Percutaneous coronary intervention with a drug-eluting balloon for in-stent restenosis is a promising effective therapeutic option with an unexpected low repeat restenosis and target lesion revascularisation rate, according to research presented at the American Heart Association’s Scientific Sessions 2011.
In this study, the drug-eluting balloon reduced the development of scar tissue within existing, narrowed bare metal stents as effectively as drug-eluting stents.
“The current approach of placing a metal drug-eluting stent inside an old bare metal stent essentially creates a metal sandwich,” said Mariusz Zadura, lead researcher and senior cardiologist at the Heart and Diabetes Center of Mecklenburg-Vorpommern in Karlsburg, Germany. “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 material (matrix) decomposes in 24 hours and appears to create less of an immune reaction.”
The researchers retrospectively compared the responses of 84 in-stent restenosis patients (58 men, 26 women, mean age 67.4 years) who underwent revascularisation with drug-eluting balloons coated with the drug paclitaxel from April 2009 to November 2010 and had been angiographically controlled after a 6–9-month period. Physicians treated 91 lesions in the following arteries: left anterior descending artery (44), right coronary artery (26), circumflex artery (14) and vein grafts (7). The device used was the Sequent Please paclitaxel-eluting balloon from B Braun. Mean balloon dimension was 3,09mm, mean balloon length 16,17mm, mean balloon pressure during angioplasty was 13,85atm and the inflation time was 46,51sec.
After six to nine months, the balloon still kept 85 (93.4%) of the lesions open. There were new narrowed areas (>50% of vessel lumen) in six stents (6.6%), but only three patients (3.3%) with 70 and 80% in-stent restenoses required an additional procedure. Two patients were treated with drug-eluting stents and one patient again with a drug-eluting balloon.
These findings complement other studies and “give a new argument from the real-life conditions in how to better perform repeated procedures to clear in-stent restenosis,” Zadura said. “We consider the drug-eluting balloon technique the best option for in-stent restenosis in clinical practice.”
Bleeding risk lower with drug-eluting balloons
In another study, the same researchers found that drug-eluting balloons are a feasible option for patients with a high risk of bleeding complications because of their health status, since the balloon treatment requires a shorter anticoagulation period.
Patients who are treated with drug-eluting stents require dual antiplatelet therapy for at least one year. An advantage for patients who receive a drug-eluting balloon is that they only need to take such dual antiplatelet therapy for one month. High-risk patients include those with mechanical prosthetic heart valves, atrial fibrillation and pulmonary embolism treated continuously within oral anticoagulants (warfarin or phenprocoumon).
The researchers followed 63 patients with de novo lesions being treated with drug-eluting balloons and after six to nine months they found no significant restenosis in 69 of 73 lesions. While four lesions showed a repeated narrowing, only two patients required a subsequent targeted revascularisation.
“This is a major benefit, especially in elderly or non-compliant patients,” Zadura said. “Due to the reduced need for dual platelet inhibition, drug-eluting balloons seem to be an interesting alternative.”
Co-authors of both studies are Frank Szigat, Birger Wolff, Peter Szigat, Ronald Bittner, Barnaba Hejazin, and Wolfgang Motz.