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Risk and timing of clinical events according to diabetic status of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting stent: 2-year results from a propensity score matched comparison of ABSORB EXTEND and SPIRIT trials

Campos CM, Caixeta A, Franken M, Bartorelli AL, Whitbourn RJ, Wu CJ, et al.

Catheter Cardiovasc Interv, 2018 02 15;91(3):387-395.
PMID: 28471086 DOI: 10.1002/ccd.27109

OBJECTIVES: to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon.
METHODS: The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR).
RESULTS: After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups.
CONCLUSION: In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals with diabetes treated with the Absorb BVS had a similar rate of MACE as compared with diabetics treated with the Xience EES. © 2017 Wiley Periodicals, Inc.

Matched MeSH terms: Absorbable Implants*
In vitro comparative study of white and dark polycaprolactone trifumarate in situ cross-linkable scaffolds seeded with rat bone marrow stromal cells

Muhammad KB, Abas WA, Kim KH, Pingguan-Murphy B, Zain NM, Akram H

Clinics (Sao Paulo), 2012;67(6):629-38.
PMID: 22760903

OBJECTIVE: Dark poly(caprolactone) trifumarate is a successful candidate for use as a bone tissue engineering scaffold. Recently, a white polymeric scaffold was developed that shows a shorter synthesis time and is more convenient for tissue-staining work. This is an in vitro comparative study of both the white and dark scaffolds.
METHODS: Both white and dark poly(caprolactone) trifumarate macromers were characterized via Fourier transform infrared spectroscopy before being chemically cross-linked and molded into disc-shaped scaffolds. Biodegradability was assessed by percentage weight loss on days 7, 14, 28, 42 and 56 (n = 5) after immersion in 10% serum-supplemented medium or distilled water. Static cell seeding was employed in which isolated and characterized rat bone marrow stromal cells were seeded directly onto the scaffold surface. Seeded scaffolds were subjected to a series of biochemical assays and scanning electron microscopy at specified time intervals for up to 28 days of incubation.
RESULTS: The degradation of the white scaffold was significantly lower compared with the dark scaffold but was within the acceptable time range for bone-healing processes. The deoxyribonucleic acid and collagen contents increased up to day 28 with no significant difference between the two scaffolds, but the glycosaminoglycan content was slightly higher in the white scaffold throughout 14 days of incubation. Scanning electron microscopy at day 1 [corrected] revealed cellular growth and attachment.
CONCLUSIONS: There was no cell growth advantage between the two forms, but the white scaffold had a slower biodegradability rate, suggesting that the newly synthesized poly(caprolactone) trifumarate is more suitable for use as a bone tissue engineering scaffold.

Matched MeSH terms: Absorbable Implants*
Comparative study between dense and porous hydroxyapatite using light and scanning electron microscopy

Pohchi A, Suzina AH, Samsudin AR, Al-Salihi KA

Med J Malaysia, 2004 May;59 Suppl B:151-2.
PMID: 15468863

This in vivo study revealed that porous hydroxyapatite (PHA) and dense hydroxyapatite (DHA) are good implant materials that can accelerate bone healing and resorbed in acceptable time. But there were differences in the mechanism of the resorption of DHA and PHA due to variability in the physical properties and osteogenicity.

Matched MeSH terms: Absorbable Implants*
Tissue engineering trachea: Malaysian experience

Aminuddin BS

Med J Malaysia, 2004 May;59 Suppl B:3-4.
PMID: 15468790

Management of severe tracheal anomalies remains a clinical challenge. Tissue engineering offers new hope in trachea reconstruction surgery. However to date no optimal technique achieved in the formation of human or animal trachea. The main problem lies on the biomaterial used and the complex city of forming trachea in vivo. This study was aimed at creating tissue-engineered trachea cartilage from easily accessible human and animal nasal septum cartilage using internal scaffold and biodegradable human and animal fibrin.

