Project description:BackgroundAmong 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.MethodsWe 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.ResultsOver 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).ConclusionsAmong 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: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:ImportanceTrials showing equivalent or better outcomes with initial evaluation using coronary computed tomography angiography (cCTA) compared with stress testing in patients with stable chest pain have informed guidelines but raise questions about overtesting and excess catheterization.ObjectiveTo test a modified initial cCTA strategy designed to improve clinical efficiency vs usual testing (UT).Design, setting, and participantsThis was a pragmatic randomized clinical trial enrolling participants from December 3, 2018, to May 18, 2021, with a median of 11.8 months of follow-up. Patients from 65 North American and European sites with stable symptoms of suspected coronary artery disease (CAD) and no prior testing were randomly assigned 1:1 to precision strategy (PS) or UT.InterventionsPS incorporated the Prospective Multicenter Imaging Study for the Evaluation of Chest Pain (PROMISE) minimal risk score to quantitatively select minimal-risk participants for deferred testing, assigning all others to cCTA with selective CT-derived fractional flow reserve (FFR-CT). UT included site-selected stress testing or catheterization. Site clinicians determined subsequent care.Main outcomes and measuresOutcomes were clinical efficiency (invasive catheterization without obstructive CAD) and safety (death or nonfatal myocardial infarction [MI]) combined into a composite primary end point. Secondary end points included safety components of the primary outcome and medication use.ResultsA total of 2103 participants (mean [SD] age, 58.4 [11.5] years; 1056 male [50.2%]) were included in the study, and 422 [20.1%] were classified as minimal risk. The primary end point occurred in 44 of 1057 participants (4.2%) in the PS group and in 118 of 1046 participants (11.3%) in the UT group (hazard ratio [HR], 0.35; 95% CI, 0.25-0.50). Clinical efficiency was higher with PS, with lower rates of catheterization without obstructive disease (27 [2.6%]) vs UT participants (107 [10.2%]; HR, 0.24; 95% CI, 0.16-0.36). The safety composite of death/MI was similar (HR, 1.52; 95% CI, 0.73-3.15). Death occurred in 5 individuals (0.5%) in the PS group vs 7 (0.7%) in the UT group (HR, 0.71; 95% CI, 0.23-2.23), and nonfatal MI occurred in 13 individuals (1.2%) in the PS group vs 5 (0.5%) in the UT group (HR, 2.65; 95% CI, 0.96-7.36). Use of lipid-lowering (450 of 900 [50.0%] vs 365 of 873 [41.8%]) and antiplatelet (321 of 900 [35.7%] vs 237 of 873 [27.1%]) medications at 1 year was higher in the PS group compared with the UT group (both P < .001).Conclusions and relevanceAn initial diagnostic approach to stable chest pain starting with quantitative risk stratification and deferred testing for minimal-risk patients and cCTA with selective FFR-CT in all others increased clinical efficiency relative to UT at 1 year. Additional randomized clinical trials are needed to verify these findings, including safety.Trial registrationClinicalTrials.gov Identifier: NCT03702244.

Project description:BACKGROUND Stable coronary artery disease is caused by a variable combination of organic coronary stenosis and functional coronary abnormalities, such as coronary artery spasm. Thus, we examined the clinical importance of comorbid significant coronary stenosis and coronary spasm. METHODS AND RESULTS We enrolled 236 consecutive patients with suspected angina who underwent acetylcholine provocation testing for coronary spasm and fractional flow reserve (FFR) measurement. Among them, 175 patients were diagnosed as having vasospastic angina (VSA), whereas the remaining 61 had no VSA (non-VSA group). The patients with VSA were further divided into the following 3 groups based on angiography and FFR: no organic stenosis (≤50% luminal stenosis; VSA-alone group, n=110), insignificant stenosis of FFR>0.80 (high-FFR group, n=36), and significant stenosis of FFR≤0.80 (low-FFR group, n=29). The incidence of major adverse cardiovascular events, including cardiovascular death, nonfatal myocardial infarction, urgent percutaneous coronary intervention, and hospitalization attributed to unstable angina was evaluated. All patients with VSA received calcium channel blockers, and 28 patients (95%) in the low-FFR group underwent a planned percutaneous coronary intervention. During a median follow-up period of 656 days, although the incidence of major adverse cardiovascular events was low and comparable among non-VSA, VSA-alone, and high-FFR groups, the low-FFR group had an extremely poor prognosis (non-VSA group, 1.6%; VSA-alone group, 3.6%; high-FFR group, 5.6%; low-FFR group, 27.6%) (P<0.001). Importantly, all 8 patients with major adverse cardiovascular events in the low-FFR group were appropriately treated with percutaneous coronary intervention and calcium channel blockers. CONCLUSIONS These results indicate that patients with VSA with significant coronary stenosis represent a high-risk population despite current guideline-recommended therapies, suggesting the importance of routine coronary functional testing in this population.

Project description:AimsCoronary flow reserve (CFR) is an integrated measure of the entire coronary vasculature, and is a powerful prognostic marker in coronary artery disease (CAD). The extent to which coronary revascularization can improve CFR is unclear. This study aimed to evaluate the impact of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) on CFR in patients with stable CAD.Methods and resultsIn a prospective, multicentre observational study, CFR was measured by 15O-water positron emission tomography as the ratio of stress to rest myocardial blood flow at baseline and 6 months after optimal medical therapy (OMT) alone, PCI, or CABG. Changes in the SYNTAX and Leaman scores were angiographically evaluated as indicators of completeness of revascularization. Follow-up was completed by 75 (25 OMT alone, 28 PCI, and 22 CABG) out of 82 patients. The median SYNTAX and Leaman scores, and baseline CFR were 14.5 [interquartile range (IQR): 8-24.5], 5.5 (IQR: 2.5-12.5), and 1.94 (IQR: 1.67-2.66), respectively. Baseline CFR was negatively correlated with the SYNTAX (ρ = -0.40, P < 0.001) and Leaman scores (ρ = -0.33, P = 0.004). Overall, only CABG was associated with a significant increase in CFR [1.67 (IQR: 1.14-1.96) vs. 1.98 (IQR: 1.60-2.39), P < 0.001]. Among patients with CFR <2.0 (n = 41), CFR significantly increased in the PCI [1.70 (IQR: 1.42-1.79) vs. 2.21 (IQR: 1.78-2.49), P = 0.002, P < 0.001 for interaction between time and CFR] and CABG groups [1.28 (IQR: 1.13-1.80) vs. 1.86 (IQR: 1.57-2.22), P < 0.001]. The reduction in SYNTAX or Leaman scores after PCI or CABG was independently associated with the percent increase in CFR after adjusting for baseline characteristics (P = 0.012 and P = 0.011, respectively).ConclusionCoronary revascularization ameliorated reduced CFR in patients with obstructive CAD. The degree of improvement in angiographic CAD burden by revascularization was correlated with magnitude of improvement in CFR.

Dataset Information

FAME 2 - The best initial strategy for patients with stable coronary artery disease: Do we have an answer at last?

Publications

FAME 2 - The best initial strategy for patients with stable coronary artery disease: Do we have an answer at last?

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets