ABSTRACT
The influence of demographic characteristics and social determinants on cancer outcomes is widely recognized in various malignancies but remains understudied in myelofibrosis (MF). This study aims to investigate social and demographic variables associated with MF survival. We retrospectively reviewed data of biopsy-proven MF patients from the Surveillance, Epidemiology and End Results (SEER) database (2000-2021) and Montefiore Medical Center (2000-2023), an underserved inner-city hospital. The SEER cohort included 5,403 MF patients and was predominantly Non-Hispanic (NH) White (82%) with a median age of 69 years. The age-adjusted incidence rate of MF was 0.32 cases per 100,000 person-years, increasing annually by 1.3% from 2000 to 2021. Two- and five- year overall survival rates were 69% and 42%, respectively. Worse cause-specific survival was associated with older age, male sex, and diagnosis before 2011 (year of Ruxolitinib approval). NH-Black ethnicity, unmarried status and lower median income were independent predictors of worse overall survival. The single-center analysis included 84 cases, with a median age of 66 years. NH-White patients comprised 37% of the sample, followed by NH-Black (28.5%). Two- and five- year overall survival rates were 90% and 61%, respectively, with NH-Black patients exhibiting the lowest median survival, although the difference was not statistically significant. Age was a significant predictor of worse survival in this cohort. NH-Black and Hispanic patients lived in areas with higher socioeconomic and demographic stress compared to NH-White patients. Overall, this study highlights the association of social and demographic factors with MF survival and emphasizes the need for equitable healthcare and further exploration of social-demographic factors affecting MF survival.
Subject(s)
Primary Myelofibrosis , SEER Program , Humans , Primary Myelofibrosis/epidemiology , Primary Myelofibrosis/mortality , Male , Female , Aged , Middle Aged , Retrospective Studies , Survival Rate , Aged, 80 and over , Socioeconomic Factors , Adult , Databases, Factual , United States/epidemiology , IncidenceABSTRACT
PURPOSE: This study evaluates the long-term adjunctive use of netarsudil ophthalmic solution 0.02% in lowering IOP in patients with refractory glaucoma. METHODS: This retrospective chart review study was conducted at a tertiary care center. Patients who were prescribed add-on netarsudil therapy and on ≥ 3 topical glaucoma medications from 01/01/2018 to 08/31/2020 were reviewed. 47 patients (69 eyes) met the inclusion criteria. Baseline IOPs prior to the addition of netarsudil were compared to IOPs measured at 3-, 6-, and 12-month intervals. Any patients with inadequate follow-up or who had glaucoma surgery after netarsudil initiation were excluded. RESULTS: Median baseline IOP (± SD) was 21 ± 5.8 mmHg (median of 2 visits prior to initiation of netarsudil). At 3-month follow-up, 64 eyes had a median IOP of 16 ± 6.7 mmHg (p < 0.01). At 6-month follow-up, 56 eyes had a median IOP of 18 ± 4.6 mmHg (p < 0.01). At 12-month follow-up, 44 eyes had a median IOP of 15 ± 6.8 mmHg (p < 0.01). At the conclusion of the study, 64% of eyes reached 1 year follow-up due to several reasons. CONCLUSIONS: Patients with refractory glaucoma showed statistically and clinically significant IOP reductions on netarsudil. IOP reduction was stable long-term with the largest decrease in IOP seen at 12 months. Although some patients will still go on to require further laser or incisional surgery, for most patients netarsudil is an effective treatment for adjunctive use in refractory glaucoma.
