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Public reporting programs for percutaneous coronary intervention (PCI) outcomes have been implemented in several states as part of a movement to improve transparency among patients, physicians, and institutions. Massachusetts has publicly reported hospital-specific PCI mortality rates since 2003.

REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial) randomized statin-treated patients with elevated triglycerides to icosapent ethyl (IPE) or placebo. There was a significant reduction in adjudicated events, including the primary endpoint (cardiovascular [CV] death, myocardial infarction [MI], stroke, coronary revascularization, unstable angina requiring hospitalization) and key secondary endpoint (CV death, MI, stroke) with IPE.The purpose of this study was to determine the effects of IPE on investigator-reported events.Potential endpoints were collected by blinded site investigators and subsequently adjudicated by a blinded Clinical Endpoint Committee (CEC) according to a prespecified charter. Investigator-reported events were compared with adjudicated events for concordance.There was a high degree of concordance between investigator-reported and adjudicated endpoints. The simple Kappa statistic between CEC-adjudicated vs site-reported events for the primary endpoint was 0.89 and for the key secondary endpoint was 0.90. Based on investigator-reported events in 8,179 randomized patients, IPE significantly reduced the rate of the primary endpoint (19.1% vs 24.6%; HR: 0.74 [95% CI: 0.67-0.81]; P 0.0001) and the key secondary endpoint (10.5% vs 13.6%; HR: 0.75 [95% CI: 0.66-0.85]; P 0.0001). Among adjudicated events, IPE similarly reduced the rate of the primary and key secondary endpoints.IPE led to consistent, significant reductions in CV events, including MI and coronary revascularization, as determined by independent, blinded CEC adjudication as well as by blinded investigator-reported assessment. These results highlight the robust evidence for the substantial CV benefits of IPE seen in REDUCE-IT and further raise the question of whether adjudication of CV outcome trial endpoints is routinely required in blinded, placebo-controlled trials. (Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT [Reduction of Cardiovascular Events With EPA - Intervention Trial]; NCT01492361).

Acute coronary syndrome (ACS) admissions are common and costly, amounting to $7 billion annually in the United States. The association between comprehensive ACS care strategies and outcomes are lacking. We identified 434,172 low-risk ACS patients (STEMI 35%, UA/NSTEMI 65%) enrolled in the Premier

Objectives The aim of this study was to evaluate the cost-effectiveness of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (AVR) for patients with severe aortic stenosis and high surgical risk. Background TAVR is an alternative to AVR for patients with severe aortic stenosis and high surgical risk. Methods We performed a formal economic analysis based on cost, quality of life, and survival data collected in the PARTNER A (Placement of Aortic Transcatheter Valves) trial in which patients with severe aortic stenosis and high surgical risk were randomized to TAVR or AVR. Cumulative 12-month costs (assessed from a U.S. societal perspective) and quality-adjusted life-years (QALYs) were compared separately for the transfemoral (TF) and transapical (TA) cohorts. Results Although 12-month costs and QALYs were similar for TAVR and AVR in the overall population, there were important differences when results were stratified by access site. In the TF cohort, total 12-month costs were slightly lower with TAVR and QALYs were slightly higher such that TF-TAVR was economically dominant compared with AVR in the base case and economically attractive (incremental cost-effectiveness ratio Conclusions In the PARTNER trial, TAVR was an economically attractive strategy compared with AVR for patients suitable for TF access. Future studies are necessary to determine whether improved experience and outcomes with TA-TAVR can improve its cost-effectiveness relative to AVR. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )

Coronary involvement in cardiac sarcoidosis is rare. A 50 year-old man suffered cardiac arrest due to ventricular fibrillation while exercising. Defibrillation with an AED was successful. Initial EKG showed ST elevation in the inferolateral leads. Coronary angiography revealed 70% stenosis of the

