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Tissue Paclitaxel And Outcomes Of Patients With Rutherford Class 5/6 Ischemia Treated With Dcb Angioplasty
Rabih Chaer, MD1, Patrick Cherfan, MD1, Adham N. Abou Ali, MD1, Sina Asaadi, MD1, Othman M. Abdul-Malak, MD1, Mohammad H. Eslami, MD1, George Al-Khoury, MD1, Michel S. Makaroun, MD1, Maria Romero, MD2, Renu Virmani, MD2.
1University of Pittsburgh Medical Center, Pittsburgh, PA, USA, 2CVPath Institute Inc., Gaithersburg, MD, USA.

OBJECTIVES: The use of DCBs in CLI has raised concerns about limb loss and wound healing. We sought to evaluate tissue Paclitaxel effect in patients with Rutherford 5/6 ischemia treated with a DCB and a planned amputation/debridement, and the impact on wound healing. METHODS: Patients with Rutherford 5/6 ischemia treated with the Admiral(Medtronic) or Lutonix(BTG) balloon and a planned ipsilateral amputation/debridement were enrolled. Tissue samples collected were analyzed at the CVPath Institute for medial necrosis, medial arterial wall inflammation, foreign-body reaction, emboli and paclitaxel crystals(Figure 1). Total Paclitaxel dose was calculated based on the DCB surface area. Primary clinical outcomes were wound healing, Major Adverse Limb Events (MALE) and Major Adverse Clinical Events (MACE). RESULTS: 50 patients with Rutherford 5(33,66%) and 6(17,34%) ischemia were enrolled, with no differences in baseline demographics. Treated segments were femoropoliteal(33,66.0%) or multilevel including tibial(17 34.0%). WIFI score on presentation was ≥4 in 80.4%(Range 2-7). 27 patients were treated with Admiral (diameter 4-6 mm,length 40-100 mm,1-2 balloons) vs 23 with Lutonix (diameter 4-6 mm,length 40-220 mm,1-2 balloons). Tissue specimens downstream from the PTA were collected immediately following the intervention in 26(52.0%) or within 90 days at planned subsequent debridement/amputation in 24(48.0%). 66.7% of patients healed or improved. Twenty-nine patients underwent planned minor amputations: 20 improved, 4 worsened, and 6 eventually required major amputation due to non-reconstructable tibial disease/infection. Eighteen underwent wound debridement: 11 improved, 1 worsened, and 6 eventually required major amputation due to non-reconstructable tibial disease/infection. Major amputation-free survival at 6 months was 71.4%(N=25). Evidence of medial necrosis was observed in 10(20.0%) specimens with no difference among DCB type(P=0.87) (Table I). There was no correlation between Paclitaxel and major amputation(P=0.78) or wound healing(P=0.25), and between DCB type and wound healing(P=0.68). Primary patency was 97.1%(N=18) at 6 months. Overall survival was 87.8%(N=31) at 6 months and 63.7%(N=14) at one year. CONCLUSIONS: Paclitaxel effect is seen in specimens of a minority patients with Rutherford 5/6 ischemia but is not dependent on DCB type or Paclitaxel dose and is not associated with MALE/MACE. This supports the safety of DCBs in patients with CLI.

Procedural details and post-procedural outcomes of patients with evidence of medial necrosis.
CharacteristicsMedial Necrosis (n=10)No Medial Necrosis (n=40)P-Value
DCB Type50% Admiral52.8% Admiral0.87
Number of balloons100% 1 balloon83.3% 1 balloon0.38
Mean DCB length8335mm10167mm0.25
Mean DCB diameter4.80.6mm50.5mm0.2
Total Paclitaxel Dose34441565 mcg51983559 mcg0.03*
Sampleobtained on PTA day60%55.6%0.8
Healed/Improved50%69.4%0.25
MALE20%69.4%0.25
30-day survival90%100%0.83


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