Subject(s)
Benzoates , Intraocular Pressure , Ophthalmic Solutions , beta-Alanine , Humans , Retrospective Studies , Male , Female , Intraocular Pressure/physiology , Intraocular Pressure/drug effects , beta-Alanine/analogs & derivatives , beta-Alanine/administration & dosage , beta-Alanine/therapeutic use , Aged , Ophthalmic Solutions/administration & dosage , Middle Aged , Benzoates/administration & dosage , Benzoates/therapeutic use , Follow-Up Studies , Treatment Outcome , Glaucoma/drug therapy , Glaucoma/physiopathology , Antihypertensive Agents/administration & dosage , Antihypertensive Agents/therapeutic use , Tonometry, Ocular , Visual Acuity , Aged, 80 and overABSTRACT
Rapid, direct identification and quantitation of protein charge variants, and assessment of critical quality attributes with high sensitivity are important drivers required to accelerate the development of biotherapeutics. We describe the use of an enhanced microfluidic chip-based integrated imaged capillary isoelectric focusing-mass spectrometry (icIEF-MS) technology to assess multiple quality attributes of intact antibodies in a single run. Results demonstrate comprehensive detection of multiple charge variants of an aglycosylated knob-into-hole bispecific antibody. Upfront, on-chip separation by icIEF coupled to MS provides the orthogonal separation required to resolve and identify acidic posttranslational modifications including difficult-to-detect deamidation and glycation events at the intact protein level. In addition, on-chip UV detection enables pI determination and relative quantitation of charge isoforms. Six charge variant peaks were resolved by icIEF, mobilized toward the on-chip electrospray tip and directly identified by in-line icIEF-MS using a connected quadrupole time-of-flight mass spectrometer. In addition to acidic charge variants, basic variants were identified as C-terminal lysine, N-terminal cyclization, proline amidation, and the combination of modifications (not typically identified by other intact methods), including lysine and one or two hexose additions. Nonspecific chain cleavages were also resolved, along with their acidic charge variants, demonstrating highly sensitive and comprehensive intact antibody multi-attribute characterization within a 15-min run time.
Subject(s)
Antibodies, Bispecific , Antibodies, Monoclonal , Antibodies, Monoclonal/analysis , Microfluidics , Capillary Isoelectric Focusing , Lysine , Electrophoresis, Capillary/methods , Mass Spectrometry/methods , Isoelectric Focusing/methods , TechnologyABSTRACT
The purpose of this retrospective, cross-sectional study was to determine and analyze the trends in ocular injuries related to landscaping activities and equipment from 2010 to 2019. A total of 168,845 ocular injuries were associated with landscaping activities with the majority of cases occurring in men (80.4%) between the ages of 41-60 during the summer months of June, July, and August. The majority of ocular injuries did not require admission (97.8%) but of those that were admitted 42% had an open globe injury (n = 399). The results of this investigation provide useful information for emergency room physicians and ophthalmologists in understanding the prevalence of these landscaping-associated ocular injuries and further draw suspicion for the incidence of open globe injuries in this population.
Subject(s)
Eye Injuries, Penetrating , Eye Injuries , Male , Humans , Child, Preschool , Retrospective Studies , Cross-Sectional Studies , Visual Acuity , Eye Injuries/epidemiology , Eye Injuries/etiology , IncidenceABSTRACT
PURPOSE: Currently, there exists a lack of recent epidemiological data concerning ocular injuries due to welding related activities. Our study analyzes trends in ocular injuries related to usage of welding equipment in the U.S. from 2010 to 2019. METHODS: Using the Consumer Product Safety Commission's National Electronic Injury Surveillance System (NEISS) Database, we queried data from January 1st 2010 to December 31st 2019 using the corresponding product code for welding equipment (896). Results were stratified by year, and standard descriptive statistical methods were applied to components including gender, age, diagnoses, and ED disposition. Circumstances leading up to the injuries were reviewed as well. RESULTS: Between 2010 and 2019 a total of 109,127 welding-associated ocular injuries occurred in the United States (95% CI, 86937-131,316). Estimates show a decreasing trend in cases from 13,415 (95% CI, 9979-16,851) in 2010 to 6944 (95% CI, 4868-9020) in 2019. A majority of cases occurred in men (98.2%) and in the 10-49 year age range (83.8%). 3.3% of cases involved spectators and 44% were bilateral. The top three ocular injury diagnoses were flash burns (62.1%), foreign body implantation (19.6%), and contusions/abrasions (11.1%). The number of radiation injuries trended down from 9286 in 2010 to 4023. With respect to a documented location, 38.9% occurred at home and 4.5% occurred in a school setting. Most patients (99.9%) were discharged from the ED; 0.1% were admitted to the hospital. CONCLUSIONS: The data suggests that number of ocular injuries related to welding has decreased significantly over the past 10 years. The most common injuries were radiation burns, foreign body disruption, and contusions/abrasions of the eye. Patients were predominantly men and between the ages of 10 and 49. Of note, almost half of all ocular injuries due to welding were bilateral, and 3% of ocular injuries were seen in spectators.
