Objective To evaluate cardiovascular (CV) outcomes in outpatients with coronary artery disease (CAD) living alone compared with those living with others.
Methods The prospeCtive observational LongitudinAl RegIstry oF patients with stable coronarY artery disease (CLARIFY) included outpatients with stable CAD. CLARIFY enrolled participants in 45 countries from November 2009 to July 2010, with 5 years of follow-up. Living arrangement was documented at baseline. The primary outcome was a composite of major adverse cardiovascular events (MACEs) defined as CV death, myocardial infarction (MI) and stroke.
Results Among 32 367 patients, 3648 patients were living alone (11.3%). After multivariate adjustment, there were no residual differences in MACE among patients living alone compared with those living with others (HR 1.04, 95% CI 0.92 to 1.18, p=0.52); however, there was significant heterogeneity in the exposure effect by sex (Pinteraction<0.01). Specifically, men living alone were at higher risk for MACE (HR 1.17, 95% CI 1.002 to 1.36, p=0.047) as opposed to women living alone (HR 0.82, 95% CI 0.65 to 1.04, p=0.1), predominantly driven by a heterogeneous effect by sex on MI (Pinteraction=0.006). There was no effect modification for MACE by age group (Pinteraction=0.3), although potential varying effects by age for MI (Pinteraction=0.046) and stroke (Pinteraction=0.05).
Conclusions Living alone was not associated with an independent increase in MACE, although significant sex-based differences were apparent. Men living alone may have a worse prognosis from CV disease than women; further analyses are needed to elucidate the mechanisms underlying this difference.
Trial registration number ISRCTN43070564.
- social isolation
- living alone
- coronary artery disease
- cardiovascular disease
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Contributors IF had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. SG wrote the first draft of the manuscript. Study conception or design: SG, SGG, GS and JAU. Acquisition, analysis or interpretation of data: all authors. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: IF, NG and PM. Administrative, technical and material support: SGG, NG and GS. Study supervision: SGG and GS. All authors have approved the final article.
Funding The CLARIFY registry is supported by Servier. The sponsor assisted with the set-up, data collection and management of the study in each country.
Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: JAU reported consultancy fees from consulting: Johnson & Johnson, Merck, Novartis, Sanofi Pasteur; Novartis (steering committee). PD reports grants and personal fees from Servier, outside the submitted work. SGG reports grants from Servier during the conduct of the study; personal fees from Servier Canada, outside the submitted work. RF reports honorarium from Servier for steering committee membership, consulting, speaker’s bureau fees and support for travel to study meetings; personal fees from Boehringer-Ingelheim, Novartis, Merck Serono and Irbtech; he is a stockholder in Medical Trials Analysis. IF reports grants and personal fees from Servier during the conduct of the study; grants and personal fees from Amgen, outside the submitted work. KMF reports personal fees and non-financial support from Servier during the conduct of the study, from Broadview Ventures; personal fees from AstraZeneca, TaurX, CelAegis, outside the submitted work; non-financial support from Armgo, Director of Vesalius Trials LtdDinimal and stockholder of Armgo and CellAegis. NG reports grants from Servier during the conduct of the study. PMS reports grants from Servier during the conduct of the study. PGS reports grants from Merck, Sanofi, Servier; personal fees from Amarin, Amgen, AstraZeneca, Bayer, Boehriner-Ingelheim, BristolMyersSquibb, CSL-Behring, Daiichi-Sankyo, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi, Servier, The Medicines Company, outside the submitted work. JCT reports personal fees from Servier, during the conduct of the study; grants from Amarin, Astra-Zeneca, DalCor, Eli Lilly, Esperion, Ionis, Merck, Pfizer, Sanofi, Servier; personal fees from DalCor, Pfizer, Sanofi, Servier, holds minor equity interest in DalCor, outside the submitted work; a patent Pharmacogenomics-Guided Therapy with CETP Inhibitor pending. MT reports personal fees from Servier during the conduct of the study; personal fees from Bayer, Celyad, KOWA, Janssen-Cilag, PERFUSE Study Group; grants from Polish National Center for Research and Development, outside the submitted work.
Ethics approval The study was approved by the National Research Ethics Service, Isle of Wight, Portsmouth and Southeast Hampshire Research Ethics Committee, UK.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
Patient consent for publication Not required.