Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization: 3-Year Outcomes From the Randomized BIOFLOW V Trial
Coronary
Central Illustration
Abstract
Objectives
The aim of this study was to compare late-term clinical outcomes among patients treated with ultrathin-strut (60-μm) bioresorbable-polymer sirolimus-eluting stents (BP SES) and thin-strut (81μm) durable-polymer everolimus-eluting stents (DP EES).
Background
Emerging evidence from comparative studies of drug-eluting stents demonstrates improved safety and efficacy with ultrathin-strut drug-eluting stents, but limited insight exists regarding late-term outcomes.
Methods
BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With Up to Three De Novo or Restenotic Coronary Artery Lesions V) is an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure. Analysis of pre-specified 3-year clinical outcomes was performed.
Results
Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 3-year rate of target lesion failure was 8.2% for BP SES and 13.6% for DP EES (p = 0.002), driven by differences in both target vessel myocardial infarction (MI) (5.0% vs. 9.2%; p = 0.003) and clinically driven target lesion revascularization (3.2% vs. 6.7%; p = 0.006). In landmark analysis, significant differences in target vessel MI and target lesion revascularization were observed favoring treatment with BP SES. Definite or probable late or very late stent thrombosis was significantly lower with BP SES (0.1% vs. 1.2%; p = 0.018). Cardiac death or MI rates were 7.7% and 11.7% (p = 0.017) for BP SES and DP EES, respectively.
Conclusions
In a large randomized trial, both target lesion failure and the outcomes of target vessel MI, clinically driven target lesion revascularization, and late or very late stent thrombosis at 3 years were significantly lower among patients treated with BP SES versus DP EES. The results endorse the continued superiority of ultrathin-strut BP SES compared with DP EES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946)
References
1. "Stent thrombogenicity early in high- risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings". Circulation 2011;123:1400-1409.
2. "Rationale and design of the BIOFLOW V study, a prospective randomized multicenter study to assess the safety and effectiveness of the Orsiro sirolimus-eluting coronary stent system in the treatment of subjects with up to three de novo or restenotic coronary artery lesions". Am Heart J 2017;193:35-45.
3. "Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial". Lancet 2017;390:1843-1852.
4. "Ultrathin bioresorbable polymer sirolimus-eluting stents versus thin durable polymer everolimus-eluting stents: BIOFLOW V 2-year results". J Am Coll Cardiol 2018;72:3287-3297.
5. "Ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents versus thin-strut, durable-polymer, everolimus-eluting stents for percutaneous coronary revascularization: 5-year outcomes of the BIOSCIENCE randomised trial". Lancet 2018;392:737-746.
6. "Thin, very thin, or ultrathin strut biodegradable or durable polymer-coated drug-eluting stents: 3-year outcomes of BIO-RESORT". J Am Coll Cardiol Intv 2019;12:1650-1660.
7. "Outcomes in patients treated with thin-strut, very thin-strut, or ultrathin-strut drug-eluting stents in small coronary vessels: a prespecified analysis of the randomized BIO-RESORT trial". JAMA Cardiol 2019;4:659-669.
8. "Clinical end points in coronary stent trials: a case for standardized definitions". Circulation 2007;115:2344-2351.
9. "On the combination of independent two-sample tests of Wilcoxon". Bull Int Stat Inst 1960;37:351-361.
10. "Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial". Lancet 2019;394:1243-1253.
11. "A randomized trial comparing a polymer-free coronary drug-eluting stent with an ultra-thin strut bioresorbable polymer-based drug-eluting stent in an allcomers patient population: SORT OUT IX". Presented at: TCT 2018; September22, 2018; San Diego, CA.
12. "Two-year clinical, angiographic, and intravascular ultrasound follow-up of the XIENCE V everolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions. The SPIRIT II trial". Circ Cardiovasc Intervent 2009;2:339-347.
13. "Five-year results of a randomized comparison of XIENCE V everolimus-eluting and TAXUS paclitaxel-eluting stents: final results from the SPIRIT III trial". J Am Coll Cardiol Intv 2013;6:1263-1266.
14. "Comparison of zotarolimus- and everolimus-eluting coronary stents. Final 5-year report of the RESOLUTE all-comers trial". Circ Cardiovasc Intervent 2015;8:e002230.
15. "Final 5-year follow-up of a randomized controlled trial of everolimus- and paclitaxel-eluting stents for coronary revascularization in daily practice: the COMPARE Trial". J Am Coll Cardiol Intv 2015;8:1157-1165.
16. "Newer generation ultrathin strut drug-eluting stents versus older second-generation thicker strut drug-eluting stents for coronary artery disease". Circulation 2018;138:2216-2226.
17. "Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO) trial". Circulation 2001;103:2816-2821.
18. "Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial". J Am Coll Cardiol 2003;41:1283-1288.
19. "The pathology of neoatherosclerosis in human coronary implants: bare-metal and drug-eluting stents". J Am Coll Cardiol 2011;57:1314-1322.
20. "Late restenosis following sirolimus-eluting stent implantation". J Am Coll Cardiol Intv 2011;4:123-128.
21. "Histopathological comparison of biodegradable polymer and permanent polymer based sirolimus eluting stents in a porcine model of coronary stent implantation". Thromb Haemost 2012;107:1161-1171.