Dataset Information

Health Status and Clinical Outcomes in Older Adults With Chronic Coronary Disease: The ISCHEMIA Trial.

ABSTRACT:

Background

Whether initial invasive management in older vs younger adults with chronic coronary disease and moderate or severe ischemia improves health status or clinical outcomes is unknown.

Objectives

The goal of this study was to examine the impact of age on health status and clinical outcomes with invasive vs conservative management in the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial.

Methods

One-year angina-specific health status was assessed with the 7-item Seattle Angina Questionnaire (SAQ) (score range 0-100; higher scores indicate better health status). Cox proportional hazards models estimated the treatment effect of invasive vs conservative management as a function of age on the composite clinical outcome of cardiovascular death, myocardial infarction, or hospitalization for resuscitated cardiac arrest, unstable angina, or heart failure.

Results

Among 4,617 participants, 2,239 (48.5%) were aged <65 years, 1,713 (37.1%) were aged 65 to 74 years, and 665 (14.4%) were aged ≥75 years. Baseline SAQ summary scores were lower in participants aged <65 years. Fully adjusted differences in 1-year SAQ summary scores (invasive minus conservative) were 4.90 (95% CI: 3.56-6.24) at age 55 years, 3.48 (95% CI: 2.40-4.57) at age 65 years, and 2.13 (95% CI: 0.75-3.51) at age 75 years (P_interaction = 0.008). Improvement in SAQ Angina Frequency was less dependent on age (P_interaction = 0.08). There were no age differences between invasive vs conservative management on the composite clinical outcome (P_interaction = 0.29).

Conclusions

Older patients with chronic coronary disease and moderate or severe ischemia had consistent improvement in angina frequency but less improvement in angina-related health status with invasive management compared with younger patients. Invasive management was not associated with improved clinical outcomes in older or younger patients. (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches [ISCHEMIA]; NCT01471522).

SUBMITTER: Nguyen DD

PROVIDER: S-EPMC10902923 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

Health Status and Clinical Outcomes in Older Adults With Chronic Coronary Disease: The ISCHEMIA Trial.

Nguyen Dan D DD Spertus John A JA Alexander Karen P KP Newman Jonathan D JD Dodson John A JA Jones Philip G PG Stevens Susanna R SR O'Brien Sean M SM Gamma Reto R Perna Gian P GP Garg Pallav P Vitola João V JV Chow Benjamin J W BJW Vertes Andras A White Harvey D HD Smanio Paola E P PEP Senior Roxy R Held Claes C Li Jianghao J Boden William E WE Mark Daniel B DB Reynolds Harmony R HR Bangalore Sripal S Chan Paul S PS Stone Gregg W GW Arnold Suzanne V SV Maron David J DJ Hochman Judith S JS

Journal of the American College of Cardiology 20230501 17

<h4>Background</h4>Whether initial invasive management in older vs younger adults with chronic coronary disease and moderate or severe ischemia improves health status or clinical outcomes is unknown.<h4>Objectives</h4>The goal of this study was to examine the impact of age on health status and clinical outcomes with invasive vs conservative management in the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial.<h4>Methods</h4>One-year angi ...[more]

