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In a randomized trial, 1845 patients undergoing PCI were assigned to receive either everolimus-eluting bioresorbable vascular scaffolds or everolimus-eluting metallic stents. The incidence of device thrombosis was higher with the bioresorbable scaffold than with the metallic stent. Drug-eluting stents are the standard of care in percutaneous coronary intervention (PCI). 1 , 2 Nevertheless, their rigid metallic cages hamper vasomotion, and they are associated with the development of neoatherosclerosis, which results in an ongoing risk of stent thrombosis (rate of 0.1 to 0.2% per year) and repeat revascularization (rate of 2 to 3% per year). 3 – 6 Bioresorbable vascular scaffolds theoretically leave no permanent implant and allow for restoration of vessel function. 7 The ABSORB III trial showed the noninferiority of the bioresorbable vascular scaffold (Absorb, Abbott Vascular) to the cobalt–chromium everolimus-eluting metallic stent (Xience, Abbott Vascular) with respect to target-lesion failure . . .

Electronic implants are often used in diagnosing and treating human illness, but permanent implants come with problems; here, devices are described that can sense temperature, pressure, pH or thermal characteristics, and—crucially—are fully resorbable by the body. A bioresorbable electronic interface to the brain This study reports the design, fabrication, and in vivo implementation of a silicon-based bioresorbable sensor for monitoring the pressure and temperature within the brain. Individually, all the materials that form the device were previously known to be resorbable. But this is the first demonstration of a functional sensor that completely dissolves in vivo after use with no apparent ill effects. Making the sensors completely resorbable avoids the need for surgical removal. The applications of such devices are not restricted to the brain — they can be modified for use in a range of medical conditions. Percutaneous wires were eliminated by implanting a telemetry device, though this device was not completely resorbable. Many procedures in modern clinical medicine rely on the use of electronic implants in treating conditions that range from acute coronary events to traumatic injury 1 , 2 . However, standard permanent electronic hardware acts as a nidus for infection: bacteria form biofilms along percutaneous wires, or seed haematogenously, with the potential to migrate within the body and to provoke immune-mediated pathological tissue reactions 3 , 4 . The associated surgical retrieval procedures, meanwhile, subject patients to the distress associated with re-operation and expose them to additional complications 5 , 6 , 7 , 8 . Here, we report materials, device architectures, integration strategies, and in vivo demonstrations in rats of implantable, multifunctional silicon sensors for the brain, for which all of the constituent materials naturally resorb via hydrolysis and/or metabolic action 9 , 10 , 11 , 12 , eliminating the need for extraction. Continuous monitoring of intracranial pressure and temperature illustrates functionality essential to the treatment of traumatic brain injury 2 , 13 ; the measurement performance of our resorbable devices compares favourably with that of non-resorbable clinical standards. In our experiments, insulated percutaneous wires connect to an externally mounted, miniaturized wireless potentiostat for data transmission. In a separate set-up, we connect a sensor to an implanted (but only partially resorbable) data-communication system, proving the principle that there is no need for any percutaneous wiring. The devices can be adapted to sense fluid flow, motion, pH or thermal characteristics, in formats that are compatible with the body’s abdomen and extremities, as well as the deep brain, suggesting that the sensors might meet many needs in clinical medicine.