Subject(s)
Burns , Contusions , Eye Injuries , Foreign Bodies , Welding , Adolescent , Adult , Child , Emergency Service, Hospital , Eye Injuries/epidemiology , Eye Injuries/etiology , Humans , Male , Middle Aged , Retrospective Studies , United States/epidemiology , Young AdultABSTRACT
PURPOSE: To explore the potential of testosterone therapy in managing cytopenias in myelodysplastic neoplasm and investigate the link between hypogonadism and hematologic malignancies. METHODS: A case of a patient with intermediate-risk myelodysplastic neoplasm and hypogonadism treated with testosterone replacement therapy is presented. Testosterone, prostate specific antigen, and erythropoietin levels were checked prior to therapy initiation and 3 months after. Blood counts were monitored over time. This is followed by a literature review of testosterone use in myelodysplastic neoplasm and the prevalence of hypogonadism in hematologic malignancies. RESULTS: The patient showed sustained improvement in anemia with testosterone therapy and reported subjective improvement in his weakness and fatigue. This improvement occurred even in the setting of an undetectable follow up erythropoietin level. His repeat prostate specific antigen levels remained low, while testosterone levels showed marked improvement. The literature review demonstrated positive response rates for testosterone in treating myelodysplastic neoplasm-related cytopenias, and showed a higher incidence of hypogonadism in hematologic malignancies. CONCLUSION: Our review suggests that the use of testosterone in low and intermediate-risk myelodysplastic neoplasm is underexplored and poses to have significant potential as a future therapeutic agent, after careful consideration of risks and benefits. In addition, the incidence of hypogonadism in myelodysplastic neoplasm and its potential impact on exacerbating cytopenias in myelodysplastic neoplasm warrants further investigation.
Subject(s)
Hypogonadism , Myelodysplastic Syndromes , Testosterone , Humans , Testosterone/therapeutic use , Male , Myelodysplastic Syndromes/drug therapy , Myelodysplastic Syndromes/complications , Hypogonadism/drug therapy , Hormone Replacement Therapy/methods , Anemia/drug therapy , Anemia/etiology , Aged , Middle Aged , CytopeniaABSTRACT
The DEBS1-TE fusion protein is comprised of the loading module, the first two extension modules, and the terminal TE domain of the Saccharopolyspora erythraea 6-deoxyerythronolide B synthase. DEBS1-TE produces triketide lactones that differ on the basis of the starter unit selected by the loading module. Typical fermentations with plasmid-based expression of DEBS1-TE produce a 6:1 ratio of propionate to isobutyrate-derived triketide lactones. Functional dissection of the loading module from the remainder of DEBS1-TE results in 50% lower titers of triketide lactone and a dramatic shift in the production to a 1:4 ratio of propionate to isobutyrate-derived products. A series of radiolabeling studies of the loading module has shown that transfer from the AT to the ACP occurs much faster for propionate than for isobutyrate. However, the equilibrium occupancy of the AT favors isobutyrate such that propionate is outcompeted for ACP occupancy. Thus, propionyl-ACP is the kinetic product, while isobutyryl-ACP is the thermodynamic product. A slowed transfer from the loading domain ACP to first-extension module KS due to functional dissection of DEBS1-TE allows this isobutyryl-ACP-favored equilibrium to be realized and likely accounts for the observed shift in triketide lactone products.
