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Randomized Controlled Trial
. 2016 Feb 15;117(4):532-538.
doi: 10.1016/j.amjcard.2015.11.044. Epub 2015 Dec 7.

Comparison of the Absorbable Polymer Sirolimus-Eluting Stent (MiStent) to the Durable Polymer Everolimus-Eluting Stent (Xience) (from the DESSOLVE I/II and ISAR-TEST-4 Studies)

Alexandra J Lansky  1 , Adnan Kastrati  2 , Elazer R Edelman  3 , Helen Parise  4 , Vivian G Ng  4 , John Ormiston  5 , William Wijns  6 , Robert A Byrne  2
Affiliations
Randomized Controlled Trial

Comparison of the Absorbable Polymer Sirolimus-Eluting Stent (MiStent) to the Durable Polymer Everolimus-Eluting Stent (Xience) (from the DESSOLVE I/II and ISAR-TEST-4 Studies)

Alexandra J Lansky et al. Am J Cardiol. .

Abstract

We compared the outcomes of a novel, thin-strut, cobalt-chromium, absorbable, polymer sirolimus-eluting stent (APSES; MiStent) to the durable polymer cobalt-chromium everolimus-eluting stent (EES; Xience). A propensity-matched analysis was performed comparing data from the DES With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in the Native Coronary Arteries (DESSOLVE) I and II studies, evaluating the APSES to the EES arm of the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents-4 study. Target lesion failure (TLF) and its components were evaluated at 12 months and annually to 3 years; 805 patients (APSES = 153; EES = 652) were included with propensity matching in 204 patients (APSES = 102; EES = 102). APSES compared with EES had lower TLF at 1 year (3.0% vs 8.0%, p = 0.12) driven by a difference in target lesion revascularization (TLR; 1% vs 6%, p = 0.05), with no difference in target vessel myocardial infarction (p = 0.56) or stent thrombosis (p = 0.31). At 3 years, TLF (5.0% vs 12.5%, p = 0.07) and TLR (2.0% vs 8.4%, p = 0.04) remained lower with APSES. By landmark analysis, there was no significant difference in TLF between 1 and 3 years (p = 0.36). In conclusion, in a propensity-matched analysis, the APSES demonstrated reduced clinically indicated TLR rates at 1 and 3 years compared with the durable polymer EES, with minimal accrual of events between 1 and 3 years.

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Figures

Figure 1
Figure 1
MiStent Design
Figure 2
Figure 2
Boxplot of propensity scores from the logistic regression (a) before and (b) after matching
Figure 3
Figure 3
Kaplan Meier estimates of 3-year target lesion failure (top) and 1 year landmark analysis for target lesion failure (bottom)
Figure 4
Figure 4
Kaplan Meier estimates of 3-year ischemia driven lesion revascularization (top) and 1 year landmark analysis for target lesion revascularization (bottom)
See this image and copyright information in PMC

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