To assess the safety of the Orsiro Mission Stent System in subjects at high bleeding risk (HBR) undergoing PCI followed by 30-days Dual Antiplatelet Therapy (DAPT).
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Composite of cardiac death, myocardial infarction (MI) and definite or probable
stent thrombosis at 12 months post index procedure in High Bleeding ( risk
(HBR) patients treated with either Orsiro Mission stent or with the Resolute
Onyx stent in combination with 30-days Dual Antiplatelet Therapy (DAPT)
regimen.
Secondary outcome
Additional endpoints will be measured at the 1-, 6-, and 12-month Follow ups:
* Rate of definite/probable stent thrombosis (ST) utilizing the Academic
Research Consortium-2 (ARC-2) definition.
* Rate of major adverse cardiac & cerebrovascular events (MACCE), defined as
the composite of all-cause death, MI, and stroke.
* Rate of major adverse cardiac events (MACE), defined as the composite of
cardiac death, MI, and Target Vessel Revascularization (TVR).
Please see protocol paragraph 4.8 for the complete list of secondary endpoints.
Background summary
Drug-eluting stents (DES) have significant advantages over bare metal stents
(BMS) in the treatment of Coronary Artery Disease (CAD). The introduction of
DES greatly reduced the incidence of restenosis and resulted in a better safety
profile compared to BMS with systemic drug administration. However, certain
clinical events were reported more frequently for DES compared to BMS,
especially late and very late stent thrombosis (ST).
Due to the potential for increased risk of ST with DES, the recommended
duration of Dual Antiplatelet Therapy (DAPT) was typically longer with DES
compared to BMS. Some meta-analyses found a significantly higher risk of
bleeding and all-cause mortality associated with a longer DAPT regimen in
comparison to a shorter DAPT regimen. Review also found a strong evidence of
reduced cardiovascular events at the expense of increased bleeding. Therefore,
further studies for subjects with a high bleeding risk were performed to
determine whether short DAPT regimen was appropriate considering the higher
bleeding risk (HBR) associated with longer DAPT regimen.
The current European guidelines for cardiology favors a shorter duration of
DAPT (1-3 months) over a longer DAPT regimen for patients at high risk of
bleeding who receive a DES.
see also protocol paragraph 1
Study objective
To assess the safety of the Orsiro Mission Stent System in subjects at high
bleeding risk (HBR) undergoing PCI followed by 30-days Dual Antiplatelet
Therapy (DAPT).
Study design
Prospective, randomized, muli-center study
Intervention
One group is randomized to receive the Orsiro Mission Drug-eluting stent (DES),
the other group is randomized to receive the Resolute Onyx DES stent. Both
groups will receive a 30-day Dual Antiplatelet Therapy (DAPT).
Study burden and risks
An in office or telephone contact is done at 1-, 6-, and 12-months after stent
implantion where two health questionnaires are administered (EQ5D & SAQ7) next
to the standard clinical assessments.
In case a medication diary is used this will take extra time. The use of a
diary is however not mandatory. .
Potential adverse events related to shortening DAPT after stent implantation
may include but are not limited to increased risk of stent thrombosis,
myocardial infarction or cardiac death.
Ackerstrasse 6
Bulach CH-8180
CH
Ackerstrasse 6
Bulach CH-8180
CH
Listed location countries
Age
Inclusion criteria
- An acceptable candidate for treatment with a Drug Eluting Stent (DES)
- Considered at high bleeding risk
- >= 18 years old
Exclusion criteria
- previously experienced stent or scaffold thrombosis in any coronary vessel.
- Revascularization of any target vessel within 9 months prior to the index
procedure or previous PCI of any non-target vessel within 72 hours prior to or
during the index procedure.
- judged by physician as inappropriate for discontinuation from DAPT at 1 month
following index procedure, due to another condition requiring chronic DAPT.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| ClinicalTrials.gov | NCT04137510 |
| CCMO | NL75712.058.21 |