Spectranetics Presents EXCITE ISR Data on Laser Atherectomy

June 4, 2014—Spectranetics, Inc. announced that findings from the EXCITE ISR (Excimer Laser Randomized Controlled Study for Treatment of Femoropopliteal In-Stent Restenosis) study demonstrated significant procedural advantage of the company’s laser atherectomy system plus percutaneous transluminal angioplasty (PTA). Principal Investigator Eric J. Dippel, MD, of Genesis Heart Institute in Davenport, Iowa, presented the data at the annual New Cardiovascular Horizons conference, which was held May 28–30, in New Orleans, Louisiana.

According to Spectranetics, the EXCITE ISR study showed a 93.5% procedural success rate with laser atherectomy plus PTA for the treatment of ISR versus 82.7% with PTA alone. The company stated that these findings, which are confirmed by an independent core lab and currently under review by the US Food and Drug Administration, represent the first randomized, multicenter clinical trial results demonstrating the benefits of atherectomy in in-stent restenosis. Study results also show a lower major dissection rate (2.4% vs 7.4% with PTA alone) and additional stenting (4.7% vs 13.6% with PTA alone).
 
In the company’s press release, Dr. Dippel commented, “Notably, the average lesion length was nearly 20 cm in both arms, indicative that this was a true real-world study as opposed to some of the stent IDE studies with average lesion lengths of 4 to 6 cm. In addition, approximately three times as many patients in the laser arm presented with severe calcification as compared to the angioplasty arm.”
 
Spectranetics conducted this treatment-to-control trial to show the safety and efficacy of treatment with laser atherectomy in patients with ISR. The EXCITE ISR trial was initially designed to enroll a maximum of 318 subjects at up to 35 sites and randomized 2:1 treatment to control. The treatment arm is laser atherectomy combined with PTA and the control arm is PTA alone. The primary efficacy endpoint is freedom from target lesion revascularization through 6 months. The primary safety endpoint is freedom from major adverse events (including all-cause mortality, major amputation in the target limb, or target lesion revascularization) at 30 days. 

In February 2014, Spectranetics announced the early success of the trial based on achieving highly significant statistical superiority in both safety and efficacy among 250 patients. In March, the company announced that with the conclusion of enrollment and early success of the EXCITE ISR clinical trial, it was submitting an application to the US Food and Drug Administration for 510(k) clearance of the laser atherectomy system used with PTA in the treatment of in-stent restenosis.