Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct

Study Overview
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Brief Summary
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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
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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).

Official Title
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Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct (BVS in STEMI)

Conditions
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Acute ST Segment Elevation Myocardial Infarction

Intervention / Treatment
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* Device: stent implant in a coronary artery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of chest pain < 12 hrs 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). Clinical decision to treat with primary PCI > 18 years Oral informed consent Exclusion Criteria: Contraindications to long term double antiplatelet therapy Known kidney failure with GFR < 45 Cardiac arrest or severe cardiogenic shock (Persistent BP <90 mmHg, despite adequate treatment) Other severe illness with life expectancy of less than 12 months (eg. malignancy, severe malnutrition, degenerative disease) Procedural contraindications: Heavy calcification, tortuous vessel or large side branch (> 2,5 mm) at culprit lesion. TIMI 0-1 flow after aspiration Unable to advance thrombus aspiration catheter

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BVS<br>Implantation of bioresorbable vascular scaffold in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention | Device: stent implant in a coronary artery<br>* Implantation of device called a stent in a coronary artery Percutaneous coronary intervention<br>|
| Active Comparator: DES<br>Implantation of drug eluting stent in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention | Device: stent implant in a coronary artery<br>* Implantation of device called a stent in a coronary artery Percutaneous coronary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary Stent Healing Index (cumulated) | Uncovered struts: 2% =1 - 5% =2 - 10% =3 - 15% =4 - 20% =5 - 25% =6 - 30% =7 - 35% =8 - 40% =9 Uncovered struts in front of side branch on acquired or persistent malposed struts. 10% =1 - 20% =2 - 30% =3 etc… til 100%=10 Persistent malposition: ≥2 nabo struts længde mindst 1 mm =1 ; ≥2mm=3 ; ≥3 mm = 3 Acquired malposition: ≥2 adjacent struts of at least 1 mm length =2 ; ≥2mm=4 ; ≥3 mm = 6 Neointimal thickness in one frame >200 =1 - >300 =2 - >400 =3 or diameter stenosis >50% =4 - > 75% =5 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 | 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. | 24 months | 
| Minimum Flow Area | Minimum flow area as defined in TROFI I, measured by OCT | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 : 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): Symptoms of ischemia ECG changes indicative of new ischemia (new ST-T changes or new LBBB) Development of pathological Q waves in the ECG Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality Sudden, unexpected cardiac death, involving cardiac arrest. | 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). | 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. | 5 years | 
| Non Target vessel revascularisation | All PCI or coronary bypass grafting of non index vessel | 5 years | 
| Stable angina | Angina as reported by patient, classified according to Canadian cardiac society class (CCS) | 5 years | 
| Vascular cerebral events | Vascular events documented by neurological permanent disabilities or by diagnostic imaging (MRI or CT). | 5 years | 
| Admission for congestive heart failure or arrhythmias | Admissions were the diagnosis at release is one of heart failure or arrhythmias | 5 years | 
| Optical Coherence tomography | Area stenosis | 12 months | 
| Angiographic endpoints at index admission | TIMI flow pre and post PCI | 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 | 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 | 12 months | 
| Thrombus analysis | Visible thrombus aspirates will be sent for analysis | At index procedure were the patient is included and randomized | 
| Optical coherence tomography | Lumen late loss | 12 months | 
| Optical coherence tomography | Crushed stent segments | 12 months | 
| Optical coherence tomography | Malposition of stent segments | 12 months | 
| Optical coherence tomography | Minimum expansion of stent struts expressed as absolute area and percentage of closest reference reference area | 12 months | 
| Optical coherence tomography | Vessel ostial stented area (acute and at FU) | 12 months | 
| Optical coherence tomography | Thrombus burden | 12 months | 
| Angiographic endpoints at index admission | Blush grade | After index procedure were the patient is included and randomized | 
| Angiographic endpoints at index admission | Thrombus burden | After index procedure were the patient is included and randomized | 
| Angiographic endpoints at index admission | Angiographic complications | After index procedure were the patient is included and randomized | 
| Angiographic endpoints at index admission | Contrast use | After index procedure were the patient is included and randomized | 
| Angiographic endpoints at index admission | Procedure time | After index procedure were the patient is included and randomized | 
| Angiographic endpoints at index admission | Radiation skin dose | After index procedure were the patient is included and randomized | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, Coronary, Bioresorbable scaffold, Drug eluting stent, Optical coherence tomography, Multislice computed tomography