Department of Cardiology, Munich University Clinic, LMU, Munich, Germany.
EuroIntervention. 2017 Dec 20;13(11):1319-1326. doi: 10.4244/EIJ-D-17-00291.
The aim of this study was to assess clinical restenosis and its predictors after implantation of bioresorbable vascular scaffolds (BVS) in everyday practice in the large-scale German-Austrian ABSORB Registry (GABI-R).
Between November 2013 and January 2016, 3,264 patients underwent BVS implantation in the 93 centres of GABI-R. At six-month follow-up, 24 patients experienced clinically indicated target lesion revascularisation (cTLR) unrelated to BVS thrombosis (cumulative incidence 0.76%; angiographically, 58.3% of in-BVS restenosis of focal pattern). Compared to patients without cTLR, patients with cTLR had more lesions per patient (1.83±1.0 vs. 1.36±0.7), complex (52.3% vs. 36.2%) and mild-to-moderately calcified lesions (65.9% vs. 60.5%) treated, and more frequently had overlapping BVS (22.2% vs. 10.8%), all p<0.05. Implanted BVS length was 40.0 mm (28.0, 46.9) vs. 23.0 mm (18.0, 30.0), p<0.001, remaining in the multivariable analysis the only independent predictor of cTLR (hazard ratio 1.02, 95% CI: 1.01-1.04, p<0.001). The myocardial infarction rate was also significantly higher among patients with cTLR, 29.2% vs. 1.7%, p<0.0001.
cTLR related to BVS restenosis at six months after BVS implantation is a rare event depending on implanted BVS length. Whether cTLR increases the myocardial infarction risk needs to be evaluated at longer-term follow-up and within the setting of adequately powered randomised trials.
本研究旨在评估在德国-奥地利 ABSORB 注册研究（GABI-R）的大型临床实践中，生物可吸收血管支架（BVS）植入后的临床再狭窄及其预测因素。
2013 年 11 月至 2016 年 1 月，3264 例患者在 GABI-R 的 93 个中心接受了 BVS 植入术。在 6 个月的随访中，24 例患者发生了与 BVS 血栓无关的临床指征性靶病变血运重建（cTLR）（累积发生率 0.76%；血管造影显示，58.3%的在 BVS 内再狭窄呈局灶性模式）。与未发生 cTLR 的患者相比，发生 cTLR 的患者每例患者的病变数量更多（1.83±1.0 对 1.36±0.7），复杂病变（52.3%对 36.2%）和轻度至中度钙化病变（65.9%对 60.5%）更多，并且 BVS 重叠的发生率更高（22.2%对 10.8%），所有差异均有统计学意义（均 P<0.05）。植入的 BVS 长度为 40.0mm（28.0，46.9）对 23.0mm（18.0，30.0），P<0.001，在多变量分析中，是 cTLR 的唯一独立预测因素（风险比 1.02，95%CI：1.01-1.04，P<0.001）。cTLR 组心肌梗死发生率也明显高于未发生 cTLR 组（29.2%对 1.7%），P<0.0001。
BVS 植入后 6 个月时与 BVS 再狭窄相关的 cTLR 是一种罕见事件，取决于植入的 BVS 长度。cTLR 是否会增加心肌梗死风险，需要在更长时间的随访中，并在经过充分功率的随机试验中进行评估。
