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57. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism

Author

Schulman, S1, Kearon, C, Kakkar, AK, Schellong, S, Eriksson, H, Baanstra, D, Kvamme, AM, Friedman, J, Mismetti, P, Goldhaber, SZ, Schulman, S, Goldhaber, S, Kakkar A, DI MINNO, GIOVANNI, Schulman, S, Kearon ,C, Kakkar ,AK, Schellong, S, Eriksson, H, Baanstra ,D, Kvamme, AM, Friedman ,J, Mismetti, P, Goldhaber, SZ, Siragusa, S, Cardiology, ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, Other departments, Schulman, S1, Kearon, C, Kakkar, Ak, Baanstra, D, Kvamme, Am, Friedman, J, Goldhaber, Sz, Goldhaber, S, Kakkar, A, DI MINNO, Giovanni, Department of Medicine (DM - McMaster), McMaster University [Hamilton, Ontario], Thrombosis Research Institute (AKK), University College of London [London] (UCL), Dresden-Friedrichstadt Hospital (DRESDEN-FRIEDRICHSTADT HOSPITAL), Dresden-Friedrichstadt Hospital, Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Saint Etienne, Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe de recherche sur la thrombose (GRT (EA 3065)), Université Jean Monnet [Saint-Étienne] (UJM), Cardiovascular Division (SZG), Brigham and Women's Hospital [Boston], Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Rheumatology, and ICaR - Circulation and metabolism

Subjects
Male, [SDV]Life Sciences [q-bio], 030204 cardiovascular system & hematology, MESH: Intention to Treat Analysis, MESH: Venous Thromboembolism, 0302 clinical medicine, MESH: Aged, 80 and over, Recurrence, 030212 general & internal medicine, MESH: Warfarin, Aged, 80 and over, MESH: Aged, MESH: Middle Aged, MESH: Risk, Hazard ratio, Atrial fibrillation, Venous Thromboembolism, General Medicine, MESH: Follow-Up Studies, Middle Aged, Intention to Treat Analysis, 3. Good health, Pulmonary embolism, MESH: International Normalized Ratio, MESH: beta-Alanine, MESH: Young Adult, Anesthesia, Female, MESH: Hemorrhage, medicine.drug, Adult, Risk, Adolescent, Hemorrhage, Lower risk, Placebo, Dabigatran, Dabigatran, Venous Thromboembolism, Young Adult, 03 medical and health sciences, medicine, Humans, International Normalized Ratio, Aged, MESH: Adolescent, Intention-to-treat analysis, MESH: Humans, business.industry, Warfarin, MESH: Adult, medicine.disease, MESH: Male, MESH: Recurrence, beta-Alanine, Benzimidazoles, business, MESH: Benzimidazoles, Venous thromboembolism, MESH: Female, Follow-Up Studies
Abstract

International audience; BACKGROUND: Dabigatran, which is administered in a fixed dose and does not require laboratory monitoring, may be suitable for extended treatment of venous thromboembolism. METHODS: In two double-blind, randomized trials, we compared dabigatran at a dose of 150 mg twice daily with warfarin (active-control study) or with placebo (placebo-control study) in patients with venous thromboembolism who had completed at least 3 initial months of therapy. RESULTS: In the active-control study, recurrent venous thromboembolism occurred in 26 of 1430 patients in the dabigatran group (1.8%) and 18 of 1426 patients in the warfarin group (1.3%) (hazard ratio with dabigatran, 1.44; 95% confidence interval [CI], 0.78 to 2.64; P=0.01 for noninferiority). Major bleeding occurred in 13 patients in the dabigatran group (0.9%) and 25 patients in the warfarin group (1.8%) (hazard ratio, 0.52; 95% CI, 0.27 to 1.02). Major or clinically relevant bleeding was less frequent with dabigatran (hazard ratio, 0.54; 95% CI, 0.41 to 0.71). Acute coronary syndromes occurred in 13 patients in the dabigatran group (0.9%) and 3 patients in the warfarin group (0.2%) (P=0.02). In the placebo-control study, recurrent venous thromboembolism occurred in 3 of 681 patients in the dabigatran group (0.4%) and 37 of 662 patients in the placebo group (5.6%) (hazard ratio, 0.08; 95% CI, 0.02 to 0.25; P

Published
2013
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58. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis

Author

Schulman, S, Kakkar, Ak, Goldhaber, Sz, Schellong, S, Eriksson, H, Mismetti, P, Christiansen, Av, Friedman, J, Le Maulf, F, Peter, N, Kearon, C, RE COVER II Trial Investigators, Arosio, Enrico, Cardiology, ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, Schulman, S, Goldhaber, S, Schellong, S, Eriksson, H, Mismetti, P, Christiansen, A, Friedman, J, Le Maulf, F, Peter, N, Kearon, C, and NOVO, S

