Clinical trial NCT00888758: Comparison of Biolimus A9 and Everolimus Drug-Eluting Stents in Patients With ST Segment Elevation Myocardial Infarction
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Heart Disease
Percutaneous Coronary Intervention
Keywords: Stents
Lead sponsor: Masaryk University
Sponsor class: OTHER
First posted: 2009-04-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Acute STEMI within 12 hours from symptoms onset
2. Native coronary disease with a lesion suitable for stenting
3. Vessel size in between 2.5-3.75mm
4. Patient is willing to provide written informed consent
5. Male or female patients between 18-85 years of age

Exclusion Criteria:

1. Significant left main disease
2. Killip class IV
3. Known allergy to aspirin and or clopidogrel/ticlopidine
4. Recent bleeding (\<1month)
5. Patient in anticoagulant therapy
6. No suitable coronary anatomy for OCT scan (ostial lesion, very distal or large vessel /\>3.75mm in diameter/)
7. Pregnancy
8. Severe liver or renal disease (Cr\>2.0)
9. Life expectancy \< 1 year

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: number of uncovered stent struts
timeFrame: 2 years
measure: number of malaposed stents struts
timeFrame: 2 years
measure: in-stent neointimal volume
timeFrame: 2 years
measure: in-segment assessment of vessel wall response to DES
timeFrame: 2 years
Other outcomes:
Locations:
city: Ústí nad Labem
country: Czech Republic
facility: Department of Cardiology, Masaryk hospital and University of JEP
Study officials:
affiliation: Krajska zdravotni a.s., Masarzk hospital Usti nad Labem
name: Pavel Cervinka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: