Abstract
Paclitaxel-coated balloon (PCB) angioplasty reduces neointimal proliferation, restenosis, and clinical need for target lesion revascularization (TLR). PCB was superior for coronary restenosis in bare-metal and drug-eluting stents compared with uncoated balloon angioplasty and was noninferior compared with paclitaxel-eluting stents. PCB angioplasty should be considered for treatment of coronary in-stent restenosis. For de novo lesions, PCB plus endothelial progenitor cell capturing stents reduced restenosis and TLR in early reports. Among patients with de novo lesions and diabetes, the combination of PCB plus bare-metal stent revealed similar results in lesions compared with paclitaxel-eluting stents. The early results for PCB in small vessels are also very encouraging. Dual antiplatelet therapy duration may be shorter with PCB angioplasty compared with drug-eluting stents. Nevertheless, the risk for thrombotic vessel occlusion is minimized. Considering peripheral arterial disease, PCB angioplasty for femoropopliteal lesions was superior to uncoated balloon angioplasty. Registries indicate PCB to also be effective in lesions below the knee. Since there is no certain class effect, efficacy and safety have to be demonstrated for different types of PCB for coronary and peripheral interventions.
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References
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Hwang CW, Wu D, Edelman ER. Physiological transport forces govern drug distribution for stent-based delivery. Circulation. 2001;104:600–5.
• Cremers B, Speck U, Kaufels N, et al. Drug-eluting balloon: very short-term exposure and overlapping. Thromb Haemost. 2009;101:201–6. Important animal study analyzing the effect of inflation time and drug dosage.
•• Scheller B, Hehrlein C, Bocksch W, Mahnkopf D, Kühler M, Böhm M, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006;355:2113–24. First randomized trial demonstrating efficacy of PCB angioplasty for treatment of BMS restenosis.
•• Wöhrle J, Birkemeyer R, Markovic S, Nguyen TV, Sinha A, Miljak T, et al. Prospective randomized trial evaluating a paclitaxel-coated balloon in patients treated with endothelial progenitor cell capturing stents for de novo coronary artery disease. Heart. 2011, 97:1338–42. First randomized trial for de novo lesions evaluating the impact of paclitaxel coated balloon angioplasty in combination with endothelial progenitor cell capturing stent.
•• Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, et al. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES Study. J Am Coll Cardiol. 2012;59:1377–82. Largest randomized clinical trial showing the superiority of paclitaxel coated balloon angioplasty for treatment of restenosis in drug-eluting stents compared with uncoated balloon angioplasty.
• Wöhrle J, Werner GS. Paclitaxel-coated balloon with bare-metal stenting in patients with chronic total occlusions in native coronary arteries. Catheter Cardiovasc Interv. 2012;doi:10.1002/ccd.24409, in press. Nonrandomized matched study evaluating the effect of paclitaxel coated balloon angioplasty plus bare-metal stenting for treatment of chronic total occlusions.
Scheller B, Speck U, Abramjuk C, et al. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004;110:810–4.
• Kelsch B, Scheller B, Biedermann M, Clever YP, Schaffner S, Mahnkopf D, et al. Dose response to Paclitaxel-coated balloon catheters in the porcine coronary overstretch and stent implantation model. Invest Radiol. 2011;46:255–63. Important study analyzing the effect of drug loss and dosage in swine model.
Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006;48:193–202.
• Planer D, Smits PC, Kereiakes DJ, Kedhi E, Fahy M, Xu K, et al. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (a clinical evaluation of the XIENCE V everolimus eluting coronary stent system) and COMPARE (a trial of everolimus-eluting stents and paclitaxel-eluting stents for coronary revascularization in daily practice) Trials. JACC Cardiovasc Interv. 2011;4:1104–15. This study demonstrates that there is no class effect for drug-eluting stents. Everolimus eluting stents were superior compared with paclitaxel eluting stents.
Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D'Ascenzo F, et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet. 2012;379:1393–402.
Wöhrle J, Rottbauer W, Imhof A. Everolimus-eluting stents for treatment of chronic total coronary occlusions. Clin Res Cardiol. 2012;101:23–8.
Cremers B, Biedermann M, Mahnkopf D, Böhm M, Scheller B. Comparison of 2 different paclitaxel-coated balloon catheters in the porcine coronary restenosis model. Clin Res Cardiol. 2009;98:325–30.
Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Tielbeek A, et al. Sirolimus-eluting vs bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial. J Vasc Interv Radiol. 2005;16:331–8.
Duda SH, Pusich B, Richter G, Landwehr P, Oliva VL, Tielbeek A, et al. Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: 6 month results. Circulation. 2002;106:1505–9.
• Habara S, Mitsudo K, Kadota K, Goto T, Fujii S, Yamamoto H, et al. Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis. JACC Cardiovasc Interv. 2011;4:149–54. First randomized trial demonstrating superiority of paclitaxel coated balloon angioplasty compared with uncoated balloon angioplasty for restenosis in sirolimus eluting stents.
