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Erschienen in: Heart and Vessels 3/2023

28.09.2022 | Original Article

Two-year clinical outcomes and predictors of restenosis following the use of polymer-coated paclitaxel-eluting stents or drug-coated balloons in patients with femoropopliteal artery disease

verfasst von: Naoki Yoshioka, Takahiro Tokuda, Akio Koyama, Takehiro Yamada, Kiyotaka Shimamura, Ryusuke Nishikawa, Yasuhiro Morita, Itsuro Morishima, the ASIGARU PAD investigators

Erschienen in: Heart and Vessels | Ausgabe 3/2023

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Abstract

We aimed to assess the clinical performance and risk factors for patency loss within 2 years following the use of polymer-coated paclitaxel-eluting stents (PC-PESs) and drug-coated balloons (DCBs) in patients with lower extremity artery disease. Multi-center registry data from 151 patients (65 and 86 treated with PC-PES and DCB, respectively) were retrospectively investigated. Two-year primary patency (PP) and clinically driven target lesion revascularization (CD-TLR) were evaluated using Kaplan–Meier analysis. Predictors of restenosis within 2 years of the procedures were analyzed using the random survival forest method. The consistent predictors of restenosis within 1 and 2 years were assessed and validated using Kaplan–Meier analysis. Two-year PP was 77.2 and 57.2% (log rank p = 0.047) and freedom from CD-TLR was 84.4 and 84.8% in the PC-PES and DCB groups, respectively (log rank p = 0.89). In the DCB group, most of the patients (n = 77, 89.5%) were treated with high-dose DCB. Consistent predictors of restenosis were lower vessel diameter and severity of Clinical Frailty Scale in the PC-PES group, and severity of peripheral artery calcification scoring system grade, severity of post dissection pattern, and smaller vessel diameter in the DCB group. The validation analysis revealed that patients with consistent predictors had significantly worse PP values than that of those without in the PC-PES (87.9% vs. 55.3%, log rank p = 0.003) and DCB groups (75.9% vs. 35.2%, log rank p = 0.001). The 2-year PP of DCBs was lower than that of PC-PESs. A smaller vessel diameter could predict restenosis in both devices. Vessel calcification and dissection should be considered when using DCB to ensure longer term patency.
Literatur
1.
Zurück zum Zitat Klein AJ, Ross CB (2016) Endovascular treatment of lower extremity peripheral arterial disease. Trends Cardiovasc Med 26:495–512CrossRef Klein AJ, Ross CB (2016) Endovascular treatment of lower extremity peripheral arterial disease. Trends Cardiovasc Med 26:495–512CrossRef
2.
Zurück zum Zitat Gray WA, Keirse K, Soga Y, Benko A, Babaev A, Yokoi Y, Schroeder H, Prem JT, Holden A, Popma J, Jaff MR, Diaz-Cartelle J, Muller-Hulsbeck S (2018) A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet 392:1541–1551CrossRef Gray WA, Keirse K, Soga Y, Benko A, Babaev A, Yokoi Y, Schroeder H, Prem JT, Holden A, Popma J, Jaff MR, Diaz-Cartelle J, Muller-Hulsbeck S (2018) A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet 392:1541–1551CrossRef
3.
Zurück zum Zitat Steiner S, Schmidt A, Zeller T, Tepe G, Thieme M, Maiwald L, Schröder H, Euringer W, Ulrich M, Brechtel K, Brucks S, Blessing E, Schuster J, Langhoff R, Schellong S, Weiss N, Scheinert D (2020) COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. Eur Heart J 41:2541–2552CrossRef Steiner S, Schmidt A, Zeller T, Tepe G, Thieme M, Maiwald L, Schröder H, Euringer W, Ulrich M, Brechtel K, Brucks S, Blessing E, Schuster J, Langhoff R, Schellong S, Weiss N, Scheinert D (2020) COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. Eur Heart J 41:2541–2552CrossRef
4.
