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ABSORB试验:评价生物可吸收依维莫洗脱冠脉支架系统治疗原发冠状动脉病变患者的3年临床结果

作者:国际循环网   日期:2010/11/30 15:08:03

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Background: Bioabsorbable polymer drug-eluting stents (DES) are an alternative approach potentially providing short-term vessel scaffolding combined with drug delivery capability but avoiding the long-term limitations of metallic stents

  Yoshinobu Onuma; Patrick W Serruys, The ABSORB Investigators
  Thorax Cntr, Erasmus MC, Rotterdam, Netherlands
  Background: Bioabsorbable polymer drug-eluting stents (DES) are an alternative approach potentially providing short-term vessel scaffolding combined with drug delivery capability but avoiding the long-term limitations of metallic stents, such as late stent thrombosis and impaired endothelial function. Two-year follow-up of this first-in-man trial using the BVS Everolimus-Eluting Stent System (Abbott Vascular, Santa Clara, CA, USA) demonstrated an in-stent late loss of 0.48mm and diameter stenosis of 27%. The two-year optical coherent tomography and intravascular ultrasound imaging analysis demonstrated luminal area enlargement compared to 6 months, due to a decrease in plaque without change in vessel size. In addition, vasomotion was restored at the stented site and adjacent coronary artery at 2 years. However, the clinical outcomes beyond 2 years after implantation of the BVS stents are not yet available.
  Methods: The purpose of the ABSORB Clinical Investigation is to assess the safety and performance of the BVS Everolimus-Eluting Coronary Stent System (Abbott Vascular, Santa Clara, CA, USA) in the treatment of patients with a single de novo native coronary artery lesion. Ischemia driven major adverse cardiac events (ID-MACE) was defined as a composite of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization.
  Results: Enrolment of 30 patients at 4 clinical sites in Europe and New Zealand was completed in July 2006. At 2 years one patient died from non-cardiac cause at 706 days post-procedure. The mean duration of follow-up was 740.9 days (minimum 707 days, maximum 800 days). At 2 year follow-up, there was one non-Q wave myocardial infarction (peak troponin 2.21ng/ml) related to the treatment of a non-flow-limiting stenosis (QCA DS 42%) in a patient who experienced a single episode of angina at rest without electrographic evidence of ischemia.
  Conclusion: Results up to 2 years indicate that the BVS stent has a low long-term MACE rate (3.6%). Clinical results at 3 years are being collected and will be presented.

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ABSORB生物可吸收依维莫洗脱冠脉支架原发冠状动脉病变

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