5-Year Outcomes After Bioresorbable Coronary Scaffold Implantation

Jul 11, 2023
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Authors:
Stone GW, Kereiakes DJ, Gori T, et al., on behalf the ABSORB IV Investigators.
Citation:
5-Year Outcomes After Bioresorbable Coronary Scaffolds Implanted With Improved Technique. J Am Coll Cardiol 2023;82:183-195.
Summary By:
Bina Ahmed, MD, FACC

Quick Takes

  • Findings from this large, randomized controlled trial of patients with both acute and chronic coronary syndromes comparing bioresorbable vascular scaffold (BVS; with improved implantation technique) to metallic DES showed that after 5 years, rates of target lesion failure were higher with BVS than DES (17.5% vs. 14.5%, p = 0.03).
  • Device thrombosis rates were greater with BVS than DES through 3-year follow-up and similar between 3-5 years.
  • Angina recurred in nearly 50% of patients within 5 years but was similar with both devices.

Study Questions:

What are long-term clinical outcomes after implantation of the coronary bioresorbable vascular scaffold (BVS) compared to cobalt chromium everolimus-eluting stents (CoCr-EES) in the ABSORB IV trial?

Methods:

A total of 2,604 patients at 147 sites with stable or acute coronary syndromes were randomized to BVS with improved technique versus CoCr-EES. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target lesion revascularization (ID-TLR) at 30 days. Five-year follow-up was completed.

Results:

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 with CoCr-EES. The risk period for increased events was restricted 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.

Perspective:

Findings from this large randomized controlled trial of patients with both acute and chronic coronary syndromes comparing BVS (with improved implantation technique) to metallic drug-eluting stents (DES) showed that after 5 years, rates of TLF were higher with BVS than DES (17.5% vs. 14.5%, p = 0.03). Device thrombosis rates were greater with BVS than DES through 3-year follow-up and similar between 3-5 years. Angina recurred in nearly 50% of patients within 5 years but was similar with both devices. The role of BVS in clinical practice remains investigational and will need development of BVS with improved mechanical properties and guidance on optimal implantation techniques.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Atherosclerotic Disease (CAD/PAD), Cardiac Surgery and SIHD, Interventions and ACS, Interventions and Coronary Artery Disease, Chronic Angina

Keywords: Absorbable Implants, Acute Coronary Syndrome, Angina, Stable, Chromium, Cobalt, Coronary Artery Disease, Drug-Eluting Stents, Everolimus, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Stents, Thrombosis


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