Objectives: Prospective optical coherence tomography (OCT) study of strut apposition and neointimal hyperplasia thickness (NIH) of a paclitaxel eluting stent (PES), (Infinium, Sahajanand Medical Technologies Pvt Ltd.).
Background: Few data exist concerning neointimal coverage of PES. Uncovered and malapposed struts are more common following stenting in acute coronary syndromes (ACS) than in non-ACS lesions.
Methods: All consecutive patients with ACS, treated with the above PES for single native coronary lesions between August 2008 and January 2009, who consented to invasive follow-up with OCT at six months (N=13), were included.
Results: At 6 months no patient demonstrated angiographic restenosis. 3180 struts from 20 stents were analyzed, and 91.3% were covered with neointima (NIH 204.8 ± 159.5 μm). Standard statistics and least squares estimates (LSE) derived from a hierarchical ANCOVA model to take into account clustering effects are presented. Rate of uncovered struts was 8.6%, LSE 7.39 (95% CI 3.05-11.73), malapposed struts 2.2%, LSE 1.76 (95% CI 0.05-3.58), and protruding struts 2.9%, LSE 2.8 (95% CI 1.35-4.65). The proportion of uncovered malapposed struts was significantly higher compared to uncovered embedded struts (55.7% vs. 6.8%, p<0.01). In total, 5 (25%) PES were fully covered by neointima. No intracoronary thrombus or clinical events were detected.
Conclusions: Six months after implantation of a specific PES in patients with ACS, most of the stents were only partially covered with neointima, especially at sites of strut malapposition or protrusion. These findings emphasize the need for optimal stent apposition during implantation and for prolonged dual antiplatelet therapy.
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