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Mechanical properties of the everolimus-eluting bioresorbable vascular scaffold compared to the metallic everolimus-eluting stent
© The Author(s). 2016
Received: 19 January 2016
Accepted: 21 May 2016
Published: 25 May 2016
Everolimus-eluting bioresorbable vascular scaffolds (BVS) represent an innovative treatment option for coronary artery disease. Clinical and angiographic results seem promising, however, data on its immediate procedural performance are still scarce. The aim of our study was to assess the mechanical properties of BVS by Optical Coherence Tomography (OCT) in clinical routine.
Post-implantation OCT images of 40 BVS were retrospectively compared to those of 40 metallic everolimus-eluting stents (EES). Post-procedural device related morphological features were assessed. This included incidences of gross underexpansion and the stent eccentricity index (SEI, minimum/maximum diameter) as a measure for focal radial strength.
Patients receiving BVS were younger than those with EES (54.0 ± 11.2 years versus 61.7 ± 11.4 years, p = 0.012), the remaining baseline, vessel and lesion characteristics were comparable between groups. Lesion pre-dilatation was more frequently performed and inflation time was longer in the BVS than in the EES group (n = 34 versus n = 23, p = 0.006 and 44.2 ± 12.8 versus 25.6 ± 8.4 seconds, p < 0.001, respectively). There were no significant differences in maximal inflation pressures and post-dilatation frequencies with non-compliant balloons between groups. Whereas gross device underexpansion was not significantly different, SEI was significantly lower in the BVS group (n = 12 (30 %) versus n = 14 (35 %), p = 0.812 and 0.69 ± 0.08 versus 0.76 ± 0.09, p < 0.001, respectively). There was no difference in major adverse cardiac event-rate at six months.
Our data show that focal radial expansion was significantly reduced in BVS compared to EES in a clinical routine setting using no routine post-dilatation protocol. Whether these findings have impact on scaffold mid-term results as well as on clinical outcome has to be investigated in larger, randomized trials.
Drug eluting stents (DES) have shown to be highly effective in the treatment of patients with coronary artery disease [1–3] as neointimal hyperplasia after a vascular injury was reduced compared to when bare metal stents were used [2, 3]. Nevertheless, delayed or absent strut endothelialization, persistent or acquired malapposition and neoatherosclerosis of DES contribute to late stent failure rates which are in the range of 1-2 % a year within the first three years after implantation [4–6]. In addition stent fractures especially at hinge points of the coronary vessels and the lack of adaptive remodelling processes in the artery wall can contribute to late events.
Bioresorbable vascular scaffolds (BVS) were developed in order to reduce those potential adverse events after a coronary intervention. After the bioresorption process is completed there will not be any potential triggers for late adverse events . In contrast to vessels caged by metallic stents, vessels transiently scaffolded by bioresorbable materials are able to perform vasoconstriction and vasodilation and therefore could also contribute to better symptom control in patients with coronary artery disease [8–11]. It was also shown that BVS are characterized by a better conformability to the vessel compared to metallic stents . On the other hand it is still unclear if the radial strength provided by BVS is sufficient throughout various clinical scenarios. It has been shown that metallic stents generate a larger acute lumen gain compared to BVS, but scaffold/stent type was not predictive for acute recoil . Intravascular imaging data describing device strength and expansion are still scarce. The aim of the present study was to assess the mechanical properties of BVS by Optical Coherence Tomography (OCT) in clinical routine.
Between March and June 2013, 26 consecutive patients underwent OCT immediately after implantation of 40 BVS (Absorb, Abbott Vascular, Santa Clara, CA, USA). Elective patients as well as patients presenting with acute coronary syndrome (ACS) were included. The OCT data of these patients were retrospectively compared with those of 34 consecutive patients after implantation of 40 metallic everolimus-eluting stents (EES, Xience, Abbott Vascular, Santa Clara, CA, USA).
Patient characteristics were collected from the medical records of each patient, device characteristics and deployment strategies were collected from the database of the cardiac catheter laboratory. This study was approved by the ethics committee of the Medical University of Vienna and all patients gave their written informed consent.
Stent eccentricity index (SEI): at the site of minimal lumen area (MLA) stent eccentricity index, defined as the ratio between minimal and maximal diameter, was calculated .
Stent symmetry index (SSI): at the site of MLA stent symmetry index, defined as (maximal-minimal diameter)/maximal diameter, was calculated .
Underexpansion: a stent was considered underexpanded if MLA was ≤ 80 % of average reference lumen area .
Plaque characteristics: plaque type was determined at proximal and distal stent ending, as well as at MLA and was considered to be either lipid-rich, fibrous or fibro-calcific .
Incomplete stent apposition (ISA): struts were considered incompletely apposed when they were separated from the underlying vessel wall in case of BVS  or when the axial distance between strut's surface and the luminal surface was greater than the strut thickness in case of EES .
