Table of Contents Preamble2647 Introduction2649 Methodology and Evidence Review2649 Organization of the GWC2649 Document Review and Approval2649 Scope of the CPG2650 Overview of ACS2650 Initial ...Evaluation and Management: Recommendations2650 Clinical Assessment and Initial Evaluation2650 Emergency Department or Outpatient Facility Presentation2650 Prognosis--Early Risk Stratification2650 Cardiac Biomarkers and the Universal Definition of Myocardial Infarction2654 Biomarkers: Diagnosis2654 Biomarkers: Prognosis2654 Discharge From the ED or Chest Pain Unit2655 Early Hospital Care: Recommendations2655 Standard Medical Therapies2655 Oxygen2655 Nitrates2655 Analgesic Therapy2655 Beta-Adrenergic Blockers2656 Calcium Channel Blockers2657 Cholesterol Management2657 Inhibitors of the Renin-Angiotensin-Aldosterone System2657 Initial Antiplatelet/Anticoagulant Therapy in Patients With Definite or Likely NSTE-ACS2657 Initial Oral and Intravenous Antiplatelet Therapy in Patients With Definite or Likely NSTE-ACS Treated With an Initial Invasive or Ischemia-Guided Strategy2657 Initial Parenteral Anticoagulant Therapy in Patients With Definite NSTE-ACS2659 Ischemia-Guided Strategy Versus Early Invasive Strategies2659 Early Invasive and Ischemia-Guided Strategies2659 Risk Stratification Before Discharge for Patients With an Ischemia-Guided Strategy of NSTE-ACS2661 Myocardial Revascularization: Recommendations2661 PCI--General Considerations2661 PCI--Oral and Intravenous Antiplatelet Agents2661 PCI--GP IIb/IIIa Inhibitors2662 Anticoagulant Therapy in Patients Undergoing PCI2663 Timing of Urgent Coronary Artery Bypass Graft in Patients With NSTE-ACS in Relation to Use of Antiplatelet Agents2663 Late Hospital Care, Hospital Discharge, and Posthospital Discharge Care: Recommendations2663 Medical Regimen and Use of Medications at Discharge2663 Late Hospital and Posthospital Oral Antiplatelet Therapy2664 Combined Oral Anticoagulant Therapy and Antiplatelet Therapy in Patients With NSTE-ACS2664 Risk Reduction Strategies for Secondary Prevention2664 Plan of Care for Patients With NSTE-ACS2665 Special Patient Groups: Recommendations2665 NSTE-ACS in Older Patients2665 Heart Failure and Cardiogenic Shock2665 Diabetes Mellitus2667 Post-CABG2668 Perioperative NSTE-ACS Related to Noncardiac Surgery2668 Chronic Kidney Disease2668 Women2668 Anemia, Bleeding, and Transfusion2668 Cocaine and Methamphetamine Users2668 Vasospastic (Prinzmetal) Angina2668 ACS With Angiographically Normal Coronary Arteries2669 Stress (Takotsubo) Cardiomyopathy2669 Quality of Care and Outcomes for ACS--Use of Performance Measures and Registries: Recommendation2669 Summary and Evidence Gaps2669 References2670 Appendix 1 Author Relationships With Industry and Other Entities (Relevant)2680 Appendix 2 Reviewer Relationships With Industry and Other Entities (Relevant)2683 Preamble The American College of Cardiology (ACC) and the American Heart Association (AHA) are committed to the prevention and management of cardiovascular diseases through professional education and research for clinicians, providers, and patients. Since 1980, the ACC and AHA have shared a responsibility to translate scientific evidence into clinical practice guidelines (CPGs) with recommendations to standardize and improve cardiovascular health.
Background Obstructive sleep apnea (OSA) is common in patients with atrial fibrillation (AF). Little is known about the impact of OSA on AF treatment and long-term outcomes. We studied whether ...patients with OSA have a greater likelihood of progressing to more persistent forms of AF or require more hospitalizations and/or worse outcomes compared with patients without OSA. Methods A total of 10,132 patients were enrolled between June 2010 and August 2011 in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) and followed for up to 2 years. The prevalence of OSA and continuous positive airway pressure (CPAP) treatment was captured at baseline. The association between OSA and major cardiovascular outcomes was analyzed using multivariable hierarchical logistic regression modeling and Cox frailty regression model. Results Of the 10,132 patients with AF, 1,841 had OSA. Patients with OSA were more symptomatic (22% vs 16% severe/disabling symptoms; P < .0001) and more often on rhythm control therapy (35% vs 31%; P = .0037). In adjusted analyses, patients with OSA had higher risk of hospitalization (hazard ratio HR, 1.12; 95% CI, 1.03-1.22; P = .0078), but no difference in the risks of death (HR, 0.94; 95% CI, 0.77-1.15; P = .54); the composite of CV death, myocardial infarction, and stroke/transient ischemic attack (HR, 1.07; 95% CI, 0.85-1.34; P = .57); major bleeding (HR, 1.18; 95% CI, 0.96-1.46; P = .11); or AF progression (HR, 1.06; 95% CI, 0.89-1.28; P = .51). Patients with OSA on CPAP treatment were less likely to progress to more permanent forms of AF compared with patients without CPAP (HR, 0.66; 95% CI, 0.46-0.94; P = .021). Conclusion Compared with those without, AF patients with OSA have worse symptoms and higher risks of hospitalization, but similar mortality, major adverse cardiovascular outcome, and AF progression rates. Clinical Trial Registration: NCT01165710 ( http://www.clinicaltrials.gov ).
