Uninterrupted Direct-acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures

Study Overview
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Brief Summary
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Up to 20-30% of patients who are candidates for direct oral anticoagulation (DOAC) present with concomitant ischemic heart disease and often require coronary angiography with or without percutaneous coronary intervention (PCI). The decision whether to continue the DOAC throughout periprocedural period or interrupt DOAC before planned procedure represents a substantial challenge in daily clinical practice. The objective of this study is to evaluate the safety of uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures.

Detailed Description
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The study design is an investigator-initiated, single-arm, open-label, pilot study in patients treated with DOAC undergoing trans-radial percutaneous coronary procedures. Because of the exploratory nature of this study, no formal sample size calculations are required. On the basis of previous pilot studies with similar designs, a sample of 200 patients is planned; with a safety stopping rule based on the occurrence of BARC type 3 or 5 bleeding. In the present trial, if during the enrollment period more than 4 cases of BARC 3 or 5 bleeding occur up to 30-day follow-up, patient recruitment will be terminated. This number is based on the reported 2.2% BARC type 3 or 5 bleeding in patients undergoing transradial percutaneous coronary procedures.

Official Title
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Uninterrupted Direct-acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures

Conditions
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Coronary Artery Disease, Bleeding, Direct Acting Anticoagulant Adverse Reaction

Intervention / Treatment
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* Drug: Direct-acting oral anticoagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients under anticoagulation with DOAC and any indication for diagnostic or therapeutic trans-radial percutaneous coronary procedures. At least 50% of the population undergoing PCI will be included. Exclusion Criteria: Aged < 18 years Cardiogenic shock Major active bleeding at the time of the procedure Use of mechanical circulatory support Chronic total occlusions Pre-planned vascular access different from radial artery access (i.e. femoral, brachial, ulnar) Inability to provide informed consent Unable to understand and follow study-related instructions or unable to comply with study protocol Currently participating in another trial Pregnant women
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uninterruped direct-acting oral anticoagulation<br>Uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures | Drug: Direct-acting oral anticoagulation<br>* Apixaban Dabigatran Edoxaban Rivaroxaban<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 |  | 30-day follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of BARC type 3, or 5 |  | 30-day follow-up | 
| Rate of all-cause death |  | 30-day follow-up | 
| Rate of cardiac death |  | 30-day follow-up | 
| Rate of stroke |  | 30-day follow-up | 
| Rate of myocardial infarction |  | 30-day follow-up | 
| Rate of definite/probable stent thrombosis |  | 30-day follow-up | 
| Rate of definite stent thrombosis |  | 30-day follow-up | 
| Rate of target-lesion revascularization |  | 30-day follow-up | 
| Rate of target-vessel revascularization |  | 30-day follow-up |