Matched MeSH terms: Absorbable Implants
Gross, radiology and ultrasonographic evaluation of coral post-implantation in sheep femur

Fadilah A, Zuki AB, Loqman MY, Zamri-Saad M, Norimah Y, Asnah H

Med J Malaysia, 2004 May;59 Suppl B:178-9.
PMID: 15468876

The study was carried out to evaluate macroscopically the ability of coral to repair a large size bone defect. A total 12 adult, male sheep were used in the study. The large bone defect (2.5cm x 0.5cm x 0.5cm) was created surgically on the left proximal femur and replaced by a block of coral (Porites sp.). Radiographs were obtained immediately after surgery and at 2, 4, 8 and 12 weeks post-implantation. Ultrasonographic examinations were carried out every 2 weeks after implantation up to 12 weeks using ultrasound machine (TOSHIBA Capasee II) connected with 7MHz frequency transducer. The sheep were euthanased at 2, 4, 8, and 12 weeks post-implantation and the bone examined grossly. Both ultrasonographs and radiographs taken at 8 and 12 weeks showed that the implants had been resorbed and left the space that much reduced in size. There was no sign of implant rejection observed in all animals. The results showed that processed coral has potential to become bone substitute for reconstructive bone surgery.

Matched MeSH terms: Absorbable Implants*
Microscopic evaluation of the natural coral (Porites spp.) post-implantation in sheep femur

Fadilah A, Zuki AB, Loqman MY, Zamri-Saad M, Al-Salihi KA, Norimah Y, et al.

Med J Malaysia, 2004 May;59 Suppl B:127-8.
PMID: 15468851

The study was carried out with the aim to evaluate natural coral (Porites spp.) implanted in sheep femur microscopically. Twelve adult, male sheep were used in this study. The defect area was implanted with coral and monitored for up to 12 weeks. The sheep were euthanased at 2,4,8, and 12 weeks post-implantation. Microscopically, natural coral implanted into bone tissue have shown gradual resorption and progressively replaced by new bone. At 12 weeks post-implantation, the implanted site was almost completely surrounded by mature bone. The results showed that natural coral was found to be a biodegradable and osteo-conductive biomaterial, which acted as a scaffold for a direct osteoblastic apposition.

Matched MeSH terms: Absorbable Implants*
Fulltext Improved Bacteriostatic and Anticorrosion Effects of Polycaprolactone/Chitosan Coated Magnesium via Incorporation of Zinc Oxide

Bakhsheshi-Rad HR, Hamzah E, Ying WS, Razzaghi M, Sharif S, Ismail AF, et al.

Materials (Basel), 2021 Apr 12;14(8).
PMID: 33921460 DOI: 10.3390/ma14081930

Magnesium has been recognized as a groundbreaking biodegradable biomaterial for implant applications, but its use is limited because it degrades too quickly in physiological solutions. This paper describes the research on the influence of polycaprolactone (PCL)/chitosan (CS)/zinc oxide (ZnO) composite coating (PCL/CS/ZnO) on the corrosion resistance and antibacterial activity of magnesium. The PCL/CS film presented a porous structure with thickness of about 40-50 μm, while after incorporation of ZnO into the PCL/CS, a homogenous film without pores and defects was attained. The ZnO embedded in PCL/CS enhanced corrosion resistance by preventing corrosive ions diffusion in the magnesium substrate. The corrosion, antibacterial, and cell interaction mechanism of the PCL/CS/ZnO composite coating is discussed in this study. In vitro cell culture revealed that the PCL/CS coating with low loaded ZnO significantly improved cytocompatibility, but coatings with high loaded ZnO were able to induce some cytotoxicity osteoblastic cells. It was also found that enhanced antibacterial activity of the PCL/CS/ZnO coating against both Escherichia coli (E. coli) and Staphylococcus aureus (S. aureus) bacteria, while less significant antibacterial activity was detected for uncoated Mg and PCL/CS coating. Based on the results, the PCL/CS coatings loaded with low ZnO content may be recommended as a candidate material for biodegradable Mg-based orthopedic implant applications.

Matched MeSH terms: Absorbable Implants
Fabrication of biodegradable Zn-Al-Mg alloy: Mechanical properties, corrosion behavior, cytotoxicity and antibacterial activities

Bakhsheshi-Rad HR, Hamzah E, Low HT, Kasiri-Asgarani M, Farahany S, Akbari E, et al.