The optimal duration of antiplatelet therapy in high–bleeding risk (HBR) patients with coronary artery disease treated with newer-generation drug-eluting bioresorbable polymer-coated stents remains unclear. MASTER DAPT (clinicaltrial.govNCT03023020) is an investigator-initiated, open-label, multicenter, randomized controlled trial comparing an abbreviated versus a standard duration of antiplatelet therapy after bioresorbable polymer-coated Ultimaster (TANSEI) sirolimus-eluting stent implantation in approximately 4,300 HBR patients recruited from ≥100 interventional cardiology centers globally. After a mandatory 30-day dual-antiplatelet therapy (DAPT) run-in phase, patients are randomized to (a) a single antiplatelet regimen until study completion or up to 5 months in patients with clinically indicated oral anticoagulation (experimental 1-month DAPT group) or (b) continue DAPT for at least 5 months in patients without or 2 in patients with concomitant indication to oral anticoagulation, followed by a single antiplatelet regimen (standard antiplatelet regimen). With a final sample size of 4,300 patients, this study is powered to assess the noninferiority of the abbreviated antiplatelet regimen with respect to the net adverse clinical and major adverse cardiac and cerebral events composite end points and if satisfied for the superiority of abbreviated as compared to standard antiplatelet therapy duration in terms of major or clinically relevant nonmajor bleeding. Study end points will be adjudicated by a blinded Clinical Events Committee. The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stent implantation.

A novel stent platform eluting biolimus, a sirolimus analogue, from a biodegradable polymer showed promising results in preliminary studies. We compared the safety and efficacy of a biolimus-eluting stent (with biodegradable polymer) with a sirolimus-eluting stent (with durable polymer). We undertook a multicentre, assessor-blind, non-inferiority study in ten European centres. 1707 patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes were centrally randomised by a computer-generated allocation sequence to treatment with either biolimus-eluting (n=857) or sirolimus-eluting (n=850) stents. The primary endpoint was a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation within 9 months. Analysis was by intention to treat. 427 patients were randomly allocated to angiographic follow-up, with in-stent percentage diameter stenosis as principal outcome measure at 9 months. The trial is registered with ClinicalTrials.gov, number NCT00389220. We analysed all randomised patients. Biolimus-eluting stents were non-inferior to sirolimus-eluting stents for the primary endpoint at 9 months (79 [9%] patients vs 89 [11%], rate ratio 0·88 [95% CI 0·64–1·19], p for non-inferiority=0·003, p for superiority=0·39). Frequency of cardiac death (14 [1·6%] vs 21 [2·5%], p for superiority=0·22), myocardial infarction (49 [5·7%] vs 39 [4·6%], p=0·30), and clinically-indicated target vessel revascularisation (38 [4·4%] vs 47 [5·5%], p=0·29) were similar for both stent types. 168 (79%) patients in the biolimus-eluting group and 167 (78%) in the sirolimus-eluting group had data for angiographic follow-up available. Biolimus-eluting stents were non-inferior to sirolimus-eluting stents in in-stent percentage diameter stenosis (20·9% vs 23·3%, difference −2·2% [95% CI −6·0 to 1·6], p for non-inferiority=0·001, p for superiority=0·26). Our results suggest that a stent eluting biolimus from a biodegradable polymer represents a safe and effective alternative to a stent eluting sirolimus from a durable polymer in patients with chronic stable coronary artery disease or acute coronary syndromes. Biosensors Europe SA, Switzerland.

Background The first-generation bioresorbable scaffolds (BRS) have been associated with higher rates of device-related adverse outcomes in comparison to everolimus-eluting stents. We aimed to evaluate the efficacy and safety of the thinner-strut (100/125 μm) poly-L-lactic acid-based sirolimus-eluting Firesorb BRS in patients with de novo coronary lesions. Methods Patient-level data derived from 1205 patients in the FUTURE-II RCT ( n  = 215) and FUTURE-III registry ( n  = 990) were prospectively collected, pooled, and analyzed. The primary endpoint of 1-year target lesion failure (TLF) was defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. The patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, or any revascularization was also analyzed. Results At 1-year follow-up, the cumulative rate of TLF was 1.67%, with an upper 95% confidence interval of 2.57%, significantly lower than the objective performance criterion goal of 6.6% ( P  < 0.001). The rate of single TLF components was 0.42% for cardiac death, 0.92% for target vessel myocardial infarction, and 0.42% for ischemia-driven target lesion revascularization. The cumulative rate of POCE at 1 year was 3.34%. No patient experienced definite or probable device thrombosis during 1-year follow-up. Conclusions This pooled, patient-level analysis indicates that the thinner strut Firesorb BRS exhibits promising 1-year efficacy and safety profiles with regard to TLF. However, our findings are only applicable to non-complex lesions; large-scale randomized clinical trials powered to assess clinical endpoints are necessary to evaluate the strategy of Firesorb BRS compared to drug-eluting stents. Trial registration ClinicalTrials.gov Identifier: NCT02890160 and NCT03660202.

