AIMS: The safety of bioresorbable scaffolds (BRS) has recently been challenged. However, it is unclear whether outcomes depend on the complexity of the lesion or on the technique used to implant the device. The aim of this study was to report on the outcomes after BRS implantation in complex lesions. METHODS AND RESULTS: This investigator-initiated, single-centre, single-arm observational study recruited 657 consecutive patients (79% male, 66.7% acute coronary syndrome, age 63±12 years). Three hundred and twenty-two lesions (42.3%) in 297 (45.2%) patients with type B2 or C lesions were classified as the "complex lesions group". Post-procedural residual stenosis was slightly but significantly greater in the complex lesions group (15.7±11.3% vs. 13.5±10.2%, p=0.0109). The median follow-up was 1,076 (762-1,206) days without difference between groups. The Kaplan-Meier rates of early scaffold thrombosis (3.5% vs. 1.1%, p=0.0478, HR 3.03 [1.06-8.70]) and scaffold restenosis (9.9% vs. 9.1%, p=0.0262, HR 2.34 [1.11-4.94]) were higher in patients with complex lesions than in those with simple lesions. Late/very late thrombosis, death, repeat myocardial infarction, or repeat coronary interventions were not different. In patients in whom strict guidelines for implantation were applied, the incidence of thrombosis was reduced by 76% in complex lesions and by 92% in simple ones, such that there were no differences between groups (2.3% vs. 0.5%, p=0.3899). In contrast, the incidence of scaffold restenosis was reduced by 59% and 89%, and a difference between groups persisted (7.0% vs. 1.6%, p=0.0235). CONCLUSIONS: BRS implantation in complex lesions is, as expected, associated with higher incidence of events as compared to simple ones. The technique used at the time of the implantation, however, reduces the incidence of adverse outcomes.
AIMS: The safety of bioresorbable scaffolds (BRS) has recently been challenged. However, it is unclear whether outcomes depend on the complexity of the lesion or on the technique used to implant the device. The aim of this study was to report on the outcomes after BRS implantation in complex lesions. METHODS AND RESULTS: This investigator-initiated, single-centre, single-arm observational study recruited 657 consecutive patients (79% male, 66.7% acute coronary syndrome, age 63±12 years). Three hundred and twenty-two lesions (42.3%) in 297 (45.2%) patients with type B2 or C lesions were classified as the "complex lesions group". Post-procedural residual stenosis was slightly but significantly greater in the complex lesions group (15.7±11.3% vs. 13.5±10.2%, p=0.0109). The median follow-up was 1,076 (762-1,206) days without difference between groups. The Kaplan-Meier rates of early scaffold thrombosis (3.5% vs. 1.1%, p=0.0478, HR 3.03 [1.06-8.70]) and scaffold restenosis (9.9% vs. 9.1%, p=0.0262, HR 2.34 [1.11-4.94]) were higher in patients with complex lesions than in those with simple lesions. Late/very late thrombosis, death, repeat myocardial infarction, or repeat coronary interventions were not different. In patients in whom strict guidelines for implantation were applied, the incidence of thrombosis was reduced by 76% in complex lesions and by 92% in simple ones, such that there were no differences between groups (2.3% vs. 0.5%, p=0.3899). In contrast, the incidence of scaffold restenosis was reduced by 59% and 89%, and a difference between groups persisted (7.0% vs. 1.6%, p=0.0235). CONCLUSIONS: BRS implantation in complex lesions is, as expected, associated with higher incidence of events as compared to simple ones. The technique used at the time of the implantation, however, reduces the incidence of adverse outcomes.