Mater Sci Eng C Mater Biol Appl, 2017 Apr 01;73:215-219.
PMID: 28183601 DOI: 10.1016/j.msec.2016.11.138

In this work, binary Zn-0.5Al and ternary Zn-0.5Al-xMg alloys with various Mg contents were investigated as biodegradable materials for implant applications. Compared with Zn-0.5Al (single phase), Zn-0.5Al-xMg alloys consisted of the α-Zn and Mg2(Zn, Al)11 with a fine lamellar structure. The results also revealed that ternary Zn-Al-Mg alloys presented higher micro-hardness value, tensile strength and corrosion resistance compared to the binary Zn-Al alloy. In addition, the tensile strength and corrosion resistance increased with increasing the Mg content in ternary alloys. The immersion tests also indicated that the corrosion rates in the following order Zn-0.5Al-0.5Mg

Matched MeSH terms: Absorbable Implants*
Single incision laparoscopic surgery (SILS) inguinal hernia repair - recent clinical experiences of this novel technique

Yussra Y, Sutton PA, Kosai NR, Razman J, Mishra RK, Harunarashid H, et al.

Clin Ter, 2013;164(5):425-8.
PMID: 24217830 DOI: 10.7417/CT.2013.1608

Inguinal hernia remains the most commonly encountered surgical problem. Various methods of repair have been described, and the most suitable one debated. Single port access (SPA) surgery is a rapidly evolving field, and has the advantage of affording 'scarless' surgery. Single incision laparoscopic surgery (SILS) for inguinal hernia repair is seen to be feasible in both total extraperitoneal (TEP) and transabdominal pre-peritoneal (TAPP) approaches. Data and peri-operative information on both of these however are limited. We aimed to review the clinical experience, feasibility and short term complications related to laparoscopic inguinal hernia repair via single port access. A literature search was performed using Google Scholar, Springerlink Library, Highwire Press, Surgical Endoscopy Journal, World Journal of Surgery and Medscape. The following search terms were used: laparoscopic hernia repair, TAPP, TEP, single incision laparoscopic surgery (SILS). Fourteen articles in English language related to SILS inguinal hernia repair were identified. Nine articles were related to TEP repair and the remaining 5 to TAPP. A total of 340 patients were reported within these studies: 294 patients having a TEP repair and 46 a TAPP. Only two cases of recurrence were reported. Various ports have been utilized, including the SILS port, Tri-Port and a custom- made port using conventional laparoscopic instruments. The duration of surgery was 40-100 minutes and the average length of hospital stay was one day. Early outcomes of this novel technique show it to be feasible, safe and with potentially better cosmetic outcome.

Matched MeSH terms: Absorbable Implants
Fulltext Lower urinary tract dysfunction resulting from a 10-year retained intravesical absorbable suture from a uterine myomectomy

Tan YL, Lo TS, Khanuengkitkong S, Dass AK

Taiwan J Obstet Gynecol, 2013 Sep;52(3):435-6.
PMID: 24075389 DOI: 10.1016/j.tjog.2013.01.027
Matched MeSH terms: Absorbable Implants/adverse effects*
Cytotoxicity evaluation of biodegradable Zn-3Mg alloy toward normal human osteoblast cells

Murni NS, Dambatta MS, Yeap SK, Froemming GRA, Hermawan H

Mater Sci Eng C Mater Biol Appl, 2015 Apr;49:560-566.
PMID: 25686984 DOI: 10.1016/j.msec.2015.01.056

The recent proposal of using Zn-based alloys for biodegradable implants was not supported with sufficient toxicity data. This work, for the first time, presents a thorough cytotoxicity evaluation of Zn-3Mg alloy for biodegradable bone implants. Normal human osteoblast cells were exposed to the alloy's extract and three main cell-material interaction parameters: cell health, functionality and inflammatory response, were evaluated. Results showed that at the concentration of 0.75mg/ml alloy extract, cell viability was reduced by ~50% through an induction of apoptosis at day 1; however, cells were able to recover at days 3 and 7. Cytoskeletal changes were observed but without any significant DNA damage. The downregulation of alkaline phosphatase protein levels did not significantly affect the mineralization process of the cells. Significant differences of cyclooxygenase-2 and prostaglandin E2 inflammatory biomarkers were noticed, but not interleukin 1-beta, indicating that the cells underwent a healing process after exposure to the alloy. Detailed analysis on the cell-material interaction is further discussed in this paper.

Matched MeSH terms: Absorbable Implants
In vitro and in vivo degradation evaluation of novel iron-bioceramic composites for bone implant applications

Ulum MF, Arafat A, Noviana D, Yusop AH, Nasution AK, Abdul Kadir MR, et al.

