EXCITE ISR Supports Spectranetics Laser Atherectomy System in Femoropopliteal ISR

September 16, 2014—The EXCITE ISR trial, the first large prospective study to examine the effectiveness of laser atherectomy for the treatment of femoropopliteal in-stent restenosis (ISR) found that the procedure, combined with percutaneous transluminal angioplasty (PTA), was more effective than PTA alone. The study was presented at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC.

The EXCITE ISR (Excimer Laser Randomized Controlled Study for Treatment of Femoropopliteal In-Stent Restenosis) was sponsored by Spectranetics Corporation. 

Spectranetics conducted this treatment-to-control trial to show the safety and efficacy of the company’s laser atherectomy system in patients with ISR. The EXCITE ISR data were initially reported in May 2014 at the New Cardiovascular Horizons conference in New Orleans, Louisiana.

As summarized in the TCT press release, the multicenter, prospective, randomized controlled EXCITE ISR trial compared the safety and efficacy of laser atherectomy with adjunctive PTA to PTA alone in the treatment of patients with femoropopliteal ISR. The primary efficacy endpoint was freedom from clinically driven target lesion revascularization (TLR) through 6 months of follow-up. The primary safety endpoint was major adverse events at 30 days, including all-cause mortality, major amputation in the target limb, or TLR. 

Major inclusion criteria included ISR target lesions ≥ 40 mm, vessel diameter between 5 and 7 mm, and Rutherford class I to IV. The trial enrolled 250 patients at 40 clinical sites, randomizing them in 2:1 fashion. A total of 169 subjects were enrolled in the treatment arm (laser atherectomy and PTA), and 81 patients were enrolled in the control arm (PTA alone).

The EXCITE ISR investigators reported that both groups were similar in baseline demographics and lesion characteristics. Lesion length averaged 190 mm, and more than 30% of patients presented with total occlusions. Compared to PTA alone, laser atherectomy with PTA demonstrated superior procedural success (93.5% vs 82.7%; P = .02). Freedom from TLR at 6 months was 73.5% for the laser atherectomy with PTA group compared to 51.8% for the PTA alone group (P < .005). The 30-day major adverse event rates were 5.8% for the laser atherectomy with PTA group compared to 20.8% for the PTA alone group (P < .001). 

Principal Investigator Eric Dippel, MD, commented in the TCT press release, “EXCITE ISR demonstrates that laser atherectomy devices used with PTA are superior to PTA alone in treating even the most complex lesions in patients with femoropopliteal peripheral artery disease. The procedure leads to better outcomes than the current practice and significantly reduces adverse events when treating in-stent restenosis compared to PTA alone.” Dr. Dippel is with the Genesis Heart Institute in Davenport, Iowa.