Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL) (REVIVAL)

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

Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.

Study Overview

• Status: Unknown
• Conditions: TAVI; Transcatheter Valve Implantation
• Intervention / Treatment: Procedure: PCI 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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10100
    • Recruiting
    • Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy
  • Milan
    • Rozzano, Milan, Italy
      • Recruiting
      • Humanitas Research Hospital, Humanitas University
      • Contact: Giulio Stefanini, MD, PhD; Phone Number: +390282241; Email: giulio.stefanini@hunimed.eu
      • Principal Investigator: Giulio Stefanini, MD,PhD
• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital Clinico San Carlos
    • Contact: Luis Nombela-Franco, MD,PhD; Phone Number: +34 91 330 30 00; Email: luisnombela@yahoo.com
    • Principal Investigator: Luis Nombela-Franco, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

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

Collaborators and Investigators

• Sponsor: San Luigi Gonzaga Hospital

Publications and helpful links

General Publications

• Stefanini GG, Cerrato E, Pivato CA, Joner M, Testa L, Rheude T, Pilgrim T, Pavani M, Brouwer J, Lopez Otero D, Munoz Garcia E, Barbanti M, Biasco L, Varbella F, Reimers B, Jimenez Diaz VA, Leoncini M, Salido Tahoces ML, Ielasi A, de la Torre Hernandez JM, Mylotte D, Garot P, Chieffo A, Nombela-Franco L; REVIVAL Investigators. Unplanned Percutaneous Coronary Revascularization After TAVR: A Multicenter International Registry. JACC Cardiovasc Interv. 2021 Jan 25;14(2):198-207. doi: 10.1016/j.jcin.2020.10.031. Erratum In: JACC Cardiovasc Interv. 2021 Apr 26;14(8):940.

Helpful Links

• Organization research website

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: PCI; TAVI
• Other Study ID Numbers: 001-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No