MRI and CT features of a disc herniation through a fractured lumbar vertebra causing lumbar spinal cord compression in a dog.

A 5-year-old intact male Saint Bernard was presented for paraparesis following a fall down the stairs. Magnetic resonance imaging revealed a chronic fragmentation of the dorsocaudal aspect of the second lumbar vertebral body (L2). Material migrated from the L2 to L3 intervertebral space through the fractured caudal vertebral endplate into the vertebral body and reached the vertebral canal, resulting in a severe extradural compressive myelopathy. Computed tomography confirmed the vertebral fragmentation. Histology of surgically removed compressive material revealed fibrocartilaginous material. The uncommon route of the extruded disc material through a fractured vertebral body makes this case of traumatic disc extrusion unusual.

Bilateral phacoemulsification and intraocular lens implantation in a young African lion (Panthera leo).

An 18-month-old intact female lioness (Panthera leo) was referred to the Clinica Veterinaria Roma Sud for evaluation of bilateral cataracts. Phacoemulsification and implantation of +30 diopter intraocular lens (IOL) were performed bilaterally. Seven years after surgery, the IOL remained centrally positioned and the patient had normal activity.

Phaco-émulsification bilatérale et implantation d'une lentille intra-oculaire chez une jeune lionne africaine (Panthera leo) . Une lionne entière âgée de 18 mois (Panthera leo) a été dirigée à la Clinica Veterinaria Roma Sud pour l'évaluation de cataractes bilatérales. La phaco-émulsification et l'implantation de lentilles intraoculaires dioptriques +30 (LID) ont été réalisées bilatéralement. Sept années après la chirurgie, les LID sont demeurées en position centrale et la patiente s'adonnait à des activités normales.(Traduit par Isabelle Vallières).

Bacteria and parasites in Podarcis sicula and P. sicula klemmerii.

BACKGROUND: New epidemiological data on bacterial and parasitic infections in 24 Italian wall lizards, namely Podarcis sicula (mainland population) and P. sicula klemmerii (insular population) in southern Italy were provided. To achieve this goal, samples were collected from individuals belonging to the two populations and analysed by microbiological and parasitological methods. RESULTS: A wide range of bacteria (e.g. Pantoea spp., Citrobacter spp., Morganella spp., Pseudomonas, Enterobacter spp., Staphylococcus spp. and Escherichia coli) and parasites (e.g. Ophionyssus natricis, coccidia, Dicrocoelidae) were detected in both P. sicula and P. sicula klemmerii individuals. Insular population presented similar bacterial and parasitic diversity to its mainland counterpart. Ampicillin was the antimicrobial with the highest resistance rate. CONCLUSION: This study highlighted various bacteria and parasites, some of them potentially zoonotic. Further studies are needed to better understand the epidemiology and transmission routes of these pathogens along with their impact on the welfare and behaviour of Italian wall lizards.

Detection of zoonotic enteropathogens in captive large felids in Italy.

AIMS: Within the One Health paradigm, infectious disease surveillance have been developed for domestic and wild animals, leaving the role of captive non-domestic populations, especially felids in zoos and circuses, less explored. This study addresses the proximity of these captive animals to urban areas, necessitating focused monitoring for potential zoonotic enteropathogens. The present work aimed to investigate the presence of such zoonotic enteropathogens in faecal samples from captive large felid populations. METHODS AND RESULTS: A total of 108 faecal samples were collected in three circuses, five zoos and one rescue centre across Italy. Salmonella spp. isolation, serotyping and antimicrobial susceptibility testing were conducted on all samples. Additionally, 60 samples were also examined for gastrointestinal parasites using standard coprological techniques. Giardia spp. detection employed direct immunofluorescent staining and specific PCR, while Toxoplasma gondii was detected using PCR targeting B1 gene. A total of 51 Salmonella enterica subsp. enterica were isolated, with predominant serovariants including Infantis (43.1%), Coeln (11.8%) and Newport (11.8%). The captive felids likely act as asymptomatic carriers of foodborne Salmonella, with notable resistance ampicillin and trimethoprim-sulfamethoxazole, no resistance to enrofloxacin was noted. Microscopic analysis revealed Toxascaris leonina eggs in 11 faecal samples (18.3%) and Giardia duodenalis cysts in one animal (1.7%). CONCLUSIONS: Captive animals in public settings may act as sources of Salmonella infection and enteroparasitosis for both occupational and general exposure. The study emphasizes the role of captive animals in antimicrobial resistance dynamics, highlighting the need for routine pathogen screening in the management practices of zoological structures.

