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Randomized Controlled Trial
. 2023 Jul 18;82(3):183-195.
doi: 10.1016/j.jacc.2023.05.003. Epub 2023 May 17.

5-Year Outcomes After Bioresorbable Coronary Scaffolds Implanted With Improved Technique

Gregg W Stone  1 , Dean J Kereiakes  2 , Tommaso Gori  3 , D Christopher Metzger  4 , Bernardo Stein  5 , Matthew Erickson  6 , Jan Torzewski  7 , Ameer Kabour  8 , Guy Piegari  9 , Jeffrey Cavendish  10 , Barry Bertolet  11 , Kelly A Stockelman  12 , Nick E J West  12 , Ori Ben-Yehuda  13 , James W Choi  14 , Steven O Marx  15 , John A Spertus  16 , Stephen G Ellis  17 ; ABSORB IV Investigators
Affiliations
Free article
Randomized Controlled Trial

5-Year Outcomes After Bioresorbable Coronary Scaffolds Implanted With Improved Technique

Gregg W Stone et al. J Am Coll Cardiol. .
Free article

Abstract

Background: Bioresorbable vascular scaffolds (BVS) were designed to improve late event-free survival compared with metallic drug-eluting stents. However, initial trials demonstrated worse early outcomes with BVS, in part due to suboptimal technique. In the large-scale, blinded ABSORB IV trial, polymeric everolimus-eluting BVS implanted with improved technique demonstrated noninferior 1-year outcomes compared with cobalt chromium everolimus-eluting stents (CoCr-EES).

Objectives: This study sought to evaluate the long-term outcomes from the ABSORB IV trial.

Methods: We randomized 2,604 patients at 147 sites with stable or acute coronary syndromes to BVS with improved technique vs CoCr-EES. Patients, clinical assessors, and event adjudicators were blinded to randomization. Five-year follow-up was completed.

Results: Target lesion failure at 5 years occurred in 216 (17.5%) patients assigned to BVS and 180 (14.5%) patients assigned to CoCr-EES (P = 0.03). Device thrombosis within 5 years occurred in 21 (1.7%) BVS and 13 (1.1%) CoCr-EES patients (P = 0.15). Event rates were slightly greater with BVS than CoCr-EES through 3-year follow-up and were similar between 3 and 5 years. Angina, also centrally adjudicated, recurred within 5 years in 659 patients (cumulative rate 53.0%) assigned to BVS and 674 (53.3%) patients assigned to CoCr-EES (P = 0.63).

Conclusions: In this large-scale, blinded randomized trial, despite the improved implantation technique, the absolute 5-year rate of target lesion failure was 3% greater after BVS compared with CoCr-EES. The risk period for increased events was limited to 3 years, the time point of complete scaffold bioresorption; event rates were similar thereafter. Angina recurrence after intervention was frequent during 5-year follow-up but was comparable with both devices.(Absorb IV Randomized Controlled Trial; NCT02173379).

Keywords: angina; bioresorbable scaffold; coronary artery disease; prognosis; randomized trial; stent.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, and Abbott; has served as a consultant to Daiichi-Sankyo, Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, Adona Medical, and Millennia Biopharma; has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; has a daughter who is an employee at IQVIA; and his employer (Mount Sinai Hospital) receives research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc, Philips, Biosense Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. Dr Kereiakes has served as a consultant for Elixer Medical, Sino Medical Inc, Svelte, and Shockwave Medical Inc. Dr Gori has received speaker honoraria and research support from Abbott Vascular. Dr Metzger has received speaker honoraria and proctor fees from Abbott Vascular; has received advisory board fees from Boston Scientific; and has received speaker honoraria from Shockwave and Penumbra. Dr Stein has served a consultant for Abbott Vascular and Boston Scientific. Dr Torzewski has received speaker honoraria from Biotronik, Abbott, and Pentracor; and has received support to attend EuroPCR 2022 from Biotronik. Dr Bertolet has received speaker honoraria from Amgen, AstraZeneca, Novartis, and Shockwave Medical; and has served as a consultant to Medtronic Vascular. Drs Stockelman and West are employees of and hold equity in Abbott. Dr Choi has served as a consultant for Medtronic; and has received speaker honoraria from Shockwave. Dr Marx has served on clinical event committees for the Cardiovascular Research Foundation, including the ABSORB IV trial. Dr Spertus has served as a consultant on patient-reported outcomes and evidence evaluation for Alnylam, AstraZeneca, Bayer, Merck, Janssen, Bristol Myers Squibb, Edwards, Kineksia, 4DT Medical, Terumo, Cytokinetics, Imbria, and United Healthcare; has received research grants from Bristol Myers Squibb, Abbott Vascular, and Janssen; owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire; and has served on the Board of Directors for Blue Cross Blue Shield of Kansas City. Dr Ellis has served as a consultant for Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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