STENTYS Xposition S in the treatment of chronic total artery occlusion (SXS-CTO trial)

Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) can lead to positive vascular remodeling after revascularization, potentially resulting in late stent malapposition. Self-expanding drug-eluting stents (SE-DES) may adapt better to dynamic vessel diameters than balloon-expandable drug-eluting stents (BE-DES), potentially reducing strut malapposition after CTO-PCI. The authors compared stent malapposition at 6 months between SE-DES and BE-DES in CTO-PCI using optical coherence tomography (OCT).

In this single-center, prospective, randomized controlled trial, 23 patients with CTO were allocated 1:1 to SE-DES (STENTYS Xposition S [STENTYS S.A]) or BE-DES following successful lesion crossing and balloon predilatation. The primary endpoint was the percentage of malapposed stent struts on 6-month OCT. Secondary endpoints included neointimal hyperplasia, late lumen loss, in-stent restenosis (ISR), and clinical outcomes.

At 6 months, OCT showed significantly lower malapposition in the SE-DES group compared with BE-DES (0.0% [0.0-0.0] vs 0.8% [0.0-2.4]; P = .01). SE-DES was associated with greater neointimal thickness (0.3 mm vs 0.1 mm; P < .001) and late lumen loss (0.7 mm vs 0.1 mm; P = .003). ISR occurred more frequently in the SE-DES group (4 vs 1 patients), without reaching statistical significance. No major clinical events were reported in either group.

SE-DES were associated with a statistically significant reduction in strut malapposition compared with BE-DES. However, the absolute malapposition burden was very low in both groups, making the clinical relevance of this imaging finding uncertain. These findings emphasize the importance of individualized stent selection and systematic intracoronary imaging in complex PCI.