The ABSORB EXTEND study: Preliminary report of the twelvemonth clinical outcomes in the first 512 patients enrolled

Alexandre Abizaid, J. Ribamar Costa, Antonio L. Bartorelli, Robert Whitbourn, Robert Jan Van Geuns, Bernard Chevalier, Tejas Patel, Ashok Seth, Marrianne Stuteville, Cécile Dorange, Wai Fung Cheong, Krishnankutty Sudhir, Patrick W. Serruys

Research output: Contribution to journalArticle

Abstract

Aims: The safety and performance of the Absorb Bioresorbable Vascular Scaffold (Absorb BVS) system (Abbott Vascular, Santa Clara, CA, USA) has been previously established in 131 patients from cohort A and cohort B of the first-in-man ABSORB trial. Following this trial, ABSORB EXTEND was initiated as a global continued access study (outside of the USA) to expand experience with the Absorb BVS system to different geographies with broader inclusion criteria to include the treatment of longer lesions and multiple vessels. We report in this manuscript the twelve-month clinical outcomes of the first 512 patients in this population. Methods and results: ABSORB EXTEND is a prospective, single-arm, open-label clinical study which will enrol up to 800 patients at up to 100 sites. Included are 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 is permitted when each lesion is located in a different epicardial vessel. An independent clinical events committee adjudicates all endpoint-related events. At one year, for the first 512 patients enrolled in the study, the composite endpoints of ischaemia-driven MACE and ischaemiadriven target vessel failure were 4.3% and 4.9%, respectively. The cumulative rate of ARC defined definite and probable scaffold thrombosis for this population was 0.8% at one year. Conclusions: This interim analysis of the ABSORB EXTEND study shows low rates of MACE and scaffold thrombosis. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).

Original languageEnglish
Pages (from-to)1396-1401
Number of pages6
JournalEuroIntervention
Volume10
Issue number12
DOIs
Publication statusPublished - Apr 1 2015

    Fingerprint

Keywords

  • Bioresorbable scaffold
  • Coronary artery disease
  • Everolimus
  • Percutaneous coronary intervention
  • Poly (L-lactide)

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Abizaid, A., Costa, J. R., Bartorelli, A. L., Whitbourn, R., Van Geuns, R. J., Chevalier, B., Patel, T., Seth, A., Stuteville, M., Dorange, C., Cheong, W. F., Sudhir, K., & Serruys, P. W. (2015). The ABSORB EXTEND study: Preliminary report of the twelvemonth clinical outcomes in the first 512 patients enrolled. EuroIntervention, 10(12), 1396-1401. https://doi.org/10.4244/EIJV10|12A243