Long-term results with interwoven nitinol stents vs. BMS vs. DCB

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1 Long-term results with interwoven nitinol stents vs. BMS vs. DCB Dierk Scheinert, MD Division of Interventional Angiology University Hospital Leipzig, Germany

2 Disclosure Advisory Board /Consultant: Abbott, Biotronik, Boston Scientific, Cook Medical, Cordis, CR Bard, Gardia Medical, Medtronic/Covidien, TriReme Medical, Trivascular, Upstream Peripheral Technologies

3 DCB BMS - Supera Institutional database comprising all-comer patient population undergoing femoropopliteal treatment with Drug coated balloon DCB Conventional nitinol stent BMS Intervowen nitinol stent Supera

4 DCB BMS - Supera Real world, all comer patient cohort Treatment of femoropopliteal disease Drug coated balloon DCB Conventional nitinol stent BMS Intervowen nitinol stent Supera Assessment of primary patency up to 40 months (duplex ultrasound, angiography)

5 Methods Symptomatic peripheral arterial disease classified as Rutherford stage 1 No restrictions for lesion characteristics including all lesion lengths, multiple lesions when treated in a single limb, de novo as well as restenotic lesions with or without prior stenting Choice of treatment was at the operator s discretion and dependent on device availability (as new devices were introduced into clinical routine)

6 DCB BMS - Supera To reduce selection bias - > Calculation of propensity scores (clinical and lesion characteristics) 1:1 match (nearest neighbour): forming matched data sets for each comparison who share a similar value of the propensity score In order to achieve a similar distribution of baseline covariates between the compared groups Survival analysis to assess differences in primary patency within the matched cohorts

7 Baseline patient characteristics Supera (N=470) BMS (N=432) DCB (N=390) Age, years 70.5 ± ± ± 10.6 Female, % Rutherford stage, % 3.0 ± ± ± 0.9 Hypertension, % Hyperlipidemia, % Obesity (BMI>30 kg/m2), % Diabetes, % Current/former smoking, % Coronary heart disease, % Chronic kidney disease, %

8 Lesion and interventional characteristics Supera (N=470) BMS (N=432) DCB (N=390) Lesion length, mm 126 ± ± ± 116 Instent restenosis, % Run-off vessels 2.0± ± ±0.9 N of devices used 1.4± ± ±1.1 Device diameter, mm 5.3± ± ±0.6 Inflow intervention, % Outflow intervention, % Retrograd access, % Residual stenosis 30%, % ABI, post intervention 0.9± ± ±0.2 Provisional stenting

9 Results - Devices BMS group: latest generation, commercially available self-expanding nitinol stents: SMART (46%), Maris (17.8%), Everflex (10.1%), Lifestent (6.4%), Absolute (5%), Luminexx (3.4%), Xpert (2%), Astron Pulsar (1.7%), Protégé GPS (1.7%) and Complete SE (1%) DCB group: 75.4% In.Pact Admiral/Pacific DCB, 21% Lutonix DCB, 4% other

10 DCB BMS - Supera 1:1 match for each comparison BMS cohort (N=432) 368 pairs, 736 patients 284 pairs, 568 patients Supera cohort (N=470) 254 pairs, 508 patients DCB cohort (N=390)

11 Percent Percent Percent Distribution of propensity scores Supera BMS DCB BMS DCB Predicted probability Supera

12 Comparison: Supera - BMS BMS cohort (N=432) 368 pairs, 736 patients 284 pairs, 568 patients Supera cohort (N=470) 254 pairs, 508 patients DCB cohort (N=390)

