Nobuaki Suzuki1, Ken Kozuma2, Sunao Nakamura3, Kazuhiko Aramaki4, Shigeru Saito5, Yoshisato Shibata6, Mamoru Nanasato7,8, Kenshi Fujii9, Hajime Kusano10, Divine Ediebah10, Masato Nakamura11. 1. Fourth Department of Internal Medicine, Teikyo University School of Medicine. 2. Department of Medicine, Teikyo University School of Medicine. 3. Department of Cardiology, Shin-Tokyo Hospital. 4. Department of Cardiovascular Medicine, Saitama Sekishinkai Hospital. 5. Department of Cardiovascular Medicine, Shonan Kamakura General Hospital. 6. Department of Cardiovascular Medicine, Miyazaki Medical Association Hospital. 7. Department of Second Cardiovascular Medicine, Red Cross Nagoya Daini Hospital. 8. Department of Cardiovascular Medicine, Sakakibara Heart Institute. 9. Department of Cardiovascular Medicine, Sakurabashi Watanabe Hospital. 10. Abbott Vascular. 11. Division of Cardiovascular Medicine, Toho University Ohashi Medical Center.
Abstract
BACKGROUND: The Japan post-marketing surveillance (PMS) for the Absorb GT1 bioresorbable vascular scaffold (BVS) mandated an intracoronary imaging-guided implantation technique.Methods and Results: We enrolled 135 patients who were planned to undergo PCI with THE Absorb GT1. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a noncompliant balloon to minimize final diameter stenosis were recommended. The primary endpoint was the scaffold thrombosis rate at 3 months. All patients successfully received at least 1 Absorb GT1 at the index procedure and completed 1-year follow-up. All 139 lesions were predilatated: cutting/scoring balloon and noncompliant balloon were used in 48 (34.5%) and 58 (41.7%) lesions, respectively. Post-dilatation was performed in 137 (98.5%) lesions with mean high pressure of 18.8 atm. Optical coherence tomography (OCT) was used in 127 of 139 (91.4%) lesions, and revealed 56.7% of lesions had incomplete scaffold apposition (ISA) but only in 1.89% in the per strut analysis. All patients received adenosine diphosphate receptor antagonist at discharge, and 132 (97.8%) patients continued therapy through the year. No definite/probable scaffold thrombosis, cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization was reported up to 1 year follow-up. CONCLUSIONS: Appropriate OCT-guided BVS implantation may prevent incomplete strut apposition, thereby reducing the risk of target lesion failure and scaffold thrombosis.
BACKGROUND: The Japan post-marketing surveillance (PMS) for the Absorb GT1 bioresorbable vascular scaffold (BVS) mandated an intracoronary imaging-guided implantation technique.Methods and Results: We enrolled 135 patients who were planned to undergo PCI with THE Absorb GT1. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a noncompliant balloon to minimize final diameter stenosis were recommended. The primary endpoint was the scaffold thrombosis rate at 3 months. All patients successfully received at least 1 Absorb GT1 at the index procedure and completed 1-year follow-up. All 139 lesions were predilatated: cutting/scoring balloon and noncompliant balloon were used in 48 (34.5%) and 58 (41.7%) lesions, respectively. Post-dilatation was performed in 137 (98.5%) lesions with mean high pressure of 18.8 atm. Optical coherence tomography (OCT) was used in 127 of 139 (91.4%) lesions, and revealed 56.7% of lesions had incomplete scaffold apposition (ISA) but only in 1.89% in the per strut analysis. All patients received adenosine diphosphate receptor antagonist at discharge, and 132 (97.8%) patients continued therapy through the year. No definite/probable scaffold thrombosis, cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization was reported up to 1 year follow-up. CONCLUSIONS: Appropriate OCT-guided BVS implantation may prevent incomplete strut apposition, thereby reducing the risk of target lesion failure and scaffold thrombosis.