Invasive Versus Conservative Management of Stable Coronary Artery Disease in CKD.
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ABSTRACT:
SUBMITTER: McCallum W
PROVIDER: S-EPMC8981847 | biostudies-literature | 2021 Jan
REPOSITORIES: biostudies-literature
Publications
Invasive Versus Conservative Management of Stable Coronary Artery Disease in CKD.
McCallum Wendy W Gilbert Scott J SJ Sarnak Mark J MJ
American journal of kidney diseases : the official journal of the National Kidney Foundation 20200630 1
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Project description:BackgroundThe ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) compared an initial invasive versus an initial conservative management strategy for patients with chronic coronary disease and moderate or severe ischemia, with no major difference in most outcomes during a median of 3.2 years. Extended follow-up for mortality is ongoing.MethodsISCHEMIA participants were randomized to an initial invasive strategy added to guideline-directed medical therapy or a conservative strategy. Patients with moderate or severe ischemia, ejection fraction ≥35%, and no recent acute coronary syndromes were included. Those with an unacceptable level of angina were excluded. Extended follow-up for vital status is being conducted by sites or through central death index search. Data obtained through December 2021 are included in this interim report. We analyzed all-cause, cardiovascular, and noncardiovascular mortality by randomized strategy, using nonparametric cumulative incidence estimators, Cox regression models, and Bayesian methods. Undetermined deaths were classified as cardiovascular as prespecified in the trial protocol.ResultsBaseline characteristics for 5179 original ISCHEMIA trial participants included median age 65 years, 23% women, 16% Hispanic, 4% Black, 42% with diabetes, and median ejection fraction 0.60. A total of 557 deaths accrued during a median follow-up of 5.7 years, with 268 of these added in the extended follow-up phase. This included a total of 343 cardiovascular deaths, 192 noncardiovascular deaths, and 22 unclassified deaths. All-cause mortality was not different between randomized treatment groups (7-year rate, 12.7% in invasive strategy, 13.4% in conservative strategy; adjusted hazard ratio, 1.00 [95% CI, 0.85-1.18]). There was a lower 7-year rate cardiovascular mortality (6.4% versus 8.6%; adjusted hazard ratio, 0.78 [95% CI, 0.63-0.96]) with an initial invasive strategy but a higher 7-year rate of noncardiovascular mortality (5.6% versus 4.4%; adjusted hazard ratio, 1.44 [95% CI, 1.08-1.91]) compared with the conservative strategy. No heterogeneity of treatment effect was evident in prespecified subgroups, including multivessel coronary disease.ConclusionsThere was no difference in all-cause mortality with an initial invasive strategy compared with an initial conservative strategy, but there was lower risk of cardiovascular mortality and higher risk of noncardiovascular mortality with an initial invasive strategy during a median follow-up of 5.7 years.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT04894877.
| S-EPMC9797439 | biostudies-literature
Project description:BackgroundHeart disease remains the leading cause of death in the United States. Although there are clear indications for revascularization in patients with acute coronary syndromes, there is debate regarding the benefits of revascularization in stable ischemic heart disease. We sought to perform a comprehensive meta-analysis to assess the role of revascularization compared to conservative medical therapy alone in patients with stable ischemic heart disease.HypothesisThere is no significant difference in all-cause mortality or cardiovascular mortality between invasive and medical arms.MethodsWe performed a systematic literature search from January 2000 to June 2020. Our literature search yielded seven randomized controlled trials. We analyzed a total of 12 013 patients (6109 in revascularization arm and 5904 in conservative medical therapy arm). Primary outcome was all-cause mortality. Secondary outcomes included major adverse cardiac events (MACE) (death, myocardial infarction [MI], or stroke), cardiovascular mortality, MI, and stroke. Additional subgroup analysis for all-cause mortality was performed comparing percutaneous coronary intervention (PCI) with bare metal stent versus conservative therapy; and PCI with drug eluting stent versus conservative therapy.ResultsThere was no statistically significant difference in primary outcome of all-cause mortality between either arm (odds ratio [OR] = 0.95; 95% CI [confidence interval], 0.83 to 1.08; p = .84). There were statistically significant lower rates of MACE (death, MI or stroke) in the revascularization arm when compared to conservative arm.ConclusionsOur analysis did not show any survival advantage of an initial invasive strategy over conservative medical therapy in patients with stable coronary artery disease (CAD).
| S-EPMC8119834 | biostudies-literature
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.).
