cardiac disorders --> coronary artery disorders "Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention" "heart disease: valve disease and coronary vessels"
Conditions
Interventions
TAVI & PCI are the same for patients participating in the trial as for all
other patients not participating, as only the sequence of procedures is
investigated in the study.
TRANSCATHETER AORTIC VA
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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 • Severe aortic stenosis defined as aortic valve area (AVA) =40 mmHg (echocardiography) and at least one of: 1) Dyspnea 2) Angina symptoms 3) Syncope 4) Decline in left ventricular ejection fraction 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(6) • At least one coronary artery lesion with 40-90% diameter stenosis and iwFR 90% 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 • Written informed consent
Exclusion criteria
Exclusion criteria: • 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 • Known pregnancy at the time of inclusion • Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiovascular events (MACE) at 1 year, defined as a composite of: • All-cause death • Non-fatal myocardial infarction (MI) • Ischemia-driven revascularization • Rehospitalization (valve- or procedure-related including heart failure) • Life-threatening/disabling or major bleeding (according to VARC-2 (5)) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be assessed at hospital discharge (first and second hospitalization), 3 months, 1 year, 2 years, and 5 years, and comprise: • Primary composite endpoint at hospital discharge (first and second hospitalization), at 3 months, 2 years, and 5 years • Single components of the primary endpoint • All-cause death and MI • All-cause death, MI, and ischemia driven revascularization • All-cause death, MI, ischemia driven revascularization, and rehospitalization • Cardiovascular death • Cardiovascular death and MI • Stroke • Peri-procedural MI (PCI) • Peri-procedural MI (TAVI) • Major vascular complications (according to VARC-2 (5)) • Bleeding events (Bleeding Academic Research Consortium [BARC] definition) • Symptom status and change from baseline in symptom status (Canadian Cardiovascular Society [CCS] and New York Heart Association [NYHA] classification) The following secondary endpoint will be assessed at hospital admission for the second procedure, 3 months, 1 year, 2 years, and 5 years: • Quality of Life (QoL) as assessed by the Kansas City Cardiomyopathy questionnaire (KCCQ) and the Toronto Aortic Stenosis Quality of Life questionnaire (TASQ) • Change from baseline in QoL as assessed by the KCCQ and the TASQ | — |
Countries
Netherlands
Outcome results
None listed