ORLANDO, FL—Drug-eluting balloons appear to be a viable alternative to drug-eluting stents (DES) in 2 patient subsets, effectively treating restenosis in bare-metal stents (BMS) and reducing the duration of dual antiplatelet therapy for patients who are at high bleeding risk. The findings were presented November 16, 2011, at the American Heart Association Scientific Sessions.

In the first study, Mariusz Zadura, MD, of the Heart and Diabetes Center of Mecklenburg-Vorpommern (Karlsburg, Germany), and colleagues retrospectively evaluated 84 patients who underwent PCI with paclitaxel-coated balloons (Sequent Please, B. Braun Melsungen, Berlin, Germany) to revascularize 91 lesions in BMS.

On angiographic follow-up at 6 to 9 months, 85 lesions (93.4%) showed no significant late loss. While repeat in-stent restenosis was identified in 6 patients, only 3 patients with 70% to 80% restenosis underwent clinically driven TLR. Two of these patients received DES and 1 was retreated with a drug-eluting balloon.

Avoids ‘Metal Sandwich’

“The current approach of placing a metal drug-eluting stent inside an old bare metal stent essentially creates a metal sandwich,” Dr. Zadura said. “With drug-eluting balloons, we can reduce the body’s reaction to a ‘full-metal jacket’ placed in an artery, because the biodegradable balloon coating matrix decomposes in 24 hours and appears to create less of an immune reaction,” he added.

In an interview with TCTMD, Sidney Smith, MD, of the University of North Carolina School of Medicine (Chapel Hill, NC), called the preliminary results very promising. “We certainly need a larger group of patients, but I think this is quite impressive,” he added.

Shortens Dual Antiplatelet Therapy   

A second study, also by Dr. Zadura’s group, suggested drug-eluting balloons also reduce the risk of bleeding complications.  

Unlike DES, which require 12 months of dual antiplatelet therapy, drug-eluting balloons require only 4 weeks of anticoagulation.

In 63 patients at high risk of bleeding who were treated with drug-eluting balloons, Dr. Zadura and colleagues found no significant renarrowing in 69 of 73 lesions at 6- to 9-month follow-up. While 4 lesions showed restenosis, only 2 patients required TLR. One received a DES and the other was referred for surgery.

“This is a major benefit, especially in elderly or noncompliant patients,” Dr. Zadura said. “Due to the reduced need for dual platelet inhibition, drug-eluting balloons seem to be an interesting alternative.” 

Sources:
Zadura M. Drug eluting balloon-PCI is a new therapeutic option for patients with in-stent restenosis in bare metal stents; Drug-eluting balloon-PCI is an alternative to drug-eluting stents in patients with a high risk of bleeding complications. Presented at: American Heart Association Scientific Sessions; November 16, 2011; Orlando, FL.

Disclosures:

• Dr. Zadura reports no relevant conflicts of interest.

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