• EuroIntervention · May 2011

    Randomized Controlled Trial Multicenter Study Comparative Study

    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.

    • Rosli Mohd Ali, Ralf Degenhardt, Robaayah Zambahari, Damras Tresukosol, Wan Azman Wan Ahmad, Haizal bin Haron Kamar, Sim Kui-Hian, Tiong Kiam Ong, Omar bin Ismail, Safari bin Elis, Wasan Udychalerm, Hanns Ackermann, Michael Boxberger, and Martin Unverdorben.
    • National Heart Institute, Kuala Lumpur, Malaysia.
    • EuroIntervention. 2011 May 1;7 Suppl K:K83-92.

    AimsCoronary 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.Methods And ResultsEighty-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).ConclusionsThe 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.

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