Jornal Vascular Brasileiro
https://jvascbras.org/article/doi/10.1590/1677-5449.007317
Jornal Vascular Brasileiro
Original Article

Real-world experience with a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries: 12-month interim results of the BIOLUX P-III registry first year of enrolment

Experiência real com balão revestido com paclitaxel para o tratamento de artérias infrainguinais ateroscleróticas: resultados após 12 meses do primeiro ano de seleção de pacientes para o registro BIOLUX P-III

Marianne Brodmann, Thomas Zeller, Johnny Christensen, Christoph Binkert, Lubomir Spak, Henrik Schröder, Paolo Righini, Giovanni Nano, Gunnar Tepe

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Abstract

Background: Endovascular management of atherosclerotic infrainguinal arteries recently shifted towards drug eluting devices, designed to locally prevent the restenosis process. Numerous clinical studies report an advantage of drug coated balloons over uncoated balloon angioplasty in treating lower extremity peripheral artery disease. However, as coating and balloon platforms are different, each device requires dedicated clinical evaluations. Objective: The aim of the study is to further investigate the safety and effectiveness of a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries in a real-world setting. Methods: 203 patients out of a final sample of 882 were enrolled in this prospective multicenter, observational, all-comers registry during the first 12 months. The primary endpoints were major adverse events (defined as procedure or device related death within 30 days post index procedure, clinically-driven target lesion revascularization or major target limb amputation) at 6 months and freedom from clinically-driven target lesion revascularization at 12 months. Both endpoints were adjudicated by a Clinical Events Committee. Results: Mean patient age was 70.2±10.4 years (60.1% male). 47.3% of the patients were diabetic and 67.5% had a history of smoking. Severe claudication was reported in 37.4% and 40% had critical limb ischemia. 257 lesions, including 13.2% in the infrapopliteal territory, were treated with Passeo-18 Lux (mean lesion length 75.1 mm±69.4, 20% occlusions, 76.3% calcified). At 6 months, the rate of major adverse events was 5.5% (95%CI 3.1-9.7). Freedom from clinically-driven target lesion revascularization at 12 months was 93.2% (95%CI 89.1-95.8). All causes mortality was 6.5% (95%CI 3.8-11.0) and overall amputation rate was 4.2% (95%CI 2.1-8.3) at 12 months. Conclusion: In a real-world environment, the BIOLUX P-III registry preliminary results confirm the safety and efficacy of the Paclitaxel-Coated Passeo-18 Lux balloon as a stand-alone treatment option for atherosclerotic infrainguinal arteries.

Keywords

Peripheral artery disease; Paclitaxel-Coated Balloon; endovascular therapy.

Resumo

Contexto: O manejo endovascular de artérias infrainguinais ateroscleróticas recentemente tem mudado para dispositivos farmacológicos, desenhados para impedir localmente o processo de reestenose. Numerosos estudos clínicos descrevem uma vantagem da angioplastia com uso de balões farmacológicos sobre os balões convencionais no tratamento de doença arterial periférica dos membros inferiores. No entanto, considerando que as plataformas do revestimento farmacológico e dos balões são diferentes, cada dispositivo requer avaliações clínicas específicas. Objetivo: Fazer investigação adicional sobre a segurança e eficácia de um balão revestido com paclitaxel para o tratamento de artérias infrainguinais ateroscleróticas em um cenário de mundo real. Métodos: 203 pacientes de uma amostra final de 882 pacientes foram incluídos neste registro prospectivo observacional multicêntrico de inclusão sequencial, durante os primeiros 12 meses. Os desfechos primários foram eventos adversos maiores (definidos como morte relacionada ao procedimento ou ao dispositivo em até 30 dias após o procedimento-índice, necessidade de revascularização da lesão-alvo ou amputação significativa do membro-alvo) em 6 meses e ausência de de revascularização da lesão-alvo em 12 meses. Ambos os desfechos foram adjudicados por um comitê de eventos clínicos. Resultados: A idade média foi 70,2±10,4 anos (60,1% sexo masculino). 47,3% dos pacientes eram diabéticos, e 67,5% tinham história de tabagismo. Claudicação severa foi relatada em 37,4%, e 40% apresentava isquemia crítica de membro. 257 lesões, incluindo 13,2% em território infrapoplíteo, foram tratadas com o balão Passeo-18 Lux (comprimento médio das lesões 75,1 mm±69,4, 20% oclusões, 76,3% calcificadas). Aos 6 meses, a taxa de eventos adversos maiores foi de 5,5% (95%CI 3,1-9,7). A ausência de revascularização da lesão-alvo aos 12 meses foi de 93,2% (95%CI 89,1-95,8). Mortalidade por todas as causas foi de 6,5% (95%CI 3,8-11,0) e a taxa geral de amputação foi de 4,2% (95%CI 2,1-8,3) aos 12 meses. Conclusão: Em um cenário de mundo real, os resultados preliminares do registro BIOLUX P-III confirmam a segurança e eficácia do balão revestido com paclitaxel Passeo-18 Lux como opção de tratamento único para artérias infrainguinais ateroscleróticas. Palavras-chave: doença arterial periférica; balão revestido com paclitaxel; terapia endovascular

