Summary Background Colchicine is effective for the treatment of acute pericarditis and first recurrences. However, conclusive data are lacking for the efficacy and safety of colchicine for treatment ...of multiple recurrences of pericarditis. Methods We did this multicentre, double-blind trial at four general hospitals in northern Italy. Adult patients with multiple recurrences of pericarditis (≥two) were randomly assigned (1:1) to placebo or colchicine (0·5 mg twice daily for 6 months for patients weighing more than 70 kg or 0·5 mg once daily for patients weighing 70 kg or less) in addition to conventional anti-inflammatory treatment with aspirin, ibuprofen, or indometacin. Permuted block randomisation (size four) was done with a central computer-based automated sequence. Patients and all investigators were masked to treatment allocation. The primary outcome was recurrent pericarditis in the intention-to-treat population. This trial is registered with ClinicalTrials.gov , number NCT00235079. Findings 240 patients were enrolled and 120 were assigned to each group. The proportion of patients who had recurrent pericarditis was 26 (21·6%) of 120 in the colchicine group and 51 (42·5%) of 120 in the placebo group (relative risk 0·49; 95% CI 0·24–0·65; p=0·0009; number needed to treat 5). Adverse effects and discontinuation of study drug occurred in much the same proportions in each group. The most common adverse events were gastrointestinal intolerance (nine patients in the colchicine group vs nine in the placebo group) and hepatotoxicity (three vs one). No serious adverse events were reported. Interpretation Colchicine added to conventional anti-inflammatory treatment significantly reduced the rate of subsequent recurrences of pericarditis in patients with multiple recurrences. Taken together with results from other randomised controlled trials, these findings suggest that colchicine should be probably regarded as a first-line treatment for either acute or recurrent pericarditis in the absence of contraindications or specific indications. Funding Azienda Sanitaria 3 of Torino (now ASLTO2).
Summary Improvements in the control of haemorrhage after trauma have resulted in the survival of many people who would otherwise have died from the initial loss of blood. However, the danger is not ...over once bleeding has been arrested and blood pressure restored. Two-thirds of patients who die following major trauma now do so as a result of causes other than exsanguination. Trauma evokes a systemic reaction that includes an acute, non-specific, immune response associated, paradoxically, with reduced resistance to infection. The result is damage to multiple organs caused by the initial cascade of inflammation aggravated by subsequent sepsis to which the body has become susceptible. This Series examines the biological mechanisms and clinical implications of the cascade of events caused by large-scale trauma that leads to multiorgan failure and death, despite the stemming of blood loss. Furthermore, the stark and robust epidemiological finding—namely, that age has a profound influence on the chances of surviving trauma irrespective of the nature and severity of the injury—will be explored. Advances in our understanding of the inflammatory response to trauma, the impact of ageing on this response, and how this information has led to new and emerging treatments aimed at combating immune dysregulation and reduced immunity after injury will also be discussed.
Contemporary series of postpericardiotomy syndrome (PPS) are lacking. The aim of this study was to evaluate the incidence, time course, features at presentation, risk factors, and prognosis of PPS. ...The study population consisted of 360 consecutive candidates to cardiac surgery enrolled in a prospective cohort study. PPS was diagnosed in 54 patients (15.0%; mean age 66 ± 12 years, 48.1% women): 79.6% in the first month, 13.0% in the second month, and 7.4% in the third month. Specific symptoms, signs, or features were pleuritic chest pain (55.6%), fever (53.7%), elevated markers of inflammation (74.1%), pericardial effusion (88.9%), and pleural effusion (92.6%). Cardiac tamponade was rare at presentation (1.9%). Female gender (hazard ratio 2.32, 95% confidence interval 1.22 to 4.39, p = 0.010), and pleura incision (hazard ratio 4.31, 95% confidence interval 2.22 to 8.33, p <0.001) were identified as risk factors in multivariate analysis. Patients with PPS had longer cardiac surgery stays (11.5 ± 4.6 vs 9.9 ± 4.7 days, p = 0.021) and rehabilitation stays (16.4 ± 6.7 vs 12.4 ± 6.2 days, p <0.001) and more readmissions (13.0% vs 0%, p <0.001). Adverse events after a mean follow-up period of 19.8 months were recurrences (3.7%), cardiac tamponade (<2%), but no cases of constriction. In conclusion, despite advances in cardiac surgery techniques, PPS is a common postoperative complication, generally occurring in the first 3 months after surgery. Severe complications are rare, but the syndrome is responsible for hospital stay prolongation and readmissions. Female gender and pleura incision are risk factors for PPS.
