Evidence map›Paper›PMID 32666097›Full record

SynthesisEuropean heart journal2020

Randomized trials of invasive cardiovascular interventions that include a placebo control: a systematic review and meta-analysis.

Lucas Lauder, Bruno R da Costa, Sebastian Ewen, Sean S Scholz, William Wijns, Thomas F Lüscher, Patrick W Serruys, Elazer R Edelman, Davide Capodanno, Michael Böhm and 2 more

Abstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in European heart journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Device-related risk of atrial fibrillation after closure of patent foramen ovale: a systematic review and meta-analysis.Clinical research in cardiology : official journal of the German Cardiac Society · 2022
    Pooled it
  3. PVI-SHAM-AF: what does this trial tell us about catheter ablation and symptoms in patients with atrial fibrillation?Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Article
  4. Renal denervation in the management of hypertension.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Article
  5. Renal denervation in the management of hypertension in adults. A clinical consensus statement of the ESC Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI).EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
    Article
  6. Review
  7. Patients' attitude towards a sham-controlled trial on pulmonary vein isolation in atrial fibrillation.Clinical research in cardiology : official journal of the German Cardiac Society · 2022
    Article
  8. Article
  9. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Lucas LauderKlinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Kirrberger Str., Gebäude 41.1, 66421 Homburg/Saar, Germany.
Bruno R da CostaApplied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, 155 College Street, Toronto, ON M5T 3M6, Canada.
Sebastian EwenKlinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Kirrberger Str., Gebäude 41.1, 66421 Homburg/Saar, Germany.
Sean S ScholzKlinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Kirrberger Str., Gebäude 41.1, 66421 Homburg/Saar, Germany.
William WijnsThe Lambe Institute for Translational Medicine and CURAM, National University of Ireland, University Road, Galway H91 TK33, Ireland.
Thomas F LüscherCenter for Molecular Cardiology, Schlieren Campus, University of Zürich, Wagistrasse 12, 8952 Schlieren, Switzerland.
Patrick W SerruysThe National Lung and Heart Institute, Imperial College London, Dovehouse St, Chelsea, London SW3 6LY, UK.
Elazer R EdelmanCardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.
Davide CapodannoDivision of Cardiology, C.A.S.T., P.O. "G. Rodolico", Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele", University of Catania, Via S. Citelli, 31 Catania, Italy.
Michael BöhmKlinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Kirrberger Str., Gebäude 41.1, 66421 Homburg/Saar, Germany.
Peter JüniApplied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, 155 College Street, Toronto, ON M5T 3M6, Canada.
Felix MahfoudKlinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Kirrberger Str., Gebäude 41.1, 66421 Homburg/Saar, Germany.

Funding

Vascular Drug Delivery - Supplement for EquipmentR01GM049039 · NIGMS · MASSACHUSETTS INSTITUTE OF TECHNOLOGY · PI EDELMAN, ELAZER R · 1994 to 2019
$8.9M
NIGMS NIH HHS R01 GM049039
6 · The paper itself

Abstract

aimsThe difference in the benefit of invasive cardiovascular interventions compared with placebo controls has not been analysed systematically. METHODS AND

resultsMEDLINE and Web of Science were searched through 29 March 2020. Randomized, placebo-controlled trials of invasive cardiovascular interventions (including catheter-based interventions and pacemaker-like devices) investigating predefined primary outcomes were included. Standardized mean differences (SMD) and odds ratios were calculated for continuous and dichotomous outcomes, respectively. Meta-regression analyses were performed to assess whether estimates of treatment effects were associated with methodological characteristics of trials. Thirty trials, including 4102 patients, were analysed. The overall risk of bias was judged to be low in only 43% of the trials. Ten trials (33%) demonstrated statistically significant superiority of invasive interventions over placebo controls for the respective predefined primary outcomes. In almost half of the 16 trials investigating continuous predefined primary outcomes, the SMD between the active and placebo procedure indicated a small (n = 4) to moderate (n = 3) treatment effect of active treatment over placebo. In contrast, one trial indicated a small treatment effect in favour of the placebo procedure. In the remaining trials, there was no relevant treatment effect of active treatment over placebo. In trials with a protocol-mandated stable and symmetrical use of co-interventions, the superiority of active procedures vs. invasive placebo procedures was significantly larger as compared with trials with frequent or unbalanced changes in co-interventions (P for interaction 0.027).

conclusionsThe additional treatment effect of invasive cardiovascular interventions compared with placebo controls was small in most trials.

Indexed as

Randomized Controlled Trials as TopicHumansHeart failurePercutaneous coronary interventionRenal denervationSham-controlled trials

Identifiers

PMID32666097
PMCPMC7360382

What OpenQuestion 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 OpenQuestion graph.