PMID: 37100486

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Project description:BackgroundThe ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) postulated that patients with stable coronary artery disease (CAD) and moderate or severe ischemia would benefit from revascularization. We investigated the relationship between severity of CAD and ischemia and trial outcomes, overall and by management strategy.MethodsIn total, 5179 patients with moderate or severe ischemia were randomized to an initial invasive or conservative management strategy. Blinded, core laboratory-interpreted coronary computed tomographic angiography was used to assess anatomic eligibility for randomization. Extent and severity of CAD were classified with the modified Duke Prognostic Index (n=2475, 48%). Ischemia severity was interpreted by independent core laboratories (nuclear, echocardiography, magnetic resonance imaging, exercise tolerance testing, n=5105, 99%). We compared 4-year event rates across subgroups defined by severity of ischemia and CAD. The primary end point for this analysis was all-cause mortality. Secondary end points were myocardial infarction (MI), cardiovascular death or MI, and the trial primary end point (cardiovascular death, MI, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest).ResultsRelative to mild/no ischemia, neither moderate ischemia nor severe ischemia was associated with increased mortality (moderate ischemia hazard ratio [HR], 0.89 [95% CI, 0.61-1.30]; severe ischemia HR, 0.83 [95% CI, 0.57-1.21]; P=0.33). Nonfatal MI rates increased with worsening ischemia severity (HR for moderate ischemia, 1.20 [95% CI, 0.86-1.69] versus mild/no ischemia; HR for severe ischemia, 1.37 [95% CI, 0.98-1.91]; P=0.04 for trend, P=NS after adjustment for CAD). Increasing CAD severity was associated with death (HR, 2.72 [95% CI, 1.06-6.98]) and MI (HR, 3.78 [95% CI, 1.63-8.78]) for the most versus least severe CAD subgroup. Ischemia severity did not identify a subgroup with treatment benefit on mortality, MI, the trial primary end point, or cardiovascular death or MI. In the most severe CAD subgroup (n=659), the 4-year rate of cardiovascular death or MI was lower in the invasive strategy group (difference, 6.3% [95% CI, 0.2%-12.4%]), but 4-year all-cause mortality was similar.ConclusionsIschemia severity was not associated with increased risk after adjustment for CAD severity. More severe CAD was associated with increased risk. Invasive management did not lower all-cause mortality at 4 years in any ischemia or CAD subgroup. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01471522.

Project description:Health care may be burdensome and of uncertain benefit for older adults with multiple chronic conditions (MCCs). Aligning health care with an individual's health priorities may improve outcomes and reduce burden. To evaluate whether patient priorities care (PPC) is associated with a perception of more goal-directed and less burdensome care compared with usual care (UC). Nonrandomized clinical trial with propensity adjustment conducted at 1 PPC and 1 UC site of a Connecticut multisite primary care practice that provides care to almost 15% of the state's residents. Participants included 163 adults aged 65 years or older who had 3 or more chronic conditions cared for by 10 primary care practitioners (PCPs) trained in PPC and 203 similar patients who received UC from 7 PCPs not trained in PPC. Participant enrollment occurred between February 1, 2017, and March 31, 2018; follow-up extended for up to 9 months (ended September 30, 2018). Patient priorities care, an approach to decision-making that includes patients' identifying their health priorities (ie, specific health outcome goals and health care preferences) and clinicians aligning their decision-making to achieve these health priorities. Primary outcomes included change in patients' Older Patient Assessment of Chronic Illness Care (O-PACIC), CollaboRATE, and Treatment Burden Questionnaire (TBQ) scores; electronic health record documentation of decision-making based on patients' health priorities; medications and self-management tasks added or stopped; and diagnostic tests, referrals, and procedures ordered or avoided. Of the 366 patients, 235 (64.2%) were female and 350 (95.6%) were white. Compared with the UC group, the PPC group was older (mean [SD] age, 74.7 [6.6] vs 77.6 [7.6] years) and had lower physical and mental health scores. At follow-up, PPC participants reported a 5-point greater decrease in TBQ score than those who received UC (ß [SE], -5.0 [2.04]; P = .01) using a weighted regression model with inverse probability of PCP assignment weights; no differences were seen in O-PACIC or CollaboRATE scores. Health priorities-based decisions were mentioned in clinical visit notes for 108 of 163 (66.3%) PPC vs 0 of 203 (0%) UC participants. Compared with UC patients, PPC patients were more likely to have medications stopped (weighted comparison, 52.0% vs 33.8%; adjusted odds ratio [AOR], 2.05; 95% CI, 1.43-2.95) and less likely to have self-management tasks (57.5% vs 62.1%; AOR, 0.59; 95% CI, 0.41-0.84) and diagnostic tests (80.8% vs 86.4%; AOR, 0.22; 95% CI, 0.12-0.40) ordered. This study's findings suggest that patient priorities care may be associated with reduced treatment burden and unwanted health care. Care aligned with patients' priorities may be feasible and effective for older adults with MCCs. ClinicalTrials.gov identifier: NCT03600389.

