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.
OBJECTIVE
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.


RESULTS
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).


CONCLUSIONS
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.
National Heart Institute, Kuala Lumpur, Malaysia.
Rosli Mohd
RM
Ali
Ralf
R
Degenhardt
Robaayah
R
Zambahari
Damras
D
Tresukosol
Wan Azman Wan
WA
Ahmad
Haizal bin Haron
Hb
Kamar
Sim
S
Kui-Hian
Tiong Kiam
TK
Ong
Omar
O
bin Ismail
Safari
S
bin Elis
Wasan
W
Udychalerm
Hanns
H
Ackermann
Michael
M
Boxberger
Martin
M
Unverdorben
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002858:Chromium Alloys; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D048909:Diabetes Complications / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D018572:Disease-Free Survival; D016503:Drug Delivery Systems / Q000295:instrumentation*; D054855:Drug-Eluting Stents; D004867:Equipment Design; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008296:Malaysia; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013785:Thailand; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D002858:Chromium Alloys; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel