Absorb GT1 Bioresorbable Vascular Scaffold System　- 1-Year Post-Marketing Surveillance in Japan

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Biomaterials Science

Background:

• Post-marketing surveillance (PMS) for the Absorb GT1 bioresorbable vascular scaffold (BVS) in Japan mandated intracoronary imaging guidance.
• This study evaluated the safety and efficacy of the Absorb GT1 BVS using a mandated imaging-guided implantation technique.

Purpose of the Study:

• To assess the scaffold thrombosis rate at 3 months and 1-year clinical outcomes after Absorb GT1 BVS implantation using intracoronary imaging guidance.
• To evaluate the impact of imaging-guided implantation on scaffold apposition and clinical events.

Main Methods:

• 135 patients underwent percutaneous coronary intervention (PCI) with Absorb GT1 BVS, with emphasis on lesion preparation, imaging-guided sizing, and high-pressure post-dilatation.
• Optical coherence tomography (OCT) was utilized in 91.4% of lesions to assess scaffold deployment.
• Patients received dual antiplatelet therapy (DAPT) for 1 year.

Main Results:

• All 135 patients completed 1-year follow-up, with 139 Absorb GT1 BVS implanted.
• High-pressure post-dilatation was performed in 98.5% of lesions.
• OCT revealed incomplete scaffold apposition (ISA) in 56.7% of lesions overall, but only 1.89% per strut.
• No definite/probable scaffold thrombosis, cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization was reported up to 1 year.

Conclusions:

• Appropriate OCT-guided BVS implantation is crucial for optimal scaffold apposition.
• This technique may effectively reduce the risk of target lesion failure and scaffold thrombosis.
• The study demonstrates favorable 1-year clinical outcomes with the Absorb GT1 BVS when implanted using an imaging-guided strategy.