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BMC Oral Health Apr 2020Bisphosphonate coating of dental implants is a promising tool for surface modification aiming to improve the osseointegration process and clinical outcome. The... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Bisphosphonate coating of dental implants is a promising tool for surface modification aiming to improve the osseointegration process and clinical outcome. The biological effects of bisphosphonates are thought to be mainly associated with osteoclasts inhibition, whereas their effects on osteoblast function are unclear. A potential of bisphosphonate coated surfaces to stimulate osteoblast differentiation was investigated by several in vitro studies with contradictory results. The purpose of this systematic review and meta-analysis was to evaluate the effect of bisphosphonate coated implant surfaces on alkaline phosphatase activity in osteoblasts.
METHODS
In vitro studies that assessed alkaline phosphatase activity in osteoblasts following cell culture on bisphosphonate coated titanium surfaces were searched in electronic databases PubMed/MEDLINE, Scopus and ISI Web of Science. Animal studies and clinical trials were excluded. The literature search was restricted to articles written in English and published up to August 2019. Publication bias was assessed by the construction of funnel plots.
RESULTS
Eleven studies met the inclusion criteria. Meta-analysis showed that coating of titanium surfaces with bisphosphonates increases alkaline phosphatase activity in osteoblasts after 3 days (n = 1), 7 (n = 7), 14 (n = 6) and 21 (n = 3) days. (7 days beta coefficient = 1.363, p-value = 0.001; 14 days beta coefficient = 1.325, p-value < 0.001; 21 days beta coefficient = 1.152, p-value = 0.159).
CONCLUSIONS
The meta-analysis suggests that bisphosphonate coatings of titanium implant surfaces may have beneficial effects on osteogenic behaviour of osteoblasts grown on titanium surfaces in vitro. Further studies are required to assess to which extent bisphosphonates coating might improve osseointegration in clinical situations.
Topics: Alkaline Phosphatase; Animals; Cell Differentiation; Cells, Cultured; Dental Implants; Diphosphonates; Osseointegration; Osteoblasts; Surface Properties; Titanium
PubMed: 32334598
DOI: 10.1186/s12903-020-01089-4 -
Molecular Biology Reports Jun 2020Sensorineural hearing loss (SNHL) is the most common form of hearing loss that is routinely treated with hearing aids or cochlear implants. Advances in regenerative...
Sensorineural hearing loss (SNHL) is the most common form of hearing loss that is routinely treated with hearing aids or cochlear implants. Advances in regenerative medicine have now led to animal studies examining the possibility of restoring injured hair cells with mesenchymal stem/stromal cell (MSC) administration. We conducted a systematic review and meta-analysis to collate the existing preclinical literature evaluating MSCs as a treatment for SNHL and quantify the effect of MSCs on functional hearing. Our protocol was published online on CAMARADES. Searches were conducted in four medical databases by two independent investigators. Twelve studies met inclusion and were evaluated for risk of bias using SYRCLE. Rodent models were commonly used (n = 8, 66%), while auditory brainstem response (ABR) and distortion product otoacoustic emissions (DPOAE) were the most frequent measures assessing hearing loss. MSCs were derived from multiple tissue sources, including bone marrow, adipose tissue, and umbilical cord blood and the dose ranged from 4 × 10 to 1 × 10 cells. Treatment with MSCs resulted in an improvement in ABR and DPOAE (mean difference-15.22, + 9.10, respectively). Despite high heterogeneity and multiple "unclear" domains in the risk of bias, this review provides evidence that MSCs may have a beneficial effect in hearing function.
Topics: Animals; Disease Models, Animal; Evoked Potentials, Auditory, Brain Stem; Hearing Loss; Hearing Loss, Sensorineural; Mesenchymal Stem Cell Transplantation; Mesenchymal Stem Cells
PubMed: 32323262
DOI: 10.1007/s11033-020-05460-0 -
Medicine Mar 2020Everolimus-eluting bioresorbable vascular scaffolds (BVS), which have the characteristics of scaffold absorption and vascular function recovery, are the latest... (Meta-Analysis)
Meta-Analysis
Mid-term outcomes of bioresorbable vascular scaffolds vs second-generation drug-eluting stents in patients with acute coronary syndromes: A systematic review and meta-analysis.
