Dataset Information

Ivabradine in patients with acute ST-elevation myocardial infarction: a meta-analysis of randomized controlled trials.

ABSTRACT:

Background

Elevated resting heart rate (HR) predicts poor outcomes in patients with coronary artery disease. Ivabradine has been recommended as a second-line anti-anginal agent in chronic coronary syndrome, while there are no clear indications for acute ST-elevation myocardial infarction (STEMI).

Results

We systematically searched PubMed, Medline, EMBASE, Clinical Trials.gov, and the Cochrane Central Register of Controlled Trials with search terms Ivabradine and Acute myocardial infarction. There are two study outcomes from this study: therapeutic and safety effects. Therapeutic effects include the efficacy of Ivabradine on HR, all-cause mortality, heart failure incidence, left ventricular function and remodeling. Safety effects include troponin levels and ischemic events (recurrent angina pectoris). A total of 6 RCTs was included and showed that Ivabradine was associated with greater resting HR reduction [MD - 5.40; 95%CI - 8.60, - 2.20], improvement of left ventricular ejection fraction [MD 2.98; 95%CI 0.44, 5.51], and left ventricular end systolic volume [MD - 3.81; 95%CI - 6.88, - 0.75]. However, Ivabradine had no impact on all-cause mortality [OR 0.76; 95%CI 0.35, 1.67], heart failure incidence [OR 0.61; 95%CI 0.21, 1.80], and recurrent angina pectoris [OR 0.71; 95%CI 0.50, 1.00].

Conclusions

Ivabradine is safe and effective for resting HR reduction in patients with STEMI; however, it has no significant influence on mortality. These results suggest that an elevated HR is only a marker of risk but not a modifiable determinant of outcomes in patients who have suffered an acute myocardial infarction.

SUBMITTER: Sasmita BR

PROVIDER: S-EPMC10079792 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Ivabradine in patients with acute ST-elevation myocardial infarction: a meta-analysis of randomized controlled trials.

Sasmita Bryan Richard BR Xie Siyuan S Liu Gang G Zhu Yuansong Y Luo Suxin S Huang Bi B

The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology 20230406 1

<h4>Background</h4>Elevated resting heart rate (HR) predicts poor outcomes in patients with coronary artery disease. Ivabradine has been recommended as a second-line anti-anginal agent in chronic coronary syndrome, while there are no clear indications for acute ST-elevation myocardial infarction (STEMI).<h4>Results</h4>We systematically searched PubMed, Medline, EMBASE, Clinical Trials.gov, and the Cochrane Central Register of Controlled Trials with search terms Ivabradine and Acute myocardial i ...[more]

PMID: 37024594

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Project description:We aimed to summarize the evidence from randomized clinical trials studies examining the efficacy of ischemic postconditioning (IPost) in ST-elevation myocardial infarction.The study was a systematic review and critical appraisal, with meta-analysis of randomized clinical trials.We searched the literature. A total of 21 randomized clinical trials were identified. Both fixed effect and random effects models were used to synthesize the results of individual studies. Heterogeneity between studies was examined by subgroup and random effects meta-regression analyses, considering ptient-related and study-level variables. Publication bias, or "small-study effect", was evaluated.Substantial heterogeneity was present. The random effects model pooled estimate for the outcome infarct size assessed by cardiac magnetic resonance was estimated by the standardized mean difference (SMD) =-0.06, 95% confidence interval (CI): -0.34 to 0.21, ie, no effect of IPost. For the end point infarct size, estimated by biomarkers of myocardial necrosis, an overall pooled effect was SMD =-0.58, 95% CI: -0.96 to -0.19. This effect disappeared in powered and nonbiased studies (SMD =0.03, 95% CI: -0.48 to 0.55). Finally, for the outcome left ventricular ejection fraction, SMD =0.47 95% CI: 0.20 to 0.74. Unfortunately, selection bias (small-study effect) was present. For this outcome, the meta-regression showed that both presence of hypertension and the inclusion of nonbiased studies explained 28.3% of the heterogeneity among the studies. Simulation by the "trim and fill" method, which controlled for selection bias using random effects model, diluted the effect (SMD =0.17 95% CI: -0.13 to 0.48). No effects by IPost on ST-segment resolution or on the majority of adverse clinical events were observed during follow up, except the incidence of congestive heart failure was found.Evidence from this study suggests no cardioprotection from IPost, on surrogate and the majority of clinical end points. A possible beneficial effect on the incidence of congestive heart failure needs to be replicated by a large clinical trial.

Project description:BackgroundRedundant clinical trials waste resources and unnecessarily put patients at risk for harm. The objectives of the study were to assess redundant randomized clinical trials (RCTs) conducted in mainland China or the USA among patients with ST segment elevation myocardial infarction (STEMI) and estimate the harm to patients enrolled in redundant RCTs.MethodsWe searched bibliographic databases for eligible RCTs comparing a routine therapy with a placebo or no treatment among patients with STEMI in mainland China or the United States. The routine therapy for STEMI included reperfusion (percutaneous coronary intervention or fibrinolytic therapy), P2Y12 receptor inhibitors, statins, and anticoagulants. Redundant RCTs were defined as those initiated or continued recruiting new patients 1 year after the experimental intervention was established as routine therapy in clinical practice guidelines. Cumulative meta-analyses were conducted to confirm the efficacy of these routine therapies. The primary outcome was the number of extra major adverse cardiac events (MACEs) attributable to the deprivation of routine therapies among patients in the control groups of redundant RCTs-that is, the number of extra MACEs that could have been prevented had these patients received routine therapy.ResultsNine hundred eighty-three eligible RCTs conducted in mainland China were identified, of which 775 (78.8%) were redundant. None of the five eligible RCTs conducted in the United States were redundant. All redundant RCTs have reiterated the benefits of routine therapies for patients with STEMI, while none were cited by the 2019 clinical practice guideline for the management of STEMI. The 18,819 patients in the control groups of redundant RCTs experienced 3305 (95% CI: 3169-3441) extra MACEs, including 1091 (1014-1165) deaths, 576 (519-633) recurrent myocardial infarctions, 31 (19-42) revascularizations, 39 (23-54) strokes, 744 (679-810) heart failures, and 823 (754-893) patients with recurrent or exacerbated angina pectoris. Cumulative meta-analyses confirmed the efficacy of the routine therapies among patients in mainland China and supported using practice guidelines to define redundant RCTs.ConclusionsRedundant RCTs conducted in mainland China have resulted in unnecessary MACEs among patients with STEMI. While the reasons behind redundant RCTs need to be further investigated, these results suggest potential research waste and violation of research ethics.

Dataset Information

Ivabradine in patients with acute ST-elevation myocardial infarction: a meta-analysis of randomized controlled trials.

Background

Results

Conclusions

Publications

Ivabradine in patients with acute ST-elevation myocardial infarction: a meta-analysis of randomized controlled trials.

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