Everolimus-Eluting Biodegradable Polymer Versus Everolimus-Eluting Durable Polymer Stent for Coronary Revascularization in Routine Clinical Practice.

Zanchin, Christian; Ueki, Yasushi; Zanchin, Thomas; Häner, Jonas; Otsuka, Tatsuhiko; Stortecky, Stefan; Koskinas, Konstantinos C; Siontis, George C M; Praz, Fabien; Moschovitis, Aris; Hunziker, Lukas; Valgimigli, Marco; Pilgrim, Thomas; Heg, Dik; Windecker, Stephan; Räber, Lorenz (2019). Everolimus-Eluting Biodegradable Polymer Versus Everolimus-Eluting Durable Polymer Stent for Coronary Revascularization in Routine Clinical Practice. JACC. Cardiovascular Interventions, 12(17), pp. 1665-1675. Elsevier 10.1016/j.jcin.2019.04.046

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OBJECTIVES

The aim of this study was to compare the efficacy and safety of a thin-strut, biodegradable-polymer everolimus-eluting stent (BP-EES; Synergy) and a thin-strut, durable-polymer everolimus-eluting stent (DP-EES; XIENCE) in an all-comers population.

BACKGROUND

BP-EES have been shown to be noninferior to DP-EES in randomized trials in patients at low to moderate risk.

METHODS

Among 7,042 consecutive patients who underwent percutaneous coronary intervention between December 2012 and December 2016, 3,870 patients were exclusively treated with BP-EES (n = 1,343) or with DP-EES (n = 2,527). After propensity score matching, the final study population consisted of 1,041 matched patients. The primary endpoint was the device-oriented composite endpoint (cardiac death, target vessel myocardial infarction, and target lesion revascularization) at 12 months.

RESULTS

The device-oriented composite endpoint did not differ between the 2 groups (7.8% with BP-EES vs. 7.1% with DP-EES; hazard ratio: 1.12; 95% confidence interval: 0.81 to 1.53; p = 0.49). There were no differences in rates of cardiac death (3.0% vs. 3.0%, p = 1.00), target vessel myocardial infarction (3.6% vs. 3.1%, p = 0.53), and target lesion revascularization (3.0% vs. 2.5%, p = 0.41). The rate of acute stent thrombosis was significantly higher in the BP-EES group compared with the DP-EES group (1.2% vs. 0.3%; hazard ratio: 4.00; 95% confidence interval: 1.13 to 14.19; p = 0.032). At 12 months, the frequency of definite stent thrombosis did not differ (1.5% vs. 0.9%; hazard ratio: 1.67; 95% confidence interval: 0.73 to 3.82; p = 0.22).

CONCLUSIONS

In this consecutively enrolled percutaneous coronary intervention population reflecting routine clinical practice, no difference in the device-oriented composite endpoint between BP-EES and DP-EES was observed throughout 12 months. There was a higher rate of acute stent thrombosis with the BP-EES, a difference that disappeared at 1 year. (CARDIOBASE Bern PCI Registry; NCT02241291).

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