Key result
Enoxaparin reduces composite efficacy-plus-safety events vs. unfractionated heparin, with an absolute ~3-point reduction.
Why the study?
Postoperative anticoagulation regimens in patients with mechanical prosthetic valves undergoing non-cardiac surgery are clear only for unfractionated heparin, while few trials evaluate low-molecular-weight heparin.
Does perioperative bridging anticoagulation with subcutaneous enoxaparin improve efficacy and safety outcomes compared to intravenous unfractionated heparin in patients with mechanical prosthetic heart valves undergoing non-cardiac surgery?
RCT (n=380)
open study period, independent commission evaluating stroke cases blinded of treatment assignment
stratified randomization method
No
Does perioperative bridging anticoagulation with subcutaneous enoxaparin improve efficacy and safety outcomes compared to intravenous unfractionated heparin in patients with mechanical prosthetic heart valves undergoing non-cardiac surgery?
Subcutaneous enoxaparin was associated with lower composite adverse event rates, shorter hospital stays, and reduced immobilization compared with intravenous unfractionated heparin for perioperative bridging in patients with mechanical heart valves undergoing non-cardiac surgery.
Answers are grounded in this paper and cite their sources.
Supports enoxaparin over heparin for perioperative bridging in mechanical valves; confirms RCT superiority on efficacy-safety composite.
Background and Objectives: Immediate postoperative anticoagulation regimens in patients with mechanical prosthetic valves undergoing non-cardiac surgery are clear only for unfractionated heparin (UH), whereas the few low-molecular-weight heparin (LMWH) trials available to date concern the use of Enoxaparin in general/orthopedic surgery. We performed a single-center real-world data study comparing the efficacy and safety of LMWH—Enoxaparin (E)— and UH during the perioperative period in non-cardiac surgical procedures in patients with mechanical prosthetic valve replacement in the mitral, aortic, or tricuspid positions. Materials and Methods: We enrolled 380 patients, who received E or UH together with oral anticoagulation with antivitamin K (acenocoumarol) until they achieved an optimal International Normalized Ratio (INR). Objective assessment of E efficacy included the following: normal value for all the parameters of ultrasound prosthetic functioning, no early thrombosis of the prosthesis, and rapid achievement of target INR with a decreased period of subcutaneous anticoagulation. Subjective assessment included the following: clinical improvement with decreased immobilization and in-hospital stay, fewer gluteal ulcerations, and fewer postoperative depression and anxiety episodes. Results: Comparing with UH, anticoagulation with E was more effective (p < 0.0001 and p = 0.02). The probability of death was smaller in the E group compared with the UH group. No major hemorrhagic event was reported. Mild bleeding episodes and thrombocytopenia were more common in the UH group. Patient’s compliance and quality of life were better with E due to shortened hospitalization, decreased need for testing of coagulation (every 6 h for UH), better dosing (SC every 12 h for E versus continuous infusion for UH), shortened immobilization during the immediate postoperative period with subsequent improvement in the psychological status, as well as due to lack of significant side effects. Conclusions: Taking into consideration the improved efficiency and safety, as well as all the supplementary advantages, such as no need for anticoagulation monitoring, the ease of administration, and reduced duration of hospitalization, E should be seen as an attractive alternative for anticoagulation which deserves further investigation.
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Iliuță et al. (2022) conducted an RCT in Mechanical prosthetic heart valve undergoing non-cardiac surgery (n=380). Enoxaparin vs. Unfractionated heparin (UH) IV continuous infusion adjusted to maintain APTT at 2.5 times normal value together with oral acenocoumarol was evaluated on Composite of 30-day mortality, in-hospital prosthesis obstructive dysfunction–thrombotic obstruction, duration of hospital stay and immobilization, plus in-hospital intracranial hemorrhage or in-hospital major bleeding other than intracranial bleeding (primary-efficacy-plus-safety endpoint) (p=0.02). Enoxaparin significantly reduced the primary efficacy-plus-safety composite endpoint compared to unfractionated heparin (6.25% vs. 9.04%, p = 0.02) and the primary efficacy endpoint (6.25% vs. 8.51%, p < 0.0001).
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