Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL)

Study Overview
=================
Brief Summary
-----------------
Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.

Detailed Description
-----------------
The increasing operator experience combined with an improved performance of devices have led to extend current transcatheter aortic valve implantation (TAVI) indications to patients at low or intermediate risk. The safety of TAVI in this population was initially tested in small observational studies and recently reported in the randomized PARTNER 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Trial (SURTAVI) trials, which demonstrated non- inferiority of TAVI in low or intermediate risk patients as compared to surgery with respect to the primary endpoint of death or disabling stroke. In view of the changes in the TAVI population, including younger patients with longer survival, the number of patients that may require coronary revascularization after TAVI is expected to increase over the time. Of note, challenges in performing percutaneous coronary interventions (PCI) in patients previously treated with TAVI have been reported in small series. Against this background, the purpose of this retrospective multicenter study is to evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI. Objectives Evaluate the incidence of PCI after TAVI Evaluate the clinical indications for PCI after TAVI Evaluate the technical feasibility of PCI in patients with prior TAVI Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI

Official Title
-----------------
A Multicenter Observational Registry on Coronary Revascularization After Implantation of Transcatheter Aortic Valve Bioprosthesis

Conditions
-----------------
Transcatheter Valve Implantation, TAVI

Intervention / Treatment
-----------------
* Procedure: PCI after TAVI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: PCI after TAVI|Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the incidence of PCI after TAVI | Evaluate the incidence of PCI after TAVI | up to 5 year after TAVI implantation | 
| Evaluate the clinical indications for PCI after TAVI | Clinical indication for PCI: stable angina; documented silent ischemia; acute coronary syndrome/non-ST elevation myocardial infarction; acute coronary syndrome/ST elevation myocardial infarction | intraoperative | 
| Evaluate the technical feasibility of PCI in patients with prior TAVI | Successful target coronary vessel revascularization | intraoperative | 
| Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI | outcome defined as MACE (Major Adverse Coronary Event) a composite of Death, Myocardial Infarction, Target Lesion Failure | up to 5 year after TAVI implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TAVI, PCI