Study on the investigation of the optimal timing of a transcatheter aortic valve intervention and a catheter treatment of coronary artery stenoses (TAVI PCI study)
Zusammenfassung der Studie
When patients with severe aortic valve stenosis also present with significant coronary artery stenosis, both conditions must be treated. For patients for whom the indication for catheter-based treatment is made (in the so-called "heart team", which is interdisciplinary and composed of specialists from different fields), it is still unclear in which order the procedures should be performed to achieve the best outcome. In some patients, the percutaneous coronary intervention (PCI) is performed prior to the heart valve implantation, while in others, such an intervention is postponed to later, i.e., after the heart valve procedure. Currently, there are no scientific data to confidently make the right decision regarding the order of the interventions. The TAVI PCI study therefore addresses this question and investigates the timing of the two treatments. A total of 986 patients will be included in the study across 5 countries, and it will be decided randomly (randomization) whether the treatment of the narrowed coronary arteries or the treatment of the narrowed aortic valve will be performed first. For patients assigned to group 1, the treatment of the coronary arteries (PCI) will be performed first, followed by the treatment of the aortic valve (TAVI) within a period of 1-45 days. For patients assigned to group 2, the treatment of the aortic valve (TAVI) will be performed first, followed by the treatment of the coronary arteries (PCI) within a period of 1-45 days. The study only investigates the order of treatments. The treatment itself is performed according to current guidelines and does not differ in execution from patients who do not participate in the study.
(BASEC)
Untersuchte Intervention
The study does not investigate the treatments themselves, but the order of the treatments of coronary intervention (PCI) and catheter aortic valve replacement (TAVI) in patients with aortic valve stenosis and coronary artery stenoses, for whom both interventions are indicated. The treatments themselves are performed according to current guidelines and do not differ in execution from those of patients who do not participate in the study. The study compares the treatment sequence "PCI before TAVI" (group 1) with the treatment sequence "PCI after TAVI" (group 2). For patients assigned to group 1, the treatment of the coronary arteries (PCI) will be performed first, followed by the treatment of the aortic valve (TAVI) within a period of 1-45 days. For patients assigned to group 2, the treatment of the aortic valve (TAVI) will be performed first, followed by the treatment of the coronary arteries (PCI) within a period of 1-45 days.
(BASEC)
Untersuchte Krankheit(en)
The aortic valve connects the heart to the circulation and functions as a valve. With increasing age, calcification and narrowing of the aortic valve, known as aortic stenosis, can occur, and blood flow into the systemic circulation is impeded. This condition is one of the most common heart valve diseases. The condition leads to symptoms such as chest pain, shortness of breath, or dizziness and loss of consciousness. Once symptoms occur, this condition has a poor prognosis if left untreated. A severe narrowing of the aortic valve is therefore treated by inserting a new heart valve. This procedure can nowadays usually be performed via catheter through the groin vessels (transcatheter aortic valve implantation, TAVI). In patients with aortic valve stenosis, about half also present with narrowing of the vessels that supply blood to the heart, the coronary arteries. This involves inflammation and calcification of the vessel wall, leading to plaque formation and thus impeding blood flow. This condition must also be treated catheterically if it exhibits a certain degree of severity, using balloon dilation and the insertion of a small vascular support, known as a stent (percutaneous coronary intervention, PCI). The TAVI PCI study now investigates the optimal sequence of treatment for aortic valve stenosis and coronary artery stenoses and addresses the question of whether the heart valve or the coronary arteries should be treated first.
(BASEC)
1. Patients ≥18 years with severe aortic stenosis and concomitant coronary artery disease accepted for transfemoral TAVI with an Edwards SAPIEN Transcatheter Heart Valve™ by transfemoral access and PCI by the multidisciplinary Heart Team 2. 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: a) Dyspnea b) Angina symptoms c) Syncope d) 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 3. 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. 4. Written informed consent (BASEC)
Ausschlusskriterien
1. TAVI by transapical, subclavian, or transaortic access 2. Admission with acute coronary syndrome within 30 days before randomization 3. Elective coronary revascularization within 3 months before randomization 4. Previous coronary artery bypass grafting (CABG) 5. Syntax Score I ≥33 6. Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel), except for patients on oral anticoagulation 7. Planned cardiac or major surgery 8. Known pregnancy at the time of inclusion 9. Life expectancy <1 year due to other severe non-cardiac disease 10. Participation in another clinical study with an investigational product 11. Acute COVID-19 infection 12. Patient with previously treated aortic stenosis (BASEC)
Studienstandort
Basel, Genf, Lausanne, Zürich
(BASEC)
Sponsor
Universität Zürich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Barbara E. Stähli
+41 43 253 05 97
barbara.staehli@clutterusz.chUniversitätsspital Zürich, Klinik für Kardiologie
(BASEC)
Allgemeine Auskünfte
University Hospital, Z?rich,University Hospital, Z?rich,
+41 44 255 11 11;
barbara.staehli@clutterusz.ch(ICTRP)
Wissenschaftliche Auskünfte
University Hospital, Z?rich,University Hospital, Z?rich,
+41 44 255 11 11;
barbara.staehli@clutterusz.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
06.08.2020
(BASEC)
ICTRP Studien-ID
NCT04310046 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
The TAVI PCI (optimal timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention) Trial (BASEC)
Wissenschaftlicher Titel
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial (ICTRP)
Öffentlicher Titel
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial (ICTRP)
Untersuchte Krankheit(en)
Aortic Stenosis;Coronary Artery Disease;TAVI;PCI (ICTRP)
Untersuchte Intervention
Procedure: PCI before TAVI;Procedure: PCI after TAVI (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
1. 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.
2. 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:
1. Dyspnea
2. Angina symptoms
3. Syncope
4. 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.
3. 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.
4. Written informed consent.
Exclusion Criteria:
1. TAVI by transapical, subclavian, or transaortic access
2. Admission with acute myocardial infarction within 30 days before randomization
3. Elective coronary revascularization within 3 months before randomization
4. Previous coronary artery bypass grafting (CABG)
5. Syntax Score I =33
6. Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor
(clopidogrel, ticagrelor or prasugrel), except for patients on oral anticoagulation
7. Planned open heart surgery
8. Known pregnancy at the time of inclusion
9. Life expectancy <1 year due to other severe non-cardiac disease
10. Participation in another clinical study with an investigational product
11. Acute COVID-19 infection
12. Patient with previously treated aortic stenosis
(ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
The primary outcome measure is the number of participants experiencing the primary outcome measure (ICTRP)
The primary outcome measure;Single components of the primary endpoint;All cause death and myocardial infarction;Cardiovascular death and myocardial infarction;All cause death, myocardial infarction and ischemia-driven revascularization;All cause death, myocardial infarction, ischemia-driven revascularization and rehospitalization;Cardiovascular death;Stroke;Peri-procedural myocardial infarction (PCI);Peri-procedural myocardial infarction (TAVI);Major vascular complications;Bleeding events;Symptom status and change from baseline in symptom status (Canadian Cardiovascular Society (CCS) and New York Hear Association (NYHA) classification);Quality of life (as assessed by the KCCQ and TASQ questionnaires);Change from baseline in Quality of life (as assessed by the KCCQ and TASQ questionnaires) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Markus Kasel, MD;Barbara E. St?hli, MD, eMBA;Barbara E. St?hli, MD, eMBA;Barbara E. St?hli, MD, eMBA, Barbara.Staehli@usz.ch; barbara.staehli@usz.ch, +41 44 255 11 11;, University Hospital, Z?rich,University Hospital, Z?rich, (ICTRP)
Sekundäre IDs
TAVI PCI (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04310046 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar