Evidence mapPaperPMID 27511965Full record

SynthesisClinical cardiology2016

The Risk of Atrial Fibrillation With Ivabradine Treatment: A Meta-analysis With Trial Sequential Analysis of More Than 40000 Patients.

İbrahim Halil Tanboğa, Selim Topçu, Enbiya Aksakal, Oktay Gulcu, Emrah Aksakal, Uğur Aksu, Vecih Oduncu, Fatih Rıfat Ulusoy, Serdar Sevimli, Cihangir Kaymaz

Open access · bronzeAbstract readMeta-AnalysisReview
In one paragraph

Synthesis in Clinical cardiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Ivabradine and AF: Coincidence, Correlation or a New Treatment?Arrhythmia & electrophysiology review · 2020
    Review
  13. Review
  14. The therapeutic role of ivabradine in heart failure.Therapeutic advances in chronic disease · 2018
    Review
  15. Article
  16. Review
  17. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

İbrahim Halil TanboğaDepartment of Cardiology, Medical School, Atatürk University, Erzurum, Turkey. haliltanboga@yahoo.com.
Selim TopçuDepartment of Cardiology, Medical School, Atatürk University, Erzurum, Turkey.
Enbiya AksakalDepartment of Cardiology, Medical School, Atatürk University, Erzurum, Turkey.
Oktay GulcuDepartment of Cardiology, Medical School, Atatürk University, Erzurum, Turkey.
Emrah AksakalDepartment of Cardiology, Medical School, Atatürk University, Erzurum, Turkey.
Uğur AksuDepartment of Cardiology, Medical School, Atatürk University, Erzurum, Turkey.
Vecih OduncuDepartment of Cardiology, Medical School, Bahçeşehir University, Istanbul, Turkey.
Fatih Rıfat UlusoyDepartment of Cardiology, Yalova State Hospital, Yalova, Turkey.
Serdar SevimliDepartment of Cardiology, Medical School, Atatürk University, Erzurum, Turkey.
Cihangir KaymazDepartment of Cardiology, Kosuyolu Heart Hospital, Istanbul, Turkey.
Atatürk University · TRBahçeşehir University · TRKartal Koşuyolu High Specialization Training and Research Hospital · TRYalova University · TR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Recent trials reported that risk of atrial fibrillation (AF) is increased in patients using ivabradine compared with controls. We performed this meta-analysis to investigate the risk of AF association with ivabradine treatment on the basis of data obtained from randomized controlled trials (RCTs). We searched PubMed, EMBASE, Scopus, and the Cochrane Library for RCTs that comprised >100 patients. The incidence of AF was assessed. We obtained data from European Medicines Agency (EMA) scientific reports for the RCTs in which the incidence of AF was not reported. We used trial sequential analysis (TSA) to provide information on when we had reached firm evidence of new AF based on a 15% relative risk increase (RRI) in ivabradine treatment. Three RCTs and 1 EMA overall oral safety set (OOSS) pooled analysis (included 5 RCTs) were included in the meta-analysis (N = 40 437). The incidence of AF was 5.34% in patients using ivabradine and 4.56% in placebo. There was significantly higher incidence of AF (24% RRI) in the ivabradine group when compared with placebo before (RR: 1.24, 95% confidence interval: 1.08-1.42, P = 0.003, I 1980 = 53%) and after excluding OOSS (RR: 1.24, 95% confidence interval: 1.06-1.44, P = 0.008). In the TSA, the cumulative z-curve crossed both the traditional boundary (P = 0.05) and the trial sequential monitoring boundary, indicating firm evidence for ≥15% increase in ivabradine treatment when compared with placebo. Study results indicate that AF is more common in the ivabradine group (24% RRI) than in controls.

Indexed as

AgedAtrial FibrillationBenzazepinesCardiovascular AgentsChi-Square DistributionCoronary DiseaseFemaleHumansIncidenceIvabradineMaleMiddle AgedOdds RatioRandomized Controlled Trials as TopicRisk AssessmentRisk FactorsBenzazepinesCardiovascular AgentsIvabradineatrial fibrillationIvabradinemeta-analysis

Identifiers

PMID27511965
PMCPMC6490712
OpenAlexW2513911398

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.