Lessons learned from acute and late scaffold failures in the ABSORB EXTEND trial

Area of Science:

• Cardiovascular medicine
• Biomaterials science
• Interventional cardiology

Background:

• Bioresorbable scaffolds are emerging as an alternative to metallic stents in percutaneous coronary interventions for coronary artery disease.
• The ABSORB EXTEND trial is evaluating the safety and efficacy of these scaffolds in a large patient cohort.

Purpose of the Study:

• To assess the incidence of acute and late scaffold failure, including scaffold dislodgement and scaffold thrombosis.
• To analyze potential mechanisms contributing to scaffold failure.
• To report on clinical outcomes at 12 months in the first 450 patients of the ABSORB EXTEND trial.

Main Methods:

• Prospective enrollment of 450 patients undergoing percutaneous coronary interventions with bioresorbable scaffolds.
• 12-month follow-up data collection focusing on clinical events and device failures.
• Detailed analysis of scaffold dislodgement and thrombosis events, including contributing factors.

Main Results:

• Low rates of 12-month ischaemia-driven major adverse cardiac events (MACE) at 4.2% and target vessel failure at 4.7%.
• Seven cases of device failure observed: three scaffold dislodgements (0.67%) and four scaffold thromboses (0.89%).
• Scaffold dislodgements occurred in the left circumflex artery; scaffold thromboses were linked to dual antiplatelet therapy (DAPT) discontinuation or resistance.

Conclusions:

• This study provides the first specific report on scaffold dislodgement and thrombosis incidence within the ABSORB EXTEND trial.
• The findings highlight the importance of adherence to dual antiplatelet therapy (DAPT) to mitigate scaffold thrombosis risk.
• Bioresorbable scaffolds demonstrate acceptable safety profiles, with rare but specific failure modes identified.