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1. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19

Author

Goligher, Ewan C, Bradbury, Charlotte A, McVerry, Bryan J, Lawler, Patrick R, Berger, Jeffrey S, Gong, Michelle N, Carrier, Marc, Reynolds, Harmony R, Kumar, Anand, Turgeon, Alexis F, Kornblith, Lucy Z, Kahn, Susan R, Marshall, John C, Kim, Keri S, Houston, Brett L, Derde, Lennie PG, Cushman, Mary, Tritschler, Tobias, Angus, Derek C, Godoy, Lucas C, McQuilten, Zoe, Kirwan, Bridget-Anne, Farkouh, Michael E, Brooks, Maria M, Lewis, Roger J, Berry, Lindsay R, Lorenzi, Elizabeth, Gordon, Anthony C, Ahuja, Tania, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Contreras, Aira, Costantini, Todd W, de Brouwer, Sophie, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Eng, Heather F, Escobedo, Jorge, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Froess, Joshua D, Fu, Zhuxuan, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, Girard, Timothy D, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Haniffa, Rashan, Hegde, Sheila M, Hendrickson, Carolyn M, Higgins, Alisa M, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Huang, David T, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei, King, Andrew J, Knudson, M Margaret, Kornblith, Aaron E, Kutcher, Matthew E, Laffan, Michael A, Lamontagne, Francois, and Le Gal, Grégoire

Subjects
Clinical Trials and Supportive Activities, Clinical Research, Comparative Effectiveness Research, Cardiovascular, Good Health and Well Being, Aged, Anticoagulants, COVID-19, Critical Illness, Female, Hemorrhage, Heparin, Hospital Mortality, Humans, Logistic Models, Male, Middle Aged, Odds Ratio, Respiration, Artificial, Thrombosis, Treatment Failure, COVID-19 Drug Treatment, REMAP-CAP Investigators, ACTIV-4a Investigators, ATTACC Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19.MethodsIn an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge.ResultsThe trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio

Published
2021

2. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19

Author

Lawler, Patrick R, Goligher, Ewan C, Berger, Jeffrey S, Neal, Matthew D, McVerry, Bryan J, Nicolau, Jose C, Gong, Michelle N, Carrier, Marc, Rosenson, Robert S, Reynolds, Harmony R, Turgeon, Alexis F, Escobedo, Jorge, Huang, David T, Bradbury, Charlotte A, Houston, Brett L, Kornblith, Lucy Z, Kumar, Anand, Kahn, Susan R, Cushman, Mary, McQuilten, Zoe, Slutsky, Arthur S, Kim, Keri S, Gordon, Anthony C, Kirwan, Bridget-Anne, Brooks, Maria M, Higgins, Alisa M, Lewis, Roger J, Lorenzi, Elizabeth, Berry, Scott M, Berry, Lindsay R, Aday, Aaron W, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Costantini, Todd W, de Brouwer, Sophie, Derde, Lennie PG, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, García-Madrona, Sebastian, Girard, Timothy D, Godoy, Lucas C, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Hamburg, Naomi M, Haniffa, Rashan, Hanna, George, Hanna, Nicholas, Hegde, Sheila M, Hendrickson, Carolyn M, Hite, R Duncan, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Iyer, Vivek N, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei L, King, Andrew J, Knudson, M Margaret, Kornblith, Aaron E, and Krishnan, Vidya

Subjects
Cardiovascular, Clinical Trials and Supportive Activities, Clinical Research, Hematology, Transplantation, Good Health and Well Being, Adult, Aged, Anticoagulants, COVID-19, Female, Hemorrhage, Heparin, Heparin, Low-Molecular-Weight, Hospital Mortality, Humans, Male, Middle Aged, Survival Analysis, Thrombosis, COVID-19 Drug Treatment, ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.MethodsIn this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care-level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level.ResultsThe trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support-free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis.ConclusionsIn noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589, NCT04505774, NCT04359277, and NCT02735707.).

Published
2021

3. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19.