Mater Sci Eng C Mater Biol Appl, 2014 Mar 1;36:336-44.
PMID: 24433920 DOI: 10.1016/j.msec.2013.12.022

Biodegradable metals such as magnesium, iron and their alloys have been known as potential materials for temporary medical implants. However, most of the studies on biodegradable metals have been focusing on optimizing their mechanical properties and degradation behavior with no emphasis on improving their bioactivity behavior. We therefore investigated the possibility of improving iron biodegradation rate and bioactivity by incorporating various bioactive bioceramics. The iron-based bioceramic (hydroxyapatite, tricalcium phosphate and biphasic calcium phosphate) composites were prepared by mechanical mixing and sintering process. Degradation studies indicated that the addition of bioceramics lowered the corrosion potential of the composites and slightly increased their corrosion rate compared to that of pure iron. In vitro cytotoxicity results showed an increase of cellular activity when rat smooth muscle cells interacted with the degrading composites compared to pure iron. X-ray radiogram analysis showed a consistent degradation progress with that found in vivo and positive tissue response up to 70 days implantation in sheep animal model. Therefore, the iron-based bioceramic composites have the potential to be used for biodegradable bone implant applications.

Matched MeSH terms: Absorbable Implants*
In vitro degradation and cell viability assessment of Zn-3Mg alloy for biodegradable bone implants

Dambatta MS, Murni NS, Izman S, Kurniawan D, Froemming GR, Hermawan H

Proc Inst Mech Eng H, 2015 May;229(5):335-42.
PMID: 25991712 DOI: 10.1177/0954411915584962

This article reports the in vitro degradation and cytotoxicity assessment of Zn-3Mg alloy developed for biodegradable bone implants. The alloy was prepared using casting, and its microstructure was composed of Mg2Zn11 intermetallic phase distributed within a Zn-rich matrix. The degradation assessment was done using potentiodynamic polarization and electrochemical impedance spectrometry. The cell viability and the function of normal human osteoblast cells were assessed using 3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2H-tetrazolium and alkaline phosphatase extracellular enzyme activity assays. The results showed that the degradation rate of the alloy was slower than those of pure Zn and pure Mg due to the formation of a high polarization resistance oxide film. The alloy was cytocompatible with the normal human osteoblast cells at low concentrations (<0.5 mg/mL), and its alkaline phosphatase activity was superior to pure Mg. This assessment suggests that Zn-3Mg alloy has the potential to be developed as a material for biodegradable bone implants, but the toxicity limit must be carefully observed.

Matched MeSH terms: Absorbable Implants*
Degradation behavior of biodegradable Fe35Mn alloy stents

Sing NB, Mostavan A, Hamzah E, Mantovani D, Hermawan H

J Biomed Mater Res B Appl Biomater, 2015 Apr;103(3):572-7.
PMID: 24954069 DOI: 10.1002/jbm.b.33242

This article reports a degradation study that was done on stent prototypes made of biodegradable Fe35Mn alloy in a simulated human coronary arterial condition. The stent degradation was observed for a short-term period from 0.5 to 168 h, which simulates the early period of stenting procedure. Potentiodynamic polarization and electrochemical impedance spectroscopy were used to quantify degradation rate and surface property of the stents. Results showed that signs of degradation were visible on both crimped and expanded stents after 1 h of test, mostly located on the stent's curvatures. The degradation rate of stent was higher compared to that of the original alloy, indicating the surface altering effect of stent fabrication processing to degradation. A single oxide layer was formed and detected as a porous structure with capacitive behavior. Expanded stents exhibited lower polarization resistance compared to the nonexpanded ones, indicating the cold work effect of expansion procedure to degradation.

