Background The COURAGE trial reported similar clinical outcomes for patients with stable ischemic heart disease (SIHD) receiving optimal medical therapy (OMT) with or without percutaneous coronary ...intervention (PCI). The current post hoc substudy analysis examined the relationship between baseline stress myocardial ischemia and clinical outcomes based on randomized treatment assignment. Methods A total of 1,381 randomized patients (OMT n = 699, PCI + OMT n = 682) underwent baseline stress myocardial perfusion single-photon emission computed tomographic imaging. Site investigators interpreted the extent of ischemia by the number of ischemic segments using a 6-segment myocardial model. Patients were divided into those with no to mild (< 3 ischemic segments) and moderate to severe ischemia (≥ 3 ischemic segments). Cox proportional hazards models were calculated to assess time to the primary end point of death or myocardial infarction. Results At baseline, moderate to severe ischemia occurred in more than one-quarter of patients (n = 468), and the incidence was comparable in both treatment groups ( P = .36). The primary end point, death or myocardial infarction, was similar in the OMT and PCI + OMT treatment groups for no to mild (18% and 19%, P = .92) and moderate to severe ischemia (19% and 22%, P = .53, interaction P value = .65). There was no gradient increase in events for the overall cohort with the extent of ischemia. Conclusions From the COURAGE trial post hoc substudy, the extent of site-defined ischemia did not predict adverse events and did not alter treatment effectiveness. Currently, evidence supports equipoise as to whether the extent and severity of ischemia impact on therapeutic effectiveness.
Given the attendant risks of mortality and morbidity, acute MI remains a principal focus of cardiovascular therapeutics. ...30-day mortality and rehospitalization rates for acute MI are publicly ...reported in an effort to promote optimal acute MI care, and aspects of MI care delivery are the focus of local, regional, and national quality initiatives (1-3). Updates or revisions to the American College of Cardiology (ACC)/American Heart Association (AHA) practice guidelines for PCI, ST-segment elevation myocardial infarction (STEMI), and unstable angina (UA)/non-ST-segment elevation myocardial infarction (NSTEMI) have been published within the last 3 years, building upon prior versions published earlier in the decade (5-7).
Establishing the validity of appropriate use criteria (AUC) for percutaneous coronary intervention (PCI) in the setting of stable ischemic heart disease can support their adoption for quality ...improvement. We conducted a post hoc analysis of 2,287 Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation trial patients with stable ischemic heart disease randomized to PCI with optimal medical therapy (OMT) or OMT alone. Within appropriateness categories, we compared rates of death, myocardial infarction, revascularization subsequent to initial therapy, and angina-specific health status as determined by the Seattle Angina Questionnaire in patients randomized to PCI + OMT to those randomized to OMT alone. A total of 1,987 patients (87.9%) were mapped to the 2012 publication of the AUC, with 1,334 (67.1%) classified as appropriate, 551 (27.7%) uncertain, and 102 (5.1%) as inappropriate. There were no significant differences between PCI and OMT alone in the rate of mortality and myocardial infarction by appropriateness classification. Rates of revascularization were significantly lower in patients initially receiving PCI + OMT who were classified as appropriate (hazard ratio 0.65; 95% confidence interval 0.53 to 0.80; p <0.001) or uncertain (hazard ratio 0.49; 95% confidence interval 0.32 to 0.76; p = 0.001). Furthermore, among patients classified as appropriate by the AUC, Seattle Angina Questionnaire scores at 1 month were better in the PCI-treated group compared with the medical therapy group (80 ± 23 vs 75 ± 24 for angina frequency, 73 ± 24 vs 68 ± 24 for physical limitations, and 68 ± 23 vs 60 ± 24 for quality of life; all p <0.01), with differences generally persisting through 12 months. In contrast, health status scores were similar throughout the first year of follow-up in PCI + OMT patients compared with OMT alone in patients classified as uncertain or inappropriate. In conclusion, these findings support the validity of the AUC in efforts to improve health care quality through optimal use of PCI.
