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©2011 Baishideng Publishing Group Co.
World J Cardiol. Mar 26, 2011; 3(3): 84-92
Published online Mar 26, 2011. doi: 10.4330/wjc.v3.i3.84
Published online Mar 26, 2011. doi: 10.4330/wjc.v3.i3.84
Table 1 Comparison between published trials of biodegradable eluting stents
Name | Polymer | Stent design | Drug | Drug per stent length (μg/mm2) | Polymer degradation | Drug release |
ISAR-TEST-3[35] | PLA | 316L stainless steel microporus stent | Sirolimus | 4.8 | 6-9 wk | 28 d (95%) |
ISAR TEST-4[36] | PLA | 316L stainless-steel microporus stent | Sirolimus | 4.8 | 6-9 wk | 28 d (95%) |
NOBORI 1[34] | PLA | Stainless-steel S-stent | Biolimus | 15.6 | 9-12 mo | Two phases: immediately after stent implantation; sustained drug release over 9-12 mo |
NOBORI CORE[33] | PLA | Stainless-steel S-stent | Biolimus | 15.6 | 9-12 mo | Two phases: immediately after stent implantation; sustained drug release over 9-12 mo |
LEADERS[28] | PLA | Flexible stainless- steel stent | Biolimus | 15.6 | 6-9 mo | 6-9 mo |
PAINT[38] | PLA+ | 316L stainless metallic platform | Paclitaxel and Sirolimus | 6.4 (PES) | 7 mo | 9-11 d (50%) |
PLGA | 6.6 (SES) | 38 d (90%) | ||||
48 d (100%) | ||||||
EUCATAX[39] | PLGA | Stainless steel open cell with glycocalix layer | Paclitaxel | 11 to 43 | 6-8 wk | 6-8 wk |
Table 2 Quantitative coronary analysis for both groups in the EUCATAX trial n (%)
PES | BMS | P value | |
Baseline QCA analysis | n = 169 | n = 153 | |
Reference diameter (mm) | 2.75 ± 0.5 | 2.85 ± 0.5 | 0.086 |
Minimal luminal diameter (mm) | 0.86 ± 0.4 | 0.85 ± 0.5 | 0.780 |
Lesion length (mm) | 16.2 ± 6.1 | 15.6 ± 6.3 | 0.410 |
Stent diameter (mm) | 21.7 ± 5.6 | 20.0 ± 4.8 | 0.160 |
Stent size (mm) | 2.96 ± 0.4 | 2.93 ± 0.5 | 0.780 |
Immediately Post PCI QCA analysis | |||
Reference diameter (mm) | 2.91 ± 0.44 | 2.96 ± 0.43 | 0.340 |
Minimal luminal diameter (mm) | 2.68 ± 0.42 | 2.72 ± 0.43 | 0.400 |
Follow up QCA analysis | n = 98 | n = 88 | |
Reference diameter (mm) | 2.75 ± 0.48 | 2.75 ± 0.36 | 0.990 |
Minimal luminal diameter (mm) | 2.16 ± 0.51 | 1.81 ± 0.75 | 0.007 |
Stenosis diameter (%) | 27.4 ± 29.8 | 39.6 ± 23.9 | 0.005 |
Acute gain | 1.82 ± 0.47 | 1.87 ± 0.62 | 0.450 |
Net gain | 1.30 ± 0.49 | 0.93 ± 0.63 | 0.002 |
Late loss (in-stent) | 0.52 ± 0.59 | 0.94 ± 0.70 | 0.002 |
Late loss (in-segment) | 0.50 ± 0.56 | 0.91 ± 0.069 | 0.001 |
Angiographic restenosis | 13 (13.2) | 31 (35.2) | 0.001 |
Follow up intravascular ultrasound analysis | n = 45 | n = 37 | |
Stent length (mm) | 21.7 ± 5.6 | 20.0 ± 4.8 | 0.160 |
Stent size (mm) | 2.96 ± 0.4 | 2.93 ± 0.5 | 0.780 |
Incomplete stent apposition | 5 (11.1) | 9 (24.3) | 0.150 |
