Damiano Regazzoli1, Azeem Latib2, Babu Ezhumalai3, Akihito Tanaka1, Pier Pasquale Leone1, Sara Khan3, Vijay Kumar3, Vishal Rastogi3, Marco Bruno Ancona1, Antonio Mangieri1, Francesco Giannini4, Satoru Mitomo1, Ashok Seth3, Antonio Colombo4. 1. Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan, Italy. 2. Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan, Italy; Unit of Cardiovascular Interventions, EMO-GVM Centro Cuore Columbus, Milan, Italy. Electronic address: alatib@gmail.com. 3. Unit of Cardiovascular Interventions, Fortis Escorts Heart Institute, New Delhi, India. 4. Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan, Italy; Unit of Cardiovascular Interventions, EMO-GVM Centro Cuore Columbus, Milan, Italy.
Abstract
OBJECTIVES: The aim of this study was to evaluate the impact of a consistent and dedicated implantation strategy on long-term outcomes after implantation of bioresorbable vascular scaffold (BVS) in a real-world cohort of patients with a high prevalence of complex lesions. BACKGROUND: Bioresorbable vascular scaffolds may result in a reduced incidence of late and very-late scaffold thrombosis (ScT) after the complete reabsorption of the scaffold, but this hypothesis is hampered by data from RCTs that showed a higher than expected incidence of late events. However, these studies did not adopt a dedicated implantation technique, that proved to be fundamental in reducing the incidence of adverse events. METHODS: 573 consecutive patients (912 lesions) treated with bioresorbable scaffolds between May 2012 and December 2014 were enrolled in 3 high-volume centers that used a dedicated implantation strategy from the beginning. Primary endpoints were target-lesion failure (TLF) and definite and probable ScT. Secondary endpoints included myocardial infarction, target-lesion and target-vessel revascularization. RESULTS: The registry enrolled a high complexity subset of lesions (69.4% of type B2 or C lesions; 10.3% of severe calcific lesions; 26.1% of bifurcations). Predilatation was performed in almost all cases (99.2%); intracoronary imaging was liberally adopted (37.3%). Mean scaffold length was 42.9 ± 27.4 mm per patient, and post-dilation with a 1:1 high-pressure (22 ± 3.5 atm) balloon was performed in 99.9% of lesions. Median follow-up (available for 98.6% of patients) was 981 days (IQR 802-1133). Overall incidence of ScT was reassuringly low: three thrombotic events occurred during the first year (0.5%), while only one event ensued in the second year of follow-up, and ScT rate remained stable thereafter up to the fourth year (0.7%). Cumulative TLF rates at 1, 2, 3 and 4 years were 3.0%, 6.0%, 7.8% and 12.2%. CONCLUSIONS: These long-term results from a complex "real-world" population appear to be reassuring as regards to the incidence of ScT and TLF when BVS are implanted by experienced operators with a dedicated implantation technique.
OBJECTIVES: The aim of this study was to evaluate the impact of a consistent and dedicated implantation strategy on long-term outcomes after implantation of bioresorbable vascular scaffold (BVS) in a real-world cohort of patients with a high prevalence of complex lesions. BACKGROUND: Bioresorbable vascular scaffolds may result in a reduced incidence of late and very-late scaffold thrombosis (ScT) after the complete reabsorption of the scaffold, but this hypothesis is hampered by data from RCTs that showed a higher than expected incidence of late events. However, these studies did not adopt a dedicated implantation technique, that proved to be fundamental in reducing the incidence of adverse events. METHODS: 573 consecutive patients (912 lesions) treated with bioresorbable scaffolds between May 2012 and December 2014 were enrolled in 3 high-volume centers that used a dedicated implantation strategy from the beginning. Primary endpoints were target-lesion failure (TLF) and definite and probable ScT. Secondary endpoints included myocardial infarction, target-lesion and target-vessel revascularization. RESULTS: The registry enrolled a high complexity subset of lesions (69.4% of type B2 or C lesions; 10.3% of severe calcific lesions; 26.1% of bifurcations). Predilatation was performed in almost all cases (99.2%); intracoronary imaging was liberally adopted (37.3%). Mean scaffold length was 42.9 ± 27.4 mm per patient, and post-dilation with a 1:1 high-pressure (22 ± 3.5 atm) balloon was performed in 99.9% of lesions. Median follow-up (available for 98.6% of patients) was 981 days (IQR 802-1133). Overall incidence of ScT was reassuringly low: three thrombotic events occurred during the first year (0.5%), while only one event ensued in the second year of follow-up, and ScT rate remained stable thereafter up to the fourth year (0.7%). Cumulative TLF rates at 1, 2, 3 and 4 years were 3.0%, 6.0%, 7.8% and 12.2%. CONCLUSIONS: These long-term results from a complex "real-world" population appear to be reassuring as regards to the incidence of ScT and TLF when BVS are implanted by experienced operators with a dedicated implantation technique.