Key result
Vascular brachytherapy with 192Ir reduced 1-year major cardiac events compared to placebo (42% with 15 Gy vs 63%, P<0.05), with further reduction using 18 Gy (22%, P<0.05 vs 15 Gy).
Why the study?
Does vascular brachytherapy with 192Ir reduce major cardiac events and angiographic restenosis in patients with diffuse in-stent restenosis?
RCT (n=240)
randomized
Does vascular brachytherapy with 192Ir reduce major cardiac events and angiographic restenosis in patients with diffuse in-stent restenosis?
Absolute Event Rate: 42% vs 63%
p-value: p=<0.05
Vascular brachytherapy with 192Ir significantly reduces angiographic restenosis and major cardiac events in patients with diffuse in-stent restenosis, with higher doses and prolonged antiplatelet therapy offering greater benefit.
Supports brachytherapy for diffuse in-stent restenosis; confirms dose-dependent event reduction in RCT.
BACKGROUND: The Washington Radiation for In-Stent Restenosis Trial for long lesions (Long WRIST) was designed to determine the safety and efficacy of vascular brachytherapy for the treatment of diffuse in-stent restenosis. METHODS AND RESULTS: A total of 120 patients with diffuse in-stent restenosis in native coronary arteries (lesion length, 36 to 80 mm) were randomized for either radiation with 192Ir with 15 Gy at 2 mm from the source axis or placebo. After enrollment, 120 additional patients with the same inclusion criteria were treated with 192Ir with 18 Gy and included in the Long WRIST High Dose registry. Antiplatelet therapy was initially prescribed for 1 month and was extended to 6 months in the last 60 patients of the Long WRIST High Dose registry. At 6 months, the binary angiographic restenosis rate was 73%, 45%, and 38% in the placebo, 15 Gy, and 18 Gy radiated groups, respectively (P<0.05). At 1 year, the primary clinical end point of major cardiac events was 63% in the placebo group and 42% in the radiated group with 15 Gy (P<0.05). The major cardiac event rate was further reduced with 18 Gy (22%; P<0.05 versus 15 Gy). Late thrombosis was 12%, 15%, and 9% in the placebo group, 15 Gy group with 1 month of antiplatelet therapy, and 18 Gy group with 6 months of antiplatelet therapy, respectively. CONCLUSIONS: Vascular brachytherapy with 192Ir is safe and reduces the rate of recurrent restenosis in diffuse in-stent restenosis. The efficacy of vascular brachytherapy on angiographic and clinical outcomes is enhanced with a radiation dose of 18 Gy and prolonged antiplatelet therapy.
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Waksman et al. (2003) conducted an RCT in Diffuse in-stent restenosis (n=240). Vascular brachytherapy with 192Ir vs. Placebo was evaluated on Major cardiac events at 1 year (p=<0.05). Vascular brachytherapy with 192Ir reduced 1-year major cardiac events compared to placebo (42% with 15 Gy vs 63%, P<0.05), with further reduction using 18 Gy (22%, P<0.05 vs 15 Gy).