Objectives This study sought to investigate the efficacy and performance of the XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in the treatment of de novo coronary ...lesions in patients with 2- to 3-vessel multivessel coronary artery disease (MV-CAD). Background Drug-eluting stents (DES) have emerged as an alternative to conventional coronary artery bypass surgery in patients with MV-CAD although first-generation DES yielded inferior efficacy and safety compared with surgery. Methods Prospective, randomized (1:1), multicenter feasibility trial was designed to assess angiographic efficacy of EES compared with the TAXUS paclitaxel-eluting stent (PES) in 200 patients, and a prospective, open-label, single-arm, controlled registry was designed to analyze the clinical outcome of EES at 1-year follow-up in 400 MV-CAD patients. For the randomized trial, the primary endpoint was in-stent late loss at 9 months. For the registry, the primary endpoint was a composite of all-cause death, myocardial infarction, and ischemia-driven target vessel revascularization at 12 months. Results The primary endpoint per single lesion was significantly lower in the EES group compared with the PES group (−0.03 ± 0.49 mm vs. 0.23 ± 0.51 mm, p = 0.001). Similar results were observed when analyzing all lesions (0.05 ± 0.51 mm vs. 0.24 ± 0.50 mm, p < 0.001). Clinical outcome at 1 year yielded a composite of major adverse cardiac events of 9.2% in the single-arm registry, and 11.1% and 16.5% in the EES and PES randomized groups, respectively (p = 0.30). Conclusions The EXECUTIVE trial was a randomized pilot trial dedicated to the comparison of the efficacy of 2 different DES among patients with 2- to 3-vessel MV-CAD. The study shows lower in-stent late loss at 9 months with the EES XIENCE V compared with the PES TAXUS Libertè, and a low major adverse cardiac event rate at 1 year in patients with 2-to 3-vessel MV-CAD. (EXECUTIVE EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease; NCT00531011 )
Background No preventive pharmacologic strategies have been proven efficacious for the prevention of postoperative effusions after cardiac surgery. Colchicine is safe and efficacious for the ...prevention of pericarditis. On this basis, we realized a substudy of the COPPS trial to assess the efficacy and safety of colchicine for the prevention of postoperative pericardial and pleural effusions. Methods The COPPS is a multicenter, double-blind, randomized trial, where 360 consecutive patients (mean age 65.7 ± 12.3 years, 66% men), 180 in each treatment arm, were randomized on the third postoperative day to receive placebo or colchicine for 1 month (1.0 mg twice daily for the first day, followed by a maintenance dose of 0.5 mg twice daily in patients ≥70 kg, and halved doses for patients <70 kg). The incidence of postoperative effusions was evaluated in each study group. Results Despite similar baseline features, colchicine significantly reduced the incidence of postoperative pericardial (12.8% vs 22.8%, P = .019, relative risk reduction 43.9%, no. of patients needed to treat 10) and pleural effusions (12.2% vs 25.6%, P = .002, relative risk reduction 52.3%, no. of patients needed to treat 8). The rate of side effects (only gastrointestinal intolerance) and drug withdrawal was similar in the study groups with a trend toward an increased rate of both events for colchicine. In multivariable analysis, female gender (hazard ratio 1.76, 95% CI 1.03-3.03, P = .040) and pleura incision (hazard ratio 2.58, 95% CI 1.53-4.53, P < .001) were risk factors for postoperative effusions. Conclusions Colchicine is safe and efficacious for the primary prevention of postoperative effusions after cardiac surgery.
Background The efficacy and safety of colchicine for the primary prevention of the postpericardiotomy syndrome (PPS), postoperative effusions, and postoperative atrial fibrillation (POAF) remain ...uncertain. Although preliminary data from a single trial of colchicine given for 1 month postoperatively (COPPS trial) were promising, the results have not been confirmed in a large, multicenter trial. Moreover, in the COPPS trial, colchicine was given 3 days postoperatively. Methods The COPPS-2 study is a multicenter, double-blind, placebo-controlled randomized trial. Forty-eight to 72 hours before planned cardiac surgery, 360 patients, 180 in each treatment arm, will be randomized to receive placebo or colchicine without a loading dose (0.5 mg twice a day for 1 month in patients weighing ≥70 kg and 0.5 mg once for patients weighing <70 kg or intolerant to the highest dose). The primary efficacy end point is the incidence of PPS, postoperative effusions, and POAF at 3 months after surgery. Secondary end points are the incidence of cardiac tamponade or need for pericardiocentesis or thoracentesis, PPS recurrence, disease-related admissions, stroke, and overall mortality. Conclusions The COPPS-2 trial will evaluate the use of colchicine for the primary prevention of PPS, postoperative effusions, and POAF, potentially providing stronger evidence to support the use of preoperative colchicine without a loading dose to prevent several postoperative complications. ClinicalTrials.gov Identifier: NCT01552187.