| S-EPMC7263833 | biostudies-literature
Project description:Upon activation, platelets release a host of soluble and vesicular signals, collectively termed the ‘platelet releasate’ (PR). The contents of this PR play a significant role in haemostasis, inflammation, and pathologic sequelae. Despite this, proteomic studies investigating the PR in coronary artery disease have not been performed. We undertook a comparative label-free quantitative (LFQ) proteomic profiling of the 1U/ml thrombin-induced PR from 13 acute coronary syndrome (ACS-STEMI) versus 14 stable angina pectoris patients using a tandem mass spectrometry approach. We identified differentially released platet proteins including tetranectin (CLEC3B), protein disulfide-isomerase-A3 (PDIA3), coagulation factor V (F5) and fibronectin (FN1). Strikingly, all 9 differential proteins were associated with the GO cellular component term ‘extracellular vesicle’ and reduced levels of EVs were detected in plasma of ACS-STEMI patients. Network analysis revealed 3 PR proteins either reduced (F5; FN1) or absent (CLEC3B) in ACS-STEMI patients, which are strongly connected to both the clotting cascade and major druggable targets on platelets. This moderated signature highlights the possible basis of platelet dysfunction in ACS-STEMI and may prove useful for non-invasive risk assessment of the progression of coronary artery disease.
2020-06-05 | PXD009356 | Pride
Project description:BackgroundISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) compared an initial invasive treatment strategy (INV) with an initial conservative strategy in 5179 participants with chronic coronary disease and moderate or severe ischemia. The ISCHEMIA research program included a comprehensive quality-of-life (QOL) substudy.MethodsIn 1819 participants (907 INV, 912 conservative strategy), we collected a battery of disease-specific and generic QOL instruments by structured interviews at baseline; at 3, 12, 24, and 36 months postrandomization; and at study closeout. Assessments included angina-related QOL (19-item Seattle Angina Questionnaire), generic health status (EQ-5D), depressive symptoms (Patient Health Questionnaire-8), and, for North American patients, cardiac functional status (Duke Activity Status Index).ResultsMedian age was 67 years, 19.2% were female, and 15.9% were non-White. The estimated mean difference for the 19-item Seattle Angina Questionnaire Summary score favored INV (1.4 points [95% CI, 0.2-2.5] over all follow-up). No differences were observed in patients with rare/absent baseline angina (SAQ Angina Frequency score >80). Among patients with more frequent angina at baseline (SAQ Angina Frequency score <80, 744 patients, 41%), those randomly assigned to INV had a mean 3.7-point higher 19-item Seattle Angina Questionnaire Summary score than conservative strategy (95% CI, 1.6-5.8) with consistent effects across SAQ subscales: Physical Limitations 3.2 points (95% CI, 0.2-6.1), Angina Frequency 3.2 points (95% CI, 1.2-5.1), Quality of Life/Health Perceptions 5.3 points (95% CI, 2.8-7.8). For the Duke Activity Status Index, no difference was estimated overall by treatment, but in patients with baseline SAQ Angina Frequency scores <80, Duke Activity Status Index scores were higher for INV (3.2 points [95% CI, 0.6-5.7]), whereas patients with rare/absent baseline angina showed no treatment-related differences. Moderate to severe depression was infrequent at randomization (11.5%-12.8%) and was unaffected by treatment assignment.ConclusionsIn the ISCHEMIA comprehensive QOL substudy, patients with more frequent baseline angina reported greater improvements in the symptom, physical functioning, and psychological well-being dimensions of QOL when treated with an invasive strategy, whereas patients who had rare/absent angina at baseline reported no consistent treatment-related QOL differences.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT01471522.
| S-EPMC9044280 | biostudies-literature
Project description:BackgroundPostoperative bleeding requiring re-exploration in cardiac surgery has been associated with complications impacting short-term outcomes and perioperative survival. Many aspects of decision-making for re-exploration still remain controversial, especially in hemodynamically stable patients with significant but not acutely cumulating chest drain output. We investigated the impact of re-exploratory surgery on short-term outcomes in a "borderline population" of CABG patients who experienced significant non-acute bleeding, but that were not in critically hemodynamic unstable conditions.MethodsA prospectively collected database of 8287 patients undergoing primary isolated elective CABG was retrospectively interrogated. A population of hemodynamically stable patients experiencing significant non-acute or rapidly cumulating bleeding (>1000 mL of blood loss in 12 h, <200 mL per hour in the first 5 h) with normal platelet and coagulation tests was identified (N = 1642). Patients belonging to this group were re-explored (N = 252) or treated conservatively (N = 1390) based on the decision of the consultant surgeon. Clinical outcomes according to the decision-making strategy were compared using a propensity score matching (PSM) approach.ResultsAfter PSM, reoperated patients exhibited significantly higher overall blood product consumption (88.4% vs. 52.6% for red packed cells, p = 0.001). The reoperated group experienced higher rates of respiratory complications (odds ratio 5.8 [4.29-7.86] with p = 0.001 for prolonged ventilation), prolonged stay in intensive care unit (coefficient 1.66 [0.64-2.67] with p = 0.001) and overall length of stay in hospital (coefficient 2.16 [0.42-3.91] with p = 0.015) when compared to conservative management. Reoperated patients had significantly increased risk of multiorgan failure (odds ratio 4.59 [1.37-15.42] with p = 0.014) and a trend towards increased perioperative mortality (odds ratio 3.12 [1.08-8.99] with p = 0.035).ConclusionsConservative management in hemodynamically stable patients experiencing significant but non-critical or emergency bleeding might be a safe and viable option and might be advantageous in terms of reduction of postoperative morbidities and hospital stay.