BACKGROUND
Everolimus-eluting bioresorbable vascular scaffolds (BVS), which have the characteristics of scaffold absorption and vascular function recovery, are the latest innovation in the treatment of coronary artery disease. This new concept has become a hot topic in the field of interventional cardiology. Data regarding mid-term clinical outcomes of BVS in acute coronary syndromes are currently scarce. The aim of this systematic review and meta-analysis is to compare mid-term outcome data for BVS and second-generation drug-eluting stents (DES) in the treatment of acute coronary syndromes.
METHODS
We searched PubMed, Embase, the Cochrane Library, Web of Science, and relevant web sites for studies with a follow-up of ≥ 1 years that studied percutaneous coronary interventions with BVS vs second-generation DES in acute coronary syndromes. A meta-analysis was performed with the software RevMan following the standards of the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0.
RESULTS
Five studies, 2 randomized controlled trials, and 3 observational studies, with a total of 1758 patients (BVS n = 917; DES n = 841) and a median follow-up duration of 24 months, were included. BVS, when compared with DES, resulted in higher rates of target lesion revascularization (TLR) (OR, 2.20; 95% CI, 1.12-3.64; P = .02) and stent/scaffold thrombosis (ST/ScT) (OR = 2.35, 95% CI: 1.13-4.89, P = .02). When TLR due to device thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR: 1.67, 95% CI: 0.73-3.82, P = .22). The risk for all-cause death (OR = 1.32 95% CI: 0.61-2.88, P = .48), cardiac death (OR = 1.29, 95% CI: 0.58-2.86 P = .52), target vessel myocardial infarction (OR = 1.50, 95% CI: 0.86-2.61, P = .15), and target lesion failure (OR = 1.34, 95% CI: 0.76-2.35, P = .31) did not differ between BVS and DES groups.
CONCLUSION
At mid-term follow-up, BVS had a higher risk of TLR and ST/ScT than the second-generation DES in patients with acute coronary syndromes. ST/ScT was the key factor indicating the decreased safety and effectiveness of BVS relative to DES.
Topics: Absorbable Implants; Acute Coronary Syndrome; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Tissue Scaffolds; Treatment Outcome
PubMed: 32150103
DOI: 10.1097/MD.0000000000019458 -
The Cochrane Database of Systematic... Mar 2020Glaucoma is a leading cause of irreversible blindness. A number of minimally-invasive surgical techniques have been introduced as a treatment to prevent glaucoma from... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Glaucoma is a leading cause of irreversible blindness. A number of minimally-invasive surgical techniques have been introduced as a treatment to prevent glaucoma from progressing; ab interno trabecular bypass surgery with the Schlemm's canal Hydrus microstent is one of them.
OBJECTIVES
To evaluate the efficacy and safety of ab interno trabecular bypass surgery with the Hydrus microstent in treating people with open angle glaucoma (OAG).
SEARCH METHODS
On 7 May 2019, we searched CENTRAL (2019, Issue 5), which contains the Cochrane Eyes and Vision Trials Register; Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov; and the WHO ICTRP.
SELECTION CRITERIA
We searched for randomised controlled trials (RCTs) of the Hydrus microstent, alone or with cataract surgery, compared to other surgical treatments (cataract surgery alone, other minimally-invasive glaucoma device techniques, trabeculectomy), laser treatment, or medical treatment.
DATA COLLECTION AND ANALYSIS
A minimum of three authors independently extracted data from reports of included studies, using a data collection form and analysed data, based on standard Cochrane methods.
MAIN RESULTS
We included three published studies, with 808 people randomised. Two studies had multiple international recruitment centres in the USA and other countries. The third study had several sites based in Europe. All three studies were sponsored by the Hydrus manufacturer Ivantis Inc. All studies included participants with mainly mild or moderate OAG (mean deviation between -3.6 dB (decibel) and -8.4 dB in all study arms), which was controlled with medication in many participants (mean medicated intraocular pressure (IOP) 17.9 mmHg to 19.1 mmHg). There were no concerns regarding allocation concealment bias, but masking of outcome assessors was high or unclear risk in all studies; masking of participants was achieved, and losses to follow-up were not a concern. Two studies compared the Hydrus microstent combined with cataract surgery to cataract surgery alone, in participants with visually significant cataracts and OAG. We found moderate-certainty evidence that adding the Hydrus microstent to cataract surgery increased the proportion of participants who were medication-free from about half to more than three quarters at 12-month, short-term follow-up (risk ratio (RR) 1.59, 95% confidence interval (CI) 1.39 to 1.83; 2 studies, 639 participants; I² = 0%; and 24-month, medium-term follow-up (RR 1.63, 95% CI 1.40 to 1.88; 2 studies, 619 participants; I² = 0%). The Hydrus microstent combined with cataract surgery reduced the medium-term mean change in unmedicated IOP (after washout) by 2 mmHg more compared to cataract surgery alone (mean difference (MD) -2.00, 95% CI -2.69 to -1.31; 2 studies, 619 participants; I² = 0%; moderate-certainty evidence), and the mean change in IOP-lowering drops (MD -0.41, 95% CI -0.56 to -0.27; 2 studies, 619 participants; I² = 0%; low-certainty evidence). We also found low-certainty evidence that adding a Hydrus microstent to cataract surgery reduced the need for secondary glaucoma surgery from about 2.5% to less than 1% (RR 0.17, 95% CI 0.03 to 0.86; 2 studies, 653 participants; I² = 27%; low-certainty evidence). Intraocular bleeding, loss of 2 or more visual acuity (VA) lines, and IOP spikes of 10 mmHg or more were rare in both groups; estimates were imprecise, and included both beneficial and harmful effects. There were no cases of endophthalmitis in either group. No data were available on the proportion of participants achieving IOP less than 21 mmHg, 17 mmHg, or 14 mmHg; health-related quality of life (HRQOL), or visual field progression. One study provided short-term data for the Hydrus microstent compared with the iStent trabecular micro-bypass stent (iStent: implantation of two devices in a single procedure) in 152 participants with OAG (148 in analyses). Use of the Hydrus increased the proportion of medication-free participants from about a quarter to about half compared to those who received iStent, but this estimate was imprecise (RR 1.94, 95% CI 1.21 to 3.11; low-certainty evidence). Use of the Hydrus microstent reduced unmedicated IOP (after washout) by about 3 mmHg more than the iStent (MD -3.10, 95% CI -4.17 to -2.03; moderate-certainty evidence), and the use of IOP-lowering medication (MD -0.60, 95% CI -0.99 to -0.21; low-certainty evidence). Both devices achieved a final IOP < 21 mmHg in most participants (Hydrus microstent: 91.8%; iStent: 84%; RR 1.09, 95% CI 0.97 to 1.23; low-certainty evidence). None of the participants who received the Hydrus microstent (N = 74) required additional glaucoma surgery; two participants who received the iStent (N = 76) did. Few adverse events were found in either group. No data were available on the proportion of participants achieving IOP less than 17 mmHg or 14 mmHg, or on HRQOL.
AUTHORS' CONCLUSIONS
In people with cataracts and generally mild to moderate OAG, there is moderate-certainty evidence that the Hydrus microstent with cataract surgery compared to cataract surgery alone, likely increases the proportion of participants who do not require IOP lowering medication, and may further reduce IOP at short- and medium-term follow-up. There is moderate-certainty evidence that the Hydrus microstent is probably more effective than the iStent in lowering IOP of people with OAG in the short-term. Few studies were available on the effects of the Hydrus microstent, therefore the results of this review may not be applicable to all people with OAG, particularly in selected people with medically uncontrolled glaucoma, since IOP was controlled with medication in many participants in the included studies. Complications may be rare using the Hydrus microstent, as well as the comparator iStent, but larger studies are needed to investigate its safety.
Topics: Cataract Extraction; Glaucoma Drainage Implants; Glaucoma, Open-Angle; Humans; Randomized Controlled Trials as Topic; Trabeculectomy
PubMed: 32147807
DOI: 10.1002/14651858.CD012740.pub2 -
Nutrients Jan 2020Several factors affect dental implant osseointegration, including surgical issues, bone quality and quantity, and host-related factors, such as patients' nutritional...
