Paclitaxel Balloon Maintains Advantage at 5 Years

PARIS, France—A paclitaxel-coated balloon offers sustained reduction in target lesion revascularization (TLR) over uncoated balloon angioplasty in patients treated for coronary in-stent restenosis, according to 5-year follow-up data presented Friday, May 20 at EuroPCR 2011.

For the analysis, Bruno Scheller, MD, of the University of Saarland (Hamburg, Germany), followed subjects enrolled in Paccocath ISR I and II, which were 2 separate, randomized, double-blind multicenter trials using an identical protocol. Patients pooled from both studies were treated with either a paclitaxel-coated balloon (3 µg/mm²; n = 54) or an otherwise similar uncoated balloon (n = 54) without repeat stenting. Inflation time was 60 seconds in both treatment groups. Major inclusion criteria were in-stent restenosis in a coronary artery with a diameter stenosis of at least 70%, lesion length less than 25 mm, and vessel diameter of 2.5 to 3.5 mm.

Earlier data (Scheller B. Clin Res Cardiol. 2008;97:779-781) showed that the Paccocath coated balloon (Bayer Schering Pharma; Berlin, Germany) reduced the need for repeat procedures through 2 years (6% vs. 37% with the uncoated balloon; P = 0.001). At 5 years, there was no sign of late catch-up in TLR and therefore the rate of MACE (TLR, MI, acute and subacute stent thrombosis, stroke, and death) remained significantly lower with the coated balloon. Apart from TLR, however, all other MACE components were equivalent between the 2 groups (table 1).

Table 1. Long-Term Follow-Up

^a TLR, MI, acute and subacute stent thrombosis, stroke, and death.

On Kaplan-Meier analysis, the composite of freedom from death, MI, TLR, and stroke was consistently better with coated vs. uncoated balloons through 5 years (P < 0.001).

Practical Implications

Drug-coated balloon catheters offer an alternative to DES treatment of BMS in-stent restenosis and has several unique aspects, Dr. Scheller explained. “You have only short-term application of the drug in contrast to the sustained release from drug-eluting stents. It is a homogenous drug distribution in contrast to the pattern from the stent struts,” he said. “But the most important difference is that you can perform local intravascular drug delivery without the need for stent implantation.”

Based on the current study and previous findings from randomized controlled trials, Dr. Scheller said that drug-coated balloon use, followed by 4 weeks of dual antiplatelet therapy, is a proven treatment for BMS in-stent restenosis. The European Society of Cardiology has given such therapy a class IIa recommendation, he reported. Other potential indications—including pediatric and cerebrovascular applications—need additional study.

Session co-chair David O. Williams, MD, of Brigham and Women’s Hospital (Boston, MA), queried whether the studies had routine angiographic follow-up.

“The answer is yes,” Dr. Scheller replied, because the trials involved primary angiographic endpoints. “The next step is, of course, a clinical endpoint trial without planned angiography. We are discussing these designs now.”

Source:Scheller B. Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter: Paccocath ISR I/II. Presented at: EuroPCR; May 20, 2011; Paris, France.

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