Zurück zum Zitat Müller-Hülsbeck S, Keirse K, Zeller T, Schroë H, Diaz-Cartelle J (2017) Long-term results from the majestic trial of the eluvia paclitaxel-eluting stent for femoropopliteal treatment: 3-year follow-up. Cardiovasc Intervent Radiol 40:1832–1838CrossRef Müller-Hülsbeck S, Keirse K, Zeller T, Schroë H, Diaz-Cartelle J (2017) Long-term results from the majestic trial of the eluvia paclitaxel-eluting stent for femoropopliteal treatment: 3-year follow-up. Cardiovasc Intervent Radiol 40:1832–1838CrossRef
5.
Zurück zum Zitat Laird JA, Schneider PA, Jaff MR, Brodmann M, Zeller T, Metzger DC, Krishnan P, Scheinert D, Micari A, Wang H, Masters M, Tepe G (2019) Long-term clinical effectiveness of a drug-coated balloon for the treatment of femoropopliteal lesions. Circ Cardiovasc Interv 12:e007702CrossRef Laird JA, Schneider PA, Jaff MR, Brodmann M, Zeller T, Metzger DC, Krishnan P, Scheinert D, Micari A, Wang H, Masters M, Tepe G (2019) Long-term clinical effectiveness of a drug-coated balloon for the treatment of femoropopliteal lesions. Circ Cardiovasc Interv 12:e007702CrossRef
6.
Zurück zum Zitat Yoshioka N, Tokuda T, Koyama A, Yamada T, Nishikawa R, Shimamura K, Takagi K, Morita Y, Tanaka A, Ishii H, Morishima I, Murohara T (2021) Clinical outcomes and predictors of restenosis in patients with femoropopliteal artery disease treated using polymer-coated paclitaxel-eluting stents or drug-coated balloons. Heart Vessels 37(4):555–566CrossRef Yoshioka N, Tokuda T, Koyama A, Yamada T, Nishikawa R, Shimamura K, Takagi K, Morita Y, Tanaka A, Ishii H, Morishima I, Murohara T (2021) Clinical outcomes and predictors of restenosis in patients with femoropopliteal artery disease treated using polymer-coated paclitaxel-eluting stents or drug-coated balloons. Heart Vessels 37(4):555–566CrossRef
7.
Zurück zum Zitat Okuno S, Iida O, Shiraki T, Fujita M, Masuda M, Okamoto S, Ishihara T, Nanto K, Kanda T, Takahara M, Uematsu M (2016) Impact of calcification on clinical outcomes after endovascular therapy for superficial femoral artery disease: assessment using the peripheral artery calcification scoring system. J Endovasc Ther 23:731–737CrossRef Okuno S, Iida O, Shiraki T, Fujita M, Masuda M, Okamoto S, Ishihara T, Nanto K, Kanda T, Takahara M, Uematsu M (2016) Impact of calcification on clinical outcomes after endovascular therapy for superficial femoral artery disease: assessment using the peripheral artery calcification scoring system. J Endovasc Ther 23:731–737CrossRef
8.
Zurück zum Zitat Fujihara M, Takahara M, Sasaki S, Nanto K, Utsunomiya M, Iida O, Yokoi Y (2017) Angiographic dissection patterns and patency outcomes after balloon angioplasty for superficial femoral artery disease. J Endovasc Ther 24:367–375CrossRef Fujihara M, Takahara M, Sasaki S, Nanto K, Utsunomiya M, Iida O, Yokoi Y (2017) Angiographic dissection patterns and patency outcomes after balloon angioplasty for superficial femoral artery disease. J Endovasc Ther 24:367–375CrossRef
9.
Zurück zum Zitat Ishwaran H, Kogalur UB, Blackstone EH, Lauer MS (2008) Random survival forests. Ann Appl Stat 2:841–860CrossRef Ishwaran H, Kogalur UB, Blackstone EH, Lauer MS (2008) Random survival forests. Ann Appl Stat 2:841–860CrossRef
11.
