Author + information
- Jose de Ribamar Costa,
- Alexandre Abizaid,
- Antonio Bartorelli,
- Robert Whitbourn and
- Patrick Serruys
Background: The long-term safety and performance of the Absorb Bioresorbable Vascular Scaffold (Absorb) System (Abbott Vascular, Santa Clara, CA) has been previously established in the B First-in-Man ABSORB Trial. The ABSORB EXTEND Trial was initiated as a global, continued access, international study to expand the clinical experience with the Absorb BVS to different geographies with broader inclusion criteria to include the treatment of longer lesions and multiple vessels. This final 3-year report provides data on the largest cohort of patients with long term follow-up who have received the device.
Methods: ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. Included were patients with lesions ≤ 28 mm in length and reference vessel diameter of 2.0 – 3.8 mm (as assessed by on-line QCA or IVUS). Treatment of a maximum of two de novo native coronary artery lesions was permitted with each lesion located in a different epicardial vessel. An independent Clinical Events Committee adjudicated all endpoint-related events.
Results: At 2 years of clinical follow-up, we reported no statistical difference between Absorb and the EES with regards to MACE (7.2% vs 7.7% p = 0.72), TLF (8.4% vs 9.3% p =0.55), ID-TLR (4.2% vs 4.6% p = 0.73) and ST (1.5% vs 0.7% p = 0.13).
Conclusions: Twenty four-month clinical results from the full study cohort demonstrated that the treatment of relatively non-complex patients with the Absorb BVS is safe and results in low rates of MACE and scaffold thrombosis. In addition, propensity score matched analysis demonstrated that the clinical safety and effectiveness of Absorb remains comparable to XIENCE V among this population. An update with the final 3- year results for the same 812 patient cohort will be presented.
Moderated Poster Contributions
Interventional Cardiology Moderated Poster Theater, Poster Hall, Hall C
Friday, March 17, 2017, 11:00 a.m.-11:10 a.m.
Session Title: Refining PCI Technique and Outcomes
Abstract Category: 21. Interventional Cardiology: Coronary Intervention: Devices
Presentation Number: 1135M-11
- 2017 American College of Cardiology Foundation