Subjects
Adult, Male, medicine.medical_specialty, RE-COVER II, recurrence, Antagonists & inhibitors, Adolescent, venous thromboembolism, Antithrombins, Dabigatran, Young Adult, Double-Blind Method, Risk Factors, Physiology (medical), Internal medicine, medicine, Humans, dabigatran, cardiovascular diseases, antagonists & inhibitor, Aged, acute venous thromboembolism, Heparin, business.industry, Warfarin, Follow up studies, Anticoagulants, antagonists & inhibitors, hemorrhage, thrombin, warfarin, Heparin, Low-Molecular-Weight, Middle Aged, Settore MED/11 - Malattie Dell'Apparato Cardiovascolare, Heparin.low molecular weight, Pooled analysis, Anesthesia, Acute Disease, beta-Alanine, Benzimidazoles, Female, Cardiology and Cardiovascular Medicine, business, Venous thromboembolism, Follow-Up Studies, medicine.drug
Abstract

Background— Dabigatran and warfarin have been compared for the treatment of acute venous thromboembolism (VTE) in a previous trial. We undertook this study to extend those findings. Methods and Results— In a randomized, double-blind, double-dummy trial of 2589 patients with acute VTE treated with low-molecular-weight or unfractionated heparin for 5 to 11 days, we compared dabigatran 150 mg twice daily with warfarin. The primary outcome, recurrent symptomatic, objectively confirmed VTE and related deaths during 6 months of treatment occurred in 30 of the 1279 dabigatran patients (2.3%) compared with 28 of the 1289 warfarin patients (2.2%; hazard ratio, 1.08; 95% confidence interval [CI], 0.64–1.80; absolute risk difference, 0.2%; 95% CI, −1.0 to 1.3; P Conclusion— Dabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE. Clinical Trial Registration— URL: www.clinicaltrials.gov . Unique identifiers: NCT00680186 and NCT00291330.

Published
2014

59. Aspirin in Patients Undergoing Noncardiac Surgery

Author

Devereaux, Pj, Mrkobrada, M, Sessler, Di, Leslie, K, Alonso Coello, P, Kurz, A, Villar, Jc, Sigamani, A, Biccard, Bm, Meyhoff, Cs, Parlow, Jl, Guyatt, G, Robinson, A, Garg, Ax, Rodseth, Rn, Botto, F, Lurati Buse, G, Xavier, D, Chan, Mt, Tiboni, M, Cook, D, Kumar, Pa, Forget, P, Malaga, G, Fleischmann, E, Amir, M, Eikelboom, J, Mizera, R, Torres, D, Wang, Cy, Vanhelder, T, Paniagua, P, Berwanger, O, Srinathan, S, Graham, M, Pasin, L, Le Manach, Y, Gao, P, Pogue, J, Whitlock, R, Lamy, A, Kearon, C, Baigent, C, Chow, C, Pettit, S, Chrolavicius, S, Yusuf, S, DeBeer J, POISE 2 I. n. v. e. s. t. i. g. a. t. o. r. s., Patel, A, Dechert, W, Jackson, P, Allard, R, Dumerton Shore, D, Mccourt, J, Jones, Pm, Lavi, R, Lavi, S, Moor, R, Dresser, Gk, Gros, Ml, Schumann, Vc, Baur, M, Macdonald, C, Wirzba, B, Regalado, O, Srinathan, Sk, Ong, Dd, Todd, A, Abbas, S, Beattie, Ws, Chan, Vw, Chin, Kj, Wijeysundera, Dn, Graham, Mm, Irwin, M, Jacka, M, El Beheiry, H, Mcmullen, Sm, Macdonald, P, Akhtar, Z, Ayad, S, Buttar, M, Deroee, A, Eshraghi, Y, Fergany, A, Finnigan, P, Fu, A, Grady, M, Helper, S, Hesler, B, Honar, H, Hutcherson, M, Krebs, V, Lee, J, Malik, M, Podolyak, A, Salmasi, V, Arora, H, Coombs, Rf, Martinelli, Sm, Bergese, Sd, Melibary, Sb, Uribe, Aa, Jordan, M, Miller, Sa, Cata, Jp, Nemergut, Ec, Candiotti, Ka, Memtsoudis, Sg, Mckay, Re, Montes, Fr, Parra, Ga, Rojas, Mf, Plata, R, Vásquez, Sm, Sarquis, T, Haider, Z, Jane, Nb, Lanjewar, Pp, Rahate, Pv, Mehra, Br, Premendaran, B, Abraham, V, George, P, Kumar, P, Gaikwad, Sb, Mohan, Nv, Sidhu, G, Alvarez, J, Gonzalez, R, Maestre, M, Popova, E, Urrutia, G, de Nadal, M, González Suárez, S, González Tallada, A, Plou, P, Mena, E, Riveira, C, del Valle, S, Tena, B, Lang, Sa, Ludbrook, Gl, Painter, Tw, Terblanche, Nc, Osborne, C, Mahood, Jr, Myles, Ps, Sivalingam, P, Riedel, B, Elhalawani, I, Drummond, L, Mugabi, A, Naidoo, P, Myburgh, Al, Porrill, Os, Diedericks, Bj, Turton, Ew, Bøgeskov, M, Dahl, Rm, Madsen, Mv, Søndergaard, Es, Bauer, Ne, Martinsen, Kr, Choi, Gy, Gin, T, Ng, Ss, Bidgoli, Sj, Van der Linden PJ, De Kock, M, Kabon, B, Luf, F, Radonic, M, Ishtiaq, O, Safdar, J, Acuna Villaorduna, A, Barrionuevo, P, Castaneda Guarderas, A, Caballero, Ja, Lau, Ve, Aphang Lam MR, Lembo, R, Gossetti, Bruno, Jara, X, Leon, P, Ong, Gs, Lee, Hs, Seeberger, Ee, Seeberger, Md, Alfonsi, P, Coriat, P, Piriou, V, Vizcaychipi, Mp, Rech, Rl, Bergo, Rr, Walker, S, Rodseth, R, Lemanach, Y, Díaz, R, Cortés, Ol, Wetterslev, J, Hoeft, A, Wittmann, M, Chan, M, Landoni, G, Conen, D, Balaji, P, Sovereign, T, Blake, L, Sephton, J, Serra, A, Agrippa, C, Lawrence, M, Biccard, B, Gluud, C, Karthikeyan, G, Auerbach, A, Beattie, S, Buckley, N, Douketis, J, Gerstein, H, Ghali, W, Hart, R, Hill, M, Mcalister, F, Mcauley, D, Miller, S, O'Donnell, M, Pais, P, Parlow, J, Schricker, T, Sessler, D, Simunovic, M, Teoh, K, Walsh, M, Wijeysundera, D, Yang, H, Alshalash, S, Bessissow, A, Duceppe, E, Khalid, Z, Khan, J, Lauw, M, Martinsen, K, Neary, J, Oczkowski, W, Papina, M, Seeberger, M, Tandon, V, Thomas, S, Friedman, L, Cheng, D, Johnstone, D, Lowenstein, E, Roberts, R., Devereaux, Pj, Mrkobrada, M, Sessler, Di, Leslie, K, Alonso Coello, P, Kurz, A, Villar, Jc, Sigamani, A, Biccard, Bm, Meyhoff, C, Parlow, Jl, Guyatt, G, Robinson, A, Garg, Ax, Rodseth, Rn, Botto, F, Lurati Buse, G, Xavier, D, Chan, Mt, Tiboni, M, Cook, D, Kumar, Pa, Forget, P, Malaga, G, Fleischmann, E, Amir M, Eikelboom J, Mizera, R, Torres, D, Wang, Cy, Vanhelder, T, Paniagua, P, Berwanger, O, Srinathan, S, Graham, M, Pasin, L, Le Manach, Y, Gao, P, Pogue, J, Whitlock, R, Lamy, A, Kearon, C, Baigent, C, Chow, C, Pettit, S, Chrolavicius, S, Yusuf, S, and Landoni, Giovanni

