None listed
Conditions
Interventions
Transcatheter aortic valve replacements.
Bivalirudin will be administered as a bolus and infusion. It is recommended that the bolus (0.75 mg/kg) be directly administered through the valve delivery sh
Sponsors
The Medicines Company
8 Sylvan Way
Parsippany, NJ07054
Eligibility
Inclusion criteria
Inclusion criteria: 1. ≥ 18 years of age; 2. High risk (Euroscore ≥18, or considered inoperable) for surgical aortic valve replacement; 3. Undergoing TAVR via transfemoral arterial access; 4. Provide written informed consent before initiation of any study related procedures.
Exclusion criteria
Exclusion criteria: 1. Contraindication to bivalirudin or UFH; 2. Refusal to receive blood transfusion; 3. Mechanical valve (any location) or mitral bioprosthetic valve; 4. Extensive calcification of the common femoral artery, or minimal luminal diameter4.0 mg/dL or dialysis dependent; 13. Administration of thrombolytics, glycoprotein IIb/IIIa inhibitors, or warfarin in the 3 days prior to the procedure; 14. Acute myocardial infarction, major surgery or any therapeutic cardiac procedure (other than balloon aortic valvuloplasty) within 30 days; 15. Percutaneous coronary intervention with drug-eluting stent(s) within 30 days; 16. Upper gastrointestinal or genitourinary bleed within 30 days; 17. Stroke or transient ischemic attack within 30 days; 18. Any surgery or biopsy within 2 weeks; 19. Administration of: A. UFH within 30 minutes of the procedure; B. Enoxaparin within 8 hours of the procedure; C. Fondaparinux or other LMWHs within 24 hours of the procedure; D. Dabigatran, rivaroxaban or other oral anti-Xa or antithrombin agent within 48 hours of the procedure; E. Thrombolytics, GPI, or warfarin within 72 hours of the procedure. 20. Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast; 21. Contraindications or allergy to aspirin or clopidogrel; 22. Known or suspected pregnant women, or nursing mothers. Women of child-bearing potential will be asked if they are pregnant and will be tested for pregnancy; 23. Previous enrolment in this study; 24. Treatment with other investigational drugs or devices within the 30 days preceding enrollment or planned use of other investigational drugs or devices before the primary endpoint of this study has been reached. Patients excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point will be major bleeding defined as Bleeding Academic Research Consortium (BARC) type ≥3 at 48 hours or hospital discharge whichever occurs first. BARC type 3 bleeding includes bleeds that are evident clinically, or by laboratory or imaging results, which result in treatment with blood transfusion, surgical intervention, or administration of intravenous vasoactive drugs; overt bleeds with a hemoglobin drop of at least 3g/dL; bleeding that causes cardiac tamponade; and intracranial or intraocular bleeds that compromise vision. BARC type 4, CABG related bleeding, is not applicable to this study. BARC type 5, fatal bleeding, describes bleeds that directly result in death with no other cause. The co-primary endpoint will be net adverse cardiac events (NACE) at 30 days that is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3). The composite of major adverse cardiovascular events (MACE) is defined as all-cause mortality, myocardial infarction, and stroke. All events will be adjudicated using source documents by an independent clinical events committee blinded to the antithrombotic agents. Each component of the co-primary endpoint will be tested in a hierarchical manner with a superiority test for bleeding followed by a non-inferiority and then superiority test for NACE. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Major bleeding according to additional scales (VARC, TIMI, GUSTOACUITY/HORIZONS); 2. Minor bleeding (BARC type 1 and 2 and TIMI minor); 3. Major adverse cardiac events (MACE) including death, non-fatal MI, and stroke; 4. The rates of the individual components of MACE; 5. Transient ischemic attack; 6. Acute kidney injury; 7. VARC major vascular complications; 8. Valve performance indicators and TAVR specific complications, with all of these endpoints defined by accepted VARC definitions; 9. Acquired thrombocytopenia; 10. Rate of new post-procedural atrial fibrillation/flutter; 11. Rate of persistent, profound hypotension; 12. Economic analysis of using bivalirudin in TAVR. All end points will be assessed at 48 hours post-procedure (or prior to hospital discharge, if that occurs earlier) and at 30-days. With respect to the economic analysis, the analysis time point will be fixed to the hospital discharge. | — |
Contacts
Public ContactIlknur Lechthaler
Innere Margarethenstrasse 5
Outcome results
None listed