Bleeding, Coronary Artery Disease, Direct Acting Anticoagulant Adverse Reaction
Conditions
Brief summary
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
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 3 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 1.6% BARC type 3 or 5 bleeding in patients undergoing transradial percutaneous coronary procedures.
Interventions
DRUGDirect-acting oral anticoagulation
Apixaban Dabigatran Edoxaban Rivaroxaban
Sponsors
Hospital Universitario La Fe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients under anticoagulation with DOAC and any indication for diagnostic or therapeutic trans-radial percutaneous coronary procedures. At least 25% of the population undergoing PCI will be included.
Exclusion criteria
1. Aged \< 18 years 2. Cardiogenic shock 3. Major active bleeding at the time of the procedure 4. Use of mechanical circulatory support 5. Chronic total occlusions 6. Pre-planned vascular access different from radial artery access (i.e. femoral, brachial, ulnar) 7. Inability to provide informed consent 8. Unable to understand and follow study-related instructions or unable to comply with study protocol 9. Currently participating in another trial 10. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 | 30-day follow-up |
Secondary
| Measure | Time frame |
|---|---|
| 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 BARC type 3, or 5 | 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 |
| Rate of definite/probable stent thrombosis | 30-day follow-up |
Countries
Italy, Spain
Contacts
Primary ContactJorge Sanz Sanchez, MD, PhD
Outcome results
None listed