Drug-eluting Balloon Catheters Research Articles

Paclitaxel-eluting balloon angioplasty and cobalt-chromium stents versus conventional angioplasty and paclitaxel-eluting stents in the treatment of native coronary artery stenoses in patients with diabetes mellitus

Coronary lesions in diabetics (DM) are associated with a high recurrence following percutaneous coronary intervention (PCI), even after drug-eluting stent (DES) deployment. Encouraging clinical data of the drug-eluting balloon catheter (DEB) SeQuent Please warrant its investigation in these patients. Eighty-four diabetic patients (60.8 ± 9.1 years, 76.2% male) were randomised to either the DEB SeQuent Please or the DES Taxus Liberté to compare the 9-month clinical and angiographic outcome of PCI in native coronary arteries. Comparing the DEB vs. the DES the 9-month results (follow-up DEB 39/45 [86.7%], DES 36/39 [92.3%]) are statistically not different at the 0.05 level for the primary endpoint of in-segment (0.37 ± 0.59 mm vs. 0.35 ± 0.63 mm) and in-stent (0.51 ± 0.61 mm vs. 0.53 ± 0.67 mm) late lumen loss, overall and cardiac deaths (2/45 [4.4%] and 3/45 [6.7%] vs. 0), target lesion revascularisation (3/45 [8.9%] vs. 4/39 [10.3%]), the total MACE rate (6/45 [13.3%] vs. 6/39 [15.4%]), and the event free survival after 10.2 ± 3.8 months (Kaplan-Meier analysis, p<0.80, log rank test). The clinical and angiographic outcome of the combination of the drug-eluting balloon SeQuent Please with a cobalt chromium stent compared to the drug eluting Taxus stent are similar.

Circulation: Clinical Summaries

<i>Circulation:</i> Clinical Summaries

Safety and efficacy of drug‐eluting balloons in percutaneous treatment of bifurcation lesions the DEBIUT (drug‐eluting balloon in bifurcaton utrecht) registry

To evaluate outcomes after percutaneous coronary intervention (PCI) with a drug-eluting balloon catheter (paclitaxel-coated) in patients with coronary artery bifurcation lesions. The current practice of provisional stenting of the main branch (MB) is reasonable; however, long-term results of side-branch (SB) treatment are suboptimal. The use of drug-eluting stents has not improved these results, regardless of the implantation technique, and could potentially lead to a significant increase in (late) thrombotic events. To evaluate short-term safety and efficacy of a drug-eluting balloon (DEB) in patients with bifurcation lesions followed by provisional stenting of the main branch, we set up the DEBIUT Registry. This registry enrolled 20 eligible patients with coronary artery bifurcation lesions. Patients received a PCI with a paclitaxel-coated balloon catheter, followed by provisional stenting of the MB with a bare-metal stent. Acute angiographic and clinical follow-up were performed after 1 and 4 months. The procedure was successful in all patients. The use of sequential predilatation with DEB was safe and well tolerated. No acute or subacute closure of side branches occurred after treating with DEB. All patients were treated according to the provisional stenting technique; no stents were placed in the SB. At 4-month follow-up no major acute coronary events and no subacute vessel closure were reported. The use of a drug-eluting balloon in patients with bifurcation lesions was effective and safe up to 4 months following PCI in patients with coronary artery bifurcation lesions.