Boston Scientific has released data from its Platinum QCA study, designed to evaluate Promus Element Everolimus-Eluting Platinum Chromium Coronary Stent.
The Promus Element Stent features a new Platinum chromium (PtCr) alloy and new stent design, which combine to offer greater radial strength and flexibility while reducing stent recoil.
Boston Scientific claimed that the stent geometry helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system.
The study results provided 30-day and nine-month clinical outcomes and nine-month quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) data supporting the safety and efficacy of the Promus Element Stent.
The Platinum QCA primary endpoint of 30-day composite cardiac events was 1%, which included target lesion revascularisation (TLR, 1%) and stent thrombosis (ARC definite/probable, 1%).
The study also met its pre-specified efficacy endpoint of in-stent late loss in workhorse lesions at nine months as measured by QCA compared to historical Taxus Express Stent data.
The study met a second pre-specified efficacy endpoint of post-procedure incomplete stent apposition as measured by IVUS compared to Promus (Xience V) data from the Spirit III trial.
Principal investigator of the Platinum QCA study Ian Meredith said that with the same drug and polymer loading and comparable release kinetics as the Promus Stent, the Promus Element Stent achieved similar late loss and better stent apposition.
Boston Scientific Cardiology vice president and chief medical officer Keith Dawkins said that the Platinum QCA results further support the performance of the Everolimus drug/polymer combination while demonstrating a highly effective Platinum chromium Promus Element Stent platform.