Subjects
Male, Myocardial Infarction, Kaplan-Meier Estimate, noncardiac surgery, postoperative period, law.invention, low drug dose, hazard ratio, Postoperative Complications, Randomized controlled trial, law, Myocardial infarction, Treatment Failure, Aspirin, Medicine (all), Hazard ratio, drug effect, article, risk assessment, General Medicine, Middle Aged, female, priority journal, Anesthesia, drug withdrawal, factorial design, Surgical Procedures, Operative, Platelet aggregation inhibitor, Female, medicine.drug, hospitalization, heart infarction, perioperative period, preoperative treatment, Postoperative Hemorrhage, Perioperative Care, length of stay, death, medicine, Humans, follow up, controlled study, human, clonidine, outcome assessment, Aged, treatment duration, Vascular disease, business.industry, Platelet Aggregation Inhibitor, patient care, acetylsalicylic acid, medicine.disease, bleeding, major clinical study, Confidence interval, purl.org/pe-repo/ocde/ford#3.02.00 [https], Clinical research, multicenter study, randomized controlled trial, placebo, Postoperative Complication, business, Platelet Aggregation Inhibitors
Abstract

BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not. METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P = 0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P = 0.04). The primary and secondary outcome results were similar in the two aspirin strata. CONCLUSIONS: Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.) Copyright © 2014 Massachusetts Medical Society.

Published
2014

63. Perioperative Aspirin for Prevention of Venous Thromboembolism

Author

Eikelboom, J. W., primary, Kearon, C., additional, Guyatt, G., additional, Sessler, D. I., additional, Yusuf, S., additional, Cook, D., additional, Douketis, J., additional, Patel, A., additional, Kurz, A., additional, Allard, R., additional, Jones, P. M., additional, Dennis, R. J., additional, Painter, T. W., additional, Bergese, S. D., additional, Leslie, K., additional, Wijeysundera, D. N., additional, Balasubramanian, K., additional, Duceppe, E., additional, Miller, S., additional, Diedericks, J., additional, and Devereaux, P. J., additional

Published
2017
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64. Long-term risk of recurrence after discontinuing anticoagulants for a first unprovoked venous thromboembolism: Protocol for a systematic review and meta-analysis

