Coronary Stenosis
Conditions
Keywords
CAD, ACS, All comers, PCI
Brief summary
The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.
Interventions
DEVICEMiStent
Percutaneous Coronary Intervention
DEVICEXIENCE EES
Percutaneous Coronary Intervention
Sponsors
Micell Technologies
Stentys
ECRI bv
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All comers patients: * Male or female patients 18 years or older; * Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. * The vessel should have a reference vessel diameter ranging from 2.5 mm to 3.75 mm (no limitation on the number of treated lesions, vessels, or lesion length); All lesions of the patient must comply with the angiographic inclusion criteria. * The patient is judged to be capable of providing voluntary informed consent and has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.
Exclusion criteria
* Known pregnancy or breastfeeding at time of randomization; * Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor; * Concurrent medical condition with a life expectancy of less than 12 months. * The patient is unwilling/ not able to return for outpatient clinic at 1 month and 12 months follow-up. * Currently participating in another trial and not yet at its primary endpoint.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE) | 12 months postprocedure | DOCE is a composite of clinical endpoint of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and clinically-indicated target lesion revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE | At 12 months | MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR) |
| Target Vessel Failure (TVF) | At 12 months | Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR |
| All-cause Death | At 12 months | All-cause death |
| POCE | At 12 months | POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization |
| Any Revascularization | At 12 months | Any revascularization |
| Stent Thrombosis | At 12 months | Definite or probably stent thrombosis according to ARC |
| Myocardial Infarction | At 12 months | Any Myocardial infarction |
Countries
France, Germany, Netherlands, Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MiStent® Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating.
MiStent: Percutaneous Coronary Intervention | 703 |
| XIENCE EES Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.
XIENCE EES: Percutaneous Coronary Intervention | 695 |
| Total | 1,398 |
Baseline characteristics
| Characteristic | MiStent® | XIENCE EES | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 446 Participants | 424 Participants | 870 Participants |
| Age, Categorical Between 18 and 65 years | 257 Participants | 271 Participants | 528 Participants |
| Age, Continuous | 66.4 years STANDARD_DEVIATION 10.7 | 66.3 years STANDARD_DEVIATION 10.7 | 66.4 years STANDARD_DEVIATION 10.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment France | 56 participants | 56 participants | 112 participants |
| Region of Enrollment Germany | 163 participants | 159 participants | 322 participants |
| Region of Enrollment Netherlands | 297 participants | 296 participants | 593 participants |
| Region of Enrollment Poland | 187 participants | 184 participants | 371 participants |
| Sex: Female, Male Female | 209 Participants | 182 Participants | 391 Participants |
| Sex: Female, Male Male | 494 Participants | 513 Participants | 1007 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 85 / 703 | 78 / 695 |
| other Total, other adverse events | 76 / 703 | 71 / 695 |
| serious Total, serious adverse events | 434 / 703 | 426 / 695 |
Outcome results
Primary
Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE)
DOCE is a composite of clinical endpoint of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and clinically-indicated target lesion revascularization.
Time frame: 12 months postprocedure
Population: Intention-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiStent® | Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE) | 40 Participants |
| XIENCE EES | Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE) | 45 Participants |
Secondary
All-cause Death
All-cause death
Time frame: At 12 months
Population: ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiStent® | All-cause Death | 25 Participants |
| XIENCE EES | All-cause Death | 18 Participants |
Secondary
Any Revascularization
Any revascularization
Time frame: At 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiStent® | Any Revascularization | 61 Participants |
| XIENCE EES | Any Revascularization | 78 Participants |
Secondary
MACE
MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR)
Time frame: At 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiStent® | MACE | 65 Participants |
| XIENCE EES | MACE | 65 Participants |
Secondary
Myocardial Infarction
Any Myocardial infarction
Time frame: At 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiStent® | Myocardial Infarction | 17 Participants |
| XIENCE EES | Myocardial Infarction | 15 Participants |
Secondary
POCE
POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization
Time frame: At 12 months
Population: ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiStent® | POCE | 93 Participants |
| XIENCE EES | POCE | 101 Participants |
Secondary
Stent Thrombosis
Definite or probably stent thrombosis according to ARC
Time frame: At 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiStent® | Stent Thrombosis | 5 Participants |
| XIENCE EES | Stent Thrombosis | 6 Participants |
Secondary
Target Vessel Failure (TVF)
Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR
Time frame: At 12 months
Population: ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiStent® | Target Vessel Failure (TVF) | 45 Participants |
| XIENCE EES | Target Vessel Failure (TVF) | 53 Participants |