May 23, 2007 — XTENT Inc. announced positive six-month follow-up data from the CUSTOM II clinical trial, which assessed the safety and efficacy of the company's investigational Custom NX drug-eluting stent (DES) system for the treatment of long and multiple lesions in patients with coronary artery disease. Results were presented during the EuroPCR Meeting taking place this week in Barcelona.
The single-arm prospective study evaluated the use of CUSTOM NX in patients with long lesions, defined as greater than 20mm, and patients with two lesions. Of the 100 patients enrolled, 69 patients were enrolled in the long lesion arm, and 31 patients were enrolled in the two-lesion arm of the study.
Up to two customizable stent deployments of up to 60mm total length were evaluated in the study. The primary endpoint was Major Adverse Cardiac Events (MACE) at six months, with clinical follow-up at one, six and 12 months, then annually for five years. Angiographic and intravascular ultrasound (IVUS) follow-up was conducted at six months. The anticoagulation regimen was clopidogrel for a minimum of three months plus aspirin.
At six-month follow-up, the MACE rate was 9 percent. Early adverse events (in hospital) occurred in five patients, including four myocardial infarctions and one death. At six months, four additional patients (4 percent) underwent target lesion revascularization. Angiographic and IVUS results demonstrated in-stent late loss was 0.31mm; in-segment late loss was 0.22mm; binary restenosis rate was 7.5 percent; and the percentage of neointimal volume was 3.3 percent.
"These data are particularly encouraging considering CUSTOM II enrolled one of the most difficult-to-treat patient populations ever studied in a DES trial and also mirrored the complex disease profile physicians are most likely to see among patients presenting today with coronary artery disease," said Professor Eberhard Grube, MD, chief of cardiology at the Helios Heart Center in Siegburg, Germany and principal investigator of the CUSTOM II trial, who presented the data at the annual EuroPCR meeting in Barcelona. "Despite the complexity of patients treated, the Custom NX system allowed for very favorable results."
In the CUSTOM II patient population, the average vessel diameter was 2.57mm and the average lesion length was 28.7mm. Of the 100 patients enrolled in the trial, 26 percent were diabetic. The percentage of patients with ACC/AHA lesion grade B2 or C was 65.1 percent. This trial includes a high percentage of patients with complex lesions and one of the longest average lesion lengths studied of any DES clinical trial.
For more information visit www.xtentinc.com.