Objective The aim of this study is to investigate the early outcomes and safety of using ABSORB Bioresorbable Vascular Scaffold (BVS) System in the treatment of significant coronary artery disease in an Asian population.
Methods This study is the first report from an Asian single centre open registry consisting of patients with symptomatic coronary artery disease requiring PCI with insertion of BVS. Inclusion criteria for stenosis severity and vessel diameter are same as the original ABSORB RCT and include epicardial vessel with stenosis of > 50% to 100% and a vessel diameter of > 2.5 mm and < 3.8 mm. Exclusion criteria include diagnosis of acute myocardial infarction, severe congestive cardiac failure, bleeding diatheses and coagulopathies. Early outcomes were examined immediately post procedures, during the hospitalisation period and at 1 week post BVS insertion. Outcome measures include procedural-related complications, device failure and major ischaemia driven adverse cardiac events such as death, myocardial infarction, emergent CABG and target lesion revascularization.
Results 19 patients were included in the study; 18 male and 1 female, with an average age of 57 + 7.9 years. 8 patients had single vessel disease, 3 patients had 2 vessel disease and 8 patients had 3 vessel disease. Of the 19 patients, 15 had BVS only and 4 had a combination BVS and drug eluting stents. A total of 55 stents were implanted, of which 47 (85.4%) were the ABSORB BVS. The number of ABSORB BVS stents used per patient ranged from 1 to 9, with an average of 2.47 stents per patient. Procedural and device success were achieved in all patients. No adverse outcomes were observed. Presently, the follow up period ranges from 3 weeks to 20 weeks and none of the patients have reported adverse clinical symptoms.
Conclusions This study demonstrates the excellent early outcomes and safety of using ABSORB BVS stents in an Asian population. During the early follow-up period, patients did not have adverse clinical outcomes.