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Patients presenting with in-stent restenosis have an increased risk of need for repeat intervention. Intracoronary brachytherapy is indicated for these patients to prevent recurrent in-stent restenosis. Three intravascular brachytherapy systems are currently FDA-approved for use in patients: one utilizing gamma-radiation (Cordis) and two using beta-radiation (Novoste and Guidant). Current evidence and labeling do not support using intracoronary brachytherapy for prevention of restenosis in de novo lesions. Brachytherapy is absolutely contraindicated in patients unable to take prolonged combination antiplatelet drugs. Aspirin and a thienopyridine should be taken for 6 months if no new stent is placed and 12 months if a new stent is placed. If possible, new stent implementation should be avoided.
Patients presenting with in-stent restenosis have an increased risk of need for repeat intervention. Intracoronary brachytherapy is indicated for these patients to prevent recurrent in-stent restenosis. Three intravascular brachytherapy systems are currently FDA-approved for use in patients: one utilizing gamma-radiation (Cordis) and two using beta-radiation (Novoste and Guidant). Current evidence and labeling do not support using intracoronary brachytherapy for prevention of restenosis in de novo lesions. Brachytherapy is absolutely contraindicated in patients unable to take prolonged combination antiplatelet drugs. Aspirin and a thienopyridine should be taken for 6 months if no new stent is placed and 12 months if a new stent is placed. If possible, new stent implementation should be avoided.
We sought to determine the correlates of failure following intracoronary radiation therapy (IRT) with Sr-90 using the Novoste Beta-Cath system for the treatment of in-stent restenosis (ISR) in a broad range of patients. IRT has been shown to be more efficacious compared to placebo for the treatment of ISR in large randomized trials. However, even in patients treated with IRT, major adverse cardiac events occur in approximately 20% of cases on follow-up. This trial sought to elucidate the correlates of failure following successful IRT for ISR. To determine the correlates of IRT failure, we retrospectively compared the demographics, lesion characteristics, and clinical outcomes of 102 consecutive patients with ISR treated with Sr-90 from September 1998 to July 2001. IRT failure was defined as death, myocardial infarction (MI), or target vessel revascularization (TVR) due to repeat ISR on follow-up. A comparison of the clinical and angiographic profile of IRT failures (n = 16) vs. IRT successes (n = 86) revealed that a history of smoking (75% vs. 40%; P = 0.012), current use of calcium channel blockers (84% vs. 45%; P = 0.013), ostial location of target lesion (44% vs. 16%; P = 0.020), and mean posttreatment minimal luminal diameter (MLD; 1.64 +/- 0.19 vs. 2.21 +/- 0.29 mm; P < 0.001), respectively, were correlated with failure using univariate analysis. After multivariate regression analysis, the correlates of failure that remained significant were treatment of an ostial lesion (OR = 31.2; 95% CI = 2.6-382.7; P = 0.007) and final posttreatment MLD (P < 0.001). Ostial location of target lesion and smaller posttreatment MLD are correlated with subsequent death, MI, and TVR following therapy with Sr-90 for ISR.
The present study examined the role of source-centering and geographical miss in vascular brachytherapy. After implantation of 13 mm long stents, 38 coronary arteries in 13 pigs were randomly assigned to centered brachytherapy (n = 13), eccentric brachytherapy (n = 13), or no radiation (n = 12). Geographical miss was avoided by careful placement of a 27 mm (32)P beta-radiation source. Restenosis was quantified by angiography, histomorphometry, and intravascular ultrasound at 28 days. Source-centering led to a significant (P < 0.001) reduction of in-stent area stenosis (centered radiation, 12% +/- 5%; eccentric radiation, 37% +/- 21%; control arteries, 41% +/- 13%). Despite 7 mm coverage of the edge segments, radiation was found to induce edge stenosis due to neointima formation and constrictive vascular remodeling. We conclude that centered radiation was superior to eccentric radiation in reducing in-stent luminal narrowing while radiation-induced edge stenosis was still observed despite extension of the radiation zone to 7 mm beyond the stent edges.
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