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. 2016;12(4):314-320.
doi: 10.5114/aic.2016.63630. Epub 2016 Nov 17.

First-generation paclitaxel- vs. second-generation zotarolimus-eluting stents in small coronary arteries: the BASKET-SMALL Pilot Study

Raban Jeger  1 , Matthias Pfisterer  1 , Otmar Pfister  1 , Peter Rickenbacher  1 , Michael Handke  1 , Nicole Gilgen  1 , Michael Coslovsky  1 , Christoph Kaiser  1
Affiliations

First-generation paclitaxel- vs. second-generation zotarolimus-eluting stents in small coronary arteries: the BASKET-SMALL Pilot Study

Raban Jeger et al. Postepy Kardiol Interwencyjnej. 2016.

Abstract

Introduction: Event rates after percutaneous coronary interventions (PCI) are higher in small than large coronary vessels but may vary between different drug-eluting stent (DES) types.

Aim: To assess the efficacy of two different DES in small vessel disease.

Material and methods: Patients with small vessel PCI were randomised 1 : 1 to a first-generation paclitaxel- vs. a second-generation zotarolimus-eluting stent. The primary endpoint was a composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularisation after 2 years.

Results: Overall, 191 patients were enrolled: 100 with a paclitaxel- and 91 with a zotarolimus-eluting stent. Baseline characteristics were similar in both groups. After 2 years, rates of the primary endpoint were numerically higher for zotarolimus- than paclitaxel-eluting stents (9.9% vs. 5.0%, hazard ratio 2.09, 95% confidence interval (CI) 0.7-6.2, p = 0.19), which was mainly driven by higher rates of target vessel revascularisation (6.6% vs. 2.0%, hazard ratio 3.39, 95% CI: 0.68-16.78, p = 0.14). Based on this, a total of 1,019 patients would be necessary to demonstrate at least non-inferiority between the DES used.

Conclusions: In this pilot study, paclitaxel-eluting stents had a favourable efficacy profile in small vessel disease, although the numbers were too small to draw final conclusions. Based on the prohibitively high sample size for a randomized controlled trial between DES, other treatment options should be considered.

Keywords: drug-eluting stent; paclitaxel; small vessel disease; zotarolimus.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Kaplan-Meier estimates of MACE (p = 0.18)
Figure 2
Figure 2
Kaplan-Meier estimates of MACE, stratified by the presence (D1, p = 0.58) or absence of diabetes mellitus (D0, p = 0.23)
See this image and copyright information in PMC

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