High exhaled nitric oxide levels may predict bronchial reversibility in allergic children with asthma or rhinitis.

BACKGROUND: Allergic asthma and rhinitis may be associated. Airway inflammation is shared by both disorders. The measure of the fractional concentration of exhaled nitric oxide (FeNO) may be considered as a surrogate marker for airway inflammation, mainly in allergic patients. Reversibility to bronchodilation (BD) testing is a functional characteristic of asthma. OBJECTIVE: The aim of this study was to evaluate whether FeNO may predict reversibility to BD in a pediatric cohort of allergic subjects with asthma (180) or rhinitis (150). METHODS: Lung function (including forced expiratory volume at the first second (FEV(1)), forced volume capacity (FVC), forced expiratory flow at 25-75% of volume capacity (FEF (25-75))), FeNO measurement, and BD testing were performed in all children. RESULTS: Lung function, FeNO, and sensitization type were significantly different in the two groups. A strong correlation was found between FeNO and ΔFEV(1) after BD. Two main predictors of reversibility were FeNO values >34 ppb [Odds RatioAdj (ORAdj) = 1.9] and sensitization to perennial allergens (ORAdj = 1.7). CONCLUSIONS: This study provided evidence that FeNO was strongly related with the response to BD testing and could predict bronchial reversibility in children with allergic rhinitis or asthma. Therefore, a simple FeNO measurement could suggest relevant information about bronchial reversibility.

Unveiling a novel parasitosis: Trichostrongylus colubriformis infection in captive ring-tailed lemurs (Lemur catta).

Ring-tailed Lemur (Lemur catta) is the only surviving semi-terrestrial diurnal lemur in Madagascar. Despite being the most intensively studied of lemur taxa, only a few helminths have been described in this species. In this study we describe a persistent infection due to Trichostrongylus colubriformis in a captive population of L. catta hosted in a zoological park of northern Italy. In the context of a parasitological survey on zoo animals, we investigated parasites in a captive colony of ring-tailed lemurs within a zoological park. Parasitological analysis included necropsy of a deceased lemur in 2019, subsequent fecal sample collections in 2021-2022, followed by coprological examination and coprocolture. Morphological and molecular analyses were conducted on adult helminths, larvae and eggs, involving microscopy, scanning electron microscopy (SEM), and sequencing of the ITS rDNA region. Trichostrongylidae parasites were primarily found after necropsy in the intestine of the lemur. Morphological and molecular investigations on adults and eggs/larvae recovered from feces collected at different times from lemurs of the same captive population, allowed to properly identify the parasite as T. colubriformis. To the best of our knowledge this is the first description of T. colubriformis in L. catta. Although its presence in wild populations is not necessarily implied by our finding, this parasitosis represent a cause of concern in captive lemurs, considering the possibility of interspecies transmission and the zoonotic implications.

Survey of co-infection by Salmonella and oxyurids in tortoises.