Author

REMAP-CAP Investigators, ACTIV-4a Investigators, ATTACC Investigators, Goligher, Ewan C, Bradbury, Charlotte A, McVerry, Bryan J, Lawler, Patrick R, Berger, Jeffrey S, Gong, Michelle N, Carrier, Marc, Reynolds, Harmony R, Kumar, Anand, Turgeon, Alexis F, Kornblith, Lucy Z, Kahn, Susan R, Marshall, John C, Kim, Keri S, Houston, Brett L, Derde, Lennie PG, Cushman, Mary, Tritschler, Tobias, Angus, Derek C, Godoy, Lucas C, McQuilten, Zoe, Kirwan, Bridget-Anne, Farkouh, Michael E, Brooks, Maria M, Lewis, Roger J, Berry, Lindsay R, Lorenzi, Elizabeth, Gordon, Anthony C, Ahuja, Tania, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Contreras, Aira, Costantini, Todd W, de Brouwer, Sophie, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Eng, Heather F, Escobedo, Jorge, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Froess, Joshua D, Fu, Zhuxuan, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, Girard, Timothy D, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Haniffa, Rashan, Hegde, Sheila M, Hendrickson, Carolyn M, Higgins, Alisa M, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Huang, David T, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei, King, Andrew J, Knudson, M Margaret, Kornblith, Aaron E, and Kutcher, Matthew E

Subjects
REMAP-CAP Investigators, ACTIV-4a Investigators, ATTACC Investigators, Humans, Thrombosis, Critical Illness, Hemorrhage, Heparin, Anticoagulants, Treatment Failure, Respiration, Artificial, Hospital Mortality, Logistic Models, Odds Ratio, Aged, Middle Aged, Female, Male, COVID-19, Clinical Research, Cardiovascular, Clinical Trials and Supportive Activities, Comparative Effectiveness Research, General & Internal Medicine, Medical and Health Sciences
Abstract

BackgroundThrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19.MethodsIn an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge.ResultsThe trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio

Published
2021

4. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19.

Author

ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Lawler, Patrick R, Goligher, Ewan C, Berger, Jeffrey S, Neal, Matthew D, McVerry, Bryan J, Nicolau, Jose C, Gong, Michelle N, Carrier, Marc, Rosenson, Robert S, Reynolds, Harmony R, Turgeon, Alexis F, Escobedo, Jorge, Huang, David T, Bradbury, Charlotte A, Houston, Brett L, Kornblith, Lucy Z, Kumar, Anand, Kahn, Susan R, Cushman, Mary, McQuilten, Zoe, Slutsky, Arthur S, Kim, Keri S, Gordon, Anthony C, Kirwan, Bridget-Anne, Brooks, Maria M, Higgins, Alisa M, Lewis, Roger J, Lorenzi, Elizabeth, Berry, Scott M, Berry, Lindsay R, Aday, Aaron W, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Costantini, Todd W, de Brouwer, Sophie, Derde, Lennie PG, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, García-Madrona, Sebastian, Girard, Timothy D, Godoy, Lucas C, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Hamburg, Naomi M, Haniffa, Rashan, Hanna, George, Hanna, Nicholas, Hegde, Sheila M, Hendrickson, Carolyn M, Hite, R Duncan, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Iyer, Vivek N, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei L, and King, Andrew J

Subjects
ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Humans, Thrombosis, Hemorrhage, Heparin, Heparin, Low-Molecular-Weight, Anticoagulants, Hospital Mortality, Survival Analysis, Adult, Aged, Middle Aged, Female, Male, COVID-19, Hematology, Clinical Trials and Supportive Activities, Transplantation, Clinical Research, Cardiovascular, General & Internal Medicine, Medical and Health Sciences
Abstract

BackgroundThrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.MethodsIn this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care-level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level.ResultsThe trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support-free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis.ConclusionsIn noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589, NCT04505774, NCT04359277, and NCT02735707.).

