To establish superiority of the biolimus-eluting (BiomatrixTM) stent compared with an otherwise identical bare-metal stent (GazelleTM) in acute ST-segment elevation myocardial infarction (STEMI) in terms of the composite endpoint of cardiac death,…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Major adverse cardiac events (MACEs) in the overall population, defined as the
composite of cardiac death, target-vessel relates myocardial infarction (Q-wave
and Non-Q wave), or ischemia-driven target lesion revascularization within 12
months.
Secondary outcome
* Clinically and non-clinicall indicated target lesion revascularization (TLR)
at 30 days, 1, 2 en 5 years
* Clinically and non-clinicall indicated target vessel revascularization (TVR)
at 30 days, 1, 2 and 5 years
* All deaths (cardiac and non-cardiac) 30 days, 1, 2 and 5 years
* Myocardial infarction (Q-wave and NQWMI) at 30 days, 1, 2 and 5 years
* Stent thrombosis rate defined, probable, possible and overall stent
thrombosis (according to ARC definition) at 30 days, 1, 2 and 5 years
Background summary
Treatment of STEMI patients with DES is effective but there remain concerns
regarding the long-term safety and adverse effects on the adjacent arterial
wall. The biolimus-eluting BiomatrixTM stent addresses these issues by
incorporating the following modifications:
- The polymer utilized for controlled drug release is biodegradable and is
absorbed within 6-9 months.
- The drug is applied solely to the abluminal stent surface.
- Preliminary results from the randomized LEADERS trial show a favorable
outcome compared with sirolimus-eluting stents.
While clinical data show a favorable safety and efficacy profile, they require
confirmation in a dedicated randomized trial in the subset of patients with
STEMI. The present study is therefore designed to compare the safety and
efficacy of the biolimus-eluting BiomatrixTM stent with a bare-metal stent of
otherwise identical design in a prospective, multi-center, randomized,
controlled trial in patients with acute ST-elevation myocardial infarction. To
address the issue of late acquired stent apposition and stent strut coverage,
an imaging substudy using grayscale IVUS and OCT will be performed.
Study objective
To establish superiority of the biolimus-eluting (BiomatrixTM) stent compared
with an otherwise identical bare-metal stent (GazelleTM) in acute ST-segment
elevation myocardial infarction (STEMI) in terms of the composite endpoint of
cardiac death, target-vessel related myocardial infarction, and target lesion
revascularization at 1 year
Study design
This is a prospective, multi-center, randomized, assessor-blind, trial to be
conducted at 10 - 15 interventional cardiology sites. A total of 1100 patients
will be randomized on a 1:1 basis to either the biolimus-eluting stent with
biodegradable polymer (Biomatrix*) or a baremetal stent (Gazelle*) of otherwise
identical design. The number of stents is not limited per patient, but it must
be consistently implanted according to the assigned treatment allocation. All
patients will be followed clinically for up to 5 years after stent
implantation.
Intervention
Not applicable
Study burden and risks
Patients will receive the routine treatment provided in our center. As a
consequence, the risk of this trial do not exceed the risk of any routine PCI
procedure at Medisch Spectrum Twente, because the PCIs in this Study will not
deviate in any way from the local clinical routine. We do not participate in
the imaging side of the protocol.
Inselspital Bern
3010 Bern
CH
Inselspital Bern
3010 Bern
CH
Listed location countries
Age
Inclusion criteria
* Age >= 18 years
* Chest pain > 10 min
* Primary PCI within 24 hours of symptom onset
* ST-segment elevation of >= 1mm in >= 2 continuous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >= 1mm in >= 2 continuous anterior leads
* Presence of at least one acute infarct artery stenoses in a native coronary artery from 2.25 to 4.0 mm in diameter that can be coverd with one or multiple stents
* Signed informed consent
Exclusion criteria
* Female of childbearing potential (age < 50 years and last mentruation within the last 12 months), who did not underwent tubal ligation, ovariectomy or hysterectomy
* Known intolerance to aspirin, clopidogrel, heparin, stainless steel, biolimus or contrast material
* Inability to provide informed consent
* Currently participating in another trial before reaching first endpoint
* Mechanical complications of acute myocardial infarction
* Acute myocardial infarction secondary to stent thrombosis
* Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the perisurgical period
* History of bleeding diathesis or known coagulopathy
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 |
|---|---|
| ClinicalTrials.gov | NCT00962416 |
| CCMO | NL30168.044.09 |