Comparison of angiographic and clinical outcomes between rotational atherectomy versus balloon angioplasty followed by radiation therapy with a rhenium-188-mercaptoacetyltriglycine-filled balloon in the treatment of diffuse in-stent restenosis

Background: The purpose of this study was to compare the efficacy of rotational atherectomy (RA) with simple balloon angioplasty, prior to beta-radiation therapy with a rhenium-188-mercaptoacetyltriglycine (Re-188-MAG,)-filled balloon for diffuse in-stent restenosis (ISR). Methods: After completing 50 cases with RA prior to beta-radiation (Group 1), we performed optimal balloon angioplasty followed by beta-radiation in the next 53 consecutive patients (Group 11) for the treatment of diffuse ISR. The radiation dose was 15 Gy at a depth of 1.0 mm into the vessel wall. Results: The baseline clinical and angiographic characteristics were similar between the two groups. The mean length of the lesion was 25.6 +/- 12.7 mm in Group I and 22.9 +/- 8.6 mm in Group 11 (p=0.26). Radiation was successfully delivered to all patients, with a mean irradiation time of 179 +/- 55 s. The 6-month angiographic restenosis rate was 10% (5150) in Group I versus 33% (17/51) in Group 11 (p=0.007). No adverse event including myocardial infarction, death, or stent thrombosis occurred during the I-year follow-up period. The risk of a target lesion revascularization or a major adverse cardiac event was significantly lower in Group I than in Group 11 (two patients in Group I vs. nine patients in Group 11; OR, 0.20; 95% Cl, 0.04-0.96; p=0.04). Conclusion: Concomitant treatment with rotational atherectomy and beta-irradiation using a Re-188-MAG,-filled balloon for diffuse ISR has a synergistic effect, in terms of 6-month angiographic restenosis and 1-year cardiac event-free survival. (c) 2004 Elsevier Ireland Ltd. All rights reserved.