Matched MeSH terms: Absorbable Implants*
Partially degradable friction-welded pure iron-stainless steel 316L bone pin

Nasution AK, Murni NS, Sing NB, Idris MH, Hermawan H

J Biomed Mater Res B Appl Biomater, 2015 Jan;103(1):31-8.
PMID: 24757071 DOI: 10.1002/jbm.b.33174

This article describes the development of a partially degradable metal bone pin, proposed to minimize the occurrence of bone refracture by avoiding the creation of holes in the bone after pin removal procedure. The pin was made by friction welding and composed of two parts: the degradable part that remains in the bone and the nondegradable part that will be removed as usual. Rods of stainless steel 316L (nondegradable) and pure iron (degradable) were friction welded at the optimum parameters: forging pressure = 33.2 kPa, friction time = 25 s, burn-off length = 15 mm, and heat input = 4.58 J/s. The optimum tensile strength and elongation was registered at 666 MPa and 13%, respectively. A spiral defect formation was identified as the cause for the ductile fracture of the weld joint. A 40-µm wide intermetallic zone was identified along the fusion line having a distinct composition of Cr, Ni, and Mo. The corrosion rate of the pin gradually decreased from the undeformed zone of pure iron to the undeformed zone of stainless steel 316L. All metallurgical zones of the pin showed no toxic effect toward normal human osteoblast cells, confirming the ppb level of released Cr and Ni detected in the cell media were tolerable.

Matched MeSH terms: Absorbable Implants
Post-corrosion mechanical properties of absorbable open cell iron foams with hollow struts

Alavi R, Akbarzadeh AH, Hermawan H

J Mech Behav Biomed Mater, 2021 05;117:104413.
PMID: 33640846 DOI: 10.1016/j.jmbbm.2021.104413

In-depth analyses of post-corrosion mechanical properties and architecture of open cell iron foams with hollow struts as absorbable bone scaffolds were carried out. Variations in the architectural features of the foams after 14 days of immersion in a Hanks' solution were investigated using micro-computed tomography and scanning electron microscope images. Finite element Kelvin foam model was developed, and the numerical modeling and experimental results were compared against each other. It was observed that the iron foam samples were mostly corroded in the periphery regions. Except for quasi-elastic gradient, other mechanical properties (i.e. compressive strength, yield strength and energy absorbability) decreased monotonically with immersion time. Presence of adherent corrosion products enhanced the load-bearing capacity of the open cell iron foams at small strains. The finite element prediction for the quasi-elastic response of the 14-day corroded foam was in an agreement with the experimental results. This study highlights the importance of considering corrosion mechanism when designing absorbable scaffolds; this is indispensable to offer desirable mechanical properties in porous materials during degradation in a biological environment.

Matched MeSH terms: Absorbable Implants*
Effect of nanofillers on the physico-mechanical properties of load bearing bone implants

Michael FM, Khalid M, Walvekar R, Ratnam CT, Ramarad S, Siddiqui H, et al.

Mater Sci Eng C Mater Biol Appl, 2016 Oct 01;67:792-806.
PMID: 27287178 DOI: 10.1016/j.msec.2016.05.037

Bones are nanocomposites consisting of a collagenous fibre network, embedded with calcium phosphates mainly hydroxyapatite (HA) nanocrystallites. As bones are subjected to continuous loading and unloading process every day, they often tend to become prone to fatigue and breakdown. Therefore, this review addresses the use of nanocomposites particularly polymers reinforced with nanoceramics that can be used as load bearing bone implants. Further, nanocomposite preparation and dispersion modification techniques have been highlighted along with thorough discussion on the influence that various nanofillers have on the physico-mechanical properties of nanocomposites in relation to that of natural bone properties. This review updates the nanocomposites that meet the physico-mechanical properties (strength and elasticity) as well as biocompatibility requirement of a load bearing bone implant and also attempts to highlight the gaps in the reported studies to address the fatigue and creep properties of the nanocomposites.

Matched MeSH terms: Absorbable Implants*
Fulltext Unrestricted use of polymer-free sirolimus eluting stents in routine clinical practice

Krackhardt F, Kočka V, Waliszewski M, Toušek P, Janek B, Trenčan M, et al.

Medicine (Baltimore), 2020 Feb;99(8):e19119.
PMID: 32080086 DOI: 10.1097/MD.0000000000019119

