Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil.
St. Vincent's Hospital, Fitzroy, Victoria, Australia.
Catheter Cardiovasc Interv. 2019 Jan 1;93(1):E1-E7. doi: 10.1002/ccd.27715. Epub 2018 Oct 4.
There is still limited data on the very long term clinical outcomes after ABSORB BRS in daily practice. We sought to evaluate the 3 year-performance of the Absorb bioresorbable vascular scaffolds for the treatment of low/moderate complexity patients enrolled in the ABSORB EXTEND trial.
ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA). To determine the independent predictors of MACE, a multivariable logistic regression model was built using a stepwise (forward/backward) procedure.
Average population age was 61 years and 26.5% had diabetes. Most patients had single target lesion (92.4%). Adequate scaffold deployment (PSP) was achieved in 14.2% of the cases. At three years, the composite endpoints of MACE and ischemia-driven target vessel failure were 9.2% and 10.6%, respectively. The cumulative rate of ARC definite/probable thrombosis was 2.2%, with 1.2% of the cases occurring after the 1st year. Independent predictors of MACE were hypertension and the need for "bail out" stent.
At three-year follow-up, the use of ABSORB in low/moderate complex PCI was associated with low and acceptable rates of major adverse clinical events, despite the infrequent use of the recommended contemporary scaffold deployment technique. However, scaffold thrombosis rate was higher than reported with current generation of metallic DES. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).
在日常实践中，关于 ABSORB BRS 非常长期的临床结果仍有有限的数据。我们旨在评估 ABSORB EXTEND 试验中入组的低/中度复杂患者接受 Absorb 生物可吸收血管支架治疗的 3 年结果。
ABSORB EXTEND 是一项前瞻性、单臂、开放性临床研究，共 56 个中心入组了 812 例患者。本研究允许治疗长度≤28mm 且参考血管直径为 2.0-3.8mm 的病变（通过在线 QCA 评估）。为了确定 MACE 的独立预测因素，使用逐步（向前/向后）程序构建了多变量逻辑回归模型。
平均人群年龄为 61 岁，26.5%的患者患有糖尿病。大多数患者为单靶病变（92.4%）。仅 14.2%的病例实现了适当的支架扩张（PSP）。3 年时，MACE 和缺血驱动的靶血管失败的复合终点分别为 9.2%和 10.6%。ARC 明确/可能血栓形成的累积发生率为 2.2%，其中 1.2%的病例发生在第 1 年后。MACE 的独立预测因素为高血压和需要“挽救”支架。
在 3 年随访时，尽管支架扩张技术的应用不频繁，但 ABSORB 在低/中度复杂 PCI 中的应用与较低和可接受的主要不良临床事件发生率相关。然而，支架血栓形成率高于目前一代金属 DES 的报告。该研究在 clinicaltrials.gov 上注册（唯一标识符 NCT01023789）。
