Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial

NCT04310046 | Active Not Recruiting

• 1 other identifier: TAVI PCI
• Study Type: interventional
• Target: 986
• Locations: 6 countries
• Sites: 48

Brief Summary

The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) by the multidisciplinary Heart Team, the safety and efficacy of angiography-guided complete revascularization performed after (within 1-45 days) with angiography-guided complete revascularization performed before (within 1-45 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.

Conditions

Aortic Stenosis; Coronary Artery Disease; TAVI; PCI

Keywords

Aortic Stenosis; Transcatheter Aortic Valve Replacement; Percutaneous Coronary Intervention; Heart Diseases; Valvular Disease; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the number of participants experiencing the primary outcome measure

  The primary outcome measure is a composite of: * All-cause death * Non-fatal myocardial infarction * Ischemia-driven revascularization * Rehospitalization (valve- or procedure-related including heart failure) * Life-threatening/disabling or major bleeding (according to VARC-2)

  1 year

Secondary Outcomes (15)

• The primary outcome measure

  Discharge (hospitalization first and second procedure), 3 months, 2 years and 5 years

• Single components of the primary endpoint

  Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years

• All cause death and myocardial infarction

  Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years

• Cardiovascular death and myocardial infarction

  Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years

• All cause death, myocardial infarction and ischemia-driven revascularization

  Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years

Other Outcomes (15)

• Procedural success (PCI)

  Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years

• Device success (TAVI)

  Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years

• Any revascularization

  Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years

Study Arms (2)

PCI before TAVI

OTHER

PCI is performed within 1-45 days before TAVI.

Procedure: PCI before TAVI

PCI after TAVI

EXPERIMENTAL

PCI is performed within 1-45 days after TAVI.

Procedure: PCI after TAVI

Interventions

PCI before TAVI PROCEDURE

TAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with ≥70% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter.

PCI before TAVI

PCI after TAVI PROCEDURE

TAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with ≥70% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter.

PCI after TAVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥18 years with severe aortic stenosis and concomitant coronary artery disease accepted for transfemoral TAVI with an Edwards SAPIEN Transcatheter Heart Valve™ and PCI by a multidisciplinary Heart Team.
• Severe aortic stenosis defined as aortic valve area (AVA) ≤1.0 cm2 and/or mean pressure gradient ≥40 mmHg (echocardiography) and at least one of the following criteria:
• Dyspnea
• Angina symptoms
• Syncope
• Decline in left ventricular ejection fraction \<50%, symptoms or fall in blood pressure on exercise testing, or presence of high-risk criteria (peak transaortic velocity \>5.5 m/s, severe valve calcification, peak transaortic velocity progression ≥0.3 m/s per year, or severe pulmonary hypertension with systolic pulmonary artery pressure \>60 mmHg) according to current guidelines.
• At least one coronary artery lesion with ≥70% diameter stenosis on coronary angiogram (by visual estimation) in a coronary artery ≥2.5 mm in diameter and Thrombolysis in Myocardial Infarction (TIMI) flow grade III, deemed amenable to PCI within 45 days before or after TAVI. Hemodynamic lesion assessment by fractional flow reserve (FFR), instantaneous wave-free ratio (iwFR), or comparable indices as well as intravascular imaging-guided PCI are left at the discretion of the operator.
• Written informed consent.

You may not qualify if:

• TAVI by transapical, subclavian, or transaortic access
• Admission with acute myocardial infarction within 30 days before randomization
• Elective coronary revascularization within 3 months before randomization
• Previous coronary artery bypass grafting (CABG)
• Syntax Score I ≥33
• Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel), except for patients on oral anticoagulation
• Planned open heart surgery
• Life expectancy \<1 year due to other severe non-cardiac disease
• Participation in another clinical study with an investigational product
• Acute COVID-19 infection
• Patient with previously treated aortic stenosis

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (48)

