Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arterial Occlusive Diseases, Vascular Diseases
Conditions
Keywords
multi-vessel coronary artery disease, revascularization, quantitative flow ratio, fractional flow reserve, instant wave-free ratio, SYNTAX score, prasugrel monotherapy, ultra-thin strut sirolimus-eluting coronary stent
Brief summary
Multivessel TALENT is a prospective, randomized, multi-center study comparing clinical outcomes between SUPRAFLEX Cruz and SYNERGY in approximately 1550 patients with de-novo three vessel disease undergoing percutaneous coronary intervention (PCI). Patients will be treated according to "state of art PCI"; not only treatment strategies based on the latest ESC guideline, such as SYNTAX Score II recommendation, Heart Team discussion, post-procedure intravascular imaging optimization, cholesterol reduction by statin or PCSK-9 inhibitor, but also exploratory treatment strategies based on the latest evidence, such as physiological assessment using quantitative flow ratio and prasugrel monotherapy following 1-month dual antiplatelet therapy after PCI.
Interventions
DEVICESUPRAFLEX Cruz
Percutaneous Coronary Intervention for multivessel disease
DEVICESYNERGY
Percutaneous Coronary Intervention for multivessel disease
Sponsors
National University of Ireland, Galway, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients' ≥18 years. 2. At least 1 stenosis (angiographic, visually determined de novo lesions with ≥50% DS) in all 3 major epicardial territories (LAD and/or side branch, LCX and/or side branch, RCA and/or side branch) supplying viable myocardium without left main involvement. 3. The vessel should have a reference vessel diameter ranging from ≥2.25 mm to ≤4.50 mm (no limitation on the number of treated lesions, vessels, or lesion length). 4. Patients with chronic coronary syndrome or stabilized acute coronary syndromes. 5. All anatomical SYNTAX Scores are eligible for initial screening with the SYNTAX Score II, provided that the SYNTAX Score II recommends equipoise risk (PCI or CABG) or PCI only. 6. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required evaluations. 7. Agree with conditional longer follow up from 2 to 5 years with one phone contact yearly.
Exclusion criteria
1. Under the age of 18. 2. Unable to give informed consent. 3. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice). 4. Known contraindication to medications such as Aspirin, Heparin, Bivalirudin, Prasugrel and Ticagrelor. 5. Prior PCI or prior CABG. 6. Ongoing ST-elevation myocardial infarction (STEMI). 7. Cardiogenic shock is also an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation | 12 months post-procedure | a non-inferiority comparison of Patient-oriented Composite Endpoint (POCE) of the SUPRAFLEX Cruz cohort to the SYNERGY cohort at 12 months post-procedure. POCE is a composite clinical endpoint of: * All cause death; * Any stroke, Modified Rankin Scale (MRS ≥1); * Any myocardial infarction (MI); * Any (repeat) revascularisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of vessels with a composite of vessel-related cardiovascular death, vessel-related MI, or CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation) | 24 months post-procedure | a superiority comparison in the as treated population (per vessel level) of the vessel-oriented composite endpoints (VOCE). VOCE is a composite clinical endpoint of: * Vessel-related cardiovascular death; * Vessel-related MI; * CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation). |
| Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation | 24 months post-procedure | a comparison of Patient-oriented Composite Endpoint (POCE) of the SUPRAFLEX Cruz cohort to the SYNERGY cohort at 24 months post-procedure. POCE is a composite clinical endpoint of: * All cause death; * Any stroke, Modified Rankin Scale (MRS ≥1); * Any myocardial infarction (MI); * Any (repeat) revascularisation |
| Number of participants with all cause death | 12 and 24 months post-procedure | a comparison of numbers of participants with all cause death |
| Number of Participants with any stroke | 12 and 24 months post-procedure | a comparison of numbers of participants with any stroke |
| Number of Participants with any myocardial infarction | 12 and 24 months post-procedure | a comparison of numbers of participants with any myocardial infarction |
| Number of Participants with any (repeat) revascularisation | 12 and 24 months post-procedure | a comparison of number of participants with any (repeat) revascularisation |
| Number of vessels with vessel-related cardiovascular death | 12 and 24 months post-procedure | a comparison of numbers of vessels with vessel-related cardiovascular death |
| Number of vessels with vessel-related MI | 12 and 24 months post-procedure | a comparison of numbers of vessels with vessel-related MI |
| Number of vessels with CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation) | 12 and 24 months post-procedure | a comparison of numbers of vessels with CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation) |
| Number of participants with a composite of cardiovascular death, target vessel MI and clinically-indicated target lesion revascularization | 12 and 24 months post-procedure | a comparison of numbers of participants with TLF / DOCE defined as cardiovascular death, target vessel MI and clinically-indicated target lesion revascularisation |
| Number of participants with a composite of cardiovascular death, target vessel MI and clinically-indicated target vessel revascularisation | 12 and 24 months post-procedure | a comparison of numbers of participants with TVF defined as cardiovascular death, target vessel MI and clinically-indicated target vessel revascularisation |
| Number of participants with cardiovascular death | 12 and 24 months post-procedure | a comparison of numbers of participants with cardiovascular death |
| Number of participants with target vessel MI | 12 and 24 months post-procedure | a comparison of numbers of participants with target vessel MI |
| Number of participants with clinically-indicated target lesion revascularisation | 12 and 24 months post-procedure | a comparison of numbers of participants with clinically-indicated target lesion revascularisation |
| Number of participants with Definite/Probable Stent thrombosis | 12 and 24 months post-procedure | a comparison of numbers of participants with Definite/Probable Stent thrombosis |
| Number of participants with device success | 7days post-procedure | a comparison of numbers of participants with device success |
| Number of participants with procedure success | 7days post-procedure | a comparison of numbers of participants with procedure success (Device success + free from POCE at discharge) |
Countries
Ireland
Contacts
STUDY_CHAIRPatrick W. Serruys, MD, PhD
National University of Ireland, Galway
STUDY_CHAIRWilliam Wijns, MD, PhD
National University of Ireland, Galway
STUDY_CHAIRYoshinobu Onuma, MD, PhD
National University of Ireland, Galway
PRINCIPAL_INVESTIGATORHelge Moellmann, MD
St. Johannes Hospital
PRINCIPAL_INVESTIGATORManel Sabate, MD, PhD
Hospital Clínic of Barcelona
PRINCIPAL_INVESTIGATORAzfar Zaman, MD
Freeman Hospital and Newcastle University
Outcome results
None listed