EXCITE ISR: Laser atherectomy improves outcomes for femoropopliteal in-stent restenosis

One-year data from the EXCITE ISR trial demonstrate that use of excimer laser atherectomy plus percutaneous transluminal angioplasty was safer and more effective compared with percutaneous transluminal angioplasty alone for the treatment of femoropopliteal in-stent restenosis, according to data presented at the New Cardiovascular Horizons’ Global Summit on Advanced Aorto-Iliac and Femoral Intervention for Peripheral Artery Disease.

Researchers for the multicenter, prospective trial randomly assigned 252 patients at 40 sites in a 2:1 ratio to excimer laser atherectomy (Spectranetics) plus percutaneous transluminal angioplasty (ELA + PTA) or PTA alone. The primary safety endpoint was freedom from major adverse events at 30 days, including all-cause mortality, major amputation in the target limb and target lesion revascularization. The primary efficacy endpoint was freedom from TLR at 6 months, according to a press release.

Patients assigned ELA + PTA had fewer major adverse events at 30 days compared with patients assigned PTA alone (5.4% vs. 20.8%; P < .001). In addition, more patients were free from TLR after ELA + PTA compared with PTA alone (78.3% vs. 58.9%; P = .002). ELA + PTA was associated with a 43% reduction in TLR at 1 year (HR = 0.57; 95% CI, 0.38-0.84), according to the release.

In addition, fewer patients assigned ELA + PTA showed residual stenosis and needed bailout stenting. ELA + PTA was associated with a procedural success rate of 92.9% compared with 81.7% for PTA alone (P < .01), according to the release.

“[These data mark] a major milestone for patients who suffer from [femoropopliteal in-stent restenosis],” Craig Walker, MD, chairman of New Cardiovascular Horizons and primary investigator of the EXCITE ISR trial, said in the release. “[The] EXCITE ISR data [show] compelling and durable 12-month clinical results treating incredibly sick patients and sets a new standard of care — one that will change clinical practice. Physicians demand proven solutions, and this transformative trial — the only trial of its kind providing Level 1 data — commands attention from the cardiovascular community on behalf of patients they treat. EXCITE IRS is having a lasting impact on physician protocols while changing lives around the world.”

In July 2014, Spectranetics received an FDA 510(k) indication for its Turbo-Tandem and Turbo-Elite peripheral atherectomy products for the treatment of in-stent restenosis, according to the release.

Reference:

Walker C, et al. Presented at: New Cardiovascular Horizons Annual Conference; May 27-29, 2015; New Orleans.

Disclosure: Walker is primary investigator of the EXCITE ISR trial.