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

Gregg W Stone; Dean J Kereiakes; Tommaso Gori; D Christopher Metzger; Bernardo Stein; Matthew Erickson; Jan Torzewski; Ameer Kabour; Guy Piegari; Jeffrey Cavendish; Barry Bertolet; Kelly A Stockelman; Nick E J West; Ori Ben-Yehuda; James W Choi; Steven O Marx; John A Spertus; Stephen G Ellis; ABSORB IV Investigators

doi:10.1016/j.jacc.2023.05.003

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

J Am Coll Cardiol. 2023 Jul 18;82(3):183-195. doi: 10.1016/j.jacc.2023.05.003. Epub 2023 May 17.

Authors

Gregg W Stone¹, Dean J Kereiakes², Tommaso Gori³, D Christopher Metzger⁴, Bernardo Stein⁵, Matthew Erickson⁶, Jan Torzewski⁷, Ameer Kabour⁸, Guy Piegari⁹, Jeffrey Cavendish¹⁰, Barry Bertolet¹¹, Kelly A Stockelman¹², Nick E J West¹², Ori Ben-Yehuda¹³, James W Choi¹⁴, Steven O Marx¹⁵, John A Spertus¹⁶, Stephen G Ellis¹⁷; ABSORB IV Investigators

Affiliations

¹ Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: gregg.stone@mountsinai.org.
² Carl and Edyth Lindner Research Center at The Christ Hospital, Cincinnati, Ohio, USA.
³ Kardiologie I University Medical Center and DZHK Rhein-Main, Mainz, Germany.
⁴ Ballad Health Systems CVA Heart Institute, Kingsport, Tennessee, USA.
⁵ Morton Plant Hospital, Clearwater, Florida, USA.
⁶ Fiona Stanley Hospital, Perth, Westwern Australia, Australia.
⁷ Cardiovascular Center Oberallgäu-Kempten, Kempten, Germany.
⁸ Mercy St Vincent Medical Center, Toledo, Ohio, USA.
⁹ Penn State Health Medical Group-Berks Cardiologists, Wyomissing, Pennsylvania, USA.
¹⁰ Scripps Memorial Hospital La Jolla, La Jolla, California, USA.
¹¹ North Mississippi Medical Center, Tupelo, Mississippi, USA.
¹² Abbott Vascular, Santa Clara, California, USA.
¹³ University of California San Diego, San Diego, California, USA.
¹⁴ Texas Health Presbyterian Hospital, Baylor Research Institute, Dallas, Texas, USA.
¹⁵ NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, USA.
¹⁶ Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri, USA.
¹⁷ Cleveland Clinic, Cleveland, Ohio, USA.

PMID: 37207924
DOI: 10.1016/j.jacc.2023.05.003

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.

Publication types

Multicenter Study
Randomized Controlled Trial

MeSH terms

Absorbable Implants
Coronary Artery Disease*
Everolimus
Humans
Percutaneous Coronary Intervention*
Prosthesis Design
Stents
Tissue Scaffolds
Treatment Outcome

Substances

Everolimus

Associated data

ClinicalTrials.gov/NCT02173379