The objective is to compare 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).
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Ultrathin strut stents have shown in vivo to be less thrombogenic compared to
thicker strut stents due to lower endothelial shear stress and flow
disturbances, which limit platelet activation. Furthermore, reduction in strut
thickness has also been shown to mitigate inflammation, vessel injury and
neointimal proliferation .These advantages seem to have effect in clinical
endpoints. Delayed strut coverage, associated with thick stent struts, is an
established predictor of late stent thrombosis. A recent meta-analysis showed
that ultrathin strut DES are associated with a relative risk reduction in TLF
at 1 year compared to thicker strut.
Supraflex Cruz is a new ultrathin (60 micron thick stent strut) DES and the
successor of the Supraflex stent, which showed non inferiority compared to the
thin strut Xience stent in the **all-comers** TALENT trial.
By changing the stent configuration, biodegradable polymer and drug release
profile, the Supraflex Cruz is a new ultrathin strut DES and is considered now
one of the most deliverable stent on the market.
In patients with high bleeding risk (HBR) a shorter dual anti-platelet therapy
(DAPT) duration is recommended by the European and American guidelines.
Although a shorter DAPT duration mitigates the bleeding risk, it can enhance
the risk on stent thrombosis and ischemic events on the other hand. Ultrathin
stent struts might reduce these ischemic events in the presence of shorter DAPT
duration. Therefore, dedicated stent studies are needed to assess the value of
ultrathin stent struts in high-risk PCI populations, like HBR patients.
No data exists of the Supraflex Cruz in a subset of patients with HBR during
and after PCI. In that respect, a direct comparison to the thin strut (80
micron) biodegradable polymer abluminal sirolimus-eluting Ultimaster Tansei
stent, which is known for rapid endothialization and which is large-scale
investigated in a landmark trial with HBR patients (Master-DAPT trial) is
useful to establish the safety and efficacy of Supraflex Cruz in this important
patient population.
Study objective
The objective is to compare 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
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
Study burden and risks
Patient selection takes place before scheduled PCI with written informed
consent. In acute patients selection is allowed after diagnostic coronary
angiography on the table with witnessed oral consent in case patients will
undergo immediate PCI.
After successful wiring of the first target lesion during the index PCI
patients are randomized to receive Supraflex Cruz stents or Ultimaster Tansei
stents.
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. All follow-up visits are preferably scheduled as a visit to
outpatient clinic. If patients are unable or unwilling to visit the outpatient
clinic, the scheduled visit can be replaced by a telephone call except for the
follow-up occurring at 12 months.
Patients are informed that data are collected at the index PCI and at scheduled
follow-ups as well as at unscheduled visits.
The investigator monitors the occurrence of Serious Adverse Events (SAEs) for
each subject during the course of the study. For the purpose of this protocol,
the reporting of SAEs begins directly after randomization when the first study
stent leaves the guiding catheter.
CK, CK-MB and Troponine I or T are measured before or at the start of the PCI
and after PCI.
No blood-samples are taken at follow-up visits.
The burden for the patient are the scheduled follow-up visits at 1-6-12 months
post index PCI.
The risks for the patient do not differ from any other PCI.
No direct benefit of the patient is expected, but important data will be
collected for future treatment of the HBR population.
Maasstadweg 21
Rotterdam 3079 DZ
NL
Maasstadweg 21
Rotterdam 3079 DZ
NL
Listed location countries
Age
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 days 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 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73419.100.20 |