Comparison of Biolimus A9 and Everolimus Drug-Eluting Stents in Patients With ST Segment Elevation Myocardial Infarction

Study Overview
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Brief Summary
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The primary objective of this study is: comparison of a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance. A rate of 9 month MACE (deaths, myocardial infarction, ischemia driven TLR) will be assessed in both groups. The secondary outcomes are a comparison of (using OCT): number of uncovered stent struts number of malapposed stents struts in-stent neointimal volume in-segment assessment of vessel wall response to DES

Detailed Description
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The aim of this multicenter, prospective, randomized trial with a core lab analysis is to assess the safety and effectiveness (at 9-month follow-up) of third generation DES (biolimus A9 and everolimus) in patients with evolving STEMI with the OCT guidance (to optimize a stent implantation) A serial OCT analysis will be performed to assess the number of either uncovered or malaposed stents strut and a degree of in-stent neointimal hyperplasia. Furthermore, the in-segment vessel wall response to DES implantation will also be analysed. The goal is to enroll 400 patients (200 in each group) with OCT guidance in 100 patients in each group.

Official Title
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Randomized Comparison of Biolimus-Eluting and Everolimus-Eluting Stents With Optical Coherence Tomography Guided Stent Implantation in ST Elevation Myocardial Infarction.A 9-Month Angiographic and Optical Coherence Tomography Follow-up.

Conditions
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Coronary Heart Disease, Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: biolimus A9
* Device: everolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute STEMI within 12 hours from symptoms onset Native coronary disease with a lesion suitable for stenting Vessel size in between 2.5-3.75mm Patient is willing to provide written informed consent Male or female patients between 18-85 years of age Exclusion Criteria: Significant left main disease Killip class IV Known allergy to aspirin and or clopidogrel/ticlopidine Recent bleeding (<1month) Patient in anticoagulant therapy No suitable coronary anatomy for OCT scan (ostial lesion, very distal or large vessel />3.75mm in diameter/) Pregnancy Severe liver or renal disease (Cr>2.0) Life expectancy < 1 year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: biolimus A9<br>* 200 patients with STEMI will be treated using Biomatrix stent.<br>* Other names: biolimus A9 eluting stent;|
| Active Comparator: 2<br> | Device: everolimus<br>* 200 patients with STEMI will be treated with PROMUS DES.<br>* Other names: everolimus eluting stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance with assessment of a MACE's at 9 month follow-up |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of uncovered stent struts |  | 2 years | 
| number of malaposed stents struts |  | 2 years | 
| in-stent neointimal volume |  | 2 years | 
| in-segment assessment of vessel wall response to DES |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stents