Robert W. Fincher, DO The Ritz-Carlton, Dove Mountain Marana, Arizona February 7th, 2015

Transcription

1 Robert W. Fincher, DO The Ritz-Carlton, Dove Mountain Marana, Arizona February 7th, 2015

2 Disclosure I have nothing to disclose

3 Randomized Controlled Studies In SFA Technology: What s The Best Tool For Your Patients

4 History The SFA can be a difficult area to treat Why? Heavily calcified Dynamic forces are constantly in play with movement Frequently occluded High degree of elastic recoil

5 History The gold standard used to be the open surgical bypass For some it still is Now, however, as we see a patient population with an increasing number of comorbid conditions and previous interventions, what technologies do we turn to for durable, minimally invasive interventions? What technologies are supported by RCT s?

6 Nitinol Stents Nickel titanium alloy with some unique properties Shape memory Superelasticity - exhibits times greater elasticity than ordinary metal Uncovered, Covered, and Drug Eluting

7 ABSOLUTE Trial First randomized study to show a benefit of stenting versus PTA Randomized 104 patients with either claudication or critical limb ischemia (Rutherford Category 3 to 5) to two treatment arms Follow-up was performed at 24 hrs, then at 3, 6 and 12 months Examination was performed with ABI s at rest and with exercise, duplex, plain radiographs to assess for stent fracture, and with either angiography or CTA Lesion length was 132+/-71 mm in stent group and 127+/-55 mm in the angioplasty group

8 ABSOLUTE Trial

9 What About Lesion Length?

10 Unlike the Seahawks

11 ASTRON Trial Nitinol Stents don t come up short! 73 patients (Rutherford Category 3 to 5) Randomized to either Stenting (34) or PTA (39) Intermediate length lesions were treated: 98 mm +/- 54 mm and 71 mm +/- 43 mm Re-stenosis rates in the stent and PTA groups were: 21.9% versus 55.6% at 6 months by CT-angiography, and 2.9% versus 18.9%, 18.2% versus 50.0%, and 34.4% versus 61.1% at 3, 6, and 12 months by duplex, respectively Primary stenting with nitinol stents gives superior results to PTA for intermediate length lesions

12 FAST Trial Or do they. 244 patients at least Rutherford Category 2 Randomized to implantation of a single Bard Luminexx 3 stent (123 patients) or stand-alone percutaneous transluminal angioplasty (PTA) (121 patients) Mean lesion length 45 mm No statistically significant difference found between these two groups So

13 FAST Trial

14 FAST Trial Short, focal SFA stenoses or occlusions can be treated with PTA alone

15 How about individual stents? A few words about some proprietary stents

16 RESILIENT Trial

17 RESILIENT Trial

18 RESILIENT Trial

19 RESILIENT Trial

20 Supera Peripheral Stent Abbott Vascular

21 Supera Peripheral Stent Abbott Vascular

22 Zilver PTX Paclitaxel eluting system linked to a stent platform

23 Zilver PTX

24 Zilver PTX

25 Covered Stents Gore Viabahn Compared to open surgical bypass for femoral to above knee popliteal interventions in RCT

26 Viabahn 4 year randomized, prospective trial of Viabahn stent grafts versus above knee femoral to popliteal artery bypass in the treatment of superficial femoral artery disease 100 limbs randomized across all 4 TASC Categories Follow-up was conducted at 3, 6, 9, 12, 18, 24, 36, and 48 months Mean lesion length was 25.6 cm (long lesions)

27 Viabahn

28 VIBRANT 3 year randomized prospective study comparing bare metal nitinol stent implantation versus non-heparin bonded Viabahn endoprosthesis 148 patients randomized to nitinol (72) or Viabahn (78) Patency was evaluated at 1, 6, 12, 24, and 36 months Lesion length was /- 8 cm No statistical difference found between the two treatment arms Primary patency favored nitinol stents; secondary patency did not significantly differ

29 Drug Coated Balloons Cross Predilate Pass catheter Inflate for 30 seconds Therapeutic levels of Paclitaxel are transferred to arterial walls

30 Drug Coated Balloons

31 LEVANT Trial Prospective, single blind study comparing PTA versus PTA and Lutonix Paclitaxel drug delivery catheter Primary endpoint was late lumen loss at 6 mths 101 patients enrolled at 9 different centers Patients enrolled ranged from Rutherford Category 2 to 5 Stratified to PTA or PTA and Lutonix Catheter and further substratified to PTA alone or stenting Mean lesion length was 8.1 +/- 3.8 cm 42% of lesions were occlusions

32 LEVANT Trial

33 LEVANT Trial

34 LEVANT Trial Statistically significant decrease in late lumen loss with regards to the Lutonix drug delivery catheter compared to PTA

35 Athrectomy Just a few words Published data is conflicting Comes in several flavors - Directional, Orbital, Laser Can be used as an adjunct to revascularization Can be used in areas where conventional stenting is limited

36 How Should You Proceed? What Do We know? Nitinol stents perform better than PTA alone for long and intermediate length lesions For short lesions, the data is unclear: PTA alone may be superior Long, complex lesions may be best treated by stent grafts or open surgical bypass Drug eluting balloons show promise, but clinical data and products on the US market are limited Adjuncts to PTA and stenting such as athrectomy hold promise, but data and sample sizes are limited at this time

37 Questions?

38 Thank You