Bioresorbable Vascular Scaffolds: Is the Light Fading at the End of the Tunnel?

To the Editor:

We congratulate Dr. Kang and colleges on their excellent work regarding the use of Absorb^TM bioresorbable vascular scaffolds (BVS) in percutaneous coronary interventions.¹ The authors highlighted some major challenges associated with BVS use and discussed the trend shift of BVS from being non-inferior to the standard-care drug-eluting stents to an alarming association with serious drawbacks in longer-term follow-up. Indeed, as correctly stated by the authors, the mid- to long-term results of the Absorb II and III trials illustrated significantly higher rates of target lesion failure (TLF) with BVS, compared with everolimus-eluting stents (EES) and thus raised question regarding the mid- to long-term safety of BVS.^2,3 With that being said, we would like to highlight the fact that newer evidence has emerged, following the release of those 2 trials, showing a significant increase in the incidences of TLF, target vessel myocardial infarction, target lesion revascularization and late/very late stent thrombosis (>1 year) with BVS as well. In a recent meta-analysis of 6 randomized trials, conducted by our group (at a mean follow of 25 months) the incidence of TLF, target vessel myocardial infarction and late/very late stent thrombosis was 11.4 vs. 7.7%, 4.9 vs. 2.6% and 0.8 vs. 0.2%, for BVS compared with EES, respectively.⁴ These results were also similar to another recent meta-analysis evaluating the long-term outcomes of these devices.⁵ Such new evidence increases the concerns regarding the safety and efficacy of current-generation BVS and puts in question the adequacy of continued utilization of these devices in their current form, especially in general practice settings.

Thus, in summary, we agree with the authors that the current generation of BVS need further technical evolution to replace the standard-care DES in routine clinical use. The results of longer-term follow-up (>5 years) of the trials evaluating BVS are crucial to determining their fate.

Conflicts of Interest

All authors have nothing to disclose.

• Ahmed N. Mahmoud, MD
• Akram Y. Elgendy, MD
• Islam Y. Elgendy, MD
• Division of Cardiovascular Medicine,
• Department of Internal Medicine,
• University of Florida, Gainesville, FL, USA

References

• 1.   Kang J, Han JK, Yang HM, Park KW, Kang HJ, Koo BK, et al. Bioresorbable vascular scaffolds: Are we facing a time of crisis or one of breakthrough? Circ J 2017; 81: 1065–1074.
• 2.   Serruys PW, Chevalier B, Sotomi Y, Cequier A, Carrie D, Piek JJ, et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): A 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet 2016; 388: 2479–2491.
• 3.   Gao R. ABSORB China: Two-year clinical results in patients with coronary artery disease randomized to the Absorb bioresorbable vascular scaffold versus metallic drug-eluting stents. Presented at TCT 2016, Washington DC, October 2016. http://www.crtonline.org/presentation-detail/absorb-china-two-year-clinical-results-in-patients (accessed January 10, 2016).
• 4.   Mahmoud AN, Barakat AF, Elgendy AY, Schneibel E, Mentias A, Abuzaid A, et al. Long-term efficacy and safety of Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: A meta-analysis of randomized trials. Circ Cardiovasc Interv 2017; 10: e005286.
• 5.   Montone RA, Niccoli G, De Marco F, Minelli S, D’Ascenzo F, Testa L, et al. Temporal trends in adverse events after everolimus-eluting bioresorbable vascular scaffold versus everolimus-eluting metallic stent implantation: A meta-analysis of randomized controlled trials. Circulation 2017; 135: 2145–2154.