Angiospastic; Disorder
Conditions
Keywords
drug eluting stent, Drug-coated balloon, Bare-Metal Stent, Revascularization
Brief summary
Ischemic heart disease, or coronary heart disease, covers a set of pathologies due to insufficient oxygen supply to the myocardium due to the development of atherosclerosis in one or more coronary arteries. To evaluate the safety of angioplasty performed in patients operated on at La Rochelle Hospital, the rate of major adverse cardiac events (MACE) will be determined and compared with data from the literature.
Detailed description
The use of active stents for the treatment of coronary stenosis is currently the standard treatment in almost all types of coronary lesions. In percutaneous transluminal treatment of coronary lesions, balloon angioplasty and bare stents have not shown satisfactory results in the past. The so-called active drug-eluting balloon could represent a new therapeutic option for the treatment of de novo lesions.
Interventions
DEVICECoronary angioplasty
Procedure used to open clogged heart arteries. Involves the insertion of a tiny balloon and/or a stent to widen the artery.
Sponsors
BBraun Medical SAS
Groupe Hospitalier de la Rochelle Ré Aunis
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Interventional revascularization of a coronary lesion, * Member or beneficiary of a social security system, * Informed of the study.
Exclusion criteria
* Language barrier, * Minor, * Pregnant woman, * Person under guardianship, * Person deprived of his/her liberty, * Refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Major Adverse Cardiac Events (MACE) | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Major Adverse Cardiac Events (MACE) | 36 months | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| c-DES If the patient was hemodynamically or rhythmically unstable, conventional drug-eluting stent (DES) angioplasty was performed | 143 |
| 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) | 294 |
| 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). | 546 |
| Total | 983 |
Baseline characteristics
| Characteristic | c-DES | BO-DES | DCB-only | Total |
|---|---|---|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 13.5 | 69.0 years STANDARD_DEVIATION 11.4 | 68.4 years STANDARD_DEVIATION 11.3 | 68.6 years STANDARD_DEVIATION 11.7 |
| Body mass index | 27.3 kg/m^2 STANDARD_DEVIATION 4.5 | 27.4 kg/m^2 STANDARD_DEVIATION 4.4 | 27.4 kg/m^2 STANDARD_DEVIATION 5 | 27.4 kg/m^2 STANDARD_DEVIATION 4.7 |
| Clinical presentation Chronic coronary syndrome | 48 Participants | 153 Participants | 365 Participants | 566 Participants |
| Clinical presentation Non-ST-Elevation Myocardial Infarction (NSTEMI) | 37 Participants | 87 Participants | 120 Participants | 244 Participants |
| Clinical presentation ST-elevation myocardial infarction (STEMI) | 58 Participants | 54 Participants | 61 Participants | 173 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment France | 143 participants | 294 participants | 546 participants | 983 participants |
| Sex: Female, Male Female | 41 Participants | 72 Participants | 137 Participants | 250 Participants |
| Sex: Female, Male Male | 102 Participants | 222 Participants | 409 Participants | 733 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 26 / 143 | 31 / 294 | 43 / 546 |
| other Total, other adverse events | 0 / 143 | 0 / 294 | 0 / 546 |
| serious Total, serious adverse events | 9 / 143 | 19 / 294 | 22 / 546 |
Outcome results
Primary
Number of Major Adverse Cardiac Events (MACE)
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.
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| c-DES | Number of Major Adverse Cardiac Events (MACE) | Number of participants without MACE | 119 Participants |
| c-DES | Number of Major Adverse Cardiac Events (MACE) | Number of in-hospital death following percutaneous coronary intervention | 9 Participants |
| c-DES | Number of Major Adverse Cardiac Events (MACE) | Number of participants who underwent MACE | 10 Participants |
| BO-DES | Number of Major Adverse Cardiac Events (MACE) | Number of participants without MACE | 254 Participants |
| BO-DES | Number of Major Adverse Cardiac Events (MACE) | Number of in-hospital death following percutaneous coronary intervention | 6 Participants |
| BO-DES | Number of Major Adverse Cardiac Events (MACE) | Number of participants who underwent MACE | 21 Participants |
| DCB-only | Number of Major Adverse Cardiac Events (MACE) | Number of in-hospital death following percutaneous coronary intervention | 2 Participants |
| DCB-only | Number of Major Adverse Cardiac Events (MACE) | Number of participants who underwent MACE | 19 Participants |
| DCB-only | Number of Major Adverse Cardiac Events (MACE) | Number of participants without MACE | 509 Participants |
Secondary
Number of Major Adverse Cardiac Events (MACE)
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.
Time frame: 36 months
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| c-DES | Number of Major Adverse Cardiac Events (MACE) | Number of participants without MACE | 94 Participants |
| c-DES | Number of Major Adverse Cardiac Events (MACE) | Number of participants who underwent MACE | 24 Participants |
| BO-DES | Number of Major Adverse Cardiac Events (MACE) | Number of participants who underwent MACE | 44 Participants |
| BO-DES | Number of Major Adverse Cardiac Events (MACE) | Number of participants without MACE | 218 Participants |
| DCB-only | Number of Major Adverse Cardiac Events (MACE) | Number of participants without MACE | 438 Participants |
| DCB-only | Number of Major Adverse Cardiac Events (MACE) | Number of participants who underwent MACE | 61 Participants |