Applications of the Drug-Eluting Balloon in Coronary Artery
               Disease

Athayde, Guilherme Rafael Sant’Anna; Gomes, Thalles Oliveira; Borges, Júlio César; Washizu, Eduardo Kei Marquesine; Mandil, Ari; Saad, Jamil Abdalla; Nunes, Maria do Carmo Pereira; Nascimento, Bruno Ramos

doi:10.1590/0104-1843000000047

Acessibilidade / Reportar erro

Brasil

Revista Brasileira de Cardiologia Invasiva

Español English

Brasil

Español English

sumário « anterior atual seguinte »

Sumário

REVIEW ARTICLE • Rev. Bras. Cardiol. Invasiva 22 (3) • Jul-Sep 2014 • https://doi.org/10.1590/0104-1843000000047 copy

Applications of the Drug-Eluting Balloon in Coronary Artery Disease

Authorship SCIMAGO INSTITUTIONS RANKINGS

Percutaneous revascularization strategies have evolved significantly in the past decades. However, every new technology has advantages over the previous ones, but also carries new risks. Neointimal hyperplasia, associated with bare metal stents, and delayed strut endothelialization and vascular inflammatory reaction to the polymer, associated with drug-eluting stents, are examples of this premise. Drug-eluting balloons were developed with the aim to modulate neointimal hyperplasia after intervention, avoiding the late risks associated with drug-eluting stents. However, the evidence and recommendations for their use have not been adequately defined. This review aims to present and characterize the different types of drug-eluting balloons commercially available worldwide, reviewing the most relevant studies in the literature in different clinical scenarios and describe the main indications and recommendations for their use.

Coronary restenosis; Angioplasty, balloon, coronary; Percutaneous coronary intervention; Paclitaxel; Review

Type of balloon	Manufacturer (country)	Principle	Characteristics
Paccocath^TM	Bayer AG (Germany)	Paclitaxel mixed with hydrophilic contrast, applied to the surface of the balloon.	80% of the anti-proliferative agent is transferred to the treated vessel segment (10-15% in the first inflation).
SeQuent Please^TM	B. Braun (Germany)
In.Pact Falcon^TM	Invatec (Italy)	Paclitaxel is released from a natural hydrophilic excipient covering the balloon.	A faster total eluting time (a 30-60-second inflation).
DIOR^TM	Eurocor (Germany)	Paclitaxel is combined with a hydrophilic matrix, which, in contact with the tissue, opens its structure and allows quick drug release, induced by balloon inflation.	Drug release in a single prolonged inflation (60 seconds) or fractional release in quick inflations