BACKGROUND: Salmonella spp. and oxyurids are among the most prevalent bacterial and parasitic agents in reptiles. These organisms are routinely isolated in healthy tortoises, although heavy infections may cause significant pathology. Tortoises are considered a common source of reptile-associated salmonellosis, an important zoonosis reported worldwide. A survey of the prevalence of Salmonella spp. and oxyurids in 53 tortoises was conducted in southern Italy and a possible correlation between the two pathogens was therefore investigated. RESULTS: Salmonella spp. and oxyurids were detected with a prevalence of 49.1 and 81.1%, respectively. A significant positive correlation between Salmonella spp. and oxyurids was demonstrated. However, confounding factors related to husbandry could have been involved in determining this correlation. CONCLUSIONS: Our results suggest that caution should be exercised in translocation, husbandry, and human contact with tortoises and other exotic pets. Further studies on the epidemiology, molecular characterization and pathogenesis of Salmonella and oxyurids are needed to assess the actual impact of these organisms, as single or associated infections, on tortoises and on other exotic pets.

A forced expiratory flow at 25-75% value <65% of predicted should be considered abnormal: a real-world, cross-sectional study.

Forced expiratory volume in 1 second (FEV1) is considered an important parameter for asthma diagnosis and follow-up. However, it has been proposed that forced expiratory flow at 25-75% (FEF(25-75)) could be more sensitive than FEV1 to detect slight airways obstruction. In this regard, a cutoff FEF(25-75) value has been recently established in a group of asthmatic children: FEF(25-75) < 65% of predicted has been considered impaired. However, the considered population was specifically selected. Therefore, the aim of the present study was to confirm an FEF(25-75) cutoff value in a large cohort of asthmatic children. Seven hundred allergic children (493 male subjects; median age, 11 years) with controlled and partly controlled asthma were evaluated by performing spirometry and skin-prick tests. Three hundred thirteen (44.7%) patients had FEF(25-75%) values of <65% of predicted. Two predictors were significantly associated with impaired FEF(25-75) values: (i) sensitization to perennial allergens (adjusted odds ratio [OR(Adj)], 3.4) and (ii) FEV(1) ≤ 86% of predicted (OR(Adj), 3.8). This study, conducted in real life, could suggest that FEF(25-75) value of <65% of predicted may be considered abnormal.

Single and Synergistic Effects of Fenbendazole and Metronidazole Against Subclinical Infection by Giardia duodenalis in Non-Human Primates in a Zoological Garden in Southern Italy.

The aim of this study was to assess the single and synergistic effects of fenbendazole (Fenb) and metronidazole (Metro) for the treatment of Giardia duodenalis infection in different species of non-human primates (NHPs) housed in a zoological garden of southern Italy. Moreover, the study also aimed to better define the circulation of G. duodenalis zoonotic assemblages in NHP and the potential occurrence of zoonotic transmission between the staff from the zoo and NHP. Briefly, six species that belonged to four families (Lemuridae, Cercopithecidae, Atelidae, and Hylobatidae) of NHP and housed in six cages (CG) were identified as Giardia positive and divided into two groups. Group F (N = 16 animals) was treated with Fenb (50 mg/kg, every 24 h for 5 consecutive days) and Group M (N = 7 animals) was treated with Metro (25 mg/kg, two times a day for 5 consecutive days). After the first round of therapy, all the animals were retreated for 5 days by inverting the drugs in each group. On each sampling day [study days (SDs) 3-24], the samples were tested for the presence of Giardia cysts using the FLOTAC technique. Multiple fecal tests for the antigen detection of Giardia, such as rapid ELISA and direct immunofluorescence (IFA), were performed at each sampling point only on samples that resulted in positive for Giardia cysts with FLOTAC. The efficacy of Fenb ranged from 30 to 67% and for Metro ranged from 82 to 96%. The results showed the synergistic effects of Metro and Fenb (98-100%) over the combination of Fenb and Metro (52-90%) against the infection by Giardia in NHPs. The overall k agreement between FLOTAC and IFA was reached 0.858 (p = 0.0001). In contrast, all the samples had a negative antigen result when using ELISA. At molecular analysis, six samples were confirmed positive for Giardia by nested PCR. Only two positive samples were successfully sequenced that showed 100% of identity with assemblage B. All the samples from the humans included in the study resulted in negative for Giardia cysts. Overall, the study emphasizes the need for regular monitoring of Giardia infections in NHP housed in zoos by traditional diagnostic tools combined with molecular characterization of the parasite.