Following extensive surgical debridement in the treatment of infection, a \"dead space\" can result following surgical closure that can fill with hematoma, an environment conducive to bacterial growth. The eradication of dead space is essential in order to prevent recurrent infection. This study describes a novel small animal model to investigate dead-space management in muscle tissue. Two absorbable test materials were implanted in each animal; beads of calcium sulfate alone, and beads loaded with vancomycin and tobramycin. In-life blood samples and radiographs were taken from each animal following implantation. Animals were sacrificed at 1, 7, 21, 42, and 63 days post-operatively (n = 4), and implant sites were analysed by micro-computed tomography, histology and immunohistochemistry. Complete resorption was confirmed radiographically at 3 weeks post-implantation. Histologically, the host tissue response to both materials was identical, and subsequent healing at the implant sites was observed with no dead space remaining. Vancomycin was not detected in blood serum. However, peak tobramycin levels were detected in all animals at 6 hours post-implantation with no detectable levels in any animals at 72 hours post implantation. Serological inflammatory cytokine expression for IL-6, TNF-α and IL-1β indicated no unusual inflammatory response to the implanted materials or surgical procedure. The model was found to be convenient and effective for the assessment of implant materials for management of dead space in muscle tissue. The two materials tested were effective in resolving the surgically created dead space, and did not elicit any unexpected adverse host response.

Biodegradable tracheal stents have been developed to overcome the limitations of metallic and removable stents in benign airway disease. This study evaluated the local and systemic inflammatory response induced by a biodegradable polydioxanone tracheal stent in a rabbit model. Twenty-one rabbits were assigned to three follow-up groups (30, 60, and 90 days). In each group, six animals received a tracheal stent, and one served as a sham control. Clinical status and respiratory symptoms were monitored, and serial peripheral blood interleukin-8 (IL-8) levels were measured. At the end of follow-up, tracheoscopy, IL-8 quantification in tracheal lavage, and necropsy were performed. No deaths or severe respiratory symptoms occurred. Tracheoscopic findings were significantly less severe after stent degradation, with reduced congestion (p = 0.030), inflammation (p = 0.003), and secretions (p = 0.030). Two granulomas and two cases of stenosis were identified. Mean IL-8 expression in tracheal lavage (relative quantification, RQ) was 14,129 ± 3007 when the stent was present and 426 ± 100 after degradation (p = 0.003). Blood IL-8 expression increased significantly on day 1 compared with baseline (p = 0.022) and subsequently decreased (p = 0.034). Inflammatory and structural alterations induced by a polydioxanone tracheal stent decrease after stent degradation.