•• Scheller B, Clever YP, Kelsch B, Hehrlein C, Bocksch W, Rutsch W, et al. Long-term follow-up after treatment of coronary in-stent restenosis with a Paclitaxel-coated balloon catheter. JACC Cardiovasc Interv. 2012;5:323–30. Important study demonstrating no late catch up with paclitaxel coated balloon angioplasty for treatment of in-stent restenosis.
Wöhrle J, Zadura M, Möbius-Winkler S, et al. SeQuent Please World Wide Registry: Clinical results of SeQuent Please paclitaxel coated balloon angioplasty in a large-scaled, prospective registry study. J Am Coll Cardiol. 2012, (in press).
Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, et al. Paclitaxel-coated balloon catheter vs paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009;119:2986–94.
Stone GW, Ellis SG, O'Shaughnessy CD, Martin SL, Satler L, McGarry T, et al. Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA. 2006;95:1253–63.
Ellis SG, O'Shaughnessy CD, Martin SL, Kent K, McGarry T, Turco MA, et al. Two-year clinical outcomes after paclitaxel-eluting stent or brachytherapy treatment for bare metal stent restenosis: the TAXUS V ISR trial. Eur Heart J. 2008;29:1625–34.
Kleber FX, Mathey DG, Rittger H, Scheller B. How to use the drug-eluting balloon: recommendations by the German consensus group. EuroIntervention. 2011;Suppl K:K125–8.
Cremers B, Clever Y, Schaffner S, Speck U, Böhm M, Scheller B. Treatment of coronary in-stent restenosis with a novel paclitaxel urea coated balloon. Minerva Cardioangiol. 2010;58:583–8.
Stella PR, Belkacemi A, Waksman R, Stahnke S, Torguson R, von Strandmann RP, et al. The Valentines Trial: results of the first one week worldwide multicentre enrolment trial, evaluating the real world usage of the second generation DIOR paclitaxel drug-eluting balloon for in-stent restenosis treatment. EuroIntervention. 2011;7:705–10.
Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, et al. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2010;99:165–74.
• Ali RM, Degenhardt R, Zambahari R, Tresukosol D, Ahmad WA, Kamar HH, et al. Paclitaxel-eluting balloon angioplasty and cobalt-chromium stents vs conventional angioplasty and paclitaxel-eluting stents in the treatment of native coronary artery stenoses in patients with diabetes mellitus. EuroIntervention. 2011;7 Suppl K:K83–92. First randomized comparison of paclitaxel coated balloon angioplasty plus bare-metal stenting compared with paclitaxel eluting stents for de novo lesions in patients with diabetes mellitus.
Aoki J, Serruys PW, van Beusekom H, Ong AT, McFadden EP, Sianos G, et al. Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry. J Am Coll Cardiol. 2005;45:1574–9.
Duckers HJ, Silber S, de Winter R, den Heijer P, Rensing B, Rau M, et al. Circulating endothelial progenitor cells predict angiographic and intravascular ultrasound outcome following percutaneous coronary interventions in the HEALING-II trial: evaluation of an endothelial progenitor cell capturing stent. EuroIntervention. 2007;3:67–75.
Beijk MA, Klomp M, Verouden NJ, van Geloven N, Koch KT, Henriques JP, et al. Genous endothelial progenitor cell capturing stent vs the Taxus Liberte stent in patients with de novo coronary lesions with a high-risk of coronary restenosis: a randomized, single-centre, pilot study. Eur Heart J. 2010;31:1055–64.
Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, et al. Comparison of a polymer-based paclitaxel eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA. 2005;294:1215–23.
Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004;350:221–31.
Werner GS, Krack A, Schwarz G, Prochnau D, Betge S, Figulla HR. Prevention of lesion recurrence in chronic total coronary occlusions by paclitaxel-eluting stents. J Am Coll Cardiol. 2004;44:2301–6.
Suttorp MJ, Laarman GJ, Rahel BM, Kelder JC, Bosschaert MA, Kiemeneij F, et al. Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions. Circulation. 2006;114:921–8.
Werner GS, Ferrari M, Fritzenwanger M, Betge S, Figulla HR. Long-term safety and efficacy of paclitaxel-eluting stents in chronic total coronary occlusions: 3 year follow-up from the paclitaxel in chronic total occlusion (PACTO) study. Eur Heart J. 2007;28(Abstract):135.
• Cortese B, Micheli A, Picchi A, Coppolaro A, Bandinelli L, Severi S, et al. Paclitaxel-coated balloon vs drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO study. Heart. 2010;96:1291–6. Randomized trial with paclitaxel coating balloon angioplasty vs drug-eluting stent implantation for lesions in small coronary vessel. This trial demonstrates that there is no class effect for paclitaxel coated balloons.
Belkacemi A, Agostoni P, Nathoe HM, Voskuil M, Shao C, Van Belle E, et al. First results of the DEB-AMI (drug eluting balloon in acute st-segment elevation myocardial infarction) Trial: A multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in primary percutaneous coronary intervention with 6-month angiographic, intravascular, functional, and clinical outcomes. J Am Coll Cardiol. 2012; in press.
