ENDOVASCULAR RECONSTRUCTION OF COMPLEX AORTO-ILIAC LESIONS: BARE METAL STENTS VS. COVERED STENTS 5-YEARS FOLLOW-UP RESULT OF COBEST TRIAL
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1 ENDOVASCULAR RECONSTRUCTION OF COMPLEX AORTO-ILIAC LESIONS: BARE METAL STENTS VS. COVERED STENTS 5-YEARS FOLLOW-UP RESULT OF COBEST TRIAL Prof. B. Patrice Mwipatayi, FCS (SA), MMed, FRACS Department of Vascular & Endovascular Surgery / RPH School of Surgery University of Western Australia, Perth
2 Potential conflicts of interest Speaker's name: B. Patrice Mwipatayi MMed, FCS, FRACS I have the following potential conflicts of interest to report: Consultant: Medtronic Australia Institutional grant/research support: Biotronik, Medtronic, Atrium Maquet
3 Conflict of Interest Research fund received from: Medtronic Australia Atrium Australia Pacific Rim
4 DISCOVER: Dutch Iliac Stent trial: COVERed balloon-expandable versus uncovered balloon-expandable stents in the common iliac artery: study protocol for a randomized controlled trial.
5 Study Design Primary endpoint Freedom From Binary Restenosis at 12 and 18 months Freedom From Stent Occlusion at 12 and 18 months Primary Patency Rate (12, 18 months and 5-Years Secondary endpoint Ankle Brachial Pressure Index (ABPI) changes from baseline Any amputation above the ankle Primary outcomes analyzed by TASC grade (B,C,D) Mortality Rate at 5-years follow-up
6 Baseline Demographics V12 stent (n=83) Bare Stent (n=85) P value AGE (years) [Mean +/- S.D] / / GENDER [%Male] Rutherford Becker - % Category Category Category Category Category Risk Factors (n) Diabetes HTN Smoking Hyperlipidemia CRF COAD CAD Hypercoagulable States
7 Baseline Lesion Characteristics V12 stent (n=83) Bare Stent (n=85) P value Pre-Op Resting-ABI (side of lesion) mean ± SEM 0.65± ± Pre-Op Duplex Scan 0.39 % Performed (n) 74.7 (62) 76.5 (65) >50% Stenosis Occlusion Pre-Op Angiogram 0.03 % Performed (n) 80.7 (67) 85.9 (73) TASC B TASC C TASC D Runoff 0.15 % Performed (n) 89.1 (74) 85.9 (73)
8 KM Curve of Primary Patency PP = 74.7% PP = 62.9% Time (Months) Advanta V12 Stent (n. at risk) Standard Error (%) BMS (n. at risk) Standard Error (%)
9 KM Curve of Primary Patency for TASC B lesion PP = 74.3% PP = 70% Time (Months) Advanta V12 Stent (n. at risk) Standard Error (%) BMS (n. at risk) Standard Error (%)
10 KM Curve of Primary Patency for TASC C/D lesion PP = 74.9% PP = 47.9% Time (Months) Advanta V12 Stent (n. at risk) Standard Error (%) BMS (n. at risk) Standard Error (%)
11 Factors independently affecting primary patency of different types of stent based on multivariate logistic regression models Variable Coefficients B SE Wald test HR (95% CI) P value Type of stent used (Advanta V12 vs. BMS) ( ).002 Rutherford stratification ( ).026
12 KM Curve of Assisted Primary Patency APP = 83.7% APP = 76.1% P = Time (Months) Advanta V12 Stent (n. at risk) Standard Error (%) BMS (n. at risk) Standard Error (%)
13 KM Curve of Secondary Patency SP = 96.3% SP = 87.3% P = Time (Months) Advanta V12 Stent (n. at risk) Standard Error (%) BMS (n. at risk) Standard Error (%)
14 Factors independently affecting secondary patency of different types of stent based on multivariate logistic regression models Variable Coefficient (B) SE Wald test HR (95% CI) P value Type of stent used (Advanta V12 vs. BMS) Number of stents used Rutherford stratification ( ) ( ) ( ).040 Hypertension ( ).020 Smoking ( ).015
15 Improvement in ABI 1,2 1 ABI (Mean) P=.0014 P=.007 P=.04 P=.06 0,8 0,6 V12 STENT BMS 0,4 0,2 0 Baseline 1 Month 6 Month 12 Month 18 Month 24 Month 60 Month
16 Long-term Survival Rate COBEST Survival = 87.8% Survival = 81.4% Time (Months) Advanta V12 Stent (n. at risk) Standard Error (%) BMS (n. at risk) Standard Error (%)
17 CONCLUSION The COBEST Trial demonstrate: For TASC B lesions, both Covered and Bare Metal Stents give acceptable results. For extensive lesions (TASC C and D lesions), covered stents perform better than bare stents in terms of patency and clinical outcome results at 12 and 18 months follow-up. These results appears to be durable and sustainable at 5-years follow-up with better patency For Covered Stent compared to Bare Metal stent (paper submitted to JVS).
18 ENDOVASCULAR RECONSTRUCTION OF COMPLEX AORTO-ILIAC LESIONS: BARE METAL STENTS VS. COVERED STENTS 5-YEARS FOLLOW-UP RESULT OF COBEST TRIAL Prof. B. Patrice Mwipatayi, FCS (SA), MMed, FRACS Department of Vascular & Endovascular Surgery / RPH School of Surgery University of Western Australia, Perth
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