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

NCT00962416 | Completed Phase 4 DMC

• 2 other identifiers: 137/091373
• Study Type: interventional
• Target: 1,161
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

ST-elevation Myocardial Infarction

Keywords

Drug eluting stent; Biolimus; Biodegradable stent; ST-elevation myocardial infarction; Coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• All deaths

  30 days, 6 months, 1,2 and 5 years

• Clinically and non-clinically indicated target lesion revascularizations

  30 days, 6 months, 1, 2 and 5 years

• Stent thrombosis ARC defined

  30 days, 1,2 and 5 years

• Stent strut coverage as assessed by OCT

  13 months

• Malapposition as assessed by OCT/IVUS

  13 months

Study Arms (2)

1

ACTIVE COMPARATOR

Biolimus eluting Stent (Biomatrix)

Device: Biolimus eluted from an erodable stent coating (Biomatrix)

2

ACTIVE COMPARATOR

Bare metal stent (Gazelle)

Device: bare-metal stent (Gazelle)

Interventions

Biolimus eluted from an erodable stent coating (Biomatrix) DEVICE

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.

1

bare-metal stent (Gazelle) DEVICE

A bare-metal stent of identical design without surface application of polymer and drug.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Swiss National Science Foundation: collaborator

Study Sites (5)

Department of Cardiology

Bern, 3010, Switzerland

Location

Dep. of Cardiology

Geneva, 1211, Switzerland

Location

Dep. of Cardiology

Lugano, 6900, Switzerland

Location

Dep. of Cardiology

University of Lausanne, 1011, Switzerland

Location

Dep. of Cardiology

Zurich, 8091, Switzerland

Location

Related Publications (17)

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MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Stephan Windecker, Professor of Cardiology

  Dep. of Cardiology, University Hospital Bern

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2016
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

CH (5)