Comparison of the Supraflex Cruz 60 Micron Versus the Ultimaster Tansei 80 Micron in HBR PCI Population

Pieter C.Smits

Status

Completed

Conditions

High Bleeding Risk

Cardiac Disease

PCI

Treatments

Device: Ultimaster Tansei 80 Micron

Device: Supraflex Cruz 60 Micron

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04500912

NL73419.100.20

Details and patient eligibility

About

The study compares the outcome of the ultrathin stent strut Supraflex Cruz stent to the thin stent strut Ultimaster Tansei stent in a PCI population at high risk for bleeding (HBR).

Full description

Study design: An Investigator-initiated, multi-center, randomized clinical trial in HBR patients receiving PCI with Supraflex Cruz or Ultimaster Tansei stents

Study population: 2 x 368 (736) patients, who undergo a PCI and are at high risk for bleeding (HBR).

Intervention: Patients are treated according to the randomized regimen at index PCI and at planned staged procedures. Either with the ultrathin stent strut Supraflex Cruz stent to the thin stent strut Ultimaster Tansei stent

DAPT treatment (combination and duration) is according to the Guidelines of the European Society of Cardiology for Myocardial Revascularization.

Follow-up is scheduled at 1 month, 6 months and 12 months post index PCI procedure.

Primary study parameters/outcome of the study:

The primary endpoint Net Adverse Clinical Endpoints (NACE) defined as a composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke and bleeding events defined as BARC 3 or 5 at 12 months follow-up after the index PCI.

Enrollment

736 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients are eligible for inclusion into the study if the following criteria are met.

Patients of 18 years and above
Written or witnessed oral consent to participate in the study
Native coronary artery lesions eligible for PCI with stents with no restrictions in number of lesions and stents, vessel size or lesion complexity, apart from stent thrombosis.
Patients at high risk for bleeding according to the HBR ARC criteria: Patients meet the HBR ARC criteria if ≥1 major or ≥2 minor criteria are met.

Major HBR criteria are the following:

Clinical indication for treatment with oral anticoagulants (OAC/NOAC) for at least 12 months
Severe or end-stage chronic kidney failure (GFR ≤ 30 ml/min)
Hemoglobin (Hb) level at screening < 11g/dl or < 6.8 mmol/l
Spontaneous bleeding requiring hospitalization or transfusion in the past 6 months or at any time, if recurrent
Moderate or severe baseline true thrombocytopenia (platelet count <100 *10^9/L)
History of chronic bleeding diathesis, like: leukemia, haemophilia, vitamin K deficiency, Factor V or VII deficiency etc.
Liver cirrhosis with portal hypertension
Active malignancy (other than skin) within the past 12 months
Spontaneous intracranial haemorrhage ICH (at any time)
Traumatic intracranial haemorrhage ICH within 12 months
Presence of a brain arterio-venous malformation (AVM)
Moderate or severe ischemic stroke within the past 6 months
Nondeferrable major surgery on DAPT after PCI
Recent major surgery or major trauma within 30 d before PCI

Minor HBR criteria are the following:

Age ≥ 75 years
Moderate chronic kidney disease (GFR >30 and <60 ml/min)
Hemoglobin (Hb) 11-12.9 g/dL / 6.8-8.0 mmol/l for men and 11-11.9 g/dL / 6.8-7.4 mmol/l for women
Any ischemic stroke at any time not meeting the major criterion
Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months
Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs

Exclusion criteria

Patients are not eligible if any of the following applies:

Treated with stents other than Supraflex Cruz or Ultimaster within 6 months prior to index procedure
Treatment of lesions with stent thrombosis
Treatment of venous or arterial coronary grafts
Treated for stent thrombosis in 12 months prior to index PCI procedure
Treated with a bioresorbable scaffold 3 years before index PCI procedure
Cardiogenic shock at index procedure
Active SARS-CoV-2 infection or suspicion of SARS-CoV-2 infection
Cannot provide written informed consent
Under judicial protection, tutorship or curatorship
Unable to understand and follow study-related instructions or unable to comply with study protocol
Active bleeding requiring medical attention (BARC≥2) at index PCI
Life expectancy less than one year
Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel, cobalt chromium or sirolimus
Any anticipated PCI after index PCI, unless planned and scheduled at index PCI
Participation in another stent or drug trial