A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, American Heart Association, American Society of Echocardiography, American Society of Nuclear ...Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons ACCF Multimodality Appropriate Use Criteria for the Detection and Risk Assessment of Ischemic Heart Disease Writing Group, Technical Panel, Task Force, and Indication Reviewers...Relationships With Industry and Other Entities (Relevant)... .403 Abstract The American College of Cardiology Foundation along with key specialty and subspecialty societies, conducted an appropriate use review of common clinical presentations for stable ischemic heart disease (SIHD) to consider use of stress testing and anatomic diagnostic procedures. The use of some modalities of testing in the initial evaluation of patients with symptoms representing ischemic equivalents, newly diagnosed heart failure, arrhythmias, and syncope was generally found to be Appropriate or May Be Appropriate, except in cases where low pre-test probability or low risk limited the benefit of most testing except exercise electrocardiogram (ECG).
A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, American Association for Thoracic Surgery, ...American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society of Critical Care Medicine, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons Technical Panel Pamela S. Douglas, MD, MACC, FAHA, FASE, Moderator Manesh R. Patel, MD, FACC, Writing Group Liaison Steven R. Bailey, MD, FACC, FSCAI, FAHA, Writing Group Liaison Philip Altus, MD, MACPdaggerAmerican College of Physicians Representative Denise D. Barnard, MD, FACCdouble daggerHeart Failure Society of America Representative James C. Blankenship, MD, MACC, FSCAI* Donald E. Casey, Jr, MD, MPH, MBA, FACP, FAHAdagger Larry S. Dean, MD, FACC, FAHA, FSCAI* Reza Fazel, MD, MSc, FACC§American Society of Nuclear Cardiology Representative Ian C. Gilchrist, MD, FACC, FSCAI, FCCM||Society of Critical Care Medicine Representative Clifford J. Kavinsky, MD, PhD, FACC, FSCAI* Susan G. Lakoski, MD, MS¶American Heart Association Representative D. Elizabeth Le, MD, FACC, FASE#American Society of Echocardiography Representative John R. Lesser, MD, FACC, FSCAI, FSCCT**Society of Cardiovascular Computed Tomography Representative Glenn N. Levine, MD, FACC, FAHAdaggerdaggerSociety for Cardiovascular Magnetic Resonance Representative Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, FSCAIdouble daggerdouble daggerAmerican College of Cardiology Foundation Representative Andrea M. Russo, MD, FACC, FHRS§§Heart Rhythm Society Representative Matthew J. Sorrentino, MD, FACCdouble daggerdouble dagger Mathew R. Williams, MD, FACC|||American Association for Thoracic Surgery/Society of Thoracic Surgeons Representative John B. Wong, MD, FACPdouble daggerdouble dagger Appropriate Use Criteria Task Force Michael J. Wolk, MD, MACC, Chair Steven R. Bailey, MD, FACC, FSCAI, FAHA Pamela S. Douglas, MD, MACC, FAHA, FASE Robert C. Hendel, MD, FACC, FAHA, FASNC Christopher M. Kramer, MD, FACC, FAHA James K. Min, MD, FACC Manesh R. Patel, MD, FACC Leslee Shaw, PhD, FACC, FASNC Raymond F. Stainback, MD, FACC, FASE Joseph M. Allen, MA Table of Contents Abstract... Preface In an effort to respond to the need for the rational use of cardiovascular services, including imaging and invasive procedures in the delivery of high-quality care, the American College of Cardiology Foundation (ACCF) in collaboration with other professional organizations has undertaken a process to determine the appropriate use of cardiovascular procedures for selected patient indications.
Abstract We investigated stroke outcomes in normal weight (body mass index BMI 18.50-24.99 kg/m2 ), overweight (BMI 25.00-29.99 kg/m2 ), and obese (BMI ≥30 kg/m2 ) patients with AF treated with ...rivaroxaban and warfarin. We compared the incidence of stroke and systemic embolic events (SEE) as well as bleeding events in normal weight (n=3289), overweight (n=5535), and obese (n=5206) patients in a post-hoc analysis of the ROCKET AF trial. Stroke and SEE rates per 100 patient-years were 2.93 in the normal weight group (reference group), 2.28 in the overweight group (adjusted hazard ratio HR 0.81, 95% confidence interval CI: 0.66-0.99, p=0.04), and 1.88 in the obese group (adjusted HR 0.69, 95% CI: 0.55-0.86, p<0.001). The risk of stroke was statistically significantly lower for obese patients with BMI ≥35 compared with normal weight patients in both the rivaroxaban and warfarin groups (rivaroxaban: HR 0.62, 95% CI: 0.40-0.96, p=0.033; warfarin: HR 0.48, 95% CI: 0.31-0.74, p<0.001). In conclusion, among patients with AF treated with anticoagulant therapy, increased BMI was associated with decreased stroke risk. Warfarin and the novel anticoagulant rivaroxoban are effective in stroke prevention in all sub-groups of obese patients.
