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首页> 外文期刊>Circulation journal >Absorb GT1 Bioresorbable Vascular Scaffold System　― 1-Year Post-Marketing Surveillance in Japan ―
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Absorb GT1 Bioresorbable Vascular Scaffold System　― 1-Year Post-Marketing Surveillance in Japan ―

机译：吸收GT1生物可吸收血管支架系统日本1年上市后监测―

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Background: The Japan post-marketing surveillance (PMS) for the Absorb GT1 bioresorbable vascular scaffold (BVS) mandated an intracoronary imaging-guided implantation technique. Methods?and?Results: We enrolled 135 patients who were planned to undergo PCI with THE Absorb GT1. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a noncompliant balloon to minimize final diameter stenosis were recommended. The primary endpoint was the scaffold thrombosis rate at 3 months. All patients successfully received at least 1 Absorb GT1 at the index procedure and completed 1-year follow-up. All 139 lesions were predilatated: cutting/scoring balloon and noncompliant balloon were used in 48 (34.5%) and 58 (41.7%) lesions, respectively. Post-dilatation was performed in 137 (98.5%) lesions with mean high pressure of 18.8 atm. Optical coherence tomography (OCT) was used in 127 of 139 (91.4%) lesions, and revealed 56.7% of lesions had incomplete scaffold apposition (ISA) but only in 1.89% in the per strut analysis. All patients received adenosine diphosphate receptor antagonist at discharge, and 132 (97.8%) patients continued therapy through the year. No definite/probable scaffold thrombosis, cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization was reported up to 1 year follow-up. Conclusions: Appropriate OCT-guided BVS implantation may prevent incomplete strut apposition, thereby reducing the risk of target lesion failure and scaffold thrombosis.
机译：背景：日本对Absorb GT1生物可吸收血管支架（BVS）的上市后监视（PMS）要求采用冠状动脉内成像引导植入技术。方法和结果：我们招募了135例计划使用THE Absorb GT1进行PCI的患者。建议进行充分的病灶准备，影像引导下的适当尺寸调整以及使用不顺应性球囊的高压后扩张术，以最大程度地减少最终直径狭窄。主要终点为3个月时支架血栓形成率。所有患者均在索引程序中成功接受至少1次Absorb GT1，并完成了1年的随访。所有139个病变均进行了扩张：切割/刻痕气囊和不顺应性气囊分别用于48个（34.5％）和58个（41.7％）病变。扩张后在137个（98.5％）病变中进行，平均高压为18.8 atm。光学相干断层扫描（OCT）用于139个病变中的127个（91.4％），发现56.7％的病变具有不完全的支架并置（ISA），但在每个支架分析中仅占1.89％。所有患者出院时均接受二磷酸腺苷受体拮抗剂，全年共有132名患者（97.8％）继续接受治疗。在长达1年的随访中，没有明确/可能的支架血栓形成，心脏死亡，心肌梗塞或缺血性靶病变血运重建的报道。结论：适当的OCT引导的BVS植入可防止不完全的支杆并置，从而降低目标病变失败和支架血栓形成的风险。

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