Five-Year Clinical Outcomes After Coronary Bioresorbable Scaffolds and Drug-Eluting Stents: The ABSORB IV Randomized Trial
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 non-inferior 1-year outcomes compared with cobalt chromium everolimus-eluting stents (CoCr-EES).
OBJECTIVES
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 (TLF) at 5 years occurred in 216 patients (17.5%) assigned to BVS and 180 patients (14.5%) 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 similar between 3-5 years. Angina, also centrally adjudicated, recurred within 5 years in 659 patients (cumulative rate 53.0%) assigned to BVS and 674 patients (53.3%) assigned to CoCr-EES (P=0.63).
CONCLUSIONS
In this large-scale, blinded randomized trial, despite improved implantation technique the absolute 5-year rate of TLF was 3% greater after BVS compared…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 2,604 participants or records.
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