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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
736
percutaneous coronary intervention
percutaneous coronary intervention
Jeroen Bosch ziekenhuis
's-Hertogenbosch, Netherlands
Meander ziekenhuis
Amersfoort, Netherlands
Rijnstate ziekenhuis
Arnhem, Netherlands
Tergooi ziekenhuis Blaricum
Blaricum, Netherlands
Net Adverse Clinical Endpoints (NACE)
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.
Time frame: 1 year
Major adverse cardiac and cerebral events (MACCE)
Major adverse cardiac and cerebral events (MACCE) defined as a composite of cardiac death, myocardial infarction, target vessel revascularization and stroke
Time frame: 1 year
Major or clinically relevant non-major bleeding (MCB)
Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events
Time frame: 1 year
Target Lesion Failure (TLF)
Target Lesion Failure (TLF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target lesion revascularization
Time frame: 1 year
Target vessel failure (TVF)
Target Vessel Failure (TVF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target vessel revascularization
Time frame: 1 year
The composite of cardiovascular death, myocardial infarction and stroke
The composite endpoint of cardiovascular death, myocardial infarction and stroke
Time frame: 1 year
The composite of cardiovascular death, myocardial infarction, stroke and major bleed BARC 3 and 5
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Amphia Ziekenhuis
Breda, Netherlands
Albert Schweitzer ziekenhuis
Dordrecht, Netherlands
Catherina ziekenhuis
Eindhoven, Netherlands
MCL Leeuwarden
Leeuwarden, Netherlands
St.Antonius ziekenhuis
Nieuwegein, Netherlands
Maasstadziekenhuis
Rotterdam, Netherlands
...and 1 more locations
The composite of cardiovascular death, myocardial infarction, stroke and major bleed according to BARC 3 and 5
Time frame: 1 year
Stent thrombosis
Stent thrombosis according to the ARC definitions
Time frame: 1 year
Myocardial infarction
Myocardial infarction.
Time frame: 1 year
Urgent target vessel revascularization
Urgent target vessel revascularization.
Time frame: 1 year
Non-target vessel revascularization
Non-target vessel revascularization.
Time frame: 1 year
Clinically indicated target vessel revascularization
Clinically indicated target vessel revascularization.
Time frame: 1 year
Bleeding events
Bleeding events according to the BARC, TIMI and GUSTO classification
Time frame: 1 year
Transfusion rates
Transfusion rates both in patients with and/or without clinically detected over bleeding
Time frame: 1 year
Event rates according to the PRECISE-DAPT
Event rates according to the PRECISE-DAPT score
Time frame: 1 year
Procedural success
Procedural success is defined as angiographic success with no in-hospital MACE, defined as death, MI with new Q-waves on electrocardiogram (ECG) or urgent target vessel revascularization (TVR) (including both repeat PCI and coronary artery bypass graft surgery (CABG)
Time frame: At completion of the baseline PCI
Device success
Device success (applying a lesion-level analysis)
Time frame: At discharge of baseline hospitalisation, on average 3 days