Principal
Investigator
(International): |
Dr.
Alexandre Abizaid |
| Title: |
A
Prospective and Retrospective, Multinational
Investigation of the Supralimus® and Supralimus-Core™ Sirolimus- |
| |
Eluting
Stents for the Treatment of Coronary Lesions in
Unselected Patients in the “Real-World” Clinical
Practice – |
| |
E-SERIES Registry |
| Study
Objectives: |
To
evaluate the procedural and clinical outcomes of the
Supralimus® and Supralimus-Core™ Sirolimus - Eluting |
| |
Stent in the treatment of unselected, high risk patients in the real-world
clinical practice. |
| Study Design: |
Prospective and retrospective, multinational (Asia
and South America), non-randomized, post-marketing
web- |
| |
based registry |
| Clinical
Sites: |
Up to 100 clinical sites in Asia and South America. |
| Follow-up: |
All patients will
undergo follow-up clinical evaluation at 1, 6, 12
and 24 months. Angiographic follow-up will be |
| |
performed in
accordance to medical indication. Data of those
patients submitted to angiographic follow-up will
also |
| |
be included in the
data base. |
| Primary
Endpoint: |
MAJOR ADVERSE CARDIAC EVENTS (MACE) at 12 months clinical follow-up |
| Secondary
Endpoints: |
1. Rates of
procedural success |
| |
2. Rates of MACE at
in-hospital, 30 days, 6 and 24 months |
| |
3. Rates of target
lesion revascularization (TLR) at 6 and 12 months |
| |
4. Rates of stent
thrombosis (acute, sub-acute, late and very-late) up
to 24 months follow-up |
| |
|
| No of Patient Enrolled : |
1274 |
| Status : |
Ongoing |
|
|
| Six Month Clinical Outcome (n = 1045) |
| Outcome |
In - Hospital |
6 - Month (Out of Hospital) |
| Death (all cause) |
0.3% |
2.1% |
| MI |
1.7% |
1.2% |
| TLR |
0.1% |
2.2% |
| Stent Thrombosis |
0.0% |
0.8% |
|
|
|
|
| Six Month Clinical Outcome in Diabetic Patient (n = 423) |
| |
Diabetics (n = 170) |
Non - Diabetics (n = 253) |
P - value |
| MACE |
5.9%(10) |
5.5%(14) |
0.61 |
| Cardiac Death |
2.9%(5) |
1.6%(4) |
0.49 |
| MI |
2.9%(5) |
4.0%(10) |
0.77 |
| TLR |
0.5%(1) |
1.8%(5) |
0.24 |
| Stent Thrombosis Definite / Probable |
0.6%(1) |
0.4%(1) |
0.99 |
|
|
|
|
| 2 year Results in Patient with Acute Coronary Syndrome (n = 459) |
| Definite / Probable Stent Thrombosis Rate : 0.6% |
| MACE free Survival Rate : 86.7% |
|
