Clinical trial NCT02067091: Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct
Official title: Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct (BVS in STEMI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute ST Segment Elevation Myocardial Infarction
Keywords: STEMI
Coronary
Bioresorbable scaffold
Drug eluting stent
Optical coherence tomography
Multislice computed tomography
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital Skejby
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Oslo University Hospital
name: St. Olavs Hospital
name: University Hospital of North Norway
name: Feiring
First posted: 2014-02-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients presenting with acute ST elevation myocardial infarct urgently need revascularization. Standard of care is establishing bloodflow through the coronary vessels using thrombus aspiration catheter, and securing the result by using a metallic drug eluting stent. New kinds of non-metallic bioresorbable stents are now available. They have however challenges in structural strength.

The investigators want to compare the new bioresorbable scaffold with traditional metallic stents in this setting in a prospective, randomized, non-blinded, multicenter study in 120 patients. The investigators will use an imaging technique, optical coherence tomography, to evaluate the results after 12 months.

The investigators also want to see if modern multislice computed tomography can give useful information in the follow-up of stented coronary arteries after 12 and 24 months.

Detailed description: Patients presenting with ST elevation myocardial infarction for primary PCI (percutaneous coronary intervention) will be screened. After thrombus aspiration, patient will be asked for oral consent if TIMI flow 2-3. Patient will then be randomized between drug eluting stent (Xience pro, Abbott Vascular Solutions) and bioresorbable scaffold (Absorb, Abbott Vascular Solutions). Optical coherence tomography (OCT) will be performed before stenting and after final result. Stent will be deployed without further predilatation if possible. Follow up at 12 months (clinical, angio with OCT and multislice CT coronary angiogram (MSCT-CA)) and 24 months (MSCT-CA).

Eligibility criteria: Inclusion Criteria:

1. History of chest pain \< 12 hrs
2. ST elevation of ≥ 2 mm in ≥2 contiguous precordial leads (V1-V6), and/or ≥ 1 mm in ≥ 2 contiguous standard leads (I, II, III, aVf, aVr,aVl).
3. Clinical decision to treat with primary PCI
4. \> 18 years
5. Oral informed consent

Exclusion Criteria:

1. Contraindications to long term double antiplatelet therapy
2. Known kidney failure with GFR \< 45
3. Cardiac arrest or severe cardiogenic shock (Persistent BP \<90 mmHg, despite adequate treatment)
4. Other severe illness with life expectancy of less than 12 months (eg. malignancy, severe malnutrition, degenerative disease)

Procedural contraindications:

1. Heavy calcification, tortuous vessel or large side branch (\> 2,5 mm) at culprit lesion.
2. TIMI 0-1 flow after aspiration
3. Unable to advance thrombus aspiration catheter

Primary outcomes:
measure: Coronary Stent Healing Index (cumulated)
timeFrame: 12 months
measure: Multislice computed tomography
timeFrame: 24 months
measure: Minimum Flow Area
timeFrame: 12 months
Secondary outcomes:
measure: Total Death
timeFrame: 5 years
measure: Cardiac death
timeFrame: 5 years
measure: Myocardial infarction
timeFrame: 5 years
measure: Stent thrombosis
timeFrame: 5 years
measure: Target Lesion and vessel Revascularization
timeFrame: 5 years
measure: Non Target vessel revascularisation
timeFrame: 5 years
measure: Stable angina
timeFrame: 5 years
measure: Vascular cerebral events
timeFrame: 5 years
measure: Admission for congestive heart failure or arrhythmias
timeFrame: 5 years
measure: Optical Coherence tomography
timeFrame: 12 months
measure: Angiographic endpoints at index admission
timeFrame: After index procedure were the patient is included and randomized
measure: Biochemical
timeFrame: 12 months
measure: Markers
timeFrame: 12 months
measure: Thrombus analysis
timeFrame: At index procedure were the patient is included and randomized
measure: Optical coherence tomography
timeFrame: 12 months
measure: Optical coherence tomography
timeFrame: 12 months
measure: Optical coherence tomography
timeFrame: 12 months
measure: Optical coherence tomography
timeFrame: 12 months
measure: Optical coherence tomography
timeFrame: 12 months
measure: Optical coherence tomography
timeFrame: 12 months
measure: Angiographic endpoints at index admission
timeFrame: After index procedure were the patient is included and randomized
measure: Angiographic endpoints at index admission
timeFrame: After index procedure were the patient is included and randomized
measure: Angiographic endpoints at index admission
timeFrame: After index procedure were the patient is included and randomized
measure: Angiographic endpoints at index admission
timeFrame: After index procedure were the patient is included and randomized
measure: Angiographic endpoints at index admission
timeFrame: After index procedure were the patient is included and randomized
measure: Angiographic endpoints at index admission
timeFrame: After index procedure were the patient is included and randomized
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: University of Bergen
name: Vegard Tuseth, PhD
role: STUDY_CHAIR
affiliation: University of Bergen
name: Jan Erik Nordrehaug, PhD
role: STUDY_CHAIR
affiliation: Helse-Bergen HF
name: Erlend Eriksen, MD
role: PRINCIPAL_INVESTIGATOR
References: