TY - JOUR
T1 - The ABSORB EXTEND study
T2 - Preliminary report of the twelvemonth clinical outcomes in the first 512 patients enrolled
AU - Abizaid, Alexandre
AU - Costa, J. Ribamar
AU - Bartorelli, Antonio L.
AU - Whitbourn, Robert
AU - Van Geuns, Robert Jan
AU - Chevalier, Bernard
AU - Patel, Tejas
AU - Seth, Ashok
AU - Stuteville, Marrianne
AU - Dorange, Cécile
AU - Cheong, Wai Fung
AU - Sudhir, Krishnankutty
AU - Serruys, Patrick W.
PY - 2015/4/1
Y1 - 2015/4/1
N2 - 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).
AB - 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).
KW - Bioresorbable scaffold
KW - Coronary artery disease
KW - Everolimus
KW - Percutaneous coronary intervention
KW - Poly (L-lactide)
UR - http://www.scopus.com/inward/record.url?scp=84928396540&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84928396540&partnerID=8YFLogxK
U2 - 10.4244/EIJV10|12A243
DO - 10.4244/EIJV10|12A243
M3 - Article
C2 - 24769555
AN - SCOPUS:84928396540
VL - 10
SP - 1396
EP - 1401
JO - EuroIntervention
JF - EuroIntervention
SN - 1774-024X
IS - 12
ER -