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Figure.  Cardiovascular Studies Selection Process

The figure displays the cardiovascular studies selection process from the 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization. ACC indicates American College of Cardiology; AHA, American Heart Association; RCT, randomized clinical trial; SCAI, Society for Cardiovascular Angiography and Interventions.

Table.  Representation of Older Adults in Observational Studies and RCTs Cited in the 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization
1.
Kumar  S, McDaniel  M, Samady  H, Forouzandeh  F.  Contemporary revascularization dilemmas in older adults.   J Am Heart Assoc. 2020;9(3):e014477. doi:
2.
Damluji  AA, Forman  DE, Wang  TY,  et al; American Heart Association Cardiovascular Disease in Older Populations Committee of the Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; and Council on Lifestyle and Cardiometabolic Health.  Management of acute coronary syndrome in the older adult population: a scientific statement from the American Heart Association.  Ìý°ä¾±°ù³¦³Ü±ô²¹³Ù¾±´Ç²Ô. 2023;147(3):e32-e62. doi:
3.
Lawton  JS, Tamis-Holland  JE, Bangalore  S,  et al.  2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines.  Ìý°ä¾±°ù³¦³Ü±ô²¹³Ù¾±´Ç²Ô. 2022;145(3):e18-e114. doi:
4.
Nanna  MG, Chen  ST, Nelson  AJ, Navar  AM, Peterson  ED.  Representation of older adults in cardiovascular disease trials since the inclusion across the lifespan policy.   JAMA Intern Med. 2020;180(11):1531-1533. doi:
5.
Park  DY, Hanna  JM, Kadian  S,  et al.  In-hospital outcomes and readmission in older adults treated with percutaneous coronary intervention for stable ischemic heart disease.   J Geriatr Cardiol. 2022;19(9):631-642. doi:
6.
Nanna  MG, Sutton  NR, Kochar  A,  et al.  Assessment and management of older adults undergoing PCI, Part 1: a JACC: advances expert panel.   JACC Adv. 2023;2(4):100389. doi:
1 Comment for this article
Clinical Trials with Geriatric population are imperative for definite answer
Rajeev Gupta, MBBS; MD;DM (Cardiology) | Spectrum Medical Center, and Burjeel Royal Hospital, Al Ain, UAE
The article suggests inclusion of geriatric population in clinical trials along with adult patients. However, the pharmacodynamic and pharmacokinetic properties of cardiovascular drugs many times are quite different in geriatric population, so dedicated clinical trials including only geriatric patients may be needed.
CONFLICT OF INTEREST: None Reported
Research Letter
Cardiology
´³³Ü±ô²âÌý12, 2024

Representation of Older Adults in the ACC/AHA/SCAI Guideline for Coronary Artery Revascularization

Author Affiliations
  • 1Department of Medicine, Yale School of Medicine, New Haven, Connecticut
  • 2Department of Medicine, Cook County Health, Chicago, Illinois
  • 3Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut
  • 4Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 5Inova Center of Outcomes Research, Falls Church, Virginia
JAMA Netw Open. 2024;7(7):e2421547. doi:10.1001/jamanetworkopen.2024.21547
Introduction

Older adults have the heaviest clinical burden across the coronary artery disease (CAD) spectrum.1 Despite this, they are less likely to be offered revascularization procedures that may improve symptoms, quality of life, and even cardiovascular mortality in select patients.1,2 Treatment gaps among older adults may be explained by underrepresentation in the literature underlying current guideline recommendations. We evaluated the representation of older adults in studies cited in the 2021 American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions (ACC/AHA/SCAI) Guideline for Coronary Artery Revascularization to assess the generalizability of the guidelines.3

Methods

This cross-sectional study followed the Strengthening the Reporting of Observational Studies in Epidemiology () reporting guideline. Institutional review board approval and informed patient consent were not required because this study used previously published, publicly available data without specific patient identifiers.

This cross-sectional study included the studies cited in the 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization.3 Screening and full-text review were conducted by 3 independent investigators (Y.J., C.S., D.Y.P.), and any disputes were resolved by discussion with the senior author (M.G.N.). The number of participants, mean age, and geriatric-centered outcomes (frailty, polypharmacy, falls, cognitive impairment, and functional independence) were documented. Representation of older adults was considered according to (1) active inclusion of older adults (aged 75 years or older or aged 80 years or older) in the methods or explicitly reporting subgroup analyses in these age groups; (2) having a first IQR or SD of 75 years or older or 80 years or older; (3) active exclusion based on age. Studies that did not report mean age, such as review articles or guidelines or those unrelated to cardiovascular conditions, were excluded. Subgroup analyses from the parent trial were considered if they specified the inclusion of older adults. Additional information can be found in eMethods in Supplement 1. The data analysis was descriptive and occurred from October 1981 to June 2021, and Excel (Microsoft) was used for calculations.

