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C-reactive protein and clinical outcomes in patients with COVID-19

Smilowitz, Nathaniel R; Kunichoff, Dennis; Garshick, Michael; Shah, Binita; Pillinger, Michael; Hochman, Judith S; Berger, Jeffrey S
BACKGROUND:A systemic inflammatory response is observed in coronavirus disease 2019 (COVID-19). Elevated serum levels of C-reactive protein (CRP), a marker of systemic inflammation, are associated with severe disease in bacterial or viral infections. We aimed to explore associations between CRP concentration at initial hospital presentation and clinical outcomes in patients with COVID-19. METHODS AND RESULTS/RESULTS:Consecutive adults aged ≥18 years with COVID-19 admitted to a large New York healthcare system between 1 March and 8 April 2020 were identified. Patients with measurement of CRP were included. Venous thrombo-embolism (VTE), acute kidney injury (AKI), critical illness, and in-hospital mortality were determined for all patients. Among 2782 patients hospitalized with COVID-19, 2601 (93.5%) had a CRP measurement [median 108 mg/L, interquartile range (IQR) 53-169]. CRP concentrations above the median value were associated with VTE [8.3% vs. 3.4%; adjusted odds ratio (aOR) 2.33, 95% confidence interval (CI) 1.61-3.36], AKI (43.0% vs. 28.4%; aOR 2.11, 95% CI 1.76-2.52), critical illness (47.6% vs. 25.9%; aOR 2.83, 95% CI 2.37-3.37), and mortality (32.2% vs. 17.8%; aOR 2.59, 95% CI 2.11-3.18), compared with CRP below the median. A dose response was observed between CRP concentration and adverse outcomes. While the associations between CRP and adverse outcomes were consistent among patients with low and high D-dimer levels, patients with high D-dimer and high CRP have the greatest risk of adverse outcomes. CONCLUSIONS:Systemic inflammation, as measured by CRP, is strongly associated with VTE, AKI, critical illness, and mortality in COVID-19. CRP-based approaches to risk stratification and treatment should be tested.
PMID: 33448289
ISSN: 1522-9645
CID: 4785432

Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial

Tardif, Jean-Claude; Bouabdallaoui, Nadia; L'Allier, Philippe L; Gaudet, Daniel; Shah, Binita; Pillinger, Michael H; Lopez-Sendon, Jose; da Luz, Protasio; Verret, Lucie; Audet, Sylvia; Dupuis, Jocelyn; Denault, André; Pelletier, Martin; Tessier, Philippe A; Samson, Sarah; Fortin, Denis; Tardif, Jean-Daniel; Busseuil, David; Goulet, Elisabeth; Lacoste, Chantal; Dubois, Anick; Joshi, Avni Y; Waters, David D; Hsue, Priscilla; Lepor, Norman E; Lesage, Frédéric; Sainturet, Nicolas; Roy-Clavel, Eve; Bassevitch, Zohar; Orfanos, Andreas; Stamatescu, Gabriela; Grégoire, Jean C; Busque, Lambert; Lavallée, Christian; Hétu, Pierre-Olivier; Paquette, Jean-Sébastien; Deftereos, Spyridon G; Levesque, Sylvie; Cossette, Mariève; Nozza, Anna; Chabot-Blanchet, Malorie; Dubé, Marie-Pierre; Guertin, Marie-Claude; Boivin, Guy
BACKGROUND:Evidence suggests a role for excessive inflammation in COVID-19 complications. Colchicine is an oral anti-inflammatory medication beneficial in gout, pericarditis, and coronary disease. We aimed to investigate the effect of colchicine on the composite of COVID-19-related death or hospital admission. METHODS:The present study is a phase 3, randomised, double-blind, adaptive, placebo-controlled, multicentre trial. The study was done in Brazil, Canada, Greece, South Africa, Spain, and the USA, and was led by the Montreal Heart Institute. Patients with COVID-19 diagnosed by PCR testing or clinical criteria who were not being treated in hospital were eligible if they were at least 40 years old and had at least one high-risk characteristic. The randomisation list was computer-generated by an unmasked biostatistician, and masked randomisation was centralised and done electronically through an automated interactive web-response system. The allocation sequence was unstratified and used a 1:1 ratio with a blocking schema and block sizes of six. Patients were randomly assigned to receive orally administered colchicine (0·5 mg twice per day for 3 days and then once per day for 27 days thereafter) or matching placebo. The primary efficacy endpoint was the composite of death or hospital admission for COVID-19. Vital status at the end of the study was available for 97·9% of patients. The analyses were done according to the intention-to-treat principle. The COLCORONA trial is registered with (NCT04322682) and is now closed to new participants. FINDINGS/RESULTS:Trial enrolment began in March 23, 2020, and was completed in Dec 22, 2020. A total of 4488 patients (53·9% women; median age 54·0 years, IQR 47·0-61·0) were enrolled and 2235 patients were randomly assigned to colchicine and 2253 to placebo. The primary endpoint occurred in 104 (4·7%) of 2235 patients in the colchicine group and 131 (5·8%) of 2253 patients in the placebo group (odds ratio [OR] 0·79, 95·1% CI 0·61-1·03; p=0·081). Among the 4159 patients with PCR-confirmed COVID-19, the primary endpoint occurred in 96 (4·6%) of 2075 patients in the colchicine group and 126 (6·0%) of 2084 patients in the placebo group (OR 0·75, 0·57-0·99; p=0·042). Serious adverse events were reported in 108 (4·9%) of 2195 patients in the colchicine group and 139 (6·3%) of 2217 patients in the placebo group (p=0·051); pneumonia occurred in 63 (2·9%) of 2195 patients in the colchicine group and 92 (4·1%) of 2217 patients in the placebo group (p=0·021). Diarrhoea was reported in 300 (13·7%) of 2195 patients in the colchicine group and 161 (7·3%) of 2217 patients in the placebo group (p<0·0001). INTERPRETATION/CONCLUSIONS:In community-treated patients including those without a mandatory diagnostic test, the effect of colchicine on COVID-19-related clinical events was not statistically significant. Among patients with PCR-confirmed COVID-19, colchicine led to a lower rate of the composite of death or hospital admission than placebo. Given the absence of orally administered therapies to prevent COVID-19 complications in community-treated patients and the benefit of colchicine in patients with PCR-proven COVID-19, this safe and inexpensive anti-inflammatory agent could be considered for use in those at risk of complications. Notwithstanding these considerations, replication in other studies of PCR-positive community-treated patients is recommended. FUNDING/BACKGROUND:The Government of Quebec, the Bill & Melinda Gates Foundation, the National Heart, Lung, and Blood Institute of the US National Institutes of Health, the Montreal Heart Institute Foundation, the NYU Grossman School of Medicine, the Rudin Family Foundation, and philanthropist Sophie Desmarais.
PMID: 34051877
ISSN: 2213-2619
CID: 4890652

Long-term dietary and weight changes following a short-term dietary intervention study: EVADE-CAD trial follow-up

Dogra, Siddhant; Woolf, Kathleen; Xia, Yuhe; Getz, Alec; Newman, Jonathan D; Slater, James; Shah, Binita
PMID: 34010190
ISSN: 1473-5830
CID: 4908372

Factors associated with participation in a short-term dietary intervention study among patients with established coronary artery disease: insights from the EVADE CAD trial

Rubinfeld, Gregory; Driggin, Elissa; Woolf, Kathleen; Slater, James; Newman, Jonathan D; Heffron, Sean; Shah, Binita
PMID: 32639244
ISSN: 1473-5830
CID: 4552562

COVID-19 complicated by acute myocardial infarction with extensive thrombus burden and cardiogenic shock [Case Report]

Harari, Rafael; Bangalore, Sripal; Chang, Ernest; Shah, Binita
A patient with coronavirus disease 19 (COVID-19) developed acute myocardial infarction (AMI) complicated by extensive coronary thrombosis and cardiogenic shock. She underwent percutaneous coronary intervention and placement of a mechanical circulatory support device but subsequently died from shock. This report illustrates the challenges in managing patients with COVID-19, AMI, and cardiogenic shock.
PMID: 32427416
ISSN: 1522-726x
CID: 4444142

Incidence, Predictors, and Outcomes of Acute Kidney Injury in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology National Cardiovascular Data Registry-Transcatheter Valve Therapy Registry

