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CRT 24: 5Y Follow-Up of Absorb Bioresorbable Vascular Scaffold
Published: 20 Mar 2024
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CRT 24 - We are joined in this short virtual interview by investigator, Dr David Power (Mount Sinai Hospital, US) to discuss the latest findings from the ABSORB trial series, revealed in 2024 at the CRT conference.
ABSORB III is a prospective, randomized, single-blind, multicenter trail aiming to support the pre-market approval of the Absorb bioresorbable vascular scaffold (Abbott) for the treatment of coronary disease. 2008 patients were enrolled in the trial, receiving either the experimental device, or the Xience commercially-approved stent system as an active comparator. The study aimed to measure the safety and effectiveness of the Absorb device in the treatment of patients, including those with diabetes, and ischemic heart disease.
Results showed that the period of upfront risk with bioresorbable vascular scaffolds ended at three years. Across 5 years, bioresorbable stents showed no difference in target lesion failure when compared to the Xience stent system.
Interview Questions:
- What is the importance of this study?
- Could you tell us a bit more about the study device?
- What was the patient population and study design?
- What are your key findings?
- What further study is still needed?
Recorded remotely from New York, 2024.
"Hi. My name is Dr. David Power. I'm an interventional cardiology fellow at Mount Sinai Hospital in New York City.
What is the importance of this study?
Our study focused on five previously published randomized controlled trials from the ABSORB clinical trial program, which investigated bioresorbable vascular scaffolds (BVS). Originally, these scaffolds were designed to improve outcomes compared to metallic stents by facilitating complete resorption, restoring physiological function, and preserving coronary bypass targets.
Could you tell us a bit more about the study device?
The ABSORB BVS, manufactured by Abbott Vascular, is a polylactic acid-based scaffold eluting everolimus, with a thicker strut platform compared to contemporary stents.
What was the patient population and study design?
Our study was an individual patient data pooled analysis from five ABSORB trials, including ABSORB 2, ABSORB Japan and China, ABSORB 3, and ABSORB 4. These trials, conducted in North America, Europe, and Asia, enrolled nearly 6000 patients from 333 centers, with comprehensive follow-up data up to five years. The patient population was predominantly male, in their early 60s, with a mix of chronic and acute coronary syndromes and comorbidities such as diabetes and prior PCI.
What are your key findings?
The key finding of our study was that the upfront risk associated with bioresorbable stents ends at three years. While these scaffolds initially showed higher rates of target lesion failure (TLF) compared to stents, between three and five years, there was no significant difference in outcomes between BVS and Xience everolimus-eluting stents. This shift in outcomes may be attributed to improvements in scaffold design, implantation techniques, and patient selection over time.
What further study is still needed?
Moving forward, optimizing scaffold design to reduce strut thickness and employing intravascular imaging for precise sizing and deployment could enhance both short-term and long-term outcomes. Additionally, considering longer dual antiplatelet therapy durations aligned with the scaffold resorption time and utilizing intravascular imaging for accurate sizing before deployment may further improve outcomes during the critical first three years post-implantation.”
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