Ultrathin-Strut versus Thin-Strut Drug-Eluting Stents for Multi- and Single-Stent Lesions: A Lesion-Level Subgroup Analysis of Two Randomized Trials.

Häner, Jonas D; Rohla, Miklos; Losdat, Sylvain; Iglesias, Juan F; Muller, Olivier; Eeckhout, Eric; Kurz, David; Weilenmann, Daniel; Kaiser, Christoph; Tapponnier, Maxime; Roffi, Marco; Heg, Dik; Windecker, Stephan; Pilgrim, Thomas (2023). Ultrathin-Strut versus Thin-Strut Drug-Eluting Stents for Multi- and Single-Stent Lesions: A Lesion-Level Subgroup Analysis of Two Randomized Trials. American Heart Journal, 263, pp. 73-84. Elsevier 10.1016/j.ahj.2023.05.004

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BACKGROUND

Whether ultrathin-strut stents are particularly beneficial for lesions requiring implantation of more than one stent is unknown.

METHODS

In a post-hoc lesion-level analysis of two randomized trials comparing ultrathin-strut biodegradable polymer Sirolimus-eluting stents (BP-SES) versus thin-strut durable polymer Everolimus-eluting stents (DP-EES), lesions were stratified into multi stent lesions (MSL) versus single-stent lesions (SSL). The primary endpoint was target lesion failure (TLF), a composite of lesion-related unclear/cardiac death, myocardial infarction (MI), or revascularization, at 24 months.

RESULTS

Among 5328 lesions in 3397 patients, 1492 (28%) were MSL (722 with BP-SES, 770 with DP-EES). At two years, TLF occurred in 63 lesions (8.9%) treated with BP-SES and 60 lesions (7.9%) treated with DP-EES in the MSL-group (subdistibution hazard ratio [SHR], 1.13; 95%CI, 0.77-1.64; p=0.53), and in 121 (6.4%) and 136 (7.4%) lesions treated with BP-SES and DP-EES respectively (SHR, 0.86; 95%CI, 0.62-1.18; p = 0.35) in the SSL-group (p for interaction = 0.241). While the rates of lesion-related MI or revascularization were significantly lower in SSL treated with BP-SES as compared to DP-EES (3.5% vs. 5.2%; SHR, 0.67; 95%CI 0.46-0.97; p=0.036), no significant difference was observed in MSL (7.1% vs. 5.4%; SHR, 1.31; 95%CI 0.85-2.03; p=0.216) with significant interaction between groups (p for interaction=0.014).

CONCLUSIONS

Rates of TLF are similar between ultrathin-strut BP-SES and thin-strut DP-EES in MSL and SSL. The use of ultrathin-strut BP-SES versus thin-strut DP-EES did not prove to be particularly beneficial for the treatment of multi-stent lesions.

CONDENSED ABSTRACT

Whether ultrathin-strut stents are particularly beneficial for lesions requiring implantation of more than one stent is unknown. In a post-hoc analysis of two randomized trials comparing ultrathin-strut biodegradable polymer Sirolimus-eluting stents (BP-SES) versus thin-strut durable polymer Everolimus-eluting stents (DP-EES), 5328 lesions in 3397 patients were stratified into multi-stent lesions (MSL) versus single-stent lesions (SSL). At 2 years, rates of target lesion failure were comparable between BP-SES and DP-EES in both MSL and SSL. In the SSL group, lesion-related myocardial infarction or revascularization were significantly lower in BP-SES as compared to DP-EES; in contrast, no significant difference between stents was observed in the MSL group (p for interaction = 0.014).

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