An Overview of Neoplasia in Captive Wild Felids in Southern Italy Zoos.

The aim of this study was to evaluate the frequency of neoplasms in captive wild felids in Southern Italy zoos over a 13-year period (2008-2021) and to investigate macroscopic and histologic tumor findings in these animals. A total of 24 cases were necropsied, 9 males and 15 females, with age ranging from 6 to 19 years, including 12 tigers (Panthera tigris), 7 leopards (Panthera pardus), 4 lions (Panthera leo), and 1 black jaguar (Panthera onca). Diagnosis of neoplasm was made in 14/24 cases (58.3%). Tumors diagnosed were two cholangiocarcinomas, two hemangiosarcomas of the liver, two uterine leiomyomas, a renal adenocarcinoma, an adrenal gland adenoma, a thyroid carcinoma, an oral squamous cell carcinoma, an osteoma, a meningioma, a mesothelioma, an esophageal leiomyosarcoma, a muscoloskeletal leiomyosarcoma and a thyroid adenoma. The malignant and benign tumors were 62.5 and 37.5%, respectively. Among malignant tumors, no metastasis was observed in 50% of cases; in 10% of cases metastasis involved only regional lymph nodes; and distant metastases were found in 40% of cases. Based on our findings, the liver was the most frequent primary tumor site (25%). The high rates of malignant and widely metastatic neoplasms suggest the importance of active monitoring and management of neoplasia in these threatened and endangered species.

Management of Transcatheter Aortic Valve Implantation and Complex Aorta Anatomy: The Importance of Pre-Procedural Planning.

Aortic stenosis is the most common primary valve lesion requiring surgery or, especially for older patients, transcatheter intervention (TAVI). We showcase a successful transfemoral TAVI procedure in a very high-risk patient and an extremely tortuous S-shaped descending aorta, characterized by heavy calcifications and multiple strong resistance points. We demonstrated that transfemoral TAVI using the "buddy stiff guidewire" technique could be a feasible, simple, quick, and easy procedure able to straighten an extremely abdominal aorta tortuosity. With all techniques available and careful pre-procedural planning, and thanks to the flexibility of new generation TAVI delivery systems, it is possible to safely perform the procedure even in the most challenging patients.

Forced expiratory flow between 25 and 75% of vital capacity might be a predictive factor for bronchial hyperreactivity in children with allergic rhinitis, asthma, or both.

Allergic rhinitis and asthma are closely associated. Bronchial hyperreactivity (BHR) is a pathophysiological characteristic of asthma. Forced expiratory flow between 25 and 75% of vital capacity (FEF(25-75)) has been previously shown to be able to predict BHR in adult patients with allergic rhinitis. Therefore, the aim of this study was (i) to evaluate the presence of BHR in a large group of children with allergic rhinitis, asthma or both and (ii) to confirm whether FEF(25-75) might be related to BHR and may predict BHR also in a pediatric population. Nine hundred fifty children with allergic rhinitis (350), asthma (300), or both (300) were enrolled. Clinical examination, skin-prick test, spirometry, and methacholine challenge were performed in all patients. Severe BHR was quite frequent in allergic children, mainly in asthmatic patients. FEF(25-75) values were significantly related to BHR grade, mainly in children with rhinitis (r = 0.69). Impaired FEF(25-75) values (such as ≤65% of predicted) constituted a relevant predictive factor for severe BHR, mainly in children with rhinitis (odds ratio, 8.9). In conclusion, this pediatric study confirmed that impaired FEF(25-75) values might predict severe BHR in children, mainly in those with allergic rhinitis. Therefore, low FEF(25-75) values could suggest BHR in children.

