Trial Outcomes & Findings for Safety Assessment of Angioplasty Procedures (NCT NCT03893396)
NCT ID: NCT03893396
Last Updated: 2024-09-19
Results Overview
The primary endpoint is a composite endpoint that includes major adverse cardiac events defined as cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke (stroke) and revascularization of target lesion (TLR) within 12 months of surgery.
Recruitment status
COMPLETED
Target enrollment
983 participants
Primary outcome timeframe
12 months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
c-DES
If the patient was hemodynamically or rhythmically unstable, conventional drug-eluting stent (DES) angioplasty was performed
|
BO-DES
Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. In cases of persistent residual stenosis, dissection at high risk of acute occlusion, or dissection at risk of secondary aneurysmal, bailout stenting with DES was performed (BO-DES)
|
DCB-only
Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. If lesion preparation was successful, the second step of angioplasty was performed with drug-coated balloon (DCB).
|
|---|---|---|---|
|
Overall Study
STARTED
|
143
|
294
|
546
|
|
Overall Study
One-year Follow-up
|
138
|
281
|
530
|
|
Overall Study
COMPLETED
|
127
|
268
|
501
|
|
Overall Study
NOT COMPLETED
|
16
|
26
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
c-DES
n=143 Participants
If the patient was hemodynamically or rhythmically unstable, conventional drug-eluting stent (DES) angioplasty was performed
|
BO-DES
n=294 Participants
Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. In cases of persistent residual stenosis, dissection at high risk of acute occlusion, or dissection at risk of secondary aneurysmal, bailout stenting with DES was performed (BO-DES)
|
DCB-only
n=546 Participants
Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. If lesion preparation was successful, the second step of angioplasty was performed with drug-coated balloon (DCB).
|
Total
n=983 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 13.5 • n=143 Participants
|
69.0 years
STANDARD_DEVIATION 11.4 • n=294 Participants
|
68.4 years
STANDARD_DEVIATION 11.3 • n=546 Participants
|
68.6 years
STANDARD_DEVIATION 11.7 • n=983 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=143 Participants
|
72 Participants
n=294 Participants
|
137 Participants
n=546 Participants
|
250 Participants
n=983 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=143 Participants
|
222 Participants
n=294 Participants
|
409 Participants
n=546 Participants
|
733 Participants
n=983 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
143 participants
n=143 Participants
|
294 participants
n=294 Participants
|
546 participants
n=546 Participants
|
983 participants
n=983 Participants
|
|
Body mass index
|
27.3 kg/m^2
STANDARD_DEVIATION 4.5 • n=143 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 4.4 • n=294 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 5.0 • n=546 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 4.7 • n=983 Participants
|
|
Clinical presentation
ST-elevation myocardial infarction (STEMI)
|
58 Participants
n=143 Participants
|
54 Participants
n=294 Participants
|
61 Participants
n=546 Participants
|
173 Participants
n=983 Participants
|
|
Clinical presentation
Non-ST-Elevation Myocardial Infarction (NSTEMI)
|
37 Participants
n=143 Participants
|
87 Participants
n=294 Participants
|
120 Participants
n=546 Participants
|
244 Participants
n=983 Participants
|
|
Clinical presentation
Chronic coronary syndrome
|
48 Participants
n=143 Participants
|
153 Participants
n=294 Participants
|
365 Participants
n=546 Participants
|
566 Participants
n=983 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe primary endpoint is a composite endpoint that includes major adverse cardiac events defined as cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke (stroke) and revascularization of target lesion (TLR) within 12 months of surgery.