Zurück zum Zitat Friedman J (2001) Greedy function approximation: a gradient boosting machine. Ann Stat 29:1189–1232CrossRef Friedman J (2001) Greedy function approximation: a gradient boosting machine. Ann Stat 29:1189–1232CrossRef
12.
Zurück zum Zitat Golzar J, Soga Y, Babaev A, Iida O, Kawasaki D, Bachinsky W, Park J, Prem JT, Vermassen F, Diaz-Cartelle J, Muller-Hulsbeck S, Gray WA (2020) Effectiveness and safety of a paclitaxel-eluting stent for superficial femoral artery lesions up to 190 mm: one-year outcomes of the single-arm imperial long lesion substudy of the eluvia drug-eluting stent. J Endovasc Ther 27:296–303CrossRef Golzar J, Soga Y, Babaev A, Iida O, Kawasaki D, Bachinsky W, Park J, Prem JT, Vermassen F, Diaz-Cartelle J, Muller-Hulsbeck S, Gray WA (2020) Effectiveness and safety of a paclitaxel-eluting stent for superficial femoral artery lesions up to 190 mm: one-year outcomes of the single-arm imperial long lesion substudy of the eluvia drug-eluting stent. J Endovasc Ther 27:296–303CrossRef
13.
Zurück zum Zitat Bisdas T, Beropoulis E, Argyriou A, Torsello G, Stavroulakis K (2018) 1-Year all-comers analysis of the eluvia drug-eluting stent for long femoropopliteal lesions after suboptimal angioplasty. JACC Cardiovasc Interv 11:957–966CrossRef Bisdas T, Beropoulis E, Argyriou A, Torsello G, Stavroulakis K (2018) 1-Year all-comers analysis of the eluvia drug-eluting stent for long femoropopliteal lesions after suboptimal angioplasty. JACC Cardiovasc Interv 11:957–966CrossRef
14.
Zurück zum Zitat Scheinert D, Micari A, Brodmann M, Tepe G, Peeters P, Jaff MR, Wang H, Schmahl R, Zeller T (2018) Drug-coated balloon treatment for femoropopliteal artery disease. Circ Cardiovasc Interv 11:e005654CrossRef Scheinert D, Micari A, Brodmann M, Tepe G, Peeters P, Jaff MR, Wang H, Schmahl R, Zeller T (2018) Drug-coated balloon treatment for femoropopliteal artery disease. Circ Cardiovasc Interv 11:e005654CrossRef
15.
Zurück zum Zitat Schmidt A, Piorkowski M, Gorner H, Steiner S, Bausback Y, Scheinert S, Banning-Eichenseer U, Staab H, Branzan D, Varcoe RL, Scheinert D (2016) drug-coated balloons for complex femoropopliteal lesions: 2-year results of a real-world registry. JACC Cardiovasc Interv 9:715–724CrossRef Schmidt A, Piorkowski M, Gorner H, Steiner S, Bausback Y, Scheinert S, Banning-Eichenseer U, Staab H, Branzan D, Varcoe RL, Scheinert D (2016) drug-coated balloons for complex femoropopliteal lesions: 2-year results of a real-world registry. JACC Cardiovasc Interv 9:715–724CrossRef
16.
Zurück zum Zitat Miki K, Fujii K, Tanaka T, Yanaka K, Yoshihara N, Nishimura M, Sumiyoshi A, Horimatsu T, Imanaka T, Fukunaga M, Akahori H, Masuyama T, Ishihara M (2020) Impact of IVUS-derived vessel size on midterm outcomes after stent implantation in Femoropopliteal Lesions. J Endovasc Ther 27:77–85CrossRef Miki K, Fujii K, Tanaka T, Yanaka K, Yoshihara N, Nishimura M, Sumiyoshi A, Horimatsu T, Imanaka T, Fukunaga M, Akahori H, Masuyama T, Ishihara M (2020) Impact of IVUS-derived vessel size on midterm outcomes after stent implantation in Femoropopliteal Lesions. J Endovasc Ther 27:77–85CrossRef
17.
