Effect of direct oral anticoagulants, warfarin, and antiplatelet agents on risk of device pocket hematoma: Combined analysis of BRUISE CONTROL 1 and 2

Vidal Essebag; Jeff S. Healey; Jacqueline Joza; Pablo B. Nery; Eli Kalfon; Tiago L.L. Leiria; Atul Verma; Felix Ayala-Paredes; Benoit Coutu; Glen L. Sumner; Giuliano Becker; François Philippon; John Eikelboom; Roopinder K. Sandhu; John Sapp; Richard Leather; Derek Yung; Bernard Thibault; Christopher S. Simpson; Kamran Ahmad; Satish Toal; Marcio Sturmer; Katherine Kavanagh; Eugene Crystal; George A. Wells; Andrew D. Krahn; David H. Birnie

doi:10.1161/CIRCEP.119.007545

Effect of direct oral anticoagulants, warfarin, and antiplatelet agents on risk of device pocket hematoma: Combined analysis of BRUISE CONTROL 1 and 2

Vidal Essebag, Jeff S. Healey, Jacqueline Joza, Pablo B. Nery, Eli Kalfon, Tiago L.L. Leiria, Atul Verma, Felix Ayala-Paredes, Benoit Coutu, Glen L. Sumner, Giuliano Becker, François Philippon, John Eikelboom, Roopinder K. Sandhu, John Sapp, Richard Leather, Derek Yung, Bernard Thibault, Christopher S. Simpson, Kamran AhmadSatish Toal, Marcio Sturmer, Katherine Kavanagh, Eugene Crystal, George A. Wells, Andrew D. Krahn, David H. Birnie

Medicine

Résultat de recherche: Article › examen par les pairs

32 Citations (Scopus)

Résumé

Background: Oral anticoagulant use is common among patients undergoing pacemaker or defibrillator surgery. BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial; NCT00800137) demonstrated that perioperative warfarin continuation reduced clinically significant hematomas (CSH) by 80% compared with heparin bridging (3.5% versus 16%). BRUISE-CONTROL-2 (NCT01675076) observed a similarly low risk of CSH when comparing continued versus interrupted direct oral anticoagulant (2.1% in both groups). Using patient level data from both trials, the current study aims to: (1) evaluate the effect of concomitant antiplatelet therapy on CSH, and (2) understand the relative risk of CSH in patients treated with direct oral anticoagulant versus continued warfarin. Methods: We analyzed 1343 patients included in BRUISE-CONTROL-1 and BRUISE-CONTROL-2. The primary outcome for both trials was CSH. There were 408 patients identified as having continued either a single or dual antiplatelet agent at the time of device surgery. Results: Antiplatelet use (versus nonuse) was associated with CSH in 9.8% versus 4.3% of patients (P<0.001), and remained a strong independent predictor after multivariable adjustment (odds ratio, 1.965; 95% CI, 1.202-3.213; P=0.0071). In multivariable analysis, adjusting for antiplatelet use, there was no significant difference in CSH observed between direct oral anticoagulant use compared with continued warfarin (odds ratio, 0.858; 95% CI, 0.375-1.963; P=0.717). Conclusions Concomitant antiplatelet therapy doubled the risk of CSH during device surgery. No difference in CSH was found between direct oral anticoagulant versus continued warfarin. In anticoagulated patients undergoing elective or semi-urgent device surgery, the patient specific benefit/risk of holding an antiplatelet should be carefully considered. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00800137, NCT01675076.