Proximal segment | 1 (2.2) | 8 (21.6) | 0.015 |
Body segment | 2 (4.4) | 1 (2.7) | 1.000 |
Distal segment | 2 (4.4) | 0 (0.0) | 0.500 |
Table 3 Comparison between published trials of biodegradable eluting stents
Name | Stent design | Cardiac death | Cardiac death or MI | MI | TVR | TLR |
LEADERS[28] | Biomatrix | 2.1 | 6.7 | 5.8 | 7.8 | 6.5 |
Cypher | 2.7 | 6.6 | 4.6 | 9.9 | 7.4 | |
Nobori | 0.0 | - | 4.7 | 7.1 | 0.0 | |
NOBORI[34] | Taxus | 0.0 | - | 8.6 | 14.3 | 2.9 |
ISAR-TEST-3[35] | Biodegradable polymer stent | 2.0 | 2.5 | 1.5 | - | 5.9 |
Permanent polymer sirolimus | 2.0 | 3.5 | 2.0 | - | 7.9 | |
Polymer free sirolimus | 2.0 | 4.0 | 2.5 | - | 12.9 | |
ISAR-TEST-4[36] | Biodegradable polymer | 2.8 | 6.3 | 4.3 | 13.7 | 8.8 |
Control1 | 3.2 | 6.2 | 4.1 | 13.9 | 9.4 | |
EUCATAX[39] | PES | 1.9 | 4.7 | 2.8 | 8.2 | 6.1 |
BMS | 1.9 | 4.3 | 2.4 | 15.0 | 12.6 |
Patients characteristics | BioMatrix | Cypher | EucaTax | P values |
No. of patients | 857 | 850 | 211 | |
Age (yr) | 65 ± 11 | 65 ± 11 | 63.8 ± 10.2 | 0.32 |
Male gender | 75.0 | 75.0 | 83.4 | 0.62 |
Hypertension | 74.0 | 73.0 | 64.0 | 0.46 |
Diabetes mellitus | 26.0 | 23.0 | 23.2 | 0.49 |
Hypercholesterolemia | 65.0 | 68.0 | 56.9 | 0.36 |
Smoking | 24.0 | 25.0 | 21.3 | 0.68 |
Previous MI | 32.0 | 33.0 | 20.4 | 0.02 |
Previous PCI | 36.0 | 37.0 | 35.5 | 0.93 |
Multi vessel disease | 37.0 | 32.0 | 55.0 | < 0.001 |
Clinical presentation | ||||
Acute coronary syndrome | 55.0 | 56.0 | 59.7 | 0.80 |
Lesions per patient | ||||
> 1 lesion | 29.0 | 22.0 | 26.1 | 0.09 |
Small vessels1 | 68.0 | 69.0 | 60.3 | 0.45 |
Procedural characteristics | ||||
Stents per lesion | 1.3 ± 0.7 | 1.3 ± 0.7 | 1.36 ± 0.5 | 0.38 |
Stent length per lesion (mm) | 24.7 ± 15.5 | 24.6 ± 14.8 | 21.7 ± 5.6 | 0.006 |
Angiographic follow-up | ||||
In-stent late loss | 0.08 ± 0.4 | 0.15 ± 0.4 | 0.52 ± 0.6 | < 0.001 |
Stent thrombosis2 | ||||
Overall stent thrombosis | 3.6 | 3.3 | 1.4 | 0.28 |
Definite ST | ||||
0-30 d | 1.6 | 1.6 | 0.5 | 0.43 |
> 30 d-12 mo | 0.4 | 0.5 | 0.9 | 0.52 |
0 d-12 mo | 2.0 | 2.0 | 1.4 | 0.82 |
Efficacy endpoints at 12 mo | ||||
Any TLR | 6.5 | 7.4 | 6.1 | 0.63 |
Any TVR | 7.8 | 9.9 | 8.2 | 0.23 |
Safety endpoints at 12 mo | ||||
All causes of death | 3.2 | 3.3 | 2.4 | 0.80 |
Cardiac death | 2.1 | 2.7 | 1.9 | 0.66 |
Myocardial infarction | 5.8 | 4.6 | 2.8 | 0.11 |
Cardiac death or MI | 6.7 | 6.6 | 4.7 | 0.46 |
- Citation: Rodriguez-Granillo A, Rubilar B, Rodriguez-Granillo G, Rodriguez AE. Advantages and disadvantages of biodegradable platforms in drug eluting stents. World J Cardiol 2011; 3(3): 84-92
- URL: https://www.wjgnet.com/1949-8462/full/v3/i3/84.htm
- DOI: https://dx.doi.org/10.4330/wjc.v3.i3.84