In the ABSORB IV trial, researchers aimed to assess the long-term outcomes of bioresorbable vascular scaffolds (BVS) compared to cobalt chromium everolimus-eluting stents (CoCr-EES). Initially, BVS showed worse early results due to suboptimal technique. However, the study revealed that BVS implanted with improved technique demonstrated noninferior 1-year outcomes to CoCr-EES. The objective was to evaluate the extended-term outcomes of this trial.
The trial involved 2,604 patients with stable or acute coronary syndromes who were randomly assigned to BVS or CoCr-EES. The randomization process was blinded for patients, clinical assessors, and event adjudicators. The study followed up with patients for five years to assess the long-term results.
After five years, target lesion failure was observed in 17.5% of patients with BVS and 14.5% of patients with CoCr-EES, with a statistically significant difference (P = 0.03). Device thrombosis occurred in 1.7% of BVS patients and 1.1% of CoCr-EES patients within the five-year period, but the difference was not statistically significant (P = 0.15). Event rates were slightly higher with BVS than CoCr-EES up to the three-year follow-up but became similar between three and five years. Recurrence of angina, as assessed centrally, was observed in 53.0% of BVS patients and 53.3% of CoCr-EES patients within the five-year timeframe (P = 0.63).
In conclusion, despite the improved implantation technique, the ABSORB IV trial showed a 3% higher rate of target lesion failure after BVS compared to CoCr-EES over the five-year period. The increased risk of adverse events was primarily observed within the first three years, coinciding with the complete bioresorption of the scaffold. After three years, the event rates were similar between the two devices. Recurrence of angina was frequent during the five-year follow-up but did not significantly differ between BVS and CoCr-EES.
J Am Coll Cardiol. 2023 Jul, 82 (3) 183–195
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