BACKGROUND:Rotational atherectomy (RA) and cutting balloon angioplasty (CBA) have been shown to effectively dilate in-stent restenosis (ISR). It is not known, however, which of these technique, when followed by beta-radiation, is more effective. Therefore, we performed a prospective randomized study comparing RA and CBA before beta-radiation therapy for diffuse ISR. METHODS:Patients with diffuse ISR were randomly assigned to receive RA (group 1, n = 58) or CBA (group 2, n = 55) before beta-radiation therapy with a rhenium 188-mercaptoacetyltriglycine-filled balloon, with the radiation dose being 18 Gy at a depth of 1.0 mm into the vessel wall. The primary end point was angiographic restenosis at 6 months, and the secondary end point was major adverse cardiac events (myocardial infarction, death, target lesion revascularization) at 9 months. RESULTS: The 2 groups were similar in baseline characteristics. Meanlesion length was 21.0 +/- 11.2 mm in group 1 and 20.8 +/- 10.2 mm in group 2 (P = .77). Radiation was delivered successfully to all patients. We obtained 6-month angiographic follow-up in 90 patients (80%). The rates of angiographic restenosis were 14.9% (7 of 47) in group 1 and 14.0% (6 of 43) in group 2 (P = .89). No patient experienced myocardial infarction or death during the 9-month follow-up period. Rates of target lesion revascularization or major adverse cardiac events were 3.4% in group 1 and 3.6% in group 2 (P = .94) during the 9-month follow-up. CONCLUSIONS: Either RA or CBA, followed by beta-radiation using a rhenium 188-mercaptoacetyltriglycine-filled balloon, is equally safe and effective for diffuse ISR in 6-month angiographic and 9-month clinical outcomes.
RCT Entities:
BACKGROUND: Rotational atherectomy (RA) and cutting balloon angioplasty (CBA) have been shown to effectively dilate in-stent restenosis (ISR). It is not known, however, which of these technique, when followed by beta-radiation, is more effective. Therefore, we performed a prospective randomized study comparing RA and CBA before beta-radiation therapy for diffuse ISR. METHODS:Patients with diffuse ISR were randomly assigned to receive RA (group 1, n = 58) or CBA (group 2, n = 55) before beta-radiation therapy with a rhenium 188-mercaptoacetyltriglycine-filled balloon, with the radiation dose being 18 Gy at a depth of 1.0 mm into the vessel wall. The primary end point was angiographic restenosis at 6 months, and the secondary end point was major adverse cardiac events (myocardial infarction, death, target lesion revascularization) at 9 months. RESULTS: The 2 groups were similar in baseline characteristics. Mean lesion length was 21.0 +/- 11.2 mm in group 1 and 20.8 +/- 10.2 mm in group 2 (P = .77). Radiation was delivered successfully to all patients. We obtained 6-month angiographic follow-up in 90 patients (80%). The rates of angiographic restenosis were 14.9% (7 of 47) in group 1 and 14.0% (6 of 43) in group 2 (P = .89). No patient experienced myocardial infarction or death during the 9-month follow-up period. Rates of target lesion revascularization or major adverse cardiac events were 3.4% in group 1 and 3.6% in group 2 (P = .94) during the 9-month follow-up. CONCLUSIONS: Either RA or CBA, followed by beta-radiation using a rhenium 188-mercaptoacetyltriglycine-filled balloon, is equally safe and effective for diffuse ISR in 6-month angiographic and 9-month clinical outcomes.
Authors: Jochen Wöhrle; Bernd Joachim Krause; Thorsten Nusser; Felix M Mottaghy; Thomas Habig; Matthias Kochs; Jörg Kotzerke; Sven N Reske; Vinzenz Hombach; Martin Höher Journal: Eur J Nucl Med Mol Imaging Date: 2006-06-22 Impact factor: 9.236