Abstract 12539: The Effect of Selective Heart Rate Reduction on Patients with Stable Coronary Artery Disease “Objective 60” a National Multicenter Study
Background: if inhibition constitutes a major advance in the control of Sino Atrial Node (SAN) activity and Ivabradine provides, for the first time, an agent capable of pure heart rate (HR) reduction. There are limited data on the subjective and objective clinical benefits of selective HR reduction in stable coronary artery disease (CAD) patients. We aimed to assess the effect and tolerability of selective HR reduction using Ivabradine given to stable CAD outpatients in everyday routine practice.
Methods: Patients were eligible for participation in this observational, prospective, non-comparative, open label, multicenter study if they presented as outpatients with documented CAD, Patients had to be stable for more than 6 months since diagnosis of angina with resting HR more than 60 bpm. The Primary end-points were resting heart rate (RHR) reduction from baseline and Improvement in exercise treadmill test (ETT) and the Secondary end-points were the Mean change in the SEATTLE Quality of life (QOL) questionnaire scales and the mean investigators’ drug efficacy and acceptability score.
Results: 524 out of the 800 recruited patients completed the 12 weeks of follow up. The mean RHR significantly decreased from 84.3 ± (12.1) bpm on recruitment to 62.6 ± (8.1) bpm at the end of 12 weeks of follow up p<0.0001. The mean time to 1mm ST- Segment depression on ETT significantly increased from 290.2 ± (124.7) sec on recruitment to 431.1 ± (173.9) sec at the end of 12 weeks of follow up p<0.0001. This was associated with highly significant improvement in all the QOL parameters of the SEATTLE QOL questionnaire. The mean Investigator’s Efficacy on ETT Score was 85.9%, the mean Investigator’s Symptoms Improvement Score was 86.1%, and the mean Investigator’s Overall Acceptability Score was 91.2%.
Conclusion: Our results support the importance of HR reduction with ivabradine as an adjuvant therapy in the management of stable CAD patients; it improves the ETT parameters, and the QOL in these patients. Ivabradine is well tolerated and has a lower rate of reported adverse drug reactions in everyday practice as compared with various available reports from controlled trials.
- © 2012 by American Heart Association, Inc.