eucalimus - First Experience

Transcription

1 A New Sirolimus Eluting Stent with a Biodegradable Polymer Early and Mid Term Experience with the eucalimus Stent in Egypt Dr. Hossam El Din Mohamed Mansour on behalf of the investigators Ahmed Emara, Amr El Hadidy, Ashraf Ahmed, Ashraf Reda, Ehab El Fiky, Essam Baliegh, Hisham Amar, Akram Abdel Bary, AMR KAMAL, Hazem Khamis, Helmy El Gawaby, Khaled Teama, Mohamed ElSeteha, Mohamed Seleem, Raouf Mahran, Safwat El-Hawary Presented during the PCR 2015 eucalimus workshop 1

2 2 eucalimus - Key Components Basic Stent Design (CoCr) Stent Delivery Catheter Sirolimus Polymer: PLGA (85/15)

3 3 In vivo release kinetics eucalimus vs. competitors 100 Percentage Sirolimus Release Time (days) Orsiro (Biotronik) Cypher (Johnson&Johnson) Xience V (ABBOTT) eucalimus (eucatech AG) Itrix (AMG) Endeavor Resolute (Medtronic) Promus Element (Boston Scientific)

4 4 Baseline Demographic, Clinical and Angiographic Characteristics Patient number 150 pt Age / yrs Male Gender 61.0% Hypertension 64.0% Dyslipidemia 56.9% Chronic Renal Failure 5.2% Cardiac Heart Failure 3.8% Current Smoker 29.4%

5 5 Baseline Demographic, Clinical and Angiographic Characteristics (cont.) Diabetes Mellitus 36.0% Peripheral vascular disease 6.7% BMI > % Family History of CAD 7.6% Previous AMI 20.4% Previous Coronary Revascularization 35.5% AMI: Acute Myocardial Infarction, CVA: Cerebrovascular Accident

6 6 Baseline Clinical and Angiographic Characteristics (cont.) Current Symptoms Unstable Angina 59.7% Stable Angina 27,5% Silent Ischemia 12.8% ACC: American College of Cardiology, AHA: American Heart Association, STEMI: ST elevation myocardial infarction, MVD: Multiple vessel disease, SA :Stable Angina

7 7 Baseline Clinical and Angiographic Characteristics (cont.) Multi Vessel Disease 68.0% 2 vessels 67.6% 3 vessels 32.4% N of treated lesions 179 N of treated vessels 164 N of treated patients 150 N of stent deployed 184 ACC: American College of Cardiology, AHA: American Heart Association, STEMI: ST elevation myocardial infarction, MVD: Multiple vessel disease, SA: Stable Angina

8 8 Baseline Angiographic Characteristics (cont.) N of lesions per patient /-0.40 N of vessel per patient / N of stent per patient / Stent Diameter / mm Stent Length Stent Length ( mm ) 37 % Stent Length ( mm ) 62 % Stent Length ( mm ) 1 %

9 Baseline Angiographic Characteristics (cont.) Treated vessel RCA 27.0% LAD 45.0% LCX 18.0% LM 10.0% Lesion location Ostial 21.0 % Non-Ostial 79.7 % Plaque Type** A+B1 46.0% B2+C 54.0% RCA: Right Coronary Artery, LAD: Left Anterior Descendent Coronary Artery, LCX: Left Circumflex Coronary Artery, LM: Left Main Coronary Artery ** According to American Heart Association Classification. 9

10 In Hospital Events Cardiac Death * 1.33% AMI 1.00% TVR 0.00% TLR 0.00% MACE 2.33% Out of Hospital Events at a mean of 270 +/- 25 days of Follow-up Cardiac Death * 0.67% AMI 2.00% TVR 5.40% TLR 4.70% MACE 12.77% TVR: Target Vessel Revascularization; TLR: Target Lesion Revascularization, MACE: Major Adverse Cardiac Events (Cardiac death, Acute Myocardial Infarction, TVR, TLR) * Not related to stent 10

11 Cumulative Results at a mean of 270 +/- 25 days of Follow-up Cardiac Death * 2.0% AMI 3.0% TVR 5.4% TLR 4.7% MACE 15.1% AMI: Acute Myocardial Infarction; TVR: Target Vessel Revascularization; TLR: Target Lesion Revascularization; MACE: Major Adverse Cardiovascular Events (Cardiac Death, MI and TLR, TVR); * not related to stent 11

12 12 Stent Thrombosis at a mean of 270 +/- 25 days of Follow-up (ARC) Overall stent thrombosis 0.0% Definitive 0.0% Probable 0.0% Possible 0.0% ARC: Academic Research Consortium

13 13 Conclusion This multicenter experience at 9 months of Follow-up demonstrates an excellent safety profile with the eucalimus stent design. In this high risk population no stent thrombosis out of the initial procedure was detected. Furthermore TLR was on a low level for the complexity and lengths of the treated lesions.