Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation (REAC-TAVI2)

Fundacin Biomedica Galicia Sur

Status and phase: Enrolling; Phase 4

Conditions: Severe Aortic Valve Stenosis; Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement (TAVR); Transcatheter Aortic Valve Implantation (TAVI)

Treatments: Drug: Ticagrelor 60mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05283356

2021-003927-13 (EudraCT Number)

REAC-TAVI 2

Details and patient eligibility

About

The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully defined and constitutes an important unmet clinical need. Recently, single antiplatelet therapy (SAPT) with Aspirin has been increasingly adopted to avoid bleeding early after TAVI compared with dual antiplatelet therapy. However, TAVI population is affected by a diversity of chronic pathologies that increase the risk of post-TAVI ischemic complications. Stroke is prevalent, especially peri- and early post-TAVI (<1-8% in the 1st year). Although peri-TAVI myocardial infarction (MI) is rare (1-3%), concomitant coronary artery disease (CAD), diabetes mellitus (DM), and peripheral vascular disease (PVD), is very frequent in the TAVI population, affecting around 30-70% of patients. In patients with CAD, the need to re-access the coronary arteries after TAVI is challenging and can be hampered by the trancatheter valve struts.

This is critical in TAVI patients with an acute coronary syndrome and in younger patients with long-life expectancy after TAVI. The use of a P2Y12 inhibitor provides significant ischemic protection in the in the coronary, cerebral and peripheral vascular territories compare to Aspirin. The use of a P2Y12 inhibitor as antiplatelet treatment can decrease the need for new coronary revascularizations and reduce the incidence of thromboembolic complications after TAVI.

Enrollment: 1,206 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of informed consent prior to any study specific procedures.

2. Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.

3. Patients with degenerative symptomatic severe aortic stenosis (AS) accepted for TAVI with any of the commercial approved TAVI devices after evaluation of the Heart Team of each center,and with at least one of the following comorbidities:

   1. Diabetes Mellitus, the current WHO diagnostic criteria for diabetes should be maintained - fasting plasma glucose ≥ 7.0mmol/l (126 mg/dl) or 2-h plasma glucose ≥ 11.1mmol/l (200mg/dl), or under treatment with an oral hypoglycemic or insulin.
   2. Prior coronary artery disease (STEMI, NSTEMI, stable angina, or others) documented by invasive or non-invasive ischemia screening tests or imaging study.
   3. Prior peripheral arterial disease documented by invasive or non-invasive ischemia screening tests or imaging study.

4. Successful TAVI performed by any vascular access.

5. Patients who are not participating in any other clinical trial or research study (registries allowed).

Exclusion criteria

1. Patients under chronic oral anticoagulation for any specific pathology.
2. Patients that cannot undergo a regimen of single antiplatelet therapy after TAVI.
3. History of overt major bleeding or intracranial hemorrhage.
4. Active pathological bleeding.
5. History of ischemic stroke within the last 30 days prior TAVI.
6. Patients with documented severe hepatic insufficiency.
7. Known pregnancy, breast-feeding, or intend to become pregnant during the study period.
8. Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the study.
9. Patients randomized in another clinical trial with an investigational product or device over the past 30 days.
10. Patients who cannot attend follow-up visits scheduled in the study.
11. History of allergic reactions or intolerance to Ticagrelor or Aspirin or any of the excipients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,206 participants in 2 patient groups

Acetylsalicylic acid 100mg/day

Active Comparator group

Description:

Aspirin 100 mg/day after TAVI

Treatment:

Drug: Ticagrelor 60mg

Ticagrelor 60mg twice per day

Experimental group

Description:

Ticagrelor 60 mg twice per day after TAVI

Treatment:

Drug: Ticagrelor 60mg