| Study Design |
|
| Principal Investigator: |
Dr. Layth Mimish |
| Objective: |
To evaluate the short and long term efficacy of the Infinnium® stent compared to Supralimus®
stent in patients |
| |
from daily
practice. |
| Study Design: |
Open label, non randomized, prospective, multi-center study |
| No. of Patients: |
434 |
| Status: |
Ongoing |
|
|
|
CAD Risk Factors |
| |
Infinnium® |
Supralimus® |
Total |
|
| No.
of Patients |
247 |
187 |
434
|
|
|
Diabetes |
137 (55.5%) |
106 (56.7%) |
243 (56%) |
|
| Hyperlipidemia |
166 (67.2%) |
132 (70.6%) |
298 (68.6%) |
|
| Hypertension |
149 (60.3%) |
111 (59.4%) |
260 (60%) |
|
| Smoking |
134 (54.2%) |
97 (51.9%) |
231 (53%) |
|
|
|
| Number of Vessels
Treated / Case |
| |
Infinnium® |
Supralimus® |
Total |
|
| No. of Patients |
247 |
187 |
434 |
|
| Single Vessel |
128 (51.8%) |
98 (52.4%) |
226 (52.1%) |
|
| Double Vessel |
80 (32.4%) |
50 (26.7%) |
130 (30%) |
|
| Triple Vessel |
39 (15.8%) |
39 (20.8%) |
78 (18%) |
|
|
|
| Lesion
Characteristics |
| |
Infinnium® |
Supralimus® |
Total |
|
| No. of Stents |
410 |
303 |
713 |
|
| Small Vessel (%) |
152 (37.1%) |
106 (35%) |
258 (36.2%) |
|
| Long Lesions (%) |
201 (49%) |
153 (50.5%) |
354 (49.7%) |
|
| Calcified Lesions |
96 (23.4%) |
85 (28%) |
181 (25.4%) |
|
| Restenotic Lesions (%) |
28 (6.8%) |
23 (7.6%) |
51 (7.1%) |
|
|
|
| 6 Month Results
|
| |
Infinnium® |
Supralimus® |
Total |
|
| No. of Patients |
219 |
152 |
371 |
|
| Stent Thrombosis |
1 (0.46%) |
0 (0%) |
1 (0.21%) |
|
| CABG |
2 (0.92%) |
1 (0.66%) |
3 (0.63%) |
|
| PCI |
1 (0.46%) |
1 (0.66%) |
2 (0.42%) |
|
| CVA |
0 (0%) |
0 (0%) |
0 (0%) |
|
| Death |
2 (0.92%) |
1 (0.66%) |
3 (0.63%) |
|
| MACE |
3 (1.3%) |
1 (0.66%) |
4 (0.84%) |
|
|
|
| 12 Month Results
|
| |
Infinnium® |
Supralimus® |
Total |
|
| No. of Patients |
185 |
100 |
285 |
|
| Stent Thrombosis |
0 (0%) |
0 (0%) |
0 (0%) |
|
| CABG |
0 (0%) |
1 (1%) |
1 (0.35%) |
|
| PCI |
6 (3.2%) |
2 (2%) |
8 (2.8%) |
|
| CVA |
0 (0%) |
0 (0%) |
0 (0%) |
|
| Death |
1 (0.54%) |
0 (0%) |
1 (0.35%) |
|
| MACE |
1 (0.54%) |
0 (0%) |
1 (0.35%) |
|
|
|
|
24 Month Cumulative Results |
| |
Infinnium® |
Supralimus® |
Total |
|
| No. of Patients |
247 |
187 |
434 |
|
| Total MACE |
16 (6.5%) |
3 (1.6%) |
19 (4.4%) |
|
| Revascularization |
12 (4.8%) |
6 (2.3%) |
18 (4.1%) |
|
| Event Free Survival |
219 (88.7%) |
178 (95.2%) |
397 (91.5%) |
|
|
