The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled.
OBJECTIVE
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.


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 ischaemia-driven 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).
Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil.
Alexandre
A
Abizaid
J
J
Ribamar Costa
Antonio L
AL
Bartorelli
Robert
R
Whitbourn
Robert Jan
RJ
van Geuns
Bernard
B
Chevalier
Tejas
T
Patel
Ashok
A
Seth
Marrianne
M
Stuteville
Cécile
C
Dorange
Wai-Fung
WF
Cheong
Krishnankutty
K
Sudhir
Patrick W
PW
Serruys
D020341:Absorbable Implants; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D023921:Coronary Stenosis / Q000628:therapy*; D003328:Coronary Thrombosis; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia; D062645:Percutaneous Coronary Intervention; D011446:Prospective Studies; D054457:Tissue Scaffolds; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D000068338:Everolimus