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Compliance With Guideline-Directed Medical Therapy in Contemporary Coronary Revascularization Trials
Ana-Catarina Pinho-Gomes1, Luis Azevedo2, Jung-Min Ahn3
1Department of Cardiac Surgery, Oxford University Hospitals NHS Trust, Oxford, United Kingdom.
Insights
Guideline-directed medical therapy (GDMT) compliance is low in coronary revascularization trials, particularly after coronary artery bypass grafting (CABG) compared to percutaneous coronary intervention (PCI). This impacts trial comparisons.
Area of Science:
- Cardiovascular Medicine
- Clinical Trials
- Interventional Cardiology
Background:
- Secondary cardiovascular prevention is crucial but concurrent medical therapy in revascularization trials is often overlooked.
- Guideline-directed medical therapy (GDMT) adherence significantly impacts patient outcomes post-revascularization.
Purpose of the Study:
- To evaluate GDMT compliance in clinical trials comparing percutaneous coronary intervention (PCI) with drug-eluting stents versus coronary artery bypass grafting (CABG).
- To assess the potential impact of GDMT compliance on the comparative effectiveness of PCI versus CABG.
Main Methods:
- Systematic review of randomized controlled trials (RCTs) published from 2005 to 2017 comparing PCI with drug-eluting stents versus CABG.
- Searched Cochrane Central Register, MEDLINE, trial registries, and reference lists.
- Defined GDMT compliance as use of antiplatelet, beta-blocker, and statin (GDMT1), with or without ACEI/ARB (GDMT2).
Main Results:
- Five RCTs involving 439 references were included.
- Overall GDMT1 compliance decreased from 67% at 1 year to 53% at 5 years; GDMT2 compliance decreased from 40% to 38% over the same period.
- GDMT compliance was consistently higher with PCI than CABG. Meta-regression indicated lower GDMT1 use was associated with adverse outcomes in PCI vs. CABG at 5 years.
Conclusions:
- GDMT compliance in contemporary revascularization trials is suboptimal.
- Lower GDMT adherence after CABG compared to PCI may confound trial endpoint comparisons.
- Optimizing GDMT in clinical trials is essential for accurate assessment of revascularization strategies.
Background:
Despite the well-established benefits of secondary cardiovascular prevention, the importance of concurrent medical therapy in clinical trials of coronary revascularization is often overlooked.
Objectives:
The goal of this study was to assess compliance with guideline-directed medical therapy (GDMT) in clinical trials and its potential impact on the comparison between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG).
Methods:
The Cochrane Central Register of Controlled Trials and MEDLINE were searched from 2005 to August 2017. Clinical trial registries and reference lists of relevant studies were also searched. Randomized controlled trials comparing PCI with drug-eluting stents versus CABG and reporting medical therapy after revascularization were included. The study outcome was compliance with GDMT, defined as the following: 1) any antiplatelet agent plus beta-blocker plus statin (GDMT1); and 2) any antiplatelet agent plus beta-blocker plus statin plus angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (GDMT2). Data collection and analysis were performed according to the methodological recommendations of The Cochrane Collaboration.
Results:
From a total of 439 references, 5 trials were included based on our inclusion and exclusion criteria. Overall, compliance with GDMT1 was low and decreased over time from 67% at 1 year to 53% at 5 years. Compliance with GDMT2 was even lower and decreased from 40% at 1 year to 38% at 5 years. Compliance with both GDMT1 and GDMT2 was higher in PCI than in CABG at all time points. Meta-regression suggested an association between lower use of GDMT1 and adverse clinical outcomes in PCI versus CABG at 5 years.
Conclusions:
Compliance with GDMT in contemporary clinical trials remains suboptimal and is significantly lower after CABG than after PCI, which may influence the comparison of clinical trial endpoints between those study groups.
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