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

Abstract

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.

Antiplatelets and Anticoagulants in Vitreoretinal Surgery: A Systematic Review

“…Andonegui et al [ 18 ], in 2019, made the first protocol of a RCT to assess the differences in perioperative complications of PPV between individuals who receive anticoagulant treatment before surgery and those who do not. This trial’s results will offer novel data about the potential for anticoagulant treatment continuation during PPV.…”

The Adequacy of Anesthesia Guidance for Vitreoretinal Surgeries with Preemptive Paracetamol/Metamizole

“…Nevertheless, there are contraindications to perform RA alone, including antiplatelet therapy, predicted impaired cooperation with the operator during long-lasting procedures due to neurological deficits, and danger of respiratory disorders during pars plana vitrectomy (PPV) under RA with monitored anesthesia care in elderly patients, which still imposes the necessity of VRS performance under GA [ 2 , 3 ]. Although attempts have been made to perform VRS under RA in patients using oral anticoagulants [ 4 ], it entails the administration of intraoperative rescue opioid analgesia (IROA) in the case of an increased heart rate and blood pressure, which are signs of inadequate analgesia. The utility of IROA has been identified as an independent risk factor for postoperative nausea and vomiting (PONV) in the first 48 h after VRS [ 4 ], and therefore RA techniques are employed to reduce the dose of IROA.…”

“…Although attempts have been made to perform VRS under RA in patients using oral anticoagulants [ 4 ], it entails the administration of intraoperative rescue opioid analgesia (IROA) in the case of an increased heart rate and blood pressure, which are signs of inadequate analgesia. The utility of IROA has been identified as an independent risk factor for postoperative nausea and vomiting (PONV) in the first 48 h after VRS [ 4 ], and therefore RA techniques are employed to reduce the dose of IROA. The addition of different preoperative, preventive RA techniques to GA in patients undergoing VRS also reduces the IROA dose [ 5 , 6 ], which in turn decreases the rate of PONV, leading to efficient postoperative analgesia and diminishing the rate of the oculocardiac reflex (OCR), although it was not completely eliminated [ 7 ].…”

Effect of Anticoagulant Therapy on the Outcome of Descemet Membrane Endothelial Keratoplasty

“…[18][19][20][21] Most surgeries are performed without stopping the anticoagulant therapy (ACT). [22][23][24] Although risks for intraocular bleeding have been reported in patients undergoing ocular surgeries while on ACT, 25 several serious downsides in stopping ACT exist, such as myocardial or cerebral infarction. 26 However, case reports and small case series on bleeding during DMEK are few.…”