V. Essebag, J. Healey, J. Joza, P. Nery, E. Kalfon, T. Leiria, A. Verma, F. Ayala-Paredes, B. Coutu, G. Sumner, G. Becker, F. Philippon, J. Eikelboom, R. Sandhu, John Sapp, R. Leather, D. Yung, B. Thibault, C. Simpson, K. Ahmad, Satish C. Toal, M. Sturmer, K. Kavanagh, E. Crystal, G. Wells, A. Krahn, D. Birnie
{"title":"直接口服抗凝剂、华法林和抗血小板药物对器械袋血肿风险的影响:擦伤控制1和2的综合分析。","authors":"V. Essebag, J. Healey, J. Joza, P. Nery, E. Kalfon, T. Leiria, A. Verma, F. Ayala-Paredes, B. Coutu, G. Sumner, G. Becker, F. Philippon, J. Eikelboom, R. Sandhu, John Sapp, R. Leather, D. Yung, B. Thibault, C. Simpson, K. Ahmad, Satish C. Toal, M. Sturmer, K. Kavanagh, E. Crystal, G. Wells, A. Krahn, D. Birnie","doi":"10.1161/CIRCEP.119.007545","DOIUrl":null,"url":null,"abstract":"BACKGROUND\nOral 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.\n\n\nMETHODS\nWe 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.\n\n\nRESULTS\nAntiplatelet 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).\n\n\nCONCLUSIONS\nConcomitant 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.\n\n\nCLINICAL TRIAL REGISTRATION\nURL: https://www.clinicaltrials.gov. Unique identifiers: NCT00800137, NCT01675076.","PeriodicalId":10167,"journal":{"name":"Circulation: Arrhythmia and Electrophysiology","volume":"11 1","pages":"e007545"},"PeriodicalIF":0.0000,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"23","resultStr":"{\"title\":\"Effect of Direct Oral Anticoagulants, Warfarin, and Antiplatelet Agents on Risk of Device Pocket Hematoma: Combined Analysis of BRUISE CONTROL 1 and 2.\",\"authors\":\"V. Essebag, J. Healey, J. Joza, P. Nery, E. Kalfon, T. Leiria, A. Verma, F. Ayala-Paredes, B. Coutu, G. Sumner, G. Becker, F. Philippon, J. Eikelboom, R. Sandhu, John Sapp, R. Leather, D. Yung, B. Thibault, C. Simpson, K. Ahmad, Satish C. Toal, M. Sturmer, K. Kavanagh, E. Crystal, G. Wells, A. Krahn, D. Birnie\",\"doi\":\"10.1161/CIRCEP.119.007545\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"BACKGROUND\\nOral 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.\\n\\n\\nMETHODS\\nWe 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.\\n\\n\\nRESULTS\\nAntiplatelet 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).\\n\\n\\nCONCLUSIONS\\nConcomitant 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.\\n\\n\\nCLINICAL TRIAL REGISTRATION\\nURL: https://www.clinicaltrials.gov. Unique identifiers: NCT00800137, NCT01675076.\",\"PeriodicalId\":10167,\"journal\":{\"name\":\"Circulation: Arrhythmia and Electrophysiology\",\"volume\":\"11 1\",\"pages\":\"e007545\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2019-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"23\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Circulation: Arrhythmia and Electrophysiology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1161/CIRCEP.119.007545\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Circulation: Arrhythmia and Electrophysiology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1161/CIRCEP.119.007545","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Effect of Direct Oral Anticoagulants, Warfarin, and Antiplatelet Agents on Risk of Device Pocket Hematoma: Combined Analysis of BRUISE CONTROL 1 and 2.
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.