INFRA-GENICULAR STENT IMPLANTATION IN PATIENTS WITH CRITICAL LIMB ISCHEMIA BARE METAL OR DRUG ELUTING STENTS? WHERE, WHEN, HOW

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1 INFRA-GENICULAR STENT IMPLANTATION IN PATIENTS WITH CRITICAL LIMB ISCHEMIA BARE METAL OR DRUG ELUTING STENTS? WHERE, WHEN, HOW Oscar R Rosales M.D. Medical Director of the Cardiac Catheterization Laboratory, Memorial Hermann Heart and Vascular Institute Houston Cardiovascular Associates Houston, Texas

2 BACKGROUND n IN 2008, OUR GROUP REPORTED THE FIRST LONG TERM- SINGLE CENTER- RESULTS WITH CYPHER STENTS IN BKA --cypher was superior to PTA historical controls at 36 months-- CCI 2008 n IN A COLLABORATIVE SYSTEMATIC REVIEW LED BY DR BIONDI IN ITALY, OUR GROUP AND OTHERS REPORTED IN 2009 THE FIRST WORLWIDE DATA ON 640 PATIENTS WHO UNDERWENT STENTING OF BKA. JEVT JUNE 26, 2009

3 n 18 STUDIES n 640 PATIENTS META-ANALYSIS 2009 RESULTS n 232 PATIENTS RECEIVED BALLOON EXPANDABLE BMS n 116 PATIENTS RECEIVED SELF-EXPANDABLE BMS n 272 RECEIVED DES: 29 PACLITAXEL-ELUTING ONLY; 126 SIROLIMUS-ELUTING ONLY; AND 117 WITH A PREDOMINANCE OF SIROLIMUS ELUTING STENTS (2:1). n PATENCY: ANGIOGRAPHY AND/OR DUPPLEX U/S JEVT JUNE 26, 2009

4 HEAD TO HEAD COMPARISONS n 1. PTS TREATED WITH BALLOON-EXPANDABLE BMS HAD SIMILAR CLINICAL OUTCOMES TO THOSE TREATED WITH SELF-EXPANDING BMS. n 2. STUDIES WITH EXCLUSIVE OR PREDOMINANT USE OF SIROLIMUS-ELUTING STENTS PROVIDED SUPERIOR OUTCOMES TO BMS: n BINARY RESTENOSIS: 16.8% TO 36.6% n PRIMARY PATENCY: 93.1% TO 73.0% n JEVT JUNE 26, 2009

5 n 3. CYPHER VS TAXUS n PRIMARY PATENCY: 93.1% TO 30% (?) n TARGET VESSEL REVASCULARIZATION: n 7.2% TO 30.5% JEVT JUNE 26, 2009

6 Meta-Analysis DES of Infra-Popliteal Arteries JACC Vol 6. No. 12, 2013

7 Meta-Analysis DES of Infra-Popliteal Arteries JACC Vol 6. No. 12, % 9% 25% 20% 50% 6% 14%

8 Meta-Analysis DES of Infra-Popliteal Arteries JACC Vol 6. No. 12, 2013

9 Results from Randomized Trials of DES in BKA ACHILLES Bosiers(Destiny) Falkowski YUKON Cypher (%) PTA (%) Xience (%) BMS (%) Cypher BMS Yukon- SES (%) TLR % 56% 9 19 Resteno sis Amputa tion % 76% NR NR 2 11 BMS (%) JACC Volume 6. No. 12, 2013

10 Xcell Trial- Xpert (Abbott) SE Nitinol Stent (BKA treated in 95%) Table I. Baseline Characteristics of the Study Subjects and Target Lesions Demographic and clinical characteristics Study subjects (N = 120) 1.Unless otherwise specified, values indicate number (%) of patients in the corresponding group. Age, y (mean ± SD) 75.5 ± 9.3 Male gender 62 (51.7) Diabetes 80 (66.7) Current or former smoker 64 (53.3) Hypertension 103 (85.8) Rutherford Classification Rutherford 4 21 (17.5) Rutherford 5 82 (68.3) Rutherford 6 17 (14.2) Estimated glomerular filtration rate, ml/min (mean ± SD) Number of runoff vessels 59.2 ± (63.3%) 2 44 (36.7%) Rocha-Singh et al, CCI Nov 2012

11 Xcell Trial- Xpert (Abbott) SE Nitinol Stent (BKA treated in 95%) Inflow vessel treatment Nontarget infrapopliteal vessel treatment Lesion characteristics 72 (60.0) 9 (7.5) Target Lesion Location Popliteal 7 (5.0) TP trunk 29 (20.7) Peroneal 32 (22.9) Posterior tibial 20 (14.3) Anterior tibial 52 (37.1) Occlusions 42 (30.0) Reference vessel diameter, cm (mean 2.8 ± 0.7 ± SD) Lesion length, cm (mean ± SD) All 4.7 ± 4.2 Occlusions 7.1 ± 4.5 Stented length, cm (mean ± SD) 7.6 ± 4.2 Total number of stents placed Number of stents/ subject Number of stents/ lesion Target lesions (N = 140)

