1. AVE Micro Stent KFSH & RC Experience with 6 months Angiographic Follow Up Layth A. Mimish, M. Bakhshi, F. Al-Nozha, A. Kinsara, O. Amoudi, J. Buraiki, K. Niazi, B. Dunn, B. Dajani, M.E. Fawzy

2. AVE Micro Stent II AVE Micro Stent II u Arterial vascular engineering, Inc. Santa Rosa CA, USA u October 1994 sales commenced u FDA study approval Nov. 1995 u 2.5 mm stent introduced Dec. 1995 u Micro stent II XL (30, 39 mm) introduced January 1996

3. AVE Micro Stent II u 316 L stainless steel u Moderate radio-opacity u Non- Ferromagnetic u Metallic surface area 8.4% u Sinusoidal ring u 0.065 inch un-expanded profile

4. AVE Microstent II u Excellent longitudinal flexibility u Shortenining less than 2 % u Available diameters 2.5-4 mm u Available lengths 6-39 mm u Clinical trials on peripheral stents

5. AVE Micro Stent II u PE ( moderately compliant ) balloon u Balloon mounted stent, no sheath u Minimal ID of guider 0.072 u Proximal and distal stent end markers u Nominal deployment at 9 Atmospheres u Excellent recrossability

6. u 1st stent deployed May 1995 u Until October 1997, 340 stents were deployed in 283 patients u By October 1997, 223 patients had completed 6 months post stent deployment, and underwent angiographic follow up

7. Demographic/ Clinical Data u 340 Stents in 283 patients u 228 Males and 55 Females u Age 55+- 13 years u Smoking in 95 patients (33%) u Diabetes in 158 (56%) u Hypertension in 166 (59%) u Hyperlipidemia in 68%

8. Demographic/ Clinical Data u History of MI in 180 (64%), 81% of which are Q- wave MI u Previous PTCA in 76 (27%) u History of CABG surgery in 9 patients u Mean CCS Class 2.2 +- 1.1

9. AVE Micro Stent II u Elective stenting in 214 (63%) u Stenting for Dissection 126 (37%) u Mean Stent Size 3.1 +- 0.4 mm u Mean Length 16.2 +- 5.8 mm u Mean Deployment Pressure 15.7 +- 2.3 Atmospheres

10. Vessel Stented u Left Main 1 u LAD 163 (48%) u Diagonal 2 u Circumflex 38 (11%) u OM 15 (4%) u Intermediate 7 (2%) u RCA 114 (33%)

11. Antiplatelet/ Anticoagulation u ASA + Warfarin in 93 initial cases u ASA, Ticlopidine, 48 hrs Heparinization u ASA, Ticlopidine, Heparin bolus only u Mean hospital stay 3.6 +-2 days

12. Successful Procedures u Recanalization with < 20% residual stenosis, without inhospital major events ( Death, Emergency CABG, Q-MI) u Success in 329/340 stents (96.8%)

13. Major Complications u Death in 1 patient with Acute MI, poor LV function and salvage PTCA/Stenting u Q wave MI in 3 patients u Emergency CABG surgery in 5 patients

14. Minor Complications u Non Q MI 10 u Hypotension 3 u Haematoma 4 u Pseudo aneurysm 1 u Subacute Occlusion 3 u Loss of stent 1 u Sepsis 1

15. 6 month follow up u 222 /340 completed 6 months u 79/222 restenosed angiographicaqlly (35%) u Elective stenting restenosis 57/162 (35%) u Dissection stenting restenosis 22/60(37%) u restenotic lesion stenting restenosis 19/50 (38%) vs. (35%)

16. Conclusion u All purpose stent u Excellent success rates u Easy deployment even in very complex lesions u Higher restenosis rate in this study compared to others !!!