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Assessment of Repeat Revascularization in Percutaneous Coronary Intervention Randomized Controlled Trials as a

Safi U Khan1, Ahmad N Lone2, Usman Ali Akbar3

  • 1Department of Cardiology, Houston Methodist DeBakey Heart & Vascular Center, Houston, TX.

Current Problems in Cardiology
|December 18, 2022
PubMed

Insights

Repeat revascularization after percutaneous coronary intervention (PCI) is not a reliable surrogate for mortality in coronary artery disease (CAD) patients. This meta-regression found no significant association between repeat procedures and mortality rates.

Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Clinical Trials Methodology

Background:

  • The prognostic value of repeat revascularization after percutaneous coronary intervention (PCI) in patients with coronary artery disease (CAD) remains uncertain.
  • Understanding this association is crucial for guiding treatment decisions and interpreting clinical trial outcomes.

Purpose of the Study:

  • To assess the association between repeat revascularization rates following PCI and mortality in patients with CAD.
  • To determine if repeat revascularization can serve as a surrogate endpoint for mortality in trials comparing PCI with other revascularization strategies or optimal medical therapy (OMT).

Main Methods:

  • A systematic review and random-effects meta-regression of 33 randomized controlled trials (21,735 patients) comparing PCI with coronary artery bypass graft (CABG) or OMT.
  • Analyzed the association between repeat revascularization rates after PCI and relative risks (RR) of all-cause and cardiovascular mortality.
  • Assessed surrogacy using the coefficient of determination (R2), with a threshold of 0.80.

Main Results:

  • Repeat revascularization was higher after PCI compared to CABG (RR: 2.45) but lower compared to OMT (RR: 0.64).
  • Meta-regression revealed no significant association between repeat revascularization after PCI and all-cause mortality (RR: 1.01, R2=0.10) or cardiovascular mortality (RR: 1.01, R2=0.09).
  • Repeat revascularization did not meet the surrogacy threshold (R2=0.0 to 0.28) in comparisons of PCI versus CABG or PCI versus OMT.

Conclusions:

  • Repeat revascularization following PCI is not a validated surrogate for all-cause or cardiovascular mortality in patients with CAD.
  • Findings were consistent across subgroup and multivariable analyses, reinforcing the lack of surrogacy.
  • This highlights the need for mortality as a primary endpoint in clinical trials evaluating PCI strategies.

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