Results

A total of 29 985 950 individuals from 540 studies were assessed (mean (SD) age, 66.0 [5.6] years), including 230 randomized clinical trials (RCTs) and 310 observational studies (Figure). This comprises 484 492 individuals in RCTs and 29 501 458 from observational studies, with mean (SD) ages of 63.4 (5.0) and 66.0 (6.0) years, respectively. When grouped according to an age cut-off, 4.4% of the included studies had a mean age of 75 years or older, and 1.5% had a mean age of 80 years or older. Moreover, 113 (20.9%) explicitly mentioned the inclusion of adults aged 75 years or older, of which 65 studies (12.0%) mentioned the inclusion of adults aged 80 years or older (Table). Of the studies that included older adults, the clinical presentation was relatively evenly distributed across CAD phenotypes. From the remaining studies that did not explicitly mention the inclusion of older adults, 146 studies (27.0%) had a mean (SD) age with the first IQR or SD inclusive of age 75 years or older, of which 29 studies (5.4%) had a mean age with IQR or SD of 80 years older. Conversely, 26 studies (4.8%) actively excluded adults aged 75 years or older, and 45 (8.3%) actively excluded adults aged 80 years or older. Lastly, only 11 studies (2.0%) reported geriatric-centered outcomes.

Discussion

These findings suggest that older adults with acute and chronic CAD were underrepresented in studies cited by the clinical practice guidelines for coronary artery revascularization. While the explicit exclusion of older adults has become less frequent than previously reported,4 less than 25% of the cited studies explicitly highlighted the inclusion of older adults, and few reported geriatric-centric outcomes. Given that older adults make up approximately one-third of individuals undergoing percutaneous coronary intervention for chronic CAD and a similar prevalence of individuals with acute coronary syndrome,2,5 these findings support the ongoing need for dedicated efforts to improve the representation of older adults in RCTs evaluating revascularization.

This study was limited by a lack of access to patient-level data, which precluded a precise estimate of the number of older adults included in the cited studies. However, as guideline recommendations play a crucial role for clinicians in making treatment decisions, the relative underrepresentation of older adults in the evidence base supporting these recommendations highlighted here may contribute to treatment gaps in older adults. Older adults frequently have unique physiological characteristics, increased procedural complexity, and a higher risk for adverse events following treatment.1,6 Additionally, older adults may have different treatment goals often not considered in revascularization studies, such as maintaining independence, function, cognition, and mobility. Thus, investigators and sponsors must prioritize the inclusion of older adults in revascularization studies to inform future guideline documents, reduce treatment heterogeneity, and assist clinicians in caring for a complex population of older adults with CAD.

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Article Information

Accepted for Publication: May 13, 2024.

Published: July 12, 2024. doi:10.1001/jamanetworkopen.2024.21547

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2024 Jamil Y et al. ÌÇÐÄvlog Open.

Corresponding Author: Michael G. Nanna, MD, MHS, Yale New Haven Hospital, 20 York St, New Haven, CT 06510 (michael.nanna@yale.edu).

Author Contributions: Drs Jamil and Nanna had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Jamil, Frampton, Damluji, Nanna.

Acquisition, analysis, or interpretation of data: Jamil, Sibindi, Park, Nanna.

Drafting of the manuscript: Jamil, Sibindi, Park, Damluji, Nanna.

Critical review of the manuscript for important intellectual content: All authors.

Statistical analysis: Jamil, Nanna.

Administrative, technical, or material support: Jamil, Park, Nanna.

Supervision: Jamil, Frampton, Nanna.

Conflict of Interest Disclosures: Dr Frampton reported receiving grants from Patient-Centered Outcomes Research Institute (PCORI) outside the submitted work. Dr Nanna reported receiving research support from the American College of Cardiology Foundation supported by the George F. and Ann Harris Bellows Foundation, PCORI, the Yale Claude D. Pepper Older Americans Independence Center (grant P30AG021342), and the National Institute on Aging of the National Institutes of Health (grant R03AG074067) outside the submitted work. No other disclosures were reported.

Data Sharing Statement: See Supplement 2.

References
1.
Kumar  S, McDaniel  M, Samady  H, Forouzandeh  F.  Contemporary revascularization dilemmas in older adults.   J Am Heart Assoc. 2020;9(3):e014477. doi:
2.
Damluji  AA, Forman  DE, Wang  TY,  et al; American Heart Association Cardiovascular Disease in Older Populations Committee of the Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; and Council on Lifestyle and Cardiometabolic Health.  Management of acute coronary syndrome in the older adult population: a scientific statement from the American Heart Association.  Ìý°ä¾±°ù³¦³Ü±ô²¹³Ù¾±´Ç²Ô. 2023;147(3):e32-e62. doi:
3.
Lawton  JS, Tamis-Holland  JE, Bangalore  S,  et al.  2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines.  Ìý°ä¾±°ù³¦³Ü±ô²¹³Ù¾±´Ç²Ô. 2022;145(3):e18-e114. doi:
4.
Nanna  MG, Chen  ST, Nelson  AJ, Navar  AM, Peterson  ED.  Representation of older adults in cardiovascular disease trials since the inclusion across the lifespan policy.   JAMA Intern Med. 2020;180(11):1531-1533. doi:
5.
Park  DY, Hanna  JM, Kadian  S,  et al.  In-hospital outcomes and readmission in older adults treated with percutaneous coronary intervention for stable ischemic heart disease.   J Geriatr Cardiol. 2022;19(9):631-642. doi:
6.
Nanna  MG, Sutton  NR, Kochar  A,  et al.  Assessment and management of older adults undergoing PCI, Part 1: a JACC: advances expert panel.   JACC Adv. 2023;2(4):100389. doi:
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