Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL)

• Conditions: Transcatheter Valve Implantation; TAVI

• Registration Number: NCT03283501
• Lead Sponsor: San Luigi Gonzaga Hospital

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

1. Evaluate the incidence of PCI after TAVI

2. Evaluate the clinical indications for PCI after TAVI

3. Evaluate the technical feasibility of PCI in patients with prior TAVI

4. Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI

Study Timeline

• Study Start: 2017-04-20
• Status Verified: 2017-09
• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-12
• Last Update Submitted: 2017-09-12
• Study First Posted: 2017-09-14
• Last Update Posted: 2017-09-14
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (3)

Humanitas Research Hospital, Humanitas University; 🇮🇹 Rozzano, Milan, Italy

Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy; 🇮🇹 Turin, Italy

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain