Key result
Ivabradine did not significantly affect all-cause mortality (RR 1.04; 95% CI 0.96 to 1.13) or quality of life in patients with angina pectoris, but increased the risk of serious adverse events.
Why the study?
The impact of ivabradine on outcomes important to patients with angina pectoris caused by coronary artery disease remained to be determined.
Does ivabradine improve mortality, serious adverse events, and quality of life in patients with angina pectoris due to coronary artery disease?
Meta-Analysis (n=35,797)
Does ivabradine improve mortality, serious adverse events, and quality of life in patients with angina pectoris due to coronary artery disease?
Relative Risk: 1.04 (95% CI 0.96–1.13)
Ivabradine does not improve mortality or quality of life in patients with angina pectoris but increases the risk of serious adverse events, suggesting current guidelines recommending its use should be reconsidered.
May warrant avoiding ivabradine in angina pectoris; challenges current guideline recommendations.
OBJECTIVE: To determine the impact of ivabradine on outcomes important to patients with angina pectoris caused by coronary artery disease. METHODS: We conducted a systematic review. We included randomised clinical trials comparing ivabradine versus placebo or no intervention for patients with angina pectoris due to coronary artery disease published prior to June 2020. We used Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, Cochrane methodology, Trial Sequential Analysis, Grading of Recommendations Assessment, Development, and Evaluation, and our eight-step procedure. Primary outcomes were all-cause mortality, serious adverse events and quality of life. RESULTS: We included 47 randomised clinical trials enrolling 35 797 participants. All trials and outcomes were at high risk of bias. Ivabradine compared with control did not have effects when assessing all-cause mortality (risk ratio [RR] 1.04; 95% CI 0.96 to 1.13), quality of life (standardised mean differences -0.05; 95% CI -0.11 to 0.01), cardiovascular mortality (RR 1.07; 95% CI 0.97 to 1.18) and myocardial infarction (RR 1.03; 95% CI 0.91 to 1.16). Ivabradine seemed to increase the risk of serious adverse events after removal of outliers (RR 1.07; 95% CI 1.03 to 1.11) as well as the following adverse events classified as serious: bradycardia, prolonged QT interval, photopsia, atrial fibrillation and hypertension. Ivabradine also increased the risk of non-serious adverse events (RR 1.13; 95% CI 1.11 to 1.16). Ivabradine might have a statistically significant effect when assessing angina frequency (mean difference (MD) 2.06; 95% CI 0.82 to 3.30) and stability (MD 1.48; 95% CI 0.07 to 2.89), but the effect sizes seemed minimal and possibly without any relevance to patients, and we identified several methodological limitations, questioning the validity of these results. CONCLUSION: Our findings do not support that ivabradine offers significant benefits on patient important outcomes, but rather seems to increase the risk of serious adverse events such as atrial fibrillation and non-serious adverse events. Based on current evidence, guidelines need reassessment and the use of ivabradine for angina pectoris should be reconsidered. PROSPERO REGISTRATION NUMBER: CRD42018112082.
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Maagaard et al. (2020) conducted a meta-analysis in angina pectoris caused by coronary artery disease (n=35,797). Ivabradine vs. placebo or no intervention was evaluated on all-cause mortality (RR 1.04, 95% CI 0.96 to 1.13). Ivabradine did not significantly affect all-cause mortality (RR 1.04; 95% CI 0.96 to 1.13) or quality of life in patients with angina pectoris, but increased the risk of serious adverse events.
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