Mitchell W Krucoff

Duke University, Durham, North Carolina, United States

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Publications (282)2087.38 Total impact

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    ABSTRACT: Early reperfusion of ischemic myocytes is essential for optimal salvage in acute myocardial infarction. VA (ventricular arrhythmia) bursts after recanalization of the culprit vessel have been found to be related to larger infarct size (IS), using SPECT. The hypothesis was tested that this finding could be confirmed in an independent cohort using a more accurate technique, i.e. delayed-enhancement cardiovascular magnetic resonance imaging (DE-CMR). All 196 patients from the PREPARE and MAST studies who had 24-hour, continuous, 12-lead Holter, started before primary percutaneous coronary intervention resulting in brisk TIMI (thrombolysis in myocardial infarction) 3 flow and stable ST-recovery were included. VA bursts were identified against subject-specific background VA rates using a previously published statistical outlier method. IS was assessed using DE-CMR. Angiography, Holter and DE-CMR results were assessed in core laboratories, blinded to all other data. VA bursts were present in 154/196 (79%) of patients. Baseline characteristics between the groups with and without bursts were similar. VA burst was associated with significantly larger infarct size in the population as a whole (median 11.3% vs 5.3%; p=0.001) and also when divided in non-anterior (median 9.9% vs 4.9%; p=0.003) and anterior myocardial infarction (median 21.4% vs 12.0%; p=0.48), the latter not reaching statistical significance due to the small subset of patients. Beyond the classical markers of "optimal" reperfusion such as TIMI 3 flow and stable ST-segment recovery, VA bursts occurring during the reperfusion phase are an early electrobiomarker of larger IS. PREPARE: ISRCTN71104460 http://www.controlled-trials.com/ISRCTN71104460. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
    International journal of cardiology 09/2015; 195. DOI:10.1016/j.ijcard.2015.05.106 · 6.18 Impact Factor
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    ABSTRACT: In the SAFE-PCI for Women trial, patient preference for radial access for future procedures was greater than for femoral access. We sought to assess whether radial or femoral access impacts formal measures of quality-of-life (QOL) among women undergoing cardiac catheterization.
    American Heart Journal 05/2015; DOI:10.1016/j.ahj.2015.04.024 · 4.56 Impact Factor
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    ABSTRACT: Whether premature dual antiplatelet therapy (DAPT) interruption is safe in patients receiving cobalt chromium everolimus-eluting stents remains controversial. We sought to examine the relationship between DAPT discontinuation and stent thrombosis (ST) after cobalt chromium everolimus-eluting stents. Outcomes from 11 219 patients were pooled from 3 randomized trials and 4 registries with 2-year follow-up period after cobalt chromium everolimus-eluting stent implantation. Rates of definite/probable ST were analyzed according to DAPT discontinuation in the following time intervals: 0 to 30, 30 to 90, 90 to 180, 180 to 365, and 365 to 730 days. Eighty-five cases of ST (0.75%) occurred in 83 patients during 2 years, with 41 (48.2%) events occurring within 30 days. The 2-year ST rate in patients interrupting DAPT at any time was similar to that in patients never interrupting DAPT through 2 years (25/4067 [0.63%] versus 58/7152 [0.83%] respectively; P=0.27]. By propensity and DAPT usage-adjusted multivariable analysis, permanent DAPT discontinuation before 30 days was independently associated with the occurrence of ST (hazard ratio [95% confidence interval], 26.8 [8.4-85.4]; P<0.0001), whereas permanent DAPT discontinuation in any interval after 90 days was not associated with ST. Only 2 ST events occurred after DAPT discontinuation between 30 and 90 days (both between 30 and 60 days), and the association between permanent DAPT discontinuation and ST during this period is unclear (hazard ratio [95% confidence interval], 8.7 [2.0-37.3]; P=0.004 for adjusted analysis and 3.4 [0.8-13.8]; P=0.07 for the unadjusted analysis). In this large pooled experience, permanent DAPT discontinuation before 30 days after cobalt chromium everolimus-eluting stent implantation was strongly associated with ST, whereas DAPT discontinuation beyond 90 days appeared safe. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00180310, NCT00180479, NCT00307047, NCT00402272, NCT00496938, NCT00676520, and NCT00631228. © 2015 American Heart Association, Inc.