...of its activities, the committee has reduced the documentation burden on clinicians and hospitals in the hope that this will thereby allow them to focus on more critical areas of quality ...measurement and improvement. ...the performance measures were extended to assess functional outcomes. Valid, reliable, disease-specific patient-reported questionnaires include the Kansas City Cardiomyopathy Questionnaire (KCCQ); Minnesota Living with Heart Failure Questionnaire (MLHFQ); and Chronic Heart Failure Questionnaire (CHFQ).2Patient symptoms have demonstrated clinically important deterioration since last assessment.3A documented plan of care may include >=1 of the following: reevaluation of medical therapy, including uptitration of doses, consideration of electrical device therapy, recommended lifestyle modifications (e.g., salt restriction, exercise training), initiation of palliative care, referral for more advanced therapies (e.g., transplant, ventricular assist device), or referral to disease management programs.4Counseling should be specific to each individual patient and include documentation of a discussion regarding the risk of sudden and nonsudden death AND the efficacy, safety, and risks of an ICD.
Objectives The aim of this study was to assess the impact of extreme (class III) obesity (body mass index BMI ≥40 kg/m2 ) on care and outcomes in patients with ST-segment elevation myocardial ...infarction (STEMI). Background Although its prevalence is increasing rapidly, little is known about the impact of extreme obesity on STEMI presentation, treatments, complication rates, and outcomes. Methods The relationship between BMI and baseline characteristics, treatment patterns, and risk-adjusted in-hospital outcomes was quantified for 50,149 patients with STEMI from the National Cardiovascular Data Registry (NCDR) ACTION Registry–GWTG. Results The proportions of patients with STEMI by BMI category were as follows: underweight (BMI <18.5 kg/m2 ) 1.6%, normal weight (18.5 kg/m2 ≤BMI <25 kg/m2 ) 23.5%, overweight (25 kg/m2 ≤BMI <30 kg/m2 ) 38.7%, class I obese (30 kg/m2 ≤BMI <35 kg/m2 ) 22.4%, class II obese (35 kg/m2 ≤BMI <40 kg/m2 ) 8.7%, and class III obese 5.1%. Extreme obesity was associated with younger age at STEMI presentation (median age 55 years for class III obese vs. 66 years for normal weight); a higher prevalence of diabetes, hypertension, and dyslipidemia; a lower prevalence of smoking; and less extensive coronary artery disease and higher left ventricular ejection fraction. Process-of-care measures were similar across BMI categories, including the extremely obese. Using class I obesity as the referent, risk-adjusted in-hospital mortality rates were significantly higher only for class III obese patients (adjusted odds ratio: 1.64; 95% confidence interval: 1.32 to 2.03). Conclusions Patients with extreme obesity present with STEMI at younger ages and have less extensive coronary artery disease, better left ventricular systolic function, and similar processes and quality of care. Despite these advantages, extreme obesity remains independently associated with higher in-hospital mortality.
Background Efficient conduct of clinical trials is essential for the timely generation of critical medical knowledge. Methods We systematically assessed size, duration, enrollment rates, and ...geographic distribution of randomized cardiovascular trials published between 2001 and 2012 in the 8 highest-impact journals in general medicine and cardiology. Results Of the 1,224 trials, 27.0% were conducted in North America, 36.5% in Western Europe, and 7.7% in other countries, and 28.8% were multiregional. Trials enrolled a median of 452 patients (interquartile range 167-1,530) in 20 sites (2-76). Median duration was 2.1 (1.3-3.3) years, with an estimated enrollment rate of 1.1 (0.5-3.5) patients/site per month. Between 2001-2003 and 2009-2012, the proportion of North American trials decreased from 34.5% to 25.7% ( P = .006), whereas that of multiregional trials (from 26.0% to 30.3%; P = .046) and trials conducted in other countries (from 4.6% to 10.3%; P = .012) increased. Over time, trials involved more patients (from 400 to 500 median; P = .032) and sites (from 20 to 22; P = .049), multiregional trials involved more countries (from 12 to 18; P = .031), and enrollment rate declined from 1.2 to 0.9 patients/site per month ( P = .017). The proportion of trials meeting their primary end point (“positive”) decreased from 69% to 57% ( P < .001). Trials with higher enrollment rates were more likely to be positive (odds ratio 1.20 per doubling, 95% CI 1.12-1.29), as were industry-sponsored compared with government-sponsored trials (odds ratio 2.62, 95% CI 1.67-4.12). Conclusions From 2001 to 2012, cardiovascular clinical trials have become larger, more global, and less likely to meet their primary end point. Enrollment rates have declined, requiring more sites and regions.
