Key result
Biodegradable polymer sirolimus-eluting stents resulted in a lower percentage of uncovered struts at 3 months compared to durable polymer zotarolimus-eluting stents (3.9% vs. 8.9%, p<0.001) in non-diabetic patients with acute coronary syndrome.
Why the study?
Does a biodegradable polymer sirolimus-eluting stent improve early neointimal coverage and vasodilator response compared to a durable polymer zotarolimus-eluting stent in non-diabetic patients with acute coronary syndrome?
RCT (n=44)
Single-blind
1:1
Yes
Does a biodegradable polymer sirolimus-eluting stent improve early neointimal coverage and vasodilator response compared to a durable polymer zotarolimus-eluting stent in non-diabetic patients with acute coronary syndrome?
In non-diabetic patients with ACS, biodegradable polymer sirolimus-eluting stents provided slightly better early stent strut coverage at 3 months compared with durable polymer zotarolimus-eluting stents, though neither stent was fully covered and vasodilator response was similar.
May favor biodegradable polymer stents for faster early coverage in non-diabetic ACS; extends OCT healing comparisons without clinical outcome data.
BACKGROUND: Patients at high bleeding risk would benefit from a shorter dual antiplatelet therapy after PCI. Compared to first-generation devices, the design of newer generation drug-eluting stents may facilitate more rapid anatomical and functional healing of stented vessel based on thinner stent platforms, biodegradable/biocompatible polymers and rapid drug elution. METHODS AND RESULTS: Forty-four non-diabetic patients with acute coronary syndrome (ACS) and culprit lesion in the LAD were randomized to receive either biodegradable polymer sirolimus-eluting stent (BP-SES) or durable polymer zotarolimus-eluting stent (DP-ZES). Neointimal strut coverage was examined using optical coherence tomography, and vasodilator response on invasive thermodilution-derived coronary flow reserve (CFR) at 3-month follow-up. The primary endpoints were percent uncovered struts and CFR. A total of 425 cross-sections (4,897 struts) were analyzed in the BP-SES group, and 425 cross-sections (5,467 struts) in the DP-ZES group. The percent uncovered struts was lower in the BP-SES group compared with the DP-ZES group, both at strut level (3.9% vs. 8.9%, respectively, P<0.001), and stent level (3.9 ± 3.2% vs. 8.9 ± 6.9%, respectively, P=0.019). No significant difference was found between the 2 groups regarding CFR (3.0 ± 1.3 vs. 3.2 ± 1.0, respectively, P>0.05). CONCLUSIONS: In non-diabetic patients with ACS, BP-SES provided slightly better stent strut coverage at 3 months compared with DP-ZES, but neither stent was fully covered. No difference in vasodilator response was seen.
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Karjalainen et al. (2014) conducted an RCT in Acute coronary syndrome (n=44). Biodegradable polymer sirolimus-eluting stent (BP-SES) vs. Durable polymer zotarolimus-eluting stent (DP-ZES) was evaluated on Percent uncovered struts (strut level) (p=<0.001). Biodegradable polymer sirolimus-eluting stents resulted in a lower percentage of uncovered struts at 3 months compared to durable polymer zotarolimus-eluting stents (3.9% vs. 8.9%, p<0.001) in non-diabetic patients with acute coronary syndrome.
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