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Pharmacodynamic Approach to Manage Patients on Direct Oral Anticoagulants Undergoing Elective Major Surgery and Operative Endoscopy

S. Testa, O. Paoletti, R. Morandini, M. Tala, C. Dellanoce, A. Biondi, V. Cancelli, E. Cancellieri, C. Zecca, S. Zambelli

ASST Cremona, Department of Laboratory Medicine, Cremona, Italy

Abstract Number: PB0292

Meeting: ISTH 2020 Congress

Theme: Coagulation and Natural Anticoagulants » Critical Care and Perioperative

Background: Direct oral anticoagulants (DOAC) have shown a high inter-individual variability. Nevertheless plasma measurements are still not recommended and perioperative management is widely proposed on the base on a pharmacokinetic approach.

Aims: To evaluate a pharmacodynamic approach to manage patients on DOAC undergoing elective surgery and invasive procedures.

Methods: Patients were classified as high or low individual thrombotic risk in relation to CHA2DS2VASc score for atrial fibrillation (AF) and risk of recurrences for venous thromboembolism (VTE). Creatinine clearance (CrCl) and DOAC C-trough levels were measured within three months from surgery and the day of intervention. DOAC were stopped from 1 to 4 days in relation to C-trough level, considering acceptable a drug concentration less than 30ng/mL. Low molecular weight heparin at prophylactic or intermediate dose was administered 12 hours after surgery or therapeutic gastrointestinal endoscopy, while DOAC treatments were resumed at day 5. Major bleeding and thrombotic events, occurring from drug interruption to 30 days after surgery, were registered.

Results: From September 2013 until December 2019, 3802 patients (2725 AF, 1077 VTE) on DOAC (1125 apixaban, 913 dabigatran, 773 edoxaban, 991 rivaroxaban) were followed by the specialized center. During 6 years, we managed 215 elective major surgery and 288 elective invasive endoscopic gastrointestinal procedures. Median CrCl was 67mL/min (21 to 185). DOAC were stopped 2 days before intervention in 49.7%, 1 day in 16.3% and 2-4 days in 38% of cases and mean DOAC levels were< 30ng/mL in all patient except 2 that showed drug concentration between 30-50ng/mL. 5 major bleedings (0.99%), were observed during the first week of DOAC resumption. No thrombotic complication were registered.

Conclusions: This individualized approach, based on pharmacodynamic approach, seems to be safe and effective for DOAC patients undergoing major surgery and operative endoscopy. Further data could help physicians to improve perioperative management and patient safety.

To cite this abstract in AMA style:

Testa S, Paoletti O, Morandini R, Tala M, Dellanoce C, Biondi A, Cancelli V, Cancellieri E, Zecca C, Zambelli S. Pharmacodynamic Approach to Manage Patients on Direct Oral Anticoagulants Undergoing Elective Major Surgery and Operative Endoscopy [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/pharmacodynamic-approach-to-manage-patients-on-direct-oral-anticoagulants-undergoing-elective-major-surgery-and-operative-endoscopy/. Accessed October 1, 2023.

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