Impact of Residual Stenosis on the Angiographic Edge Restenosis of a Second-Generation Drug-Eluting Stent

Abstract

Edge restenosis has gained attention as a main cause of restenosis after first-generation drug-eluting stent (DES) implantation. The aim of this study was to assess the incidence of edge restenosis and identify the predictors of edge restenosis after second-generation DES implantation. Data were obtained from several postmarketing surveillance (PMS) studies on a cobalt-chromium everolimus-eluting stent (CoCr-EES; Xience V/ PROMUS, Xience Prime, Xience Prime SV, and Xience Expedition SV), a second-generation DES, in Japan. Angiographic analysis was conducted at the baseline and after eight months on the following subsegments: instent region, proximal edge, and distal edge. Restenosis was defined as !50% diameter stenosis (DS) at followup. We used multivariate logistic regression (with lesions as a random effect) to compare the instances of restenosis between the proximal and the distal edges. Univariate and multivariate analyses of the risk factors for restenosis were performed for each subsegment. We analyzed 1,966 lesions in 1,687 patients. The restenosis rates at the in-stent region, proximal edge, and distal edge were 4.4%, 3.0%, and 1.1%, respectively. The risk of restenosis at the distal edge was significantly lower than that at the proximal edge, when adjusted for 13 variables. The predictors of restenosis were postprocedural % diameter stenosis (%DS), postprocedural reference diameter, !45°bending, stent overlap at the proximal edge, and postprocedural %DS at the distal edge. Our analysis of eight-month angiographic outcomes from CoCr-EES PMS demonstrated that postprocedural %DS is a major predictor of edge restenosis. Edge restenosis is more likely attributable to postprocedural angiographic results than to the patient's background.

Cobalt exposure in relation to cardiovascular disease in the United States general population

“…However, normal coronary angiography has been reported for patients with cobalt poisoning (Samar et al 2015), and no signi cant difference was found in serum troponin levels (Berber et al 2017). Additionally, with the common use of cobalt in drug-eluting stents, no cases of cobalt poisoning have been reported (Kozuma et al 2019;Romaguera et al 2014;Sotomi et al 2018). However, another study has shown signi cantly increased serum enzymes and low voltages on ECG in patients with cobalt poisoning (Packer 2016).…”

Over-expansion of second-generation drug-eluting stents, risk of restenosis, and relation to major adverse cardiac events

“…Stent norm-expansion is undoubtedly expected to have favorable outcomes, whereas under-expansion leads to unfavorable outcomes whether bare metal stents or DESs were used (Fujii et al, 2005;Nakamura et al, 2016). Numerous previous studies showed that immediate residual stenosis of ≤ 20% was acceptable (Kozuma et al, 2019;Watanabe et al, 2018) and was considered an angiographic success (Smith et al, 2006), because the cutoff point was associated with relatively lower rate of ISR and ST. However, an increasing amount of evidence indicated that postprocedural MLD was a key determinant of ISR (Kuntz et al, 1993).…”