Objectives The authors sought to describe the association between post-procedural bleeding and long-term recurrent bleeding, major adverse cardiac events (MACE), and mortality among older patients ...undergoing percutaneous coronary intervention (PCI). Background Bleeding complications after PCI are associated with an increased risk for acute morbidity and long-term mortality, but the association of these bleeding complications with other events is unknown. Methods Patients entered into the National Cardiovascular Data Registry (NCDR) CathPCI Registry (n = 461,311; 946 sites) from January 2004 to December 2008 were linked with claims from the Centers for Medicare & Medicaid Services and grouped according to in-hospital post-PCI bleeding. The association between post-PCI bleeding and 1-, 12-, and 30-month readmission for bleeding, MACE, and all-cause mortality was examined with Cox regression that included patient and procedural characteristics using no bleeding as the reference. Results Overall, 3.1% (n = 14,107) of patients experienced post-PCI bleeding. Patients who bled were older, more often female, had more medical comorbidities, less often received bivalirudin, and more often underwent PCI via the femoral approach. After adjustment, bleeding after the index procedure was significantly associated with readmission for bleeding (adjusted hazard ratios 95% confidence interval: 1 month, 1.54 1.42 to 1.67; 12 months, 1.52 1.40 to 1.66; 30 months, 1.29 1.11 to 1.50), MACE (1 month, 1.11 1.07 to 1.15; 12 months, 1.17 1.13 to 1.21; 30 months, 1.12 1.06 to 1.19) and all-cause mortality (1 month, 1.32 1.26 to 1.38; 12 months, 1.33 1.27 to 1.40); 30 months, 1.22 1.15 to 1.30). Conclusions Post-PCI bleeding complications are associated with an increased risk for short- and long-term recurrent bleeding, MACE, and all-cause mortality. These data underscore the prognostic importance of periprocedural bleeding and the need for identifying strategies to reduce long-term bleeding risk among patients undergoing PCI.
Chronic kidney disease (CKD) is a risk factor for poor outcomes in patients with coronary artery disease (CAD), but it is unknown whether CKD influences the efficacy of alternative CAD treatment ...strategies. Thus, we compared outcomes in stable CAD patients with and without CKD randomized to percutaneous coronary intervention (PCI) and optimal medical therapy (OMT) or OMT alone in a post hoc analysis of the 2,287 patient COURAGE study. At baseline, 320 patients (14%) had CKD defined as a glomerular filtration rate of <60 mL/min/1.73 m2 , as estimated by the abbreviated 4-variable Modification of Diet in Renal Disease equation. The patients with CKD were older (68 ± 9 vs 61 ± 10 years; p <0.001) and more often had diabetes mellitus (42% vs 33%; p = 0.002), hypertension (81% vs 65%; p <0.03), heart failure (13% vs 3.4%; p <001), and three-vessel CAD (37% vs 29%, p = 0.01). After adjustment for these differences, CKD remained an independent predictor of death or nonfatal myocardial infarction (hazard ratio 1.48, 95% confidence interval 1.15 to 1.90). PCI had no effect on these outcomes. Furthermore, at 36 months, a similar percentage of patients with CKD treated with OMT (70%) and PCI plus OMT (76%) were angina free compared to patients without CKD. In conclusion, CKD is an important determinant of clinical outcomes in patients with stable CAD, regardless of the treatment strategy. Although PCI did not reduce the risk of death or myocardial infarction when added to OMT for patients with CKD, it also was not associated with worse outcomes in this high-risk group.
Facilitating Interoperability1351 Overview1351 Historical Context1352 Integration Profile Development Cycle1352 Benefits of Interoperability/IHE1352 Cardiology Profiles1354 Overview of the ...Profiles1354 Cardiac Catheterization Workflow1354 Echocardiography Workflow1354 Retrieve Electrocardiogram for Display Content Profile1354 Resting Electrocardiogram Workflow Profile1354 Evidence Documents1355 Stress Testing Workflow1355 Displayable Reports Profile1355 Cardiac Imaging Report Content1355 Image-Enabled Office Workflow1355 Electrophysiology Laboratory Report Content-Implant/Explant1355 Implantable Device Cardiac Observations1356 Cardiac Cath Report Content1356 Registry Content Submission1356 Nuclear Medicine Image1356 Profiles in Development1356 Clinical Research and Quality Metrics1356 Promoting the IHE Interoperability Framework1356 Request for Proposals1357 Advantages to Vendors/Users1357 Office of the National Coordinator1358 Measuring Success1358 The Patient's Perspective on Interoperability and Quality1358 Conclusions1359 Appendix 1 Author Listing of Relevant Relationships With Industry and Other Entities--2016 ACC/ASE/ASNC/HRS/SCAI Health Policy Statement on Integrating the Healthcare Enterprise1361 Appendix 2 Peer Reviewer Listing of Relevant Relationships With Industry and Other Entities (Relevant)--2016 ACC/ASE/ASNC/HRS/SCAI Health Policy Statement on Integrating the Healthcare Enterprise1362 Appendix 3 Abbreviations1364 Preamble This document has been developed as a health policy statement by the American College of Cardiology (ACC), in conjunction with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, and Society for Cardiovascular Angiography and Interventions. By capturing and reporting high-quality data, the NCDR serves as a tool to measure, benchmark, and improve cardiovascular care (5).