A Phase 1/2 Single-arm Clinical Trial of Recombinant Bacillus Calmette-Guérin (BCG) VPM1002BC Immunotherapy in Non-muscle-invasive Bladder Cancer Recurrence After Conventional BCG Therapy: SAKK 06/14.

BACKGROUND: VPM1002BC is a genetically modified Mycobacterium bovis bacillus Calmette-Guérin (BCG) strain with potentially improved immunogenicity and attenuation. OBJECTIVE: To report on the efficacy, safety, tolerability and quality of life of intravesical VPM1002BC for the treatment of non-muscle-invasive bladder cancer (NMIBC) recurrence after conventional BCG therapy. DESIGN, SETTING, AND PARTICIPANTS: We designed a phase 1/2 single-arm trial (NCT02371447). Patients with recurrent NMIBC after BCG induction ± BCG maintenance therapy and intermediate to high risk for cancer progression were eligible. INTERVENTION: Patients were scheduled for standard treatment of six weekly instillations with VPM1002BC followed by maintenance for 1 yr. Treatment was stopped in cases of recurrence. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was defined as the recurrence-free rate (RFR) in the bladder 60 wk after trial registration. The sample size was calculated based on the assumption that ≥30% of the patients would be without recurrence at 60 wk after registration. RESULTS AND LIMITATIONS: After exclusion of two ineligible patients, 40 patients remained in the full analysis set. All treated tumours were of high grade and 27 patients (67.5%) presented with carcinoma in situ. The recurrence-free rate in the bladder at 60 wk after trial registration was 49.3% (95% confidence interval [CI] 32.1-64.4%) and remained at 47.4% (95% CI 30.4-62.6%] at 2 yr and 43.7% (95% CI 26.9-59.4%) at 3 yr after trial registration. At the same time, progression to muscle-invasive disease had occurred in three patients and metastatic disease in four patients. Treatment-related grade 1, 2, and 3 adverse events (AEs) were observed in 14.3%, 54.8%, and 4.8% of the patients, respectively. No grade ≥4 AEs occurred. Two of the 42 patients did not tolerate five or more instillations during induction. Limitations include the single-arm trial design and the low number of patients for subgroup analysis. CONCLUSIONS: At 1 yr after treatment start, almost half of the patients remained recurrence-free after therapy with VPM100BC. The primary endpoint of the study was met and the therapy is safe and well tolerated. PATIENT SUMMARY: We conducted a trial of VPM100BC, a genetically modified bacillus Calmette-Guérin (BCG) strain for treatment of bladder cancer not invading the bladder muscle. At 1 year after the start of treatment, almost half of the patients with a recurrence after previous conventional BCG were free from non-muscle-invasive bladder cancer (NMIBC). The results are encouraging and VPM1002BC merits further evaluation in randomised studies for patients with NMIBC.

[Benign prostatic hyperplasia treatment: Surgical alternatives to transurethral resection of the prostate]. / Traitement de l'hyperplasie bénigne de la prostate - Alternatives chirurgicales à la résection transurétrale de la prostate.

Benign prostatic hyperplasia is one of the most common diseases in ageing men and the most common cause of lower urinary tract symptoms. The gold standard of surgical treatments for benign prostatic hyperplasia for decades has been transurethral resection of the prostate. New minimally invasive techniques have been developed with the aim of reducing morbidity or resecting large prostate volumes endoscopically. In this article, we summarize the different surgical alternatives to transurethral resection of the prostate.

L'hyperplasie bénigne de la prostate est l'une des maladies les plus fréquentes de l'homme âgé et est la principale cause de symptômes du bas appareil urinaire. Depuis des décennies, le gold standard des traitements chirurgicaux pour soulager les symptômes du bas appareil urinaire, dus à l'hyperplasie bénigne de la prostate, est la résection transurétrale de la prostate. De nouvelles techniques mini-invasives se sont développées dans le but de réduire la morbidité ou de pouvoir prendre en charge des volumes prostatiques plus importants par voie endoscopique. Nous résumons dans cet article les différentes alternatives chirurgicales à la résection transurétrale de la prostate.

[Cancer center clinical nurse: The experience of the CHUV Prostate Cancer Center]. / Infirmière clinicienne de centre du cancer : l'expérience du Centre de la prostate du CHUV.

The University Hospital of Lausanne has heavily invested in the development of interdisciplinary oncology centers to improve the quality of care, and structure research and training. By integrating specialist nurses, it follows international recommendations. These specialists' nurses rephrase the information given by the doctor and ensure patients' understanding. They assess the patient's psychosocial situation and provides guidance if necessary. They support the patient in making informed choices about treatment and coping strategies. In addition to the outpatient clinics planned in accordance with the care pathway, she can be contacted between appointments to answer questions or concerns of any kind. This article shows the added value of these nurses in the care of oncology patients.