Several factors affect dental implant osseointegration, including surgical issues, bone quality and quantity, and host-related factors, such as patients' nutritional status. Many micronutrients might play a key role in dental implant osseointegration by influencing some alveolar bone parameters, such as healing of the alveolus after tooth extraction. This scoping review aims to summarize the role of dietary supplements in optimizing osseointegration after implant insertion surgery. A technical expert panel (TEP) of 11 medical specialists with expertise in oral surgery, bone metabolism, nutrition, and orthopedic surgery performed the review following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) model. The TEP identified micronutrients from the "European Union (EU) Register of nutrition and health claims made on foods" that have a relationship with bone and tooth health, and planned a PubMed search, selecting micronutrients previously identified as MeSH (Medical Subject Headings) terms and adding to each of them the words "dental implants" and "osseointegration". The TEP identified 19 studies concerning vitamin D, magnesium, resveratrol, vitamin C, a mixture of calcium, magnesium, zinc, and vitamin D, and synthetic bone mineral. However, several micronutrients are non-authorized by the "EU Register on nutrition and health claims" for improving bone and/or tooth health. Our scoping review suggests a limited role of nutraceuticals in promoting osseointegration of dental implants, although, in some cases, such as for vitamin D deficiency, there is a clear link among their deficit, reduced osseointegration, and early implant failure, thus requiring an adequate supplementation.
Topics: Animals; Bone-Anchored Prosthesis; Dental Implantation, Endosseous; Dental Implants; Dietary Supplements; Humans; Nutritional Status; Osseointegration; Prosthesis Design; Treatment Outcome
PubMed: 31968626
DOI: 10.3390/nu12010268 -
Advanced Drug Delivery Reviews 2020Microneedles (MNs) have been used to deliver drugs for over two decades. These platforms have been proven to increase transdermal drug delivery efficiency dramatically...
Microneedles (MNs) have been used to deliver drugs for over two decades. These platforms have been proven to increase transdermal drug delivery efficiency dramatically by penetrating restrictive tissue barriers in a minimally invasive manner. While much of the early development of MNs focused on transdermal drug delivery, this technology can be applied to a variety of other non-transdermal biomedical applications. Several variations, such as multi-layer or hollow MNs, have been developed to cater to the needs of specific applications. The heterogeneity in the design of MNs has demanded similar variety in their fabrication methods; the most common methods include micromolding and drawing lithography. Numerous materials have been explored for MN fabrication which range from biocompatible ceramics and metals to natural and synthetic biodegradable polymers. Recent advances in MN engineering have diversified MNs to include unique shapes, materials, and mechanical properties that can be tailored for organ-specific applications. In this review, we discuss the design and creation of modern MNs that aim to surpass the biological barriers of non-transdermal drug delivery in ocular, vascular, oral, and mucosal tissue.
Topics: Administration, Topical; Biological Transport; Drug Delivery Systems; Equipment Design; Humans; Microinjections; Microtechnology; Polymers; Prostheses and Implants
PubMed: 31837356
DOI: 10.1016/j.addr.2019.11.010 -
Journal of Orthopaedic Surgery and... Nov 2019Despite advances in surgery, the treatment of chronic osteomyelitis remains complex and is often associated with a significant financial burden to healthcare systems....
BACKGROUND
Despite advances in surgery, the treatment of chronic osteomyelitis remains complex and is often associated with a significant financial burden to healthcare systems. The aim of this systematic review was to identify the different single-stage procedures that have been used to treat adult chronic osteomyelitis and to evaluate their effectiveness.
METHODS
Ovid Medline and Embase databases were searched for articles on the treatment of chronic osteomyelitis over the last 20 years. A total of 3511 journal abstracts were screened by 3 independent reviewers. Following exclusion of paediatric subjects, animal models, non-bacterial osteomyelitis and patients undergoing multiple surgical procedures, we identified 13 studies reported in English with a minimum follow-up period of 12 months. Data extraction and quality assessment were performed for all studies. Non-recurrence was defined as resolution of pain without recurrence of sinuses or need for a second procedure to treat infection within the described follow-up period.
RESULTS
A total of 505 patients with chronic osteomyelitis underwent attempted single-stage procedures. Following debridement, a range of techniques have been described to eliminate residual dead space including biologic and non-biologic approaches. These include musculocutaneous flaps, insertion of S53P4 glass beads or packing with antibiotic-loaded ceramic or calcium-sulphate pellets. The average follow-up ranged from 12 to 110 months. The most common organism isolated was Staphylococcus aureus (35.2%). Non-recurrence ranged from 0 to 100%. Debridement alone was statistically significantly inferior to approaches that included dead space management (54.5% versus 90% non-recurrence). Biologic and non-biologic approaches to dead space management were comparable (89.8% versus 94.2% non-recurrence).
CONCLUSION
A wide range of single-stage procedures have been performed for the treatment of chronic osteomyelitis. In general, studies were small and observational with various reporting deficiencies. No one dead space management technique appears to be superior, but debridement alone that leaves residual dead space should be avoided.
Topics: Bone and Bones; Chronic Disease; Humans; Osteomyelitis
PubMed: 31779664
DOI: 10.1186/s13018-019-1388-2 -
Journal of Biomaterials Applications Feb 2020Medical devices made of polydioxanone (a synthetic biodegradable polymer) have been available since the early 1980s. However, no review regarding their performance and...
BACKGROUND
Medical devices made of polydioxanone (a synthetic biodegradable polymer) have been available since the early 1980s. However, no review regarding their performance and safety has been published.
OBJECTIVE
This systematic review intends to review and assess commercially available polydioxanone implants and their safety and performance in patients.
METHODS
We searched for approved polydioxanone implants in several Food and Drug Administration databases. Then, we performed a literature search for publications and clinical trials where polydioxanone devices were implanted in patients. This search was performed on MEDLINE, Embase, Scopus and other databases. Safety and performance of polydioxanone implants in patients were assessed and compared with the implantation of non-polydioxanone devices, when possible, based on scoring systems developed by the authors that analyse surgical site infection rates, inflammatory reaction rates, foreign body response, postoperative pain and fever.
RESULTS
Food and Drug Administration databases search revealed that 48 implants have been approved since 1981, with 1294 adverse reactions or product malfunction in the last decade and 16 recalls. A total of 49 clinical trials and 104 scientific publications were found. Polydioxanone sutures and meshes/plates had low rates of surgical site infection, inflammatory reaction, foreign body response and postoperative fever. Polydioxanone clips/staples reported high rates of surgical site infection, postoperative fever and pain, with sub-optimal clinical performance and poor safety rates. The remaining implants identified showed high levels of safety and performance. Safety scores of polydioxanone implants and non-polydioxanone alternatives are similar. Polydioxanone monofilament sutures perform better than non-polydioxanone alternatives but performance did not differ with remaining polydioxanone implant types.
CONCLUSIONS
Although polydioxanone clips/staples should be implanted with caution and monitored carefully, in general, safety and performance scores of other polydioxanone implants did not differ from non-polydioxanone alternatives. This review will be a useful reference for researchers and industries developing new polydioxanone medical devices.
Topics: Absorbable Implants; Biocompatible Materials; Device Approval; Humans; Inflammation; Medical Device Recalls; Polydioxanone
PubMed: 31771403
DOI: 10.1177/0885328219888841 -
Indian Journal of Ophthalmology Nov 2019This systematic review aimed to evaluate the effectiveness and safety of intravitreal dexamethasone (DEX) implant and intravitreal anti-vascular endothelial growth... (Meta-Analysis)
Meta-Analysis
Comparison between Ozurdex and intravitreal anti-vascular endothelial growth factor treatment for retinal vein occlusion-related macular edema: A systematic review and meta-analysis of randomized controlled trials.
This systematic review aimed to evaluate the effectiveness and safety of intravitreal dexamethasone (DEX) implant and intravitreal anti-vascular endothelial growth factor (VEGF) treatments for macular edema (ME) secondary to retinal vein occlusion (RVO), central retinal vein occlusion (CRVO), and branch retinal vein occlusion (BRVO). The electronic databases comprehensively searched for the studies that compared DEX with anti-VEGF treatments in patients suffering from RVO-related ME. The effectiveness was estimated using best-corrected visual acuity (BCVA), central retinal thickness (CRT), and intraocular pressure (IOP). All data were analyzed by Review Manager (RevMan) 5.3. According to the meta-analysis from five randomized control trials, both DEX implant and anti-VEGF agent treatments were effective, but no significant differences in BCVA and CRT were observed between these two treatments. Novartis' two studies indicated that anti-VEGF agents significantly reduced the CRT compared with DEX implant at 6 months [weighted mean difference: 158.53 μm, 95% confidence interval (CI): (71.09, 245.96), P= 0.0004]. Furthermore, anti-VEGF agents showed some advantages on cataract formation [risk ratio (RR): 3.43, 95% CI: (1.35, 8.71), P= 0.009] and other adverse events [RR: 1.19, 95% CI: (1.09, 1.31), P= 0.0002] without heterogeneity (P = 0.20, I = 35%). Anti-VEGF agents were also effective treatments for cataract formation or less adverse events for RVO-related ME. In contrast, DEX implant had higher risk for IOP elevation and lower cataract incidence than anti-VEGF agents. Hence, complementary and alternative treatments are expected.
