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.
|
Randomizado, multicêntrico |
Paccocath®
|
DEB vs. balão |
Reestenose (BMS) |
52 |
Perda tardia (6 meses) |
0,03 ± 0,48 vs. 0,74 ± 0,86 mm
(p = 0,002) |
PACCOCATH ISR I e 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
|
Randomizado, multicêntrico |
Paccocath®
|
DEB vs. balão |
Reestenose (BMS) |
108 |
Perda tardia (6 meses) |
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]
|
Randomizado, multicêntrico |
SeQuent Please®
|
DEB vs. DES (Taxus®) |
Reestenose (BMS) |
131 |
perda tardia (6 meses) |
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.
|
Randomizado, multicêntrico |
SeQuent Please®
|
DEB vs. balão |
Reestenose (DES, sirolimus) |
50 |
Perda tardia (6 meses) |
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.
|
Randomizado, multicêntrico |
SeQuent Please®
|
DEB vs. balão |
Reestenose (DES) |
110 |
Perda tardia (6 meses) |
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.
|
Randomizado, multicêntrico |
SeQuent Please®
|
DEB vs. balão vs. DES (paclitaxel) |
Reestenose (DES, “limus”) |
402 |
Diâmetro da estenose (6-8 meses) |
DEB: 38% vs. DES: 37,4% (p
não inferioridade = 0,007) vs. balão: 54,1% (p
superioridade < 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.
|
Randomizado, multicêntrico |
Sequent Please®
|
DEB vs. DES (Xience®) |
Reestenose de BMS |
189 |
Diâmetro luminal mínimo (9 meses) |
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.
|
Registro, prospectivo |
SeQuent Please®
|
DEB |
Lesões de novo, vasos ≤ 2,75 mm |
120 |
Perda tardia (6 meses) |
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.
|
Randomizado, unicêntrico |
DIOR®
|
DEB vs. DES (Taxus®) |
Lesões de novo, vasos ≤ 2,75 mm |
57 |
porcentual de estenose (6 meses) |
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.
|
Piloto, prospectivo |
DIOR®
|
DEB |
Lesões de bifurcação |
20 |
Eventos clínicos (4 meses) |
Nenhuma ocorrência |
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]
|
Randomizado, unicêntrico |
Elutax® e SeQuent
Please®
|
BMS + pós-dilatação com DEB vs. BMS |
SCA sem supra-ST |
85 |
Perda tardia (6 meses) Reestenose (6
meses) |
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.
|
Randomizado, multicêntrico |
DIOR®
|
BMS vs. DEB + BMS vs. DES |
IAM com supra-ST |
150 |
Perda tardia (6 meses) |
0,74 ± 0,57 vs. 0,64 ± 0,56 vs. 0,21 ± 0,32
mm (p < 0,01) |