Study goal is to compare the performance of the Absorb bioresorbable scaffold with a metallic drug eltuting stent in the STEMI patient.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Minimum flow area by OCT after 12 months
Secondary outcome
OCT endpoints
1. Area stenosis
2. Lumen late loss
3. Crushed stent segments
4. Malapposition of stent struts
5. Minimum expansion of the stents expressed as absolute area and percentage of
the closest reference area,
6. Vessel ostial stent area (acute and at FU)
7. Thrombus burden
Angiographic endpoints
1.TIMI flow pre and post PCI,
2.Blush grade
3.Thrombus burden
4. Angiographic complications
5. Contrast use
6. Procedure time
7. Radiation skin dose
Clinical endpoints
Index admission:
1. Total death
2. Cardiac death
3. Non-index procedure myocardial infarction
4. Stent thrombosis (definite and probable)
5. TLR and TVR
6. non-TVR
Follow up:
1. Total death
2. Cardiac death
3. Non-index procedure myocardial infarction
4. Stent thrombosis (definite and probarble)
5. TLR and TVR
6. non-TVR
7. CCS angina class
8. Vascular cerebral events
9. Admissions for congestive heart failure or arrhythmia
Background summary
In patients presenting with myocardial infarct with ST elevation, Primary
percutaneous coronary intervention (PCI) is the preferred treatment (ESC
guidelines recommendation I A). Stenting has I A recommendation, and
preferably with drug eluting stents (DES) in patients who are likely to be
compliant to dual antiplatelet therapy (DAPT) and are not at an increased
bleeding risk (II A recommendation). Thrombus aspiration with specialized
catheter has an equally strong II A recommendation[1]. Thrombus aspiration
followed by direct stenting without any further balloon dilatation has been
shown to give better 1 year survival. Metallic drug eluting stents are being
challenged by new stents made from biodegradable platforms. The Absorb BVS
(Abbott Vascular, Santa Clara, CA) is the first of these being commercially
available in Norway. The second-generation Absorb BVS is a balloon-expandable
device consisting of a polymer backbone of poly-L-lactide (PLLA) coated with a
thin layer of a 1:1 mixture of an amorphous matrix of poly-D, L-lactide (PDLLA)
polymer and 100 *g/cm2 of the antiproliferative drug everolimus. Two platinum
markers located at each Absorb BVS edge allow for accurate visualization of the
radiolucent Absorb BVS during angiography or other imaging modalities. The
PDLLA controls the release of everolimus, 80% of which is eluted within the
first 30 days. Both PLLA and PDLLA are fully bioresorbable. The polymers are
degraded via hydrolysis of the ester bonds, and the resulting lactate and its
oligomers are quickly transformed to pyruvate and metabolized in the Krebs
energy cycle. Small particles, less than 2 *m in diameter, have also been shown
to be phagocytized and degraded by macrophages. According to preclinical
studies, the time for complete bioresorption of the polymer backbone is 2 to 3
years. It has been proven to be safe and non-inferior to metallic everolimus
stents in the ABSORB II, cohort B trial [7, 8]. The bioresorbable scaffold has
obvious advantages over metallic, as it will not hinder any future
revascularization. However there are concerns regarding the strength of the
scaffold. It is therefore recommended with more rigorous lesion preparation,
using balloons for predilatation. Currently only one small study has been
published studying specifically BVS in STEMI patients. This study is not
randomized and does not address the issue of predilatation.
Study objective
Study goal is to compare the performance of the Absorb bioresorbable scaffold
with a metallic drug eltuting stent in the STEMI patient.
Study design
The study is a prospective, randomized, controlled, non-blinded, single center
study comparing metallic drug eluting stent with bioresorbable scaffold in
STEMI patients. Primary endpoint is minimum flow area (MinFA) measured by OCT
after 12 months.
Intervention
Randomization between Xience metallic stent and bioresorbable scaffold
Study burden and risks
The additional risk of complications from using the OCT catheter is very low.
There is a small change that the catheter will cause a dissection, 1 at 1000
patients. Usually this will heal by itself without further invasive actions,
sometimes another stent needs to be placed to close this dissection. The risk
of death, cerebrovascular accident or myocardial infarction is expected to be
similar to an angiography without OCT measurements. Furthermore patients will
be asked to undergo an extra angiography after 2 years with additional
OCTmeasurements, this is an extra burden for the patient. After this follow-up,
there are no additional visits or examines for this substudy.
Haukelandveien 22
Bergen (noorwegen) 5021
NL
Haukelandveien 22
Bergen (noorwegen) 5021
NL
Listed location countries
Age
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 DAPT
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 contra-indications:
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57201.018.16 |