Outcome measures
| Measure |
c-DES
n=138 Participants
If the patient was hemodynamically or rhythmically unstable, conventional drug-eluting stent (DES) angioplasty was performed
|
BO-DES
n=281 Participants
Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. In cases of persistent residual stenosis, dissection at high risk of acute occlusion, or dissection at risk of secondary aneurysmal, bailout stenting with DES was performed (BO-DES)
|
DCB-only
n=530 Participants
Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. If lesion preparation was successful, the second step of angioplasty was performed with DCB.
|
|---|---|---|---|
|
Number of Major Adverse Cardiac Events (MACE)
Number of in-hospital death following percutaneous coronary intervention
|
9 Participants
|
6 Participants
|
2 Participants
|
|
Number of Major Adverse Cardiac Events (MACE)
Number of participants without MACE
|
119 Participants
|
254 Participants
|
509 Participants
|
|
Number of Major Adverse Cardiac Events (MACE)
Number of participants who underwent MACE
|
10 Participants
|
21 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: All consecutive patients in whom coronary angioplasty was performed, i.e. acute coronary syndrome non-ST myocardial infarction (NSTEMI) or ST myocardial infarction (STEMI), chronic coronary syndrome including angina, silent ischemia, ischemic heart disease, were eligible. The exclusion criteria were patients \<18 years of age, pregnancy, legally protected patients or deprived of liberty, and refusal to participate. In-hospital deaths following percutaneous coronary intervention were excluded.
The secondary endpoint is a composite endpoint that includes major adverse cardiac events defined as cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke (stroke) and revascularization of target lesion (TLR) within 12 months of surgery.
Outcome measures
| Measure |
c-DES
n=118 Participants
If the patient was hemodynamically or rhythmically unstable, conventional drug-eluting stent (DES) angioplasty was performed
|
BO-DES
n=262 Participants
Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. In cases of persistent residual stenosis, dissection at high risk of acute occlusion, or dissection at risk of secondary aneurysmal, bailout stenting with DES was performed (BO-DES)
|
DCB-only
n=499 Participants
Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. If lesion preparation was successful, the second step of angioplasty was performed with DCB.
|
|---|---|---|---|
|
Number of Major Adverse Cardiac Events (MACE)
Number of participants without MACE
|
94 Participants
|
218 Participants
|
438 Participants
|
|
Number of Major Adverse Cardiac Events (MACE)
Number of participants who underwent MACE
|
24 Participants
|
44 Participants
|
61 Participants
|
Adverse Events
c-DES
Serious events: 9 serious events
Other events: 0 other events
Deaths: 26 deaths
BO-DES
Serious events: 19 serious events
Other events: 0 other events
Deaths: 31 deaths
DCB-only
Serious events: 22 serious events
Other events: 0 other events
Deaths: 43 deaths
Serious adverse events
| Measure |
c-DES
n=143 participants at risk
If the patient was hemodynamically or rhythmically unstable, conventional drug-eluting stent (DES) angioplasty was performed
|
BO-DES
n=294 participants at risk
Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. In cases of persistent residual stenosis, dissection at high risk of acute occlusion, or dissection at risk of secondary aneurysmal, bailout stenting with DES was performed (BO-DES)
|
DCB-only
n=546 participants at risk
Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. If lesion preparation was successful, the second step of angioplasty was performed with DCB.
|
|---|---|---|---|
|
Cardiac disorders
Coronary restenosis
|
2.8%
4/143 • Number of events 5 • Up to three year after percutaneous coronary intervention
|
5.4%
16/294 • Number of events 19 • Up to three year after percutaneous coronary intervention
|
2.4%
13/546 • Number of events 15 • Up to three year after percutaneous coronary intervention
|
|
Nervous system disorders
Stroke
|
2.8%
4/143 • Number of events 4 • Up to three year after percutaneous coronary intervention
|
0.68%
2/294 • Number of events 2 • Up to three year after percutaneous coronary intervention
|
1.1%
6/546 • Number of events 6 • Up to three year after percutaneous coronary intervention
|
|
Cardiac disorders
Myocardial infarction
|
0.70%
1/143 • Number of events 1 • Up to three year after percutaneous coronary intervention
|
0.34%
1/294 • Number of events 1 • Up to three year after percutaneous coronary intervention
|
0.55%
3/546 • Number of events 3 • Up to three year after percutaneous coronary intervention
|
Other adverse events
Adverse event data not reported
Additional Information
Caroline Allix-Béguec, clinical research manager
Groupe Hospitalier de la Rochelle Ré Aunis
Phone: +33516494246
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place