Paclitaxel-coated balloon angioplasty without stent shows promise for ISR in first-in-man study

I thought this was interesting.

Bill

_____________________________



Paclitaxel-coated balloon angioplasty without stent shows promise for ISR in
first-in-man study


May 25, 2005 Shelley Wood






Paris, France - In what smacks of a one-step-forward, two-steps-back strategy
in the battle against restenosis, a group of German researchers has taken the
unusual approach of dispensing with stents altogether for the treatment of
in-stent restenosis (ISR) and returning to plain old balloon angioplasty, with
a twist. Presenting the first-in-man (FIM) results from the PACCOCATH ISR I
study here at the EuroPCR 2005 meeting, Dr Bruno Scheller
(Universitätsklinikum des Saarlandes, Homburg/Saar, Germany) explained that
the method he and his coinvestigators are evaluating involves the use of a
paclitaxel-coated angioplasty balloon.

Drug-eluting stents have proven themselves effective in de novo restenosis,
but the use of a "stent-in-stent approach" for cases of ISR is "less
desirable," Scheller explained. Animal studies have suggested that the benefit
of paclitaxel can still be exploited without the need for a second stent.

In PACCOCATH ISR I, Scheller and colleagues evaluated the safety and efficacy
of a paclitaxel-coated PTCA catheter (3 µg paclitaxel/mm² balloon surface) in
comparison with a conventional PTCA catheter in patients undergoing repeat
PTCA for coronary ISR. As Scheller told his EuroPCR audience, this FIM study
enrolled 52 patients who were then followed for six months.

At follow-up, late lumen loss in segment was significantly lower in the
paclitaxel-coated balloon group, as was binary restenosis. While there were no
deaths in either group, the target lesion revascularization (TLR) rate was 0
in the paclitaxel group, compared with 24% in the uncoated-balloon group.

PACCOCATH ISR I: Main results



End point
Paclitaxel-coated balloon
Plain balloon
p

Late lumen loss (mm)*
0.13
0.82
0.002

Binary restenosis (%)
8.7
40.9
0.017

TLR (%)
0
24
0.009





*Primary end point

To download table as a slide, click on slide logo below

Clearly, said Scheller, the PACCOCATH approach will also need to be tested
against drug-eluting stents for ISR. Of note, however, in ISAR DESIRE, which
examined drug-eluting stents for ISR, in-segment late loss following
implantation of the Taxus stent was 0.55 mm and 0.32 mm for the Cypher, both
higher than the 0.13 mm seen in the PACCOCATH ISR I study. Should further
evaluation of the approach provide consistently favorable results, the
drug-coated balloon could also be valuable in other settings in which metal
stents are undesirable, including small vessels and bifurcations, Scheller
said.

Commenting on the study for heartwire, Dr Alec Vahanian (Bichat Hospital,
Paris, France) called the results "surprising" and "provocative," although
very preliminary.

"It's a new concept, and the results are impressive, but this is only a
first-in-man study, so it is difficult to make a statement on the results."




begin 666 pixel.gif
K1TE&.#EA`0`!`( ``-W>YP```"'Y! $`````+ `````!``$```("1 $`.P``
`
end

begin 666 article_datedivemail.gif
M1TE&.#EA"P`-`( ``/___YF9F2'Y! ``````+ `````+``T```(0A!VGRY<-
,UXMT4F@ORUKE`@`[
`
end

.