Subject(s)
Lactones/chemistry , Polyketide Synthases/chemistry , Saccharopolyspora/enzymology , Base Sequence , Chromatography, High Pressure Liquid , DNA Primers , Fermentation , Hydrolysis , Mass Spectrometry , Plasmids , Polymerase Chain ReactionABSTRACT
OBJECTIVES: We compared the incidence of polymorphisms activating the NLRP3 inflammasome between controls and patients with cholesteatoma and its potential association with bone erosion in patients with cholesteatoma. METHODS: This is a case-control study assessing the mutation rates in genes of interest in patients with and without cholesteatoma. A total of 133 saliva samples from control (n = 65) and cholesteatoma (n = 68) patients were collected for DNA extraction. Caspase recruitment domain family member 8 (CARD8) (AA: homozygous wild type, AT: heterozygous, TT: homozygous mutant polymorphism) and NLRP3 (CC: homozygous wild type, CA: heterozygous, AA: homozygous mutant) polymorphisms were analyzed with TaqMan single-nucleotide polymorphism (SNP) quantitative polymerase chain reaction (ThermoFisher Scientific, Waltham, MA). Mutation status was correlated with a novel bone erosion scoring model developed as a part of this study. Summary statistics, including frequencies (%) and median (Q1, Q3) were used to describe the sample. RESULTS: The presence of CARD8 and NLRP3 homozygous wild-type polymorphisms were generally similar for the control and cholesteatoma patient groups. CARD8 homozygous TT polymorphisms were an exception, occurring more frequently in patients who developed a cholesteatoma compared to the control group (29% vs. 10%, P = .009). Those patients with CARD8 homozygous TT polymorphism had higher median scores of bone erosion as compared to subjects with nonhomozygous mutant genotypes (median [interquartile range]: 4.0 [3.0, 5.5] vs. 2.5 [1.0, 3.5], P = .0142). CONCLUSION: Cholesteatoma patients have a significant, twofold higher incidence of CARD8 homozygous TT polymorphism. Furthermore, cholesteatoma patients with this homozygous polymorphism had greater bone erosion rates than controls. These findings suggest that genetic mutations may increase host susceptibility to cholesteatomas. Specifically, the CARD8 TT polymorphism may influence the severity of cholesteatoma-induced bone erosion. LEVEL OF EVIDENCE: 3B.
Subject(s)
CARD Signaling Adaptor Proteins/genetics , Cholesteatoma, Middle Ear/genetics , NLR Family, Pyrin Domain-Containing 3 Protein/genetics , Neoplasm Proteins/genetics , Polymorphism, Single Nucleotide/genetics , Temporal Bone/pathology , Case-Control Studies , Cholesteatoma, Middle Ear/etiology , Cholesteatoma, Middle Ear/pathology , Codon, Nonsense/genetics , Gene Frequency/genetics , Genetic Predisposition to Disease/genetics , Humans , Mutation, Missense/geneticsABSTRACT
The pikromyin polyketide synthase (PKS) in Streptomyces venezulae is comprised of a loading module and six extension modules, which generate the corresponding 14-membered macrolactone product. PikAI is a multimodular component of this PKS and houses both the loading domain and the first two extension modules, joined by short intraprotein linkers. We have shown that PikAI can be separated into two proteins at either of these linkers, only when matched pairs of docking domains (DDs) from a heterologous modular phoslactomycin PKS are used in place of the intraprotein linker. In both cases the yields of pikromycin produced by the S. venezuelae mutant were 50% of that of a S. venezuelae strain expressing the native trimodular PikAI. This observation provides the first demonstration that such separations do not dramatically impact the efficiency of the entire in vivo biosynthetic process. Expression of module 2 as a monomodular protein fused to a heterologous N-terminal docking domain was also observed to give almost a tenfold improvement in the in vivo generation of pikromycin from a synthetic diketide intermediate. These results demonstrate the utility of DDs to manipulate biosynthetic processes catalyzed by modular PKSs and the quest to generate novel polyketide products.
Subject(s)
Anti-Bacterial Agents/metabolism , Macrolides/metabolism , Peptides/metabolism , Polyketide Synthases/metabolism , Anti-Bacterial Agents/biosynthesis , Anti-Bacterial Agents/chemistry , Genetic Vectors , Lactones/chemistry , Lactones/metabolism , Macrolides/chemistry , Mutagenesis, Insertional , Polyketide Synthases/genetics , Streptomyces/enzymologyABSTRACT
OBJECTIVES: This study sought to report the late multimodality imaging and clinical outcomes of the novel poly-l-lactic-acid-based DESolve novolimus-eluting bioresorbable coronary scaffold for the treatment of de novo coronary lesions. BACKGROUND: Bioresorbable scaffolds are an alternative to drug-eluting metallic stents and provide temporary vascular scaffolding, which potentially may allow vessel restoration and reduce the risk of future adverse events. METHODS: Overall, 126 patients were enrolled at 13 international sites between November 2011 and June 2012. The primary endpoint was in-scaffold late lumen loss at 6 months. Major adverse cardiac events, the main safety endpoint, were defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. All patients underwent angiography at 6 months. Serial intravascular ultrasound and optical coherence tomography were performed in a subset of patients. RESULTS: The scaffold device success rate was 97% (n = 122 of 126), and procedural success was 100% (n = 122 of 122). The major adverse cardiac event rate was 3.3% (n = 4 of 122) at 6 months and 7.4% (n = 9 of 122) at 24 months, including 1 probable stent thrombosis within the first month. At 6-month angiographic follow-up, in-scaffold late lumen loss was 0.20 ± 0.32 mm. Paired intravascular ultrasound analysis demonstrated a significant increase in vessel, lumen and scaffold dimensions between post-procedure and 6-month follow-up, and strut-level optical coherence tomography analysis showed full strut coverage in 99 ± 1.7%. CONCLUSIONS: Our results showed favorable performance of the DESolve scaffold, effective inhibition of neointimal hyperplasia, and for the first time, early luminal and scaffold growth at 6 months with sustained efficacy and safety through 2 years. (Elixir Medical Clinical Evaluation of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System-The DESolve Nx Trial; NCT02086045).
