Debulking and stenting versus debulking only of coronary artery disease in patients treated with cilostazol (final results of ESPRIT)

Abstract

Stenting inhibits vascular constrictive remodeling after directional coronary atherectomy (DCA). Cilostazol has been reported to control neointimal proliferation after stenting. This study’s aim was to examine the effect of debulking and stenting with antirestenotic medication on restenosis. After optimal DCA, 117 lesions were randomly assigned to either the DCA with stent (DCA-stent) (58 lesions) group or the DCA only (59 lesions) group. Multilink stents were implanted in the DCA-stent group. Cilostazol (200 mg/day) without aspirin was administered to both groups for 6 months. Ticlopidine (200 mg/day) was given to the DCA-stent group for 1 month. Serial quantitative angiography and intravascular ultrasound (IVUS) were performed at the time of the procedure and at 6-month follow-up. The primary end point was 6-month angiographic restenosis. Clinical event rates at 1 year were also assessed. Baseline characteristics were similar. All procedures were successful. No adverse effects to cilostazol were observed. Postprocedural lumen diameter was significantly larger (3.27 vs 2.92 mm; p <0.0001) in the DCA-stent group. However, the follow-up lumen diameter was not significantly different (2.53 vs 2.41 mm, DCA-stent vs DCA). IVUS revealed that intimal proliferation was significantly larger in the DCA-stent group (4.2 vs 1.5 mm 2; p <0.0001), which accounted for the similar follow-up lumen area (6.5 vs 7.1 mm 2). The restenosis rate was low in both groups (5.4% vs 8.9%), and the difference was not significant. Clinical event rates at 1 year were also not significantly different. These results suggest that optimal lesion debulking by DCA does not always need adjunctive stenting if cilostazol is administered.