Project description:BackgroundBy 2030, the number of US adults age ≥65 will exceed 70 million. Their quality of life has been declared a national priority by the US government.ObjectiveAssess effects of an eHealth intervention for older adults on quality of life, independence, and related outcomes.DesignMulti-site, 2-arm (1:1), non-blinded randomized clinical trial. Recruitment November 2013 to May 2015; data collection through November 2016.SettingThree Wisconsin communities (urban, suburban, and rural).ParticipantsPurposive community-based sample, 390 adults age ≥65 with health challenges.Exclusionslong-term care, inability to get out of bed/chair unassisted.InterventionAccess (vs. no access) to interactive website (ElderTree) designed to improve quality of life, social connection, and independence.MeasuresPrimary outcome: quality of life (PROMIS Global Health). Secondary: independence (Instrumental Activities of Daily Living); social support (MOS Social Support); depression (Patient Health Questionnaire-8); falls prevention (Falls Behavioral Scale). Moderation: healthcare use (Medical Services Utilization). Both groups completed all measures at baseline, 6, and 12 months.ResultsThree hundred ten participants (79%) completed the 12-month survey. There were no main effects of ElderTree over time. Moderation analyses indicated that among participants with high primary care use, ElderTree (vs. control) led to better trajectories for mental quality of life (OR=0.32, 95% CI 0.10-0.54, P=0.005), social support received (OR=0.17, 95% CI 0.05-0.29, P=0.007), social support provided (OR=0.29, 95% CI 0.13-0.45, P<0.001), and depression (OR= -0.20, 95% CI -0.39 to -0.01, P=0.034). Supplemental analyses suggested ElderTree may be more effective among people with multiple (vs. 0 or 1) chronic conditions.LimitationsOnce randomized, participants were not blind to the condition; self-reports may be subject to memory bias.ConclusionInterventions like ET may help improve quality of life and socio-emotional outcomes among older adults with more illness burden. Our next study focuses on this population.Trial registrationClinicalTrials.gov ; registration ID number: NCT02128789.

Project description:BackgroundPatients with chronic kidney disease (CKD) and coronary artery disease frequently undergo preemptive revascularization before kidney transplant listing.ObjectivesIn this post hoc analysis from ISCHEMIA-CKD (International Study of Comparative Health Effectiveness of Medical and Invasive Approaches-Chronic Kidney Disease), we compared outcomes of patients not listed versus those listed according to management strategy.MethodsIn the ISCHEMIA-CKD trial (n = 777), 194 patients (25%) with chronic coronary syndromes and at least moderate ischemia were listed for transplant. The primary (all-cause mortality or nonfatal myocardial infarction) and secondary (death, nonfatal myocardial infarction, hospitalization for unstable angina, heart failure, resuscitated cardiac arrest, or stroke) outcomes were analyzed using Cox multivariable modeling. Heterogeneity of randomized treatment effect between listed versus not listed groups was assessed.ResultsCompared with those not listed, listed patients were younger (60 years vs 65 years), were less likely to be of Asian race (15% vs 29%), were more likely to be on dialysis (83% vs 44%), had fewer anginal symptoms, and were more likely to have coronary angiography and coronary revascularization irrespective of treatment assignment. Among patients assigned to an invasive strategy versus conservative strategy, the adjusted hazard ratios for the primary outcome were 0.91 (95% confidence interval [CI]: 0.54-1.54) and 1.03 (95% CI: 0.78-1.37) for those listed and not listed, respectively (pinteraction= 0.68). Adjusted hazard ratios for secondary outcomes were 0.89 (95% CI: 0.55-1.46) in listed and 1.17 (95% CI: 0.89-1.53) in those not listed (pinteraction = 0.35).ConclusionsIn ISCHEMIA-CKD, an invasive strategy in kidney transplant candidates did not improve outcomes compared with conservative management. These data do not support routine coronary angiography or revascularization in patients with advanced CKD and chronic coronary syndromes listed for transplant. (ISCHEMIA-Chronic Kidney Disease Trial [ISCHEMIA-CKD]; NCT01985360).

Dataset Information

Health Status and Clinical Outcomes in Older Adults With Chronic Coronary Disease: The ISCHEMIA Trial.

Background

Objectives

Methods

Results

Conclusions

Publications

Health Status and Clinical Outcomes in Older Adults With Chronic Coronary Disease: The ISCHEMIA Trial.

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