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Article from TCTMD - Study sponsored by Abbot

DES Strut Coverage Findings Suggest Differences in Thrombosis Risk

 

Key Points:

Incomplete endothelialization a factor in late stent thrombosis

 

Among DES, strut coverage better for Xience and Endeavor

 

Biomarkers of endothelial recovery support strut findings

By Kim Dalton

 

In a rabbit model, differences in arterial healing following drug-eluting stent (DES) implantation suggest that the risk of late stent thrombosis may be somewhat lower with the new Xience and Endeavor stents compared to first-generation DES. Differences in the degree of strut neointimal coverage and expression of several biomarkers of incomplete endothelialization favor the newer DES designs, according to a study published in the July 29, 2008, issue of the Journal of the American College of Cardiology.

 

To assess the effect of various polymer-based DES on endothelialization, researchers led by Renu Virmani, MD, of CVPath Institute (Gaithersburg, MD), first used a balloon catheter to denude the endothelium of the iliac arteries of adult rabbits. They then implanted a sirolimus-eluting (Cypher, Cordis/Johnson & Johnson, Miami, FL), paclitaxel-eluting (Taxus, Boston Scientific, Natick, MA), zotarolimus-eluting (Endeavor, Medtronic Vascular, Santa Monica, CA), or everolimus-eluting (Xience V, Abbott Vascular, Santa Clara, CA) stent. The bare-metal cobalt-chromium Multi-Link Vision (Abbott Vascular) stent served as a control.

 

After stent retrieval at 14 or 28 days, the stented arteries were bisected, with half examined via scanning electron microscopy and half immunostained. Other stented arteries were harvested after the same periods for culturing. (Although 28 days in rabbits is often considered the equivalent of 1 year in humans, the investigators suggest that the shorter 14-day duration may reveal more about the course of vascular healing with DES.)

 

Coverage Gap

 

Differences in total surface area of uncovered struts for the various DES vs. bare-metal stents were most pronounced at 14 days. At that point, the uncovered strut area was smallest for Xience, while Cypher, Taxus, and Endeavor each showed at least a 5-fold greater uncovered area compared to bare-metal controls (table 1). At 28 days, the total uncovered area had decreased ~50% in all DES, although the difference persisted in Taxus.

 

Table 1. Total Area of Uncovered Struts (mm2)

 

 Cypher                Taxus             Endeavor               Xience V        Bare Metal

 

14 Days

 5.17 ± 0.36a      7.26 ± 2.04a     5.66 ± 0.70a       2.75 ± 2.37         0.85 ± 0.90

 

28 Days

 3.08 ± 1.80         3.84 ± 1.46b    2.54 ± 2.61         1.33 ± 1.60        0.12 ± 0.12

 

Longitudinal coverage of DES was poorest in the middle regions, whereas the ends were generally well endothelialized—except for Cypher.

 

Biomarkers Signal Delayed Endothelialization

 

In addition, levels of biomarkers indicating the stage of endothelial recovery varied among the different DES along lines similar to those for strut coverage. Expression of platelet-endothelial cell adhesion molecule-1 (PECAM-1) over struts was generally poor in Cypher and Taxus at both 14 and 28 days, suggesting inhibition of endothelial cell proliferation and migration, endothelial cell injury, and/or increased cell turnover. Likewise, expression of thrombomodulin, which regulates platelets and coagulation, was weak or absent in DES, rendering the endothelium thrombogenic. On the other hand, expression of vascular endothelial growth factor (VEGF) was especially elevated in Cypher, Taxus, and Endeavor, an indication of incomplete endothelialization.

 

While acknowledging that the risk of stent thrombosis is associated with a variety of factors, including procedural, lesion, and patient characteristics, the researchers conclude:

 Attention should focus on stent strut coverage rather than late loss alone because the persistent lack of coverage . . . may serve as a nidus for thrombosis.

 Improved stent designs with thinner struts, more biocompatible polymers, or elimination of polymers with optimized drug elution profiles will likely have a profound impact on endothelial coverage."

 

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