Clinical trial NCT03283501: Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL)
Official title: A Multicenter Observational Registry on Coronary Revascularization After Implantation of Transcatheter Aortic Valve Bioprosthesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transcatheter Valve Implantation
TAVI
Keywords: TAVI
PCI
Lead sponsor: San Luigi Gonzaga Hospital
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

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

Primary outcomes:
measure: Evaluate the incidence of PCI after TAVI
timeFrame: up to 5 year after TAVI implantation
measure: Evaluate the clinical indications for PCI after TAVI
timeFrame: intraoperative
measure: Evaluate the technical feasibility of PCI in patients with prior TAVI
timeFrame: intraoperative
measure: Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI
timeFrame: up to 5 year after TAVI implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital, Humanitas University
state: Milan
city: Turin
country: Italy
facility: Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
References:
citation: 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.