The main objective of the study is to investigate whether of the biolimus eluting and biodegradable polymer NOBORI* stent is non-inferior or even superior to the everolimus eluting XIENCE-V/XIENCE-PRime/PROMUS* stent in daily practice.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end point of the study is the composite of safety (cardiac death,
non fatal myocardial infarction) and efficacy (target vessel revascularization)
at 12 months.
Secondary outcome
The secondary end points of the study are:
A) The combined endpoint of cardiac death, non fatal myocardial infarction,
ischemic driven target lesion revascularization (TLR) rate at
12 months follow-up.
B) Incidence of Cardiac Death and Post-Procedural (>48h) MI rate at 12 months,
3 and 5 years
C) Target lesion revascularization at 12 months, 3 and 5 years
D) The combined endpoint of cardiac death, non fatal myocardial infarction,
target vessel revascularization (TVR)
rate at 3 and 5 years follow-up.
E) The combined endpoint of cardiac death, non fatal myocardial infarction and
target vessel revascularization at
12 months, 3 and 5 years in STEMI patients, small vessels (<
2.75 mm RVD), long lesions (> 20 mm), Female
patients, DM patients and octogenarians.
F) Procedural performance at the index procedures, measured by the ability to
cross the lesions with the
designated DES stent.
G) Incidence of definite and probable stent thrombosis at 12 months, 3 and 5
years time.
H) Incidence of definite, probable and possible stent thrombosis at 12 months,
3 and 5 years time.
Background summary
Randomized studies with drug eluting stents (DES), like Taxus (paclitaxel
eluting) en Cypher (sirolimus eluting) stents have shown that in almost all
indications for percutaneous coronary interventions (PCI) the risk on
re-stenosis significantly descrease compared to the use of bare-metal stents.
Comparative studies between Taxus and Cypher did not show any clear difference
in clinical outcome between both stents.
Since 2002 the Cypher and later the Taxus stent were used as the default stent
for all patients referred for PCI in the Rotterdam region (2 intervention
centers EMC and Maasstad Ziekenhuis). In the beginning this was done as a
registry (RESEARCH and T-SEARCH registry).
In 2006 the XIENCE-V/ PROMUS stent received CE marking and became available on
the European market. Compared to the first generation DES , this stent has a
different drug (everolimus) that elutes from a different durable polymer
coating and the stent has a different metal alloy (cobalt chromium), which
makes the stent more flexible.
The Xience-V/Promus stent has in comparison to the Taxus stent a lower
angiographic in-stent restenosis (late loss). Whether this surrogate end-point
of late loss results in better clinical outcome of the patient needs to be
determined and is part of current studies like the ongoing SPIRIT IV and
COMPARE I trials.
Recently a new phenomena in PCI has been identified: late stent thrombosis (>
30 days after stenting). Stent thrombosis is rare (incidence 0.6-1.2 %), but
results in severe morbidity (infarction) and mortality. Currently it is unclear
whether DES results in an increase of late stent thrombosis. Meta-analysis
shows momentarily no clear increase of risk, however several patho-anatomical
case reports describe a relationship. In those cases a hypersensitivity
reaction of the vessel wall at the site of the DES results in delayed healing
and impaired re-endothelization of the stent. The durable polymer of the stent
is potentially responsible for this rare complication.
One of the latest development in stents is the biodegradable polymer coating on
the DES. The polymer coating and drug resolves within 1-3 months after stent
placement. A recent conducted and publicized (Lancet sept 2008) study with this
new stent platform in all-comers (LEADERS trial) shows similar good clinical
results compared to the first generation Cypher DES. Whether the stent with a
biodegradable polymer has a lower incidence of late stent thrombosis needs to
be established. This is one of the reasons why the COMPARE II study has a
follow-up of 5 years.
Study objective
The main objective of the study is to investigate whether of the biolimus
eluting and biodegradable polymer NOBORI* stent is non-inferior or even
superior to the everolimus eluting XIENCE-V/XIENCE-PRime/PROMUS* stent in daily
practice.
Study design
Prospective, randomized, open-label, multi-center study of consecutive patients
referred for PCI.
Study burden and risks
The only requirement of the patient is to fill in a questionaire (1 single A4
form) send by post at 1, 6, 12 months and 2,3,4,5 year. The information within
the first 3 questionaire (1 year) is required by the Dutch Ministry of Health
(VWS) and the Dutch Society of Cardiology (NVVC).
In case an admission has occurred within the follow-up period, the patient
chart will be checked by authorized personel.
There is no risk for the patient related to participation in this study. The
patient will receive the CE marked Nobori or Xience-V/Xience-Prime/Promus stent
anyhow, if the indication for a DES stent exsists.
Groene Hilledijk 315
3015 EA Rotterdam
Nederland
Groene Hilledijk 315
3015 EA Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
All patients referred for PCI according to dutch and european guidelines
Age between 18-85 years
Exclusion criteria
1 Expected non-adherence to dual antiplatelet therapy for 1 year (e.g: known allergy to ASA or thienopyridines like clopidogrel)
2 Expected major surgery within 30 days (these patients will receive bare metal stents)
3 Cardiogenic shock (Kilip class 4)
4 Previous PCI procedures with implantation of drug eluting stents within 1 year.
5 Expected loss for follow up
6 Enrollment in an investigative stent study with different stents
7 Inability to implant Nobori or Xience-V / Promus stent(s)
Design
Recruitment
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 | NL25754.101.08 |