Journal of the American College of Cardiology · 2017
Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents.
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Sorrentino Sabato, Giustino Gennaro, Mehran Roxana, Kini Anapoorna S, Sharma Samin K, Faggioni Michela, Farhan Serdar, Vogel Birgit, Indolfi Ciro, Dangas George D
Аннотация
BACKGROUND: Recent evidence suggests that bioresorbable vascular scaffolds (BVS) are associated with an excess of thrombotic complications compared with metallic everolimus-eluting stents (EES).
OBJECTIVES: This study sought to investigate the comparative effectiveness of the Food and Drug Administration-approved BVS versus metallic EES in patients undergoing percutaneous coronary intervention at longest available follow-up.
METHODS: The authors searched MEDLINE, Scopus, and web sources for randomized trials comparing BVS and EES. The primary efficacy and safety endpoints were target lesion failure and definite or probable stent thrombosis, respectively.
RESULTS: Seven trials were included: in sum, 5,583 patients were randomized to receive either the study BVS (n = 3,261) or the EES (n = 2,322). Median time of follow-up was 2 years (range 2 to 3 years). Compared with metallic EES, risk of target lesion failure (9.6% vs. 7.2%; absolute risk difference: +2.4%; risk ratio: 1.32; 95% confidence interval: 1.10 to 1.59; number needed to harm: 41; p = 0.003; I2 = 0%) and stent thrombosis (2.4% vs. 0.7%; absolute risk difference: +1.7%; risk ratio: 3.15; 95% confidence interval: 1.87 to 5.30; number needed to harm: 60; p < 0.0001; I2 = 0%) were both significantly higher with BVS. There were no significant differences in all-cause or cardiovascular mortality between groups. The increased risk for ST associated with BVS was concordant across the early (<30 days), late (30 days to 1 year), and very late (>1 year) periods (pinteraction = 0.49).
CONCLUSIONS: Compared with metallic EES, the BVS appears to be associated with both lower efficacy and higher thrombotic risk over time. (Bioresorbable vascular scaffold compare to everolimus stents in long term follow up; CRD42017059993).
OBJECTIVES: This study sought to investigate the comparative effectiveness of the Food and Drug Administration-approved BVS versus metallic EES in patients undergoing percutaneous coronary intervention at longest available follow-up.
METHODS: The authors searched MEDLINE, Scopus, and web sources for randomized trials comparing BVS and EES. The primary efficacy and safety endpoints were target lesion failure and definite or probable stent thrombosis, respectively.
RESULTS: Seven trials were included: in sum, 5,583 patients were randomized to receive either the study BVS (n = 3,261) or the EES (n = 2,322). Median time of follow-up was 2 years (range 2 to 3 years). Compared with metallic EES, risk of target lesion failure (9.6% vs. 7.2%; absolute risk difference: +2.4%; risk ratio: 1.32; 95% confidence interval: 1.10 to 1.59; number needed to harm: 41; p = 0.003; I2 = 0%) and stent thrombosis (2.4% vs. 0.7%; absolute risk difference: +1.7%; risk ratio: 3.15; 95% confidence interval: 1.87 to 5.30; number needed to harm: 60; p < 0.0001; I2 = 0%) were both significantly higher with BVS. There were no significant differences in all-cause or cardiovascular mortality between groups. The increased risk for ST associated with BVS was concordant across the early (<30 days), late (30 days to 1 year), and very late (>1 year) periods (pinteraction = 0.49).
CONCLUSIONS: Compared with metallic EES, the BVS appears to be associated with both lower efficacy and higher thrombotic risk over time. (Bioresorbable vascular scaffold compare to everolimus stents in long term follow up; CRD42017059993).