Transcript paccocath isr

PACCOCATH ISR
Treatment of In-Stent Restenosis by Paclitaxel
Coated PTCA Balloons
Presented at
The American Heart Association
Scientific Session 2006
Presented by Dr. Bruno Scheller
PACCOCATH ISR: Background
• Treatment of coronary in-stent restenosis is hampered by high incidence
of recurrent in-stent restenosis.
• Multiple studies have shown the benefit of drug-eluting stents in
preventing restenosis in de novo lesions, but only one randomized trial,
ISAR-DESIRE, has been conducted for patients with pre-existing lesions.
• While the ISAR-DESIRE trial showed a reduction in restenosis for drugeluting stents compared with bare metal stents, the stent-in-stent
approach for treating restenosis may not be optimal or feasible for all
patients.
• The goal of this trial was to assess the efficacy and safety of a paclitaxel
eluting balloon catheter compared with a non-eluting balloon catheter
among patients with coronary in-stent restenosis.
www. Clinical trial results.org
Presented at AHA 2006
PACCOCATH ISR : Study Design
52 Patients with single in-stent restenosis in a coronary artery with a diameter stenosis
of > 70%, < 25mm length, and vessel diameter of 2.5 mm to 3.5 mm; stable or unstable angina
or a positive functional study.
Randomized. Double-Blind. Parallel.
29% female, mean age 64 years, mean follow-up: 12 months
Paclitaxel-Eluting Balloon Catheter
(3 µg paclitaxel/mm2)
n=26


Non-Eluting Balloon Catheter
(same balloon design without drug)
n=26
Primary Endpoint: Angiographic late lumen loss at 6 months
Secondary Endpoint: Rates of restenosis; major adverse cardiac events (MACE)
www. Clinical trial results.org
Presented at AHA 2006
PACCOCATH ISR : Primary Endpoint
In-segment late Lumen Loss (mm)
mm
P=0.002
2.0
1.8
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0.0
0.740 ± 0.86
0.03 ± 0.48
Paclitaxel-Eluting Balloon
www. Clinical trial results.org
Bare Balloon Group
• In-segment late
lumen loss was
smaller in the
paclitaxel group
than the bare
balloon group
(0.03+/- 0.48 vs. 0.74
+/- 0.86, p=0.002).
• Minimum lumen
diameter at 6months was larger
in the paclitaxel
group than the bare
balloon group (2.22
mm vs 1.57 mm,
p=0.005).
Presented at AHA 2006
PACCOCATH ISR: Secondary Endpoint
Binary Restenosis (%)
p=0.002
50%
43.0%
40%
30%
• Binary restenosis
occurred less
frequently in the
paclitaxel-eluting
group than the bare
balloon group (5% vs.
43%, p=0.002).
20%
10%
5.0%
0%
Paclitaxel Eluting
Group
www. Clinical trial results.org
Bare Balloon Group
Presented at AHA 2006
PACCOCATH ISR: Secondary Endpoint
Rate of Major Adverse Cardiac Events (%)
40%
p=0.01
31.0%
30%
20%
10%
4.0%
0%
Paclitaxel Eluting
Group
www. Clinical trial results.org
Bare Balloon Group
• At 12 months, the
rate of major adverse
cardiac events was
31% in the bare
balloon group and 4%
in the coated-balloon
group (p=0.01).
• This difference was
primarily due to the
need for target lesion
revascularization in
six patients in the
bare balloon group
(p=0.02).
Presented at AHA 2006
PACCOCATH ISR: Limitations
• The scale of the trial does not justify clinical application or
regulatory approval of the drug-coated balloons.
• Although the core laboratory was not aware of study-group
status, the coated balloons have a faintly white color, a difference
that might have unblinded the clinical investigators.
• Larger clinical trials should be conducted in order to determine
whether the results of this trial can be replicated.
• This trial does not evaluate whether paclitaxel eluting balloons
would be efficacious in the treatment of de novo lesions as
opposed to in-stent restenosis.
www. Clinical trial results.org
Presented at AHA 2006
PACCOCATH ISR: Summary
• In this pilot study, treatment with a paclitaxel-eluting balloon catheter
was associated with lower late lumen loss at 6 month angiography
compared with a bare balloon catheter among patients with coronary
in-stent restenosis.
• The study also showed that treatment of coronary in-stent restenosis
with paclitaxel-coated balloon catheters significantly lowered the
incidence of adverse events.
• The findings suggest that the inhibition of restenosis by local drug
delivery may not require the implantation of stents and the prolonged
release of a drug.
www. Clinical trial results.org
Presented at AHA 2006