Boston Scientific's 2.25mm Promus Element everolimus-eluting platinum chromium (PtCr) stent system has demonstrated safety and effectiveness in treating de novo coronary lesions in small coronary vessels.
The Promus Element stent system incorporates a low-profile delivery system with a dual-layer balloon and a bi-segment inner lumen catheter to provide precise stent delivery across challenging lesions and minimise balloon growth during inflation, for high-pressure stent deployment.
The two-year Platinum Small Vessel study is a prospective, multicentre, single-arm subtrial of the Platinum clinical programme, designed to assess the safety and efficacy of the Promus Element stent.
The study previously met its primary endpoint of target lesion failure (TLF) at 12 months with a rate of 2.4% for the 2.25mm Promus Element stent, compared to a pre-specified performance goal of 21.1% based on historical outcomes for the 2.25 mm Taxus Express paclitaxel-eluting stent.
The TLF rate at two years was 4.7% with the 2.25mm Promus Element stent, while the rate of target lesion revascularisation (TLR) was 2.5%.
Ian Meredith, MonashHeart director at Monash Medical Centre, Australia, and co-principal investigator for the Platinum clinical programme, said the Platinum Small Vessel data continued to demonstrate very low revascularisation rates, with no myocardial infarction or stent thrombosis through two years of follow up in patients treated with the 2.25mm Promus Element Stent.
"These long-term results are impressive, especially considering the small vessel diameters that were evaluated in this study," Meredith added.
Boston Scientific global chief medical officer, Keith Dawkins, said the Platinum Small Vessel data built on the positive long-term outcomes from the Platinum Workhorse trial, which reported safety and effectiveness of the Promus Element stent in workhorse lesions and demonstrated superior efficacy compared to the Xience stent in a landmark analysis of revascularisation outcomes from year one to year two.
"The results demonstrate a highly effective platinum chromium small vessel stent platform with an excellent safety profile. This study of the 2.25mm Promus Element Stent reconfirms our commitment to providing a complete range of stenting solutions and sizes for physicians and their patients," Dawkins added.
Image: The Promus Element everolimus-eluting platinum chromium stent met its primary endpoint. Photo courtesy of: Boston Scientific.