Compliance With Guideline-directed Medical Therapy In Contemporary Coronary Revascularisation Trials
Ana-Catarina Pinho-Gomes1, Luis Azevedo2, SJ Park3, Michael Farkouh4, Arie Pieter Kappetein5, Gregg Stone6, Valentin Fuster7, Andre Lamy8, David P. Taggart9.
1Manchester Royal Infirmary, Manchester, United Kingdom, 2Department of Community Medicine, Information and Health Decision Sciences (MEDCIDS) & Centre for Health Technology and Services Research (CINTESIS), Faculty of Medicine, Porto University, Portugal, Porto, Portugal, 3Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea, Republic of, 4Peter Munk Cardiac Centre and Heart and Stroke Richard Lewar Centre, Unversity of Toronto, Toronto, ON, Canada, 5Dept Thoracic Surgery, Erasmus University, Rotterdam, Netherlands, 67The New York Presbyterian Hospital, Columbia University Medical Center, and the Cardiovascular Research Foundation, New York, NY, USA, 7Mount Sinai Cardiovascular Institute, New York, NY and Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid Spain., New York, NY, USA, 8Dept of Cardiac Surgery, McMaster University, Hamilton, ON, Canada, 9Dept of Cardiac Surgery, University of Oxford, Oxford, United Kingdom.
Background: Despite the well-established benefits of secondary cardiovascular prevention, the importance of concurrent medical therapy in clinical trials of coronary revascularisation is often overlooked. Therefore, compliance with guideline-directed medical therapy (GDMT) in clinical trials and its potential impact on the comparison between percutaneous coronary intervention (PCI) and coronary bypass grafting (CABG) remains poorly documented. Methods: Data regarding medical therapy were retrieved from databases of individual trials for the entire duration of follow-up. GDMT was defined as (1) any antiplatelet agent plus beta-blocker plus statin; and (2) any antiplatelet agent plus beta-blocker plus statin plus angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. Meta-analyses were performed to calculate pooled estimates of overall compliance in the clinical trials and the difference between PCI and CABG. Results: Overall, compliance with GDMT1 was low and decreased over time from 67% at 1-year to 43% at 5-years. Compliance with GDMT2 was even lower and decreased from 40% at 1-year to 34% at 5-years. This poor compliance rates were mainly due to low compliance with beta-blockers and renin-angiotensin-aldosterone system antagonists, as compliance with antiplatelet drugs and statins was ranged from 75% to 95%. However, there was significant variability between the clinical trials. Although compliance with both GDMT1 and GDMT2 was higher in PCI than in CABG at all time points, the difference only reached statistical significance for GDMT2. Meta-regression demonstrated an apparent correlation between lower use of GDMT1 at 5-years 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. The potential consequences of poor compliance with GDMT on long-term clinical outcomes are substantial. Therefore, there is a pressing need to develop effective strategies to improve adherence to life-saving drugs. Clinical trials have an important role to play by serving as an example of ensuring outstanding compliance with GDMT.
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