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Austria

Location

University Hospital Dijon

Dijon, France

Location

The Clinique de l'Infirmerie Protestante

Lyon, France

Location

Cardiology Department, CHU Timone Marseille

Marseille, France

Location

Arnault Tzanck Institute Saint Laurent du Var

Nice, France

Location

Toulouse University Hospital

Toulouse, France

Location

Zentralklinik Bad Berka

Bad Berka, Germany

Location

Heart and Vascular Centre Bad Bevensen

Bad Bevensen, Germany

Location

Universitäts-Herzzentrum Freiburg Bad Krozingen, Freiburg & Bad Krozingen

Bad Krozingen, Germany

Location

Campus Kerckhoff of the Justus Liebig University Giessen

Bad Nauheim, Germany

Location

Cardiovascular Center Bad Neustadt/Saale

Bad Neustadt an der Saale, Germany

Location

Schüchtermann-Clinic Bad Rothenfelde

Bad Rothenfelde, Germany

Location

Segeberger Kliniken GmbH

Bad Segeberg, Germany

Location

German Heart Center of Charité

Berlin, Germany

Location

University Hospital Bergmannsheil

Bochum, Germany

Location

Herzzentrum Dresden

Dresden, Germany

Location

Heinrich-Heine University

Düsseldorf, Germany

Location

Helios Hospital Erfurt

Erfurt, Germany

Location

University Hospital Erlangen

Erlangen, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Germany

Location

Klinikum Fulda

Fulda, Germany

Location

Academic Teaching Hospital of the Friedrich-Alexander-University Erlangen-Nuremberg

Fürth, Germany

Location

Justus-Liebig University of Giessen

Giessen, Germany

Location

University Heart and Vascular Centre Hamburg

Hamburg, Germany

Location

Klinikum Ingolstadt

Ingolstadt, Germany

Location

University Hospital Jena

Jena, Germany

Location

Municipial Hospital Karlsruhe

Karlsruhe, Germany

Location

University Hospital Schleswig-Holstein

Kiel, Germany

Location

Heart Center Leipzig at University of Leipzig

Leipzig, Germany

Location

Otto-von-Guericke University Magdeburg

Magdeburg, Germany

Location

LMU Munich

Munich, Germany

Location

TUM University Hospital

Munich, Germany

Location

University of Oldenburg

Oldenburg, Germany

Location

Helios Hospital Pforzheim

Pforzheim, Germany

Location

Prosper Hospital

Recklinghausen, Germany

Location

University Hospital Regensburg

Regensburg, Germany

Location

Krankenhaus der Barmherzigen Brüder

Trier, Germany

Location

Ulm University Heart Center

Ulm, Germany

Location

Azienda Santa Croce e Carle

Cuneo, Italy

Location

IRCCS Azienda Ospedaliera Metropolitana

Genova, Italy

Location

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)

Palermo, Italy

Location

Cardiology Department Azienda Ospedaliera Ordine Mauriziano di Torino

Turin, Italy

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Thoraxcenter, Erasmus MC

Rotterdam, Netherlands

Location

University Hospital Basel

Basel, Switzerland

Location

Geneva University Hospitals

Geneva, Switzerland

Location

Lausanne University Hospital

Lausanne, Switzerland

Location

University Hospital Zürich, Cardiology Department

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Stahli BE, Linke A, Westermann D, Van Mieghem NM, Leistner DM, Massberg S, Alber H, Mugge A, Musumeci G, Kesterke R, Schneider S, Kastrati A, Ford I, Ruschitzka F, Kasel MA; TAVI PCI Investigators. A randomized comparison of the treatment sequence of percutaneous coronary intervention and transcatheter aortic valve implantation: Rationale and design of the TAVI PCI trial. Am Heart J. 2024 Nov;277:104-113. doi: 10.1016/j.ahj.2024.07.019. Epub 2024 Aug 8.

  PMID: 39121916 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Coronary Artery Disease; Heart Diseases; Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease

Study Officials

• Markus Kasel, MD

  University Hospital, Zürich

  PRINCIPAL INVESTIGATOR

• Barbara E. Stähli, MD, eMBA

  University Hospital, Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: March 17, 2020
• Study Start: September 30, 2020
• Primary Completion: July 1, 2026
• Study Completion (Estimated): July 1, 2031
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4); DE (32); AU (1); IT (4); FR (5); NL (2)