Dataset Information

Initial Invasive or Conservative Strategy for Stable Coronary Disease.

ABSTRACT: 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.).

SUBMITTER: Maron DJ

PROVIDER: S-EPMC7263833 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Initial Invasive or Conservative Strategy for Stable Coronary Disease.

Maron David J DJ Hochman Judith S JS Reynolds Harmony R HR Bangalore Sripal S O'Brien Sean M SM Boden William E WE Chaitman Bernard R BR Senior Roxy R López-Sendón Jose J Alexander Karen P KP Lopes Renato D RD Shaw Leslee J LJ Berger Jeffrey S JS Newman Jonathan D JD Sidhu Mandeep S MS Goodman Shaun G SG Ruzyllo Witold W Gosselin Gilbert G Maggioni Aldo P AP White Harvey D HD Bhargava Balram B Min James K JK Mancini G B John GBJ Berman Daniel S DS Picard Michael H MH Kwong Raymond Y RY Ali Ziad A ZA Mark Daniel B DB Spertus John A JA Krishnan Mangalath N MN Elghamaz Ahmed A Moorthy Nagaraja N Hueb Whady A WA Demkow Marcin M Mavromatis Kreton K Bockeria Olga O Peteiro Jesus J Miller Todd D TD Szwed Hanna H Doerr Rolf R Keltai Matyas M Selvanayagam Joseph B JB Steg P Gabriel PG Held Claes C Kohsaka Shun S Mavromichalis Stavroula S Kirby Ruth R Jeffries Neal O NO Harrell Frank E FE Rockhold Frank W FW Broderick Samuel S Ferguson T Bruce TB Williams David O DO Harrington Robert A RA Stone Gregg W GW Rosenberg Yves Y

The New England journal of medicine 20200330 15

<h4>Background</h4>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.<h4>Methods</h4>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 the ...[more]

PMID: 32227755

Similar Datasets

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: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.).

Project description:Cardiovascular disease is costly, and annual expenditures are projected to increase. Our objective was to examine the variation in patient-level costs and identify drivers of cost in patients with stable coronary artery disease.In this retrospective cohort study using administrative databases in Ontario, Canada, we identified all patients with stable coronary artery disease after index angiography between Oct. 1, 2008, and Sept. 30, 2011. We excluded patients with a myocardial infarction within 90 days before the index, with normal coronaries, or with mild coronary disease. We categorized hospitals into low, medium or high revascularization ratio centres. The primary outcome was cumulative 1-year health care costs. A hierarchical generalized linear model identified patient, physician and hospital characteristics associated with patient costs, with 2 main covariates of interest: treatment allocation (medical v. percutaneous coronary intervention v. coronary artery bypass grafting) and hospital revascularization ratio.A total of 183?630 angiography procedures were performed in Ontario during the study period. The final cohort included 39?126 patients with stable coronary artery disease, of which 15?138 received medical treatment and 23?988 received revascularization. The mean 1-year cost was $24 026 (interquartile range $8235-$30 511). The mean costs for medical management and revascularization were $18 069 and $27 786, respectively. The strongest predictor of costs was revascularization (percutaneous coronary intervention: cost ratio 1.27, 95% CI [confidence interval] 1.24-1.31; coronary artery bypass grafting: cost ratio 2.62, 95% CI 2.53-2.71). Hospital revascularization ratio did not significantly affect costs. There was no significant interaction between treatment and revascularization ratio.Most health care costs were due to acute care hospital admissions, and costs were higher for patients undergoing revascularization than medical therapy. This study suggests that treatment decision has a substantial impact on health care resources.