Langue d'origine	English
Numéro d'article	e007545
Journal	Circulation: Arrhythmia and Electrophysiology
Volume	12
Numéro de publication	10
DOI	https://doi.org/10.1161/CIRCEP.119.007545
Statut de publication	Published - oct. 1 2019

Note bibliographique

Funding Information:
Dr Essebag reports personal fees from Bayer, personal fees from Boehringer Ingelheim, personal fees from BMS Pfizer, personal fees from Servier, during the conduct of the study (Modest). Dr Healey reports Research grants and speaking fees from Bristol-Meyers-Squibb and Pfizer. Speaking fees from Servier; research grants and speaking fees from Medtronic and Boston Scientific (Modest). Dr Verma reports grants from Bayer, grants from Medtronic, grants from Biosense Webster, outside the submitted work (Modest). Dr Coutu reports personal fees from Bayer, outside the submitted work (Modest). Dr Eikelboom reports honoraria and grant support from Astra Zeneca, Bayer, Boehringer Ingelheim, Bristol-Myers-Squibb/Pfizer, Daiichi Sankyo, Glaxo Smith Kline, Janssen, Sanofi Aventis and Eli Lilly as well as a personnel award from the Heart and Stroke Foundation (Modest). Dr Sandhu reports grant support from Servier (Modest). Dr Thibault reports personal fees and other from Medtronic, personal fees and other from Abbott (Modest). Dr Birnie reports grants from Boehringer Ingelheim, Germany, grants from Pfizer and Bristol-Myers Squibb, New York, during the conduct of the study (Modest). The other authors report no conflicts.

Funding Information:
Bruise Control-1 was supported by an operating grant from the Canadian Institutes of Health Research (CIHR), a CIHR Clinician Scientist Award (Dr Esse-bag) and an Innovations grant from the University of Ottawa Heart Institute Academic Medical Organization Alternate Funding Program (funded by the Ministry of Health of Ontario). Bruise Control-2 was supported by a grant from the Heart and Stroke Foundation of Canada (grant number G-14-0005725), a Fonds de recherché du Quebec-Santé (FRQS) Clinical Research Scholar Award (Dr Essebag) and grants from Boehringer Ingelheim, Germany; Bayer HealthCare AG, Leverkusen, Germany; Pfizer and Bristol-Myers Squibb, NY.

Publisher Copyright:
© 2019 Lippincott Williams and Wilkins. All rights reserved.

ASJC Scopus Subject Areas

Cardiology and Cardiovascular Medicine
Physiology (medical)

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10.1161/CIRCEP.119.007545

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Essebag, V., Healey, J. S., Joza, J., Nery, P. B., Kalfon, E., Leiria, T. L. L., Verma, A., Ayala-Paredes, F., Coutu, B., Sumner, G. L., Becker, G., Philippon, F., Eikelboom, J., Sandhu, R. K., Sapp, J., Leather, R., Yung, D., Thibault, B., Simpson, C. S., ... Birnie, D. H. (2019). Effect of direct oral anticoagulants, warfarin, and antiplatelet agents on risk of device pocket hematoma: Combined analysis of BRUISE CONTROL 1 and 2. Circulation: Arrhythmia and Electrophysiology, 12(10), Article e007545. https://doi.org/10.1161/CIRCEP.119.007545

Essebag, V, Healey, JS, Joza, J, Nery, PB, Kalfon, E, Leiria, TLL, Verma, A, Ayala-Paredes, F, Coutu, B, Sumner, GL, Becker, G, Philippon, F, Eikelboom, J, Sandhu, RK, Sapp, J, Leather, R, Yung, D, Thibault, B, Simpson, CS, Ahmad, K, Toal, S, Sturmer, M, Kavanagh, K, Crystal, E, Wells, GA, Krahn, AD & Birnie, DH 2019, 'Effect of direct oral anticoagulants, warfarin, and antiplatelet agents on risk of device pocket hematoma: Combined analysis of BRUISE CONTROL 1 and 2', Circulation: Arrhythmia and Electrophysiology, vol. 12, n° 10, e007545. https://doi.org/10.1161/CIRCEP.119.007545

