Direct Oral Anticoagulant Management for Cardiac Device Implantation (StimAOD)

Influence of Peri-procedural Management of Direct Oral Anticoagulants on the Incidence of Pocket Hematoma in Patients Undergoing Cardiac Rhythm Device Implantation

Each year, tens of thousands of cardiac rhythm devices including pacemaker (PM) or implantable cardioverter-defibrillator (ICD) are implanted in France. More than 25% of patients undergoing cardiac device implantation receive long-term anticoagulation therapy, that increases the incidence of pocket hematoma with potential serious consequences for patients. Although more and more patients receive direct oral anticoagulants (DOACs), limited data currently exist on the perioperative management of DOAC-treated patients undergoing cardiac device implantation and the optimal strategy remains unclear. Especially, the time of DOAC resumption after the procedure is controversial.

We hypothesize that the time of DOAC resumption is the main risk factor of bleeding event in DOAC-treated patients undergoing cardiac device implantation, that is to say that a delayed DOAC resumption > 48 hours following the procedure will reduce pocket hematoma incidence compared with an early resumption, ≤ 48 hours, without increasing thromboembolic events. We propose here an observational multicentre national study to find out the optimal strategy.

Study Overview

• Status: Unknown
• Conditions: Anticoagulant, Perioperative

• Study Type: Observational
• Enrollment (Anticipated): 680

Contacts and Locations

• Study Contact: Name: Nassima Oukkal; Phone Number: 01 56 09 20 00; Email: nassima.oukkal-ext@aphp.fr
• Study Contact Backup: Name: Nassima Oukkal; Email: nassima.oukkal-ext@aphp.fr

Study Locations

• France
  • Paris, France, 75000
    • Recruiting
    • HEGP
    • Contact: Nassima Oukkal
    • Principal Investigator: Eloi Marijon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Inclusion Criteria:

• receiving DOAC (apixaban, rivaroxaban, dabigatran) for stroke prevention in atrial fibrillation at least 5 days prior to enrolment
• undergoing a cardiac rhythm device implantation (implantation or replacement of PM (1 or 2 leads) and ICD (1or 2 leads) with or without cardiac-resynchronization therapy
• informed

Description

Inclusion Criteria:

• receiving DOAC (apixaban, rivaroxaban, dabigatran) for stroke prevention in atrial fibrillation at least 5 days prior to enrolment
• undergoing a cardiac rhythm device implantation (implantation or replacement of PM (1 or 2 leads) and ICD (1or 2 leads) with or without cardiac-resynchronization therapy
• informed

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with clinically significant pocket hematoma	hematoma requiring reoperation, and/or resulting in prolongation of hospitalization, and/or requiring interruption of all anticoagulation.	30 +/- 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with thromboembolic event	transient ischemic attack, stroke, peripheral embolus, venous thromboembolism	30 +/- 5 days

Collaborators and Investigators

• Sponsor: Institut Necker Enfants Malades
• Investigators: Principal Investigator: Anne-Céline Martin, MD, PhD, INSERM 1140

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ANTICIPATED): February 1, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (ACTUAL): March 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 15, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CV185-614

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No