Subject(s)
Absorbable Implants , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Coronary Angiography , Coronary Artery Disease/therapy , Coronary Vessels/drug effects , Macrolides/administration & dosage , Percutaneous Coronary Intervention/instrumentation , Tomography, Optical Coherence , Ultrasonography, Interventional , Aged , Brazil , Cardiovascular Agents/adverse effects , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Vessels/diagnostic imaging , Europe , Female , Humans , Hyperplasia , Macrolides/adverse effects , Male , Middle Aged , Neointima , New Zealand , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Predictive Value of Tests , Prospective Studies , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Filamentous fungi and bacteria form mixed-species biofilms in nature and diverse clinical contexts. They secrete a wealth of redox-active small molecule secondary metabolites, which are traditionally viewed as toxins that inhibit growth of competing microbes. RESULTS: Here, we report that these "toxins" can act as interspecies signals, affecting filamentous fungal development via oxidative stress regulation. Specifically, in coculture biofilms, Pseudomonas aeruginosa phenazine-derived metabolites differentially modulated Aspergillus fumigatus development, shifting from weak vegetative growth to induced asexual sporulation (conidiation) along a decreasing phenazine gradient. The A. fumigatus morphological shift correlated with the production of phenazine radicals and concomitant reactive oxygen species (ROS) production generated by phenazine redox cycling. Phenazine conidiation signaling was conserved in the genetic model A. nidulans and mediated by NapA, a homolog of AP-1-like bZIP transcription factor, which is essential for the response to oxidative stress in humans, yeast, and filamentous fungi. Expression profiling showed phenazine treatment induced a NapA-dependent response of the global oxidative stress metabolome, including the thioredoxin, glutathione, and NADPH-oxidase systems. Conidiation induction in A. nidulans by another microbial redox-active secondary metabolite, gliotoxin, also required NapA. CONCLUSIONS: This work highlights that microbial redox metabolites are key signals for sporulation in filamentous fungi, which are communicated through an evolutionarily conserved eukaryotic stress response pathway. It provides a foundation for interspecies signaling in environmental and clinical biofilms involving bacteria and filamentous fungi.
Subject(s)
Aspergillus fumigatus/metabolism , Microbial Interactions , Oxidative Stress , Phenazines/metabolism , Pseudomonas aeruginosa/metabolism , Aspergillus fumigatus/growth & development , Basic-Leucine Zipper Transcription Factors/metabolism , Biofilms , Coculture Techniques , Fungal Proteins/metabolism , Gliotoxin/metabolism , Methylphenazonium Methosulfate , Phenotype , Spores, Fungal/growth & developmentABSTRACT
OBJECTIVES: This study sought to perform clinical and imaging assessments of the DESolve Bioresorbable Coronary Scaffold (BCS). BACKGROUND: BCS, which is drug eluting, may have potential advantages compared with conventional metallic drug-eluting stents. The DESolve system, designed to provide vessel support and neointimal suppression, combines a poly-l-lactic acid-based scaffold with the antiproliferative myolimus. METHODS: The DESolve First-in-Man (a non-randomized, consecutive enrollment evaluation of the DESolve myolimus eluting bioresorbable coronary stent in the treatment of patients with de novo native coronary artery lesions) trial was a prospective multicenter study enrolling 16 patients eligible for treatment. The principal safety endpoint was a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization. The principal imaging endpoint was in-scaffold late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 6 months. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging was performed at baseline and 6 months; multislice computed tomography (MSCT) was performed at 12 months. RESULTS: Acute procedural success was achieved in 15 of 15 patients receiving a study scaffold. At 12 months, there was no scaffold thrombosis and no major adverse cardiac events directly attributable to the scaffold. At 6 months, in-scaffold LLL (by QCA) was 0.19 ± 0.19 mm; neointimal volume (by IVUS) was 7.19 ± 3.56%, with no evidence of scaffold recoil or late malapposition. Findings were confirmed with OCT and showed uniform, thin neointimal coverage (0.12 ± 0.04 mm). At 12 months, MSCT demonstrated excellent vessel patency. CONCLUSIONS: This study demonstrated the feasibility and efficacy of the DESolve BCS. Results showing low in-scaffold LLL, low % neointimal volume at 6 months, no chronic recoil, and maintenance of lumen patency at 12 months prompt further study. (DESolve First-in-Man; EudraCT number 2011-000027-32).