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter-society consensus for the management of peripheral arterial disease. Int Angiol. 2007;26:81–157.
Beschorner U, Sixt S, Schwarzwälder U, Rastan A, Mayer C, Noory E, et al. Recanalization of chronic occlusions of the superficial femoral artery using the Outback re-entry catheter: a single centre experience. Catheter Cardiovasc Interv. 2009;74:934–8.
Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, et al. Balloon angioplasty vs implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879–88.
Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, et al. Nitinol stent implantation vs balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: 3-year follow-up from the RESILIENT randomized trial. J Endovasc Ther. 2012;19:1–9.
Schillinger M, Sabeti S, Dick P, Amighi J, Mlekusch W, Schlager O, et al. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007;115:2745–9.
Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, et al. Balloon angioplasty vs stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009;74:1090–5.
Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clément D, Collet JP, et al. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32:2851–906.
Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwälder U, Beregi J, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358:689–99.
• Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: 12-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011;4:495–504. First randomized trial showing better results with non-polymeric coated drug eluting stents for treatment of femoropopliteal lesions compared with balloon angioplasty.
Dake MD, Scheinert D, Tepe G, Tessarek J, Fanelli F, Bosiers M, et al. Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: 12-month safety and effectiveness results from the Zilver PTX single-arm clinical study. J Endovasc Ther. 2011;18:613–23.
Micari A, Cioppa A, Vadalà G, Castriota F, Liso A, Marchese A, et al. Clinical evaluation of a Paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter italian registry. JACC Cardiovasc Interv. 2012;5:331–8.
Zeller T, Rastan A, Sixt S, Schwarzwälder U, Schwarz T, Frank U, et al. Long-term results after directional atherectomy of femoro-popliteal lesions. J Am Coll Cardiol. 2006;48:1573–8.
• Tosaka A, Soga Y, Iida O, Ishihara T, Hirano K, Suzuki K, et al. Classification and clinical impact of restenosis after femoropopliteal stenting. J Am Coll Cardiol. 2012;59:16–23. Lesion classification including lesion length has an impact on outcome.
Karnabatidis D, Spiliopoulos S, Diamantopoulos A, Katsanos K, Kagadis GC, Kakkos S, et al. Primary everolimus-eluting stenting vs balloon angioplasty with bailout bare metal stenting of long infrapopliteal lesions for treatment of critical limb ischemia. J Endovasc Ther. 2011;18:1–12.
Siablis D, Karnabatidis D, Katsanos K, Kagadis GC, Kraniotis P, Diamantopoulos A, et al. Sirolimus-eluting vs bare stents after suboptimal infrapopliteal angioplasty for critical limb ischemia: enduring 1-year angiographic and clinical benefit. J Endovasc Ther. 2007;14:241–50.
Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, et al. Randomized comparison of everolimus-eluting vs bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012;55:390–8.
Lookstein R, Ward T, Kim E, Fischman A, Nowakowksi F, Ellozy S, et al. Value of drug-eluting stents after failed percutaneous transluminal angioplasty in the infrapopliteal vessels for the treatment of critical limb ischemia: favorable mid-term patency and limb salvage results. J Cardiovasc Surg. 2011;52:461–6.
Biondi-Zoccai GG, Sangiorgi G, Lotrionte M, Feiring A, Commeau P, Fusaro M, et al. Infragenicular stent implantation for below-the-knee atherosclerotic disease: clinical evidence from an international collaborative meta-analysis on 640 patients. J Endovasc Ther. 2009;16:251–60.
Rastan A, Noory E, Zeller T. Drug-eluting stents for treatment of focal infrapopliteal lesions. Vasa. 2012;41:90–5.
Schmidt A, Piorkowski M, Werner M, Ulrich M, Bausback Y, Bräunlich S, et al. First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome. J Am Coll Cardiol. 2011;58:1105–9.
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Conflicts of interest: J. Wöhrle: has received grant support from B. Braun, Melsungen, Germany and OrbusNeich, Germany.
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Wöhrle, J. Drug-Coated Balloons for Coronary and Peripheral Interventional Procedures. Curr Cardiol Rep 14, 635–641 (2012). https://doi.org/10.1007/s11886-012-0290-x
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DOI: https://doi.org/10.1007/s11886-012-0290-x
Keywords
- Drug-coated balloon
- Drug-eluting balloon
- Paclitaxel-coated balloon
- Paclitaxel-eluting balloon
- Paclitaxel
- In-stent restenosis
- de novo lesion
- Chronic total occlusion
- Below-the-knee
- Femoropopliteal
- Drug-eluting stents
- Bare-metal stents
- Late loss
- Target lesion revascularization
- Dual antiplatelet therapy
- Stent thrombosis
- Thrombotic event
- Coronary and peripheral interventional procedures