title: 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).
abstract: OBJECTIVE
  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).
authors.affiliation: Genesis Medical Center, Davenport, Iowa. Electronic address: dippel@cvmedpc.com.
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Dippel
authors.affiliation: Cardiology Associates of Northwest Indiana, Munster, Indiana.
authors.forename: Prakash
authors.initials: P
authors.lastname: Makam
authors.affiliation: Deborah Heart and Lung Center, Browns Mills, New Jersey.
authors.forename: Richard
authors.initials: R
authors.lastname: Kovach
authors.affiliation: Deborah Heart and Lung Center, Browns Mills, New Jersey.
authors.forename: Jon C
authors.initials: JC
authors.lastname: George
authors.affiliation: Cardiovascular Clinic of Hattiesburg, Hattiesburg, Mississippi.
authors.forename: Raghotham
authors.initials: R
authors.lastname: Patlola
authors.affiliation: Wellmont Holston Valley, Kingsport, Tennessee.
authors.forename: D Christopher
authors.initials: DC
authors.lastname: Metzger
authors.affiliation: Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Carlos
authors.initials: C
authors.lastname: Mena-Hurtado
authors.affiliation: Division of Radiology, Mount Sinai Heart Institute, Miami Beach, Florida.
authors.forename: Robert
authors.initials: R
authors.lastname: Beasley
authors.affiliation: The Miriam Hospital, Providence, Rhode Island.
authors.forename: Peter
authors.initials: P
authors.lastname: Soukas
authors.affiliation: Centro Cardiovascular de Puerto Rico y el Caribe, San Juan, Puerto Rico.
authors.forename: Pedro J
authors.initials: PJ
authors.lastname: Colon-Hernandez
authors.affiliation: The Spectranetics Corporation, Colorado Springs, Colorado.
authors.forename: Matthew A
authors.initials: MA
authors.lastname: Stark
authors.affiliation: Cardiovascular Institute of the South, Houma, Louisiana.
authors.forename: Craig
authors.initials: C
authors.lastname: Walker
mesh_terms: D000368:Aged; D000497:Alloys; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects* / Q000295:instrumentation* / Q000401:mortality; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D002908:Chronic Disease; D003131:Combined Modality Therapy; D003251:Constriction, Pathologic; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D053685:Laser Therapy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D054018:Lasers, Excimer / Q000009:adverse effects / Q000627:therapeutic use*; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D011150:Popliteal Artery / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014654:Vascular Patency
chemical_list: D000497:Alloys; C013616:nitinol
keywords: excimer laser atherectomy; femoropopliteal artery; in-stent restenosis; percutaneous transluminal angioplasty; peripheral artery disease; randomized controlled trial