Subject(s)
Absorbable Implants , Cardiovascular Agents/administration & dosage , Coronary Artery Disease/therapy , Drug-Eluting Stents , Multimodal Imaging , Percutaneous Coronary Intervention/instrumentation , Tissue Scaffolds , Aged , Aged, 80 and over , Belgium , Coronary Angiography , Coronary Artery Disease/diagnosis , Coronary Artery Disease/mortality , Coronary Artery Disease/physiopathology , Coronary Restenosis/diagnosis , Coronary Restenosis/etiology , Female , Humans , Lactic Acid/chemistry , Male , Materials Testing , Models, Cardiovascular , Multidetector Computed Tomography , Multimodal Imaging/methods , Myocardial Infarction/diagnosis , Myocardial Infarction/etiology , Neointima , New Zealand , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Polyesters , Polymers/chemistry , Predictive Value of Tests , Prospective Studies , Prosthesis Design , Time Factors , Tomography, Optical Coherence , Treatment Outcome , Ultrasonography, Interventional , Vascular PatencyABSTRACT
The development of a wireless, microfluidic pressure sensor composed of Polydimethylsiloxane (PDMS) and dyed glycerol is presented for point-of-care glaucoma diagnosis. Design, fabrication and test results are presented.
Subject(s)
Contact Lenses , Glaucoma/diagnosis , Point-of-Care Systems , Radio Waves , Equipment Design , Glaucoma/physiopathology , Humans , Intraocular Pressure , PressureABSTRACT
AIMS: First generation DES have markedly reduced restenosis. However, there is a major interest in developing new DES with greater flexibility, radiopacity and safety profile. The Elixir Medical drug eluting stent is a novel DES that combines a chromium-cobalt platform with novolimus (an antiproliferative sirolimus-analogue drug) and a polymer from the methacrylate family. As potential advantages, it provides a lower drug dose as compared to Cypher (85 microg of novolimus vs. 140 microg of sirolimus) and therefore has a lower polymer load. We sought to evaluate the safety and efficacy of this novel device in reducing neointimal hyperplasia as assessed by QCA and IVUS. METHODS AND RESULTS: In April 2007 a consecutive cohort of patients with de novo lesions < or = 14 mm in length, located in native coronaries of diameter from 3.0 to 3.5 mm were consecutively enrolled in this First-in-Man study (FIM). By protocol, angiography and IVUS would be done at baseline and repeated at four and eight months. Dual anti-platelet therapy was maintained for a minimum of 12 months. The primary endpoint was QCA lumen loss at 4-month follow-up. Secondary endpoints included MACE, in-stent neointimal obstruction by IVUS and device success. A total of 15 patients were included with 67% female patients and diabetes was detected in 47% of the cohort. Angiographic and procedural success was achieved in all patients. At 4-month angiographic follow-up there was in-stent late lumen loss (0.15 +/- 0.29 mm) by QCA and % volume obstruction (2.6 +/- 2.6) by IVUS. The angiographic in-stent late lumen loss results at eight months were 0.31 +/- 0.25 mm and % volume obstruction by IVUS was 6.0 +/- 4.4%. Late incomplete stent apposition (ISA) were not observed among these patients and no MACE was evidenced through nine month clinical follow-up. CONCLUSIONS: In this FIM study, implantation of the novolimus-eluting stent was proven to be feasible, safe and elicited minimum neointimal proliferation. Additional large clinical trials should be considered to confirm these promising results.