Key Points
- Evidence-based therapies that reduce cardiovascular risk remain underused among individuals with type 2 diabetes and cardiovascular disease
- The COORDINATE-Diabetes cluster-randomized clinical trial included 43 cardiology clinics treating individuals with type 2 diabetes and atherosclerotic cardiovascular disease and randomized them to a multifaceted intervention of assessment, education, and feedback or usual care. The primary outcome was the proportion of participants who were prescribed all three recommended groups of preventative medications (high-intensity statins, ACEIs or ARBs, and SGLT2 inhibitors and/or GLP-1RAs) at the last follow-up visit (either 6-month or 12-month).
- The coordinated, multifaceted intervention increased the prescription of all three therapies as compared to usual care (37.9% vs 14.5%, respectively) in individuals with T2D and atherosclerotic cardiovascular disease
Medications that reduce cardiovascular risk among individuals with type 2 diabetes and atherosclerotic cardiovascular disease are underused. Less than one in twenty individuals with type 2 diabetes and atherosclerotic cardiovascular disease are taking the combination of high-intensity statins, angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), and sodium-glucose co-transporter 2 (SGLT-2) inhibitors and/or Glucagon-like peptide-1 receptor agonists (GLP-1RA). On March 6th, 2023 during the American College of Cardiology 2023 Scientific Sessions Late-Breaking Clinical Trials Session, Dr. Neha Pagidipati presented the results of the COORDINATE-Diabetes trial which was simultaneously published in the Journal of the American Medical Association.
COORDINATE-Diabetes was a cluster-randomized clinical trial (NCT03936660) which randomized 49 cardiology clinics across the United States treating individuals with type 2 diabetes and atherosclerotic cardiovascular disease to a multifaceted intervention or usual care. The intervention included 6 components: a clinic specific analysis of barriers to evidence-based care, development of pathways to address barriers, improved coordination of care between clinicians, clinician education, participant education, and an audit and feedback of quality metrics to participating sites. Individuals with an estimated glomerular filtration rate of less than 30 ml/min/1.73m2 or those already on all guideline-recommended therapies for type 2 diabetes and cardiovascular disease were excluded. The primary outcome was the proportion of individuals taking all three groups of recommended medications (high-intensity statins, ACEIs or ARBs, and SGLT2 inhibitors and/or GLP-1RAs) at the last follow-up visit (either 6 month or 12 month follow-up visit). Of the 49 randomized clinics, 43 enrolled a total of 1049 participants. The average age of participants was 70 years and 32% were women. The proportion of participants taking a high-intensity statin and an ACEI or ARB at baseline was higher in the intervention arm compared to the usual care arm (49.5% versus 41.0%, respectively).
At the last follow-up visit, those in the intervention arm were more likely to be prescribed all three therapies as compared to individuals in the usual care arm (37.9% versus 14.5%, respectively; adjusted odds ratio, 4.38, [95% CI 2.49 to 7.71]), which is a difference of 23.4% (adjusted odds ratio [OR], 4.38 [95% CI, 2.49 to 7.71]; P < .001).Prescriptions of all three individual medication groups were higher in the intervention group. The intervention was not associated with reductions in specific cardiovascular risk factors; systolic and diastolic blood pressure, hemoglobin A1c, and LDL cholesterol. There was no difference in a composite clinical event secondary endpoint (all-cause death or hospitalization for MI, stroke, heart failure, or urgent revascularization) which was experienced by 5% of individuals in the intervention group and 6.8% of individuals in the usual care group (adjusted hazard ratio, 0.79 [95% CI 0.46-1.3]).
The authors noted that a 23% absolute increase in these recommended therapies is clinically meaningful and, based on clinical trial evidence for those therapies, should result in substantial improvement in patient outcomes over time.