Single or Dual Antiplatelet Therapy After Transcatheter Aortic Valve Implantation
Status:
Recruiting
Trial end date:
2025-06-30
Target enrollment:
Participant gender:
Summary
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.