Author + information
- Received January 14, 2017
- Revision received April 10, 2017
- Accepted April 10, 2017
- Published online April 12, 2017.
- Sabato Sorrentino, MDa,b,∗,
- Gennaro Giustino, MDa,∗,
- Roxana Mehran, MDa,
- Anapoorna S. Kini, MDa,
- Samin K. Sharma, MDa,
- Michela Faggioni, MDa,c,
- Serdar Farhan, MDa,
- Birgit Vogel, MDa,
- Ciro Indolfi, MDb,d and
- George D. Dangas, MD, PhDa,∗ ( )()
- aThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- bDivision of Cardiology, Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy
- cCardiothoracic Department, Division of Cardiology, University Hospital of Pisa, Italy
- dURT-CNR, Department of Medicine, Consiglio Nazionale delle Ricerche of IFC, Viale Europa S/N, Catanzaro, 88100, Italy
- ↵∗Corresponding Author: George D. Dangas MD The Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai One Gustave L. Levy Place Box 1030 New York, New York 10029 Telephone: 212-241-7014 Fax: 212-241-0273.
Background Recent evidence suggests that bioresorbable vascular scaffolds (BVS) are associated with an excess of thrombotic complications compared with metallic everolimus-eluting stents (EES).
Objective We sought to investigate the comparative effectiveness of the FDA approved Absorb BVS versus metallic EES in patients undergoing percutaneous coronary intervention at longest available follow-up.
Methods We searched MEDLINE, Scopus and web sources for randomized trials comparing the BVS and EES. The primary efficacy and safety endpoints were target lesion failure and definite/probable stent thrombosis, respectively. This study is registered with PROSPERO, number CRD42017059993.
Results Seven trials were included: in sum, 5,583 patients were randomized to receive either the study Absorb BVS (n=3,261) versus 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 [ARD] = +2.4%, relative risk [RR]: 1.32, 95% confidence interval [CI]: 1.10 to 1.59, number needed to harm [NNH] = 41, p=0.003, I2=0%) and stent thrombosis (2.4% vs. 0.7%, ARD: +1.7%, RR: 3.15, 95% CI: 1.87 to 5.30, NNH = 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).
Conclusion Compared with metallic EES, the Absorb BVS appears to be associated with both lower efficacy and higher thrombotic risk over time.
↵∗ The first two authors contributed equally to this work.
Disclosures: GD is consultant to Bayer, Boston Scientific, Daiichi-Sankyo, Medtronic his spouse has received speaker honoraria (modest level) from Abbott, CSI, Janssen, and Astra Zeneca. RM has is a consultant to Janssen, Bayer, Daiichi-Sankyo, Osprey Medical Inc., and has received speaker honoraria (modest level) from Abbott, CSI, Janssen and Astra Zeneca. SKS is on the Speakers Bureau for Abbott, Boston Scientific, Cardiovascular Systems Inc., and TriReme. CI received research and educational grants from Abbott vascular (not for this specific study). All other authors report no relevant conflicts of interest.
- Received January 14, 2017.
- Revision received April 10, 2017.
- Accepted April 10, 2017.