Vanessa Selak, MBChB, PhD; Rod Jackson, MBChB, PhD; Katrina Poppe, PhD; Billy Wu, MPH; Matire Harwood, MBChB, PhD; Corina Grey, MBChB, PhD; Romana Pylypchuk, PhD; Suneela Mehta, MBChB, MPH; Yeun-Hyang Choi, MSc; Andrew Kerr, MBChB, MD; Sue Wells, MBChB, PhD
Note: The PREDICT cohort was developed through a collaboration among epidemiologists and other clinical researchers at the University of Auckland, information technology specialists at Enigma Solutions (a private information technology company that developed and maintains the PREDICT software and Web server), primary health care organizations (and their physician members), nongovernmental organizations (New Zealand Guidelines Group, Heart Foundation of New Zealand, Diabetes New Zealand, Diabetes Auckland), several district health boards, and the Ministry of Health. The PREDICT software platform is owned by Enigma Publishing (PREDICT is a trademark of Enigma Solutions).
Acknowledgment: The authors thank the primary health care organizations, affiliated primary care physicians, nurses, and patients for their contributions to this study. They also thank Kushan Gandhi for his review of studies that provided an individualized assessment of the balance of benefits and harms of aspirin for primary prevention.
Financial Support: This research was funded by a project grant (15/165) from the Health Research Council of New Zealand (HRC). Drs. Jackson, Poppe, Harwood, Grey, Mehta, Kerr, and Wells and Mr. Wu are receiving funding from the HRC for program, project, and clinical research training grants for CVD research. Dr. Poppe is the recipient of a Heart Foundation of New Zealand Hynds Senior Fellowship, and Dr. Grey is the recipient of a National Heart Foundation of New Zealand Research Fellowship.
Disclosures: Drs. Selak, Poppe, and Grey report grants from the HRC and National Heart Foundation of New Zealand during the conduct of the study. Drs. Jackson, Harwood, Mehta, and Kerr report grants from the HRC during the conduct of the study. Dr. Wells reports grants from the HRC of New Zealand and Stevenson Foundation during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-1132.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Catharine B. Stack, PhD, MS, Deputy Editor, Statistics, reports that she has stock holdings in Pfizer, Johnson & Johnson, and Colgate-Palmolive. Christina C. Wee, MD, MPH, Deputy Editor, reports employment with Beth Israel Deaconess Medical Center. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Yu-Xiao Yang, MD, MSCE, Deputy Editor, reports that he has no financial relationships or interest to disclose.
Reproducible Research Statement: Study protocol: Not available. Statistical code: Available from Dr. Selak (e-mail, firstname.lastname@example.org). Data set: Available with approval of the contributing primary health care organizations and the New Zealand Health and Disability Ethics Committee.
Corresponding Author: Vanessa Selak, MBChB, PhD, Section of Epidemiology and Biostatistics, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand; e-mail, email@example.com.
Current Author Addresses: Drs. Selak, Jackson, Poppe, Grey, Pylypchuk, Mehta, Kerr, and Wells; Mr. Wu; and Ms. Choi: Section of Epidemiology and Biostatistics, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.
Dr. Harwood: Department of General Practice and Primary Health Care, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.
Author Contributions: Conception and design: V. Selak, R. Jackson, A. Kerr, S. Wells.
Analysis and interpretation of the data: V. Selak, R. Jackson, K. Poppe, M. Harwood, C. Grey, S. Mehta, Y.H. Choi, A. Kerr, S. Wells.
Drafting of the article: R. Pylypchuk, S. Wells.
Critical revision for important intellectual content: V. Selak, R. Jackson, K. Poppe, M. Harwood, C. Grey, R. Pylypchuk, S. Mehta, A. Kerr, S. Wells.
Final approval of the article: V. Selak, R. Jackson, K. Poppe, B. Wu, M. Harwood, C. Grey, R. Pylypchuk, S. Mehta, Y.H. Choi, A. Kerr, S. Wells.
Provision of study materials or patients: R. Jackson.
Statistical expertise: K. Poppe.
Obtaining of funding: V. Selak, R. Jackson, M. Harwood, A. Kerr.
Administrative, technical, or logistic support: R. Jackson, B. Wu.
Collection and assembly of data: R. Jackson, B. Wu, S. Wells.
Whether the benefits of aspirin for the primary prevention of cardiovascular disease (CVD) outweigh its bleeding harms in some patients is unclear.
To identify persons without CVD for whom aspirin would probably result in a net benefit.
Individualized benefit–harm analysis based on sex-specific risk scores and estimates of the proportional effect of aspirin on CVD and major bleeding from a 2019 meta-analysis.
New Zealand primary care.
245 028 persons (43.6% women) aged 30 to 79 years without established CVD who had their CVD risk assessed between 2012 and 2016.
The net effect of aspirin was calculated for each participant by subtracting the number of CVD events likely to be prevented (CVD risk score × proportional effect of aspirin on CVD risk) from the number of major bleeds likely to be caused (major bleed risk score × proportional effect of aspirin on major bleeding risk) over 5 years.
2.5% of women and 12.1% of men were likely to have a net benefit from aspirin treatment for 5 years if 1 CVD event was assumed to be equivalent in severity to 1 major bleed, increasing to 21.4% of women and 40.7% of men if 1 CVD event was assumed to be equivalent to 2 major bleeds. Net benefit subgroups had higher baseline CVD risk, higher levels of most established CVD risk factors, and lower levels of bleeding-specific risk factors than net harm subgroups.
Risk scores and effect estimates were uncertain. Effects of aspirin on cancer outcomes were not considered. Applicability to non–New Zealand populations was not assessed.
For some persons without CVD, aspirin is likely to result in net benefit.
Health Research Council of New Zealand.
Selak V, Jackson R, Poppe K, et al. Personalized Prediction of Cardiovascular Benefits and Bleeding Harms From Aspirin for Primary Prevention: A Benefit–Harm Analysis. Ann Intern Med. 2019;171:529–539. [Epub ahead of print 17 September 2019]. doi: https://doi.org/10.7326/M19-1132
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Published: Ann Intern Med. 2019;171(8):529-539.
Published at www.annals.org on 17 September 2019
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