Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons Presented at The American Heart...

Treatment of In-Stent Restenosis by Paclitaxel Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA BalloonsCoated PTCA Balloons

Treatment of In-Stent Restenosis by Paclitaxel Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA BalloonsCoated PTCA Balloons

Presented atPresented atThe American Heart Association The American Heart Association

Scientific Session 2006Scientific Session 2006

Presented by Dr. Bruno SchellerPresented by Dr. Bruno Scheller

PACCOCATH ISRPACCOCATH ISRPACCOCATH ISRPACCOCATH ISR

www. Clinical trial results.org

PACCOCATH ISR: BackgroundPACCOCATH ISR: BackgroundPACCOCATH ISR: BackgroundPACCOCATH ISR: Background

• Treatment of coronary in-stent restenosis is hampered by high incidence of Treatment of coronary in-stent restenosis is hampered by high incidence of recurrent in-stent restenosis. recurrent in-stent restenosis.

• Multiple studies have shown the benefit of drug-eluting stents in preventing Multiple studies have shown the benefit of drug-eluting stents in preventing restenosis in de novo lesions, but only one randomized trial, ISAR-restenosis in de novo lesions, but only one randomized trial, ISAR-DESIRE, has been conducted for patients with pre-existing lesions.DESIRE, has been conducted for patients with pre-existing lesions.

• While the ISAR-DESIRE trial showed a reduction in restenosis for drug-While the ISAR-DESIRE trial showed a reduction in restenosis for drug-eluting stents compared with bare metal stents, the stent-in-stent approach eluting stents compared with bare metal stents, the stent-in-stent approach for treating restenosis may not be optimal or feasible for all patients. 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 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 eluting balloon catheter compared with a non-eluting balloon catheter among patients with coronary in-stent restenosis. among patients with coronary in-stent restenosis.

• Treatment of coronary in-stent restenosis is hampered by high incidence of Treatment of coronary in-stent restenosis is hampered by high incidence of recurrent in-stent restenosis. recurrent in-stent restenosis.

• Multiple studies have shown the benefit of drug-eluting stents in preventing Multiple studies have shown the benefit of drug-eluting stents in preventing restenosis in de novo lesions, but only one randomized trial, ISAR-restenosis in de novo lesions, but only one randomized trial, ISAR-DESIRE, has been conducted for patients with pre-existing lesions.DESIRE, has been conducted for patients with pre-existing lesions.

• While the ISAR-DESIRE trial showed a reduction in restenosis for drug-While the ISAR-DESIRE trial showed a reduction in restenosis for drug-eluting stents compared with bare metal stents, the stent-in-stent approach eluting stents compared with bare metal stents, the stent-in-stent approach for treating restenosis may not be optimal or feasible for all patients. 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 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 eluting balloon catheter compared with a non-eluting balloon catheter among patients with coronary in-stent restenosis. among patients with coronary in-stent restenosis.

Presented at AHA 2006Presented at AHA 2006Presented at AHA 2006Presented at AHA 2006


PACCOCATH ISR : Study DesignPACCOCATH ISR : Study DesignPACCOCATH ISR : Study DesignPACCOCATH ISR : Study Design

Primary Endpoint: Angiographic late lumen loss at 6 monthsPrimary Endpoint: Angiographic late lumen loss at 6 months Secondary Endpoint: Rates of restenosis; major adverse cardiac events (MACE)Secondary Endpoint: Rates of restenosis; major adverse cardiac events (MACE)

Primary Endpoint: Angiographic late lumen loss at 6 monthsPrimary Endpoint: Angiographic late lumen loss at 6 months Secondary Endpoint: Rates of restenosis; major adverse cardiac events (MACE)Secondary Endpoint: Rates of restenosis; major adverse cardiac events (MACE)