Bare-metal stents versus drug-eluting stents for primary angioplasty: long-term outcome.

Percutaneous transluminal coronary intervention (PCI) is the most used myocardial revascularization technique for patients with coronary artery disease. Primary PCI with stent implantation is widely considered the gold standard for the treatment of ST-elevation myocardial infarction patients. Coronary stents, compared with balloon angioplasty, have reduced focal lesion restenosis. To reduce in-stent restenosis, drug-eluting stents (DES) were designed to locally release drugs inhibiting neointimal growth. Recent concerns have emerged on the potential higher risk of stent thrombosis with DES that might be even more pronounced among myocardial infarction patients. For these reasons, DES for primary PCI remains an "off-label" use. In the last several years, a number of randomized trials and registries have tested the safety and efficacy of DES in primary PCI. Data from these studies were analyzed in several meta-analyses, reasonably consistently demonstrating that the use of DES significantly decreased the need for revascularization without an increase in the incidence of death, recurrent infarction, or stent thrombosis at long-term follow-up.

Wild geladas (Theropithecus gelada) in crops-more than in pasture areas-reduce aggression and affiliation.

Human-primate interfaces are expanding and, despite recent studies on primates from peri-urban environments, little research exists on the impact of agriculture and/or pasture areas on primate social behavior and health. We assessed how crop/pasture areas potentially alter social behavior and health of wild geladas (Theropithecus gelada) frequenting the unprotected area of Kundi (Ethiopia). We predicted that compared to pasture areas, crop areas (i) would be more challenging for geladas (prediction 1) and (ii) would have a greater impact on both aggressive and affiliative behavior, by reducing grooming time and enhancing competition (prediction 2). During January-May 2019 and December 2019-February 2020, we collected data (via scan, focal animal sampling, and video analyses) on direct human disturbance, external signs of pathologies and social behavior of 140 individuals from 14 one-male units and two all-male units. Animals experienced the highest level of human disturbance in crop areas (in line with prediction 1). Individuals from the groups preferentially frequenting crop areas showed the highest prevalence of external signs of pathologies consistent with chemical and biological contamination (alopecia/abnormally swollen parts). We collected 48 fecal samples. Samples from frequent crop users contained the highest rates of parasitic elements/gram (egg/larva/oocyst/cyst) from Entamoeba histolytica/dispar, a parasite common in human settlements of the Amhara region. In crop areas, subjects spent less time grooming but engaged in lower rates of intense aggression (in partial agreement with prediction 2). We speculate that the reduction in social behavior may be a tactic adopted by geladas to minimize the likelihood of detection and maximize food intake while foraging in crops.

Long-Term outcome of drug-eluting stents compared with bare metal stents in ST-segment elevation myocardial infarction: results of the paclitaxel- or sirolimus-eluting stent versus bare metal stent in Primary Angioplasty (PASEO) Randomized Trial.

