbable Polymer-Coated Platinum Chromium Coronary Stent System to the PROMUS Element Stent System were presented at the annual EuroPCR Scientific Programme in Paris.
The NG PROMUS Clinical Trial evaluated the clinical and angiographic outcomes for the Promus PREMIER Stent System at 30 days. John Ormiston, MD, of Mercy Angiography, Auckland City, New Zealand is the primary investigator for the trial and presented data at the conference.
"The Promus PREMIER Stent demonstrated excellent safety and effectiveness with zero percent target lesion revascularization and stent thrombosis," said Dr Ormiston. "In addition, the rate of technical success, the primary endpoint of the trial, was very high at 99.2 per cent. The Promus PREMIER Stent System truly is a major step forward in stent technology."
The Promus PREMIER Stent System features the only customized stent architecture of its kind providing strength without compromising flexibility. An enhanced low-profile delivery system with a shorter, more visible tip, dual-layer balloon and Bi-Segment inner lumen catheter is designed to facilitate precise stent delivery across challenging lesions.
Two-year follow-up data from the EVOLVE Trial were also presented at EuroPCR by Professor Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia. The primary clinical and angiographic endpoints of this non-inferiority study, which compares the SYNERGY Stent to the PROMUS Element Stent, have already been published.
"The clinical results of the SYNERGY Stent in EVOLVE continue to impress with respect to safety and efficacy. At two years, we see no increase in the 1.1 per cent target lesion revascularization (TLR) and zero percent stent thrombosis rates that we observed in the full-dose SYNERGY Stent at one year," said Professor Meredith. "Interestingly, the difference in TLR between the PROMUS Element Stent at 6.1 per cent and the SYNERGY Stent at 1.1 per cent is approaching statistical significance (p=0.07). 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 PLGA polymer and everolimus drug combination to create a low initial weight, ultra-thin, uniform coating that is applied to the abluminal (outer) surface of the stent. The proprietary PLGA polymer completes absorption shortly after drug elution ends at three months, leaving only a bare platinum chromium stent. 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 Stent Systems are the latest additions to our growing pipeline of drug-eluting stent technologies," said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. "These innovations reflect our commitment to interventional cardiologists and the patients they serve."
Coronary heart disease is a narrowing of the vessels that supply blood and oxygen to the heart. Patients living with coronary heart disease, also known as coronary artery disease, may experience pain, shortness of breath and fatigue. They may also be at risk for a heart attack. One treatment option is the placement of a stent in the artery to help keep it open and allow the blood to flow more freely.
The Promus PREMIER and SYNERGY Stents 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.
The NG PROMUS Clinical Trial supports the safety and efficacy of the Promus PREMIER Stent System.
EVOLVE is the first human use prospective, randomized, single-blind, study evaluating the non-inferiority of the SYNERGY Stent, which employs a bioabsorbable polymer coating applied to the abluminal (outer) surface of the stent, compared to the Boston Scientific PROMUS Element Stent, which utilizes a durable polymer coating applied to the entire stent (inner and outer) surface.
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