bleeding PCI
Conditions
Interventions
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
Sponsors
Research Maatschap Cardiologen Rotterdam Zuid
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 = 75 years - Moderate chronic kidney disease (GFR >30 and
Exclusion criteria
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 of 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of the study are the following: 1) Major adverse cardiac and cerebral events (MACCE) defined as a composite of cardiac death, myocardial infarction, target vessel revascularization and stroke 2) Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events 3) Target Lesion Failure (TLF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target lesion revascularization 4) Target Vessel Failure (TVF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target vessel revascularization 5) The individual components of the composite primary endpoint 6) The composite of cardiovascular death, myocardial infarction and stroke 7) The composite of cardiovascular death, myocardial infarction, stroke and major bleed according to BARC 3 and 5 8) Stent thrombosis according to the ARC definitions 9) Myocardial infarction 10) Urgent target vessel revascularization 11) Non-target vessel revascularization (urgent and non-urgent) 12) Clinically indicated target vessel revascularization 13) Bleeding events according to the BARC, TIMI and GUSTO classification 14) Transfusion rates both in patients with and/or without clinically detected over bleeding 15) Event rates according to the PRECISE-DAPT score 16) Procedural and device success | — |
Countries
Netherlands
Outcome results
None listed