Trial Outcomes & Findings for Study Comparing the MiStent SES Versus the XIENCE EES Stent (NCT NCT02385279)
NCT ID: NCT02385279
Last Updated: 2023-05-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1398 participants
Primary outcome timeframe
12 months postprocedure
Results posted on
2023-05-08
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
703
|
695
|
|
Overall Study
COMPLETED
|
676
|
677
|
|
Overall Study
NOT COMPLETED
|
27
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MiStent®
n=703 Participants
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
|
XIENCE EES
n=695 Participants
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
|
Total
n=1398 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=703 Participants
|
0 Participants
n=695 Participants
|
0 Participants
n=1398 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
257 Participants
n=703 Participants
|
271 Participants
n=695 Participants
|
528 Participants
n=1398 Participants
|
|
Age, Categorical
>=65 years
|
446 Participants
n=703 Participants
|
424 Participants
n=695 Participants
|
870 Participants
n=1398 Participants
|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 10.7 • n=703 Participants
|
66.3 years
STANDARD_DEVIATION 10.7 • n=695 Participants
|
66.4 years
STANDARD_DEVIATION 10.7 • n=1398 Participants
|
|
Sex: Female, Male
Female
|
209 Participants
n=703 Participants
|
182 Participants
n=695 Participants
|
391 Participants
n=1398 Participants
|
|
Sex: Female, Male
Male
|
494 Participants
n=703 Participants
|
513 Participants
n=695 Participants
|
1007 Participants
n=1398 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Netherlands
|
297 participants
n=703 Participants
|
296 participants
n=695 Participants
|
593 participants
n=1398 Participants
|
|
Region of Enrollment
Poland
|
187 participants
n=703 Participants
|
184 participants
n=695 Participants
|
371 participants
n=1398 Participants
|
|
Region of Enrollment
France
|
56 participants
n=703 Participants
|
56 participants
n=695 Participants
|
112 participants
n=1398 Participants
|
|
Region of Enrollment
Germany
|
163 participants
n=703 Participants
|
159 participants
n=695 Participants
|
322 participants
n=1398 Participants
|
PRIMARY outcome
Timeframe: 12 months postprocedurePopulation: Intention-to-treat
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.
Outcome measures
| Measure |
MiStent®
n=703 Participants
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
|
XIENCE EES
n=695 Participants
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
|
|---|---|---|
|
Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE)
|
40 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: ITT
POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization
Outcome measures
| Measure |
MiStent®
n=703 Participants
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
|
XIENCE EES
n=695 Participants
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
|
|---|---|---|
|
POCE
|
93 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: At 12 monthsMACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR)
Outcome measures
| Measure |
MiStent®
n=703 Participants
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
|
XIENCE EES
n=695 Participants
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
|
|---|---|---|
|
MACE
|
65 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: ITT
Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR
Outcome measures
| Measure |
MiStent®
n=703 Participants
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
|
XIENCE EES
n=695 Participants
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
|
|---|---|---|
|
Target Vessel Failure (TVF)
|
45 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: ITT
All-cause death
Outcome measures
| Measure |
MiStent®
n=703 Participants
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
|
XIENCE EES
n=695 Participants
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
|
|---|---|---|
|
All-cause Death
|
25 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: At 12 monthsAny Myocardial infarction
Outcome measures
| Measure |
MiStent®
n=703 Participants
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
|
XIENCE EES
n=695 Participants
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
|
|---|---|---|
|
Myocardial Infarction
|
17 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: At 12 monthsAny revascularization
Outcome measures
| Measure |
MiStent®
n=703 Participants
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
|
XIENCE EES
n=695 Participants
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
|
|---|---|---|
|
Any Revascularization
|
61 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: At 12 monthsDefinite or probably stent thrombosis according to ARC
Outcome measures
| Measure |
MiStent®
n=703 Participants
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
|
XIENCE EES
n=695 Participants
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
|
|---|---|---|
|
Stent Thrombosis
|
5 Participants
|
6 Participants
|
Adverse Events
MiStent®
Serious events: 434 serious events
Other events: 76 other events
Deaths: 85 deaths
XIENCE EES
Serious events: 426 serious events
Other events: 71 other events
Deaths: 78 deaths
Serious adverse events
| Measure |
MiStent®
n=703 participants at risk
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
|
XIENCE EES
n=695 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
2.4%
17/703 • 12 months (primary reporting), and yearly up to 5 years.
Adverse event reporting in the context of a post-marketing trial.
|
2.2%
15/695 • 12 months (primary reporting), and yearly up to 5 years.
Adverse event reporting in the context of a post-marketing trial.
|
|
Cardiac disorders
Definite stent thrombosis
|
0.43%
3/703 • 12 months (primary reporting), and yearly up to 5 years.
Adverse event reporting in the context of a post-marketing trial.
|
0.72%
5/695 • 12 months (primary reporting), and yearly up to 5 years.
Adverse event reporting in the context of a post-marketing trial.
|
|
General disorders
Other
|
58.9%
414/703 • 12 months (primary reporting), and yearly up to 5 years.
Adverse event reporting in the context of a post-marketing trial.
|
58.4%
406/695 • 12 months (primary reporting), and yearly up to 5 years.
Adverse event reporting in the context of a post-marketing trial.
|
Other adverse events
| Measure |
MiStent®
n=703 participants at risk
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
|
XIENCE EES
n=695 participants at risk
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
|
|---|---|---|
|
General disorders
Non Serious AE
|
10.8%
76/703 • 12 months (primary reporting), and yearly up to 5 years.
Adverse event reporting in the context of a post-marketing trial.
|
10.2%
71/695 • 12 months (primary reporting), and yearly up to 5 years.
Adverse event reporting in the context of a post-marketing trial.
|
Additional Information
Dr. E. Spitzer
European Cardiovascular Research Institute
Phone: +31102062828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place