No Difference in Device End Points for Biodegradable vs Durable Everolimus Polymer Stents

For patients undergoing percutaneous coronary intervention, treatment with thin-strut biodegradable-polymer everolimus-eluting stent (BP-EES) may be noninferior to thin-strut durable-polymer everolimus-eluting stent (DP-EES) at 12 months, according to results published in JACC: Cardiovascular Interventions. There was, however, a notable higher rate of acute stent thrombosis with BP-EES. This increased thrombosis rate was not detected at 1 year.

The study included 7042 participants who underwent percutaneous coronary intervention between December 2012 and December 2016. Of these, 1343 were exclusively treated with BP-EES and 2527 were treated with DP-EES. The researchers performed propensity score matching to determine a final study population of 1041 matched participants. The primary endpoint was the device-oriented composite endpoints of cardiac death, target vessel myocardial infarction, and target lesion revascularization at 12 months.

The results indicated that device-oriented composite endpoints did not significantly differ between participants treated with BP-EES (7.8%) compared with DP-EES (7.1%; hazard ratio [HR], 1.12; 95% CI, 0.81-1.53; P_superiority =.49).

After comparing BP-EES outcomes with DP-EES outcomes, the researchers did not find significant differences in rates of cardiac death (3.0% vs 3.0%; P =.998), target vessel myocardial infarction (3.6% vs 3.1%; P =.534), and target lesion revascularization (3.0% vs 2.5%; P =.418).

Compared with the DP-EES group, the BP-EES group had a significantly higher rate of acute stent thrombosis (1.2% vs 0.3%; HR, 4.00; 95% CI, 1.13-14.19; P =.032); however, at 12 months, this difference was no longer significant (1.5% vs 0.9%; HR, 1.67; 95% CI, 0.73-3.82; P =.22).

The study included several limitations. Despite propensity matching, residual confounding cannot be excluded. The researchers also noted that the follow-up duration was limited to 12 months, and event capture was based on questionnaires and review of hospital databases, which could lead to underreporting of events.

“Studies providing further mechanistic insights using optical coherence tomography and careful attention to optimization of antithrombotic treatment strategies are required,” the researchers wrote.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Zanchin C, Ueki Y, Zanchin T, et al. Everolimus-eluting biodegradable polymer versus everolimus-eluting durable polymer stent for coronary revascularization in routine clinical practice [published online August 14, 2019]. JACC Cardiovasc Interv. doi:10.1016/j.jcin.2019.04.046