A Novel Issue for Vitreoretinal Surgeons

McClellan, Andrew J.; Flynn, Harry W.; Gayer, Steven

doi:10.1097/iae.0000000000000763

Cited by 3 publications

(1 citation statement)

References 13 publications

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“…With regard to retrobulbar haemorrhages, they also resolve spontaneously, although their appearance may cause the surgical intervention to be delayed. This circumstance has led to many authors proposing a change in this paradigm and considering PPV as having moderate or even low haemorrhagic risk and considering continuing anticoagulant therapy before surgery [23–25], an assertion that the present trial will attempt to assess.…”

Section: Discussionmentioning

confidence: 99%

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

Andonegui

Capdevila

Zubicoa

et al. 2019

Trials

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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.

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Section: Discussionmentioning

confidence: 99%