Project description:BackgroundWhether an initial invasive strategy in patients with stable ischemic heart disease and at least moderate ischemia improves outcomes in the setting of a history of heart failure (HF) or left ventricular dysfunction (LVD) when ejection fraction is ≥35% but <45% is unknown.MethodsAmong 5179 participants randomized into ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches), all of whom had left ventricular ejection fraction (LVEF) ≥35%, we compared cardiovascular outcomes by treatment strategy in participants with a history of HF/LVD at baseline versus those without HF/LVD. Median follow-up was 3.2 years.ResultsThere were 398 (7.7%) participants with HF/LVD at baseline, of whom 177 had HF/LVEF >45%, 28 HF/LVEF 35% to 45%, and 193 LVEF 35% to 45% but no history of HF. HF/LVD was associated with more comorbidities at baseline, particularly previous myocardial infarction, stroke, and hypertension. Compared with patients without HF/LVD, participants with HF/LVD were more likely to experience a primary outcome composite of cardiovascular death, nonfatal myocardial infarction, or hospitalization for unstable angina, HF, or resuscitated cardiac arrest (4-year cumulative incidence rate, 22.7% versus 13.8%; cardiovascular death or myocardial infarction, 19.7% versus 12.3%; and all-cause death or HF, 15.0% versus 6.9%). Participants with HF/LVD randomized to the invasive versus conservative strategy had a lower rate of the primary outcome (17.2% versus 29.3%; difference in 4-year event rate, -12.1% [95% CI, -22.6 to -1.6%]), whereas those without HF/LVD did not (13.0% versus 14.6%; difference in 4-year event rate, -1.6% [95% CI, -3.8% to 0.7%]; P interaction = 0.055). A similar differential effect was seen for the primary outcome, all-cause mortality, and cardiovascular mortality when invasive versus conservative strategy-associated outcomes were analyzed with LVEF as a continuous variable for patients with and without previous HF.ConclusionsISCHEMIA participants with stable ischemic heart disease and at least moderate ischemia with a history of HF or LVD were at increased risk for the primary outcome. In the small, high-risk subgroup with HF and LVEF 35% to 45%, an initial invasive approach was associated with better event-free survival. This result should be considered hypothesis-generating. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.

Project description:ObjectivesTo examine the association of early invasive management of acute coronary syndrome with adverse renal outcomes and survival, and to determine whether the risks or benefits of early invasive management differ in people with pre-existing chronic kidney disease.DesignPropensity score matched cohort study.SettingAcute care hospitals in Alberta, Canada, 2004-09.Participants10,516 adults with non-ST elevation acute coronary syndrome.InterventionsParticipants were stratified by baseline estimated glomerular filtration rate and matched 1:1 on their propensity score for early invasive management (coronary catheterisation within two days of hospital admission).Main outcome measuresRisks of acute kidney injury, kidney injury requiring dialysis, progression to end stage renal disease, and all cause mortality were compared between those who received early invasive treatment versus conservative treatment.ResultsOf 10,516 included participants, 4276 (40.7%) received early invasive management. After using propensity score methods to assemble a matched cohort of conservative management participants with characteristics similar to those who received early invasive management (n=6768), early invasive management was associated with an increased risk of acute kidney injury (10.3% v 8.7%, risk ratio 1.18, 95% confidence interval 1.03 to 1.36; P=0.019), but no difference in the risk of acute kidney injury requiring dialysis (0.4% v 0.3%, 1.20, 0.52 to 2.78; P=0.670). Over a median follow-up of 2.5 years, the risk of progression to end stage renal disease did not differ between the groups (0.3 v 0.4 events per 100 person years, hazard ratio 0.91, 95% confidence interval 0.55 to 1.49; P=0.712); however, early invasive management was associated with reduced long term mortality (2.4 v 3.4 events per 100 person years, 0.69, 0.58 to 0.82; P<0.001). These associations were consistent among people with pre-existing reduced estimated glomerular filtration rate and with alternate definitions for early invasive management.ConclusionsCompared with conservative management, early invasive management of acute coronary syndrome is associated with a small increase in risk of acute kidney injury but not dialysis or long term progression to end stage renal disease.

Dataset Information

Initial Invasive or Conservative Strategy for Stable Coronary Disease.

Publications

Initial Invasive or Conservative Strategy for Stable Coronary Disease.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure