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International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design.

ABSTRACT: BACKGROUND:Prior trials comparing a strategy of optimal medical therapy with or without revascularization have not shown that revascularization reduces cardiovascular events in patients with stable ischemic heart disease (SIHD). However, those trials only included participants in whom coronary anatomy was known prior to randomization and did not include sufficient numbers of participants with significant ischemia. It remains unknown whether a routine invasive approach offers incremental value over a conservative approach with catheterization reserved for failure of medical therapy in patients with moderate or severe ischemia. METHODS:The ISCHEMIA trial is a National Heart, Lung, and Blood Institute supported trial, designed to compare an initial invasive or conservative treatment strategy for managing SIHD patients with moderate or severe ischemia on stress testing. Five thousand one-hundred seventy-nine participants have been randomized. Key exclusion criteria included estimated glomerular filtration rate (eGFR) <30 mL/min, recent myocardial infarction (MI), left ventricular ejection fraction <35%, left main stenosis >50%, or unacceptable angina at baseline. Most enrolled participants with normal renal function first underwent blinded coronary computed tomography angiography (CCTA) to exclude those with left main coronary artery disease (CAD) and without obstructive CAD. All randomized participants receive secondary prevention that includes lifestyle advice and pharmacologic interventions referred to as optimal medical therapy (OMT). Participants randomized to the invasive strategy underwent routine cardiac catheterization followed by revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery, when feasible, as selected by the local Heart Team to achieve optimal revascularization. Participants randomized to the conservative strategy undergo cardiac catheterization only for failure of OMT. The primary endpoint is a composite of cardiovascular (CV) death, nonfatal myocardial infarction (MI), hospitalization for unstable angina, hospitalization for heart failure, or resuscitated cardiac arrest. Assuming the primary endpoint will occur in 16% of the conservative group within 4 years, estimated power exceeds 80% to detect an 18.5% reduction in the primary endpoint. Major secondary endpoints include the composite of CV death and nonfatal MI, net clinical benefit (primary and secondary endpoints combined with stroke), angina-related symptoms and disease-specific quality of life, as well as a cost-effectiveness assessment in North American participants. Ancillary studies of patients with advanced chronic kidney disease and those with documented ischemia and non-obstructive coronary artery disease are being conducted concurrently. CONCLUSIONS:ISCHEMIA will provide new scientific evidence regarding whether an invasive management strategy improves clinical outcomes when added to optimal medical therapy in patients with SIHD and moderate or severe ischemia.

SUBMITTER: ISCHEMIA Trial Research Group

PROVIDER: S-EPMC6005768 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design.

Maron David J DJ Hochman Judith S JS O'Brien Sean M SM Reynolds Harmony R HR Boden William E WE Stone Gregg W GW Bangalore Sripal S Spertus John A JA Mark Daniel B DB Alexander Karen P KP Shaw Leslee L Berger Jeffrey S JS Ferguson T Bruce TB Williams David O DO Harrington Robert A RA Rosenberg Yves Y

American heart journal 20180421

<h4>Background</h4>Prior trials comparing a strategy of optimal medical therapy with or without revascularization have not shown that revascularization reduces cardiovascular events in patients with stable ischemic heart disease (SIHD). However, those trials only included participants in whom coronary anatomy was known prior to randomization and did not include sufficient numbers of participants with significant ischemia. It remains unknown whether a routine invasive approach offers incremental ...[more]

PMID: 29778671

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Project description:BackgroundPatients with chronic kidney disease (CKD) and stable ischemic heart disease are at markedly increased risk of cardiovascular events. Prior trials comparing a strategy of optimal medical therapy (OMT) with or without revascularization have largely excluded patients with advanced CKD. Whether a routine invasive approach when compared with a conservative strategy is beneficial in such patients is unknown.MethodsISCHEMIA-CKD is a National Heart, Lung, and Blood Institute-funded randomized trial designed to determine the comparative effectiveness of an initial invasive strategy (cardiac catheterization and optimal revascularization [percutaneous coronary intervention or coronary artery bypass graft surgery, if suitable] plus OMT) versus a conservative strategy (OMT alone, with cardiac catheterization and revascularization [percutaneous coronary intervention or coronary artery bypass graft surgery, if suitable] reserved for failure of OMT) on long-term clinical outcomes in 777 patients with advanced CKD (defined as those with estimated glomerular filtration rate <30 mL/min/1.73m2 or on dialysis) and moderate or severe ischemia on stress testing. Participants were randomized in a 1:1 fashion to the invasive or a conservative strategy. The primary end point is a composite of death or nonfatal myocardial infarction. Major secondary endpoints are a composite of death, nonfatal myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, or resuscitated cardiac arrest; angina control; and disease-specific quality of life. Safety outcomes such as initiation of maintenance dialysis and a composite of initiation of maintenance dialysis or death will be reported. The trial is projected to have 80% power to detect a 22% to 24% reduction in the primary composite end point with the invasive strategy when compared with the conservative strategy.ConclusionsISCHEMIA-CKD will determine whether an initial invasive management strategy improves clinical outcomes when added to OMT in patients with advanced CKD and stable ischemic heart disease.

