Abstract
Aim
We investigated the efficacy and safety of using paclitaxel-coated balloon (PCB) to treat small vessel disease.
Methods and results
In this multicenter, prospective, randomized controlled trial, one-hundred and thirty-five patients with native coronary lesions in small vessels were randomized into a PCB group and plain balloon angioplasty (POBA) group at a ratio of 2:1. There were no differences in target vessel failure (TVF) that was defined as cardiac death or target vessel-related myocardial infarction or target lesion revascularization (TLR), between the two groups (3.4 vs. 10.3%; P = 0.20), and TLR was slightly lower in the PCB group (2.3%) than that in the POBA group (10.3%) during 24 weeks follow-up. The late lumen loss (LLL) was significantly lower in the PCB group (0.01 ± 0.31 vs. 0.32 ± 0.34 mm; P < 0.01) and late lumen enlargement (LLE) was more frequently observed in the PCB group (48 vs. 15%; P < 0.01) by angiographic follow-up after 24 weeks. There were no cases of death, myocardial infarction, thrombosis and reocclusion in either group.
Conclusions
This study was not able to demonstrate superiority of PCB compared with POBA.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
Explore related subjects
Discover the latest articles and news from researchers in related subjects, suggested using machine learning.References
Habara S, Iwabuchi M, Inoue N, Nakamura S, Asano R, Nanto S, Hayashi Y, Shiode N, Saito S, Ikari Y, Kimura T, Hosokawa J, Nakamura M, Kotani J, Kozuma K, Mitsudo K (2013) A multicenter randomized comparison of paclitaxel-coated balloon catheter with conventional balloon angioplasty in patients with bare-metal stent restenosis and drug-eluting stent restenosis. Am Heart J 166:527–533
Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B (2010) Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol 99:165–174
Latib A, Colombo A, Castriota F, Micari A, Cremonesi A, De Felice F, Marchese A, Tespili M, Presbitero P, Sgueglia GA, Buffoli F, Tamburino C, Varbella F, Menozzi A (2012) A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol 60:2473–2480
Park SW, Lee CW, Hong MK, Kim JJ, Cho GY, Nah DY, Park SJ (2000) Randomized comparison of coronary stenting with optimal balloon angioplasty for treatment of lesions in small coronary arteries. Eur Heart J 21:1785–1789
Morice MC (2003) Stenting for small coronary vessels. J Invasive Cardiol 15:377–379
Kastrati A, Schomig A, Dirschinger J, Mehilli J, Dotzer F, von Welser N, Neumann FJ (2000) A randomized trial comparing stenting with balloon angioplasty in small vessels in patients with symptomatic coronary artery disease. ISAR-SMART Study Investigators. Intra-coronary stenting or angioplasty for restenosis reduction in small arteries. Circulation 102:2593–2598
Mehilli J, Dibra A, Kastrati A, Pache J, Dirschinger J, Schomig (2006) A for the intracoronary drug-eluting stenting to abrogate restenosis in small arteries (ISAR-SMART3) Study Investigators. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur Heart J 27:260–266
Gao R, Abizaid A, Banninga Bartorelli AL, Zavik V, Ellis S, Jeong MH, Legrand V, Spaulding C, Urban P, for the e-SELECT Invertigators (2013) One-Year outcome of small-vessel disease treated with sirolimus-eluting stents: a subgroup analysis of the e-SELECT Registry. J Interven Cardiol 26:163–172
Zimarino M, Corazzini A, Ricci F, Di Nicola M, De Caterina R (2013) Late thrombosis after double versus single drug-eluting stent in the treatment of coronary bifurcations: a meta-analysis of randomized and observational studies. JACC Cardiovasc Interv 6:687–695
Koning R, Eltchaninoff H, Commeau P, Khalife K, Gilard M, Lipiecki J, Costa P, Bedossa M, Lefevre T, Brunel P, Morice MC, Maillard L, Guyon P, Puel J, Cribier A (2001) Stent placement compared with balloon angioplasty for small coronary arteries: in-hospital and 6-months clinical and angiographic results. Circulation 104:1604–1608
Doucent S, Schalij MJ, Vrolix MC, Hilodeau D, Chenu P, Bruyne B, Udayachalerm W, Seth A, Bilodeau L, Reiber J, Harel F, Lesperance J (2001) Stent placement to prevent restenosis after angioplasty in small coronary arteries. Circulation 104:2029–2033
