Abstract

BackgroundDrug-eluting stents (DES) compared to bare metal stents (BMS) have shown superior clinical performance, but are considered less suitable in complex cases. Most studies do not distinguish between DES and BMS with respect to their mechanical performance. The objective was to obtain mechanical parameters for direct comparison of BMS and DES.MethodsIn vitro bench tests evaluated crimped stent profiles, crossability in stenosis models, elastic recoil, bending stiffness (crimped and expanded), and scaffolding properties. The study included five pairs of BMS and DES each with the same stent platforms (all n = 5; PRO-Kinetic Energy, Orsiro: BIOTRONIK AG, Bülach, Switzerland; MULTI-LINK 8, XIENCE Xpedition: Abbott Vascular, Temecula, CA; REBEL Monorail, Promus PREMIER, Boston Scientific, Marlborough, MA; Integrity, Resolute Integrity, Medtronic, Minneapolis, MN; Kaname, Ultimaster: Terumo Corporation, Tokyo, Japan). Statistical analysis used pooled variance t tests for pairwise comparison of BMS with DES.ResultsCrimped profiles in BMS groups ranged from 0.97 ± 0.01 mm (PRO-Kinetic Energy) to 1.13 ± 0.01 mm (Kaname) and in DES groups from 1.02 ± 0.01 mm (Orsiro) to 1.13 ± 0.01 mm (Ultimaster). Crossability was best for low profile stent systems. Elastic recoil ranged from 4.07 ± 0.22% (Orsiro) to 5.87 ± 0.54% (REBEL Monorail) including both BMS and DES. The bending stiffness of crimped and expanded stents showed no systematic differences between BMS and DES neither did the scaffolding.ConclusionsBased on in vitro measurements BMS appear superior to DES in some aspects of mechanical performance, yet the differences are small and not class uniform. The data provide assistance in selecting the optimal system for treatment and assessment of new generations of bioresorbable scaffolds.Trial registration: not applicable

Highlights

  • Drug-eluting stents (DES) compared to bare metal stents (BMS) have shown superior clinical perfor‐ mance, but are considered less suitable in complex cases

  • Exceptions include the Integrity and Resolute Integrity that are made from a CoNi-base alloy (MP35N) and the REBEL and Promus PREMIER stents that are made from a platinum-chromium alloy (PtCr)

  • In technically demanding cases even minor differences in performance characteristics may be decisive in BMS, DES or bioresorbable scaffolds (BRS)

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Summary

Introduction

Drug-eluting stents (DES) compared to bare metal stents (BMS) have shown superior clinical perfor‐ mance, but are considered less suitable in complex cases. Most studies do not distinguish between DES and BMS with respect to their mechanical performance. The superior clinical performance of drug-eluting stents (DES) compared to bare metal stents (BMS) has been widely documented and confirmed. While being mostly discussed based on clinical empiricism, differences between BMS and DES with respect to their mechanical properties have been rarely considered. It is widely believed that the potential advantages of BMS compared to DES may be better mechanical properties, such as low profile, better trackability and crossability. We report in vitro measurements of crossing profiles and flexibility of representative DES and BMS stent delivery systems (SDS) allowing objective estimates of expected behaviour in vivo. Measurements of the cell sizes of stents inflated to nominal pressures have been performed to allow estimates of scaffolding efficacy

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