Two-Year Results Presented for Boston Scientific's PLATINUM Long Lesion Trial at TCT

October 23, 2012—Boston Scientific Corporation (Natick, MA) announced that clinical endpoint data from the PLATINUM Long Lesion (LL) trial demonstrated positive outcomes for the company's Promus Element everolimus-eluting platinum-chromium (PtCr) stent system in patients with long coronary lesions. The study's coprincipal investigator, Paul S. Teirstein, MD, of the Scripps Clinic in La Jolla, California, presented the study findings at the TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida.

The PLATINUM LL trial compared the Promus Element stent system in patients with long de novo lesions (> 24 to ≤ 34 mm in length and ≥ 2.50 to ≤ 4.25 mm in diameter) to a predefined 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," commented Dr. Teirstein. “This durable polymer everolimus-based stent, built on the advanced PtCr platform, demonstrated low rates of revascularization while reporting no myocardial infarction or stent thrombosis at 2 years, and should offer physicians confidence and flexibility in treating longer lesions with a single stent.”

According to the company's press release, the PLATINUM LL 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 prespecified performance goal of 19.4% (P < .001) based on historical outcomes for the Taxus Express stent. The Promus Element stent also demonstrated low event rates through 2-year follow-up as evidenced by no myocardial infarction (MI) and a 5.2% ischemia-driven target lesion revascularization rate. There were no Academic Research Consortium definite/probable stent thrombosis events through 2 years.

The Promus Element stent system received CE Mark approval and was launched in Europe and other international markets in 2009. In November 2011, Boston Scientific launched the system in the United States. The long lengths of the Promus Element Plus were introduced in United States in June 2012.