    Circulation Cardiovascular Interventions 05/2015; 8(5). DOI:10.1161/CIRCINTERVENTIONS.114.001362 · 6.98 Impact Factor
  • Connie N Hess, Mitchell W Krucoff, Sunil V Rao
    JACC. Cardiovascular Interventions 04/2015; 8(4):639. DOI:10.1016/j.jcin.2015.01.010 · 7.44 Impact Factor
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    ABSTRACT: This white paper provides a summary of presentations and discussions that were held at an Anticoagulant-Induced Bleeding and Reversal Agents Think Tank co-sponsored by the Cardiac Safety Research Consortium and the US Food and Drug Administration (FDA) at the FDA's White Oak Headquarters on April 22, 2014. Attention focused on a development pathway for reversal agents for the novel oral anticoagulants (NOACs). This is important because anticoagulation is still widely underused for stroke prevention in patients with atrial fibrillation. Undertreatment persists, although NOACs, in general, overcome some of the difficulties associated with anticoagulation provided by vitamin K antagonists. One reason for the lack of a wider uptake is the absence of NOAC reversal agents. As there are neither widely accepted academic and industry standards nor a definitive regulatory policy on the development of such reversal agents, this meeting provided a forum for leaders in the fields of cardiovascular clinical trials and cardiovascular safety to discuss the issues and develop recommendations. Attendees included representatives from pharmaceutical companies; regulatory agencies; end point adjudication specialist groups; contract research organizations; and active, academically based physicians. There was wide and solid consensus that NOACs overall offer improvements in convenience, efficacy, and safety compared with warfarin, even without reversal agents. Still, it was broadly accepted that it would be helpful to have reversal agents available for clinicians to use. Because it is not feasible to do definitive outcomes studies demonstrating a reversal agent's clinical benefits, it was felt that these agents could be approved for use in life-threatening bleeding situations if the molecules were well characterized preclinically, their pharmacodynamic and pharmacokinetic profiles were well understood, and showed no harmful adverse events in early human testing. There was also consensus that after such approval, efforts should be made to augment the available clinical information until such time as there is a body of evidence to demonstrate real-world clinical outcomes with the reversal agents. No recommendations were made for more generalized use of these agents in the setting of non-life-threatening situations. This article reflects the views of the authors and should not be construed to represent FDA's views or policies. Copyright © 2015 Elsevier Inc. All rights reserved.
    American Heart Journal 03/2015; 169(6). DOI:10.1016/j.ahj.2015.03.010 · 4.56 Impact Factor
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    ABSTRACT: Background Many patients have symptoms suggestive of coronary artery disease (CAD) and are often evaluated with the use of diagnostic testing, although there are limited data from randomized trials to guide care. Methods We randomly assigned 10,003 symptomatic patients to a strategy of initial anatomical testing with the use of coronary computed tomographic angiography (CTA) or to functional testing (exercise electrocardiography, nuclear stress testing, or stress echocardiography). The composite primary end point was death, myocardial infarction, hospitalization for unstable angina, or major procedural complication. Secondary end points included invasive cardiac catheterization that did not show obstructive CAD and radiation exposure. Results The mean age of the patients was 60.8±8.3 years, 52.7% were women, and 87.7% had chest pain or dyspnea on exertion. The mean pretest likelihood of obstructive CAD was 53.3±21.4%. Over a median follow-up period of 25 months, a primary end-point event occurred in 164 of 4996 patients in the CTA group (3.3%) and in 151 of 5007 (3.0%) in the functional-testing group (adjusted hazard ratio, 1.04; 95% confidence interval, 0.83 to 1.29; P=0.75). CTA was associated with fewer catheterizations showing no obstructive CAD than was functional testing (3.4% vs. 4.3%, P=0.02), although more patients in the CTA group underwent catheterization within 90 days after randomization (12.2% vs. 8.1%). The median cumulative radiation exposure per patient was lower in the CTA group than in the functional-testing group (10.0 mSv vs. 11.3 mSv), but 32.6% of the patients in the functional-testing group had no exposure, so the overall exposure was higher in the CTA group (mean, 12.0 mSv vs. 10.1 mSv; P<0.001). Conclusions In symptomatic patients with suspected CAD who required noninvasive testing, a strategy of initial CTA, as compared with functional testing, did not improve clinical outcomes over a median follow-up of 2 years. (Funded by the National Heart, Lung, and Blood Institute; PROMISE ClinicalTrials.gov number, NCT01174550 .).
