Oct. 23, 2012
/PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports clinical endpoint data from the PLATINUM Long Lesion trial, demonstrating positive outcomes for the PROMUS Element™ Everolimus-Eluting Platinum Chromium (PtCr) Stent System in patients with long coronary lesions. Results were presented today by
Paul S. Teirstein
, M.D., of the Scripps Clinic in
La Jolla, California
, and Co-Principal Investigator of the trial, at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
"The PROMUS Element Stent achieved impressive clinical outcomes in this patient population with long lesions," said Dr. Teirstein. "This durable polymer everolimus-based stent, built on the advanced platinum chromium platform, demonstrated low rates of revascularization 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 percent rate for the PROMUS Element Stent in the per protocol population compared to a pre-specified performance goal of 19.4 percent (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 (MI or heart attack) and a 5.2 percent ischemia-driven target lesion revascularization (TLR) rate. There were no ARC definite/probable stent thrombosis events through two years.
"The PLATINUM Long Lesion two-year data build on the positive outcomes from the PLATINUM Workhorse, Small Vessel and QCA studies, confirming the successful transfer and favorable outcomes associated with everolimus to the novel platinum chromium thin-strut stent design," said
Keith D. Dawkins
, M.D., executive vice president and chief medical officer at Boston Scientific. "These results confirm an effective PtCr long lesion stent platform."
The PLATINUM Long Lesion trial compared the PROMUS Element Stent System in patients with long
lesions (>24 to </=34 mm in length and >/=2.50 to </=4.25 mm in diameter) to a pre-defined performance goal based on historical results in patients treated with the 32 mm TAXUS
Express™ Paclitaxel-Eluting Stent System. The prospective, single-arm trial enrolled 102 patients at 30 sites.
The PROMUS Element Stent System received CE Mark approval and was launched in
and other international markets in 2009. In November of 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. The PROMUS Element Stent features an innovative PtCr alloy and a stent design that offers greater radial strength, exceptional deliverability, and high fracture resistance and 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 placement of the stent across challenging lesions.
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