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

Haukeland University Hospital

Status and phase: Unknown; Phase 3

Conditions: Acute ST Segment Elevation Myocardial Infarction

Treatments: Device: stent implant in a coronary artery

Study type: Interventional

Funder types: Other

Identifiers

NCT02067091

2013/2006

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

BVS

Active Comparator group

Description:

Implantation of bioresorbable vascular scaffold in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention

Treatment:

Device: stent implant in a coronary artery

DES

Active Comparator group

Description:

Implantation of drug eluting stent in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention

Treatment:

Device: stent implant in a coronary artery