The Paclitaxel-Eluting Coroflex™ Please Stent Pilot Study (PECOPS I): Acute and 6-Month Clinical and Angiographic Follow-Up

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Abstract

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: ≥ 70%, < 100%; reference diameter ≥ 2.25 mm and <3.3 mm; lesion length ≤ 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).

Conclusion:

The data of the paclitaxel-eluting Coroflex™. Please stent tested in PECOPS I are within the range other available paclitaxel-eluting stent.

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