Author

Khan, F, Rahman, A, Carrier, M, Kearon, C, Schulman, S, Couturaud, F, Prandoni, P, Eichinger, S, Becattini, C, Agnelli, G, Büller, HR, Brighton, TA, Palareti, G, Pinede, L, Sabri, E, Hutton, B, Wells, GA, Rodger, MA, Khan, F, Rahman, A, Carrier, M, Kearon, C, Schulman, S, Couturaud, F, Prandoni, P, Eichinger, S, Becattini, C, Agnelli, G, Büller, HR, Brighton, TA, Palareti, G, Pinede, L, Sabri, E, Hutton, B, Wells, GA, and Rodger, MA

Abstract

Introduction For patients with a first unprovoked venous thromboembolism (VTE), the optimal duration of anticoagulation is a crucial clinical dilemma which has yet to be resolved. The decision to stop anticoagulant therapy (AT) after the initial 3-6 months or to continue AT indefinitely, is primarily governed by the long-term risk of recurrence when treatment is discontinued. This risk however, is not well established, hindering decision making. Methods and analysis We will conduct a systematic review and a meta-analysis of studies involving patients diagnosed with a first, symptomatic unprovoked VTE or VTE provoked by minor transient risk factors, who have completed at least 3 months of initial AT; and who were followed-up for standardised time intervals of 1, 2, 5, 10 and 20 years (±3 months) after stopping AT. We will search (from inception to January 2017) MEDLINE, Embase and the Cochrane library for randomised controlled trials and prospective observational studies. Two reviewers will conduct all screening and data collection independently. The primary outcome of the rate of recurrent VTE at the standardised time intervals will be calculated for each study from the total number of recurrent events and the corresponding number of patient-years of follow-up. We will use a random-effects model to pool study results and report a weighted estimate of the absolute rate of recurrent VTE (events per 100 patient-years) over standardised time intervals of 1, 2, 5, 10 and 20 years after discontinuing anticoagulants. Ethics and dissemination Ethical approval is not applicable for this study. Findings from this study will be disseminated through peer-reviewed journal publication as well as relevant national and international conference presentations. PROSPERO registration number CRD42017056309.

Published
2017

66. Clonidine in patients undergoing noncardiac surgery

Author

Devereaux, Pj, Sessler, Di, Leslie, K, Kurz, A, Mrkobrada, M, Alonso Coello, P, Villar, Jc, Sigamani, A, Biccard, Bm, Meyhoff, Cs, Parlow, Jl, Guyatt, G, Robinson, A, Garg, Ax, Rodseth, Rn, Botto, F, Lurati Buse, G, Xavier, D, Chan, Mt, Tiboni, M, Cook, D, Kumar, Pa, Forget, P, Malaga, G, Fleischmann, E, Amir, M, Eikelboom, J, Mizera, R, Torres, D, Wang, Cy, Vanhelder, T, Paniagua, P, Berwanger, O, Srinathan, S, Graham, M, Pasin, L, Le Manach, Y, Gao, P, Pogue, J, Whitlock, R, Lamy, A, Kearon, C, Chow, C, Pettit, S, Chrolavicius, S, Yusuf, S, Debeer, J, Patel, A, Dechert, W, Jackson, P, Allard, R, Dumerton Shore, D, Mccourt, J, Jones, Pm, Lavi, R, Lavi, S, Moor, R, Dresser, Gk, Gros, Ml, Schumann, Vc, Baur, M, Macdonald, C, Wirzba, B, Regalado, O, Srinathan, Sk, Ong, Dd, Todd, A, Abbas, S, Beattie, Ws, Chan, Vw, Chin, Kj, Wijeysundera, Dn, Graham, Mm, Irwin, M, Jacka, M, El Beheiry, H, Mcmullen, Sm, Macdonald, P, Akhtar, Z, Ayad, S, Buttar, M, Deroee, A, Eshraghi, Y, Fergany, A, Finnigan, P, Fu, A, Grady, M, Helper, S, Hesler, B, Honar, H, Hutcherson, M, Krebs, V, Lee, J, Malik, M, Podolyak, A, Salmasi, V, Arora, H, Coombs, Rf, Martinelli, Sm, Bergese, Sd, Melibary, Sb, Uribe, Aa, Jordan, M, Miller, Sa, Cata, Jp, Nemergut, Ec, Candiotti, Ka, Memtsoudis, Sg, Mckay, Re, Montes, Fr, Parra, Ga, Rojas, Mf, Plata, R, Vásquez, Sm, Sarquis, T, Haider, Z, Jane, Nb, Lanjewar, Pp, Rahate, Pv, Mehra, Br, Premendaran, B, Abraham, V, George, P, Kumar, P, Gaikwad, Sb, Mohan, Nv, Sidhu, G, Alvarez, J, Gonzalez, R, Maestre, M, Popova, E, Urrutia, G, de Nadal, M, González Suárez, S, González Tallada, A, Plou, P, Mena, E, Riveira, C, del Valle, S, Tena, B, Lang, Sa, Ludbrook, Gl, Painter, Tw, Terblanche, Nc, Osborne, C, Mahood, Jr, Myles, Ps, Sivalingam, P, Riedel, B, Elhalawani, I, Drummond, L, Mugabi, A, Naidoo, P, Myburgh, Al, Porrill, Os, Diedericks, Bj, Turton, Ew, Bøgeskov, M, Dahl, Rm, Madsen, Mv, Søndergaard, Es, Bauer, Ne, Martinsen, Kr, Choi, Gy, Gin, T, Ng, Ss, Bidgoli, Sj, Van der Linden PJ, De Kock, M, Kabon, B, Luf, F, Radonic, M, Ishtiaq, O, Safdar, J, Acuna Villaorduna, A, Barrionuevo, P, Castaneda Guarderas, A, Caballero, Ja, Lau, Ve, Aphang Lam MR, Lembo, R, Gossetti, Bruno, Jara, X, Leon, P, Ong, G, Lee, Hs, Seeberger, Ee, Seeberger, Md, Alfonsi, P, Coriat, P, Piriou, V, Vizcaychipi, Mp, Rech, Rl, Bergo, Rr, Walker, S, Rodseth, R, Lemanach, Y, Díaz, R, Cortés, Ol, Wetterslev, J, Hoeft, A, Wittmann, M, Chan, M, Landoni, G, Conen, D, Balaji, P, Sovereign, T, Blake, L, Sephton, J, Serra, A, Agrippa, C, Lawrence, M, Biccard, B, Gluud, C, Baigent, C, Karthikeyan, G, Auerbach, A, Beattie, S, Buckley, N, Douketis, J, Gerstein, H, Ghali, W, Hart, R, Hill, M, Mcalister, F, Mcauley, D, Miller, S, O'Donnell, M, Pais, P, Parlow, J, Schricker, T, Sessler, D, Simunovic, M, Teoh, K, Walsh, M, Wijeysundera, D, Yang, H, Alshalash, S, Bessissow, A, Duceppe, E, Khalid, Z, Khan, J, Lauw, M, Martinsen, K, Neary, J, Oczkowski, W, Papina, M, Seeberger, M, Tandon, V, Thomas, S, Friedman, L, Cheng, D, Johnstone, D, Lowenstein, E, and Roberts, R.