Proceedings from Duke Resistant Hypertension Think Tank Vemulapalli, Sreekanth, MD; Ard, Jamy, MD; Bakris, George L., MD ...
American heart journal,
06/2014, Letnik:
167, Številka:
6
Journal Article, Conference Proceeding
Recenzirano
To identify patients at increased risk for cardiovascular outcomes, apparent treatment resistant hypertension (aTRH) is defined as having a blood pressure (BP) above goal despite the use of ≥3 ...antihypertensive therapies of different classes at maximally tolerated doses, ideally including a diuretic. In light of growing scientific interest in the treatment of this group, a multistakeholder think tank was convened to discuss the current state of knowledge, improve the care of these patients, and identify appropriate study populations for future observational and randomized trials in the field. Although recent epidemiologic studies in selected populations estimate that the prevalence of aTRH is 10% to 15% of hypertensive patients, further large-scale observational studies will be needed to better elucidate risk factors. To spur the development of therapies for aTRH, the development of an “aTRH” label for pharmacologic and device therapies with a developmental pathway including treatment added to the use of existing therapies is favored. Although demonstration of adequate BP lowering should be sufficient to gain Food and Drug Administration approval for therapies targeting aTRH, assessment of improvement in quality of life and cardiovascular outcomes is also desirable and considered in Centers for Medicare and Medicaid Services coverage decisions. Device trials under the aTRH label will need uniform and consistent processes for defining appropriate patient populations as well as postapproval registries assessing both long-term safety and duration of responses. Finally, patients with aTRH are likely to benefit from evaluation by a hypertension team to assure proper patient identification, diagnostic work-up, and therapeutic management before consideration of advanced or novel therapies to lower BP.
Background Anticoagulation therapy reduces thromboembolic events in patients with atrial fibrillation (AF) and has a class I indication for ischemic stroke patients with AF and no contraindications. ...We determined the patient and hospital level characteristics associated with an increased use of anticoagulation, including participation in the Get With The Guidelines–Stroke (GWTG-Stroke) Program. Methods We assessed the use of anticoagulation at hospital discharge in eligible AF patients with stroke or transient ischemic attack (TIA) at 1,354 participating hospitals between April 1, 2003, and April 1, 2010. Results Patients with AF (n = 197,778) represented 20.5% of patients with ischemic stroke/TIA. Among patients with AF, 47.6% (n = 94,119) were deemed eligible for anticoagulation, and of these, 94.0% were discharged on therapy. Older patients, African American or Hispanic patients, and those with diabetes were less likely to receive anticoagulation. Hospitals with a higher volume of patients with stroke were more likely to treat with anticoagulation. The Joint Commission Primary Stroke Centers were also more likely to treat eligible patients (odds ratio 2.16, 95% CI 1.82-2.56, P < .0001). From 2003 to 2010, contraindications to anticoagulation therapy declined from 69.7% to 28.4% ( P < .0001 for trend). Anticoagulation among eligible patients improved from 88.4% to 95.2% ( P < .0001) for 7 years of participation. Time in GWTG-Stroke was associated with improved anticoagulation use (adjusted odds ratio per year in program, 1.11, 95% CI 1.06-1.16, P < .001). Conclusions Use of anticoagulation among stroke patients with AF has increased to very high levels overall in GWTG-Stroke over time. Future efforts should focus on improving use among selected populations.
Cardiovascular Drug Development Fordyce, Christopher B., MD, MSc; Roe, Matthew T., MD, MHS; Ahmad, Tariq, MD, MPH ...
Journal of the American College of Cardiology,
04/2015, Letnik:
65, Številka:
15
Journal Article
Recenzirano
Odprti dostop
Abstract Despite the global burden of cardiovascular disease, investment in cardiovascular drug development has stagnated over the past 2 decades, with relative underinvestment compared with other ...therapeutic areas. The reasons for this trend are multifactorial, but of primary concern is the high cost of conducting cardiovascular outcome trials in the current regulatory environment that demands a direct assessment of risks and benefits, using clinically-evident cardiovascular endpoints. To work toward consensus on improving the environment for cardiovascular drug development, stakeholders from academia, industry, regulatory bodies, and government agencies convened for a think tank meeting in July 2014 in Washington, DC. This paper summarizes the proceedings of the meeting and aims to delineate the current adverse trends in cardiovascular drug development, understand the key issues that underlie these trends within the context of a recognized need for a rigorous regulatory review process, and provide potential solutions to the problems identified.
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