Palavras-chave

doença arterial periférica; balão revestido com paclitaxel; terapia endovascular.

References

1. Fowkes FG, Rudan D, Rudan I, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;382(9901):1329-40. PMid:23915883. http://dx.doi.org/10.1016/S0140-6736(13)61249-0.

2. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FGR, and the TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33(Suppl 1):1-75. PMid:17140820. http://dx.doi.org/10.1016/j.ejvs.2006.09.024.

3. Costa MA, Simon DI. Molecular basis of restenosis and drug-eluting stents. Circulation. 2005;111(17):2257-73. PMid:15867193. http://dx.doi.org/10.1161/01.CIR.0000163587.36485.A7.

4. Tepe G, Laird J, Schneider P, et al., and the 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. PMid:25472980. http://dx.doi.org/10.1161/CIRCULATIONAHA.114.011004.

5. Rosenfield K, Jaff MR, White CJ, et al., and the LEVANT 2 Investigators. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373(2):145-53. PMid:26106946. http://dx.doi.org/10.1056/NEJMoa1406235.

6. Aghel A, Armstrong EJ. Recent advances in self-expanding stents for use in the superficial femoral and popliteal arteries. Expert Rev Cardiovasc Ther. 2014;12(7):833-42. PMid:24830846. http://dx.doi.org/10.1586/14779072.2014.918505.

7. Scheinert D, Duda S, Zeller T, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014;7(1):10-9. PMid:24456716. http://dx.doi.org/10.1016/j.jcin.2013.05.022.

8. Kayssi A, Al-Atassi T, Oreopoulos G, Roche-Nagle G, Tan KT, Rajan DK. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2016;8(8):CD011319. PMid:27490003.

9. Scheinert D, Schulte KL, Zeller T, Lammer J, Tepe G. Paclitaxelreleasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial. J Endovasc Ther. 2015;22(1):14-21. PMid:25775674. http://dx.doi.org/10.1177/1526602814564383.

10. 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):1614-22. PMid:26493253. http://dx.doi.org/10.1016/j.jcin.2015.07.011.

11. Ansel GM. The IN.PACT global registry: one-year outcomes using the IN.PACT DCB in an unrestricted, real-world environment. TCT; 2015.

12. Krishnan P. 12-Month Interim Results of ILLUMENATE Global Study with Stellarex Drug-Coated Balloon. NCVH; 2016.

13. Thieme M. 12 Month Outcomes From the Lutonix Global SFA Real-World Registry. TCT; 2015.

14. Nascimento BR, Brant LC, Lana ML, Lopes EL, Ribeiro AL. Trends in procedure type, morbidity and in-hospital outcomes of patients with peripheral artery disease: data from the brazilian public health system. Ann Vasc Surg. 2016;31:143-51. PMid:26616503. http://dx.doi.org/10.1016/j.avsg.2015.08.019.

15. Katsanos K, Geisler BP, Garner AM, Zayed H, Cleveland T, Pietzsch JB. Economic analysis of endovascular drug-eluting treatments for femoropopliteal artery disease in the UK. BMJ Open. 2016;6(5):e011245. PMid:27160845. http://dx.doi.org/10.1136/bmjopen-2016-011245.

16. Kearns BC, Michaels JA, Stevenson MD, Thomas SM. Cost-effectiveness analysis of enhancements to angioplasty for infrainguinal arterial disease. Br J Surg. 2013;100(9):1180-8. PMid:23842832. http://dx.doi.org/10.1002/bjs.9195.

17. Pietzsch JB, Geisler BP, Garner AM, Zeller T, Jaff MR. Economic analysis of endovascular interventions for femoropopliteal arterial disease: A systematic review and budget impact model for the United States and Germany. Catheter Cardiovasc Interv. 2014;84(4):546-54. PMid:24782424. http://dx.doi.org/10.1002/ccd.25536.

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