Subjects
Male, hypotension, drug safety, Heart disease, Myocardial Infarction, Kaplan-Meier Estimate, high risk patient, noncardiac surgery, surgery, low drug dose, hazard ratio, Postoperative Complications, dose response, Adrenergic alpha-2 Receptor Agonists, Myocardial infarction, Treatment Failure, risk reduction, Aspirin, Hazard ratio, drug effect, article, risk assessment, General Medicine, Middle Aged, Clonidine, aged, female, priority journal, Anesthesia, factorial design, Surgical Procedures, Operative, Female, Hypotension, medicine.drug, medicine.medical_specialty, heart infarction, perioperative period, preoperative treatment, Placebo, bradycardia, Perioperative Care, length of stay, death, medicine, Humans, controlled study, human, Aged, treatment duration, business.industry, Perioperative, Vascular surgery, acetylsalicylic acid, medicine.disease, major clinical study, purl.org/pe-repo/ocde/ford#3.02.00 [https], drug efficacy, multicenter study, randomized controlled trial, incidence, treatment outcome, placebo, business, heart arrest
Abstract

Background: Marked activation of the sympathetic nervous system occurs during and after noncardiac surgery. Low-dose clonidine, which blunts central sympathetic outflow, may prevent perioperative myocardial infarction and death without inducing hemodynamic instability. Methods: We performed a blinded, randomized trial with a 2-by-2 factorial design to allow separate evaluation of low-dose clonidine versus placebo and low-dose aspirin versus placebo in patients with, or at risk for, atherosclerotic disease who were undergoing noncardiac surgery. A total of 10,010 patients at 135 centers in 23 countries were enrolled. For the comparison of clonidine with placebo, patients were randomly assigned to receive clonidine (0.2 mg per day) or placebo just before surgery, with the study drug continued until 72 hours after surgery. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. Results: Clonidine, as compared with placebo, did not reduce the number of primary-outcome events (367 and 339, respectively; hazard ratio with clonidine, 1.08; 95% confidence interval [CI], 0.93 to 1.26; P=0.29). Myocardial infarction occurred in 329 patients (6.6%) assigned to clonidine and in 295 patients (5.9%) assigned to placebo (hazard ratio, 1.11; 95% CI, 0.95 to 1.30; P=0.18). Significantly more patients in the clonidine group than in the placebo group had clinically important hypotension (2385 patients [47.6%] vs. 1854 patients [37.1%]; hazard ratio 1.32; 95% CI, 1.24 to 1.40; P

Published
2014

67. Reducing the intensity of warfarin therapy does not decrease risk of recurrent VTE

Author

Kearon, C, Ginsberg, JS, and Kovacs, MJ

Subjects
Thromboembolism -- Prevention, Thromboembolism -- Risk factors, Warfarin -- Adverse and side effects, Warfarin -- Dosage and administration, Health, Seniors
Abstract

Conventional-intensity warfarin therapy is more effective for preventing recurrent thrombosis in patients who have had unprovoked venous thromboembolism than low-intensity therapy, and conventional-intensity therapy is not associated with an increased [...]

