DESPITE THE rapid adoption of drug-eluting stents (DES) and their effectiveness in preventing in-stent restenosis, there is a concern about long term safety of DES, a permanent implant, the possibility of live-long dual antiplatelet therapy and their suitability in a challenging anatomy. At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Washington, DC, Dr Pieter R Stella, Director CardioVascular Research, University Medical Centre Utrecht, The Netherlands, discussed whether a paclitaxel drug-eluting balloon is a valid alternative to DES for bifurcation lesions. Stella began by stating that bifurcation lesion intervention is performed in about 8–15% of percutaneous coronary interventions at most centers and most of these lesions are complex (type C of ACC/AHA class). They are technically challenging with higher learning curve and many of these lesions requires higher number of devices, and result in higher MACE and higher restenosis rates. He highlighted two studies (Tanabe et al, Am J Cardiol 2004; 91:115; Steigen et al, ACC 2006) that demonstrated MACE, thrombosis and re-intervention rates and procedure-related (DES) biomarker elevation. According to Stella, drug-eluting balloons provide an easier procedure as they require no scaffolding of the Side Branch ostium or crushing of DES-material (polymer/ drug). Drug-eluting balloons will also results in a significant decrease in dual antiplatelet therapy and the dilatation of small diameter coronary artery (Side Branch) with better long-term results. He discussed his experience with the Dior device (EuroCor), that incorporates a paclitaxel loading/balloon surface (3μg/mm2) with a balloon inflation time of 35–45 second with nominal balloon pressure. Stella reported the results from the Drug Eluting Balloon in bIfUrcation Trial (DEBIUT) Registry, which enrolled 20 patients between June and August 2007. Clinical follow-up was for four months (+/-1) and sequential predilatation was used for Main and Side Branch followed by a bare metal stent in the main branch, with final kissing with regular balloons. Clopidogrel was stopped in all patients at three months after index procedure. All the procedure were successful and there were no occurrences of subacute thrombosis or MACE. Stella said that the preliminary results look very promising although the long term results in de novo lesions are unknown, He added that the indications could be used mainly in difficult anatomy. The first results from the randomised DEBIUT with 120 patients will be presented at TCT in 2008.
PEPCAD II
Separately, results from two studies were presented at TCT, one of which was the first direct comparison between DES and drug eluting balloons. In the PEPCAD II study, Dr Martin Unverdorben, Rotenburg, Germany, directly compared SeQuent Please to another manufacturer’s DES in 131 patients over six months. The team evaluated restenosis and the rate of MACE such as heart attack, bypass, repeat stenosis, or death. Proving patients treated with the drug eluting balloons experienced only 3.7% restenosis and 4.8% MACE, as compared to patients with DES, wherein restenosis was 20.8% with 22.0% MACE rate.
PEPCAD I
Further supporting these results, a separate study by Unverdorben evaluated the use of drug eluting balloons for the treatment of small vessel disease in 120 patients. PEPCAD I is the first study to investigate the use of drug eluting balloons in native lesions. After six months, native lesions treated solely with SeQuent Please showed only a 5.5% binary restenosis rate and 6.1% MACE. These results compare quite favourably with previously published results using drug-eluting stents for the treatment of small vessel disease with 31.2% restenosis and 18.9% MACE.
