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Published on: September 9, 2011
The paclitaxel-eluting Coroflex Please stent pilot study (PECOPS I): acute and 6-month clinical and angiographic
Martin Unverdorben1, Ralf Degenhardt, Christian Vallbracht
1Clinical Research Institute, Center for Cardiovascular Diseases, Rotenburg an der Fulda, Germany.
Background And Objectives:
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
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).
Conclusion:
The data of the paclitaxel-eluting Coroflex. Please stent tested in PECOPS I are within the range other available paclitaxel-eluting stent.