Study/year	Type	DEB	Groups	Scenario	n	Primary outcome	Results
PACCOCATH ISR I¹⁶16 Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006; 355(20):2113-24.	Randomized, multicenter	Paccocath^TM	DEB vs. balloon	Restenosis (BMS)	52	Late loss (at 6 months)	0.03 ± 0.48 vs. 0.74 ± 0.86 mm (p = 0.002)
PACCOCATH ISR I and II¹⁸18 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(3):323-30	Randomized, multicenter	Paccocath^TM	DEB vs. balloon	Restenosis (BMS)	108	Late loss (at 6 months)	0.11 ± 0.45 vs. 0.81 ± 0.79 mm (p < 0.001)
PEPCAD II ISR¹⁹19 Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis: the three-year results of the PEPCAD II ISR study. EuroIntervention. 2014 Aug 30. [Epub ahead of print]	Randomized, multicenter	SeQuent Please^TM	DEB vs. DES (Taxus^TM)	Restenosis (BMS)	131	Late loss (at 6 months)	0.17 ± 0.42 vs. 0.38 ± 0.61 mm (p = 0.032)
Habara et al.²⁰20 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(2):149-54.	Randomized, multicenter	SeQuent Please^TM	DEB vs. balloon	Restenosis (DES, sirolimus)	50	Late loss (at 6 months)	0.18 ± 0.45 vs. 0.72 ± 0.55 mm (p = 0.001)
PEPCAD-DES²¹21 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(15):1377-82.	Randomized, multicenter	SeQuent Please^TM	DEB vs. balloon	Restenosis (DES)	110	Late loss (at 6 months)	0.43 ± 0.61 vs. 1.03 ± 0.77 mm (p < 0.001)
ISAR-DESIRE²²22 Byrne RA, Neumann FJ, Mehilli J, Pinieck S, Wolff B, Tiroch K, et al. Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial. Lancet. 2013;381(9865):461-7.	Randomized, multicenter	SeQuent Please^TM	DEB vs. balloon vs. DES (paclitaxel)	Restenosis (DES, “limus”)	402	Stenosis diameter (at 6 to 8 months)	DEB: 38% vs. DES: 37.4% (Pof non-inferiority = 0.007) vs. balloon: 54.1% (p of superiority < 0.0001)
RIBS V²³23 Alfonso F, Perez-Vizcayno MJ, Cardenas A, García Del Blanco B, Seidelberger B, Iñiguez A, et al. A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent). J Am Coll Cardiol. 2014;63(14):1378-86.	Randomized, multicenter	SeQuent Please^TM	DEB vs. DES (Xience^TM)	Restenosis of BMS	189	Minimal lumen diameter (at 9 months)	2.01 ± 0.6 vs. 2.36 ± 0.6 mm (p < 0.001)
PEPCAD I²⁴24 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(3):165-74.	Register, prospective	SeQuent Please^TM	DEB	De novo lesions, vessels ≤ 2.75 mm	120	Late loss (at 6 months)	0.16 ± 0.38 mm
PICOLETTO²⁵25 Cortese B, Micheli A, Picchi A, Coppolaro A, Bandinelli L, Severi S, et al. Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO study. Heart. 2010; 96(16):1291-6.	Randomized, single-center	DIOR^TM	DEB vs. DES (Taxus^TM)	De novo lesions, vessels ≤ 2.75 mm	57	Stenosis percent (at 6 months)	43.6% vs. 24.3% (p = 0.029)
DEBIUT²⁶26 Fanggiday JC, Stella PR, Guyomi SH, Doevendans PA. Safety and efficacy of drug-eluting balloons in percutaneous treatment of bifurcation lesions: the DEBIUT (drug-eluting balloon in bifurcation Utrecht) registry. Catheter Cardiovasc Interv. 2008; 71(5):629-35.	Pilot, prospective	DIOR^TM	DEB	Bifurcation lesions	20	Clinical events (at 4 months)	No occurrence
Besic et al.²⁷27 Besic KM, StrozziM, Margetic E, Bulum J, Kolaric B. Drug-eluting balloons in patients with non-ST elevation acute coronary syndrome. J Cardiol. 2014 Jun 26. [Epub ahead of print]	Randomized, single-center	Elutax^TM and SeQuent Please^TM	BMS + post-dilation with DEB vs.BMS	ACS without ST elevation	85	Late loss (at 6 months)	0.22 (0.00-2.35) vs. 0.68 (0.00-2.15) mm (p = 0.002) 17.1% vs. 22.7% (p = 0.593)
DEB-AMI²⁸28 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;59(25):2327-37.	Randomized, multicenter	DIOR^TM	BMS vs. DEB + BMS vs.DES	AMI with ST elevation	150	Restenosis (at 6 months)	0.74 ± 0.57 vs. 0.64 ± 0.56 vs.0.21 ± 0.32 mm (p < 0.01)

Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista - SBHCI R. Beira Rio, 45, 7o andar - Cj 71, 04548-050 São Paulo SP, Tel. (55 11) 3849-5034, Fax (55 11) 4081-8727 - São Paulo - SP - Brazil
E-mail: sbhci@sbhci.org.br

Acompanhe os números deste periódico no seu leitor de RSS

[1] Correspondence to: Bruno Ramos Nascimento. Rua Tenente Garro, 137/1.202 – Santa Efigênia – CEP: 30240-360 – Belo Horizonte, MG, Brazil. E-mail: ramosnas@gmail.com