Author + information
- Received September 5, 2014
- Accepted September 29, 2014
- Published online January 1, 2015.
- Eric J. Dippel, MD∗∗ (, )
- Prakash Makam, MD†,
- Richard Kovach, MD‡,
- Jon C. George, MD‡,
- Raghotham Patlola, MD§,
- D. Christopher Metzger, MD‖,
- Carlos Mena-Hurtado, MD¶,
- Robert Beasley, MD#,
- Peter Soukas, MD∗∗,
- Pedro J. Colon-Hernandez, MD††,
- Matthew A. Stark, PhD‡‡,
- Craig Walker, MD§§,
- EXCITE ISR Investigators
- ∗Genesis Medical Center, Davenport, Iowa
- †Cardiology Associates of Northwest Indiana, Munster, Indiana
- ‡Deborah Heart and Lung Center, Browns Mills, New Jersey
- §Cardiovascular Clinic of Hattiesburg, Hattiesburg, Mississippi
- ‖Wellmont Holston Valley, Kingsport, Tennessee
- ¶Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut
- #Division of Radiology, Mount Sinai Heart Institute, Miami Beach, Florida
- ∗∗The Miriam Hospital, Providence, Rhode Island
- ††Centro Cardiovascular de Puerto Rico y el Caribe, San Juan, Puerto Rico
- ‡‡The Spectranetics Corporation, Colorado Springs, Colorado
- §§Cardiovascular Institute of the South, Houma, Louisiana
- ↵∗Reprint requests and correspondence:
Dr. Eric J. Dippel, Cardiovascular Medicine, PC, Genesis Medical Center, 1236 East Rusholme Street, Davenport, Iowa 52803.
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)
- femoropopliteal artery
- excimer laser atherectomy
- in-stent restenosis
- percutaneous transluminal angioplasty
- peripheral artery disease
- randomized controlled trial
The EXCITE ISR trial was supported by the Spectranetics Corporation. Dr. Dippel is a consultant for and shareholder in the Spectranetics Corporation. Drs. Beasley, George, Kovach and Walker are consultants for the Spectranetics Corporation. Dr. Metzger has received symposium honoraria from the Spectranetics Corporation, Bard, Abbott Vascular, and Boston Scientific; has received payment for teaching courses from Abbott Vascular; and was a proctor for courses with Medtronic. Dr. Stark is an employee of the Spectranetics Corporation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 5, 2014.
- Accepted September 29, 2014.
- 2015 American College of Cardiology Foundation