Background: While stent restenosis and late thrombosis still occur even with drug-eluting-stents (DES), there remains a need to explore other strategies for preventing restenosis.
Methods and results: Five hundred and twenty-one patients were randomized: 260 to cutting-balloon angioplasty (CBA) before bare-metal stent (CBA-BMS) and 261 to balloon-angioplasty (BA) before BMS (BA-BMS). Intravascular ultrasound (IVUS)-guided procedures were performed in 279 (54%) patients and angiographic guidance was used in the remainder. Minimal lumen diameter was significantly greater in CBA-BMS than BA-BMS (2.65+/-0.40 mm vs 2.52+/-0.4 mm, p<0.01) and % diameter stenosis (%DS)-post was less in CBA-BMS than BA-BMS (14.0+/-5.9% vs 16.3+/-6.8%, p<0.01). %DS-follow-up was subsequently less in CBA-BMS than BA-BMS (32.4+/-15.1% vs 35.4+/-15.3%, p<0.05) associated with lower rates of restenosis in CBA-BMS than BA-BMS (11.8% vs 19.6%, p<0.05) and less target lesion revascularization (TLR) in CBA-BMS than BA-BMS (9.6% vs 15.3%, p<0.05). Patients were divided into 4 groups based on the device used before stenting and IVUS use (IVUS-CBA-BMS: 137 patients; Angio-CBA-BMS: 123; IVUS-BA-BMS: 142; and Angio-BA-BMS: 119). At follow-up IVUS-CBA-BMS had a significantly lower restenosis rate (6.6%) than Angio-CBA-BMS (17.9%), IVUS-BA-BMS (19.8%) and Angio-BA-BMS (18.2%, p<0.05).
Conclusions: Restenosis and TLR were significantly lower in CBA-BMS than BA-BMS. This favorable outcome was achieved because of the lower restenosis rate conferred by the IVUS-guided-CBA-BMS strategy (6.6%). The restenosis rates obtained with this strategy were comparable to those achieved with DES.