Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy.
Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy.
Int J Cardiol. 2018 Sep 1;266:67-74. doi: 10.1016/j.ijcard.2018.01.063.
The objective of this study was to investigate mid-term clinical outcomes of patients treated with 'full-plastic jacket' (FPJ) everolimus-eluting Absorb bioresorbable vascular scaffold (BRS) implantation.
FPJ with BRS may represent an interesting option for patient with diffuse coronary artery disease (CAD), but data on the clinical impact of FPJ using the Absorb BRS are scant.
FPJ was defined as the implantation of >56 mm of overlapping BRS in at least one vessel. We compared outcomes of patients receiving Absorb FPJ vs. non-FPJ within the multicenter prospective RAI Registry.
Out of 1505 consecutive patients enrolled in the RAI registry, 1384 were eligible for this analysis. Of these, 143 (10.3%) were treated with BRS FPJ. At a median follow-up of 649 days, no differences were observed between FPJ and non-FPJ groups in terms of the device-oriented composite endpoint (DoCE) (5.6% vs. 4.4%, p = 0.675) or the patient-related composite endpoint (PoCE) (20.9% vs. 15.9%, p = 0.149). Patients receiving FPJ had higher rates of target vessel repeat revascularization (TVR) (11.2% vs. 6.3%, p = 0.042). In the FPJ group, there was no cardiac death and only one (very late) stent thrombosis (ST) (0.7%).
Mid-term outcomes of a FPJ PCI strategy in the setting of diffuse CAD did not show a significant increase in composite device- and patient-related events, with rates of cardiac death and ST comparable to non-FPJ Absorb BRS implantation. However, these findings are hypothesis generating and requiring further validation.
本研究旨在探讨采用“全塑套”（FPJ）Everolimus 洗脱可吸收生物可降解血管支架（BRS）植入治疗患者的中期临床结果。
对于弥漫性冠状动脉疾病（CAD）患者，FPJ 联合 BRS 可能是一种很有前途的选择，但关于 Absorb BRS 中 FPJ 的临床影响的数据很少。
FPJ 定义为至少在一个血管中植入>56mm 的重叠 BRS。我们比较了接受 Absorb FPJ 与非 FPJ 的患者在多中心前瞻性 RAI 注册研究中的结果。
在 RAI 注册研究中连续纳入的 1505 例患者中，有 1384 例符合本分析的纳入标准。其中，143 例（10.3%）接受 BRS FPJ 治疗。在中位随访 649 天期间，FPJ 组与非 FPJ 组在器械导向的复合终点（DoCE）（5.6%比 4.4%，p=0.675）或患者相关的复合终点（PoCE）（20.9%比 15.9%，p=0.149）方面无差异。接受 FPJ 的患者靶血管再次血运重建（TVR）的发生率更高（11.2%比 6.3%，p=0.042）。在 FPJ 组中，没有心脏死亡，只有 1 例（极晚期）支架血栓形成（ST）（0.7%）。
弥漫性 CAD 患者中 FPJ PCI 策略的中期结果并未显示出复合器械和患者相关事件显著增加，心脏死亡和 ST 的发生率与非 FPJ Absorb BRS 植入相当。然而，这些发现只是假设性的，需要进一步验证。