12 Xcell Trial- Xpert (Abbott) SE Nitinol Stent 120 patients (140 limbs, 212 implanted devices) The primary endpoint was 12-month amputation-free survival (AFS); secondary endpoints included limb salvage, target lesion revascularization (TLR), 6- month angiographic patency, and 6- and 12-month outcomes of wound healing and pain relief. Results: A. 6-month binary stent restenosis rate of 68.5% B. 12-month AFS rate was 78.3%. Stratified according to baseline Rutherford classes 4, 5 and 6, the 12-month AFS rates were 100%, 77.3%, and 55.2%, respectively. C. Freedom from major amputation rates according to baseline Rutherford 4, 5, and 6 were 100%, 90.9%, and 70.1%, respectively. D. The 6- and 12-month complete wound-healing rates were 49.0% and 54.4%, respectively. Rutherford class 4 patients had significant pain relief through 12-months (P<0.05). Rocha-Singh et al, CCI Nov 2012

13 Paclitaxel Coated Balloon Vs. DES (IDEAS Trial) IN.PACT (Medtronic) 3 and 4 mm X mm DES: Resolute (Medtronic) 3 to 4 mm X <30 mm Cypher (Cordis) 3 to 3.5 mm X < 33 mm Promus (BS) 3 to 4 mm X < 38 mm Infrapopliteal vessels Rutherford >3 Single lesion > 70 mm (max. 2 arteries) CTOs were included Patients with below ankle dx - excluded JACC: Cardiovasc. Interv: Siablis et al, Sept 2014

14 Paclitaxel Coated Balloon Vs. DES 1. Immediate Post PCI stenosis was lower in DES : 9.6 Vs. 24% (P<0.0001) 2. Angiographic Binary Restenosis (>50%) at 6 ms: PCB: 57.9% DES: 28% (P<0.04) 3. Length of restenosed vessel segment PCB: 4.3 cm DES: 3.6 cm (no difference)

15 Paclitaxel Coated Balloon Vs. DES 1. Wound healing rate was similar 2. Rutherford improvement was similar 3. Amputation rate was similar 4. Total vessel closure was similar 5. No difference in TLR

16 Which Stent In Focal Infra-Popliteal Disease: n 1. BE-DES are superior to BE-BMS, SE-BMS and PCB regarding short and long term primary patency, restenosis rate and in most studies TLR and amputation rate. n With regard to mortality, there is no significant difference up to 12 months. n Most studies are not long enough to address whether or not DES better long term patency translates into a lower long term (> 3-5 year) CLI recurrence, limb preservation and lower mortality.

17 2. In the absence of Cypher, the only other approved stent in the USA with proven efficacy in tibial arteries is Xcience. 3. By default, Xcience has become my DES of choice in tibial vessels ( mm; at times post-dilate to 4 mm)

18 Where to stent With BE-DES If popliteal stent is needed, a Self Expanding Stent is the stent of choice Proximal Margin

19 PT-Peroneal Trunk- YES Baseline 6 Month follow up Most instances: mm diameter

20 Shaft and intra-compartment Tibial Arteries. YES Baseline 4 Cypher DES Post-PTA 9 ms after

21 How Distal? Distal Margin

22 In AT/PT-Peroneal trunk bifurcations, I favor: A. to stent along the dominant vessel of the plantar arch and PTA the ostium of the second branch. B. I try to avoid stenting the ostium of both branches. If bifurcation stenting is necessary, finish with kissing balloons. C. Just as in LM bifurcation stenting, my experience with simultaneous AT/PT-Peroneal trunk bifurcation stenting is that is linked to a higher Restenosis rate. Techniques in Vascular and Interventional Radiology, Volume 17, Issue 3, 2014,

23 When to use DES n 1. If money were not an issue, I would use DES in tibial lesions up to 12 cm as the primary strategy. This is the longest treated segment with data to support its use (Achilles Trial). n 2. It is my primary choice in PT/Peroneal trunk n 3. In cases of PTA complicated by spiral dissections, procedural residual stenosis > 50% or significant flow limitation following balloon dilatation.

24 When n 4. In patients with significant restenosis after PTA or BMS in whom CLI or life style limiting claudication develops. n 5. In patients with 1 vessel run-off in whom long term patency is essential to overcome or minimize the development of CLI. Randomized trials with longer follow up are needed to provide definite answers

25 THANKS

26 INFRA-GENICULAR STENT IMPLANTATION IN PATIENTS WITH CRITICAL LIMB ISCHEMIA BARE METAL OR DRUG ELUTING STENTS? WHERE, WHEN, HOW Oscar R Rosales M.D. Medical Director of the Cardiac Catheterization Laboratory, Memorial Hermann Heart and Vascular Institute Houston Cardiovascular Associates Houston, Texas