Objectives The purpose of this study was to describe hospital variability in the rate of finding obstructive coronary artery disease (CAD) at elective coronary angiography. Background A recent ...national study found that obstructive CAD was found in less than one-half of patients undergoing elective coronary angiography. Methods We performed a retrospective analysis of 565,504 patients without prior myocardial infarction or revascularization undergoing elective coronary angiography using CathPCI Registry data from 2005 to 2008 to evaluate the rate of finding obstructive CAD (any major epicardial vessel stenosis ≥50%) at coronary angiography at 691 U.S. hospitals. Results The rate of obstructive coronary disease found at elective coronary angiography varied from 23% to 100% among hospitals (median 45%; interquartile range: 39% to 52%), and were consistent from year to year and when alternative definitions of coronary stenosis were applied. Sites with lower rates of finding obstructive CAD were more likely to perform procedures on younger patients, those with low Framingham risk (33% in lowest yield quartile vs. 21% in highest yield quartile, p < 0.0001); with no or atypical symptoms (73% vs. 58%, p < 0.0001); and with a negative, equivocal, or unperformed functional status assessment. Hospitals with lower rates of finding obstructive CAD also less frequently prescribed aspirin, beta-blockers, platelet inhibitors, and statins (all p < 0.0001). The CAD rate was lower at facilities with small-volume catheterization laboratories and was not associated with hospital ownership or teaching program status. Conclusions The rate of finding obstructive CAD at elective coronary angiography varied considerably among reporting centers and was associated with patient selection and pre-procedure assessment strategies. This institutional variation suggests that an important opportunity may exist for quality improvement.
Abstract Nonvitamin K-dependent oral anticoagulant agents (NOACs) are currently recommended for patients with atrial fibrillation at risk for stroke. As a group, NOACs significantly reduce stroke, ...intracranial hemorrhage, and mortality, with lower to similar major bleeding rates compared with warfarin. All NOACs are dependent on the kidney for elimination, such that patients with creatinine clearance <25 ml/min were excluded from all the pivotal phase 3 NOAC trials. It therefore remains unclear how or if NOACs should be prescribed to patients with advanced chronic kidney disease and those on dialysis. The authors review the current pharmacokinetic, observational, and prospective data on NOACs in patients with advanced chronic kidney disease (creatinine clearance <30 ml/min) and those on dialysis. The authors frame the evidence in terms of risk versus benefit to bring greater clarity to NOAC-related major bleeding and efficacy at preventing stroke specifically in patients with creatinine clearance <30 ml/min.
Abstract Background Despite overwhelming data demonstrating the efficacy of antiplatelet therapy in heart disease and stroke, data in peripheral artery disease (PAD) are less compelling. Aspirin has ...modest evidence supporting a reduction in cardiovascular events in patients with PAD, while clopidogrel monotherapy may be more effective in PAD. Ticagrelor, a potent, reversibly binding P2Y12 receptor antagonist, is beneficial in patients with acute coronary syndrome and prior myocardial infarction. The EUCLID trial is designed to address the need for effective antiplatelet therapy in PAD to decrease the risk of cardiovascular events. Study Design EUCLID is a randomized, double-blind, parallel-group, multinational clinical trial designed to evaluate the efficacy and safety of ticagrelor compared with clopidogrel for the prevention of major adverse cardiovascular events in subjects with symptomatic PAD. Subjects with established PAD will be randomized in a 1:1 fashion to ticagrelor 90 mg twice daily or clopidogrel 75 mg daily. The primary end point is a composite of cardiovascular death, myocardial infarction, or ischemic stroke. Other end points address limb events including acute leg ischemia, need for revascularization, disease progression by ankle-brachial index, and quality of life. The primary safety objective is Thrombolysis in Myocardial Infarction (TIMI)-defined major bleeding. Recruitment began in December 2012 and completed in March 2014; 13,887 patients were randomized. The trial will continue until at least 1364 adjudicated primary end points occur. Conclusions The EUCLID study is investigating whether treatment with ticagrelor versus clopidogrel, given as antiplatelet monotherapy, will reduce the incidence of cardiovascular and limb-specific events in patients with symptomatic PAD.
Background In the TRACER trial, vorapaxar, a protease-activated receptor-1 antagonist, plus standard care in non–ST-segment elevation acute coronary syndrome (NSTE ACS) patients did not significantly ...reduce the primary composite end point but reduced a key secondary end point and significantly increased bleeding. History of peripheral artery disease (PAD) was a risk-enrichment inclusion criterion. We investigated the efficacy and safety of vorapaxar in NSTE ACS patients with documented PAD. Methods TRACER was a double-blind, randomized trial comparing vorapaxar with placebo in 12,944 patients with NSTE ACS. Results In total, 936 (7.2%) patients had a history of PAD. Ischemic events occurred more frequently among patients with PAD (25.3%) versus no PAD (12.2%, P < .001), and Global Use of Strategies to Open Occluded Coronary Arteries moderate/severe bleeding was more common in PAD (9.1%) versus no PAD (5.0%, P = .004). Similar rates of the composite end point (cardiovascular death, myocardial infarction, or stroke) occurred in patients with PAD treated with vorapaxar and placebo (21.7% vs 24.8%, P interaction = .787). Patients with PAD treated with vorapaxar, when compared with placebo, also had a numerical reduction in peripheral revascularization procedures (8.1% vs 9.0%, P = .158) and a lower extremity amputation rate (0.9% vs 1.5%, P = .107). Vorapaxar increased Global Use of Strategies to Open Occluded Coronary Arteries moderate/severe bleeding similarly in patients with PAD (hazard ratio 1.47, 95% CI 0.89-2.45) and without (hazard ratio 1.48, 95% CI 1.22-1.79; P interaction = .921). Conclusions Patients with NSTE ACS and PAD were at increased risk for ischemic events. Lower rates of ischemic end points, peripheral revascularization, and amputation with vorapaxar did not reach statistical significance but warrant further investigation. Vorapaxar increased bleeding in both patients with and without PAD at a similar magnitude of risk.
