BACKGROUND: The potential exists for microcirculatory impairment during rotational coronary atherectomy (RA) due to embolization of plaque debris, platelet aggregation, or vasospasm. This prospective randomized pilot study aimed to confirm favorable effects of nicorandil during RA compared with verapamil. METHODS: We randomly assigned 200 patients with 219 coronary lesions planned to undergoRA with intracoronary infusion of nicorandil cocktail (100 patients, 109 lesions), which contained nicorandil 24 mg, nitroglycerin 5 mg, and heparin 10,000 U in 1000 mL saline, or verapamil cocktail (100 patients, 110 lesions), which contained verapamil 10 mg instead of nicorandil. Drug cocktails were infused through a 4F Teflon sheath of the rotablator system during RA. The primary end point was incidence of no-reflow/slow-flow phenomenon; secondary end points were those of continuous ST elevation, Q-wave myocardial infarction (MI), and non-Q-wave MI. RESULTS: Group baseline and coronary angiographic characteristics were similar. Rotational atherectomy was performed successfully, and no patients died or required emergency coronary artery bypass grafting. Incidence of no-reflow/slow-flow phenomenon was significantly lower in the nicorandil group (nicorandil 5/109 lesions, verapamil 13/110 lesions, P < .005). Incidences of persistent ST-segment elevation and non-Q-wave MI were significantly lower in the nicorandil group (ST-segment elevation: nicorandil 3/100 patients, verapamil 10/100 patients, P < .05; non-Q-wave MI: nicorandil 2/100, verapamil 9/100 patients, P < .05). One patient each in the 2 groups experienced Q-wave MI. CONCLUSION: Our findings suggest that continuous intracoronary infusion of nicorandil during RA prevents acute periprocedural complications. Nicorandil should be used as adjunctive treatment during RA.
RCT Entities:
BACKGROUND: The potential exists for microcirculatory impairment during rotational coronary atherectomy (RA) due to embolization of plaque debris, platelet aggregation, or vasospasm. This prospective randomized pilot study aimed to confirm favorable effects of nicorandil during RA compared with verapamil. METHODS: We randomly assigned 200 patients with 219 coronary lesions planned to undergo RA with intracoronary infusion of nicorandil cocktail (100 patients, 109 lesions), which contained nicorandil 24 mg, nitroglycerin 5 mg, and heparin 10,000 U in 1000 mL saline, or verapamil cocktail (100 patients, 110 lesions), which contained verapamil 10 mg instead of nicorandil. Drug cocktails were infused through a 4F Teflon sheath of the rotablator system during RA. The primary end point was incidence of no-reflow/slow-flow phenomenon; secondary end points were those of continuous ST elevation, Q-wave myocardial infarction (MI), and non-Q-wave MI. RESULTS: Group baseline and coronary angiographic characteristics were similar. Rotational atherectomy was performed successfully, and no patients died or required emergency coronary artery bypass grafting. Incidence of no-reflow/slow-flow phenomenon was significantly lower in the nicorandil group (nicorandil 5/109 lesions, verapamil 13/110 lesions, P < .005). Incidences of persistent ST-segment elevation and non-Q-wave MI were significantly lower in the nicorandil group (ST-segment elevation: nicorandil 3/100 patients, verapamil 10/100 patients, P < .05; non-Q-wave MI: nicorandil 2/100, verapamil 9/100 patients, P < .05). One patient each in the 2 groups experienced Q-wave MI. CONCLUSION: Our findings suggest that continuous intracoronary infusion of nicorandil during RA prevents acute periprocedural complications. Nicorandil should be used as adjunctive treatment during RA.
Authors: Paul Bamford; Michael David Parkinson; Brendan Gunalingam; Michael David; George Tat-Ming Lau Journal: Clin Med Insights Cardiol Date: 2019-06-07