Multivessel TALENT

N/AActive Not RecruitingNCT04390672

National University of Ireland, Galway, Ireland1,550 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,550

Conditions

Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 exclusion criteria. 8. Concurrent medical condition with a life expectancy of less than 2 years. 9. Currently participating in another trial and not yet at its primary endpoint. 10. Patient with both ostial LAD and ostial LCX stenosis, or left main stenosis. 11. Previous intracranial haemorrhage.

Outcomes

Primary Outcomes

Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation

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

Time frame: 12 months post-procedure

Secondary Outcomes

Number of vessels with a composite of vessel-related cardiovascular death, vessel-related MI, or CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation)

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).

Time frame: 24 months post-procedure

Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation

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

Time frame: 24 months post-procedure

Number of participants with all cause death

a comparison of numbers of participants with all cause death