Paclitaxel-Eluting Balloon Catheter Paclitaxel-Eluting Balloon Catheter (3 (3 µµg paclitaxel/mmg paclitaxel/mm22))

n=26n=26

Paclitaxel-Eluting Balloon Catheter Paclitaxel-Eluting Balloon Catheter (3 (3 µµg paclitaxel/mmg paclitaxel/mm22))

n=26n=26

Non-Eluting Balloon CatheterNon-Eluting Balloon Catheter (same balloon design without drug) (same balloon design without drug)

n=26n=26

Non-Eluting Balloon CatheterNon-Eluting Balloon Catheter (same balloon design without drug) (same balloon design without drug)

n=26n=26

52 Patients with single in-stent restenosis in a coronary artery with a diameter stenosis 52 Patients with single in-stent restenosis in a coronary artery with a diameter stenosis of of >> 70%, < 25mm length, and vessel diameter of 2.5 mm to 3.5 mm; stable or unstable angina 70%, < 25mm length, and vessel diameter of 2.5 mm to 3.5 mm; stable or unstable angina

or a positive functional study. or a positive functional study. Randomized. Double-Blind. Parallel.Randomized. Double-Blind. Parallel.

29% female, mean age 64 years, mean follow-up: 12 months29% female, mean age 64 years, mean follow-up: 12 months

52 Patients with single in-stent restenosis in a coronary artery with a diameter stenosis 52 Patients with single in-stent restenosis in a coronary artery with a diameter stenosis of of >> 70%, < 25mm length, and vessel diameter of 2.5 mm to 3.5 mm; stable or unstable angina 70%, < 25mm length, and vessel diameter of 2.5 mm to 3.5 mm; stable or unstable angina

or a positive functional study. or a positive functional study. Randomized. Double-Blind. Parallel.Randomized. Double-Blind. Parallel.

29% female, mean age 64 years, mean follow-up: 12 months29% female, mean age 64 years, mean follow-up: 12 months



PACCOCATH ISR : Primary EndpointPACCOCATH ISR : Primary EndpointPACCOCATH ISR : Primary EndpointPACCOCATH ISR : Primary Endpoint

0.00.20.40.60.81.01.21.41.61.82.0

Paclitaxel-Eluting Balloon Bare Balloon Group

0.00.20.40.60.81.01.21.41.61.82.0

Paclitaxel-Eluting Balloon Bare Balloon Group

• In-segment late In-segment late lumen loss was lumen loss was smaller in the smaller in the paclitaxel group paclitaxel group than the bare than the bare balloon group balloon group (0.03+/- 0.48 vs. 0.74 (0.03+/- 0.48 vs. 0.74 +/- 0.86, p=0.002).+/- 0.86, p=0.002).

• Minimum lumen Minimum lumen diameter at 6-diameter at 6-months was larger months was larger in the paclitaxel in the paclitaxel group than the bare group than the bare balloon group (2.22 balloon group (2.22 mm vs 1.57 mm, mm vs 1.57 mm, p=0.005)p=0.005)..

In-segment late Lumen Loss (mm)In-segment late Lumen Loss (mm)

mm

mm

P=0.002P=0.002

0.03 0.03 ± ± 0.480.48

0.740 ± 0.860.740 ± 0.86



PACCOCATH ISRPACCOCATH ISR: Secondary Endpoint: Secondary Endpoint PACCOCATH ISRPACCOCATH ISR: Secondary Endpoint: Secondary Endpoint

• Binary restenosis Binary restenosis occurred less occurred less frequently in the frequently in the paclitaxel-eluting paclitaxel-eluting group than the bare group than the bare balloon group (5% vs. balloon group (5% vs. 43%, p=0.002).43%, p=0.002).

5.0%

43.0%

0%

10%

20%

30%

40%

50%

Paclitaxel ElutingGroup

Bare Balloon Group

5.0%

43.0%

0%

10%

20%

30%

40%

50%


Bare Balloon Group

Binary Restenosis (%)Binary Restenosis (%)

p=0.002p=0.002



PACCOCATH ISRPACCOCATH ISR: Secondary Endpoint: Secondary Endpoint PACCOCATH ISRPACCOCATH ISR: Secondary Endpoint: Secondary Endpoint

• At 12 months, the At 12 months, the rate of major adverse rate of major adverse cardiac events was cardiac events was 31% in the bare 31% in the bare balloon group and 4% balloon group and 4% in the coated-balloon in the coated-balloon group (p=0.01). group (p=0.01).

• This difference was This difference was primarily due to the primarily due to the need for target lesion need for target lesion revascularization in revascularization in six patients in the six patients in the bare balloon group bare balloon group (p=0.02).(p=0.02).

