Anaesthetic management of patients being treated with anticoagulants

et al. 2019

Trials

BackgroundVitreoretinal surgery in anticoagulated patients is a challenging situation for vitreoretinal surgeons, who have to choose between being faced with the systemic thromboembolic risks that the interruption of anticoagulation involves, or the intra- and postoperative haemorrhagic risks associated with maintenance of this therapy. So far, no trial has compared, in a prospective and randomized manner, perioperative complications and the visual results associated with continuation or interruption of oral anticoagulant therapy before pars plana vitrectomy (PPV) under retrobulbar anaesthesia. The main objective of this trial is to compare haemostasis-related perioperative complications of PPV in patients maintaining anticoagulant therapy before surgery compared to patients with an interruption in this therapy before surgery.MethodsNinety-six patients will be randomly assigned to either the control group, in whom oral anticoagulant therapy will be interrupted and substituted with subcutaneous heparin according to local clinical practice, or the intervention group in whom oral anticoagulant therapy will not be interrupted before surgery. Patients will be stratified according to the oral anticoagulant they were taking (direct or indirect anticoagulation). They will be followed up for 12 weeks, and the primary outcome, and haemorrhagic complications until 15 days after surgery, will be evaluated.DiscussionThis trial will provide novel information on the possibility of continuing anticoagulant therapy during PPV. The benefits expected from the change in the current surgical management paradigm for anticoagulated patients would be a decreased risk in the incidence of perioperative thromboembolic events and the possibility of performing surgery without delay and without the need for patients to change their usual anticoagulation protocol to the more complex and less safe substitutive therapy.Trial registrationClinical Trials Register EudraCT, 2018–000753-45. Registered on 11 November 2018.

Section: Discussionmentioning

confidence: 99%

Randomised controlled trial on vitreoretinal surgery with and without oral anticoagulants: surgical complications, visual results and perioperative thromboembolic events

et al. 2019

Trials

“…Cases of serious complications, and even death, have been described in patients who had interrupted anticoagulant treatment before surgery (13)(14)(15). Some investigators have also suggested that anticoagulant therapy interruption could produce a rebound hypercoagulability state due to the alteration of the balance between vitamin K dependent factors and proteins C and S (16)(17)(18)(19). Moreover, it is a situation that makes it necessary to postpone surgery Even though some authors have found an increased risk of haemorrhagic complications in anticoagulated patients undergoing PPV, the incidence has been low, without statistical significance and without serious consequences for visual acuity (9,10,11,20,21).…”

Section: Discussionmentioning

confidence: 99%

Randomised controlled trial on vitreoretinal surgery with and without oral anticoagulants: surgical complications, visual results and perioperative thromboembolic events

et al. 2019

Preprint

Background Vitreoretinal surgery in anticoagulated patients is a challenging situation for vitreoretinal surgeons, who have to choose between being faced with the systemic thromboembolic risks that the interruption of anticoagulation involves, or the intra and postoperative haemorrhagic risks associated with maintenance of this therapy. So far, no trial has compared, in a prospective and randomized manner, perioperative complications and the visual results associated with continuation or interruption of oral anticoagulant therapy before pars plana vitrectomy under retrobulbar anaesthesia. The main objective of this trial is to compare haemostasis-related perioperative complications of PPV in patients maintaining anticoagulant therapy before surgery compared to patients who interrupt this therapy before surgery. Methods Ninety six patients will be randomly assigned to either the control group, to whom oral anticoagulant therapy will be interrupted and substituted with subcutaneous heparin according to local clinical practice, or the intervention group to whom oral anticoagulant therapy will not be interrupted before surgery. Patients will be stratified according to the oral anticoagulant they were taking (direct or indirect anticoagulation). They will be followed-up for 12 weeks, and the primary outcome, and haemorrhagic complications until 15 days after surgery, will be evaluated. Discusion This trial will provide novel information on the possibility of continuing anticoagulant therapy during PPV. The benefits expected from the change in the current surgical management paradigm for anticoagulated patients would be a decreased risk in the incidence of perioperative thromboembolic events and the possibility of performing surgery without delay and without the need for patients to change their usual anticoagulation protocol to the more complex and less safe substitutive therapy.

“…Cases of serious complications, and even death, have been described in patients who had interrupted anticoagulant treatment before surgery (13)(14)(15). Some investigators have also suggested that anticoagulant therapy interruption could produce a rebound hypercoagulability state due to the alteration of the balance between vitamin K dependent factors and proteins C and S (16)(17)(18)(19). Moreover, it is a situation that makes it necessary to postpone surgery for a number of days, and this can compromise visual recovery in some surgical indications such as retinal detachment.…”

Section: Discussionmentioning

confidence: 99%

Randomised controlled trial on vitreoretinal surgery with and without oral anticoagulants: surgical complications, visual results and perioperative thromboembolic events

et al. 2019

Preprint

Background Vitreoretinal surgery in anticoagulated patients is a challenging situation for vitreoretinal surgeons, who have to choose between being faced with the systemic thromboembolic risks that the interruption of anticoagulation involves, or the intra and postoperative haemorrhagic risks associated with maintenance of this therapy. So far, no trial has compared, in a prospective and randomized manner, perioperative complications and the visual results associated with continuation or interruption of oral anticoagulant therapy before pars plana vitrectomy under retrobulbar anaesthesia. The main objective of this trial is to compare haemostasis-related perioperative complications of PPV in patients maintaining anticoagulant therapy before surgery compared to patients who interrupt this therapy before surgery. Methods Ninety six patients will be randomly assigned to either the control group, to whom oral anticoagulant therapy will be interrupted and substituted with subcutaneous heparin according to local clinical practice, or the intervention group to whom oral anticoagulant therapy will not be interrupted before surgery. Patients will be stratified according to the oral anticoagulant they were taking (direct or indirect anticoagulation). They will be followed-up for 12 weeks, and the primary outcome, and haemorrhagic complications until 15 days after surgery, will be evaluated. Discusion This trial will provide novel information on the possibility of continuing anticoagulant therapy during PPV. The benefits expected from the change in the current surgical management paradigm for anticoagulated patients would be a decreased risk in the incidence of perioperative thromboembolic events and the possibility of performing surgery without delay and without the need for patients to change their usual anticoagulation protocol to the more complex and less safe substitutive therapy.