OCT - acquisition and analysis
Patients were pre-treated with a dual antiplatelet therapy, a weight-adjusted intravenous bolus of unfractionated heparin, and 200 μg intracoronary nitroglycerine. The OCT images were obtained using a frequency domain (FD) - OCT system (LightLab Imaging, Inc., Westford, MS, USA). The FD-OCT imaging catheters were delivered over a 0.014-inch (0.0356 cm) guide wire through a 6-F guiding catheter. Images were acquired using a motorized pullback system at a speed of 36 mm/s during a flush of 4 to 6 ml/s of iso-osmolar contrast (Iodixanol 320, VisipaqueTM, GE Health Care, Cork, Ireland) through the guiding catheter to replace the blood flow and permit the visualization of the stented segment and intima-lumen interface. Whenever the stented segment was too long to be completely imaged in a single pullback, the image acquisition was repeated from the same position during a second contrast injection. Anatomic landmarks such as side branches, calcifications or stent overlap segments were used for longitudinal view orientation.
OCT imaging was performed after what was deemed to be an angiographically successful intervention at the operator’s discretion. All OCT frames were digitally stored and independently analyzed using an offline software (LightLab Console) by one operator, who is experienced in and familiar with assessing OCT images. Cross-sections within the stented segment were analyzed every frame.
The statistical analysis was conducted with SPSS® Statistics 21.0 (SPSS Inc, Chigago, USA). Quantitative data were presented as mean ± standard deviation. Qualitative data were presented as frequencies. Categorical variables were assessed by χ2 statistics and Fisher's exact test. Continuous variables were compared using an unpaired t-test. A p-value <0.05 was considered statistically significant.
BVS (n = 26)
EES (n = 34)
54.0 ± 11.2
61.7 ± 11.4
Male, n (%)
No, n (%)
NIDDM, n (%)
IDDM, n (%)
Hypertension, n (%)
Hyperlipidemia, n (%)
Positive family history, n (%)
No, n (%)
Ex, n (%)
Current, n (%)
Indication for PCI
ACS - STEMI, n (%)
ACS - NSTEMI, n (%)
Non-ACS elective, n (%)
LAD, n (%)
CX, n (%)
RCA, n (%)
Ramus intermedius, n (%)
Type B1, n (%)
Type B2, n (%)
Type C, n (%)
Device and procedural characteristics
BVS (n = 40)
EES (n = 40)
Nominal diameter, mm
3.23 ± 0.34
3.07 ± 0.54
21.80 ± 5.62
21.13 ± 9.21
81 ± 14
89 ± 14
Inflation time, sec
44 ± 13
26 ± 8
Inflation pressure, atm
13 ± 3
13 ± 3
Predilatation, n (%)
Predilatation-ballon diameter, mm
2.64 ± 0.51
2.34 ± 0.46
Predilatation-ballon inflation pressure, atm
13 ± 2
12 ± 3
Postdilatation, n (%)
Postdilatation-ballon diameter, mm
3.41 ± 0.47
3.27 ± 0.60
Postdilatation-ballon inflation pressure, atm
15 ± 3
16 ± 4
Postdilatation with NC-ballon, n (%)
Contrast volume, ml
215.2 ± 150.9
213.9 ± 96.8
Radiation time, min
12.1 ± 9.2
11.8 ± 6.5
BVS (n = 40)
EES (n = 40)
Plaque type distal stent ending
Lipid rich, n (%)
Fibrous, n (%)
Fibro-calcific, n (%)
Plaque type proximal stent ending
Lipid rich, n (%)
Fibrous, n (%)
Fibro-calcific, n (%)
Plaque type MLA
Lipid rich, n (%)
Fibrous, n (%)
Fibro-calcific, n (%)
Plaque rupture - hematoma, n (%)
Reference vessel area distal, mm2
6.40 ± 2.11
6.49 ± 2.57
Reference vessel diameter distal, mm
2.78 ± 0.49
2.80 ± 0.64
Reference vessel area proximal, mm2
8.98 ± 2.55
9.43 ± 4.15
Reference vessel diameter proximal, mm
3.37 ± 0.51
3.44 ± 0.76
Reference vessel area, mm2
7.69 ± 2.17
7.96 ± 3.30
Reference vessel diameter, mm
3.07 ± 0.44
3.09 ± 0.62
Distal stent ending area, mm2
6.77 ± 2.34
6.97 ± 2.75
Distal stent ending diameter, mm
2.88 ± 0.53
2.92 ± 0.56
Proximal stent ending area, mm2
7.48 ± 2.35
8.62 ± 3.51
Proximal stent ending diameter, mm
3.04 ± 0.49
3.25 ± 0.63
Difference nominal diameter-proximal stent ending diameter, mm
0.19 ± 0.37
- 0.18 ± 0.52
Mean stent area, mm2
7.12 ± 2.20
7.79 ± 2.30
Mean stent diameter, mm
2.96 ± 0.48
3.08 ± 0.57
Minimal lumen area, mm2
6.38 ± 2.00
6.42 ± 2.42
Minimal stent diameter, mm
2.46 ± 0.43
2.53 ± 0.54
Maximal stent diameter, mm
3.53 ± 0.52
3.31 ± 0.64
Stent eccentricity index
0.69 ± 0.08
0.76 ± 0.09
Stent symmetry index
0.30 ± 0.09
0.23 ± 0.09
16.99 ± 12.86
17.70 ± 11.50
Rate of ISA, %
3.4 ± 1.9
2.9 ± 1.9
Underexpansion, n (%)
Underexpansion & hematoma, n (%)
Stent fracture, n (%)
Six months clinical follow-up
BVS (n = 26)
EES (n = 34)
MACE, n (%)
Death, n (%)
MI, n (%)
TV-Revasc., n (%)
Non-TV-Revasc. n (%)
Whereas BVS were rapidly adopted in clinical routine, prospective data especially with regard to complex lesions are still rare [19–21]. Recent data suggest that acute and late stent thrombosis are more frequent in BVS compared to DES , which is potentially associated with the unique mechanical properties of BVS. It has been shown that OCT is a valuable tool in determining post-procedural success with both BVS and DES as it potentially reduces late complications caused by mechanical shortcomings of the devices not detected when using angiography. This is the first OCT study comparing BVS and EES in a clinical routine setting.
