A Randomized Controlled Trial to Investigate Whether a Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at the Time of Device Surgery, in Patients With Moderate to High Risk of Arterial Thrombo-embolic Events, Leads to a Reduction in the Incidence of Clinically Significant Hematoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 663
- 试验地点
- 15
- 主要终点
- Clinically significant hematoma
研究概览
简要总结
The purpose of this study is to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.
详细描述
This is a prospective, open-label, randomized trial, with 1:1 randomization to either continued NOAC or interrupted NOAC in patients with non-rheumatic atrial fibrillation or atrial flutter and at moderate to high risk of arterial thrombo-embolic events who require device surgery.
All patients in the study will be receiving Dabigatran or Rivaroxaban or Apixaban for at least 5 days prior to enrollment. The peri-operative management of the NOAC the patient is receiving is randomized to Interrupted NOAC or Continued NOAC.
Interrupted NOAC arm:
- Interrupted Dabigatran
- based on renal function, patients will discontinue Dabigatran 1 day before surgery if GFR > 50 mL/min, and 2 days before surgery if GFR is 30-50 mL/min.
- Dabigatran will be resumed at the next regular dose time, > or = 24 hours after the end of surgery.
- Interrupted Rivaroxaban
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any patient undergoing device surgery (ie. de novo device implant or pulse generator change or lead replacement or pocket revision)
- •receiving Dabigatran or Rivaroxaban or Apixaban for at least 5 days prior to enrollment
- •non-rheumatic atrial fibrillation and/or atrial flutter at moderate or high risk of ATE defined as: i) CHA2DS2VASc score greater than or equal to 2 OR ii) CHA2DS2VASc score < 2 with plan for cardioversion or defibrillation threshold testing at time of device surgery
排除标准
- •unable or unwilling to provide informed consent
- •history of noncompliance of medical therapy
- •active device infection
- •eGFR < 30 mL/min
- •contraindication to NOAC
- •rheumatic valvular disease with hemodynamically significant valve lesion
- •mechanical heart valve
研究组 & 干预措施
Continued NOAC
- Patients continue on their chronic dose of Dabigatran or Rivaroxaban or Apixaban throughout
干预措施: Apixaban (Drug)
Continued NOAC
- Patients continue on their chronic dose of Dabigatran or Rivaroxaban or Apixaban throughout
干预措施: Dabigatran (Drug)
Continued NOAC
- Patients continue on their chronic dose of Dabigatran or Rivaroxaban or Apixaban throughout
干预措施: Rivaroxaban (Drug)
Interrupted NOAC
Interrupted Dabigatran:
- Discontinue Dabigatran 1 day before surgery if GFR > 50 mL/min or discontinue 2 days before surgery if GFR 30-50 mL/min
- Resume Dabigatran at next regular dose timing >or = 24 hours after the end of surgery
Interrupted Rivaroxaban:
- Discontinue Rivaroxaban 1 full day before surgery
- Resume Rivaroxaban at next regular dose timing >or = 24 hours after the end of surgery
Interrupted Apixaban:
- Discontinue Apixaban 1 full day before surgery
- Resume Apixaban at next regular dose timing >or = 24 hours after the end of surgery
干预措施: Dabigatran (Drug)
Interrupted NOAC
Interrupted Dabigatran:
- Discontinue Dabigatran 1 day before surgery if GFR > 50 mL/min or discontinue 2 days before surgery if GFR 30-50 mL/min
- Resume Dabigatran at next regular dose timing >or = 24 hours after the end of surgery
Interrupted Rivaroxaban:
- Discontinue Rivaroxaban 1 full day before surgery
- Resume Rivaroxaban at next regular dose timing >or = 24 hours after the end of surgery
Interrupted Apixaban:
- Discontinue Apixaban 1 full day before surgery
- Resume Apixaban at next regular dose timing >or = 24 hours after the end of surgery
干预措施: Rivaroxaban (Drug)
Interrupted NOAC
Interrupted Dabigatran:
- Discontinue Dabigatran 1 day before surgery if GFR > 50 mL/min or discontinue 2 days before surgery if GFR 30-50 mL/min
- Resume Dabigatran at next regular dose timing >or = 24 hours after the end of surgery
Interrupted Rivaroxaban:
- Discontinue Rivaroxaban 1 full day before surgery
- Resume Rivaroxaban at next regular dose timing >or = 24 hours after the end of surgery
Interrupted Apixaban:
- Discontinue Apixaban 1 full day before surgery
- Resume Apixaban at next regular dose timing >or = 24 hours after the end of surgery
干预措施: Apixaban (Drug)
结局指标
主要结局
Clinically significant hematoma
时间窗: 2 weeks post-op or until resolution of hematoma
Defined as: 1. Hematoma requiring re-operation - Defined as a hematoma that continues to expand despite all appropriate non-operative measures, or is producing impending or actual wound breakdown or skin necrosis. Minor hematomas that are evacuated at the time of other re-operation (eg. for lead repositioning) are not considered as a primary outcome. or 2. Hematoma resulting in prolongation of hospitalization - Defined as extended hospitalization or rehospitalization for \> 24 hours, post index surgery, primarily due to hematoma. or 3. Hematoma requiring interruption of anti-coagulation. - Defined as reversal or intentional withholding of all anticoagulation for \> or = 24 hours, in response to wound hematoma.
次要结局
- Composite of major peri-operative bleeding events and thrombo-embolic events(2 weeks post-op)