@article{ce29e772b65045249ea77add895085cc,

title = "Effect of direct oral anticoagulants, warfarin, and antiplatelet agents on risk of device pocket hematoma: Combined analysis of BRUISE CONTROL 1 and 2",

abstract = "Background: Oral anticoagulant use is common among patients undergoing pacemaker or defibrillator surgery. BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial; NCT00800137) demonstrated that perioperative warfarin continuation reduced clinically significant hematomas (CSH) by 80% compared with heparin bridging (3.5% versus 16%). BRUISE-CONTROL-2 (NCT01675076) observed a similarly low risk of CSH when comparing continued versus interrupted direct oral anticoagulant (2.1% in both groups). Using patient level data from both trials, the current study aims to: (1) evaluate the effect of concomitant antiplatelet therapy on CSH, and (2) understand the relative risk of CSH in patients treated with direct oral anticoagulant versus continued warfarin. Methods: We analyzed 1343 patients included in BRUISE-CONTROL-1 and BRUISE-CONTROL-2. The primary outcome for both trials was CSH. There were 408 patients identified as having continued either a single or dual antiplatelet agent at the time of device surgery. Results: Antiplatelet use (versus nonuse) was associated with CSH in 9.8% versus 4.3% of patients (P<0.001), and remained a strong independent predictor after multivariable adjustment (odds ratio, 1.965; 95% CI, 1.202-3.213; P=0.0071). In multivariable analysis, adjusting for antiplatelet use, there was no significant difference in CSH observed between direct oral anticoagulant use compared with continued warfarin (odds ratio, 0.858; 95% CI, 0.375-1.963; P=0.717). Conclusions Concomitant antiplatelet therapy doubled the risk of CSH during device surgery. No difference in CSH was found between direct oral anticoagulant versus continued warfarin. In anticoagulated patients undergoing elective or semi-urgent device surgery, the patient specific benefit/risk of holding an antiplatelet should be carefully considered. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00800137, NCT01675076.",

author = "Vidal Essebag and Healey, {Jeff S.} and Jacqueline Joza and Nery, {Pablo B.} and Eli Kalfon and Leiria, {Tiago L.L.} and Atul Verma and Felix Ayala-Paredes and Benoit Coutu and Sumner, {Glen L.} and Giuliano Becker and Fran{\c c}ois Philippon and John Eikelboom and Sandhu, {Roopinder K.} and John Sapp and Richard Leather and Derek Yung and Bernard Thibault and Simpson, {Christopher S.} and Kamran Ahmad and Satish Toal and Marcio Sturmer and Katherine Kavanagh and Eugene Crystal and Wells, {George A.} and Krahn, {Andrew D.} and Birnie, {David H.}",

note = "Funding Information: Dr Essebag reports personal fees from Bayer, personal fees from Boehringer Ingelheim, personal fees from BMS Pfizer, personal fees from Servier, during the conduct of the study (Modest). Dr Healey reports Research grants and speaking fees from Bristol-Meyers-Squibb and Pfizer. Speaking fees from Servier; research grants and speaking fees from Medtronic and Boston Scientific (Modest). Dr Verma reports grants from Bayer, grants from Medtronic, grants from Biosense Webster, outside the submitted work (Modest). Dr Coutu reports personal fees from Bayer, outside the submitted work (Modest). Dr Eikelboom reports honoraria and grant support from Astra Zeneca, Bayer, Boehringer Ingelheim, Bristol-Myers-Squibb/Pfizer, Daiichi Sankyo, Glaxo Smith Kline, Janssen, Sanofi Aventis and Eli Lilly as well as a personnel award from the Heart and Stroke Foundation (Modest). Dr Sandhu reports grant support from Servier (Modest). Dr Thibault reports personal fees and other from Medtronic, personal fees and other from Abbott (Modest). Dr Birnie reports grants from Boehringer Ingelheim, Germany, grants from Pfizer and Bristol-Myers Squibb, New York, during the conduct of the study (Modest). The other authors report no conflicts. Funding Information: Bruise Control-1 was supported by an operating grant from the Canadian Institutes of Health Research (CIHR), a CIHR Clinician Scientist Award (Dr Esse-bag) and an Innovations grant from the University of Ottawa Heart Institute Academic Medical Organization Alternate Funding Program (funded by the Ministry of Health of Ontario). Bruise Control-2 was supported by a grant from the Heart and Stroke Foundation of Canada (grant number G-14-0005725), a Fonds de recherch{\'e} du Quebec-Sant{\'e} (FRQS) Clinical Research Scholar Award (Dr Essebag) and grants from Boehringer Ingelheim, Germany; Bayer HealthCare AG, Leverkusen, Germany; Pfizer and Bristol-Myers Squibb, NY. Publisher Copyright: {\textcopyright} 2019 Lippincott Williams and Wilkins. All rights reserved.",

