ST-elevation Myocardial Infarction Clinical Trial
— COMFORTABLEOfficial title:
Comparison of Biolimus Eluted From an Erodable Stent Coating With Bare-Metal Stents in Acute ST-Elevation Myocardial Infarction and In Vivo 3-Vessel Assessment of Time-Related Changes of Culprit and Non-Culprit Lesions by IVUS/OCT in AMI
Verified date | March 2016 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
Stent study:
Treatment of patients with acute myocardial infarction with drug eluting stents (DES) is
effective but there remain concerns regarding the long-term safety and adverse effects on
the adjacent arterial wall. The biolimus-eluting Biomatrix stent addresses the issues by
incorporating modifications as a biodegradable polymer and a drug application solely to the
abluminal stent surface. While clinical data about the biolimus-eluting stent show a
favorable safety and efficacy profile, they require confirmation in a dedicated randomised
trial in the subset of patients with STEMI. Therefore, the study is designed to compare the
safety and efficacy of biolimus-eluting Biomatrix stent as compared to a bare metal stent of
otherwise identical design in a prospective, multicenter, randomized, controlled superiority
trial in patients with acute ST-elevation myocardial infarction.
Stent and Plaque Imaging Substudy:
In a substudy of the above mentioned stent trial, the investigators will perform a
prospective, multicenter, longitudinal cohort study of 100 consecutive STEMI patients
undergoing urgent coronary angiography and will employ high-resolution Optical Coherence
Tomography (OCT) imaging technology and intra-vascular ultrasound and virtual histology
(IVUS-VH) of the culprit STEMI lesions pre- and postprocedural as well as at a 13 months
follow up. Assessment of vascular wall responses, including volumetric measurements of
vessel, stent, lumen, peri-stent plaque, and intimal hyperplasia, indices of remodeling,
stent expansion, and stent-vessel wall apposition in response to biolimus-eluting and
bare-metal stent implantation will be performed. Moreover, IVUS, IVUS-VH and OCT will be
performed in all three epicardial vessels in order to quantify and map the number, frequency
and distribution of ruptured plaques at baseline and follow-up and quantify the
morphological changes of ruptured and vulnerable plaques at baseline and follow-up and
quantify the morphological changes over time in response to standard medical treatment.
Therefore, new insight regarding the frequency, distribution, composition and evolution of
coronary artery plaques and their prognostic impact on patients clinical outcome can be
expected from the present study. Since patients suffer from a recurrent ischemic event rate
of 5-10% during the first year, these findings may have important therapeutic implications
for the medical treatment of affected patients to further reduce the risk of recurrence and
improve prognosis.
Status | Completed |
Enrollment | 1161 |
Est. completion date | January 2016 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age equal or more than 18 years - Chest pain > 10 minutes - Primary pci - ST-segment elevation of > 1 mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of > 1 mm in > 2 contiguous anterior leads - Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25-4 mm in diameter that can be covered with 1-multiple stents Exclusion Criteria: - Female of childbearing potential (age 50 and last menstruation 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 complication 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 - Noncardiac comorbid conditions are present with life expectancy 1 year or that may result in protocol malcompliance - History of bleeding diathesis or known coagulopathy - Use of Coumadin - Additional for Imaging Substudy: - Age > 90 years - Hemodynamic instability - Renal failure - OCT/IVUS technically not feasible - Any patient in whom angiography demonstrates the infarct lesion to be at the site of a previously implanted stent |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Cardiology | Bern | |
Switzerland | Dep. of Cardiology | Geneva | |
Switzerland | Dep. of Cardiology | Lugano | |
Switzerland | Dep. of Cardiology | University of Lausanne | |
Switzerland | Dep. of Cardiology | Zürich |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | Swiss National Science Foundation |
Switzerland,
Costa RA, Lansky AJ, Abizaid A, Müeller R, Tsuchiya Y, Mori K, Cristea E, Leon MB, Sousa JE, Schmidt T, Hauptmann KE, Grube E. Angiographic results of the first human experience with the Biolimus A9 drug-eluting stent for de novo coronary lesions. Am J Cardiol. 2006 Aug 15;98(4):443-6. Epub 2006 Jun 23. — View Citation
Stone GW, Lansky AJ, Pocock SJ, Gersh BJ, Dangas G, Wong SC, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Möckel M, Ochala A, Kellock A, Parise H, Mehran R; HORIZONS-AMI Trial Investigators. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Engl J Med. 2009 May 7;360(19):1946-59. doi: 10.1056/NEJMoa0810116. — View Citation
Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P. Biolimus-eluting stent with biodegradable — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major adverse cardiac events (MACEs) in the overall population, defined as the composite of cardiac death, target-vessel related myocardial infarction (Q-wave and non-Q-wave), or ischemia-driven target lesion revascularization within 12 months | 30 days, 6 months, 1,2 and 5 years | Yes | |
Secondary | All deaths | 30 days, 6 months, 1,2 and 5 years | Yes | |
Secondary | Clinically and non-clinically indicated target lesion revascularizations | 30 days, 6 months, 1, 2 and 5 years | No | |
Secondary | Stent thrombosis ARC defined | 30 days, 1,2 and 5 years | Yes | |
Secondary | Stent strut coverage as assessed by OCT | 13 months | Yes | |
Secondary | Malapposition as assessed by OCT/IVUS | 13 months | Yes |
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