P-093 - REAL-WORLD OUTCOMES OF COOK ZILVER PTX IN FEMORO-POPLITEAL DISTRICT FROM MULTICENTER EXPERIENCE

TOPIC:
Peripheral Occlusive Arterial Disease
AUTHORS:
Bianchini Massoni C. (Vascular Surgery, Department of Medicine and Surgery, Azienda Ospedaliero-Universitaria di Parma ~ Parma ~ Italy) , Strozzi F. (Vascular Surgery, Department of General and Specialist Surgery, Arcispedale S. Maria Nuova ~ Reggio Emilia ~ Italy) , Epifani E. (Radiology, Diagnostic Department - Azienda Ospedaliero-Universitaria di Parma ~ Parma ~ Italy) , Zenunaj G. (Vascular Surgery, Department of Surgery, Azienda Ospedaliero-Universitaria di Ferrara ~ Ferrara ~ Italy) , Ucci A. (Vascular Surgery, Department of Medicine and Surgery, Azienda Ospedaliero-Universitaria di Parma ~ Parma ~ Italy) , Paladini I. (Radiology, Diagnostic Department - Azienda Ospedaliero-Universitaria di Parma ~ Parma ~ Italy) , Gasbarro V. (Vascular Surgery, Department of Surgery, Azienda Ospedaliero-Universitaria di Ferrara ~ Ferrara ~ Italy) , Tusini N. (Vascular Surgery, Department of General and Specialist Surgery, Arcispedale S. Maria Nuova ~ Reggio Emilia ~ Italy) , Freyrie A. (Vascular Surgery, Department of Medicine and Surgery, Azienda Ospedaliero-Universitaria di Parma ~ Parma ~ Italy)
Introduction:
The Zilver PTX drug-eluting stent is largely supported by randomized control trial, pre-market and post-market studies(1-4). However, the majority of these publications includes high rate of claudicant patients and are directly supported by Cook(1-4). For these reasons, obtained data risk to be poor comparable with other experiences resulting worthless in daily practice activity. The aim of the study is to report the outcomes of Zilver PTX drug-eluting stent in femoro-popliteal district from a multicenter real-world experience.
Methods:
Prospectively collected data from four Units were retrospectively joined and analyzed considering Zilver PTX deployed from August 2009 according to the instruction for use. Patient demographics, preoperative comorbidities, Rutherford classification, arterial characteristics and stent data were considered. Target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms. Primary outcome was the freedom from TLR (ffTLR) and its risk factors. Secondary outcomes were primary patency (PP) of the stent, amputation-free survival (AFS) and their risk factors.
Results:
Considering 203 patients (mean age: 73.5 years ±10.6; male: 66.5%) and 263 stents (median 2 stents/patient, range 1-5stent/patient), chronic limb-threatening ischemia (CLTI) affected 154 patients (75.9%). The length of the treated lesion was <120mm in 99 (48.8%), ≥120mm and <200mm in 65 (32%) and ≥200mm in 39 (19.2%) cases, respectively; the reference vessel mean diameter was 5.5±0.7mm; chronic total occlusion was treated in 153 (75.4%) patients, the popliteal artery was involved in 56 (27.6%) cases and prior endovascular intervention was performed in 27 (13.3%) cases. Two or more tibial run-off vessels were patent in 124 (61.1%). Mean follow-up was 23.2 months ±21.3. At 1, 2 and 3 years, the ffTLR was 90.6%±4.2%, 86.4%±6.1% and 80.4%±8.3%, respectively (Figure 1), and the PP was 85.6%±5.0%, 74.2%±7.6% and 72.7%±8.2%, respectively (Figure 2). Negative prognostic factor for ffTLR and PP was the reference vessel diameter (p=0.001 and p<0.001, respectively). At 1, 2 and 3 years, the AFS was 81.8%±6.0%, 75.5%±7.1% and 74.2%±7.5% respectively; coronary artery disease (p=0.041) and CLTI (p=0.011) resulted negative prognostic factors.
Conclusion:
In the real-world practice, around 3/4 of patients were treated for CLTI. The rate of ffTLR is high, and PP is substantially lower. A small vessel diameter (<5mm) is a negative factor for both ffTLR and PP. The rate of AFS is about 75% at 2 years and CLTI and coronary artery disease are negative prognostic factors.
References:
1. Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Machan LS, Snyder SA, O'Leary EE, Ragheb AO, Zeller T; Zilver PTX Investigators. Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial. Circulation. 2016 Apr 12;133(15):1472-83; discussion 1483. doi: 10.1161/CIRCULATIONAHA.115.016900. Epub 2016 Mar 11. Erratum in: Circulation. 2019 Feb 19;139(8):e42. PMID: 26969758; PMCID: PMC4823823. 2. Kichikawa K, Ichihashi S, Yokoi H, Ohki T, Nakamura M, Komori K, Nanto S, O'Leary EE, Lottes AE, Snyder SA, Dake MD. Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results. Cardiovasc Intervent Radiol. 2019 Mar;42(3):358-364. doi: 10.1007/s00270-018-2110-1. Epub 2018 Nov 8. PMID: 30411151; PMCID: PMC6373439. 3. Dake MD, Scheinert D, Tepe G, Tessarek J, Fanelli F, Bosiers M, Ruhlmann C, Kavteladze Z, Lottes AE, Ragheb AO, Zeller T; Zilver PTX Single-Arm Study Investigators. Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study. J Endovasc Ther. 2011 Oct;18(5):613-23. doi: 10.1583/11-3560.1. PMID: 21992630. 4. Dake MD, Fanelli F, Lottes AE, O'Leary EE, Reichert H, Jiang X, Fu W, Iida O, Zen K, Schermerhorn M, Zeller T, Ansel GM. Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent. Cardiovasc Intervent Radiol. 2021 Feb;44(2):196-206. doi: 10.1007/s00270-020-02648-6. Epub 2020 Oct 6. PMID: 33025243; PMCID: PMC7806559.
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