Summary Background In ROCKET AF, rivaroxaban was non-inferior to adjusted-dose warfarin in preventing stroke or systemic embolism among patients with atrial fibrillation (AF). We aimed to investigate ...whether the efficacy and safety of rivaroxaban compared with warfarin is consistent among the subgroups of patients with and without previous stroke or transient ischaemic attack (TIA). Methods In ROCKET AF, patients with AF who were at increased risk of stroke were randomly assigned (1:1) in a double-blind manner to rivaroxaban 20 mg daily or adjusted dose warfarin (international normalised ratio 2·0–3·0). Patients and investigators were masked to treatment allocation. Between Dec 18, 2006, and June 17, 2009, 14 264 patients from 1178 centres in 45 countries were randomly assigned. The primary endpoint was the composite of stroke or non-CNS systemic embolism. In this substudy we assessed the interaction of the treatment effects of rivaroxaban and warfarin among patients with and without previous stroke or TIA. Efficacy analyses were by intention to treat and safety analyses were done in the on-treatment population. ROCKET AF is registered with ClinicalTrials.gov , number NCT00403767. Findings 7468 (52%) patients had a previous stroke (n=4907) or TIA (n=2561) and 6796 (48%) had no previous stroke or TIA. The number of events per 100 person-years for the primary endpoint in patients treated with rivaroxaban compared with warfarin was consistent among patients with previous stroke or TIA (2·79% rivaroxaban vs 2·96% warfarin; hazard ratio HR 0·94, 95% CI 0·77–1·16) and those without (1·44% vs 1·88%; 0·77, 0·58–1·01; interaction p=0·23). The number of major and non-major clinically relevant bleeding events per 100 person-years in patients treated with rivaroxaban compared with warfarin was consistent among patients with previous stroke or TIA (13·31% rivaroxaban vs 13·87% warfarin; HR 0·96, 95% CI 0·87–1·07) and those without (16·69% vs 15·19%; 1·10, 0·99–1·21; interaction p=0·08). Interpretation There was no evidence that the relative efficacy and safety of rivaroxaban compared with warfarin was different between patients who had a previous stroke or TIA and those who had no previous stroke or TIA. These results support the use of rivaroxaban as an alternative to warfarin for prevention of recurrent as well as initial stroke in patients with AF. Funding Johnson and Johnson Pharmaceutical Research and Development and Bayer HealthCare.
Factors Associated With Major Bleeding Events Goodman, Shaun G., MD, MSc; Wojdyla, Daniel M., MS; Piccini, Jonathan P., MD ...
Journal of the American College of Cardiology,
03/2014, Volume:
63, Issue:
9
Journal Article
Peer reviewed
Open access
Objectives This study sought to report additional safety results from the ROCKET AF (Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of ...Stroke and Embolism Trial in Atrial Fibrillation). Background The ROCKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin. Methods The risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared, and factors associated with major bleeding were examined in a multivariable model. Results The principal safety endpoint was similar in the rivaroxaban and warfarin groups (14.9 vs. 14.5 events/100 patient-years; hazard ratio: 1.03; 95% confidence interval: 0.96 to 1.11). Major bleeding risk increased with age, but there were no differences between treatments in each age category (<65, 65 to 74, ≥75 years; pinteraction = 0.59). Compared with those without (n = 13,455), patients with a major bleed (n = 781) were more likely to be older, current/prior smokers, have prior gastrointestinal (GI) bleeding, mild anemia, and a lower calculated creatinine clearance and less likely to be female or have a prior stroke/transient ischemic attack. Increasing age, baseline diastolic blood pressure (DBP) ≥90 mm Hg, history of chronic obstructive pulmonary disease or GI bleeding, prior acetylsalicylic acid use, and anemia were independently associated with major bleeding risk; female sex and DBP <90 mm Hg were associated with a decreased risk. Conclusions Rivaroxaban and warfarin had similar risk for major/nonmajor clinically relevant bleeding. Age, sex, DBP, prior GI bleeding, prior acetylsalicylic acid use, and anemia were associated with the risk of major bleeding. (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: NCT00403767 )
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