Salman Waheed1, Simcha Pollack2, Marguerite Roth3, Nathaniel Reichek4, Alan Guerci3, Jie J Cao5. 1. Saint Francis Hospital, Roslyn, NY, USA; University of Kansas Medical Center, Kansas City, KS, USA. 2. Saint Francis Hospital, Roslyn, NY, USA; St. John's University, Queens, New York, USA. 3. Saint Francis Hospital, Roslyn, NY, USA. 4. Saint Francis Hospital, Roslyn, NY, USA; State University of New York at Stony Brook, New York, USA. 5. Saint Francis Hospital, Roslyn, NY, USA; State University of New York at Stony Brook, New York, USA. Electronic address: Jane.Cao@chsli.org.
Abstract
BACKGROUND AND AIMS: The efficacy of statin therapy remains unknown in patients eligible for statin therapy with and without elevated coronary calcium score (CAC). The study sought to evaluate how cardiovascular risk factors, expressed in terms of statin eligibility for primary prevention, and CAC modify clinical outcomes with and without statin therapy. METHODS: We conducted a post-hoc analysis of the St. Francis Heart Study treatment trial, a double-blind, placebo-controlled randomized controlled trial of atorvastatin (20 mg), vitamin C (1 g), and vitamin E (1000 U) daily, versus placebos in 990 asymptomatic individuals with CAC ≥ 80th percentile for age and gender. Primary cardiovascular outcomes included non-fatal myocardial infarction or coronary death, coronary revascularization, stroke, and peripheral arterial revascularization. We further stratified the treatment and placebo groups by eligibility (eligible when statin indicated) for statin therapy based on 2013 ACC/AHA guidelines and based on CAC categories. RESULTS: After a median follow-up of 4.8 years, cardiovascular events had occurred in 3.9% of the statin treated but not eligible, 4.6% of the untreated and not eligible, 8.9% of the treated and eligible and 13.4% of the untreated and eligible groups, respectively (p<0.001). Low CAC (<100) occurred infrequently in statin eligible subjects (≤4%) and was associated with low 10-year event rate (<1 per 100 person-years). In contrast, high CAC (>300) occurred frequently in more than 35% of the statin not eligible subjects and was associated with a high 10-year event rate (≥17 per 100 person-years). Risk prediction improved significantly when both clinical risk profile and CAC score were combined (net reclassification index p = 0.002). CONCLUSIONS: Under the current statin treatment guidelines a small number of statin eligible subjects with low CAC might not benefit from statin therapy within 5 years. However, the statin not eligible subjects with high CAC have high event rate attributing to loss of opportunity for effective primary prevention. Copyright Â
RCT Entities:
BACKGROUND AND AIMS: The efficacy of statin therapy remains unknown in patients eligible for statin therapy with and without elevated coronary calcium score (CAC). The study sought to evaluate how cardiovascular risk factors, expressed in terms of statin eligibility for primary prevention, and CAC modify clinical outcomes with and without statin therapy. METHODS: We conducted a post-hoc analysis of the St. Francis Heart Study treatment trial, a double-blind, placebo-controlled randomized controlled trial of atorvastatin (20 mg), vitamin C (1 g), and vitamin E (1000 U) daily, versus placebos in 990 asymptomatic individuals with CAC ≥ 80th percentile for age and gender. Primary cardiovascular outcomes included non-fatal myocardial infarction or coronary death, coronary revascularization, stroke, and peripheral arterial revascularization. We further stratified the treatment and placebo groups by eligibility (eligible when statin indicated) for statin therapy based on 2013 ACC/AHA guidelines and based on CAC categories. RESULTS: After a median follow-up of 4.8 years, cardiovascular events had occurred in 3.9% of the statin treated but not eligible, 4.6% of the untreated and not eligible, 8.9% of the treated and eligible and 13.4% of the untreated and eligible groups, respectively (p<0.001). Low CAC (<100) occurred infrequently in statin eligible subjects (≤4%) and was associated with low 10-year event rate (<1 per 100 person-years). In contrast, high CAC (>300) occurred frequently in more than 35% of the statin not eligible subjects and was associated with a high 10-year event rate (≥17 per 100 person-years). Risk prediction improved significantly when both clinical risk profile and CAC score were combined (net reclassification index p = 0.002). CONCLUSIONS: Under the current statin treatment guidelines a small number of statin eligible subjects with low CAC might not benefit from statin therapy within 5 years. However, the statin not eligible subjects with high CAC have high event rate attributing to loss of opportunity for effective primary prevention. Copyright Â
Authors: Donna K Arnett; Roger S Blumenthal; Michelle A Albert; Andrew B Buroker; Zachary D Goldberger; Ellen J Hahn; Cheryl Dennison Himmelfarb; Amit Khera; Donald Lloyd-Jones; J William McEvoy; Erin D Michos; Michael D Miedema; Daniel Muñoz; Sidney C Smith; Salim S Virani; Kim A Williams; Joseph Yeboah; Boback Ziaeian Journal: J Am Coll Cardiol Date: 2019-03-17 Impact factor: 24.094
Authors: Donna K Arnett; Roger S Blumenthal; Michelle A Albert; Andrew B Buroker; Zachary D Goldberger; Ellen J Hahn; Cheryl Dennison Himmelfarb; Amit Khera; Donald Lloyd-Jones; J William McEvoy; Erin D Michos; Michael D Miedema; Daniel Muñoz; Sidney C Smith; Salim S Virani; Kim A Williams; Joseph Yeboah; Boback Ziaeian Journal: J Am Coll Cardiol Date: 2019-03-17 Impact factor: 24.094
Authors: Donna K Arnett; Roger S Blumenthal; Michelle A Albert; Andrew B Buroker; Zachary D Goldberger; Ellen J Hahn; Cheryl Dennison Himmelfarb; Amit Khera; Donald Lloyd-Jones; J William McEvoy; Erin D Michos; Michael D Miedema; Daniel Muñoz; Sidney C Smith; Salim S Virani; Kim A Williams; Joseph Yeboah; Boback Ziaeian Journal: Circulation Date: 2019-03-17 Impact factor: 29.690
Authors: Donna K Arnett; Roger S Blumenthal; Michelle A Albert; Andrew B Buroker; Zachary D Goldberger; Ellen J Hahn; Cheryl Dennison Himmelfarb; Amit Khera; Donald Lloyd-Jones; J William McEvoy; Erin D Michos; Michael D Miedema; Daniel Muñoz; Sidney C Smith; Salim S Virani; Kim A Williams; Joseph Yeboah; Boback Ziaeian Journal: Circulation Date: 2019-03-17 Impact factor: 29.690