完全生物可吸收支架技术有可能对 PCI进行彻底改革，与传统药物洗脱支架一样在冠脉血运重建时有相同的疗效。然而，药物释放和支架吸收后，留下一个治愈了的人体自然血管。该技术被称为血管恢复治疗（ VRT），力求将血管从永久性支架的“牢笼”中解放出来，使患者长期获益，包括血管舒缩功能的恢复、晚期管腔扩大，还可能得到持久的疗效。

    ABSORB临床试验观察了雅培的 BVS。ABSORB一期试验称为 ABSORB Cohort A，30例单支原位冠脉狭窄患者应用 BVS治疗。 2009年末公布了 3年随访数据，证实该技术能够成功地治疗冠脉疾病，支架在 2年后被再吸收。该期试验中的患者 3年没有血栓发生， 6个月到 3年无新发主要不良心血管事件（MACE）， 3年时 MACE率3.4%。此外， 2年时对一组患者进行的血管舒缩功能试验发现血管舒缩功能恢复。

    总共 101例患者入选 ABSORB二期试验（ Cohort B）。该期试验采用改进的支架设计从而改善支架的输送能力和血管支撑的时间。第一组 45例患者 6个月临床和血管造影随访数据近期公布，结果显示不良事件率 4.4%，血管造影晚期丢失 0.19mm。全部 101例患者 6个月和 9个月临床数据将在今年 TCT上公布。

    此外，雅培开始了 ABSORB EXTEND试验的入选，该试验将入选欧洲、亚太地区、加拿大和拉丁美洲 100个中心的近 1000例患者。 ABSORB EXTEND试验设计为单组研究，进一步评估 BVS在更加复杂冠脉疾病中的应用情况。

    TCT 2010上研发不同完全生物可吸收支架的其他公司也将公布他们的研究结果。

EXCITING NEW DATA ON BIORESORBABLE STENTS TO BE PRESENTED AT TCT2010

    Fully bioresorbable scaffold technology has the potential to revolutionize PCI by providing revascularization of the coronary artery in the same efficacious way as traditional drug eluting stents.  However, once support from the scaffold is no longer needed, the device gradually disappears, leaving behind a healed vessel that is no longer constrained by an implant.  Termed Vascular Restoration Therapy (VRT), this treatment option seeks to free the vessel from the ‘cage’ of a permanent stent, allowing for potential long term benefits for patients, including restoration of vasomotor function, late lumen enlargement, and perhaps providing greater durability of results.

    Abbott’s BVS has been investigated in the ABSORB first-in-man clinical trial.  In the first phase of the ABSORB trial, called ABSORB Cohort A, 30 patients with single, de novo coronary artery stenoses were treated with a BVS.  Three-year follow-up data from this group of patients were presented in late 2009, demonstrating that this technology was able to successfully treat coronary artery disease and the device was resorbed after two years.  Patients in this first phase of the ABSORB trial experienced no thrombosis out to three years and no new major adverse cardiac events (MACE) between six months and three years, with a MACE rate of 3.4% at three years.  Further, restoration of vasomotion was observed at two years in a subset of patients undergoing vasomotor function testing.

    A total of 101 patients were enrolled in ABSORB Cohort B, the second phase of the ABSORB trial.  This phase incorporated device enhancements designed to improve deliverability and the duration of vessel support.  The six-month clinical and angiographic follow-up data on the first group of 45 patients were recently presented, showing a low adverse event rate of 4.4%, and an angiographic late loss of 0.19 mm.  The six-month and nine-month clinical data on all 101 patients will be presented at TCT this year.

    Additionally, Abbott has initiated enrollment in a large-scale trial called ABSORB EXTEND, which will enroll approximately 1,000 patients from up to 100 centers in Europe, Asia Pacific, Canada and Latin America.  ABSORB EXTEND is a single-arm study designed to further evaluate the performance of the BVS technology in patients with more complex coronary artery disease.

    Multiple other companies who are also developing different fully bioresorbable stents will present their promising results at TCT 2010.