Project description:Background: Several clinical trials support the efficacy of music therapy (MT) for improving outcomes in hospitalized patients, but few studies have evaluated the real-world delivery and integration of MT across multiple medical centers. This article describes the rationale, design, and population characteristics of a retrospective study examining the delivery and integration of MT within a large health system. Methods: A retrospective electronic health record (EHR) review was conducted of hospitalized patients seen by and/or referred to MT between January 2017 and July 2020. MT was provided across ten medical centers, including an academic medical center, a freestanding cancer center, and eight community hospitals. Discrete demographic, clinical, and MT treatment and referral characteristics were extracted from the EHR, cleaned, and organized using regular expressions functions, and they were summarized using descriptive statistics. Results: The MT team (average 11.6 clinical fulltime equivalent staff/year) provided 14,261 sessions to 7378 patients across 9091 hospitalizations. Patients were predominantly female (63.7%), White (54.3%) or Black/African American (44.0%), 63.7 ± 18.5 years of age at admission, and insured under Medicare (51.1%), Medicaid (18.1%), or private insurance (14.2%). Patients' hospitalizations (median length of stay: 5 days) were primarily for cardiovascular (11.8%), respiratory (9.9%), or musculoskeletal (8.9%) conditions. Overall, 39.4% of patients' hospital admissions included a mental health diagnosis, and 15.4% were referred to palliative care. Patients were referred by physicians (34.7%), nurses (29.4%), or advanced practice providers (24.7%) for coping (32.0%), anxiety reduction (20.4%), or pain management (10.1%). Therapists provided sessions to patients discharged from medical/surgical (74.5%), oncology (18.4%), or intensive care (5.8%) units. Conclusions: This retrospective study indicates that MT can be integrated across a large health system for addressing the needs of socioeconomically diverse patients. However, future research is needed to assess MT's impact on health care utilization (i.e., length of stay and rates of readmission) and immediate patient-reported outcomes.

Project description:BackgroundThe ISCHEMIA and the ISCHEMIA-CKD trials found no statistical difference in the primary clinical endpoint between initial invasive management and initial conservative management of patients with chronic coronary disease and moderate to severe ischemia on stress testing without or with advanced chronic kidney disease (CKD). In ISCHEMIA, there was numerically lower cardiovascular mortality but higher non-cardiovascular mortality with no significant difference in all-cause death with an initial invasive strategy when compared with a conservative strategy. However, an invasive strategy increased peri-procedural myocardial infarction (MI) but decreased spontaneous MI with continued separation of curves over time, which potentially may lead to reduced risk of cardiovascular and all-cause mortality. Thus, the long-term effect of invasive management strategy on mortality remains unclear. In ISCHEMIA-CKD, the treatment and cause-specific mortality rates were similar during follow-up.MethodsFunded by the National Heart, Lung, and Blood Institute, the ISCHEMIA-EXTEND observational study is the long-term follow-up of surviving participants (projected median of 10 years) with chronic coronary disease from the ISCHEMIA trial. In the ISCHEMIA trial, 5,179 participants with moderate or severe stress-induced ischemia were randomized to initial invasive management with angiography, revascularization when feasible, and guideline-directed medical therapy (GDMT), or initial conservative management with GDMT alone and angiography reserved for failure of medical therapy. ISCHEMIA-CKD EXTEND is the long-term follow-up of surviving participants (projected median of 9 years) from the ISCHEMIA-CKD trial, a companion trial that included 777 patients with advanced CKD. Ascertainment of death will be conducted via direct participant contact, medical record review, and/or vital status registry search. The overarching objective of long-term follow-up is to assess whether there are between-group differences in long-term all-cause, cardiovascular, and non-cardiovascular mortality, and increase precision around the treatment effect estimates for risk of all-cause, cardiovascular, and non-cardiovascular mortality. We will conduct Bayesian survival modeling to take advantage of rich inferences using the posterior distribution of the treatment effect.ConclusionsThe long-term effect of an initial invasive versus conservative strategy on all-cause, cardiovascular, and non-cardiovascular mortality will be assessed. The findings of ISCHEMIA-EXTEND and ISCHEMIA-CKD EXTEND will inform patients, practitioners, practice guidelines, and health policy.

Project description:BackgroundThe benefits of minimally invasive surgery (MIS) for low-risk or minor liver resection are well established. There is growing interest in MIS for major hepatectomy (MH) and other challenging resections, but there remain unanswered questions of safety that prevent broad adoption of this technique.Study designWe conducted a retrospective cohort study of patients undergoing hepatectomy at 65 hospitals participating in the NSQIP Hepatopancreatobiliary Collaborative in 2014. We assessed serious morbidity or mortality (SMM; including organ/space infection and organ failure). Secondary outcomes included transfusion, bile leak, liver failure, reoperation or intervention, and 30-day readmission. We also measured factors considered to make resection more challenging (ie large tumors, cirrhosis, ≥3 concurrent resections, previous neoadjuvant chemotherapy, and morbid obesity).ResultsThere were 2,819 patients who underwent hepatectomy (aged 58 ± 14 years; 53% female; 25% had MIS). After adjusting for clinical and operative factors, the odds of SMM (odds ratio [OR] = 0.57; 95% CI 0.34 to 0.96; p = 0.03) and reoperation or intervention (OR = 0.52; 95% CI 0.29 to 0.93; p = 0.03) were significantly lower for patients undergoing MIS compared with open. In the MH group (n = 1,015 [13% MIS]), there was no difference in the odds of SMM after MIS (OR = 0.37; 95% CI 0.13 to 1.11; p = 0.08); however, minimally invasive MH met criteria for noninferiority. There were no differences in liver-specific complications or readmission between the groups. Odds of SMM were significantly lower after MIS among patients who had received neoadjuvant chemotherapy (OR = 0.33; 95% CI 0.15 to 0.70; p = 0.004).ConclusionsIn this large study of minimally invasive MH, we found safety outcomes that are equivalent or superior to conventional open surgery. Although the decision to offer MIS might be influenced by factors not included in this evaluation (eg surgeon experience and other patient factors), these findings support its current use in MH.

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International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design.

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International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design.

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