Published
2021

6. The association of race and COVID-19 mortality

Author

Golestaneh, Ladan, Neugarten, Joel, Fisher, Molly, Billett, Henny H, Gil, Morayma Reyes, Johns, Tanya, Yunes, Milagros, Mokrzycki, Michele H, Coco, Maria, Norris, Keith C, Perez, Hector R, Scott, Shani, Kim, Ryung S, and Bellin, Eran

Subjects
Epidemiology, Public Health, Health Sciences, Emerging Infectious Diseases, Clinical Research, Coronaviruses, Social Determinants of Health, Infectious Diseases, Good Health and Well Being, Race, Covid, Mortality, Hospitalization, Disparity, Clinical sciences, Health services and systems, Public health
Abstract

BackgroundCOVID-19 mortality disproportionately affects the Black population in the United States (US). To explore this association a cohort study was undertaken.MethodsWe assembled a cohort of 505,992 patients receiving ambulatory care at Bronx Montefiore Health System (BMHS) between 1/1/18 and 1/1/20 to evaluate the relative risk of hospitalization and death in two time-periods, the pre-COVID time-period (1/1/20-2/15/20) and COVID time-period (3/1/20-4/15/20). COVID testing, hospitalization and mortality were determined with the Black and Hispanic patient population compared separately to the White population using logistic modeling. Evaluation of the interaction of pre-COVID and COVID time periods and race, with respect to mortality was completed.FindingsA total of 9,286/505,992 (1.8%) patients were hospitalized during either or both pre-COVID or COVID periods. Compared to Whites the relative risk of hospitalization of Black patients did not increase in the COVID period (p for interaction=0.12). In the pre- COVID period, compared to Whites, the odds of death for Blacks and Hispanics adjusted for comorbidity was statistically equivalent. In the COVID period compared to Whites the adjusted odds of death for Blacks was 1.6 (95% CI 1.2-2.0, p = 0.001). There was a significant increase in Black mortality risk from pre-COVID to COVID periods (p for interaction=0.02). Adjustment for relevant clinical and social indices attenuated but did not fully explain the observed difference in Black mortality.InterpretationThe BMHS COVID experience demonstrates that Blacks do have a higher mortality with COVID incompletely explained by age, multiple reported comorbidities and available metrics of sociodemographic disparity.FundingN/A.

Published
2020

7. Voxelotor for Sickle Cell Disease: Initial Report from the Real-world PROSPECT Study

Author

Shah, Nirmish, primary, Andemariam, Biree, additional, Billett, Henny H, additional, Ershler, William B, additional, Bergmann, Shayla, additional, Sakhalkar, Vishwas S, additional, Xu, Michelle, additional, Chang, Alicia, additional, Desai, Payal C, additional, Pennington, Sharon, additional, Miller, Robin, additional, De Castro, Laura M, additional, Hayward, Brooke, additional, Yu, Ching-Ray, additional, and Liles, Darla K K, additional

Published
2024
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11. A Pharmacogenetic versus a Clinical Algorithm for Warfarin Dosing

Author

Kimmel, Stephen E, French, Benjamin, Kasner, Scott E, Johnson, Julie A, Anderson, Jeffrey L, Gage, Brian F, Rosenberg, Yves D, Eby, Charles S, Madigan, Rosemary A, McBane, Robert B, Abdel-Rahman, Sherif Z, Stevens, Scott M, Yale, Steven, Mohler, Emile R, Fang, Margaret C, Shah, Vinay, Horenstein, Richard B, Limdi, Nita A, Muldowney, James AS, Gujral, Jaspal, Delafontaine, Patrice, Desnick, Robert J, Ortel, Thomas L, Billett, Henny H, Pendleton, Robert C, Geller, Nancy L, Halperin, Jonathan L, Goldhaber, Samuel Z, Caldwell, Michael D, Califf, Robert M, and Ellenberg, Jonas H