Savage MP, Fischman DL, Rake R, Leon MB, Schatz RA, Penn I, Nobuyoshi M, Moses J, Hirshfeld J, Heuser R, Brim D, Cleman M, Brinker J, Gebhardt S, Goldberg S (1998) Efficacy of coronary stenting versus balloon angioplasty in small coronary arteries. J Am Coll Cardiol 31:307–311
Moer R, Myreng Y, Molstad P, Albertsson P, Gunnes P, Lindvall B, Wiseth R, Ytre-Arene K, Kjekshus J, Golf S (2001) Stenting in small coronary arteries (SISCA) trial: a randomized comparison between balloon angioplasty and the heparin-coated be Stent. J Am Coll Cardiol 38:1598–1603
Vaquerizo B, Miranda-Guardiola F, Fernandez E, Rumoroso JR, Gomez-Hospital JA, Bossa F, Iniguez A, Oategui I, Serra A (2015) Treatment of small vessel disease with the paclitaxel drug-eluting balloon: 6-month angiographic and 1-year clinical outcomes of the Spanish multicenter registry. J Interven Cardiol 28:430–438
Ito H, Hermiller JB, Yaqub M, Newman W, Sood P, Wang JC, Cannon L, Maddux JE, Sudhir K, Stone GW (2011) Performance of everolimus-eluting versus paclitaxel-eluting coronary stents in small vessels: results from the SPIRIT III and SPIRIT IV clinical trials. J Interven Cardiol 24:505–513
Habara S, Mitsudo K, Kadota K, Goto T, Fujii S, Yamamoto H, Katoh H, Oka N, Fuku Y, Hosogi S, Hirono A, Maruo T, Tanaka H, Shigemoto Y, Hasegawa D, Takase H, Kusunose M, Otsuru S, Okamomto Y, Saito N, Tsujimoto Y, Eguchi H, Miyake K, Yoshino M (2011) Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis. JACC Cardiovasc Interv 4:149–154
Kleber FX, Schulz A, Waliszewski M, Hauschild T, Böhm M, Dietz U, Cremers B, Scheller B, Clever YP (2015) Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol 104:217–225
Cortese B, Orrego PS, Agostoni P, Buccheri D, Piraino D, Andolina G, Seregni RG (2015) Effect of drug-coated balloons in native coronary artery disease left with a dissection. J Am Coll Cardiol Intv 8:2003–2009
Scheller B, Fischer D, Clever YP, Kleber FX, Speck U, Bohm M, Cremers B (2013) Treatment of a coronary bifurcation lesion with drug-coated balloon: lumen enlargement and plaque modification after 6 months. Clin Res Cardiol 102:469–472
Poerner TC, Duderstadt C, Goebel B, Kretzschmar D, Figulla HR, Otto S (2016) Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implanation: feasibility. Safety and 6-month results by angiography and optical coherence tomography. Clin Res Cardiol 106:18–27
Taguchi I, Kageyama M, Kanaya T, Abe S, Node K, Inoue T (2014) Clinical significance of non-slip element balloon angioplasty for patients of coronary artery disease: a preliminary report. J Cardiol 63:19–23
Unverdorben M, Kleber F, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hadt S, Michael B, Ackermann H, Boxberger M, Degenhardt R, Scheller B (2013) Treatment of small coronary arteries with a pacliraxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months? EuroIntervention 9:620–628
Naganuma T, Latib A, Sgueglia GA, Menozzi A, Castriota F, Micari A, Cremonesi A, Felice FD, Marchese A, Tespili M, Presbitero P, Panoulas VF, Buffoli F, Tamburino C, Varbella F, Colombo A (2015) A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessel the BELLO study. Int J Cardiol 184:17–21
Kleber FX, Rittger H, Bonaventura K, Zeymer U, Wöhrle J, Jeger R, Levenson B, Möbius-Winkler S, Bruch L, Fischer D, Hengstenberg C, Pörner T, Mathey D, Scheller B (2013) Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group. Clin Res Cardiol 102:785–797
Acknowledgements
The authors thank other following investigators and institutions participated in this study. Y. Hayashi and N. Shiode, Tsuchiya General Hospital, Hiroshima; Y. Ikari, Tokai University Hospital, Isehara; J. Hosokawa, Tokyo Heart Center, Tokyo; J. Kotani, National Cardiovascular Center, Suita.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Funding
The study was supported by Nipro Corporation (Osaka, Japan) which had exclusive distribution rights to sell Sequent Please balloon catheter in Japan.
Conflict of interest
S Nakamura has served as a consultant for Nipro Corporation. The other authors report no conflict of interest.
Rights and permissions
About this article
Cite this article
Funatsu, A., Nakamura, S., Inoue, N. et al. A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients with small vessel disease. Clin Res Cardiol 106, 824–832 (2017). https://doi.org/10.1007/s00392-017-1126-x
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00392-017-1126-x