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 |
PaccocathTM
|
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 |
PaccocathTM
|
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 PleaseTM
|
DEB vs. DES (TaxusTM) |
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 PleaseTM
|
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 PleaseTM
|
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 PleaseTM
|
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 PleaseTM
|
DEB vs. DES (XienceTM) |
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 PleaseTM
|
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 |
DIORTM
|
DEB vs. DES (TaxusTM) |
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 |
DIORTM
|
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 |
ElutaxTM and SeQuent
PleaseTM
|
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 |
DIORTM
|
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) |