    New England Journal of Medicine 03/2015; 372(14). DOI:10.1056/NEJMoa1415516 · 54.42 Impact Factor
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    ABSTRACT: The lack of consistent definitions and nomenclature across clinical trials of novel devices, drugs, or biologics poses a significant barrier to accrual of knowledge in and across peripheral artery disease therapies and technologies. Recognizing this problem, the Peripheral Academic Research Consortium, together with the U.S. Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, has developed a series of pragmatic consensus definitions for patients being treated for peripheral artery disease affecting the lower extremities. These consensus definitions include the clinical presentation, anatomic depiction, interventional outcomes, surrogate imaging and physiological follow-up, and clinical outcomes of patients with lower-extremity peripheral artery disease. Consistent application of these definitions in clinical trials evaluating novel revascularization technologies should result in more efficient regulatory evaluation and best practice guidelines to inform clinical decisions in patients with lower extremity peripheral artery disease. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
    Journal of the American College of Cardiology 03/2015; 65(9):931-941. DOI:10.1016/j.jacc.2014.12.036 · 15.34 Impact Factor
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    ABSTRACT: Circulating levels of cardiac troponin I (cTnI) after ST-segment elevation myocardial infarction (STEMI) are associated with infarct size and chronic left ventricular dysfunction, but the relation to clinical end points and biochemical measures of global cardiac function remains less well defined. One thousand sixty-six patients receiving primary percutaneous coronary intervention (PCI) in the PROTECTION AMI trial were studied in a post hoc analysis. Cardiac troponin I was measured at several time points during the index hospitalization, and patients were followed up for 3 months before reassessment including N-terminal pro-B-type natriuretic peptide (NT-proBNP) and left ventricular ejection fraction (LVEF) measurements. The median (quartile 1-3) cTnI levels were 0.4 (0.1-0.4) μg/L at admission, 33.1 (12.8-72.1) μg/L after 16 to 24 hours, and 9.1 (3.9-17.5) μg/L after 70 to 80 hours. In adjusted models, all post-PCI single points, peak, and area under curve were found to be independently associated with clinical events, NT-proBNP >118 pmol/L, or LVEF <40% (P for all <.001). When cTnI was added to a baseline risk model for prediction of clinical events, the C statistic improved from 0.779 to 0.846 (16-24 hours) and 0.859 (70-80 hours). Quantified by integrated discrimination improvement, the addition of cTnI significantly augmented prediction ability (relative integrated discrimination improvement 44%-154%; P for all ≤.001). Consistent improvements in discrimination of NT-proBNP >118 pmol/L and LVEF <40% were observed. Cardiac troponin I measured after primary PCI for STEMI is independently associated with clinical outcomes and cardiac function through 3-month follow-up. These results suggest that cTnI levels are a useful risk stratification tool in STEMI patients. Copyright © 2014 Elsevier Inc. All rights reserved.