Currently, no data are available on the direct comparison between the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) and conventional metallic drug-eluting stents. The ABSORB II study is a randomized, active-controlled, single-blinded, multicenter clinical trial aiming to compare the second-generation Absorb BVS with the XIENCE everolimus-eluting metallic stent. Approximately 501 subjects will be enrolled on a 2:1 randomization basis (Absorb BVS/XIENCE stent) in approximately 40 investigational sites across Europe and New Zealand. Treated lesions will be up to 2 de novo native coronary artery lesions, each located in different major epicardial vessels, all with an angiographic maximal luminal diameter between 2.25 and 3.8 mm as estimated by online quantitative coronary angiography (QCA) and a lesion length of ≤48 mm. Clinical follow-up is planned at 30 and 180 days and at 1, 2, and 3 years. All subjects will undergo coronary angiography, intravascular ultrasound (IVUS) and IVUS-virtual histology at baseline (pre-device and post-device implantation) and at 2-year angiographic follow-up. The primary end point is superiority of the Absorb BVS vs XIENCE stent in terms of vasomotor reactivity of the treated segment at 2 years, defined as the QCA quantified change in the mean lumen diameter prenitrate and postnitrate administration. The coprimary end point is the noninferiority (reflex to superiority) of the QCA-derived minimum lumen diameter at 2 years postnitrate minus minimum lumen diameter postprocedure postnitrate by QCA. In addition, all subjects allocated to the Absorb BVS group will undergo multislice computed tomography imaging at 3 years. The ABSORB II randomized controlled trial (ClinicalTrials.gov NCT01425281) is designed to compare the safety, efficacy, and performance of Absorb BVS against the XIENCE everolimus-eluting stent in the treatment of de novo native coronary artery lesions.

Currently, both drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR) of metallic stents. However, the clinical results of repeated interventions in patients with restenosis of bioresorbable vascular scaffolds (BVS) remain unsettled. We sought to assess the results of interventions in patients with BVS-ISR as compared with those obtained in patients with ISR of DES and bare-metal stents (BMS). Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis (RIBS VII) is a prospective multicenter study (23 Spanish sites) that included 117 consecutive patients treated for BVS-ISR. Inclusion/exclusion criteria were similar to those of previous RIBS studies. Patients in the RIBS IV (DES-ISR, n = 309) and RIBS V (BMS - ISR, n = 189) randomized trials, were used as controls. Most patients with BVS-ISR were treated with DES (76%). Patients with BVS-ISR were younger, had larger vessels, and after interventions had higher in-segment residual diameter stenosis (19 ± 13%, 15 ± 11%, 15 ± 12%, p <0.001) than those treated for DES-ISR and BMS-ISR, respectively. At 1-year clinical follow-up (obtained in 100% of patients) target lesion revascularization (6%) was similar to that seen in patients with DES-ISR and BMS-ISR (8.7% and 3.7%, p = 0.32). Freedom from death, myocardial infarction, and target vessel revascularization (primary clinical end point) was 8.5%, also similar to that found in patients with DES-ISR and BMS-ISR (14.2% and 7.4%, p = 0.09). Results were also similar when only patients treated with DES in each group were compared and remained unchanged after adjusting for potential confounders in baseline characteristics. Time to BVS-ISR did not influence angiographic or clinical results. This study demonstrates the safety and efficacy of coronary interventions for patients presenting with BVS-ISR. One-year clinical results in these patients are comparable to those seen in patients with ISR of metallic stents (ClinicalTrials.gov ID:NCT03167424).

Implants made of biodegradable polymers are replaced by regenerating tissues through inflammation. The changes occurring in tissues and the organism are of practical interest for studying the biocompatibility of the material and searching for systemic markers in the blood that reflect inflammation in peri-implantation tissues. The highly sensitive C-reactive protein (hs-CRP) measurements in blood and morphometric studies of tissue surrounding the implant were carried out in the experiment within three months of implantation of a biopolymer consisting of polycaprolactone (PCL) and polytrimethylene carbonate (PTMC). During the first month, tissue inflammation decreased, and the blood level of hs-CRP did not increase. The polymer biotransformation began in the tissues after a month of implantation and was accompanied by inflammation moving deeper into the matrix. Proliferation of inflammatory cells in tissues was reflected in an increase in the hs-CRP level three months after polymer installation. The result achieved confirmed the polymer’s bioinertness. The level of hs-CRP in the blood of the animals correlated with the level of inflammation in peri-implantation tissues, reflecting the activity of inflammation in the process of polymer biotransformation. This inflammation protein can be recommended for assessing tissue processes following implantation of biopolymers and their biocompatibility.