title: Three-year follow-up after intravascular gamma-radiation for in-stent restenosis in saphenous vein grafts.
abstract: The Washington Radiation for In-Stent Restenosis Trial in Saphenous Vein Grafts (SVG WRIST) demonstrated safety and efficacy of intravascular radiation therapy (IRT) for the treatment of in-stent restenosis (ISR) in SVG at 12 months. In this study, we aimed to examine whether the safety and efficacy of IRT is durable up to 36 months. One hundred twenty patients with diffuse ISR in SVG underwent balloon angioplasty, laser or atherectomy ablation, and/or additional stenting. After successful intervention, patients were randomly assigned in a double-blind fashion to intravascular treatment with a ribbon containing either iridium (Ir)-192 (n = 60) or nonradioactive seeds (n = 60). The prescribed dose at 2 mm from the source was either 14 or 15 Gy in vessels 2.5-4.0 mm or 18 Gy in vessels > 4.0 mm in diameter. At 36 months, target lesion revascularization (TLR; 43% vs. 66%; P = 0.02) and target lesion revascularization-major adverse cardiac event (TLR-MACE; 49% vs. 71%; P = 0.02) rates continued to be lower in the IRT group, but both target vessel revascularization (TVR; 59% vs. 71%; P = 0.17) and TVR-MACE (63% vs. 77%; P = 0.11) rates were not. In SVG WRIST, patients with ISR treated with IRT had a marked reduction in the need for repeat TLR at 36 months, with sustained clinical benefit at 3 years despite late recurrences, which were more pronounced in the radiation group.
authors.affiliation: Division of Cardiology, Washington Hospital Center, Washington, District of Columbia 20010, USA.
authors.forename: Seung-Woon
authors.initials: SW
authors.lastname: Rha
authors.forename: Pramod
authors.initials: P
authors.lastname: Kuchulakanti
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Ajani
authors.forename: Edouard
authors.initials: E
authors.lastname: Cheneau
authors.forename: Ellen E
authors.initials: EE
authors.lastname: Pinnow
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Canos
authors.forename: Rebecca
authors.initials: R
authors.lastname: Torguson
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: Steven
authors.initials: S
authors.lastname: Ramee
authors.forename: Paul
authors.initials: P
authors.lastname: Teirstein
authors.forename: Joseph
authors.initials: J
authors.lastname: Lindsay
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
mesh_terms: D000368:Aged; D002406:Catheterization, Peripheral; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005720:Gamma Rays / Q000627:therapeutic use*; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011859:Radiography; D012501:Saphenous Vein / Q000637:transplantation*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome