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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute ST Segment Elevation Myocardial Infarction
• Intervention / Treatment: Device: stent implant in a coronary artery

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).

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus University Hospital, Skejby
• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BVS; 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; Implantation of device called a stent in a coronary artery Percutaneous coronary intervention
Active Comparator: DES; 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; Implantation of device called a stent in a coronary artery Percutaneous coronary intervention

What is the study measuring?

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 ischemiaECG changes indicative of new ischemia (new ST-T changes or new LBBB)Development of pathological Q waves in the ECGImaging 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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Oslo University Hospital; Aarhus University Hospital Skejby; University Hospital of North Norway; St. Olavs Hospital; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Feiring
• Investigators: Study Chair: Vegard Tuseth, PhD, University of Bergen; Study Chair: Jan Erik Nordrehaug, PhD, University of Bergen; Principal Investigator: Erlend Eriksen, MD, Helse-Bergen HF

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: February 19, 2014
• First Posted (Estimate): February 20, 2014

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 26, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Optical coherence tomography; STEMI; Drug eluting stent; Coronary; Bioresorbable scaffold; Multislice computed tomography
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 2013/2006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No