    American Heart Journal 02/2015; 169(2):257-265.e1. DOI:10.1016/j.ahj.2014.10.015 · 4.56 Impact Factor
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    ABSTRACT: Background Dual antiplatelet therapy is recommended after coronary stenting to prevent thrombotic complications, yet the benefits and risks of treatment beyond 1 year are uncertain. Methods Patients were enrolled after they had undergone a coronary stent procedure in which a drug-eluting stent was placed. After 12 months of treatment with a thienopyridine drug (clopidogrel or prasugrel) and aspirin, patients were randomly assigned to continue receiving thienopyridine treatment or to receive placebo for another 18 months; all patients continued receiving aspirin. The coprimary efficacy end points were stent thrombosis and major adverse cardiovascular and cerebrovascular events (a composite of death, myocardial infarction, or stroke) during the period from 12 to 30 months. The primary safety end point was moderate or severe bleeding. Results A total of 9961 patients were randomly assigned to continue thienopyridine treatment or to receive placebo. Continued treatment with thienopyridine, as compared with placebo, reduced the rates of stent thrombosis (0.4% vs. 1.4%; hazard ratio, 0.29 [95% confidence interval {CI}, 0.17 to 0.48]; P<0.001) and major adverse cardiovascular and cerebrovascular events (4.3% vs. 5.9%; hazard ratio, 0.71 [95% CI, 0.59 to 0.85]; P<0.001). The rate of myocardial infarction was lower with thienopyridine treatment than with placebo (2.1% vs. 4.1%; hazard ratio, 0.47; P<0.001). The rate of death from any cause was 2.0% in the group that continued thienopyridine therapy and 1.5% in the placebo group (hazard ratio, 1.36 [95% CI, 1.00 to 1.85]; P=0.05). The rate of moderate or severe bleeding was increased with continued thienopyridine treatment (2.5% vs. 1.6%, P=0.001). An elevated risk of stent thrombosis and myocardial infarction was observed in both groups during the 3 months after discontinuation of thienopyridine treatment. Conclusions Dual antiplatelet therapy beyond 1 year after placement of a drug-eluting stent, as compared with aspirin therapy alone, significantly reduced the risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events but was associated with an increased risk of bleeding. (Funded by a consortium of eight device and drug manufacturers and others; DAPT ClinicalTrials.gov number, NCT00977938 .).
    New England Journal of Medicine 11/2014; DOI:10.1056/NEJMoa1409312 · 54.42 Impact Factor
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    ABSTRACT: Background In the setting of ST segment elevation myocardial infarction (STEMI), timely restoration of normal blood flow is associated with improved myocardial salvage and survival. Despite improvements in door-to-needle and door-to-balloon times, there remains an unmet need with respect to improved symptom-to-door times. A prior report of an implanted device to monitor ST segment deviation demonstrated very short times to reperfusion among patients with an acute coronary syndrome (ACS) with documented thrombotic occlusion. The goal of the ANALYZE ST study is to evaluate the safety and effectiveness of a novel ST segment monitoring feature using an existing implantable cardioverter defibrillator (ICD) among patients with known coronary artery disease (CAD). Methods The ANALYZE ST study is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study enrolling 5,228 patients with newly implanted ICD systems for standard clinical indications who also have a documented history of CAD. Patients will be monitored for 48 months, during which effectiveness of the device for the purpose of early detection of cardiac injury will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to identify clinical acute coronary syndrome events. In addition, the safety of the ST Monitoring Feature will be evaluated through the assessment of the percentage of patients for which monitoring produces a false positive event over the course of 12 months. Conclusions The ANALYZE ST trial is testing the hypothesis that the ST Monitoring Feature in the Fortify® ST ICD system (or other ICD systems with the ST Monitoring Feature) will accurately identify patients with clinical acute coronary syndrome events.
    American Heart Journal 10/2014; 168(4). DOI:10.1016/j.ahj.2014.05.010 · 4.56 Impact Factor
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    ABSTRACT: Although percutaneous coronary intervention with everolimus-eluting stent (EES) implantation for native coronary artery disease has favorable results compared to first-generation drug-eluting stents, outcomes with EES for the treatment of in-stent restenosis (ISR) are unknown.