Published
2003

69. Controversies in diagnosis of pulmonary embolism

Author

Stein, P. D., Sostman, H. D., Dalen, J. E., Bailey, D. L., Bajc, M., Goldhaber, S. Z., Goodman, L. R., Gottschalk, A., Hull, R. D., Matta, F., Pistolesi, M., Tapson, V. F., Weg, J. G., Wells, P. S., Woodard, P. K., Bailey, Dl, Bajc, M, Coleman, Re, Freeman, Lm, Frey, Ka, Gottschalk, A, Goodman, Lr, Naidich, Dp, Sostman, Hd, Woodard, Pk, Dalen, Je, Douketis, Jd, Elliott, Cg, Geibel, A, Goldhaber, Sz, Le Gal, G, Hales, Ca, Harris, B, Huisman, Mv, Hull, Rd, Kearon, C, Kucher, N, Leeper, Kv, Matta, F, Miniati, M, Pistolesi, M, Prandoni, Paolo, Sasahara, Aa, Stein, Pd, Tapson, Vf, Weg, Jg, Wells, Ps, Wakefield, T., Department of Internal Medicine and Research and Advanced Studies Program (DIMRASP), Michigan State University [East Lansing], Michigan State University System-Michigan State University System, Cardiovascular Division (SZG), Brigham and Women's Hospital [Boston], Thrombosis Research Unit, University of Calgary, Clinical Epidemiology Unit, Ottawa Hospital, Thrombosis Program, University of Ottawa [Ottawa], Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)-Université de Brest (UBO)

Subjects
Male, MESH: Pulmonary Embolism, medicine.medical_specialty, [SDV]Life Sciences [q-bio], 030204 cardiovascular system & hematology, Single-photon emission computed tomography, Scintigraphy, MESH: Tomography, Emission-Computed, Single-Photon, 030218 nuclear medicine & medical imaging, Diagnosis, Differential, 03 medical and health sciences, 0302 clinical medicine, MESH: Diagnosis, Differential, medicine, Humans, MESH: Data Collection, MESH: Lung, Lung, Tomography, Emission-Computed, Single-Photon, MESH: Angiography, Ct pulmonary angiography, MESH: Humans, medicine.diagnostic_test, business.industry, Data Collection, Angiography, Hematology, General Medicine, Lung scan, medicine.disease, MESH: Male, 3. Good health, Pulmonary embolism, Acute Disease, MESH: Acute Disease, Female, Radiology, Chest radiograph, business, Nuclear medicine, Pulmonary Embolism, Tomography, X-Ray Computed, MESH: Tomography, X-Ray Computed, Lower limbs venous ultrasonography, Perfusion, MESH: Female
Abstract

International audience; The approach to the diagnosis of acute pulmonary embolism (PE) is under constant revision with advances in technology, noninvasive approaches, and increasing awareness of the risks of ionizing radiation. Optimal approaches in some categories of patients are controversial. Data are insufficient for evidence-based recommendations. Therefore, this survey of investigators in the field was undertaken. Even among experts there were marked differences of opinion regarding the approach to the diagnosis of acute PE. Although CT pulmonary angiography was usually the imaging test of choice, the respondents were keenly aware of the dangers of ionizing radiation. In view of advances in scintigraphic diagnosis since the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED) trial, ventilation/perfusion (V/Q) lung scans or perfusion scans alone and single photon emission computed tomography (SPECT) V/Q lung scans are often recommended. The choice depends on the patient's age, gender, and complexity of the findings on the plain chest radiograph.

Published
2011
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75. Exclusion of deep vein thrombosis using the Wells rule in clinically important subgroups: individual patient data meta-analysis

Author

Geersing, G. J., Zuithoff, N. P. A., Kearon, C., Anderson, D. R., ten Cate-Hoek, A. J., Elf, Johan, Bates, S. M., Hoes, A. W., Kraaijenhagen, R. A., Oudega, R., Schutgens, R. E. G., Stevens, S. M., Woller, S. C., Wells, P. S., Moons, K. G. M., Geersing, G. J., Zuithoff, N. P. A., Kearon, C., Anderson, D. R., ten Cate-Hoek, A. J., Elf, Johan, Bates, S. M., Hoes, A. W., Kraaijenhagen, R. A., Oudega, R., Schutgens, R. E. G., Stevens, S. M., Woller, S. C., Wells, P. S., and Moons, K. G. M.

Abstract

Objective To assess the accuracy of the Wells rule for excluding deep vein thrombosis and whether this accuracy applies to different subgroups of patients. Design Meta-analysis of individual patient data. Data sources Authors of 13 studies (n=10 002) provided their datasets, and these individual patient data were merged into one dataset. Eligibility criteria Studies were eligible if they enrolled consecutive outpatients with suspected deep vein thrombosis, scored all variables of the Wells rule, and performed an appropriate reference standard. Main outcome measures Multilevel logistic regression models, including an interaction term for each subgroup, were used to estimate differences in predicted probabilities of deep vein thrombosis by the Wells rule. In addition, D-dimer testing was added to assess differences in the ability to exclude deep vein thrombosis using an unlikely score on the Wells rule combined with a negative D-dimer test result. Results Overall, increasing scores on the Wells rule were associated with an increasing probability of having deep vein thrombosis. Estimated probabilities were almost twofold higher in patients with cancer, in patients with suspected recurrent events, and (to a lesser extent) in males. An unlikely score on the Wells rule (<= 1) combined with a negative D-dimer test result was associated with an extremely low probability of deep vein thrombosis (1.2%, 95% confidence interval 0.7% to 1.8%). This combination occurred in 29% (95% confidence interval 20% to 40%) of patients. These findings were consistent in subgroups defined by type of D-dimer assay (quantitative or qualitative), sex, and care setting (primary or hospital care). For patients with cancer, the combination of an unlikely score on the Wells rule and a negative D-dimer test result occurred in only 9% of patients and was associated with a 2.2% probability of deep vein thrombosis being present. In patients with suspected recurrent events, only the modified Wells rule

