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Clinical and Quality-of-Life Outcomes Following Invasive vs Conservative Treatment of Patients With Chronic Coronary
Sripal Bangalore1, Judith S Hochman1, Susanna R Stevens2
1New York University Grossman School of Medicine, New York.
Insights
For patients with chronic coronary disease (CCD) and chronic kidney disease (CKD), invasive management increased stroke and procedural MI risk, with no survival benefit. Quality of life benefits were limited to earlier CKD stages.
Area of Science:
- Cardiology
- Nephrology
- Clinical Trials
Background:
- Prior studies on invasive vs. conservative management for chronic coronary disease (CCD) excluded patients with severe chronic kidney disease (CKD).
- Outcomes for patients with CCD across the spectrum of kidney function remain incompletely characterized.
Purpose of the Study:
- To evaluate clinical and quality-of-life (QoL) outcomes in patients with CCD and varying stages of CKD.
- To compare invasive treatment strategies (angiography and revascularization) versus conservative management (guideline-directed medical therapy alone).
Main Methods:
- Analysis of participants from the ISCHEMIA and ISCHEMIA-CKD trials, categorized by CKD stage (1-5) based on estimated glomerular filtration rate (eGFR).
- Initial invasive management (angiography/revascularization + GDMT) compared to initial conservative management (GDMT alone).
- Primary outcomes included a composite of death or nonfatal myocardial infarction (MI), and QoL assessed by the Seattle Angina Questionnaire (SAQ) summary score.
Main Results:
- A monotonic increase in the risk of the primary composite endpoint, death, cardiovascular death, MI, and stroke was observed with higher CKD stages.
- Invasive management increased stroke and procedural MI risk but decreased spontaneous MI risk, with similar effects across CKD stages and no difference in overall death.
- Quality of life (QoL) improvements with invasive management were seen in CKD stages 1-3 but not in stages 4-5.
Conclusions:
- For patients with CCD, adverse event rates increased as kidney function declined.
- Invasive management in CCD patients showed no survival benefit and increased risks of stroke and procedural MI, with QoL benefits limited to earlier CKD stages.
- These findings highlight the importance of considering kidney function when deciding on treatment strategies for chronic coronary disease.
Importance:
Prior trials of invasive vs conservative management of chronic coronary disease (CCD) have not enrolled patients with severe chronic kidney disease (CKD). As such, outcomes across kidney function are not well characterized.
Objectives:
To evaluate clinical and quality-of-life (QoL) outcomes across the spectrum of CKD following conservative and invasive treatment strategies.
Design, Setting, And Participants:
Participants from the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) and ISCHEMIA-Chronic Kidney Disease (CKD) trials were categorized by CKD stage: stage 1 (estimated glomerular filtration rate [eGFR] 90 mL/min/1.73m2 or greater), stage 2 (eGFR 60-89 mL/min/1.73m2), stage 3 (eGFR 30-59 mL/min/1.73m2), stage 4 (eGFR 15-29 mL/min/1.73m2), or stage 5 (eGFR less than 15 mL/min/1.73m2 or receiving dialysis). Enrollment took place from July 26, 2012, through January 31, 2018, with a median follow-up of 3.1 years. Data were analyzed from January 2020 to May 2021.
Interventions:
Initial invasive management of coronary angiography and revascularization with guideline-directed medical therapy (GDMT) vs initial conservative management of GDMT alone.
Main Outcomes And Measures:
The primary clinical outcome was a composite of death or nonfatal myocardial infarction (MI). The primary QoL outcome was the Seattle Angina Questionnaire (SAQ) summary score.
Results:
Among the 5956 participants included in this analysis (mean [SD] age, 64 [10] years; 1410 [24%] female and 4546 [76%] male), 1889 (32%), 2551 (43%), 738 (12%), 311 (5%), and 467 (8%) were in CKD stages 1, 2, 3, 4, and 5, respectively. By self-report, 18 participants (<1%) were American Indian or Alaska Native; 1676 (29%), Asian; 267 (5%), Black; 861 (16%), Hispanic or Latino; 18 (<1%), Native Hawaiian or Other Pacific Islander; 3884 (66%), White; and 13 (<1%), multiple races or ethnicities. There was a monotonic increase in risk of the primary composite end point (3-year rates, 9.52%, 10.72%, 18.42%, 34.21%, and 38.01% respectively), death, cardiovascular death, MI, and stroke in individuals with higher CKD stages. Invasive management was associated with an increase in stroke (3-year event rate difference, 1%; 95% CI, 0.3 to 1.7) and procedural MI (1.6%; 95% CI, 0.9 to 2.3) and a decrease in spontaneous MI (-2.5%; 95% CI, -3.9 to -1.1) with no difference in other outcomes; the effect was similar across CKD stages. There was heterogeneity of treatment effect for QoL outcomes such that invasive management was associated with an improvement in angina-related QoL in individuals with CKD stages 1 to 3 and not in those with CKD stages 4 to 5.
Conclusions And Relevance:
Among participants with CCD, event rates were inversely proportional to kidney function. Invasive management was associated with an increase in stroke and procedural MI and a reduced risk in spontaneous MI, and the effect was similar across CKD stages with no difference in other outcomes, including death. The benefit for QoL with invasive management was not observed in individuals with poorer kidney function.
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