Clinical trial NCT04500912: Comparison of the Supraflex Cruz 60 Micron Versus the Ultimaster Tansei 80 Micron in HBR PCI Population
Official title: Comparison of the Supraflex Cruz 60 Micron Stent Strut Versus the Ultimaster Tansei 80 Micron Stent Strut in High Bleeding Risk PCI Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
PCI
High Bleeding Risk
Lead sponsor: Research Maatschap Cardiologen Rotterdam Zuid
Sponsor class: OTHER
Collaborators: name: Sahajanand Medical Technologies Limited
First posted: 2020-08-05
Enrollment: 736
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility 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 ≤ 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

Primary outcomes:
measure: Net Adverse Clinical Endpoints (NACE)
timeFrame: 1 year
Secondary outcomes:
measure: Major adverse cardiac and cerebral events (MACCE)
timeFrame: 1 year
measure: Major or clinically relevant non-major bleeding (MCB)
timeFrame: 1 year
measure: Target Lesion Failure (TLF)
timeFrame: 1 year
measure: Target vessel failure (TVF)
timeFrame: 1 year
measure: The composite of cardiovascular death, myocardial infarction and stroke
timeFrame: 1 year
measure: The composite of cardiovascular death, myocardial infarction, stroke and major bleed BARC 3 and 5
timeFrame: 1 year
measure: Stent thrombosis
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 1 year
measure: Urgent target vessel revascularization
timeFrame: 1 year
measure: Non-target vessel revascularization
timeFrame: 1 year
measure: Clinically indicated target vessel revascularization
timeFrame: 1 year
measure: Bleeding events
timeFrame: 1 year
measure: Transfusion rates
timeFrame: 1 year
measure: Event rates according to the PRECISE-DAPT
timeFrame: 1 year
measure: Procedural success
timeFrame: At completion of the baseline PCI
measure: Device success
timeFrame: At discharge of baseline hospitalisation, on average 3 days
Other outcomes:
Locations:
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch ziekenhuis
city: Amersfoort
country: Netherlands
facility: Meander ziekenhuis
city: Arnhem
country: Netherlands
facility: Rijnstate ziekenhuis
city: Blaricum
country: Netherlands
facility: Tergooi ziekenhuis Blaricum
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catherina ziekenhuis
city: Leeuwarden
country: Netherlands
facility: MCL Leeuwarden
city: Nieuwegein
country: Netherlands
facility: St.Antonius ziekenhuis
city: Rotterdam
country: Netherlands
facility: Maasstadziekenhuis
city: Terneuzen
country: Netherlands
facility: Ziekenhuis Zorgsaam
Study officials:
affiliation: Research Maatschap Cardiologen Rotterdam Zuid
name: Pieter Smits, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Capodanno D. Another Coronary Stent for Patients at High Bleeding Risk. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1884-1887. doi: 10.1016/j.jcin.2021.07.028. No abstract available.