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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Implantation of device called a stent in a coronary artery Percutaneous coronary intervention
Aarhus University Hospital, Skejby
Aarhus, Denmark
Haukeland University Hospital
Bergen, Norway
Coronary Stent Healing Index (cumulated)
1. Uncovered struts: 2% =1 - 5% =2 - 10% =3 - 15% =4 - 20% =5 - 25% =6 - 30% =7 - 35% =8 - 40% =9 2. Uncovered struts in front of side branch on acquired or persistent malposed struts. 10% =1 - 20% =2 - 30% =3 etc… til 100%=10 3. Persistent malposition: ≥2 nabo struts længde mindst 1 mm =1 ; ≥2mm=3 ; ≥3 mm = 3 4. Acquired malposition: ≥2 adjacent struts of at least 1 mm length =2 ; ≥2mm=4 ; ≥3 mm = 6 5. Neointimal thickness in one frame \>200 =1 - \>300 =2 - \>400 =3 or diameter stenosis \>50% =4 - \> 75% =5 6. Cumulated extra stent lumen increase in match cross sectional analysis: (gns. areal mål): ≥0.2mm2 =1 ; ≥0.4 mm2 = 2; ≥0.6mm2=3 ; ≥0.8 mm2 = 4 ; ≥1.0 mm2=5 ; ≥1.2 mm2 = 6
Time frame: 12 months
Multislice computed tomography
MSCT-CA will be done at 24 months to extend the observational time by a non-invasive measure. MSCT-CA will be compared to conventional angiogram with OCT at 12 months to verify MSCT-CA findings at 24 months. Results will be reported in separate paper.
Time frame: 24 months
Minimum Flow Area
Minimum flow area as defined in TROFI I, measured by OCT
Time frame: 12 months
Total Death
Total death encompasses cardiac death and other fatal categories, which include cerebrovascular death, death from other cardiovascular disease (i.e. pulmonary embolism, dissection aortic aneurysm will be included in this category), death from malignant disease, death from suicide, violence or accident, or death from other reasons.
Time frame: 5 years
Cardiac death
Cardiac death encompasses coronary heart disease death including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death from heart failure including cardiogenic shock, and death related to a cardiac procedure or surgery within 28 days from the procedure.
Time frame: 5 years
Myocardial infarction
Evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Under these conditions any one of the following criteria meets the diagnosis for myocardial infarction : 1. Detection of rise and/or fall of preferably troponin T with at least one value above the 99th percentile of the upper reference limit (URL) together with evidence of myocardial ischemia with at least one of the following (MI types 1 or 2): 1. Symptoms of ischemia 2. ECG changes indicative of new ischemia (new ST-T changes or new LBBB) 3. Development of pathological Q waves in the ECG 4. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality 2. Sudden, unexpected cardiac death, involving cardiac arrest.
Time frame: 5 years
Stent thrombosis
Stent thrombosis is recognized when documented by angiography and/or autopsy and when meeting the criteria for spontaneous myocardial infarction occurring in the territory of the treated vessel (11). Stent thrombosis are categorized as acute, sub-acute, late and very late and as definite, probable and possible according to the ARC-criteria (12).
Time frame: 5 years
Target Lesion and vessel Revascularization
Coronary artery bypass grafting with grafting or PCI of index lesion. Coronary artery bypass grafting with grafting or PCI of index vessel.
Time frame: 5 years
Non Target vessel revascularisation
All PCI or coronary bypass grafting of non index vessel
Time frame: 5 years
Stable angina
Angina as reported by patient, classified according to Canadian cardiac society class (CCS)
Time frame: 5 years
Vascular cerebral events
Vascular events documented by neurological permanent disabilities or by diagnostic imaging (MRI or CT).
Time frame: 5 years
Admission for congestive heart failure or arrhythmias
Admissions were the diagnosis at release is one of heart failure or arrhythmias
Time frame: 5 years
Optical Coherence tomography
Area stenosis
Time frame: 12 months
Angiographic endpoints at index admission
TIMI flow pre and post PCI
Time frame: After index procedure were the patient is included and randomized
Biochemical
Creatinine, hemoglobin, Troponin T will be analyzed during index procedure post procedure and at 12 months follow-up. ProBNP will be analyzed at 12 months follow-up
Time frame: 12 months
Markers
Plasma, full blood, serum and urine will be drawn immediately after the procedure and frozen in a bio bank for later analysis
Time frame: 12 months
Thrombus analysis
Visible thrombus aspirates will be sent for analysis
Time frame: At index procedure were the patient is included and randomized
Optical coherence tomography
Lumen late loss
Time frame: 12 months
Optical coherence tomography
Crushed stent segments
Time frame: 12 months
Optical coherence tomography
Malposition of stent segments
Time frame: 12 months
Optical coherence tomography
Minimum expansion of stent struts expressed as absolute area and percentage of closest reference reference area
Time frame: 12 months
Optical coherence tomography
Vessel ostial stented area (acute and at FU)
Time frame: 12 months
Optical coherence tomography
Thrombus burden
Time frame: 12 months
Angiographic endpoints at index admission
Blush grade
Time frame: After index procedure were the patient is included and randomized
Angiographic endpoints at index admission
Thrombus burden
Time frame: After index procedure were the patient is included and randomized
Angiographic endpoints at index admission
Angiographic complications
Time frame: After index procedure were the patient is included and randomized
Angiographic endpoints at index admission
Contrast use
Time frame: After index procedure were the patient is included and randomized
Angiographic endpoints at index admission
Procedure time
Time frame: After index procedure were the patient is included and randomized
Angiographic endpoints at index admission
Radiation skin dose
Time frame: After index procedure were the patient is included and randomized
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