Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis)
Eric J Dippel, Prakash Makam, Richard Kovach, Jon C George, Raghotham Patlola, D Christopher Metzger, Carlos Mena-Hurtado, Robert Beasley, Peter Soukas, Pedro J Colon-Hernandez, Matthew A Stark, Craig Walker, EXCITE ISR Investigators, Jon Robken, Nicolas Shammas, Ulrich Luft, Jeffrey Goldstein, Gregory Mishkel, Jeffrey Stewart, David Mego, Ian Cawich, Lonnie Harrison, Wail Asfour, Agostino Ingraldi, Louis Salvaggio, Brian Nelson, Thomas Shimshak, Rahul Sakhuja, Grayson Wheatley, Julio Rodriguez, Venkatesh Ramaiah, Nelson Bernardo, Kenneth Kollmeyer, Pablo Uceda, Jack Chamberlin, Tony Das, Robert Foster, James Trimm, Robert Gallino, John Laird, Frank Bunch, Anjan Gupta, Jean Panneton, Deepak Deshmukh, Donald Jacobs, Antonis Pratsos, Sean Janzer, Sarang Mangalmurti, Anvar Babaev, William Eaves, Robert Wilkins, Wayne Falcone, David Weatherford, Jihad Mustapha, Barbara Karenko, John Colleran, Edwin Pérez Marrero, Juan Pastor-Cervantes, M Laiq Raja, Marcel Zughaib, Kalyan Veerina, Robert Menuet, Jayaraman Venkatesan, Robert Lookstein, Ageliki Vouyouka, Mario Rossbach, Jason Yoho, Rahul Bose, Jeff Carr, Richard Lowry, Arthur Lee, James O'Meara, Daniel Van Roy, Eric J Dippel, Prakash Makam, Richard Kovach, Jon C George, Raghotham Patlola, D Christopher Metzger, Carlos Mena-Hurtado, Robert Beasley, Peter Soukas, Pedro J Colon-Hernandez, Matthew A Stark, Craig Walker, EXCITE ISR Investigators, Jon Robken, Nicolas Shammas, Ulrich Luft, Jeffrey Goldstein, Gregory Mishkel, Jeffrey Stewart, David Mego, Ian Cawich, Lonnie Harrison, Wail Asfour, Agostino Ingraldi, Louis Salvaggio, Brian Nelson, Thomas Shimshak, Rahul Sakhuja, Grayson Wheatley, Julio Rodriguez, Venkatesh Ramaiah, Nelson Bernardo, Kenneth Kollmeyer, Pablo Uceda, Jack Chamberlin, Tony Das, Robert Foster, James Trimm, Robert Gallino, John Laird, Frank Bunch, Anjan Gupta, Jean Panneton, Deepak Deshmukh, Donald Jacobs, Antonis Pratsos, Sean Janzer, Sarang Mangalmurti, Anvar Babaev, William Eaves, Robert Wilkins, Wayne Falcone, David Weatherford, Jihad Mustapha, Barbara Karenko, John Colleran, Edwin Pérez Marrero, Juan Pastor-Cervantes, M Laiq Raja, Marcel Zughaib, Kalyan Veerina, Robert Menuet, Jayaraman Venkatesan, Robert Lookstein, Ageliki Vouyouka, Mario Rossbach, Jason Yoho, Rahul Bose, Jeff Carr, Richard Lowry, Arthur Lee, James O'Meara, Daniel Van Roy
Abstract
Objectives: The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR).
Background: Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging.
Methods: The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure.
Results: Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74).
Conclusions: The EXCITE ISR trial is the first large, prospective, randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR. (Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis [EXCITE ISR]; NCT01330628).
Keywords: excimer laser atherectomy; femoropopliteal artery; in-stent restenosis; percutaneous transluminal angioplasty; peripheral artery disease; randomized controlled trial.
Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed