Initial Results Published for Spectranetics' EXCITE ISR Trial

December 10, 2014—Initial results from the EXCITE ISR (Excimer Laser Randomized Controlled Study for Treatment of Femoropopliteal In-Stent Restenosis) trial were published by Eric J. Dippel, MD, et al online ahead of print in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

The purpose of this study was to evaluate the safety and efficacy of Spectranetics Corporation’s excimer laser atherectomy system with adjunctive percutaneous transluminal angioplasty (ELA + PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR).

The investigators concluded that the EXCITE ISR trial is the first large, prospective, randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR.

As summarized in JACC: Cardiovascular Interventions, the multicenter, prospective, randomized, controlled EXCITE ISR trial was conducted across 40 centers in the United States. Patients with Rutherford class 1 to 4 and lesions of target lesion length ≥ 4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow-up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days after the procedure.

In the EXCITE ISR study, enrollment was stopped at 250 patients because early efficacy was demonstrated at a prospectively specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age, 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age, 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion.

ELA + PTA patients demonstrated superior procedural success (93.5% vs 82.7%; P = .01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (P < .005), and 30-day major adverse event rates were 5.8% versus 20.5% (P < .001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74), reported the investigators in JACC: Cardiovascular Interventions.