13 Supera - BMS Lesion and procedural BMS Supera Std diff characteristics (n=368) (n=368) Lesion length, mm 138.5± ± In-stent stenosis 58 (15.8%) 57 (15.5%) 0.01 Popliteal involvement 103 (28%) 128 (35%) Total occlusions 205 (55.7%) 200 (54.4%) 0.03 Vessel run-off 2.1± ± Treatment of Inflow lesions 13 (3.5%) 18 (4.9%) Treatment of Outflow lesions 34 (9.2%) 40 (10.9%) Use of re-entry device 15 (4.1%) 13 (3.5%) 0.02 Use of special devices/lysis 0.11 Atherectomy 2 (0.5%) 3 (0.8%) Thrombolysis 3 (0.8%) 1 (0.3%) Rotarex 5 (1.4%) 5 (1.4) Retrograde recanalisation 2 (0.5%) 15 (4.1%) Residual stenosis >30% 5 (1.4%) 2 (0.5%) 0.08

14 Survival probability: Primary patency Supera - BMS K-M curve with 95% Confidence Interval Supera BMS Hazard ratio (95%CI): 0.36 ( ) No. at risk Supera BMS

15 Comparison: DCB - BMS BMS cohort (N=432) 368 pairs, 736 patients 284 pairs, 568 patients Supera cohort (N=470) 254 pairs, 508 patients DCB cohort (N=390)

16 DCB - BMS Lesion and procedural BMS (n=284) DCB (n=284) Std diff characteristics Lesion length, mm 158.9± ± In-stent stenosis 51 (18%) 54 (19%) 0.03 Popliteal involvement 77 (27%) 85 (30%) 0.07 Total occlusions 152 (53.5%) %) Vessel run-off 2.2± ± Treatment of Inflow lesions 12 (4.3%) 20 (7%) 0.12 Treatment of Outflow lesions 28 (9.9%) 25 (8.8%) Use of re-entry device 9 (3.2%) 7 (2.5%) Use of special devices/lysis 0.59 Atherectomy 1 (0.4%) 16 (5.6%) Thrombolysis 5 (1.8%) 12 (4.2%) Rotarex 4 (1.4%) 34 (12%) Retrograde recanalisation 2 (0.7%) 5 (1.8%) 0.10 Residual stenosis >30% 3 (1.1%) 24 (8.5%) 0.35 Provisional stenting NA 52 (18.3%) NA

17 Survival probability: Primary patency DCB - BMS K-M curve with 95% Confidence Interval DCB BMS Hazard ratio (95%CI): 0.87 ( ) No. at risk DCB BMS

18 Comparison: Supera - DCB BMS cohort (N=432) 368 pairs, 736 patients 284 pairs, 568 patients Supera cohort (N=470) 254 pairs, 508 patients DCB cohort (N=390)

19 Supera-DCB Lesion and procedural DCB (n=254) Supera Std diff characteristics (n=254) Lesion length, mm 157.2± ± In-stent stenosis 45 (17.7%) 41 (16.1%) 0.04 Popliteal involvement 83 (33%) 91 (36%) Total occlusions 128 (50.4%) 124 (48.8%) 0.03 Vessel run-off 2.1± ± Treatment of Inflow lesions 25 (9.8%) 25 (9.8%) 0 Treatment of Outflow lesions 29 (11.4%) 33 (13.0%) 0.04 Use of re-entry device 15 (4.1%) 13 (3.5%) 0.02 Use of special devices/lysis 0.11 Atherectomy 2 (0.5%) 3 (0.8%) Thrombolysis 3 (0.8%) 1 (0.3%) Rotarex 5 (1.4%) 5 (1.4) Retrograde recanalisation 2 (0.5%) 15 (4.1%) Residual stenosis >30% 5 (1.4%) 2 (0.5%) 0.08 Provisional stenting xx NA NA

20 Survival probability: Primary patency Supera -DCB K-M curve with 95% Confidence Interval Supera DCB Hazard ratio (95%CI): 0.49 ( ) No. at risk Supera DCB

21 Summary Real world data of patients undergoing femoropoliteal interventions Different patterns of disease progression observed with DCB, conventional, and interwoven nitinol stents Limitations of non-randomized data

22 Long-term results with interwoven nitinol stents vs. BMS vs. DCB Dierk Scheinert, MD Division of Interventional Angiology University Hospital Leipzig, Germany

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