Stent designs with ultrathin struts may further increase the procedural success of challenging lesion subsets. The objective of this study was to assess the safety and efficacy of ultrathin strut, polymer-free sirolimus eluting stent (PF-SES) implantations in a large scale, unselected patient population.Adult patients underwent percutaneous coronary interventions (PCI) with a thin-strut PF-SES. Data from two all-comers observational studies having the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled. The accumulated target lesion revascularization (TLR) rate at 9-12 months was the primary endpoint. All dual antiplatelet therapy strategies according to the applicable guidelines were permissible.In total, 7243 patients were prospectively enrolled for PCI with PF-SES in stable coronary artery disease or acute coronary syndrome (ACS). Major risk factors in the overall cohort were diabetes (37.3%), ST elevation myocardial infarction (18.1%) and non-ST myocardial infarction (24.6%). The follow-up rate was 88.6% in the overall population. The TLR rate in the overall cohort was 2.2% whereas definite/probable stent thrombosis (ST) occurred in 0.7%. In patients with in-stent restenosis lesions, the major adverse cardiac events rate was 6.4% whereas the corresponding rate for isolated left main coronary artery (LMCA) disease was highest with 6.7% followed by patients with culprit lesions in vein bypasses (VB, 7.1%). The mortality rate in patients treated in VB lesions was highest with 5.4%, followed by the isolated LMCA subgroup (3.4%) and ACS (2.6%).PCI with PF-SES in an unselected patient population, is associated with low clinical event and ST rates. Furthermore, PF-SES angioplasty in niche indications demonstrated favorable safety and efficacy outcomes with high procedural success rates.

Matched MeSH terms: Absorbable Implants/adverse effects
Comparison of One-Year Outcomes in Patients >75 Versus ≤75 Years With Coronary Artery Disease Treated With COMBO Stents (From The MASCOT Registry)

Chandrasekhar J, Sartori S, Aquino MB, Baber U, Hájek P, Atzev B, et al.

Am J Cardiol, 2020 07 15;127:1-8.
PMID: 32418717 DOI: 10.1016/j.amjcard.2020.04.014

Older patients who undergo coronary interventions are at greater risk of ischemic events and less likely to tolerate prolonged dual antiplatelet therapy (DAPT) due to bleeding risk. The COMBO biodegradable polymer sirolimus-eluting stent promotes rapid endothelialization through endothelial progenitor cell capture technology which may be advantageous in elderly patients. We compared 1-year clinical outcomes and DAPT cessation events in patients >75 versus ≤75 years from the MASCOT registry. MASCOT was a prospective, multicenter cohort study of all-comers undergoing attempted COMBO stenting. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a nontarget vessel or clinically driven target lesion revascularization. Bleeding was adjudicated using the Bleeding Academic Research Consortium criteria. Adjusted outcomes were analyzed using Cox regression methods. The study included 18% (n = 479) patients >75 years and 72% (n = 2,135) patients ≤75 years. One-year TLF occurred in 4.6% patients >75 years versus 3.1% patients ≤75years of age, p = 0.10; adj hazard ratio 1.36, 95% confidence intervals 0.77 to 2.38, p = 0.29. There were no significant differences in cardiac death (1.7% vs 1.3%, p = 0.55), MI (2.1% vs 1.2%, p = 0.14), target lesion revascularization (1.7% vs 1.4%, p = 0.60) and definite stent thrombosis (0.8% vs 0.4%, p = 0.19). Major Bleeding Academic Research Consortium 3,5 bleeding (3.1% vs 1.5%, p = 0.01) and DAPT cessation rates (32.4% vs 23.0%, p <0.001) were significantly higher in elderly patients. In conclusion, elderly patients >75 years treated with COMBO stents had similar TLF but significantly greater incidence of bleeding than younger patients and DAPT cessation in one-third of patients over 1 year.

Matched MeSH terms: Absorbable Implants*
Process of prototyping coronary stents from biodegradable Fe-Mn alloys

Hermawan H, Mantovani D

Acta Biomater, 2013 Nov;9(10):8585-92.
PMID: 23665503 DOI: 10.1016/j.actbio.2013.04.027

Biodegradable stents are considered to be a recent innovation, and their feasibility and applicability have been proven in recent years. Research in this area has focused on materials development and biological studies, rather than on how to transform the developed biodegradable materials into the stent itself. Currently available stent technology, the laser cutting-based process, might be adapted to fabricate biodegradable stents. In this work, the fabrication, characterization and testing of biodegradable Fe-Mn stents are described. A standard process for fabricating and testing stainless steel 316L stents was referred to. The influence of process parameters on the physical, metallurgical and mechanical properties of the stents, and the quality of the produced stents, were investigated. It was found that some steps of the standard process such as laser cutting can be directly applied, but changes to parameters are needed for annealing, and alternatives are needed to replace electropolishing.

Matched MeSH terms: Absorbable Implants*

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