Background The purpose of our study was to evaluate the impact of laparoscopic adrenalectomy on patients with incidentalomas. We analyzed the results of a multicentre trial that was performed to ...evaluate the effectiveness of imaging (computed tomography and magnetic resonance imaging) to obtain a correct preoperative diagnosis. Methods We obtained our data from the results of a questionnaire that was distributed by mail or email in May 2005 to several surgical units operating in the Campania Region, Italy. Lap Club, a collaborative laparoscopic surgery study group founded in Naples in 1995, distributed the questionnaire. Thirteen centres participated in the audit. In all, we analyzed 255 adrenalectomies performed on 250 patients. We performed statistical analysis using SPSS software. Results The distribution of pathologic findings demonstrates that the number of lesions caused by cancer discovered from a preoperative indication of incidentaloma has been even smaller (1/114, 0.8%) than the previous numbers reported in the literature. Moreover, whereas most patients with adrenal cancer had lesions larger than 6 cm (7/8, 87.5%), the majority of patients with adrenal metastases had lesions 6 cm or smaller (10/12, 83.3%). Different indications for adrenalectomy emerged on comparison of endocrine surgery units with general surgery units. This difference appears to be significant ( p < 0.001), especially on evaluation of the number of nonfunctioning adenomas and the number of endocrine lesions that were observed and treated. Conclusion Laparoscopy remains the gold standard method for adrenalectomy, but its availability must not obligate physicians to treat with surgery when an incidentaloma is detected through imaging. Adrenal malignancies when metastatic are often 6 cm or smaller. If they are single and they originated from a non–small lung cancer, they must be removed. The endocrine surgery unit remains the best setting to evaluate and treat adrenal gland surgical pathology. Contexte Notre étude avait pour objectif d’évaluer l’impact de la surrénalectomie par laparoscopie sur les patients présentant un incidentalome. Nous avons analysé les résultats d’un essai multicentrique visant à évaluer l’efficacité de l’imagerie (tomographie par ordinateur et imagerie par résonance magnétique) pour obtenir un diagnostic préopératoire exact. Méthodes Nous avons tiré nos données des résultats d’un questionnaire distribué par la poste ou par courriel en mai 2005 à plusieurs unités de chirurgie élective dans la région de Campanie, en Italie. Lap Club, groupe collaboratif d’étude de la chirurgie par laparoscopie fondé à Naples en 1995, a distribué le questionnaire. Treize centres ont participé à l’étude. Nous avons analysé au total 255 surrénalectomies pratiquées sur 250 patients. Nous avons procédé à l’analyse statistique au moyen du logiciel SPSS. Résultats La distribution des résultats pathologiques démontre que le nombre de lésions causées par le cancer découvertes à la suite d’une indication préopératoire d’incidentalome est encore plus faible (1/114, 0,8 %) que les totaux précédents signalés dans les publications. De plus, alors que la plupart des patients atteints d’un cancer des surrénales avaient une lésion de plus de 6 cm (7/8, 87,5 %), la majorité de ceux qui présentaient des métastases aux surrénales avaient des lésions de 6 cm ou moins (10/12, 83,3 %). La comparaison entre les unités de chirurgie endocrinienne et les unités de chirurgie générale a dégagé des indications différentes pour la surrénalectomie. Cette différence semble importante ( p < 0,001), particulièrement pour ce qui est de l’évaluation du nombre d’adénomes non fonctionnels et du nombre de lésions endocriniennes observées et traitées. Conclusion La laparoscopie demeure la méthode de choix pour la surrénalectomie, mais sa disponibilité ne doit pas obliger les médecins à procéder par chirurgie lorsque l’on détecte un incidentalome à l’imagerie. Par ailleurs, les métastases aux surrénales sont souvent de 6 cm ou moins. Si elles sont uniques et proviennent d’un cancer du poumon non à petites cellules, il faut les exciser. L’unité de chirurgie endocrinienne demeure le meilleur contexte pour évaluer et traiter la pathologie chirurgicale des surrénales.
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