BACKGROUND: Drug-eluting stents may offer benefits in terms of repeat revascularization that may be counterbalanced by a potential higher risk of stent thrombosis, especially among ST-segment elevation myocardial infarction (STEMI) patients. No data have been reported so far on the long-term benefits and safety of drug-eluting stents in STEMI. Thus, the aim of the present study was to evaluate the short- and long-term benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) compared with bare metal stents (BMS) in patients undergoing primary angioplasty. METHODS AND RESULTS: Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary percutaneous coronary intervention capability were randomly assigned to BMS, PES, or SES. All patients received upstream glycoprotein IIb/IIIa inhibitors. The primary end point was target lesion revascularization at the 1-year follow-up. Secondary end points were death and/or reinfarction, in-stent thrombosis, and major adverse cardiac events (combined death and/or reinfarction and/or target lesion revascularization) at long-term follow-up (up to 4 to 6 years). Cumulative incidence of end points was investigated. No patient was lost to follow-up. From October 1, 2003, to December 31, 2005, 270 patients with STEMI were randomized to BMS (n=90), PES (n=90), or SES (n=90). Procedural success was obtained in 93% to 95% of patients. Follow-up data were available for all patients. Compared with BMS (14.4%), both PES (4.4%; hazard ratio, 0.29; 95% confidence interval, 0.095 to 0.89; P=0.023) and SES (3.3%; hazard ratio, 0.21; 95% confidence interval, 0.06 to 0.75; P=0.016) were associated with a significant reduction in target lesion revascularization at the 1-year follow-up (primary study end point). At the long-term follow-up (4.3 years; 25th to 75th percentile, 3.7 to 5 years), no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but compared with BMS (22.2%), both PES (6.7%; hazard ratio, 0.27; 95% confidence interval, 0.11 to 0.68; P=0.005) and SES (5.6%; hazard ratio, 0.22; 95% confidence interval, 0.083 to 0.59; P=0.003) were associated with a significant reduction in target lesion revascularization. CONCLUSIONS: This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are associated with significant benefits in terms of target lesion revascularization at the long-term follow-up compared with BMS with no excess risk of thrombotic complications. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered among STEMI patients undergoing primary angioplasty.

Exhaled nitric oxide in children with allergic rhinitis and/or asthma: a relationship with bronchial hyperreactivity.

BACKGROUND: Nowadays, the measure of the fractional concentration of exhaled nitric oxide (FeNO) enables to assess airway inflammation during an office visit and there is international consensus on this testing methodology. The aim of this study was to evaluate whether FeNO measurement is predictable for bronchial hyperreactivity (BHR) in children with allergic rhinitis, asthma, or both. METHODS: Two hundred and eighty children with allergic rhinitis, allergic asthma, or both were evaluated. Bronchial function (FEV1 and FEF(25-75)), BHR (assessed by methacholine challenge), FeNO, and sensitizations were assessed. RESULTS: Bronchial function, BHR, and FeNO were significantly different in the three groups (p < .001). A strong inverse correlation between FeNO and BHR was found in patients with asthma and with asthma and rhinitis (r = -0.63 and r = -0.61, respectively). A cutoff of 32 ppb of FeNO was a predictive factor for BHR. CONCLUSIONS: This study highlights the relevance of FeNO as possible marker for BHR in allergic children and underlines the close link between upper and lower airways.

Impact of diabetes on long-term outcome in STEMI patients undergoing primary angioplasty with glycoprotein IIb-IIIa inhibitors and BMS or DES.

Diabetes has been shown to be associated with worse survival and repeat revascularization (TVR) after primary angioplasty. Drug-eluting stent (DES) may offer benefits in terms of TVR, that may be counterbalanced by an higher risk of stent thrombosis, especially among STEMI patients. Aim of the current study was to evaluate the impact of diabetes on 5-year outcome in patients undergoing primary angioplasty with glycoprotein IIb-IIIa inhibitors in the era of DES. Our population is represented by STEMI patients undergoing primary angioplasty and stent implantation at a tertiary center with 24-h primary PCI capability within 12 h of symptom onset. All patients received glycoprotein IIb-IIIa inhibitors. No patient was lost to follow up. From 2003 to 2005, 270 STEMI patients were treated with DES (n = 180), or BMS (n = 90). A total of 69 patients had history of diabetes at admission (25.5%). At a follow-up of 1510 +/- 406 days, diabetes was associated with a higher rate of death (29.5 vs. 5.1%, P < 0.0001), reinfarction (24.1 vs. 9.1%, P < 0.0001), TVR (19.1 vs. 13.1%, P = 0.052), IST (17.2 vs. 6.8%, P < 0.001) and MACE (51.9 vs. 25.1%, P < 0.001). These results were confirmed in both patients receiving BMS or DES, except for TVR, where no difference was observed between diabetic and non-diabetic patients. This study shows that among STEMI patients undergoing primary angioplasty with Gp IIb-IIIa inhibitors, diabetes is associated with worse long-term mortality, reinfarction, and IST, even with DES implantation, that, however, were able to equalize the outcome in terms of TVR as compared to non diabetic patients.

