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Eligibility and Preventive Potential for New Evidence-Based Cardiovascular Drugs in Secondary Prevention
Martin Bødtker Mortensen1,2,3, Michael Joseph Blaha4, Børge Grønne Nordestgaard2,3
1Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Importance:
Recently, 12 randomized clinical trials (RCTs) have demonstrated the efficacy of novel therapies for mainly secondary prevention of atherosclerotic cardiovascular disease. However, given the potential overlapping eligibility of the RCTs, along with the cost of the new therapies, there are uncertainty and questions about implementing these RCT findings in real-world clinical practice.
Objective:
To determine the eligibility and preventive potential for these new preventive therapies in a contemporary population.
Design, Setting, And Participants:
This population-based contemporary cohort study included 6292 patients with known ischemic heart disease (IHD) and 2277 with a previous myocardial infarction (MI) enrolled between November 2003 and February 2015. Analyses were performed in the Copenhagen General Population Study with a mean (SD) of 7.7 (3.5) years of follow-up. The data were analyzed between January and October 2019.
Main Outcomes And Measures:
We determined the drug eligibility and evidence-based potential for preventing major cardiovascular events of the 12 cardiovascular drugs tested in the following recent RCTs: IMPROVE-IT, PEGASUS, EMPA-REG, LEADER, SUSTAIN-6, FOURIER, CANVAS, REVEAL, CANTOS, COMPASS, ODYSSEY-OUTCOMES, and REDUCE-IT. The analyses were performed in patients with known IHD or with a previous MI at baseline.
Results:
Of 6292 participants, 3861 (61%) were men and the mean (interquartile range) age was 69 (62-76) years. In patients with IHD or MI at baseline, eligibility for 1 or more new medications was 80% (n = 5036) and 99% (n = 2273), respectively, by meeting RCT enrollment criteria. Dividing the new therapies into 4 drug classes (lipid-modifying, antithrombotic, anti-inflammatory, and antidiabetic drugs), 2594 and 1834 patients with IHD or MI (41% and 81%, respectively) were eligible for 2 or more drug classes simultaneously. The 5-year estimated percentage of major cardiovascular events that could be prevented for each new therapy was 1% to 20% in patients with IHD or MI at baseline.
Conclusions And Relevance:
Most patients with known IHD or previous MI are eligible for additional new secondary prevention therapies. This raises questions for the cardiovascular community and health care authorities about access to these potentially expensive therapies, including strategies for prioritizing their use.
Insights
Most patients with ischemic heart disease (IHD) or myocardial infarction (MI) qualify for new secondary prevention therapies. High eligibility suggests a need to address access and cost for these advanced cardiovascular treatments.
Area of Science:
- Cardiovascular Medicine
- Clinical Pharmacology
- Public Health
Background:
- Recent randomized clinical trials (RCTs) show efficacy of novel therapies for secondary prevention of atherosclerotic cardiovascular disease.
- Uncertainty exists regarding real-world implementation due to overlapping eligibility criteria and therapy costs.
Purpose of the Study:
- To assess eligibility and preventive potential of new cardiovascular therapies in a contemporary population.
- To evaluate the applicability of findings from 12 major RCTs to patients with established ischemic heart disease (IHD) or myocardial infarction (MI).
Main Methods:
- Population-based cohort study using data from the Copenhagen General Population Study (2003-2015).
- Included 6292 patients with IHD and 2277 with prior MI.
- Assessed eligibility for 12 specific cardiovascular drugs and their potential to prevent major cardiovascular events.
Main Results:
- 80% of IHD patients and 99% of MI patients met eligibility criteria for at least one new medication.
- 41% of IHD patients and 81% of MI patients were eligible for two or more drug classes simultaneously.
- Estimated 5-year prevention of major cardiovascular events ranged from 1% to 20% per therapy.
Conclusions:
- A high proportion of patients with IHD or MI are eligible for novel secondary prevention therapies.
- Significant questions arise regarding accessibility, cost, and prioritization strategies for these expensive treatments.
- Further consideration by healthcare providers and authorities is needed to optimize the use of these therapies.
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