    The Journal of invasive cardiology 09/2014; 26(9):420-426. DOI:10.1016/j.jacc.2013.08.1198 · 0.82 Impact Factor
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    ABSTRACT: Significant improvements in door-to-balloon times have led to a reduction in mortality in ST-segment elevation myocardial infarction; however, mean symptom-to-door times remain at 2 to 3 hours. An intracardiac electrogram monitoring device may be beneficial in high-risk patients by alerting them to rapidly progressive ST-segment changes indicative of acute coronary occlusion. The Cardiosaver and DETECT phase I clinical studies demonstrated the safety, feasibility, and potential benefit of using an intracardiac electrogram monitoring device to alert the patient to seek medical attention. The goal of the randomized, prospective ALERTS Trial (Clinicaltrials.gov no. NCT00781118) is to evaluate the efficacy of an implantable monitoring device (IMD) in reducing the composite of either cardiac or unexplained death, new Q-wave myocardial infarction, or symptom-to-door time of >2 hours for confirmed thrombotic events. The IMD alerts the patient in real time when ST-segment deviation from a personalized baseline exceeds the trigger threshold. The trial is designed to enroll high-risk post-acute coronary syndrome patients or patients with previous multivessel coronary artery bypass surgery. All patients have the IMD implanted, with 1:1 unblinded randomization to the alerting feature being either turned on versus turned off for the first 6 months. Randomization occurs at the first follow-up visit, 7 to 14 days after the implantation of the IMD. Subjects then return for follow-up visits at months 1, 3, and 6 and thereafter every 6 months until closure of the investigational device exemption. Subjects who cannot be implanted successfully or who have the device explanted are removed from the study and followed up for a minimum of 30 days post-procedure. If a subject experiences a device-related complication and/or adverse experience, the subject is followed up until resolution or until the condition becomes stable and no further change is anticipated.
    American Heart Journal 08/2014; 168(2). DOI:10.1016/j.ahj.2014.05.008 · 4.56 Impact Factor
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    ABSTRACT: OBJECTIVES This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial. BACKGROUND Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear. METHODS Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population. RESULTS The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access. CONCLUSIONS In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (C) 2014 by the American College of Cardiology Foundation.
    JACC Cardiovascular Interventions 08/2014; 7(8):857-67. DOI:10.1016/j.jcin.2014.04.007 · 7.44 Impact Factor
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    ABSTRACT: Establishing epicardial flow with percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) is necessary but not sufficient to ensure nutritive myocardial reperfusion. We evaluated whether adding myocardial blush grade (MBG) and quantitative reperfusion ventricular arrhythmia "bursts" (VABs) surrogates provide a more informative biosignature of optimal reperfusion in patients with Thrombolysis in Myocardial Infarction (TIMI) 3 flow and ST-segment recovery (STR).
    07/2014; 4(1). DOI:10.1177/2048872614532414
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    ABSTRACT: Objectives: The purpose of this study was to evaluate the 1-year clinical outcomes of more complex XIENCE V USA real-world patients with small versus non-small vessel lesions. Background: Patients with small vessel lesions undergoing coronary stent placement are at higher risk of major adverse cardiac events. Improved safety and efficacy of XIENCE V everolimus eluting stents (EES) have been previously demonstrated in selected low-risk small vessel populations in randomized clinical trials. Methods: The XIENCE V USA study was a condition of approval, single-arm study in unselected real-world patients. Baseline and 1-year clinical outcomes were compared between XIENCE V USA patients who received a single 2.5 mm stent (small vessel group, N = 838) and patients implanted with a single > 2.5 mm stent (non-small vessel group, N = 2015). Mean reference vessel diameter was 2.55 + 0.36 and 3.25 + 0.46 mm in the small and non-small vessel groups, respectively (p<0.001). Results: Small vessel group had more females, presented with a higher rate of diabetes, and had more complex lesion characteristics. The definite or probable ST rates analyzed using Kaplan-Meier method were low and not significantly different between the groups at 0.37% and 0.40% for the small and non-small vessel group (p=0.88), respectively. The composite rate of cardiac death or MI was comparable at 4.5% for the small and 5.1% for the non-small vessel 1 groups (p=0.57). The one-year target lesion revascularization rate was also comparable in the small vessel group (3.8% vs 3.0%, p=0.35) Conclusions: Despite gender difference, higher prevalence of diabetes and more complex lesions in the small vessel groups, the 1-year clinical outcomes were similar in both small and non-small vessel groups. These results demonstrate the therapeutic benefit of XIENCE V EES in a real-world all inclusive patient population with small vessel disease. © 2013 Wiley Periodicals, Inc.
    Catheterization and Cardiovascular Interventions 07/2014; 84(1). DOI:10.1002/ccd.25325 · 2.40 Impact Factor
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    ABSTRACT: Background Suspected coronary artery disease (CAD) is one of the most common, potentially life threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. Methods The PROMISE study is a prospective, randomized trial comparing the effectiveness of two initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either: 1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram); or 2) anatomic testing with >=64 slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core lab quality and completeness assessment. All subjects are followed for ≥1 year. The primary end-point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis and renal failure) or hospitalization for unstable angina. Results Over 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care and anesthesiology sites. Conclusion Multi-specialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. PROMISE will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomic testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost effectiveness and radiation exposure will be assessed.