year = "2019",

month = oct,

day = "1",

doi = "10.1161/CIRCEP.119.007545",

language = "English",

volume = "12",

journal = "Circulation: Arrhythmia and Electrophysiology",

issn = "1941-3149",

publisher = "Lippincott Williams and Wilkins",

number = "10",

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TY - JOUR

T1 - Effect of direct oral anticoagulants, warfarin, and antiplatelet agents on risk of device pocket hematoma

T2 - Combined analysis of BRUISE CONTROL 1 and 2

AU - Essebag, Vidal

AU - Healey, Jeff S.

AU - Joza, Jacqueline

AU - Nery, Pablo B.

AU - Kalfon, Eli

AU - Leiria, Tiago L.L.

AU - Verma, Atul

AU - Ayala-Paredes, Felix

AU - Coutu, Benoit

AU - Sumner, Glen L.

AU - Becker, Giuliano

AU - Philippon, François

AU - Eikelboom, John

AU - Sandhu, Roopinder K.

AU - Sapp, John

AU - Leather, Richard

AU - Yung, Derek

AU - Thibault, Bernard

AU - Simpson, Christopher S.

AU - Ahmad, Kamran

AU - Toal, Satish

AU - Sturmer, Marcio

AU - Kavanagh, Katherine

AU - Crystal, Eugene

AU - Wells, George A.

AU - Krahn, Andrew D.

AU - Birnie, David H.

N1 - Funding Information: Dr Essebag reports personal fees from Bayer, personal fees from Boehringer Ingelheim, personal fees from BMS Pfizer, personal fees from Servier, during the conduct of the study (Modest). Dr Healey reports Research grants and speaking fees from Bristol-Meyers-Squibb and Pfizer. Speaking fees from Servier; research grants and speaking fees from Medtronic and Boston Scientific (Modest). Dr Verma reports grants from Bayer, grants from Medtronic, grants from Biosense Webster, outside the submitted work (Modest). Dr Coutu reports personal fees from Bayer, outside the submitted work (Modest). Dr Eikelboom reports honoraria and grant support from Astra Zeneca, Bayer, Boehringer Ingelheim, Bristol-Myers-Squibb/Pfizer, Daiichi Sankyo, Glaxo Smith Kline, Janssen, Sanofi Aventis and Eli Lilly as well as a personnel award from the Heart and Stroke Foundation (Modest). Dr Sandhu reports grant support from Servier (Modest). Dr Thibault reports personal fees and other from Medtronic, personal fees and other from Abbott (Modest). Dr Birnie reports grants from Boehringer Ingelheim, Germany, grants from Pfizer and Bristol-Myers Squibb, New York, during the conduct of the study (Modest). The other authors report no conflicts. Funding Information: Bruise Control-1 was supported by an operating grant from the Canadian Institutes of Health Research (CIHR), a CIHR Clinician Scientist Award (Dr Esse-bag) and an Innovations grant from the University of Ottawa Heart Institute Academic Medical Organization Alternate Funding Program (funded by the Ministry of Health of Ontario). Bruise Control-2 was supported by a grant from the Heart and Stroke Foundation of Canada (grant number G-14-0005725), a Fonds de recherché du Quebec-Santé (FRQS) Clinical Research Scholar Award (Dr Essebag) and grants from Boehringer Ingelheim, Germany; Bayer HealthCare AG, Leverkusen, Germany; Pfizer and Bristol-Myers Squibb, NY. Publisher Copyright: © 2019 Lippincott Williams and Wilkins. All rights reserved.