Julien, Howard M; Stebbins, Amanda; Vemulapalli, Sreekanth; Nathan, Ashwin S; Eneanya, Nwamaka D; Groeneveld, Peter; Fiorilli, Paul N; Herrmann, Howard C; Szeto, Wilson Y; Desai, Nimesh D; Anwaruddin, Saif; Vora, Amit; Shah, Binita; Ng, Vivian G; Kumbhani, Dharam J; Giri, Jay
[Figure: see text].
PMID: 33877860
ISSN: 1941-7632
CID: 4889112

Risk of thrombotic events after respiratory infection requiring hospitalization

Smilowitz, Nathaniel R; Subashchandran, Varun; Newman, Jonathan; Barfield, Michael E; Maldonado, Thomas S; Brosnahan, Shari B; Yuriditsky, Eugene; Horowitz, James M; Shah, Binita; Reynolds, Harmony R; Hochman, Judith S; Berger, Jeffrey S
Thrombosis is a major concern in respiratory infections. Our aim was to investigate the magnitude and duration of risk for arterial and venous thrombosis following discharge after respiratory infection. Patients with respiratory infections were identified using the United States Nationwide Readmission Database from 2012 to 2014. Patients admitted with asthma or cellulitis served as comparators. Readmissions for acute myocardial infarction (MI) and venous thromboembolism (VTE) were evaluated at 30 to 180 days. The likelihood of a first thrombotic event after discharge was compared with a 30-day period prior to hospitalization. Among 5,271,068 patients discharged after a respiratory infection, 0.56% and 0.78% were readmitted within 30-days with MI and VTE, respectively. Relative to asthma and cellulitis, respiratory infection was associated with a greater age and sex-adjusted hazard of 30-day readmission for MI (adjusted HR [aHR] 1.48 [95% CI 1.42-1.54] vs. asthma; aHR 1.36 [95% CI 1.31-1.41] vs. cellulitis) and VTE (aHR 1.28 [95% CI 1.24-1.33] vs. asthma; aHR 1.26, [95% CI 1.22-1.30] vs. cellulitis). Risks of MI and VTE attenuated over time. In a crossover-cohort analysis, the odds of MI (OR 1.68 [95% CI 1.62-1.73]) and VTE (OR 3.30 [95% 3.19-3.41]) were higher in the 30 days following discharge after respiratory infection than during the 30-day baseline period. Hospitalization for respiratory infection was associated with increased risks of thrombosis that were highest in the first 30-days after discharge and declined over time.
PMID: 33602977
ISSN: 2045-2322
CID: 4787172

Coronary Optical Coherence Tomography and Cardiac Magnetic Resonance Imaging to Determine Underlying Causes of MINOCA in Women

