Comparison of Biomatrix Versus Gazelle in ST-Elevation Myocardial Infarction (STEMI) (COMFORTABLE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00962416
First received: August 19, 2009
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
ST-elevation Myocardial Infarction
Device: Biolimus eluted from an erodable stent coating (Biomatrix)
Device: bare-metal stent (Gazelle)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • 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 [ Time Frame: 30 days, 6 months, 1,2 and 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All deaths [ Time Frame: 30 days, 6 months, 1,2 and 5 years ] [ Designated as safety issue: Yes ]
  • Clinically and non-clinically indicated target lesion revascularizations [ Time Frame: 30 days, 6 months, 1, 2 and 5 years ] [ Designated as safety issue: No ]
  • Stent thrombosis ARC defined [ Time Frame: 30 days, 1,2 and 5 years ] [ Designated as safety issue: Yes ]
  • Stent strut coverage as assessed by OCT [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
  • Malapposition as assessed by OCT/IVUS [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]

Enrollment: 1161
Study Start Date: September 2009
Estimated Study Completion Date: December 2015
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Biolimus eluting Stent (Biomatrix)
Device: Biolimus eluted from an erodable stent coating (Biomatrix)
The Biolimus-eluting stent (Biomatrix) has a corrugated ring design available in six and nine cell models and is laser cut from 316L VM stainless steel hypotube. The nominal dosage of Biolimus A9 goes from 133 to 442 microgram. The producer of the drug is Nippoon Kayaku Co., Ltd Takasaki Plant, 239, Iwahanamachi, Takasaki-shi, Gumma 370-1028 Japan. The biodegradable polymer is polylactic acid, which has become one of the most commonly used biodegradable polymers. Polylactic acid, its co-polymers, and mixtures have been evaluated in the preclinical, and clinical studies, revealing a favorable biocompatability profile. The polymer has been demonstrated to be safe when used as implant of drug release-control polymer for both animals and humans.
Active Comparator: 2
Bare metal stent (Gazelle)
Device: bare-metal stent (Gazelle)
A bare-metal stent of identical design without surface application of polymer and drug.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962416

Locations
Switzerland
Department of Cardiology
Bern, Switzerland, 3010
Dep. of Cardiology
Geneva, Switzerland, 1211
Dep. of Cardiology
Lugano, Switzerland, 6900
Dep. of Cardiology
University of Lausanne, Switzerland, 1011
Dep. of Cardiology
Zürich, Switzerland, 8091
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss National Science Foundation
Investigators
Study Chair: Stephan Windecker, Professor of Cardiology Dep. of Cardiology, University Hospital Bern
Study Director: Lorenz Räber, MD Dep. of Cardiology, University Hospital Bern
Study Director: Peter Jüni, Professor of Biostatistics Dep. of Social and Preventive Med., University Bern
Study Director: Hector Garcia Garcia, MD Erasmus Thoraxcenter Rotterdam, The Netherlands
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Stephan Windecker, Cardiology Department, University Hospital Bern
ClinicalTrials.gov Identifier: NCT00962416     History of Changes
Other Study ID Numbers: 137/09, Inselspital Study No 1373
Study First Received: August 19, 2009
Last Updated: May 16, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
Drug eluting stent
Biolimus
Biodegradable stent
ST-elevation myocardial infarction
Coronary artery disease

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014