Randomized trial comparing the efficacy between different types of paclitaxel-eluting stents: The comparison of Efficacy between COroflex PLEASe ANd Taxus stent (ECO-PLEASANT) randomized controlled trial
- Affiliated Author(s)
- 허승호
- Alternative Author(s)
- Hur, Seung Ho
- Journal Title
- American Heart Journal
- ISSN
- 0002-8703
- Issued Date
- 2013
- Abstract
- Aims Paclitaxel-eluting stents (PESs) have been shown to inhibit neointimal hyperplasia after percutaneous coronary
intervention. Coroflex Please (B Braun, Melsungen, Germany) is a newly developed PES. We compared the clinical and
angiographic efficacy of Coroflex Please with Taxus Liberte (Boston Scientific, Natick, MA) in a real-world practice.
Methods and Results We performed a prospective, open-label, randomized, controlled study that enrolled 945 patients
undergoing percutaneous coronary interventions in 18 centers in Korea. The primary end point was clinically driven target vessel
revascularization at 9 months. The baseline characteristics were mostly similar and comparable between 2 groups. At 9 months, the
incidence of clinically driven target vessel revascularization was 14.6% for Coroflex and 6.4% for Taxus, which was significantly
different (hazard ratio 2.43, 95% CI 1.50-3.94, noninferiority P value = 1.000). This iswell corroborated by the difference of in-stent
late loss between 2 stents (0.71 ± 0.64 mm vs 0.52 ± 0.50mm, P b .001) by 9-month follow-up angiography (n = 415 vs 215).
Among secondary clinical end points, stent thrombosis (definite and probable) for 1 year was 2.2% in Coroflex and 1.3% in Taxus
(P = .317).Also,myocardial infarction for 9months was higher inCoroflex group than that in Taxus (4.9%vs 1.6%, P = .012),which
was partly contributed by the higher incidence of periprocedural myocardial infarction in Coroflex arm (2.2% vs 0.3%, P = .028).
Conclusions Coroflex Please was inferior to Taxus Liberte with regard to clinical and angiographic efficacy. (Am Heart J
2013;165:733-43.)
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