PY - 2019/10/1

Y1 - 2019/10/1

N2 - Background: Oral anticoagulant use is common among patients undergoing pacemaker or defibrillator surgery. BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial; NCT00800137) demonstrated that perioperative warfarin continuation reduced clinically significant hematomas (CSH) by 80% compared with heparin bridging (3.5% versus 16%). BRUISE-CONTROL-2 (NCT01675076) observed a similarly low risk of CSH when comparing continued versus interrupted direct oral anticoagulant (2.1% in both groups). Using patient level data from both trials, the current study aims to: (1) evaluate the effect of concomitant antiplatelet therapy on CSH, and (2) understand the relative risk of CSH in patients treated with direct oral anticoagulant versus continued warfarin. Methods: We analyzed 1343 patients included in BRUISE-CONTROL-1 and BRUISE-CONTROL-2. The primary outcome for both trials was CSH. There were 408 patients identified as having continued either a single or dual antiplatelet agent at the time of device surgery. Results: Antiplatelet use (versus nonuse) was associated with CSH in 9.8% versus 4.3% of patients (P<0.001), and remained a strong independent predictor after multivariable adjustment (odds ratio, 1.965; 95% CI, 1.202-3.213; P=0.0071). In multivariable analysis, adjusting for antiplatelet use, there was no significant difference in CSH observed between direct oral anticoagulant use compared with continued warfarin (odds ratio, 0.858; 95% CI, 0.375-1.963; P=0.717). Conclusions Concomitant antiplatelet therapy doubled the risk of CSH during device surgery. No difference in CSH was found between direct oral anticoagulant versus continued warfarin. In anticoagulated patients undergoing elective or semi-urgent device surgery, the patient specific benefit/risk of holding an antiplatelet should be carefully considered. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00800137, NCT01675076.

AB - Background: Oral anticoagulant use is common among patients undergoing pacemaker or defibrillator surgery. BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial; NCT00800137) demonstrated that perioperative warfarin continuation reduced clinically significant hematomas (CSH) by 80% compared with heparin bridging (3.5% versus 16%). BRUISE-CONTROL-2 (NCT01675076) observed a similarly low risk of CSH when comparing continued versus interrupted direct oral anticoagulant (2.1% in both groups). Using patient level data from both trials, the current study aims to: (1) evaluate the effect of concomitant antiplatelet therapy on CSH, and (2) understand the relative risk of CSH in patients treated with direct oral anticoagulant versus continued warfarin. Methods: We analyzed 1343 patients included in BRUISE-CONTROL-1 and BRUISE-CONTROL-2. The primary outcome for both trials was CSH. There were 408 patients identified as having continued either a single or dual antiplatelet agent at the time of device surgery. Results: Antiplatelet use (versus nonuse) was associated with CSH in 9.8% versus 4.3% of patients (P<0.001), and remained a strong independent predictor after multivariable adjustment (odds ratio, 1.965; 95% CI, 1.202-3.213; P=0.0071). In multivariable analysis, adjusting for antiplatelet use, there was no significant difference in CSH observed between direct oral anticoagulant use compared with continued warfarin (odds ratio, 0.858; 95% CI, 0.375-1.963; P=0.717). Conclusions Concomitant antiplatelet therapy doubled the risk of CSH during device surgery. No difference in CSH was found between direct oral anticoagulant versus continued warfarin. In anticoagulated patients undergoing elective or semi-urgent device surgery, the patient specific benefit/risk of holding an antiplatelet should be carefully considered. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00800137, NCT01675076.

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Effect of direct oral anticoagulants, warfarin, and antiplatelet agents on risk of device pocket hematoma: Combined analysis of BRUISE CONTROL 1 and 2

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