Stenting After Optimal Lesion Debulking (SOLD) Registry

Abstract

Background—Coronary stenting has reduced restenosis in focal de novo lesions, but its impact has been less pronounced in complex lesion subsets. Preliminary data suggest a role for plaque burden in promoting intimal hyperplasia after stent implantation. The aim of this study was to test the hypothesis that plaque removal with directional atherectomy before stent implantation may lower the intensity of late neointimal hyperplasia, reducing the incidence of in-stent restenosis. Methods and Results—Seventy-one patients with 90 lesions underwent directional atherectomy before coronary stenting. Intravascular ultrasound–guided stenting was performed in 73 lesions (81%). Clinical success was achieved in 96% of patients. Procedural complications were as follows: emergency bypass surgery in 1 patient (1.4%), who died 2 weeks later; Q-wave myocardial infarction in 2 patients (2.8%); and non–Q-wave myocardial infarction in 8 patients (11.3%). None of the patients had stent thrombosis at follow-up. Angiographic follow-up was performed in 89% of eligible patients at 5.7±1.7 months. Loss index was 0.33 (95% CI, 0.26 to 0.40), and angiographic restenosis was 11% (95% CI, 5% to 20%). Clinical follow-up was performed in all patients at 18±3 months. Target lesion revascularization was 7% (95% CI, 3% to 14%). Conclusions—Directional atherectomy followed by coronary stenting could be performed with good clinical success rate. Also, these data point to a possible reduction in angiographic restenosis and a significant reduction in the need for repeated coronary interventions. Therefore, a randomized clinical trial seems appropriate to test the validity of this approach.