title: Device selection in the treatment of in-stent restenosis with and without radiation (from the Gamma Radiation Trials).
abstract: In-stent restenosis (ISR) is a major limitation of coronary stenting and is associated with high recurrence rates after intervention with all available devices. Intracoronary gamma (gamma) radiation was proved to reduce the recurrence rate after conventional therapy. The purpose of this study was to compare the different devices utilized for the treatment of ISR with and without gamma radiation. To search for the optimal device for the treatment of ISR, 685 patients from the radiation trials for ISR who were randomized to either iridium-192 gamma radiation (559 patients) or placebo (126 patients) following intervention were evaluated. Devices used included balloon percutaneous transluminal coronary angioplasty, excimer laser coronary angioplasty (ELCA), rotational atherectomy, and additional stent implantation. Baseline clinical and angiographic characteristics were similar between the gamma radiation and placebo groups. One- and 6-month clinical and angiographic outcomes were compared. The use of stenting compared with other devices was associated with increased late loss. Device selection used as adjunctive therapy did not influence the 30-day outcome. Patients treated with gamma radiation and placebo therapy had similar rates of composite major adverse coronary events (MACE) (death, Q-wave myocardial infarction, target vessel revascularization) (3% vs 2%, p = NS). At 6 months, MACE rates in irradiated patients were similar among POBA (29%), ELCA (28%), rotational atherectomy (18%), and additional stent implantation (30%, p = NS), and were significantly lower compared with placebo for the entire cohort and for each device subgroup. The overall recurrence rate of ISR was lower in patients treated with gamma radiation using iridium-192 compared with placebo. Device selection did not influence late clinical outcomes in irradiated and nonirradiated groups.
authors.affiliation: Vascular Brachytherapy Institute, Cardiology Research Institute, Washington Hospital Center, Washington, DC 20010, USA.
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Ajani
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
authors.forename: Marco
authors.initials: M
authors.lastname: Zimarino
authors.forename: Hans Soo
authors.initials: HS
authors.lastname: Kim
authors.forename: Augusto D
authors.initials: AD
authors.lastname: Pichard
authors.forename: Lowell F
authors.initials: LF
authors.lastname: Satler
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Kent
authors.forename: R Larry
authors.initials: RL
authors.lastname: White
authors.forename: Ellen
authors.initials: E
authors.lastname: Pinnow
authors.forename: Roxanna
authors.initials: R
authors.lastname: Mehran
authors.forename: Alexandra
authors.initials: A
authors.lastname: Lansky
authors.forename: Joe
authors.initials: J
authors.lastname: Lindsay
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D017130:Angioplasty / Q000295:instrumentation*; D015906:Angioplasty, Balloon, Coronary; D016009:Chi-Square Distribution; D003327:Coronary Disease / Q000401:mortality / Q000532:radiotherapy* / Q000628:therapy; D004307:Dose-Response Relationship, Radiation; D005260:Female; D006801:Humans; D007496:Iridium Radioisotopes / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D055502:Secondary Prevention; D015607:Stents; D016896:Treatment Outcome; D014654:Vascular Patency / Q000528:radiation effects*
chemical_list: D007496:Iridium Radioisotopes