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Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
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The sham effect of invasive interventions in chronic coronary syndromes: a systematic review and meta-analysis

Catarina Palma1, Cláudio David2,3,4, Ricardo M Fernandes2,3,5

  • 1Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.

BMC Cardiovascular Disorders
|May 15, 2022
PubMed

Insights

Sham interventions significantly improved exercise time, reduced angina symptoms, and enhanced quality of life in chronic coronary syndromes patients. These findings underscore the importance of sham-controlled trials for evaluating invasive procedures.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Evidence-Based Medicine

Background:

  • Efficacy of invasive procedures for chronic coronary syndromes (CCS) lacks robust evidence from randomized sham-controlled trials (RCTs).
  • Understanding the sham effect is crucial for accurate assessment of interventional efficacy.

Purpose of the Study:

  • To determine the sham effect in patients with CCS undergoing invasive procedures.
  • To systematically review and meta-analyze data from RCTs comparing invasive procedures with sham interventions.

Main Methods:

  • A systematic literature search was conducted in April 2022 for patient-blinded RCTs involving sham procedures.
  • Included studies reported pre-post effects in the sham arm for patients with Canadian Cardiovascular Society (CCS) angina or equivalents.
  • Data from 16 RCTs with 546 patients in the sham arm were pooled for meta-analysis.

Main Results:

  • Sham interventions led to a 7% improvement in exercise time and a decrease in CCS angina class.
  • Significant reductions were observed in anginal episodes (53%) and nitroglycerin (NTG) use (25%).
  • Improvements were noted in Seattle Angina Questionnaire (SAQ) domains, including physical functioning and quality of life.

Conclusions:

  • Sham interventions demonstrate a significant positive effect in patients with CCS, impacting angina symptoms, medication use, and quality of life.
  • Results necessitate cautious interpretation of previous non-sham-controlled trials.
  • Future invasive interventions for CCS should be rigorously evaluated against sham procedures to establish true efficacy.
Abstract

Keywords:
Chronic coronary syndromesInvasive treatmentSham effectSham procedure

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