Filippo Cademartiri1, Jerome Garot2, Michal Tendera3, Jose Luis Zamorano4. 1. Department of Radiology, Erasmus University Medical Center, Wytemaweg 80, 3015 CN Rotterdam, The Netherlands. Electronic address: filippocademartiri@gmail.com. 2. Department of Cardiovascular Magnetic Resonance, Institut Cardiovasculaire Paris Sud, Hospital Jacques Cartier, Generale de Santé, Massy, France. 3. 3rd Division of Cardiology, Medical University of Silesia, Katowice, Poland. 4. Department of Cardiology, University Hospital Ramon y Cajal, Madrid, Spain.
Abstract
BACKGROUND:Low heart rates (HRs) are preferable for coronary CT angiography (CTA). We evaluated the use of an intravenous bolus of ivabradine, a selective sinus node inhibitor, to lower HR before coronary CTA in a prospective, randomized, double-blind, placebo-controlled multicenter trial. METHODS: A total of 370 patients scheduled for CTA, with sinus rhythm ≥70 beats/min but ineligible for intravenous beta-blockers, were randomized to an intravenous bolus of 10 mg (HR, 70-79 beats/min) or 15 mg (HR ≥80 beats/min) ivabradine or placebo. Primary end point was the proportion of patients achieving HR ≤65 beats/min at the initiation of coronary CTA (Ta). RESULTS: Baseline HR was 79 ± 8.5 beats/min. At Ta, HR ≤65 beats/min was achieved in 55% of the ivabradine group vs. 23% for placebo (P < .0001) and in 68% vs. 16% 1-hour after bolus administration (P < .0001). Contrast-enhanced coronary CTA was performed in 87% of the ivabradine group vs. 65% for placebo (P < .0001). Mean HR at Ta was 67 ± 10 beats/min for ivabradine vs. 75 ± 10 beats/min for placebo (P < .0001). Procedural convenience was scored better with ivabradine ("good" or "very good" in 79% vs 63% for placebo; P = .0005). The effective radiation dose of contrast-enhanced CTA was 13 ± 7 mSv for ivabradine vs. 16 ± 7 mSv for placebo (P < .05). Ivabradine was well tolerated. CONCLUSIONS: An intravenous bolus of ivabradine achieves rapid, safe, and sustained HR lowering during coronary CTA, increasing procedural convenience and reducing radiation exposure vs placebo.
RCT Entities:
BACKGROUND: Low heart rates (HRs) are preferable for coronary CT angiography (CTA). We evaluated the use of an intravenous bolus of ivabradine, a selective sinus node inhibitor, to lower HR before coronary CTA in a prospective, randomized, double-blind, placebo-controlled multicenter trial. METHODS: A total of 370 patients scheduled for CTA, with sinus rhythm ≥70 beats/min but ineligible for intravenous beta-blockers, were randomized to an intravenous bolus of 10 mg (HR, 70-79 beats/min) or 15 mg (HR ≥80 beats/min) ivabradine or placebo. Primary end point was the proportion of patients achieving HR ≤65 beats/min at the initiation of coronary CTA (Ta). RESULTS: Baseline HR was 79 ± 8.5 beats/min. At Ta, HR ≤65 beats/min was achieved in 55% of the ivabradine group vs. 23% for placebo (P < .0001) and in 68% vs. 16% 1-hour after bolus administration (P < .0001). Contrast-enhanced coronary CTA was performed in 87% of the ivabradine group vs. 65% for placebo (P < .0001). Mean HR at Ta was 67 ± 10 beats/min for ivabradine vs. 75 ± 10 beats/min for placebo (P < .0001). Procedural convenience was scored better with ivabradine ("good" or "very good" in 79% vs 63% for placebo; P = .0005). The effective radiation dose of contrast-enhanced CTA was 13 ± 7 mSv for ivabradine vs. 16 ± 7 mSv for placebo (P < .05). Ivabradine was well tolerated. CONCLUSIONS: An intravenous bolus of ivabradine achieves rapid, safe, and sustained HR lowering during coronary CTA, increasing procedural convenience and reducing radiation exposure vs placebo.