Author + information
- 1University of Tennessee, Memphis, Tennessee, United States
- 2University of Tennessee, Memphis, United States
- 3UT school of Medicine, Memphis, Tennessee, United States
- 4UTHSC, Germantown, Tennessee, United States
- 5UT Memphis, Memphis, Tennessee, United States
- 6University of Tennessee Health Science Center, Memphis, Tennessee, United States
Several meta-analyses of RCTs have shown that bioresorbable vascular scaffolds (BVSs) are associated with increased risk of device thrombosis (DT). However, those meta-analyses used follow up data that extended no more than two years. As a result, it is unclear whether the increased risk of DT with BVSs persists beyond two years. Recently, 3-year follow-up data for several RCTs have been reported. Therefore, we performed an updated comprehensive meta-analysis to evaluate whether the increased risk of DT with BVSs persists beyond two years.
After a literature search for relevant RCTs, pooled risk ratios were calculated using random-effect models. To determine overall (cumulative) DT risk, data for the longest available follow-up from each RCT were used. Additional analyses were performed for very late DT (DT at 1-2 years) and very very late DT (DT at 2-3 years).
Data from 7 trials involving 5567 patients were included. Overall, BVSs were associated with increased risk of DT compared to metallic stents (RR ;3.19, 95% CI,1.89-5.36: P <0.001). Similarly, they were associated with increased risk of very late (1-2 years) DT (RR ;3.58, 95% CI,1.31 -9.75: P =0.012).). However, no difference in very very late (2-3 years) DT risk was found (RR ;2.75, 95% CI,0.31-23.6 P=0.357).
The increased risk of DT with BVSs seems to disappear 2 years post-implant. Continued long-term follow-up of all relevant RCTs is needed to confirm these findings.
CORONARY: Bioresorbable Vascular Scaffolds