Published
2014

77. Safety of withholding heparin in pregnant women with a history of venous thromboembolism.

Author

Couture G., Kearon C., Geerts W., Kovacs M., Weitz J.I., Robinson K.S., Whittom R., Brill-Edwards P., Ginsberg J.S., Gent M., Hirsh J., Burrows R., Couture G., Kearon C., Geerts W., Kovacs M., Weitz J.I., Robinson K.S., Whittom R., Brill-Edwards P., Ginsberg J.S., Gent M., Hirsh J., and Burrows R.

Abstract

Background: Women with a history of venous thromboembolism may be at increased risk for venous thromboembolic events during pregnancy. In these women, the decision to give or withhold heparin in the antepartum period is controversial, because accurate estimates of the frequency of recurrent thromboembolic events if antepartum heparin is withheld are not available. Method(s): We prospectively studied 125 pregnant women with a single previous episode of venous thromboembolism. Antepartum heparin was withheld, but anticoagulant therapy was given for four to six weeks post partum. Our primary objective was to determine the rate of antepartum recurrence of venous thromboembolism. Laboratory studies were performed to identify thrombophilia in 95 women. Result(s): Three of the 125 women (2.4 percent) had an antepartum recurrence of venous thromboembolism (95 percent confidence interval, 0.2 to 6.9 percent). There were no recurrences in the 44 women who had no evidence of thrombophilia and who also had a previous episode of thrombosis that was associated with a temporary risk factor. Among the 51 women with abnormal laboratory results or a previous episode of idiopathic thrombosis, or both, 3 (5.9 percent) had an antepartum recurrence of venous thromboembolism (95 percent confidence interval, 1.2 to 16.2 percent). Conclusion(s): The risk of recurrent antepartum venous thromboembolism in women with a history of venous thromboembolism is low, and therefore routine antepartum prophylaxis with heparin is not warranted. (C) 2000, Massachusetts Medical Society.

Published
2012

78. Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism

Author

Schulman, S., Kearon, C., Kakkar, A.K., Mismetti, P., Schellong, S., Eriksson, H., Baanstra, D., Schnee, J., Goldhaber, S.Z., Baker, R.I., Schulman, S., Kearon, C., Kakkar, A.K., Mismetti, P., Schellong, S., Eriksson, H., Baanstra, D., Schnee, J., Goldhaber, S.Z., and Baker, R.I.

Abstract

BACKGROUND The direct oral thrombin inhibitor dabigatran has a predictable anticoagulant effect and may be an alternative therapy to warfarin for patients who have acute venous thromboembolism. METHODS In a randomized, double-blind, noninferiority trial involving patients with acute venous thromboembolism who were initially given parenteral anticoagulation therapy for a median of 9 days (interquartile range, 8 to 11), we compared oral dabigatran, administered at a dose of 150 mg twice daily, with warfarin that was dose-adjusted to achieve an international normalized ratio of 2.0 to 3.0. The primary outcome was the 6-month incidence of recurrent symptomatic, objectively confirmed venous thromboembolism and related deaths. Safety end points included bleeding events, acute coronary syndromes, other adverse events, and results of liver-function tests. RESULTS A total of 30 of the 1274 patients randomly assigned to receive dabigatran (2.4%), as compared with 27 of the 1265 patients randomly assigned to warfarin (2.1%), had recurrent venous thromboembolism; the difference in risk was 0.4 percentage points (95% confidence interval [CI], −0.8 to 1.5; P<0.001 for the prespecified noninferiority margin). The hazard ratio with dabigatran was 1.10 (95% CI, 0.65 to 1.84). Major bleeding episodes occurred in 20 patients assigned to dabigatran (1.6%) and in 24 patients assigned to warfarin (1.9%) (hazard ratio with dabigatran, 0.82; 95% CI, 0.45 to 1.48), and episodes of any bleeding were observed in 205 patients assigned to dabigatran (16.1%) and 277 patients assigned to warfarin (21.9%; hazard ratio with dabigatran, 0.71; 95% CI, 0.59 to 0.85). The numbers of deaths, acute coronary syndromes, and abnormal liver-function tests were similar in the two groups. Adverse events leading to discontinuation of the study drug occurred in 9.0% of patients assigned to dabigatran and in 6.8% of patients assigned to warfarin (P=0.05). CONCLUSIONS For the treatment of acute venous thromboembol