Zurück zum Zitat Iida O, Takahara M, Soga Y, Nakano M, Yamauchi Y, Zen K, Kawasaki D, Nanto S, Yokoi H, Uematsu M (2015) 1-Year results of the ZEPHYR registry (Zilver PTX for the femoral artery and proximal popliteal artery): predictors of restenosis. JACC Cardiovasc Interv 8:1105–1112CrossRef Iida O, Takahara M, Soga Y, Nakano M, Yamauchi Y, Zen K, Kawasaki D, Nanto S, Yokoi H, Uematsu M (2015) 1-Year results of the ZEPHYR registry (Zilver PTX for the femoral artery and proximal popliteal artery): predictors of restenosis. JACC Cardiovasc Interv 8:1105–1112CrossRef
18.
Zurück zum Zitat Yoshioka N, Takagi K, Morishima I, Morita Y, Uemura Y, Inoue Y, Umemoto N, Shibata N, Negishi Y, Yoshida R, Tanaka A, Ishii H, Murohara T (2019) Influence of preadmission frailty on short- and mid-term prognoses in octogenarians with st-elevation myocardial infarction. Circ J 84(1):109–118CrossRef Yoshioka N, Takagi K, Morishima I, Morita Y, Uemura Y, Inoue Y, Umemoto N, Shibata N, Negishi Y, Yoshida R, Tanaka A, Ishii H, Murohara T (2019) Influence of preadmission frailty on short- and mid-term prognoses in octogenarians with st-elevation myocardial infarction. Circ J 84(1):109–118CrossRef
19.
Zurück zum Zitat Drudi LM, Ades M, Mancini R, Boudrias C, Obrand DI, Steinmetz OK, Afilalo J (2019) Frailty assessment in older adults undergoing interventions for peripheral arterial disease. J Vasc Surg 70:1594-1602.e1CrossRef Drudi LM, Ades M, Mancini R, Boudrias C, Obrand DI, Steinmetz OK, Afilalo J (2019) Frailty assessment in older adults undergoing interventions for peripheral arterial disease. J Vasc Surg 70:1594-1602.e1CrossRef
20.
Zurück zum Zitat Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A (2005) A global clinical measure of fitness and frailty in elderly people. CMAJ 173:489–495CrossRef Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A (2005) A global clinical measure of fitness and frailty in elderly people. CMAJ 173:489–495CrossRef
21.
Zurück zum Zitat Hendrickse P, Degens H (2019) The role of the microcirculation in muscle function and plasticity. J Muscle Res Cell Motil 40:127–140CrossRef Hendrickse P, Degens H (2019) The role of the microcirculation in muscle function and plasticity. J Muscle Res Cell Motil 40:127–140CrossRef
22.
Zurück zum Zitat Soga Y, Iida O, Hirano K, Suzuki K, Tosaka A, Yokoi H, Nobuyoshi M (2011) Utility of new classification based on clinical and lesional factors after self-expandable nitinol stenting in the superficial femoral artery. J Vasc Surg 54:1058–1066CrossRef Soga Y, Iida O, Hirano K, Suzuki K, Tosaka A, Yokoi H, Nobuyoshi M (2011) Utility of new classification based on clinical and lesional factors after self-expandable nitinol stenting in the superficial femoral artery. J Vasc Surg 54:1058–1066CrossRef
23.
Zurück zum Zitat Rigatelli G, Zuin M, Dell’Avvocata F, Vassilev D, Barison S, Osti S, Mazza A, Sacco A (2020) Impact of number of run-off vessels on interwoven nitinol mesh stents patency in the femoropopliteal segment. J Geriatr Cardiol 17:561–565 Rigatelli G, Zuin M, Dell’Avvocata F, Vassilev D, Barison S, Osti S, Mazza A, Sacco A (2020) Impact of number of run-off vessels on interwoven nitinol mesh stents patency in the femoropopliteal segment. J Geriatr Cardiol 17:561–565
24.