ObjectivesThe goal of this analysis was to evaluate the association of impaired Thrombolysis In Myocardial Infarction myocardial perfusion grade (TMPG) with sustained ventricular tachycardia (VT) or ventricular fibrillation (VF).BackgroundImpaired TMPG after successful restoration of epicardial flow among patients treated with fibrinolytic therapy for ST-segment elevation myocardial infarction (STEMI) has been associated with adverse clinical outcomes, but its relationship to VT/VF has not been evaluated.MethodsIn the CLARITY-TIMI 28 (Clopidogrel as Adjunctive Reperfusion Therapy–Thrombolysis In Myocardial Infarction 28) study, 3,491 patients underwent angiography a median of 3.5 days after fibrinolytic administration for STEMI; TMPG was assessed, and its association with VT/VF was evaluated.ResultsWe observed VT/VF in 4.8% of patients. Impaired myocardial perfusion (TMPG 0/1/2) was associated with an increased incidence of VT/VF (7.1% vs. 2.6% with TMPG 3; log-rank p < 0.001). Among patients with restoration of normal epicardial flow (Thrombolysis In Myocardial Infarction flow grade 3), the incidence of VT/VF was increased among patients with impaired TMPG (4.7% vs. 2.7%; p = 0.02). Among patients with left ventricular ejection fraction ≥30%, impaired TMPG remained associated with an increased incidence of VT/VF (4.7% vs. 2.5%; p = 0.03). We found that VT/VF was associated with increased mortality (25.2% vs. 3.5%; p < 0.0001). Furthermore, among patients with VT/VF, impaired TMPG was associated with increased mortality (17.1% vs. 2.3%; p = 0.02). All but 1 death among patients who had VT/VF were among patients with impaired myocardial perfusion.ConclusionsDespite restoration of normal epicardial flow or a left ventricular ejection fraction ≥30%, impaired myocardial perfusion on angiography 3.5 days after fibrinolytic administration for STEMI is associated with an increased incidence of VT/VF.

Objectives The objectives of the study were to evaluate the effect of angiographic follow-up on revascularization rates in the TAXUS-IV trial and to determine whether the relative benefit of paclitaxel-eluting stent implantation compared with bare metal stent implantation was modified by angiographic follow-up. Background Although several clinical trials have demonstrated that drug-eluting stents (DES) reduce restenosis compared with bare-metal stents (BMS), virtually all of these studies have incorporated angiographic follow-up. Methods In the TAXUS-IV trial, 1,314 percutaneous coronary intervention patients were randomized to receive paclitaxel-eluting stents (PES) (n = 662) or identical-appearing BMS (n = 652). Clinical outcomes were compared, stratified by assignment to angiographic follow-up or clinical follow-up alone. Results Compared with clinical follow-up alone, angiographic follow-up patients had a significantly higher rate of target vessel revascularization (TVR) at 1 year (adjusted hazard ratio [HR] 1.46; p = 0.04), with similar relative increases in PES and BMS patients. Because PES reduced TVR by ∼60% regardless of type of follow-up, assignment to angiographic follow-up tended to overestimate the absolute benefit of PES relative to clinical follow-up alone. In contrast, assessment of end points immediately before the time of follow-up angiography led to substantial underestimation of the absolute benefit of PES implantation. Conclusions Performance of mandatory angiographic follow-up increases rates of TVR among patients receiving both BMS and PES and overestimates the absolute clinical benefits of PES relative to clinical follow-up alone. Nonetheless, PES substantially reduces TVR regardless of assignment to mandatory angiographic follow-up or not. Future studies designed to determine the true clinical benefits of DES should either forgo routine angiographic follow-up or separate the time of repeat angiography from the primary clinical end point by as long as possible.

ObjectivesWe hypothesized that elevated blood urea nitrogen (BUN) would be associated with adverse outcomes independent of serum creatinine (sCr)-based estimates of kidney function in patients with acute coronary syndromes (ACS).BackgroundAlthough lower glomerular filtration rates (GFR) have prognostic significance among patients with ACS, estimates of GFR based on sCr may perform less accurately among patients with milder kidney dysfunction. In this population in particular, BUN, which can reflect increased proximal tubular reabsorption in addition to decreased GFR, may have independent prognostic value.MethodsData were drawn from 9,420 patients with unstable coronary syndromes from Orbofiban in Patients With Unstable Coronary Syndromes-Thrombolysis In Myocardial Infarction (OPUS-TIMI)-16, a trial that excluded patients with sCr >1.6 mg/dl or estimated creatinine clearance