Topics: Angiogenesis Inhibitors; Bevacizumab; Dexamethasone; Drug Implants; Drug Therapy, Combination; Glucocorticoids; Humans; Intravitreal Injections; Macular Edema; Randomized Controlled Trials as Topic; Ranibizumab; Receptors, Vascular Endothelial Growth Factor; Recombinant Fusion Proteins; Retinal Vein Occlusion; Tomography, Optical Coherence; Vascular Endothelial Growth Factor A; Visual Acuity
PubMed: 31638037
DOI: 10.4103/ijo.IJO_382_19 -
JAMA Cardiology Dec 2019Bioresorbable scaffolds were designed to provide clinical benefits after their complete bioresorption. Prior studies demonstrated early risks with the Absorb polymeric... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Bioresorbable scaffolds were designed to provide clinical benefits after their complete bioresorption. Prior studies demonstrated early risks with the Absorb polymeric bioresorbable vascular scaffold (BVS). Whether this risk profile changes over time during the course of its bioresorption is unknown.
OBJECTIVE
To examine outcomes of the first-generation BVS before and after 3 years, the point of its complete bioresorption in animals.
DATA SOURCES
We searched MEDLINE and the Cochrane database, conference proceedings, and public websites for relevant studies.
STUDY SELECTION
Eligible studies were randomized clinical trials of BVS vs metallic drug-eluting stents in patients with coronary artery disease with at least 5-year follow-up. Four trials of BVS vs everolimus-eluting stents (EES) with 3384 patients met criteria.
DATA EXTRACTION AND SYNTHESIS
Individual patient data from the 4 trials were pooled, and summary-level meta-analysis was performed.
MAIN OUTCOMES AND MEASURES
The major effectiveness and safety measures were target lesion failure (TLF; cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis. Outcomes were examined through 5-year follow-up and between 0 to 3 and 3 to 5 years.
RESULTS
Mean age for the 3384 patients was 62.8 years; 2452 patients were men (72.5%), and diabetes was present in 1020 patients (30.2%). Through 5-year follow-up, treatment with BVS compared with EES was associated with higher rates of TLF (14.9% vs 11.6%; HR, 1.26; 95% CI, 1.03-1.54; P = .03) and device thrombosis (2.5% vs 0.8%; HR, 2.87; 95% CI, 1.46-5.65; P = .002). Target lesion failure occurred in 11.6% of BVS-treated patients vs 7.9% of EES-treated patients between 0 to 3 years (HR, 1.42; 95% CI, 1.12-1.80), and 4.3% of BVS-treated patients vs 4.5% of EES-treated patients between 3 to 5 years (HR, 0.92; 95% CI, 0.64-1.31) (P for interaction = .046). Device thrombosis occurred in 2.4% of BVS-treated patients vs 0.6% of EES-treated patients between 0 to 3 years (HR, 3.86; 95% CI, 1.75-8.50) and 0.1% of BVS-treated patients vs 0.3% of EES-treated patients between 3 to 5 years (HR, 0.44; 95% CI, 0.07-2.70) (P for interaction = .03). These results were consistent by spline analysis and after multiple imputation and multivariable analysis.
CONCLUSIONS AND RELEVANCE
The period of excess risk for the first-generation Absorb BVS ends at 3 years. These data provide mechanistic insights into the timing of adverse events after BVS and identify the hurdles to be overcome for bioresorbable technology to be accepted as a valid alternative for patients with coronary artery disease.
TRIAL REGISTRATION
ClinicalTrials.gov identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281.
Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Myocardial Ischemia; Myocardial Revascularization; Randomized Controlled Trials as Topic; Thrombosis; Tissue Scaffolds
PubMed: 31561250
DOI: 10.1001/jamacardio.2019.4101