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Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease.

ABSTRACT: BACKGROUND:In the ISCHEMIA-CKD trial, the primary analysis showed no significant difference in the risk of death or myocardial infarction with initial angiography and revascularization plus guideline-based medical therapy (invasive strategy) as compared with guideline-based medical therapy alone (conservative strategy) in participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per minute per 1.73 m2 or receipt of dialysis). A secondary objective of the trial was to assess angina-related health status. METHODS:We assessed health status with the Seattle Angina Questionnaire (SAQ) before randomization and at 1.5, 3, and 6 months and every 6 months thereafter. The primary outcome of this analysis was the SAQ Summary score (ranging from 0 to 100, with higher scores indicating less frequent angina and better function and quality of life). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate the treatment effect with the invasive strategy. RESULTS:Health status was assessed in 705 of 777 participants. Nearly half the participants (49%) had had no angina during the month before randomization. At 3 months, the estimated mean difference between the invasive-strategy group and the conservative-strategy group in the SAQ Summary score was 2.1 points (95% credible interval, -0.4 to 4.6), a result that favored the invasive strategy. The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3). By 6 months, the between-group difference in the overall trial population was attenuated (0.5 points; 95% credible interval, -2.2 to 3.4). CONCLUSIONS:Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease did not have substantial or sustained benefits with regard to angina-related health status with an initially invasive strategy as compared with a conservative strategy. (Funded by the National Heart, Lung, and Blood Institute; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).

SUBMITTER: Spertus JA

PROVIDER: S-EPMC7255621 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease.

Spertus John A JA Jones Philip G PG Maron David J DJ Mark Daniel B DB O'Brien Sean M SM Fleg Jerome L JL Reynolds Harmony R HR Stone Gregg W GW Sidhu Mandeep S MS Chaitman Bernard R BR Chertow Glenn M GM Hochman Judith S JS Bangalore Sripal S

The New England journal of medicine 20200330 17

<h4>Background</h4>In the ISCHEMIA-CKD trial, the primary analysis showed no significant difference in the risk of death or myocardial infarction with initial angiography and revascularization plus guideline-based medical therapy (invasive strategy) as compared with guideline-based medical therapy alone (conservative strategy) in participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per ...[more]

PMID: 32227754

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Project description:BACKGROUND:In the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients. METHODS:We assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency. RESULTS:At baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina). CONCLUSIONS:In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).

Project description:BACKGROUND:Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS:We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS:Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS:Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).

Project description:Background Patients with chronic kidney disease (CKD) can experience acute coronary syndromes (ACS) with high morbidity and mortality. Early invasive management of ACS is recommended for most high-risk patients; however, choosing between an early invasive versus conservative management approach may be influenced by the unique risk of kidney failure for patients with CKD. Methods and Results This discrete choice experiment measured the preferences of patients with CKD for future cardiovascular events versus acute kidney injury and kidney failure following invasive heart procedures for ACS. The discrete choice experiment, consisting of 8 choice tasks, was administered to adult patients attending 2 CKD clinics in Calgary, Alberta. The part-worth utilities of each attribute were determined using multinomial logit models, and preference heterogeneity was explored using latent class analysis. A total of 140 patients completed the discrete choice experiment. The mean age of patients was 64 years, 52% were male, and mean estimated glomerular filtration rate was 37 mL/min per 1.73 m2. Across the range of levels, risk of mortality was the most important attribute, followed by risk of end-stage kidney disease and risk of recurrent myocardial infarction. Latent class analysis identified 2 distinct preference groups. The largest group included 115 (83%) patients, who placed the greatest value on treatment benefits and expressed the strongest preference for reducing mortality. A second group of 25 (17%) patients was identified who were procedure averse and had a strong preference toward conservative management of ACS and avoiding acute kidney injury requiring dialysis. Conclusions The preferences of most patients with CKD for management of ACS were most influenced by lowering mortality. However, a distinct subgroup of patients was strongly averse to invasive management. This highlights the importance of clarifying patient preferences to ensure treatment decisions are aligned with patient values.

Project description:BACKGROUND:Conservative care is argued to be a reasonable treatment alternative for dialysis in older patients with advanced chronic kidney disease (CKD). However, comparisons are scarce and generally focus on survival only. Comparative data on more patient-relevant outcomes are needed to truly foster shared decision-making on an individual level, and cost comparison is needed to assess value of care. METHODS:We conducted a retrospective observational single-center cohort study in 366 patients aged ≥70 years with advanced CKD, who chose dialysis (n = 240) or conservative care (n = 126) after careful counselling by a multidisciplinary team in a non-academic teaching hospital in The Netherlands. Using a value-based health care approach (value = outcomes/cost): survival, health-related quality of life-cross-sectionally assessed with the Kidney Disease Quality of Life Short Form™-treatment burden, and treatment costs were evaluated. RESULTS:The overall survival benefit of patients on a dialysis pathway compared with patients on conservative care diminished or lost significance in patients aged ≥80 years or with severe comorbidity. There were no differences between patients managed conservatively and dialysis patients on physical and mental health summary scores (all P > 0.1). Patients on conservative care had 352.7 hospital free days per year versus 282.7 in patients on a dialysis pathway, calculated from treatment decision (adjusted incidence rate ratio: 1.15, 95% confidence interval: 1.09 to 1.21, P < 0.001). Annual treatment costs were lower in patients on conservative care (adjusted cost ratio: 0.43, 95% confidence interval: 0.28 to 0.67, P < 0.001). CONCLUSIONS:In this study, conservative care is shown to be a viable treatment option in older patients with advanced CKD, particularly in the oldest old and those with severe comorbidity. By achieving similar outcomes at lower treatment burden and treatment costs, value was generated for older patients choosing conservative care and society.

Project description:Rationale & objectiveIt is relatively unusual for US patients with advanced chronic kidney disease (CKD) to forgo initiation of maintenance dialysis. Our objective was to describe practice approaches of US nephrologists who have provided conservative care for members of this population.Study designQualitative study using semi-structured interviews.Setting & participantsA national sample of 21 nephrologists experienced in caring for patients with advanced CKD who decided not to start dialysis.Analytical approachGrounded theory methods to identify dominant themes reflecting nephrologists' experiences with and approaches to conservative care for patients with advanced CKD.ResultsNephrologists who participated in this study were primarily from academic practices (n=14) and urban areas (n=15). Two prominent themes emerged from qualitative analysis reflecting nephrologists' experiences with and approaches to conservative care: (1) person-centered practices, which described a holistic approach to care that included basing treatment decisions on what mattered most to individual patients, framing dialysis as an explicit choice, being mindful of sources of bias in medical decision making, and being flexible to the changing needs, values, and preferences of patients; and (2) improvising a care infrastructure, which described the challenges of managing patients conservatively within health systems that are not optimally configured to support their needs. Participating nephrologists described cobbling together resources, assuming a range of different health care roles, preparing patients to navigate health systems in which initiation of dialysis served as a powerful default, and championing the principles of conservative care among their colleagues.LimitationsThe themes identified likely are not generalizable to most US nephrologists.ConclusionsInsights from a select group of US nephrologists who are early adopters of conservative care signal the need for a stronger cultural and health system commitment to building care models capable of supporting patients who choose to forgo dialysis.

Dataset Information

Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease.

Publications

Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease.

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