Data from the EXCITE ISR clinical trial presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference show that laser atherectomy (Turbo-Tandem, Spectranetics) used with balloon angioplasty delivers superior results when compared to angioplasty alone in both safety and efficacy.
Eric Dippel, Genesis Heart Institute in Davenport, USA, presented the EXCITE ISR data as part of TCT’s Late-Breaking Clinical Trials.
Critical data findings include:
- 93.5% procedural success rate using Turbo-Tandem with angioplasty (also known as balloon angioplasty) vs. 82.7% with angioplasty alone (p=0.01).
- Primary safety endpoint, major adverse event rates at 30 days 5.8% vs. 20.5% with angioplasty alone (p<0.001).
- Primary efficacy endpoint, 73.5% freedom from target lesion revascularisation at six months vs. 51.8% with angioplasty alone (p<0.005).
- Excimer laser atherectomy with adjunctive angioplasty was associated with a 52% reduction in target lesion revascularisation (hazard ratio 0.48; 95% CI 0.31–0.74).
- Dissection rate of 7.7% vs. 17.2% with angioplasty alone (p=0.03).
- Bailout stenting 4.1% vs. 11.1% with angioplasty alone (p=0.05).
- There was no procedurally related stent damage observed in either cohort.
The study’s average lesion length was approximately 20cm as compared to various stent IDE studies with average lesion lengths of 4 to 6cm. Additionally, a high number of complex or advanced disease-state patients were enrolled in the trial, indicative of success in treating many types of in-stent restenosis lesions, including the most complex cases.
The EXCITE ISR (Excimer laser randomized controlled study for treatment of femoropopliteal in-stent restenosis) is the first large multicentre, prospective randomised trial ever conducted for the treatment of femoropopliteal in-stent restenosis. In July, Spectranetics received an FDA 510(k) indication of its peripheral atherectomy products, Turbo-Tandem and Turbo-Elite, to treat in-stent restenosis.
Dippel states: “When it comes to patient care, physicians demand proven results that exhibit superior outcomes, with safety and efficacy as a priority. With 73.5% freedom from target lesion revascularisation at six months versus 51.8% with angioplasty alone, the data tell the story. The EXCITE results demonstrate that Spectranetics has set a new standard of care for in-stent restenosis.”
