The purpose of the study is to compare the combination of DEB/BMS versus DES versus BMS alone in patients with an AMI.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Late loss of lumen diameter between index procedure and 6 month angiographic
follow-up.
Secondary outcome
1) Binary restenosis ( > 50 % ) at 6 month follow*up
2) Stent malapposition at 6 month follow*up
3) Endothelial dysfunction at 6 month follow*up
4) Clinical outcome at 1 and 5 year follow*up
Background summary
Patients with an acute myocardial infarction (AMI) are currently being treated
with percutaneous coronary intervention (PCI) with placement of one ore more
stents into the coronary vessel. A stent is a thin metal device, pre-mounted on
a balloon. At the site of the stenosis the balloon is temporarily inflated
which results in expansion and placement of the stent against the vessel wall.
Within a couple of months the inner side of bare metal stents (BMS) is
re-endothelialized. Unfortunately, in 10-25 % of cases there is an exaggerated
reaction of neointimal growth resulting in re-stenosis of the stent. The
currently wide used drug eluting stent (DES) have a medical coating to prevent
exaggerated neo-intimal growth. However this can lead to a delayed and
incomplete re-endothelialization of the stent. Malapposed and uncovered metal
parts of DES are associated with an increased risk of late stent thrombosis and
fatal or non-fatal AMI. Another disadvantage of the use of DES may be the
negative effect on endothelial function in the distal coronary vessel due to
the extended release of medication from the coated stent. An interesting new
development is the drug eluting balloon (DEB) which allows a short period of
delivery of medication (Paclitaxel) into the vessel wall. It has been
hypothesized that the placement of BMS after DEB may prevent the risk of
restenosis while allowing normal re-endothelialization of the BMS. Data from
animals and patients with stable angina are encouraging. To our knowledge no
studies with DEB have been performed in patients with AMI.
Study objective
The purpose of the study is to compare the combination of DEB/BMS versus DES
versus BMS alone in patients with an AMI.
Study design
A total of 200 patients will be randomly allocated to one of three treatment
arms. Randomisation will be blinded and performed via closed envelope. After 6
months all patients will undergo a control coronary angiography in order to
evaluate the efficacy of the index treatment. In addition, 40 patients (10 of
each group) will undergo optical coherence tomography (OCT) in order to
evaluate stent endothelialization and malappostion, and acetylcholine derived
evaluation of endothelial dysfunction.
Intervention
PCI is currently the standard treatment for patients with AMI. Several types
of balloons and stents are being used. In the current study we will
investigate different approaches of DEB and DES and BMS. Intra-coronary
thrombo-suction prior to PCI is also a standard treatment in our center.
Study burden and risks
PCI with different types of balloons/stents is currently the treatment of
choice in patients with AMI. In the current study a DEB is introduced prior
BMS. The invasive treatment is not different as compared to standard PCI,
except the 6 month angiographic follow-up. Due to the invasive nature of this
investigation a small risk is involved. However these catheterizations are
performed by high volume operators who do these procedures more than 300 times/
year. The potential advantage for patients is that they know the status of
their coronary anatomy after 6 months and in case of a re stenosis a re-PCI can
be performed immediately.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
- Age: 18-80 year
- STEMI within 12 hours of onset of complaints
- Candidate for primary PCI with stent-implantation
- Successful thrombus aspiration defined by no angiographic signs of thrombus a the site of plaque rupture and TIMI flow * 1.
Exclusion criteria
- Unable to give written informed consent
- Previous PCI or CABG of infarct related vessel
- Left main stenosis * 50%.
- Severe triple vessel disease with stenosis * 50% in 3 epicardial coronary arteries.
- Target vessel reference diameter < 2.5 and > 4.0 mm
- Target lesion length < 25 mm
- Intolerance for aspirin or clopidogrel
- Life expentancy < 12 month
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 | NL24127.041.08 |