ObjectivesWe hypothesized that impaired renal function would also be associated with poorer clinical outcomes among patients with ST-segment elevation myocardial infarction (STEMI) treated with fibrinolysis.BackgroundPrevious studies have demonstrated that impaired renal function is associated with poorer clinical outcomes in the setting of unstable angina and non-STEMI and after percutaneous coronary intervention.MethodsData were drawn from the Thrombolysis In Myocardial Infarction (TIMI)-10, TIMI-14, and Intravenous nPA for the Treatment of Infarcting Myocardium Early (InTIME-II) trials.ResultsWithin each TIMI risk score (TRS) for STEMI category (0 to 2, 3 to 4, ≥5), 30-day mortality increased stepwise among patients with normal (creatinine [Cr] ≤1.2 mg/dl), mildly (Cr >1.2 to 2 mg/dl), and severely (Cr >2.0 mg/dl) impaired renal function (p < 0.001) and in patients with normal (creatinine clearance [CrCl] ≥90 ml/min), mildly (60 to

To the Editor: Hyperglycemia, with or without pre-existing diabetes mellitus, is associated with adverse outcomes in patients with acute coronary syndromes ([1][1]). Whereas blood glucose levels (BGLs) ≥200 mg/dl are associated with adverse outcomes after acute myocardial infarction (AMI), the

Current management of orthostatic hypotension includes midodrine (A), steroids (B) and knee or thigh high stocking (C). There is no guideline or clinical clues when to use which and which combination. Patients with diagnosis of orthostatic hypotension who arrived to the emergency room were enrolled

Current definitions of heart failure (HF) are vague and impractical. So we devise a new classification of HF which can guide its management and improve its outcome. The classification is based on the status of fluid volume in 3 compartments of the body. The intravascular compartment includes the

Current management of heart failure includes intravenous or oral diuretic. However, many times, diuretics caused severe increase of blood urea nitrogen (BUN) or creatinine level. These increases may require discontinuation of diuretics or even resumption of IV fluid. How to predict which HF patient

The objectives of the study were to evaluate the effect of angiographic follow-up on revascularization rates in the TAXUS-IV trial and to determine whether the relative benefit of paclitaxel-eluting stent implantation compared with bare metal stent implantation was modified by angiographic follow-up.Although several clinical trials have demonstrated that drug-eluting stents (DES) reduce restenosis compared with bare-metal stents (BMS), virtually all of these studies have incorporated angiographic follow-up.In the TAXUS-IV trial, 1,314 percutaneous coronary intervention patients were randomized to receive paclitaxel-eluting stents (PES) (n = 662) or identical-appearing BMS (n = 652). Clinical outcomes were compared, stratified by assignment to angiographic follow-up or clinical follow-up alone.Compared with clinical follow-up alone, angiographic follow-up patients had a significantly higher rate of target vessel revascularization (TVR) at 1 year (adjusted hazard ratio [HR] 1.46; p = 0.04), with similar relative increases in PES and BMS patients. Because PES reduced TVR by approximately 60% regardless of type of follow-up, assignment to angiographic follow-up tended to overestimate the absolute benefit of PES relative to clinical follow-up alone. In contrast, assessment of end points immediately before the time of follow-up angiography led to substantial underestimation of the absolute benefit of PES implantation.Performance of mandatory angiographic follow-up increases rates of TVR among patients receiving both BMS and PES and overestimates the absolute clinical benefits of PES relative to clinical follow-up alone. Nonetheless, PES substantially reduces TVR regardless of assignment to mandatory angiographic follow-up or not. Future studies designed to determine the true clinical benefits of DES should either forgo routine angiographic follow-up or separate the time of repeat angiography from the primary clinical end point by as long as possible.

New York mandated open access to data regarding outcomes associated with percutaneous coronary intervention (PCI) in 1991, and in the subsequent 2 decades, public reporting has been a divisive topic [(1)][1]. Over that time, Pennsylvania and Massachusetts have also instituted public reporting of