Eligibility and Preventive Potential for New Evidence-Based Cardiovascular Drugs in Secondary Prevention.

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.

[1]  Deepak L. Bhatt,et al.  Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia , 2019, The New England journal of medicine.

[2]  J Wouter Jukema,et al.  Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome , 2018, The New England journal of medicine.

[3]  Deepak L. Bhatt,et al.  External applicability of the COMPASS trial: an analysis of the reduction of atherothrombosis for continued health (REACH) registry , 2018, European heart journal.

[4]  M. Mortensen,et al.  Comparison of Five Major Guidelines for Statin Use in Primary Prevention in a Contemporary General Population , 2018, Annals of Internal Medicine.

[5]  Deepak L. Bhatt,et al.  Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome , 2018, The New England journal of medicine.

[6]  M. Landray,et al.  Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease , 2017, The New England journal of medicine.

[7]  P. Libby,et al.  Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease , 2017, The New England journal of medicine.

[8]  Deepak L. Bhatt,et al.  Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease , 2017, The New England journal of medicine.

[9]  K. Mahaffey,et al.  Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes , 2017, The New England journal of medicine.

[10]  A. Keech,et al.  Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease , 2017, The New England journal of medicine.

[11]  Lawrence A Leiter,et al.  Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. , 2016, The New England journal of medicine.

[12]  John B Buse,et al.  Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. , 2016, The New England journal of medicine.

[13]  B. Zinman,et al.  Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. , 2015, The New England journal of medicine.

[14]  Improve-It Investigators Ezetimibe added to statin therapy after acute coronary syndromes , 2015 .

[15]  Marc P. Bonaca,et al.  Long-term use of ticagrelor in patients with prior myocardial infarction. , 2015, The New England journal of medicine.

[16]  A. Kiss,et al.  Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. , 2007, JAMA.