Aspirin Use for Primary Prevention of Cardiovascular Disease
Aspirin Use for Primary Prevention of Cardiovascular Disease
Background Among patients without cardiovascular disease (CVD) and low 10-year CVD risk, the risks of gastrointestinal bleeding and hemorrhagic strokes associated with aspirin use outweigh any potential atheroprotective benefit. According to the guidelines on primary prevention of CVD, aspirin use is considered appropriate only in patients with 10-year CVD risk ≥6% and inappropriate in patients with 10-year CVD risk <6%.
Objectives The goal of this study was to examine the frequency and practice-level variation in inappropriate aspirin use for primary prevention in a large U.S. nationwide registry.
Methods Within the National Cardiovascular Disease Registry's Practice Innovation and Clinical Excellence registry, we assessed 68,808 unique patients receiving aspirin for primary prevention from 119 U.S. practices. The frequency of inappropriate aspirin use was determined for primary prevention (aspirin use in those with 10-year CVD risk <6%). Using hierarchical regression models, the extent of practice-level variation using the median rate ratio (MRR) was assessed.
Results Inappropriate aspirin use frequency was 11.6% (7,972 of 68,808) in the overall cohort. There was significant practice-level variation in inappropriate use (range 0% to 71.8%; median 10.1%; interquartile range 6.4%) for practices; adjusted MRR was 1.63 (95% confidence interval [CI]: 1.47 to 1.77). Results remained consistent after excluding 21,052 women age ≥65 years (inappropriate aspirin use 15.2%; median practice-level inappropriate aspirin use 13.8%; interquartile range 8.2%; adjusted MRR 1.61 [95% CI: 1.46 to 1.75]) and after excluding patients with diabetes (inappropriate aspirin use 13.9%; median practice-level inappropriate aspirin use 12.4%; interquartile range 7.6%; adjusted MRR 1.55 [95% CI: 1.41 to 1.67]).
Conclusions More than 1 in 10 patients in this national registry were receiving inappropriate aspirin therapy for primary prevention, with significant practice-level variations. Our findings suggest that there are important opportunities to improve evidence-based aspirin use for the primary prevention of CVD.
Cardiovascular disease (CVD) has been the leading cause of death in the United States for the past century and is the underlying cause of death in 32.3% of people. Therefore, emphasis has been placed on the primary and secondary prevention of this disease. Aspirin use is recommended for secondary prevention in patients with pre-existing CVD, and it is recommended for primary prevention in patients without CVD who have a moderate to high 10-year risk of developing CVD. However, in patients without CVD and a low 10-year CVD risk, there is no proof that aspirin use is associated with a reduction in adverse cardiovascular events. In this primary prevention population, the increased risk of gastrointestinal bleeding and hemorrhagic strokes associated with aspirin use outweighs any potential benefit from CVD risk reduction.
Based on these findings, the American Heart Association (AHA) guidelines on primary prevention of CVD and stroke in 2002 recommended aspirin for patients with 10-year coronary and stroke risk ≥10%. The U.S. Preventive Services Task Force recommendation on aspirin use for prevention of CVD from 2009 advised an approach of weighing the benefit of preventing CVD against the risk of increased gastrointestinal bleeding and hemorrhagic strokes, with recommendations to use aspirin if 5-year coronary heart disease (CHD) risk is ≥3% (10-year CHD risk of ≥6%). The recent AHA/American Stroke Association guidelines for primary prevention of stroke in 2011 recommend aspirin use for primary prevention if 10-year CVD risk is at least 6% to 10% (Class I; Level of Evidence: A). Thus, aspirin use for primary prevention would be considered appropriate in patients with 10-year CVD risk ≥6%. Given the risk of gastrointestinal bleeding and hemorrhagic strokes, aspirin use for primary prevention in patients at low risk of cardiovascular events (10-year CVD risk <6%) would be potentially inappropriate.
The U.S. Food and Drug Administration also recently issued a public advisory against the general use of aspirin for the primary prevention of heart attacks and strokes. This decision followed its denial of a request to change professional labeling to allow marketing of aspirin for primary prevention of heart attacks.
Accordingly, we examined the frequency and practice-level variation in inappropriate aspirin use for primary CVD prevention in a national cohort of patients enrolled in the American College of Cardiology's National Cardiovascular Disease Registry's Practice Innovation and Clinical Excellence (PINNACLE) registry.
