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

This is an interventional treatment trial for Cardiac Disease Read More

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