| S-EPMC10179715 | biostudies-literature
Project description:To compare the effectiveness of in-hospital medical therapy versus coronary revascularisation added to medical therapy in patients who stabilised after an acute coronary syndrome (ACS).Propensity score-matched cohort study from the database of the Tampere ACS registry.A single academic hospital in Finland.1149 patients with a recent ACS, but no serious coexisting conditions: recurrent ischaemic episodes despite adequate medical therapy, haemodynamic instability, overt congestive heart failure and serious ventricular arrhythmias.The composite endpoint of major acute cardiovascular events (MACEs): unstable angina requiring rehospitalisation, stroke, myocardial infarction and all-cause mortality, at 6-month follow-up.Compared with standard medical treatment, revascularisation was associated with a lower rate of MACEs at 6 months in patients of the first quintile (HR 0.81; 95% CI 0.66 to 0.99), but a higher rate of MACEs in the fifth quintile (HR 4.74, CI 1.36 to 16.49; p=0.014). There were no significant differences in the rates of MACEs in the remaining three quintiles. Patients of the first quintile were the oldest (79.7±8.3 years) and had a more significant (p<0.001) history of prior myocardial infarction (37%) and poor renal function (creatine, µmol/l: 114.9±70.7). They also showed the highest C reactive protein (7.3±9.5 mg/l) levels.Our findings suggest that in-hospital coronary revascularisation did not lead to any advantage with signal of possible harm in the great majority of patients who stabilised after an ACS. An early invasive management strategy may be best reserved for elderly patients having high-risk clinical features and biochemical evidence of a strong inflammatory activity.
| S-EPMC3641503 | biostudies-other
Project description:Coronary artery disease (CAD) is highly prevalent in chronic kidney disease (CKD). CKD modifies the effects of traditional risk factors on atherosclerosis, with CKD-specific mechanisms, such as inflammation and altered mineral metabolism, playing a dominant pathophysiological role as kidney function declines. Traditional risk models and cardiovascular screening tests perform relatively poorly in the CKD population, and medical treatments including lipid-lowering therapies have reduced efficacy. Clinical presentation of cardiac ischemia in CKD is atypical, whereas invasive therapies are associated with higher rates of complications than in with patients with normal or near normal kidney function. The main focus of the present review is on the invasive approach to management of CAD in late-stage CKD, with an in-depth discussion of the findings of the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)-CKD trial, and their implications for therapeutic approach and future research in this area. We also briefly discuss the existing evidence in the epidemiology, pathogenesis, diagnosis, and medical management of CAD in late-stage CKD, end-stage kidney disease (ESKD), and kidney transplant recipients. We enumerate the evidence gap left by the frequent exclusion of patients with CKD from randomized controlled trials and highlight the priority areas for future research in the CKD population.
| S-EPMC8207307 | biostudies-literature
Project description: Not available
| S-EPMC1767237 | biostudies-literature
Project description:Chronic inflammation plays a crucial role in coronary artery disease (CAD), but differences in specific cytokine profiles between acute coronary syndrome (ACS) and stable CAD remain unknown. We investigated cytokine differences between these two manifestations of CAD. The study included 308 patients with angiographically detected, hemodynamically significant CAD: 150 patients undergone angiography for ACS, 158 patients undergone angiography for stable CAD. To assess dynamic changes, 116 patients had index angiogram at least 3 months earlier. We measured the serum concentrations of 48 circulating cytokines. The ACS group had decreased interleukin (IL) 4 (p = 0.005), and increased IL-8 (p = 0.008), hepatocyte growth factor (HGF) (p < 0.001) and macrophage colony-stimulating factor (M-CSF) (p = 0.002) levels compared with the stable CAD group. Multivariable logistic regression revealed increased levels of HGF (OR 18.050 [95% CI 4.372-74.517], p < 0.001), M-CSF (OR 2.257 [1.375-3.705], p = 0.001) and IL-6 (OR 1.586 [1.131-2.224], p = 0.007), independently associated with ACS. In the post-angiography group, only diminished platelet-derived growth factor-BB levels in ACS-manifested patients were observed (OR 0.478, [0.279-0.818], p = 0.007). Cytokine profiles differ between ACS and stable CAD. Such differences seem to be mainly reversible within 3 months after ACS. Thus, targeting one or two cytokines only might not offer one-size fits all-therapeutic approach for CAD-associated inflammation.Trial registration: NCT03444259.
| S-EPMC11283453 | biostudies-literature