Phase 3
N=231
Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)
Aortic Valve Stenosis · Cardiovascular Diseases · Heart Valve Diseases · Ventricular Outflow Obstruction · Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT02833948 ↗Enrolled (actual)
231
Serious AEs
4.3%
Results posted
Jan 2020
Primary outcome: Primary: Rate of Patients With at Least One Prosthetic Leaflet With >50% Motion Reduction as Assessed by Cardiac 4DCT-scan — 11; 2 Participants — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Acetylsalicylic acid (Drug); Clopidogrel (Drug); Rivaroxaban (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ECRI bv
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Patients With at Least One Prosthetic Leaflet With >50% Motion Reduction as Assessed by Cardiac 4DCT-scan |
11; 2 | 0.01 sig |
| SECONDARY The Rate of Prosthetic Leaflets With > 50% Motion Reduction as Assessed by Cardiac 4DCT-scan |
14; 3 | — |
| SECONDARY The Rate of Patients With at Least One Prosthetic Leaflet With Thickening as Assessed by Cardiac 4DCT-scan |
33; 12 | — |
| SECONDARY The Rate of Prosthetic Leaflets With Thickening as Assessed by Cardiac 4DCT-scan |
53; 16 | — |
| SECONDARY Aortic Transvalvular Mean Pressure Gradient (mmHg) as Determined by Transthoracic Echocardiography. |
10; 10 | 0.01 sig |
| SECONDARY Effective Orifice Area (cm^2) as Determined by Transthoracic Echocardiography. |
1.8; 1.8 | — |
| SECONDARY Death Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (HALT) - as Exploratory Analysis. |
0; 0 | — |
| SECONDARY Death Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (RLM)- as Exploratory Analysis. |
0; 0 | — |
| SECONDARY Thromboembolic Event Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (HALT)- as Exploratory Analysis. |
2; 0 | — |
| SECONDARY Thromboembolic Event Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (RLM) - as Exploratory Analysis. |
2; 0 | — |
Summary
The aortic valve is located between the left ventricle and the aorta. Patients with symptomatic, severe aortic valve stenosis conventionally have it surgically replaced requiring direct access to the heart through the chest. Transcatheter aortic valve replacement (TAVR) is now a well-established alternative for treating severe aortic valve stenosis. Both types of intervention improve prognosis and alleviate symptoms.
The optimal choice of blood thinning therapy after TAVR is unknown. It has been reported that leaflet thrombosis with reduced leaflet motion can occur and this phenomenon has been suggested to be potentially related with neurological events. In addition, the occurence of this phenomenon can be reduced with anticoagulation blood thinning therapy.
The purpose of this study is to evaluate if anticoagulation compared to the usual double platelet inhibitor therapy after TAVR can reduce the risk of leaflet thrombosis.
Eligibility Criteria
Inclusion Criteria
- Successful TAVR of a native aortic valve stenosis
- By iliofemoral or subclavian access
- With any approved/marketed TAVR device
- Written informed consent
Exclusion Criteria
- Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant treatment
- Any other indication for continued treatment with any oral anticoagulant
- Known bleeding diathesis (such as but not limited to platelet count ≤ 50,000/mm3 at screening, hemoglobin level < 8.5 g/dL or < 5.3 mmol/l, history of intracranial hemorrhage, or subdural hematoma)
- Any indication for dual antiplatelet therapy (DAPT) for more than three months after randomization (such as coronary, carotid, or peripheral stent implantation)
- Clinically overt stroke within the last three months
- Planned coronary or vascular intervention or major surgery
- Severe renal insufficiency (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction ≥ stage 2
- Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy
- Iodine contrast allergy or other condition that prohibits CT imaging
Data sourced from ClinicalTrials.gov (NCT02833948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.