    American Heart Journal 06/2014; 167(6). DOI:10.1016/j.ahj.2014.03.003 · 4.56 Impact Factor
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    ABSTRACT: Delcasertib is a selective inhibitor of delta-protein kinase C (delta-PKC), which reduced infarct size during ischaemia/reperfusion in animal models and diminished myocardial necrosis and improved reperfusion in a pilot study during primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI). A multicentre, double-blind trial was performed in patients presenting within 6 h and undergoing primary PCI for anterior (the primary analysis cohort, n = 1010 patients) or inferior (an exploratory cohort, capped at 166 patients) STEMI. Patients with anterior STEMI were randomized to placebo or one of three doses of delcasertib (50, 150, or 450 mg/h) by intravenous infusion initiated before PCI and continued for ∼2.5 h. There were no differences between treatment groups in the primary efficacy endpoint of infarct size measured by creatine kinase MB fraction area under the curve (AUC) (median 5156, 5043, 4419, and 5253 ng h/mL in the placebo, delcasertib 50, 150, and 450 mg/mL groups, respectively) in the anterior STEMI cohort. No treatment-related differences were seen in secondary endpoints of infarct size, electrocardiographic ST-segment recovery AUC or time to stable ST recovery, or left ventricular ejection fraction at 3 months. No differences in rates of adjudicated clinical endpoints (death, heart failure, or serious ventricular arrhythmias) were observed. Selective inhibition of delta-PKC with intravenous infusion of delcasertib during PCI for acute STEMI in a population of patients treated according to contemporary standard of care did not reduce biomarkers of myocardial injury. ClinicalTrials.gov Identifier: NCT00785954.
    European Heart Journal 05/2014; 35(37). DOI:10.1093/eurheartj/ehu177 · 14.72 Impact Factor
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    ABSTRACT: The annual cost of heart failure (HF) is estimated at $39.2 billion. This has been acknowledged to underestimate the true costs for care. The objective of this analysis is to more accurately assess these costs. Publicly available data sources were used. Cost calculations incorporated relevant factors such as Medicare hospital cost-to-charge ratios, reimbursement from both government and private insurance, and out-of-pocket expenditures. A recently published Atherosclerosis Risk in Communities (ARIC) HF scheme was used to adjust the HF classification scheme. Costs were calculated with HF as the primary diagnosis (HF in isolation, or HFI) or HF as one of the diagnoses/part of a disease milieu (HF syndrome, or HFS). Total direct costs for HF were calculated at $60.2 billion (HFI) and $115.4 billion (HFS). Indirect costs were $10.6 billion for both. Costs attributable to HF may represent a much larger burden to US health care than what is commonly referenced. These revised and increased costs have implications for policy makers.
    Clinical Cardiology 05/2014; 37(5):312-21. DOI:10.1002/clc.22260 · 2.23 Impact Factor
  • Drew Leder, Mitchell W Krucoff
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    ABSTRACT: Abstract The pharmaceutical industry has undergone a vast expansion in the 20th and 21st centuries. This article explores the central role now played by pills in clinical practice, but also in the public imagination. First, this article analyzes four properties that, together, account for many of the promises and perils associated with pills: They are ingestible, potent, reproducible, and miniaturized. This allows them to serve as ideal consumer items for widespread distribution and sale and also as model technological "devices" capable of downloading into the body healing chemicals. As such, they seem to promise a disburdening solution to many of life's ills. In our cultural fantasy, often shared by physician and patient alike, pills can be used not only to treat and prevent disease but also raise energy, lose weight, lessen pain, lift mood, cope with stress, and enhance sexual and athletic performance. This article also explores many adverse effects not only of pills themselves but of this exaggerated cultural fantasy of the pill. It tends to distract us from other, more holistic understandings of the locus of disease and healing. It even fosters misunderstandings of the ways in which pills themselves work, which is to assist bodily processes, and the mind's "meaning response." The intent here is not to demonize all pills-many have great therapeutic potential-but to learn how to better choose and use them wisely. We propose that this process be assisted through recontextualizing the pill as a multidimensional gift. Taken in such a way, with appropriate gratitude and discernment, we may ingest fewer pills, but with greater efficacy.