Dexmedetomidine and ketamine simultaneous administration in tigers (Panthera tigris): pharmacokinetics and clinical effects.

BACKGROUND: The study determines the pharmacokinetic profiles of dexmedetomidine (DEX), ketamine (KET) and its active metabolite, norketamine (NORKET), after simultaneous administration. Moreover, the study evaluates the sedative effects of this protocol, its influence on the main physiological variables and the occurrence of adverse effects. METHODS: Eighteen captive tigers were initially administered with a mixture of DEX (10 µg/kg) and KET (2 mg/kg) by remote intramuscular injection. In case of individual and specific needs, the protocol was modified and tigers could receive general anaesthesia, propofol or additional doses of DEX and KET. RESULTS: Based on the immobilisation protocol, nine animals were assigned to the standard protocol group and the other nine to the non-standard protocol group. Higher area under the first moment curve (AUMC0-last) and longer mean residence time (MRT0-last) (P<0.05) were observed in the non-standard protocol group for DEX, KET and NORKET, and higher area under the concentration-time curve from administration to the last measurable concentration (AUC0-last) only for KET. The KET metabolisation rate was similar (P=0.296) between groups. No differences between groups were detected in terms of stages of sedation and recoveries. All physiological variables remained within normality ranges during the whole observation period. During the hospitalisation period, no severe adverse reactions and signs of resedation were observed. CONCLUSION: The simultaneous administration of 10 µg/kg of DEX and 2 mg/kg of KET can be considered an effective protocol for chemical immobilisation of captive tigers, along with dosage adjusments or when other drugs are needed.

Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial.

BACKGROUND: Drug-eluting stent (DES) may offer benefits in terms of repeat revascularization, which may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with STEMI. No data have been reported so far on the long-term benefits and safety of DES in STEMI. The aim of the current study was to evaluate the short- and long-term benefits of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) as compared to bare-metal stent (BMS) in patients undergoing primary angioplasty. METHODS: Consecutive patients with STEMI admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary percutaneous coronary intervention capability were randomly assigned to BMS, PES, and SES. All patients received upstream glycoprotein IIb-IIIa inhibitors. Primary end point was target-lesion revascularization at 1-year follow-up. Secondary end points were (1) cumulative combined incidence of death and/or reinfarction; (2) cumulative incidence of in-stent thrombosis; and (3) major adverse cardiac events (MACE) (combined death and/or reinfarction and/or target lesion revascularization [TLR]) at long-term follow-up (up to 4 years). No patient was lost to follow-up. RESULTS: From October 1, 2003, to December 2005, 270 patients with STEMI were randomized to BMS (n = 90), PES (n = 90), or SES (n = 90). Procedural success was obtained in 93% to 95% of patients. Follow-up data were available for all patients. As compared to BMS (14.4%), both PES (4.4%, hazard ratio [HR] 0.29, 95% CI 0.095-0.89, P = .023) and SES (3.3%, HR 0.21, 95% CI 0.06-0.75, P = .016) were associated with a significant reduction in TLR at 1-year follow-up (primary study end point). At long-term follow-up (1,233 +/- 215 days), no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but as compared to BMS (21.1%), both PES (6.7%, HR 0.29, 95% CI 0.12-0.73, P = .008) and SES (5.6%, HR 0.24, 95% CI 0.09-0.63, P = .002), respectively, were associated with a significant reduction in TLR. CONCLUSIONS: This study shows that among patients with STEMI undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of TLR up to 4 years' follow-up, as compared to BMS. Thus, until the results of further large randomized trials with long-term follow-up become available, DES may be considered among patients with STEMI undergoing primary angioplasty.