\n Jude Medical None None John S. Rumsfeld Official Reviewer--ACC Board of Trustees U.S. Veterans Health Administration--National Director of Cardiology None None None None None None Joyce Sensmeier Organizational Reviewer--HIMSS HIMSS North America--Vice President Informatics None None None None None None H. Vernon Anderson Content Reviewer--NCDR Management Board University of Texas Health Science Center, McGovern Medical School, Houston, Texas--Professor of Medicine None None None MedPace Medical Devices (DSMB) None None Shyam Bhakta Content Reviewer--Advocacy Steering Committee Northeast Ohio Medical University College of Medicine--Assistant Professor of Internal Medicine; Cleveland Clinic Akron General None None None None None None Gilead I. Lancaster Content Reviewer--Advocacy Steering Committee Bridgeport Hospital/Yale New Haven Health System--Director, Non-Invasive Cardiology None None None None None None William A. Van Decker Content Reviewer--Advocacy Steering Committee Temple University Hospital--Assistant Professor of Medicine None None None None None None Paul G. Varghese Content Reviewer--Data Standards Task Force Harvard Medical School--National Library of Medicine Informatics Fellow None None ChartWise Medicallow * None None None Siqin Kye Ye Content Reviewer--Informatics and Health Information Technology Task Force Columbia University Medical Center--Assistant Professor of Medicine, Division of Cardiology, Department of Medicine None None None None None None * This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant to this document.
Background It is unknown if baseline angiographic findings can be used to estimate residual risk of patients with chronic stable angina treated with both optimal medical therapy (OMT) and ...protocol-assigned or symptom-driven percutaneous coronary intervention (PCI). Methods Death, myocardial infarction (MI), and hospitalization for non–ST-segment elevation acute coronary syndrome were adjudicated in 2,275 COURAGE patients. The number of vessels diseased (VD) was defined as the number of major coronary arteries with ≥50% diameter stenosis. Proximal left anterior descending, either isolated or in combination with other disease, was also evaluated. Depressed left ventricular ejection fraction (LVEF) was defined as ≤50%. Cox regression analyses included these anatomical factors as well as interaction terms for initial treatment assignment (OMT or OMT + PCI). Results Percutaneous coronary intervention and proximal left anterior descending did not influence any outcome. Death was predicted by low LVEF (hazard ratio HR 1.86, CI 1.34-2.59, P < .001) and VD (HR 1.45, CI 1.20-1.75, P < .001). Myocardial infarction and non–ST-segment elevation acute coronary syndrome were predicted only by VD (HR 1.53, CI 1.30-1.81 and HR 1.24, CI 1.06-1.44, P = .007, respectively). Conclusions In spite of OMT and irrespective of protocol-assigned or clinically driven PCI, LVEF and angiographic burden of disease at baseline retain prognostic power and reflect residual risk for secondary ischemic events.
Objectives This study sought to assess percutaneous coronary intervention (PCI) for unprotected left main coronary artery (ULMCA) stenosis in routine U.S. clinical practice. Background Percutaneous ...coronary intervention for ULMCA stenosis is controversial; however, current use and outcomes of ULMCA PCI in routine U.S. clinical practice have not been described. Methods We evaluated 5,627 patients undergoing ULMCA PCI at 693 centers within the National Cardiovascular Data Registry Catheterization Percutaneous Coronary Intervention Registry for temporal trends in PCI use (2004 to 2008), patient characteristics, and in-hospital mortality. Thirty-month mortality and composite major adverse events (death, myocardial infarction, and revascularization) with drug-eluting versus bare-metal stents were compared using inverse probability weighted (IPW) hazard ratios (HRs) in a nonrandomized Medicare-linked (age ≥65 years) patient cohort (n = 2,765). Results ULMCA PCI was performed in 4.3% of patients with ULMCA stenosis. Unadjusted in-hospital mortality rates ranged from 2.9% for elective cases to 45.1% for emergent/salvage cases. By 30 months, 57.9% of the elderly ULMCA PCI population experienced death, myocardial infarction, or revascularization, and 42.7% died. Patients receiving drug-eluting stents (versus bare-metal stents) had a lower 30-month mortality (IPW HR: 0.84, 95% confidence interval CI: 0.73 to 0.96), but the composite of major adverse events were similar (IPW HR: 0.95, 95% CI: 0.84 to 1.06). Conclusions In the United States, ULMCA PCI is performed in <5% of patients with ULMCA disease and is generally reserved for those at high procedural risk. Adverse events are common in elderly patients and are related to patient and procedural characteristics, including stent type.
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