    Journal of alternative and complementary medicine (New York, N.Y.) 04/2014; 20(6). DOI:10.1089/acm.2013.0447 · 1.52 Impact Factor
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    ABSTRACT: Adoption of TRI in the United States is low and may be related to challenges learning the technique. We examined the relationships between operator transradial percutaneous coronary intervention (TRI) volume and procedural metrics and outcomes. We used CathPCI Registry® data from 07/2009-12/2012 to identify new radial operators, defined by an exclusively femoral PCI approach for 6 months after their first PCI in the database and ≥15 total TRIs thereafter. Primary outcomes of fluoroscopy time, contrast volume, and procedure success were chosen as markers of technical proficiency. Secondary outcomes included in-hospital mortality, bleeding, and vascular complications. Adjusted outcomes were analyzed using operator TRI experience as a continuous variable with generalized linear mixed models. Among 54,561 TRI procedures performed at 704 sites, 942 operators performed 1-10 cases; 942 operators performed 11-50 cases; 375 operators performed 51-100 cases; and 148 operators performed 101-200 cases. As radial caseload increased, more TRIs were performed in women, in STEMI patients, and for emergency indications. Decreased fluoroscopy time and contrast use were non-linearly associated with greater operator TRI experience, with faster reductions observed for newer (<30-50 cases) compared with more experienced (>30-50 cases) operators. Procedure success was high, while mortality, bleeding, and vascular complications remained low across TRI volumes. As operator TRI volume increases, higher risk patients are chosen for TRI. Despite this, operator proficiency improves with greater TRI experience, and safety is maintained. The threshold to overcome the learning curve appears to be approximately 30-50 cases.
    Circulation 04/2014; 131(8). DOI:10.1161/CIRCULATIONAHA.113.006356 · 14.95 Impact Factor

Publication Stats

7k Citations
2,087.38 Total Impact Points

Institutions

  • 1996–2015
    • Duke University
      • Department of Medicine
      Durham, North Carolina, United States
  • 1988–2015
    • Duke University Medical Center
      • • Duke Clinical Research Institute
      • • Division of Cardiology
      • • Department of Medicine
      Durham, North Carolina, United States
    • University of California, Los Angeles
      Los Ángeles, California, United States
  • 2001–2014
    • North Carolina Clinical Research
      Raleigh, North Carolina, United States
    • University of Santiago, Chile
      CiudadSantiago, Santiago Metropolitan, Chile
  • 2013
    • Thomas Jefferson University
      Filadelfia, Pennsylvania, United States
  • 2012
    • Erasmus Universiteit Rotterdam
      Rotterdam, South Holland, Netherlands
  • 2011
    • Stony Brook University Hospital
      Stony Brook, New York, United States
  • 2008–2011
    • Loyola University Maryland
      • Department of Philosophy
      Baltimore, MD, United States
  • 2005–2011
    • Columbia University
      • Division of Cardiology
      New York, New York, United States
    • Sahlgrenska University Hospital
      • Department of Cardiology
      Goeteborg, Västra Götaland, Sweden
  • 2009
    • University of North Carolina at Chapel Hill
      North Carolina, United States
    • Hackensack University Medical Center
      Hackensack, New Jersey, United States
  • 2004
    • Brigham and Women's Hospital
      • TIMI Study Group
      Boston, MA, United States
  • 1999–2004
    • University of California, San Francisco
      • • Department of Physiological Nursing
      • • School of Nursing
      San Francisco, CA, United States
    • Pontifical Catholic University of Chile
      • División Enfermedades Cardiovasculares
      CiudadSantiago, Santiago Metropolitan, Chile
  • 2002
    • Henry Ford Hospital
      Detroit, Michigan, United States
  • 1986–1991
    • Georgetown University
      • Division of Cardiology
      Washington, Washington, D.C., United States