Tom 17, Nr 2 (2022)
Inne materiały uzgodnione z Redakcją
Opublikowany online: 2022-09-02
Wyświetlenia strony
665
Wyświetlenia/pobrania artykułu
13
Czy powinniśmy stosować balony uwalniające leki w przezskórnym leczeniu tętnic obwodowych?
Kardiol Inwazyjna 2022;17(2):70-76.
Streszczenie
Balony pokrywane lekami antyproliferacyjnymi (DEB, drug-eluting balloon; DCB, drug-coated balloon) mają wiele zastosowań w leczeniu zwężeń naczyń. Obecnie stosuje się je w leczeniu długich zmian, restenoz, przewlekłych okluzji, a po odpowiednim przygotowaniu (litotrypsja, aterektomia) także do leczenia zmian
uwapnionych. Od niedawna wykorzystywane są także w leczeniu zwężeń przetok dializacyjnych. Balony uwalniające paklitaksel mają ugruntowaną pozycję przede wszystkim w leczeniu zwężeń odcinka udowo-podkolanowego. Pomimo sygnałów o szkodliwości urządzeń uwalniających paklitaksel, nie wykazano
w stosunku do balonów i stentów uwalniających tę substancję jednoznacznego związku ze zwiększoną śmiertelnością w porównaniu z balonami niepokrywanymi lekiem. Dzięki zastosowaniu
technologii fosfolipidowych nanonośników udało się zwiększyć dostarczalność sirolimusu do ściany naczynia, co spowodowało wprowadzenie balonów pokrywanych sirolimusem do leczenia zwężeń tętnic, w tym miażdżycy tętnic obwodowych. Jeśli wstępne, obiecujące wyniki leczenia balonami uwalniającymi sirolimus w piętrze naczyniowym poniżej kolana potwierdzą się w dłuższej obserwacji, być może dojdzie do znaczącej zmiany w zakresie interwencji „bezstentowych” w tętnicach goleni, gdzie DCB (DEB) będą urządzeniami pierwszego wyboru.
Słowa kluczowe: restenozabalony pokrywane lekamipaklitakselsirolimusmiażdżyca tętnic obwodowych
Referencje
- Aboyans V, Ricco JB, Bartelink MLEL, et al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018; 39(9): 763–816.
- Brodmann M, Keirse K, Scheinert D, et al. Drug-Coated balloon treatment for femoropopliteal artery disease: the IN.PACT global study de novo in-stent restenosis imaging cohort. JACC Cardiovasc Interv. 2017; 10(20): 2113–2123.
- Stavroulakis K, Borowski M, Torsello G, et al. One-year results of first-line treatment strategies in patients with critical limb ischemia (CRITISCH registry). J Endovasc Ther. 2018; 25(3): 320–329.
- Torsello G, Stavroulakis K, Brodmann M, et al. Three-Year sustained clinical efficacy of drug-coated balloon angioplasty in a real-world femoropopliteal cohort. J Endovasc Ther. 2020; 27(5): 693–705.
- Tzafriri AR, Garcia-Polite F, Zani B, et al. Calcified plaque modification alters local drug delivery in the treatment of peripheral atherosclerosis. J Control Release. 2017; 264: 203–210.
- Cioppa A, Stabile E, Salemme L, et al. Combined use of directional atherectomy and drug-coated balloon for the endovascular treatment of common femoral artery disease: immediate and one-year outcomes. EuroIntervention. 2017; 12(14): 1789–1794.
- Liistro F. Why BTK DCB trials do not show uniformity better results: technical factors matter. Presented on VEITH 2021.
- Axel DI, Kunert W, Göggelmann C, et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation. 1997; 96(2): 636–645.
- Wessely R, Schömig A, Kastrati A. Sirolimus and paclitaxel on polymer-based drug-eluting stents: similar but different. J Am Coll Cardiol. 2006; 47(4): 708–714.
- Tepe G, Laird J, Schneider P, et al. IN.PACT SFA Trial Investigators. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation. 2015; 131(5): 495–502.
- Rosenfield K, Jaff MR, White CJ, et al. LEVANT 2 Investigators. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015; 373(2): 145–153.
- Jia X, Zhang J, Zhuang B, et al. Acotec drug-coated balloon catheter: randomized, multicenter, controlled clinical study in Femoropopliteal arteries: evidence from the acoart i trial. JACC Cardiovasc Interv. 2016; 9(18): 1941–1949.
- Katsanos K, Spiliopoulos S, Paraskevopoulos I, et al. Systematic review and meta-analysis of randomized controlled trials of paclitaxel-coated balloon angioplasty in the femoropopliteal arteries: role of paclitaxel dose and bioavailability. J Endovasc Ther. 2016; 23(2): 356–370.
- Laird JA, Schneider PA, Jaff MR, et al. Long-Term clinical effectiveness of a drug-coated balloon for the treatment of femoropopliteal lesions. Circ Cardiovasc Interv. 2019; 12(6): e007702.
- Tepe G. 5-year results from the IN.PACT Global Study prespecified cohorts: ISR, CTO and long lesions. Presented at VIVA, 2021.
