The paclitaxel-eluting Coroflex Please stent pilot study (PECOPS I): acute and 6-month clinical and angiographic follow-up.
OBJECTIVE
Various active stent coatings significantly reduce restenosis rates and target lesion revascularization compared to bare metal stents. Therefore, the procedural and 6-month performance of the new paclitaxel-eluting Coroflex. Please stent was investigated.


METHODS
Ninety-seven patients (66 +/- 7.6 years, 34/97(35.1%) diabetics, 11/97(11.3%) unstable angina) were enrolled per protocol for elective single stent deployment into native coronary de-novo or post-PTCA restenotic lesions (stenosis: >or= 70%, < 100%; reference diameter >or= 2.25 mm and <3.3 mm; lesion length <or= 16 mm) with 13/97(13.4%) lesion type A, 64/97(66%) type B1, 20/97(20.6%) type B2). The mean reference diameter was 2.88 +/- 0.42 mm, the lesion length 10.03 +/- 2.93 mm, and the minimal lumen diameter 0.64 +/- 0.22 mm.


RESULTS
The success rates of procedure and study stent deployment were 100% and 94.8%, respectively. In 5/97(5.2%) two stents were implanted. Follow-up was performed clinically in 86/87(98.9%) and angiographically in 77/87(88.5%) patients after 6.1 +/- 0.7 months. Major adverse cardiac events occurred in 7/87(8%) 1/87(1.2%) subacute thrombosis 10.3hrs post procedure, 1/87(1.2%) myocardial infarction, 5/87(5.7%) target lesion revascularizations. The in-segment stenosis declined from 78 +/- 7.2% to 9.4 +/- 6.2% after stenting increasing to 31.9 +/- 18.6% at follow-up. The in-segment late loss and the late loss index were 0.47 +/- 0.6 mm and 0.23 +/- 0.29 resulting in 6/77(7.8%) in-segment restenoses three each of which were located either within or beyond the stent structure. The outcome was neither influenced by the prevalence of diabetes ( p = 0.4), hypercholesterolemia ( p = 1), hypertension ( p = 1), overweight ( p = 1), nor by the family history of coronary artery disease ( p = 0.7).


CONCLUSIONS
The data of the paclitaxel-eluting Coroflex. Please stent tested in PECOPS I are within the range other available paclitaxel-eluting stent.
Clinical Research Institute, Center for Cardiovascular Diseases, Rotenburg an der Fulda, Germany.
Martin
M
Unverdorben
Ralf
R
Degenhardt
Christian
C
Vallbracht
Marcus
M
Wiemer
Dieter
D
Horstkotte
Henrik
H
Schneider
Christoph
C
Nienaber
Wolfgang
W
Bocksch
Michael
M
Gross
Michael
M
Boxberger
D000368:Aged; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage*; D010865:Pilot Projects; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D015607:Stents; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D017239:Paclitaxel