Subjects
Hematology, Genetics, Clinical Research, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, Development of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 5.1 Pharmaceuticals, Adult, Aged, Algorithms, Anticoagulants, Aryl Hydrocarbon Hydroxylases, Cytochrome P-450 CYP2C9, Double-Blind Method, Female, Follow-Up Studies, Genotype, Hemorrhage, Humans, International Normalized Ratio, Male, Pharmacogenetics, Thromboembolism, Treatment Failure, Vitamin K Epoxide Reductases, Warfarin, COAG Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThe clinical utility of genotype-guided (pharmacogenetically based) dosing of warfarin has been tested only in small clinical trials or observational studies, with equivocal results.MethodsWe randomly assigned 1015 patients to receive doses of warfarin during the first 5 days of therapy that were determined according to a dosing algorithm that included both clinical variables and genotype data or to one that included clinical variables only. All patients and clinicians were unaware of the dose of warfarin during the first 4 weeks of therapy. The primary outcome was the percentage of time that the international normalized ratio (INR) was in the therapeutic range from day 4 or 5 through day 28 of therapy.ResultsAt 4 weeks, the mean percentage of time in the therapeutic range was 45.2% in the genotype-guided group and 45.4% in the clinically guided group (adjusted mean difference, [genotype-guided group minus clinically guided group], -0.2; 95% confidence interval, -3.4 to 3.1; P=0.91). There also was no significant between-group difference among patients with a predicted dose difference between the two algorithms of 1 mg per day or more. There was, however, a significant interaction between dosing strategy and race (P=0.003). Among black patients, the mean percentage of time in the therapeutic range was less in the genotype-guided group than in the clinically guided group. The rates of the combined outcome of any INR of 4 or more, major bleeding, or thromboembolism did not differ significantly according to dosing strategy.ConclusionsGenotype-guided dosing of warfarin did not improve anticoagulation control during the first 4 weeks of therapy. (Funded by the National Heart, Lung, and Blood Institute and others; COAG ClinicalTrials.gov number, NCT00839657.).

Published
2013

15. List of Contributors

Author

Acharya, Suchitra S., primary, Aeschlimann, Judith, additional, Al-Huniti, Ahmad, additional, Antun, Ana G., additional, Arinsburg, Suzanne A., additional, Avecilla, Scott T., additional, Bahar, Burak, additional, Bailey, Debra Jo, additional, Batsuli, Glaivy, additional, Billett, Henny H., additional, Bloch, Evan M., additional, Briones, Michael A., additional, Bussel, James B., additional, Carden, Marcus A., additional, Chandler, Wayne L., additional, Chen, Dong, additional, Csete, Marie, additional, Cuker, Adam, additional, Cushing, Melissa M., additional, Davila, Jennifer, additional, DeSimone, Robert A., additional, Dodd, Roger Y., additional, Dunbar, Nancy M., additional, Dunn, Amy L., additional, Erdman, Patrick A., additional, Francischetti, Ivo M.B., additional, Francis, Richard O., additional, Ginzburg, Yelena Z., additional, Godbey, Elizabeth A., additional, Goel, Ruchika, additional, Gokhale, Amit, additional, Goldstein, Yitz, additional, Gorlin, Jed B., additional, Goss, Cheryl A., additional, Hamilton, Janis R., additional, Hendrickson, Jeanne E., additional, He, Rong, additional, Hillyer, Christopher D., additional, Hod, Eldad A., additional, Hsu, Yen-Michael S., additional, Hume, Heather A., additional, Jacob, Jack, additional, Jain, Shilpa, additional, Jalikis, Florencia G., additional, Jimenez, Alexandra, additional, Jobe, Shawn M., additional, Josephson, Cassandra D., additional, Karafin, Matthew S., additional, Katz, Louis M., additional, Kempton, Christine L., additional, Kessler, Debra A., additional, Kushnir, Margarita, additional, Lambert, Michele P., additional, Li, Marissa, additional, Manwani, Deepa, additional, Maramica, Irina, additional, Marschner, Susanne, additional, Frenet, Emeline Masson, additional, McGuinn, Catherine E., additional, Meeks, Shannon L., additional, Miller, Connie H., additional, Minniti, Caterina P., additional, Mitchell, William B., additional, Monis, Grace F., additional, Nester, Theresa, additional, Norris, Philip, additional, Novotny, Angela, additional, Paroder-Belenitsky, Monika, additional, Pati, Shibani, additional, Peck, Kim, additional, Pham, Huy P., additional, Pishko, Allyson, additional, Quinley, Eva D., additional, Racine-Brzostek, Sabrina, additional, Rahorst, Lynsi, additional, Rennert, Hanna, additional, Restivo, Joseph S.A., additional, Reyes Gil, Morayma, additional, Rosenbaum-Marinaro, Liz, additional, Roshal, Mikhail, additional, Rutter, Sara, additional, Sachais, Bruce S., additional, Saini, Surbhi, additional, Sarangi, Susmita N., additional, Savage, William J., additional, Scaradavou, Andromachi, additional, Schwartz, Joseph, additional, Seheult, Jansen N., additional, Senaldi, Eric, additional, Shaikh, Salima, additional, Sharathkumar, Anjali, additional, Shaz, Beth H., additional, Shi, Patricia A., additional, Simmons, Sierra C., additional, Staley, Elizabeth M., additional, Storch, Emily K., additional, Strauss, Donna, additional, Tanhehco, Yvette C., additional, Tobian, Aaron A.R., additional, Tormey, Christopher A., additional, Townsend, Mary, additional, Tran, Duc Q., additional, Van Buren, Nancy L., additional, Vege, Sunitha, additional, Velliquette, Randall, additional, Vinchi, Francesca, additional, Weinberg, Rona S., additional, Weisberg, Stuart P., additional, Westhoff, Connie M., additional, White, Michael, additional, Winkler, Anne M., additional, Wolgast, Lucia R., additional, Woods, Kalinda, additional, Dimberg, Lina Y., additional, Yazer, Mark H., additional, Young, Carolyn T., additional, Zerra, Patricia E., additional, and Zimowski, Karen L., additional

Published
2019
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20. Leg Ulcer Prevalence and Outcomes in a Real-World, Multicenter, Retrospective Study of Patients Treated with Voxelotor

Author

Minniti, Caterina P, primary, Billett, Henny H., additional, McMahon, Daniel, additional, Idowu, Modupe, additional, Shah, Nirmish, additional, Drachtman, Richard A., additional, Sharma, Archana, additional, Glaros, Alexander, additional, Achebe, Maureen Okam Okam, additional, Nero, Alecia C, additional, Curtis, Susanna, additional, and Andemariam, Biree, additional

Published
2022
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21. Older Age and Neutrophil-to-Lymphocyte Ratio (NLR) Are Predictors of Illness Severity and COVID-Related Mortality in a Multiethnic Urban Cohort of Hematologic Neoplasms Patients: An Updated Analysis

Author

D'Aiello, Angelica, primary, Zareef, Sumaira, additional, Atalla, Eleftheria, additional, Abbasi, Ahmed, additional, Pradhan, Kith, additional, Lombardo, Amanda, additional, Khatun, Fariha, additional, Mustafa, Jennat, additional, De Castro, Alyssa, additional, Joseph, Felisha, additional, Gillick, Kailyn, additional, Thakkar, Astha, additional, Shapiro, Lauren C, additional, Rahman, Shafia, additional, Cui, Zhu, additional, Gonzalez Lugo, Jesus D, additional, Mienko, Fiona, additional, Rahman, Numa, additional, Lopez, Robert, additional, Ko, Heidi Chwan, additional, Podolski, Amanda, additional, Mehta, Vikas, additional, Goel, Sanjay, additional, Kabarriti, Rafi, additional, Sparano, Joseph, additional, Packer, Stuart, additional, Fernandes, David Lawrence, additional, Castelucci, Enrico, additional, Kushnir, Margarita, additional, Chaitowitz, Mark, additional, Paoluzzi, Luca, additional, Steidl, Ulrich G., additional, Zavras, Phaedon, additional, Cooper, Dennis, additional, Konopleva, Marina, additional, Halmos, Balazs, additional, Mantzaris, Ioannis, additional, Kornblum, Noah, additional, Shastri, Aditi, additional, Bachier-Rodriguez, Lizamarie, additional, Gritsman, Kira, additional, Billett, Henny H., additional, Bartash, Rachel, additional, Puius, Yoram, additional, McCort, Margaret, additional, Braunschweig, Ira, additional, Goldfinger, Mendel, additional, Verma, Amit, additional, and Sica, R. Alejandro, additional

Published
2022
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36. North American Physician Practice Patterns in the Management of Anticoagulation in Pregnancy

Author

Cohen, Alice J., primary, Boggio, Lisa, additional, Billett, Henny H., additional, DeSancho, Maria Teresa, additional, Gaddh, Manila, additional, Kouides, Peter, additional, Lim, Ming, additional, Nyak, Lalitha, additional, Rajan, Sandeep, additional, Rosovsky, Rachel, additional, Streiff, Michael, additional, Wang, Tzu-Fei, additional, and Baumann Kreuziger, Lisa, additional

