Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent

Conditions

Coronary Stenosis

Keywords

CAD, ACS, All comers, PCI

Brief summary

The primary objective of this study is to compare the performance of SUPRAFLEX to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.

Detailed description

This is a prospective, randomized, 1:1 balanced, controlled, single-blind, multi-center study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in a Real world, all comers patient population (patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions). The objective is to compare the SUPRAFLEX SES with the XIENCE EES with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a real world patient population. All patients will be (at minimum) contacted at 30 days, 6 months, and 12 months post procedure to assess clinical status and adverse events. The 30 day and 12 month will be a clinic visit. All patients will have annual contact through 3 years follow-up to assess clinical status and adverse events.

Robbert J. de Winter, Azfar Zaman, Rutao Wang, Chao Gao, Masafumi Ono et al. (17 authors)

PubMed2022-08-1913 citations

10.4244/eij-d-21-00766

Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials

Rutao Wang, Hideyuki Kawashima, Hironori Hara, Chao Gao, Masafumi Ono et al. (14 authors)

Circulation Cardiovascular Quality and Outcomes2021-10-208 citations

10.1161/circoutcomes.121.008055

A prospective multicentre randomized all-comers trial to assess the safety and effectiveness of the ultra-thin-strut sirolimus-eluting coronary stent Supraflex: 2-year results of the TALENT trial

Chao Gao, Norihiro Kogame, Pieter C. Smits, Pim A.L. Tonino, Raúl Moreno et al. (15 authors)

European Heart Journal2020-11-012 citations

10.1093/ehjci/ehaa946.2534

Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial.

Zaman A, de Winter RJ, Kogame N, Chang CC, Modolo R, Spitzer E, Tonino P, Hofma S, Zurakowski A, Smits PC, Prokopczuk J, Moreno R, Choudhury A, Petrov I, Cequier A, Kukreja N, Hoye A, Iniguez A, Ungi I, Serra A, Gil RJ, Walsh S, Tonev G, Mathur A, Merkely B, Colombo A, Ijsselmuiden S, Soliman O, Kaul U, Onuma Y, Serruys PW, TALENT trial investigators.

2019-02-2872 citations

10.1016/s0140-6736(18)32467-x

Interventions

DEVICESUPRAFLEX

Percutaneous Coronary Intervention

DEVICEXIENCE

Percutaneous Coronary Intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

All comers patients: * Male or female patients 18 years or older; * Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. * The vessel should have a reference vessel diameter ranging from ≥2.25 mm to ≤4.5 mm (no limitation on the number of treated lesions, vessels, or lesion length); All lesions of the patient must comply with the angiographic inclusion criteria. * The patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed. Patient is willing to comply with all protocol-required evaluations.

Exclusion criteria

* Known pregnancy or breastfeeding at time of randomization; * Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor; * Any PCI treatment within 6 months (\<6 months) prior to the index procedure. * Concurrent medical condition with a life expectancy of less than 12 months. * The patient is unwilling/ not able to return for outpatient clinic at 12 months follow-up. * Currently participating in another trial and not yet at its primary endpoint.

Design outcomes

Primary

Measure	Time frame	Description
Non inferiority comparison of a device oriented composite endpoint (DOCE) or Target Lesion Failure (TLF) of the SUPRAFLEX group to the XIENCE group	12 months post-procedure	TLF is a composite of clinical endpoint of cardiac death, target vessel myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization.

Secondary

Measure	Time frame
Target Vessel Failure (TVF) defined as cardiac death, TV MI, and clinically indicated target vessel revascularization	30 days, 6 months, 1 year, 2 years and 3 years
TLF (DoCE) defined as cardiac death, TV MI and clinically-indicated target lesion revascularization (for all follow-up/visits other than 12 months)	30 days, 6 months, 1 year, 2 years and 3 years
Mortality (All death, Cardiac death, and Non-cardiac death (vascular and non-cardiovascular)	30 days, 6 months, 1 year, 2 years and 3 years
Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, and any revascularization	30 days, 6 months, 1 year, 2 years and 3 years
Revascularization (Any revascularisation, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR.	30 days, 6 months, 1 year, 2 years and 3 years
Stent thrombosis rates according to ARC classification	30 days, 6 months, 1 year, 2 years and 3 years
Myocardial Infarction (All MI, Target Vessel MI, Non-Target Vessel MI)	30 days, 6 months, 1 year, 2 years and 3 years

Countries

Bulgaria, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom

Outcome results

None listed