The Absorb GT1 Bioresorbable Vascular Scaffold System　- 5-Year Post-Market Surveillance Study in Japan

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Biomaterials Science

Background:

• Previous 1-year data suggested intracoronary imaging guidance for Absorb GT1 bioresorbable vascular scaffold (BVS) implantation may lower risks of target lesion failure (TLF) and scaffold thrombosis (ST).
• This study presents the long-term clinical outcomes up to 5 years for the Absorb GT1 BVS from a Japanese post-market surveillance registry.

Purpose of the Study:

• To evaluate the 5-year clinical outcomes of the Absorb GT1 BVS in patients with ischemic heart disease.
• To assess the impact of an appropriate intracoronary imaging-guided implantation technique on long-term safety and efficacy.

Main Methods:

• A prospective post-market surveillance study involving 135 patients (139 lesions) treated with Absorb GT1 BVS.
• Emphasis on adequate lesion preparation, imaging-guided sizing, and high-pressure post-dilatation.
• Intracoronary imaging (primarily OCT) used in 91.4% of lesions; adherence to recommended implantation techniques was high.

Main Results:

• No definite or probable scaffold thrombosis was reported through 5 years.
• The cumulative target lesion failure rate was 5.1% (6/118 lesions) at 5 years.
• Event breakdown included 2 cardiac deaths, 1 target vessel myocardial infarction, and 3 ischemia-driven target lesion revascularizations.

Conclusions:

• Appropriate intracoronary imaging-guided BVS implantation, coupled with pre- and post-balloon dilatation, appears beneficial.
• This technique may reduce the risk of target lesion failure and scaffold thrombosis up to 5 years.
• Adherence to recommended implantation protocols is crucial for favorable long-term outcomes with BVS.