At TCT, Paul S Teirstein, Scripps Clinic in La Jolla, California, presented clinical endpoint data from the PLATINUM Long Lesion trial, demonstrating positive outcomes for the Promus Element Everolimus-Eluting Platinum Chromium (PtCr) Stent System (Boston Scientific) in patients with long coronary lesions.
“The Promus Element Stent achieved impressive clinical outcomes in this patient population with long lesions,” said Teirstein, co-principal investigator of the trial. “This durable polymer everolimus-based stent, built on the advanced platinum chromium platform, demonstrated low rates of revascularisation while reporting no myocardial infarction or stent thrombosis at two years, and should offer physicians confidence and flexibility in treating longer lesions with a single stent.”
The PLATINUM Long Lesion study met its primary endpoint of target lesion failure (TLF) at 12 months with a 3.2% rate for the Promus Element Stent in the per protocol population compared to a pre-specified performance goal of 19.4% (p<0.001) based on historical outcomes for the Taxus Express Stent. The Promus Element Stent also demonstrated low event rates through two-year follow-up as evidenced by no myocardial infarction and a 5.2% ischaemia-driven target lesion revascularisation (TLR) rate. There were no ARC definite/probable stent thrombosis events through two years.
The PLATINUM Long Lesion trial compared the Promus Element Stent System in patients with long de novo lesions >24 to /=2.50 to Taxus Express Paclitaxel-Eluting Stent System. The prospective, single-arm trial enrolled 102 patients at 30 sites.
The Promus Element Stent System received the CE mark and was launched in Europe and other international markets in 2009. In November 2011, Boston Scientific announced the launch of the System in the United States. The long lengths of Promus Element Plus were launched earlier this year.