Zurück zum Zitat Fanelli F, Cannavale A, Gazzetti M, Lucatelli P, Wlderk A, Cirelli C, d’Adamo A, Salvatori FM (2014) Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol 37:898–907CrossRef Fanelli F, Cannavale A, Gazzetti M, Lucatelli P, Wlderk A, Cirelli C, d’Adamo A, Salvatori FM (2014) Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol 37:898–907CrossRef
25.
Zurück zum Zitat Tepe G, Zeller T, Schnorr B, Claussen CD, Beschorner U, Brechtel K, Scheller B, Speck U (2013) High-grade, non-flow-limiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty: an additional analysis from the THUNDER study. J Endovasc Ther 20:792–800CrossRef Tepe G, Zeller T, Schnorr B, Claussen CD, Beschorner U, Brechtel K, Scheller B, Speck U (2013) High-grade, non-flow-limiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty: an additional analysis from the THUNDER study. J Endovasc Ther 20:792–800CrossRef
26.
Zurück zum Zitat Giannopoulos S, Strobel A, Rudofker E, Kovach C, Schneider PA, Armstrong EJ (2021) Association of postangioplasty femoropopliteal dissections with outcomes after drug-coated balloon angioplasty in the femoropopliteal arteries. J Endovasc Ther 28:593–603CrossRef Giannopoulos S, Strobel A, Rudofker E, Kovach C, Schneider PA, Armstrong EJ (2021) Association of postangioplasty femoropopliteal dissections with outcomes after drug-coated balloon angioplasty in the femoropopliteal arteries. J Endovasc Ther 28:593–603CrossRef
27.
Zurück zum Zitat Kozuki A, Takahara M, Shimizu M, Kijima Y, Nagoshi R, Fujiwara R, Shibata H, Suzuki A, Soga F, Miyata T, Sakamoto Y, Seo H, Asada H, Isawa K, Higuchi K, Shite J (2021) Outcomes of dissection angles as predictor of restenosis after drug-coated balloon treatment. J Atheroscler Thromb 28(9):954–962CrossRef Kozuki A, Takahara M, Shimizu M, Kijima Y, Nagoshi R, Fujiwara R, Shibata H, Suzuki A, Soga F, Miyata T, Sakamoto Y, Seo H, Asada H, Isawa K, Higuchi K, Shite J (2021) Outcomes of dissection angles as predictor of restenosis after drug-coated balloon treatment. J Atheroscler Thromb 28(9):954–962CrossRef
28.
Zurück zum Zitat Kawamori H, Konishi A, Shinke T, Akahori H, Ishihara M, Tsujita H, Otake H, Toba T, Nakano S, Tanimura K, Tsukiyama Y, Nanba I, Kakei Y, Yasuda T, Omori T, Kubo T, Kozuki A, Shite J, Hirata KI (2021) Efficacy of optical frequency domain imaging in detecting peripheral artery disease: the result of a multi-center, open-label, single-arm study. Heart Vessel 36:818–826CrossRef Kawamori H, Konishi A, Shinke T, Akahori H, Ishihara M, Tsujita H, Otake H, Toba T, Nakano S, Tanimura K, Tsukiyama Y, Nanba I, Kakei Y, Yasuda T, Omori T, Kubo T, Kozuki A, Shite J, Hirata KI (2021) Efficacy of optical frequency domain imaging in detecting peripheral artery disease: the result of a multi-center, open-label, single-arm study. Heart Vessel 36:818–826CrossRef
Metadaten
Titel
Two-year clinical outcomes and predictors of restenosis following the use of polymer-coated paclitaxel-eluting stents or drug-coated balloons in patients with femoropopliteal artery disease
verfasst von
Naoki Yoshioka
Takahiro Tokuda
Akio Koyama
Takehiro Yamada
Kiyotaka Shimamura
Ryusuke Nishikawa
Yasuhiro Morita
Itsuro Morishima
the ASIGARU PAD investigators
Publikationsdatum
28.09.2022
Verlag
Springer Japan
Erschienen in
Heart and Vessels / Ausgabe 3/2023
Print ISSN: 0910-8327
Elektronische ISSN: 1615-2573
DOI
https://doi.org/10.1007/s00380-022-02182-0

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