EXCITE ISR: Laser Atherectomy Superior to Angioplasty Alone for Femoropopliteal In-Stent Restenosis

Addition of laser atherectomy provides better short-term results than balloon angioplasty alone in patients with restenosis in peripheral stents. In fact, the randomized, multicenter EXCITE ISR trial comparing both approaches was stopped early after analysis showed superiority of laser atherectomy, Eric J. Dippel, MD, of the Genesis Heart Institute in Davenport, Iowa, reported at TCT 2014.

Out of a planned total of 335 patients, the trial randomized 250 patients with restenosis in femoropopliteal stents in a 2:1 ratio to angioplasty with (n=169) or without (n=81) prior atherectomy using a Turbo Elite or Turbo Tandem excimer laser catheter (Spectranetics).

The combination strategy showed better procedural success in terms of events, including dissection, bailout stenting, procedural target lesion revascularization (TLR), embolization, thrombosis and abrupt closure (see Figure).

Additionally, the primary safety endpoint of freedom from major adverse events at 30 days was higher with laser atherectomy (94.2% vs. 79.2%; P<.001) as was the primary efficacy endpoint of freedom from TLR through 6 months (73.5% vs. 51.8%; P<.005) compared with balloon angioplasty alone. “Whether intention-to-treat, minus the bailout stenting or per-protocol analyses, [the primary safety and efficacy endpoints] all favored the laser group,” Dippel said.

Cox proportional hazards analysis also favored adjunctive use of laser atherectomy over percutaneous transluminal angioplasty alone across numerous subgroups, including older age and previous in-stent restenosis. The only subgroup that did not reach statistical significance was patients with diabetes, although there was a trend in favor of the laser group, Dippel said.

‘New standard of care’ 

“The EXCITE ISR trial is the first large, prospective, randomized study to show the superiority of laser atherectomy plus percutaneous transluminal angioplasty vs. [balloon angioplasty] alone for the treatment of in-stent restenosis in femoropopliteal peripheral arterial disease,” Dippel told TCT Daily. “It is a landmark study that we believe will establish a new standard of care in the treatment of [in-stent restenosis].”

Noting that the study results led to recent FDA approval of the device for this indication, Dippel added that “all other treatment methods are either not indicated or contraindicated.” He concluded, “The trial results provide physicians [with] clinical outcomes-based evidence to treat this complicated patient population.”

Participants in the trial had Rutherford class 1 to 4 disease, total target treatment length ≥4 cm, vessel diameter ranging from 5 to 7 mm, and fully crossable lesions. Lesions averaged 19 cm in length, and 30% were total occlusions. The groups were similar with regard to baseline demographics and lesion characteristics. Almost two-thirds were men (62%), 47% had diabetes, and 32% had a history of in-stent restenosis. 

Disclosures: 

Dippel reports being a shareholder and consultant for Spectranetics and receiving consultant fees/honoraria from Abbott Vascular, Boston Scientific, Covidien and Spectranetics.