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

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Abstract

Aims

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

Methods and results

MEDLINE 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).

Conclusions

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

Related collections

Most cited references 35

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Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial

Laura Mauri, Michel Azizi, Roland E Schmieder … (2018)

Early studies suggest that radiofrequency-based renal denervation reduces blood pressure in patients with moderate hypertension. We investigated whether an alternative technology using endovascular ultrasound renal denervation reduces ambulatory blood pressure in patients with hypertension in the absence of antihypertensive medications.

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Chronic vagal stimulation for the treatment of low ejection fraction heart failure: results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) randomized controlled trial

Faiez Zannad, Gaetano De Ferrari, Anton Tuinenburg … (2014)

Aim The neural cardiac therapy for heart failure (NECTAR-HF) was a randomized sham-controlled trial designed to evaluate whether a single dose of vagal nerve stimulation (VNS) would attenuate cardiac remodelling, improve cardiac function and increase exercise capacity in symptomatic heart failure patients with severe left ventricular (LV) systolic dysfunction despite guideline recommended medical therapy. Methods Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The primary endpoint was the change in LV end systolic diameter (LVESD) at 6 months for control vs. therapy, with secondary endpoints of other echocardiography measurements, exercise capacity, quality-of-life assessments, 24-h Holter, and circulating biomarkers. Results Of the 96 implanted patients, 87 had paired datasets for the primary endpoint. Change in LVESD from baseline to 6 months was −0.04 ± 0.25 cm in the therapy group compared with −0.08 ± 0.32 cm in the control group (P = 0.60). Additional echocardiographic parameters of LV end diastolic dimension, LV end systolic volume, left ventricular end diastolic volume, LV ejection fraction, peak V02, and N-terminal pro-hormone brain natriuretic peptide failed to show superiority compared to the control group. However, there were statistically significant improvements in quality of life for the Minnesota Living with Heart Failure Questionnaire (P = 0.049), New York Heart Association class (P = 0.032), and the SF-36 Physical Component (P = 0.016) in the therapy group. Conclusion Vagal nerve stimulation as delivered in the NECTAR-HF trial failed to demonstrate a significant effect on primary and secondary endpoint measures of cardiac remodelling and functional capacity in symptomatic heart failure patients, but quality-of-life measures showed significant improvement.

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Differential effectiveness of placebo treatments: a systematic review of migraine prophylaxis.

Karin Meissner, Margrit Fässler, Gerta Rücker … (2013)

When analyzing results of randomized clinical trials, the treatment with the greatest specific effect compared with its placebo control is considered to be the most effective one. Although systematic variations of improvements in placebo control groups would have important implications for the interpretation of placebo-controlled trials, the knowledge base on the subject is weak.

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Author and article information

Journal

Title: European Heart Journal

Publisher: Oxford University Press (OUP)

ISSN (Print): 0195-668X

ISSN (Electronic): 1522-9645

Publication date Created: July 14 2020

Publication date Other: July 14 2020

Publication date (Print): July 14 2020

Publication date (Electronic): July 14 2020

Volume: 41

Issue: 27

Pages: 2556-2569

Affiliations

[1 ]Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Kirrberger Str., Gebäude 41.1, 66421 Homburg/Saar, Germany

[2 ]Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael’s Hospital, University of Toronto, 155 College Street, Toronto, ON M5T 3M6, Canada

[3 ]Institute of Primary Health Care (BIHAM), University of Bern, Mittelstraße 43, 3012 Bern, Switzerland

[4 ]The Lambe Institute for Translational Medicine and CURAM, National University of Ireland, University Road, Galway H91 TK33, Ireland

[5 ]Center for Molecular Cardiology, Schlieren Campus, University of Zürich, Wagistrasse 12, 8952 Schlieren, Switzerland

[6 ]Royal Brompton and Harefield Hospital Trust, Imperial College London, Sydney Street, London SW3 6NP, UK

[7 ]The National Lung and Heart Institute, Imperial College London, Dovehouse St, Chelsea, London SW3 6LY, UK

[8 ]Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA

[9 ]Institute for Medical Engineering and Science, MIT, 77 Massachusetts Ave., Cambridge, MA 02139, USA

[10 ]Division 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

[11 ]Department of Medicine, Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street, Suite 425, Toronto, ON M5T 3M6, Canada

Article

DOI: 10.1093/eurheartj/ehaa495

PubMed ID: 32666097

SO-VID: d0c84da7-a4cf-4701-92bf-0981c315be6a

License:

https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model

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