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Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease.
- Source :
-
The New England journal of medicine [N Engl J Med] 2020 Apr 23; Vol. 382 (17), pp. 1619-1628. Date of Electronic Publication: 2020 Mar 30. - Publication Year :
- 2020
-
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 m <superscript>2</superscript> or receipt of dialysis). A secondary objective of the trial was to assess angina-related health status.<br />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.<br />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).<br />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.).<br /> (Copyright © 2020 Massachusetts Medical Society.)
- Subjects :
- Aged
Exercise Test
Female
Follow-Up Studies
Healthy Lifestyle
Humans
Intention to Treat Analysis
Male
Middle Aged
Myocardial Ischemia complications
Myocardial Ischemia mortality
Odds Ratio
Proportional Hazards Models
Surveys and Questionnaires
Coronary Angiography
Coronary Artery Bypass
Health Status
Myocardial Ischemia drug therapy
Myocardial Ischemia surgery
Percutaneous Coronary Intervention
Renal Insufficiency, Chronic complications
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 382
- Issue :
- 17
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 32227754
- Full Text :
- https://doi.org/10.1056/NEJMoa1916374