4.0%

31.0%

0%

10%

20%

30%

40%


Bare Balloon Group

4.0%

31.0%

0%

10%

20%

30%

40%


Bare Balloon Group

Rate of Major Adverse Cardiac Events (%) Rate of Major Adverse Cardiac Events (%)

p=0.01p=0.01



PACCOCATH ISR: LimitationsPACCOCATH ISR: LimitationsPACCOCATH ISR: LimitationsPACCOCATH ISR: Limitations

• The scale of the trial does not justify clinical application or The scale of the trial does not justify clinical application or regulatory approval of the drug-coated balloons. regulatory approval of the drug-coated balloons.

• Although the core laboratory was not aware of study-group Although the core laboratory was not aware of study-group status, the coated balloons have a faintly white color, a difference status, the coated balloons have a faintly white color, a difference that might have unblinded the clinical investigators.that might have unblinded the clinical investigators.

• Larger clinical trials should be conducted in order to determine Larger clinical trials should be conducted in order to determine whether the results of this trial can be replicated. whether the results of this trial can be replicated.

• This trial does not evaluate whether paclitaxel eluting balloons This trial does not evaluate whether paclitaxel eluting balloons would be efficacious in the treatment of de novo lesions as would be efficacious in the treatment of de novo lesions as opposed to in-stent restenosis. opposed to in-stent restenosis.

• The scale of the trial does not justify clinical application or The scale of the trial does not justify clinical application or regulatory approval of the drug-coated balloons. regulatory approval of the drug-coated balloons.

• Although the core laboratory was not aware of study-group Although the core laboratory was not aware of study-group status, the coated balloons have a faintly white color, a difference status, the coated balloons have a faintly white color, a difference that might have unblinded the clinical investigators.that might have unblinded the clinical investigators.

• Larger clinical trials should be conducted in order to determine Larger clinical trials should be conducted in order to determine whether the results of this trial can be replicated. whether the results of this trial can be replicated.

• This trial does not evaluate whether paclitaxel eluting balloons This trial does not evaluate whether paclitaxel eluting balloons would be efficacious in the treatment of de novo lesions as would be efficacious in the treatment of de novo lesions as opposed to in-stent restenosis. opposed to in-stent restenosis.



PACCOCATH ISR: SummaryPACCOCATH ISR: SummaryPACCOCATH ISR: SummaryPACCOCATH ISR: Summary

• In this pilot study, treatment with a paclitaxel-eluting balloon catheter In this pilot study, treatment with a paclitaxel-eluting balloon catheter was associated with lower late lumen loss at 6 month angiography was associated with lower late lumen loss at 6 month angiography compared with a bare balloon catheter among patients with coronary compared with a bare balloon catheter among patients with coronary in-stent restenosis. in-stent restenosis.

• The study also showed that treatment of coronary in-stent restenosis The study also showed that treatment of coronary in-stent restenosis with paclitaxel-coated balloon catheters significantly lowered the with paclitaxel-coated balloon catheters significantly lowered the incidence of adverse events.incidence of adverse events.

• The findings suggest that the inhibition of restenosis by local drug The findings suggest that the inhibition of restenosis by local drug delivery may not require the implantation of stents and the prolonged delivery may not require the implantation of stents and the prolonged release of a drug.release of a drug.

• In this pilot study, treatment with a paclitaxel-eluting balloon catheter In this pilot study, treatment with a paclitaxel-eluting balloon catheter was associated with lower late lumen loss at 6 month angiography was associated with lower late lumen loss at 6 month angiography compared with a bare balloon catheter among patients with coronary compared with a bare balloon catheter among patients with coronary in-stent restenosis. in-stent restenosis.

• The study also showed that treatment of coronary in-stent restenosis The study also showed that treatment of coronary in-stent restenosis with paclitaxel-coated balloon catheters significantly lowered the with paclitaxel-coated balloon catheters significantly lowered the incidence of adverse events.incidence of adverse events.

• The findings suggest that the inhibition of restenosis by local drug The findings suggest that the inhibition of restenosis by local drug delivery may not require the implantation of stents and the prolonged delivery may not require the implantation of stents and the prolonged release of a drug.release of a drug.


Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons Presented at The American Heart...

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