Abstract and Introduction
Abstract
Background Among patients without cardiovascular disease (CVD) and low 10-year CVD risk, the risks of gastrointestinal bleeding and hemorrhagic strokes associated with aspirin use outweigh any potential atheroprotective benefit. According to the guidelines on primary prevention of CVD, aspirin use is considered appropriate only in patients with 10-year CVD risk ≥6% and inappropriate in patients with 10-year CVD risk <6%.
Objectives The goal of this study was to examine the frequency and practice-level variation in inappropriate aspirin use for primary prevention in a large U.S. nationwide registry.
Methods Within the National Cardiovascular Disease Registry's Practice Innovation and Clinical Excellence registry, we assessed 68,808 unique patients receiving aspirin for primary prevention from 119 U.S. practices. The frequency of inappropriate aspirin use was determined for primary prevention (aspirin use in those with 10-year CVD risk <6%). Using hierarchical regression models, the extent of practice-level variation using the median rate ratio (MRR) was assessed.
Results Inappropriate aspirin use frequency was 11.6% (7,972 of 68,808) in the overall cohort. There was significant practice-level variation in inappropriate use (range 0% to 71.8%; median 10.1%; interquartile range 6.4%) for practices; adjusted MRR was 1.63 (95% confidence interval [CI]: 1.47 to 1.77). Results remained consistent after excluding 21,052 women age ≥65 years (inappropriate aspirin use 15.2%; median practice-level inappropriate aspirin use 13.8%; interquartile range 8.2%; adjusted MRR 1.61 [95% CI: 1.46 to 1.75]) and after excluding patients with diabetes (inappropriate aspirin use 13.9%; median practice-level inappropriate aspirin use 12.4%; interquartile range 7.6%; adjusted MRR 1.55 [95% CI: 1.41 to 1.67]).
Conclusions More than 1 in 10 patients in this national registry were receiving inappropriate aspirin therapy for primary prevention, with significant practice-level variations. Our findings suggest that there are important opportunities to improve evidence-based aspirin use for the primary prevention of CVD.
Introduction
Cardiovascular disease (CVD) has been the leading cause of death in the United States for the past century and is the underlying cause of death in 32.3% of people. Therefore, emphasis has been placed on the primary and secondary prevention of this disease. Aspirin use is recommended for secondary prevention in patients with pre-existing CVD, and it is recommended for primary prevention in patients without CVD who have a moderate to high 10-year risk of developing CVD. However, in patients without CVD and a low 10-year CVD risk, there is no proof that aspirin use is associated with a reduction in adverse cardiovascular events. In this primary prevention population, the increased risk of gastrointestinal bleeding and hemorrhagic strokes associated with aspirin use outweighs any potential benefit from CVD risk reduction.
Based on these findings, the American Heart Association (AHA) guidelines on primary prevention of CVD and stroke in 2002 recommended aspirin for patients with 10-year coronary and stroke risk ≥10%. The U.S. Preventive Services Task Force recommendation on aspirin use for prevention of CVD from 2009 advised an approach of weighing the benefit of preventing CVD against the risk of increased gastrointestinal bleeding and hemorrhagic strokes, with recommendations to use aspirin if 5-year coronary heart disease (CHD) risk is ≥3% (10-year CHD risk of ≥6%). The recent AHA/American Stroke Association guidelines for primary prevention of stroke in 2011 recommend aspirin use for primary prevention if 10-year CVD risk is at least 6% to 10% (Class I; Level of Evidence: A). Thus, aspirin use for primary prevention would be considered appropriate in patients with 10-year CVD risk ≥6%. Given the risk of gastrointestinal bleeding and hemorrhagic strokes, aspirin use for primary prevention in patients at low risk of cardiovascular events (10-year CVD risk <6%) would be potentially inappropriate.
The U.S. Food and Drug Administration also recently issued a public advisory against the general use of aspirin for the primary prevention of heart attacks and strokes. This decision followed its denial of a request to change professional labeling to allow marketing of aspirin for primary prevention of heart attacks.
Accordingly, we examined the frequency and practice-level variation in inappropriate aspirin use for primary CVD prevention in a national cohort of patients enrolled in the American College of Cardiology's National Cardiovascular Disease Registry's Practice Innovation and Clinical Excellence (PINNACLE) registry.