Paul S Teirstein, Scripps Clinic La Jolla, California, USA, presented positive clinical endpoint data from the PLATINUM Long Lesion trial at the Cardiovascular Research Foundation’s annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium (San Francisco, USA, 7−11 November 2011).
The PLATINUM Long Lesion trial compared the Promus Element stent system (Boston Scientific) in patients with long de novo lesions (>24 to less than or equal to 34 mm in length and greater than or equal to 2.50 to less than or equal to 4.25 mm in diameter) to a pre-defined performance goal based on historical results in patients treated with the 32 mm Taxus Express2 Paclitaxel-Eluting stent system. The prospective, single-arm trial enrolled 102 patients at 30 sites.
“The Promus Element stent achieved impressive clinical outcomes in this patient population with long lesions,” said Teirstein, co-principal investigator of the trial. “This everolimus-based stent, built on an advanced platinum chromium platform, demonstrated low rates of revascularisation while reporting no cardiac death, myocardial infarction or stent thrombosis at one year, and should offer physicians greater confidence and flexibility in treating longer lesions with a single stent.”
The PLATINUM Long Lesion study met its primary endpoint of target lesion failure 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. Components of target lesion failure in the per protocol population for the Promus Element stent included cardiac death related to the target vessel (0.0%), myocardial infarction related to the target vessel (0.0%) and ischaemia-driven target lesion revascularisation (3.2%). Clinical outcome rates at 12 months in the intent-to-treat population were low for all death (1.0%), cardiac death (0.0%), myocardial infarction (0.0%), target lesion revascularisation (3.1%) and ARC definite/probable stent thrombosis (0.0 %). Clinical procedural success was achieved in 100% of patients.
“The PLATINUM Long Lesion data build on the positive outcomes from the PLATINUM Workhorse, Small Vessel and QCA studies, confirming the successful transfer of favorable outcomes associated with everolimus to the novel platinum chromium thin-strut stent design,” said Keith D Dawkins, senior vice president and chief medical officer for Boston Scientific’s Cardiology, Rhythm and Vascular Group. “These results demonstrate a highly effective PtCr long lesion stent platform with an excellent safety profile.”
The Promus Element stent system received CE mark approval and was launched in Europe and other international markets in 2009. In February 2011, it was launched in India, and, in October, Boston Scientific announced the commencement of a phased launch in China. The Promus Element stent features an innovative PtCr alloy and new stent design to offer greater radial strength, exceptional deliverability and high visibility. The thin-strut stent is designed for improved conformability, minimal recoil and uniform lesion coverage and drug distribution. The advanced low-profile delivery system, coupled with increased radiopacity, facilitates precise delivery of the stent across challenging lesions.
In the USA, the Promus Element stent is an investigational device, limited by Federal law to investigational use only and not available for sale.