This is a retrospective, single center, non-randomized observational study in a limited number of patients. Although patient characteristics were well matched no propensity adjustments have been performed. Final OCT assessment was performed, when the operators deemed to be angiographically successful, which provides a potential bias.
Nevertheless in the learning curve of a new technology it is of high value to identify potential safety concerns additionally to large randomized trials in clinical studies. In our routine setting we could reveal significant differences in the post-procedural geometry between BVS and EES using OCT. Whether these differences may contribute to the somewhat higher stent thrombosis rates observed in other series remains unclear. To avoid inappropriate BVS expansion it seems advisable to incorporate routine post-dilatation with NC-balloons in the procedural protocol. The role of aggressive pre-dilatation with its potential complications remains a matter of debate and the use of intravascular imaging may further delineate the appropriate use of BVS.
Although minimal lumen areas and rates of device underexpansion were comparable between BVS and EES, local radial expansion is significantly reduced in BVS in a clinical routine setting using no post-dilatation protocol. The clinical importance of this finding remains unclear and has to be evaluated in larger, randomized trials. However, a lower uniform expansion of the BVS could contribute to clinical events such as scaffold thrombosis and should be considered when implanting these devices. Considering the relatively low number of post-dilatations with non-compliant balloons in the BVS group our data further suggest that routine post-dilatation should be strongly considered.
ACS, acute coronary syndrome; BVS, bioresorbable vascular scaffold; CAD, coronary artery disease; DES, drug eluting stent; EES; everolimus eluting stent; FD, frequency domain; ISA, incomplete stent apposition; IVUS, intra vascular ultra sound, MACE, major adverse cardiovascular event; MLA, minimal lumen area; NC, non compliant; OCT, optical coherence tomography; SEI, stent eccentricity index; SSI, stent symmetry index.
No funding was obtained for this study.
Availability of data and materials
Data cannot be shared due to current calculations regarding additional projects.
DD, MD Conception and design, analysis and interpretation of data, drafting of the manuscript, approval of the final version. CG, MD Conception and design, analysis and interpretation of data, drafting of the manuscript, approval of the final version. CR, MD Analysis and interpretation of data, revising the manuscript critically for important intellectual content, approval of the final version. LK, MD Analysis and interpretation of data, revising the manuscript critically for important intellectual content, approval of the final version. SS, MD Conception and design, analysis and interpretation of data, revising the manuscript critically for important intellectual content, approval of the final version. MV Analysis and interpretation of data, revising the manuscript critically for important intellectual content, approval of the final version. IL, MD Analysis and interpretation of data, revising the manuscript critically for important intellectual content, approval of the final version. GM, MD Analysis and interpretation of data, revising the manuscript critically for important intellectual content, approval of the final version. TN, MD Conception and design, analysis and interpretation of data, drafting of the manuscript, approval of the final version. RB, MD Analysis and interpretation of data, revising the manuscript critically for important intellectual content, approval of the final version. GDK, MD Conception and design, analysis and interpretation of data, drafting of the manuscript, approval of the final version.
Irene Lang has relationships with drug and device companies including AOPOrphan Pharmaceuticals, Actelion, Bayer-Schering, Astra-Zeneca, Abbott, Servier, Cordis, Medtronic, GlaxoSmithKline, Novartis, Pfizer and United Therapeutics. In addition to being investigator in trials involving these companies, relationships include consultancy service, research grants, and membership of scientific advisory boards. The authors declare that they have no competing interests.
Consent for publication
Ethics and consent to participate
The study was approved by the ethics committee of the Medical University of Vienna (EK#1722/2013) and written informed consent was obtained from all patients.
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