Published
2009

79. Venous thromboembolism in association with features of the metabolic syndrome

Author

Ray, J. G., Lonn, E., Yi, Q., Rathe, A., Sheridan, P., Kearon, C., Held, Claes, Ray, J. G., Lonn, E., Yi, Q., Rathe, A., Sheridan, P., Kearon, C., and Held, Claes

Abstract

Background: Central obesity, diabetes mellitus, dyslipidaemia and chronic hypertension-features of the metabolic syndrome-have been individually associated with venous thromboembolism (VTE). However, whether each of these factors additively increases the risk of VTE is uncertain. Aim: To determine whether features of the metabolic syndrome independently increase the risk of VTE. Design: Prospective cohort study derived from the Heart Outcomes Prevention Evaluation 2 (HOPE-2) randomized clinical trial. Setting: One hundred and forty-five clinical centres in 13 countries. Methods: We studied 5522 adults aged >55 years with cardiovascular disease or diabetes mellitus. At enrolment, 35% had 0-1 features of the metabolic syndrome, 30% had two, 24% had three and 11% had four. We defined symptomatic VTE as an objectively confirmed new episode of deep-vein thrombosis or pulmonary embolism. Results: VTE occurred in 88 individuals during a median 5.0 years of follow-up. The incidence rate of VTE (per 100 person-years) was 0.30 with 0-1 features, 0.36 with two features, 0.38 with three features and 0.40 with four features of the metabolic syndrome (trend p=0.43). Relative to the presence of 0-1 features of the metabolic syndrome, the adjusted hazard ratio (95%Cl) for VTE was 1.22 (0.71-2.08) with two features, 1.25 (0.70-2.24) with three features, and 1.26 (0.59-2.69) with four features. Discussion: The number of features of the metabolic syndrome present was not a clinically important risk factor for VTE in older adults with vascular arterial disease.

Published
2007
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92. Influence of warfarin use on symptoms of fatigue: a randomized cross-over trial

Author

Kovacs, M., primary, Kearon, C., additional, Julian, J., additional, Mackinnon, B., additional, Douketis, J., additional, Demers, C., additional, Wells, P., additional, Turpie, A. G. G., additional, Anderson, D. R., additional, Kahn, S., additional, Van Nguyen, P., additional, Green, D., additional, Kassis, J., additional, Geerts, W., additional, and Ginsberg, J. S., additional

Published
2003
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95. Noninvasive diagnosis of deep venous thrombosis. McMaster Diagnostic Imaging Practice Guidelines Initiative.

Author

Kearon C, Julian JA, Newman TE, Ginsberg JS, Kearon, C, Julian, J A, Newman, T E, and Ginsberg, J S

Abstract

Purpose: To review noninvasive methods for diagnosis of first and recurrent deep venous thrombosis and provide evidence-based recommendations for the diagnosis of deep venous thrombosis in symptomatic, asymptomatic, and pregnant patients.Data Sources: Accuracy (comparison with contrast venography) and management (safety of withholding anticoagulants when results were normal) studies that evaluated tests for diagnosis of deep venous thrombosis were identified from a MEDLINE search, personal files, and bibliographies of reviews and original studies.Study Selection: Prospective cohort studies (accuracy and management studies) and randomized comparisons (management studies) that satisfied predefined methodologic criteria were included.Data Extraction: Sensitivity, specificity, and positive and negative predictive values were determined for accuracy studies. Rates of venous thromboembolism during long-term follow-up of patients with normal results were determined for management studies.Data Synthesis: Data from individual studies were combined under a random-effects model. The accuracy of noninvasive tests was compared, with emphasis on within-study comparisons. Recommendations for diagnosis of deep venous thrombosis were developed by a multidisciplinary group and graded according to the strength of the supporting evidence. Venous ultrasonography is the most accurate noninvasive test for the diagnosis of a first symptomatic proximal deep venous thrombosis. However, neither ultrasonography nor impedance plethysmography is accurate in asymptomatic postoperative patients. Venous ultrasonography is less accurate for symptomatic isolated distal (calf) deep venous thrombosis than for proximal deep venous thrombosis, and the clinical utility of venous ultrasonography of the distal veins is uncertain. Withholding anticoagulant therapy in symptomatic patients with suspected deep venous thrombosis who have normal results on serial venous ultrasonography or impedance plethysmography is safe. Diagnosis of recurrent deep venous thrombosis requires evidence of new thrombus formation, such as a new noncompressible venous segment detected by venous ultrasonography, conversion of a normal result on impedance plethysmography to abnormal, or presence of an intraluminal filling defect on venography. Suspected deep venous thrombosis in pregnant patients can usually be managed with serial venous ultrasonography or impedance plethysmography. In symptomatic patients with a suspected first episode of deep venous thrombosis, clinical assessment and D-dimer testing are complementary to testing with venous ultrasonography and impedance plethysmography.Conclusions: Patients with suspected deep venous thrombosis can usually be managed with noninvasive testing. However, if the results of this testing are nondiagnostic or are discordant with the clinical assessment, venography should be considered. [ABSTRACT FROM AUTHOR]

Published
1998
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