Reynolds, Harmony R; Maehara, Akiko; Kwong, Raymond Y; Sedlak, Tara; Saw, Jacqueline; Smilowitz, Nathaniel R; Mahmud, Ehtisham; Wei, Janet; Marzo, Kevin; Matsumura, Mitsuaki; Seno, Ayako; Hausvater, Anais; Giesler, Caitlin; Jhalani, Nisha; Toma, Catalin; Har, Bryan; Thomas, Dwithiya; Mehta, Laxmi S; Trost, Jeffrey; Mehta, Puja K; Ahmed, Bina; Bainey, Kevin R; Xia, Yuhe; Shah, Binita; Attubato, Michael; Bangalore, Sripal; Razzouk, Louai; Ali, Ziad A; Bairey-Merz, C Noel; Park, Ki; Hada, Ellen; Zhong, Hua; Hochman, Judith S
Background: Myocardial infarction with non-obstructive coronary arteries (MINOCA) occurs in 6-15% of MI and disproportionately affects women. Scientific statements recommend multi-modality imaging in MINOCA to define the underlying cause. We performed coronary optical coherence tomography (OCT) and cardiac magnetic resonance imaging (CMR) to assess mechanisms of MINOCA. Methods: In this prospective, multicenter, international, observational study, we enrolled women with a clinical diagnosis of MI. If invasive coronary angiography revealed <50% stenosis in all major arteries, multi-vessel OCT was performed, followed by CMR (cine imaging, late gadolinium enhancement, and T2-weighted imaging and/or T1 mapping). Angiography, OCT, and CMR were evaluated at blinded, independent core laboratories. Culprit lesions identified by OCT were classified as definite or possible. The CMR core laboratory identified ischemia-related and non-ischemic myocardial injury. Imaging results were combined to determine the mechanism of MINOCA, when possible. Results: Among 301 women enrolled at 16 sites, 170 were diagnosed with MINOCA, of whom 145 had adequate OCT image quality for analysis; 116 of these underwent CMR. A definite or possible culprit lesion was identified by OCT in 46.2% (67/145) of participants, most commonly plaque rupture, intra-plaque cavity or layered plaque. CMR was abnormal in 74.1% (86/116) of participants. An ischemic pattern of CMR abnormalities (infarction or myocardial edema in a coronary territory) was present in 53.4% of participants undergoing CMR (62/116). A non-ischemic pattern of CMR abnormalities (myocarditis, takotsubo syndrome or non-ischemic cardiomyopathy) was present in 20.7% (24/116). A cause of MINOCA was identified in 84.5% of the women with multi-modality imaging (98/116), higher than with OCT alone (p<0.001) or CMR alone (p=0.001). An ischemic etiology was identified in 63.8% of women with MINOCA (74/116), a non-ischemic etiology was identified in 20.7% (24/116), and no mechanism was identified in 15.5% (18/116). Conclusions: Multi-modality imaging with coronary OCT and CMR identified potential mechanisms in 84.5% of women with a diagnosis of MINOCA, three-quarters of which were ischemic and one-quarter of which were non-ischemic, alternate diagnoses to MI. Identification of the etiology of MINOCA is feasible and has the potential to guide medical therapy for secondary prevention. Clinical Trial Registration: URL: Unique Identifier: NCT02905357.
PMID: 33191769
ISSN: 1524-4539
CID: 4672212

Response to: 'Correspondence on 'Anti-inflammatory therapy for COVID-19 infection: the case for colchicine'' by Perricone et al

Shah, Binita; Reyes, Aaron Z; Hu, Kelly A; Teperman, Jacob; Wampler Muskardin, Theresa L; Tardif, Jean-Claude; Pillinger, Michael H
PMID: 33509798
ISSN: 1468-2060
CID: 4767552

Cost of coronary syndrome treated with percutaneous coronary intervention and 30-day unplanned readmission in the United States

Kwok, Chun Shing; Amin, Amit P; Shah, Binita; Kinnaird, Tim; Alkutshan, Raed; Balghith, Muhammad; Ratib, Karim; Nolan, James; Bagur, Rodrigo; Mamas, Mamas A
OBJECTIVES/OBJECTIVE:This study aimed to examine the cost of coronary syndrome treated with percutaneous coronary intervention (PCI) and 30-day unplanned readmissions. BACKGROUND:There is limited understanding of the hospital cost of index PCI and 30-day unplanned readmissions. METHODS:Patients undergoing PCI between 2010 and 2014 in the U.S. Nationwide Readmission Database were included. The primary outcome was total cost defined by cost of index PCI and first unplanned readmission within 30 days. RESULTS:This analysis included 2,294,244 patients who underwent PCI, and the mean cost was $23,541 ± $20,730 (~$10.8 billion/year). There was a modest increase in cost over the study years of 17.5%. Of the 9.4% with an unplanned readmission within 30 days, the mean total cost was $35,333 ± 24,230 versus $22,323 ± 19,941 for those not readmitted. The variables most strongly associated with the highest quartile of cost were heart failure (adjusted odds ratio (aOR) 25.60 [95% CI 21.59-30.35]), need for circulatory support (aOR 11.62 [10.13-13.32]), periprocedural coronary artery bypass graft (CABG, aOR 585.08 [357.85-956.58]), and readmission within 30 days (aOR 24.49 [22.40-26.77]). An acute kidney injury (AKI; 8.5%), major bleed (0.8%), vascular injury (0.8%), or need for periprodedural CABG (1.4%) had an average increased cost of $21,935; $30,898; $27,875; and $43,005, respectively, compared to PCI without adverse outcome. CONCLUSIONS:The annual 30-day hospital cost of PCI is approximately $10.8 billion, and the costs associated with in-hospital adverse events, particularly the need for AKI and periprocedural CABG, were significant.
PMID: 31876371
ISSN: 1522-726x
CID: 4268512