- Karnabatidis D, Katsanos K, Spiliopoulos S, et al. Incidence, anatomical location, and clinical significance of compressions and fractures in infrapopliteal balloon-expandable metal stents. J Endovasc Ther. 2009; 16(1): 15–22.
- Schmidt A, Piorkowski M, Werner M, et al. First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome. J Am Coll Cardiol. 2011; 58(11): 1105–1109.
- Liistro F, Porto I, Angioli P, et al. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013; 128(6): 615–621.
- Zeller T, Baumgartner I, Scheinert D, et al. IN.PACT DEEP Trial Investigators. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014; 64(15): 1568–1576.
- Zeller T, Beschorner U, Pilger E, et al. Paclitaxel-Coated balloon in infrapopliteal arteries: 12-month results from the BIOLUX P-II randomized trial (biotronik's-first in man study of the passeo-18 LUX drug releasing PTA balloon catheter vs. the uncoated passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries). JACC Cardiovasc Interv. 2015; 8(12): 1614–1622.
- Siablis D, Kitrou PM, Spiliopoulos S, et al. Paclitaxel-coated balloon angioplasty versus drug-eluting stenting for the treatment of infrapopliteal long-segment arterial occlusive disease: the IDEAS randomized controlled trial. JACC Cardiovasc Interv. 2014; 7(9): 1048–1056.
- Thieme M, Lichtenberg M, Brodmann M, et al. Lutonix® 014 DCB global Below the Knee Registry Study: interim 6-month outcomes. J Cardiovasc Surg (Torino). 2018; 59(2): 232–236.
- Katsanos K, Spiliopoulos S, Kitrou P, et al. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2018; 7(24): e011245.
- Katsanos K, Spiliopoulos S, Kitrou P, et al. Risk of death and amputation with use of paclitaxel-coated balloons in the infrapopliteal arteries for treatment of critical limb ischemia: a systematic review and meta-analysis of randomized controlled trials. J Vasc Interv Radiol. 2020; 31(2): 202–212.
- The Food and Drug Administration executive summary: circulatory system devices panel meeting. https://www.fda.gov/media/127698/download (4.09.2019).
- Schneider PA, Laird JR, Doros G, et al. Mortality not correlated with paclitaxel exposure: an independent patient-level meta-analysis of a drug-coated balloon. J Am Coll Cardiol. 2019; 73(20): 2550–2563.
- Behrendt CA, Sedrakyan A, Peters F, et al. Editor's choice - long term survival after femoropopliteal artery revascularisation with paclitaxel coated devices: a propensity score matched cohort analysis . Eur J Vasc Endovasc Surg. 2020; 59(4): 587–596.
- Heidemann F, Peters F, Kuchenbecker J, et al. Long term outcomes after revascularisations below the knee with paclitaxel coated devices: a propensity score matched cohort analysis. Eur J Vasc Endovasc Surg. 2020; 60(4): 549–558.
- Secemsky EA, Shen C, Schermerhorn M, et al. Longitudinal assessment of safety of femoropopliteal endovascular treatment with paclitaxel-coated devices among medicare beneficiaries: the SAFE-PAD study. JAMA Intern Med. 2021; 181(8): 1071–1080.
- Jia X, Zhuang B, Wang F, et al. Drug-Coated balloon angioplasty compared with uncoated balloons in the treatment of infrapopliteal artery lesions (acoart II-BTK). J Endovasc Ther. 2021; 28(2): 215–221.
- Habib A, Karmali V, Polavarapu R, et al. Sirolimus-FKBP12.6 impairs endothelial barrier function through protein kinase C-α activation and disruption of the p120-vascular endothelial cadherin interaction. Arterioscler Thromb Vasc Biol. 2013; 33(10): 2425–2431.
- Zeller T, Brechtel K, Meyer DR, et al. Six-Month outcomes from the first-in-human, single-arm SELUTION sustained-limus-release drug-eluting balloon trial in femoropopliteal lesions. J Endovasc Ther. 2020; 27(5): 683–690.
- Lemos PA, Farooq V, Takimura CK, et al. Emerging technologies: polymer-free phospholipid encapsulated sirolimus nanocarriers for the controlled release of drug from a stent-plus-balloon or a stand-alone balloon catheter. EuroIntervention. 2013; 9(1): 148–156.
- Ahmad WA, Nuruddin AA, Abdul Kader MA, et al. Treatment of coronary drug-eluting stent restenosis by a sirolimus- or paclitaxel-coated balloon. JACC Cardiovasc Interv. 2019; 12(6): 558–566.
- Cortese B, Di Palma G, Latini R. Magic Touch®: preliminary clinical evidence with a novel sirolimus drug coated balloon. Minerva Cardioangiol. 2018; 66(4): 508–517.
- Mori M, Sakamoto A, Kawakami R, et al. Paclitaxel- and sirolimus-coated balloons in peripheral artery disease treatment: current perspectives and concerns. Vascular and Endovascular Review. 2021; 4.
- Choke E, Tang TY, Peh E, et al. MagicTouch PTA sirolimus coated balloon for femoropopliteal and below the knee disease: results from XTOSI pilot study up to 12 months. J Endovasc Ther. 2021 [Epub ahead of print]: 15266028211064816.
