接受依维莫司洗脱生物可吸收血管支架治疗患者的中长期结局：哥廷根生物可吸收血管支架注册研究数据，主要来自急性冠状动脉综合征患者。
Mid- to long-term outcome of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Data of the BVS registry Göttingen predominantly from ACS patients.
作者信息
Hellenkamp Kristian, Becker Alexander, Gabriel Yannick D, Hasenfuß Gerd, Hünlich Mark, Jacobshagen Claudius, Schillinger Wolfgang, Schroeter Marco R
机构信息
Clinic for Cardiology & Pneumology/Heart Center, University Medical Center Göttingen, DZHK - German Center for Cardiovascular Research, Germany.
Clinic for Cardiology & Pneumology/Heart Center, University Medical Center Göttingen, DZHK - German Center for Cardiovascular Research, Germany; Clinic for Cardiology, Robert-Bosch Hospital, Stuttgart, Germany.
出版信息
Int J Cardiol. 2017 May 1;234:58-63. doi: 10.1016/j.ijcard.2017.02.069. Epub 2017 Feb 21.
BACKGROUND
Bioresorbable vascular scaffolds (BVS) are widely used in routine clinical practice. While previous studies reported acceptable short- to midterm outcome after BVS implantation, data on longer-term outcome are rare.
METHODS
Patients treated with at least one Absorb®-BVS were consecutively enrolled. Follow-up data were assessed after 834.0 [769.0-1026.0] days. The primary device-oriented composite endpoint (DOCE) was defined as cardiovascular death, myocardial infarction (MI) and/or target lesion revascularization (TLR).
RESULTS
Between 2012 and 2014, 195 patients were included into study analysis. Overall, 244 BVS were implanted. Mean patient age was 64.0[54.3-74.0] years. Three-quarter of patients had an ACS; of those 42.9% had ST-elevation-MI and 40.8% had non-ST-elevation-MI. DOCE occurred in 3.1%, 6.7%, 11.8% and 15.4% of patients during hospital stay, within 6-months, 18-months or during the complete follow-up period, respectively. In those patients, median time until DOCE was 211.5[43.25-567.25] days. In 11 (36.7%) patients DOCE occurred after >12months. Using univariable analysis, bifurcation stenting was associated with a hazard ratio (HR) of 11.8[2.38-58.57] for TLR (p=0.002) and 2.1[1.02-4.49] for DOCE (p=0.045). Similarly, in ACS patients, bifurcation stenting was associated with an increased risk for TLR (HR=10.4[2.01-53.56]; p=0.005) and for DOCE (HR=2.4[1.09-5.32]; p=0.029) and in multivariable analysis, it remained an independent predictor of DOCE (HR=3.0; p=0.018).
CONCLUSIONS
Although, the rates of (potentially) device-related complications following BVS implantation are acceptable, they are nonetheless not negligible. Interestingly, they did not decline over time. Bifurcation stenting could be found as relevant procedure-related predictor of DOCE, especially in ACS patients. Randomized trials are warranted to confirm these findings.
背景
生物可吸收血管支架（BVS）在常规临床实践中被广泛应用。虽然先前的研究报告了BVS植入术后可接受的短期至中期结果，但关于长期结果的数据却很少。
方法
连续纳入至少接受过一次Absorb®-BVS治疗的患者。在834.0[769.0 - 1026.0]天之后评估随访数据。主要的以器械为导向的复合终点（DOCE）被定义为心血管死亡、心肌梗死（MI）和/或靶病变血运重建（TLR）。
结果
在2012年至2014年期间，195例患者被纳入研究分析。总体而言，植入了244个BVS。患者平均年龄为64.0[54.3 - 74.0]岁。四分之三的患者患有急性冠状动脉综合征（ACS）；其中42.9%患有ST段抬高型心肌梗死，40.8%患有非ST段抬高型心肌梗死。DOCE分别在住院期间、6个月内、18个月内或整个随访期间发生在3.1%、6.7%、11.8%和15.4%的患者中。在这些患者中，直至DOCE的中位时间为211.5[43.25 - 567.25]天。在11例（36.7%）患者中，DOCE发生在>12个月之后。使用单变量分析，分叉支架置入术与TLR的风险比（HR）为11.8[2.38 - 58.57]（p = 0.002），与DOCE的风险比为2.1[1.02 - 4.49]（p = 0.045）。同样，在ACS患者中，分叉支架置入术与TLR风险增加相关（HR = 10.4[2.01 - 53.56]；p = 0.005）以及与DOCE风险增加相关（HR = 2.4[1.09 - 5.32]；p = 0.029），并且在多变量分析中，它仍然是DOCE的独立预测因素（HR = 3.0；p = 0.018）。
结论
尽管BVS植入术后（潜在）与器械相关的并发症发生率是可接受的，但它们仍然不可忽视。有趣的是，它们并没有随着时间的推移而下降。分叉支架置入术可被发现是DOCE的相关手术相关预测因素，尤其是在ACS患者中。需要进行随机试验来证实这些发现。
Zotero 插件