Published
2021
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37. Treatment of catheter-related thrombosis in patients with hematologic malignancies: A Venous thromboEmbolism Network U.S. retrospective cohort study

Author

Baumann Kreuziger, Lisa, primary, Gaddh, Manila, additional, Onadeko, Oluwatomiloba, additional, George, Gemlyn, additional, Wang, Tzu-Fei, additional, Oo, Thein H., additional, Jaglal, Michael, additional, Houghton, Damon E., additional, Streiff, Michael B., additional, Gali, Radhika, additional, Feng, Mingen, additional, Simpson, Pippa, additional, and Billett, Henny H., additional

Published
2021
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39. Primary Analysis of Spartan: A Phase 2 Trial to Assess the Efficacy and Safety of Crizanlizumab in Patients with Sickle Cell Disease Related Priapism

Author

Idowu, Modupe, DeBaun, Michael R., Burnett, Arthur, Darbari, Deepika S., Adam, Soheir, Anderson, Alan Randall, Kanter, Julie, Billett, Henny H., Liles, Darla K., Nickel, Robert S., Decastro, Laura M., Andemariam, Biree, Blyden, Gershwin Theophilus, Heeney, Matthew M., Ramadas, Poornima, McLemore, Morgan L., Kolekar, Yogita, Laine, Dramane, Paulose, Jincy, Sarkar, Rajendra, Vignogna, Mary Beth, and El Rassi, Fuad

Published
2023
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49. Increased Incidence of Thrombosis in a Cohort of Cancer Patients with COVID-19.

Author

Zavras, Phaedon Dimitrios, Mehta, Vikas, Goel, Sanjay, Pradhan, Kith, and Billett, Henny H.

Subjects
COVID-19, VENOUS thrombosis, CANCER patients, THROMBOSIS, LENGTH of stay in hospitals, INFARCTION, CEREBRAL embolism & thrombosis
Abstract

Background: Increased rates of thromboembolism (TE) have been reported in patients with COVID-19, even without prior predisposition to thrombosis. Cancer patients are already predisposed to a hypercoagulable state. This study was designed to assess the TE incidence in COVID-19+ patients with active cancer and its impact on survival. Methods: Data from cancer patients with documented COVID-19 during the dates March 15th–April 10th, 2020, were retrospectively reviewed. Active cancer was defined as disease treated within the past year. Diagnosis and evaluation of thrombosis were done at the clinicians' discretion. All imaging studies' reports within 30 days of the COVID-19 positive test were reviewed for identification of new arterial and/or venous TE. Patients were followed for 30 days from the date of COVID-19+ test for development of TE, hospital length of stay (LOS), and mortality. Results: Of 90 patients, 11 (12.2%) were found to have 13 new TE within 30 days of COVID-19+ test: 8 (8.9%) arterial and 5 (5.6%) venous. Arterial TE was primarily new strokes and/or microvascular cerebral disease (7) with 1 splenic infarct. Venous TE was superficial (1) and deep (3) venous thromboses with 1 pulmonary embolism. Peak D-dimer (DD) values were numerically higher in the TE group versus those with no TE, median peak DD, 7.7 versus 3.2 μg/mL, p = 0.25. Kidney disease was more frequent among patients with TE (72.7%) versus those without TE (31.6%), p = 0.02. Prophylactic or therapeutic anticoagulation (AC) in the inpatient setting was more common among those without TE, any AC, TE versus no TE, 9.1% versus 79.0%, p < 0.0001. Only 1 patient on enoxaparin prophylaxis developed TE. Mortality was higher in the TE group than in those without TE (hazard ratio: 2.6; 95% CI [1.2–5.6], p = 0.009). Cancer type, presence of metastases, administration of prior chemotherapy, patient setting (inpatient, intensive care unit, outpatient, emergency department visit), LOS, and ventilation did not correlate with increased incidence of TE. Conclusion: Cancer patients with COVID-19 have high overall TE rates with a significant incidence of arterial events. TE was associated with worse survival outcomes. [ABSTRACT FROM AUTHOR]

Published
2022
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