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 - 26/04/13

Doi : 10.1016/j.ahj.2013.02.009

Jae-Bin Seo, MD ^a,^{^{s
Equal contributors.}}, Si-Hyuck Kang, MD ^b,^{^{s
Equal contributors.}}, Seung-Ho Hur, MD, PhD ^c, Kyung Woo Park, MD, PhD ^b, Tae-Jin Youn, MD, PhD ^d, Jong-Seon Park, MD, PhD ^e, Han-Mo Yang, MD, PhD ^b, Hae-Young Lee, MD, PhD ^b, Hyun-Jae Kang, MD, PhD ^b, Bon-Kwon Koo, MD, PhD ^b, Jang-Ho Bae, MD, PhD ^f, Sang-Wook Kim, MD, PhD ^g, Keon-Woong Moon, MD, PhD ^h, Jae-Woong Choi, MD, PhD ⁱ, Sang-Gon Lee, MD, PhD ^j, Woo-Young Chung, MD, PhD ^a, Soo-Joong Kim, MD, PhD ^k, Doo-Il Kim, MD, PhD ^l, Byung-Ok Kim, MD, PhD ^m, Min-Su Hyon, MD, PhD ⁿ, Keum-Soo Park, MD, PhD ^o, Tae-Joon Cha, MD, PhD ^p, Chul-Woong Yoo, MD, PhD ^q, Hui-Kyung Jeon, MD, PhD ^r,^{^⁎} , Hyo-Soo Kim, MD, PhD ^b,^{^⁎}
^a Seoul National University Boramae Medical Center, Seoul, Korea
^b Seoul National University Hospital, Seoul, Korea
^c Keimyung University Dongsan Medical Center, Daegu, Korea
^d Seoul National University Bundang Hospital, Seongnam, Korea
^e Yeungnam University Medical Center, Daegu, Korea
^f Konyang University Hospital, Daejeon, Korea
^g Chung-Ang University Medical Center, Seoul, Korea
^h St Vincent's Hospital, Suwon, Korea
ⁱ Eulji General Hospital, Seoul, Korea
^j Ulsan University Hospital, Ulsan, Korea
^k Kyunghee University Medical Center, Seoul, Korea
^l Inje University Pusan Paik Hospital, Busan, Korea
^m Inje University Sang-gye Paik Hospital, Seoul, Korea
ⁿ Soon Chun Hyang University Hospital, Seoul, Korea
^o Inha University Hospital, Incheon, Korea
^p Kosin University Gospel Hospital, Busan, Korea
^q Sejong General Hospital, Bucheon, Korea
^r Uijeongbu St Mary's Hospital, Uijeongbu, Korea

^⁎Reprint requests: Hyo-Soo Kim, MD, PhD, is to be contacted at the Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, 101 DaeHak-ro, JongRo-gu, Seoul 110-744, Korea. Hui-Kyung Jeon, MD, PhD, Department of Internal Medicine, Cardiovascular Center, Uijeongbu St Mary's Hospital, 65-1, Geumo-dong, Uijeongbu, Gyeonggi-do 480-717, Korea.

Résumé

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 is well corroborated by the difference of in-stent late loss between 2 stents (0.71 ± 0.64 mm vs 0.52 ± 0.50 mm, P < .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 9 months was higher in Coroflex 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.

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Plan

Methods

Stents description

Study design and population

Randomization and procedures

Follow-up

Quantitative coronary angiography

Study end points

Statistical analysis

Results

Baseline characteristics and procedural results

Clinical outcomes at 9 months

Angiographic results

Subgroup analysis

Discussion

Introduction of several PESs to the market

Comparison of efficacy and safety between 2 different PESs

Subgroup analysis: diabetes

Limitations of the study

Disclosures

RCT reg #NCT00699543.

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Vol 165 - N° 5

P. 733-743 - mai 2013 Retour au numéro

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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 - 26/04/13

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