Le CHUV s'est fortement investi dans le développement de centres interdisciplinaires en oncologie afin d'améliorer la qualité de la prise en charge, de structurer la recherche et la formation. En y intégrant des infirmières cliniciennes, il suit les recommandations internationales. Ces infirmières reprennent les informations données par le médecin et s'assurent de la compréhension du patient. Elles évaluent sa situation psychosociale et l'orientent au besoin. Elles soutiennent le patient dans ses choix de traitement ainsi que dans ses stratégies d'adaptation. Outre les entretiens planifiés en fonction du parcours de soins, elles sont joignables entre les rendez-vous pour répondre à des questions ou préoccupations de tout ordre. Cet article montre la plus-value que la présence de ces infirmières offre à la prise en charge des patients oncologiques.

Seminal Vesical Sparing Cystectomy for Bladder Cancer is Feasible with Good Functional Results without Impairing Oncological Outcomes: A Longitudinal Long-Term Propensity-Matched Single Center Study.

PURPOSE: Seminal vesicle-sparing radical cystectomy has been reported to improve short-term functional results without compromising oncological outcomes. However, there is still a lack of data on long-term outcomes after seminal vesicle-sparing radical cystectomy. The aim of this study was to compare oncological and functional outcomes in patients after seminal vesicle-sparing vs nonseminal vesicle-sparing radical cystectomy. MATERIALS AND METHODS: Oncological and functional outcomes of 470 consecutive patients after radical cystectomy and orthotopic ileal reservoir from 2000 to 2017 were evaluated. They were stratified into 6 groups according to nerve-sparing and seminal vesicle-sparing status as attempted during surgery: no sparing at all (55), unilateral nerve sparing (159), bilateral nerve sparing (132), unilateral seminal vesicle-sparing and unilateral nerve sparing (30), unilateral seminal vesicle sparing and bilateral nerve sparing (45), and bilateral seminal vesicle sparing (49) and used propensity modeling to adjust for preoperative differences. RESULTS: Median followup among the entire cohort was 64 months. Among the 6 groups, our analysis showed no difference in local recurrence-free survival (p=0.173). However, progression-free, cancer-specific and overall survival were more favorable in patients with seminal vesicle-sparing radical cystectomy (p <0.001, p=0.006 and p <0.001, respectively). Proportions of patients with erectile function recovery were higher in the seminal vesicle-sparing groups at all time points in all analyses, respectively, with pronounced earlier recovery in patients with bilateral seminal vesicle sparing. Importantly, patients with seminal vesicle sparing were significantly less in need of erectile aids to achieve erection and intercourse. Over the whole period, daytime urinary-continence was significantly better in the seminal vesicle sparing groups (OR 2.64 to 5.21). CONCLUSIONS: In a highly selected group of patients, seminal vesicle sparing radical cystectomy is oncologically safe and results in excellent functional outcomes that are reached at an earlier time point after surgery and remain superior over a longer period of time.

Functional Results, Complications Associated with the Serosa-lined Tunnel, and Quality of Life with a Cross-folded Ileal Reservoir Combined with an Afferent Tubular Isoperistaltic Segment for Heterotopic Continent Urinary Diversion: An Observational Long-term Cohort Analysis.

BACKGROUND: In patients who do not qualify for an orthotopic urinary diversion, for example, the urethra cannot be spared or is functionally impaired, a heterotopic continent cutaneous cross-folded ileal reservoir offers a good alternative. OBJECTIVE: To describe the indication, surgical technique, and postoperative management, and to report the reservoir-related outcomes and complications associated with the serosa-lined tunnel. DESIGN, SETTING, AND PARTICIPANTS: Perioperative outcomes of 118 consecutive patients after cystectomy and a heterotopic ileal reservoir adapted from the Studer bladder substitute technique, operated between 2000 and 2018, were evaluated. The catheterisable serosa-lined tunnel was constructed from the appendix (Mitrofanoff, n = 63), an ileal segment (Yang-Monti, n = 48), or a fallopian tube (n = 7). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Pre- and postoperative data until last follow-up appointment were entered prospectively in the departmental database. The chi-square test was used to compare proportions. RESULTS AND LIMITATIONS: Median follow-up was 94 (interquartile range 36-152) mo. No peri- or postoperative mortality was observed within 90 d of surgery. Patient satisfaction was high in 77.5% and moderate in 16.9%. Overall, complications associated with the serosa-lined tunnel occurred in 52% (61/118) of patients. Stenosis of the continent outlet developed in 38% (45/118) of patients: 33/45 (75%) were simply dilated/incised at the outpatient clinic, of those 24% (8/33) required additional endoscopic dilatation. Of patients with stenosis of the continent outlet, 27% (12/45) needed open revision surgery. During follow-up, 8% (nine/118) of patients required revision of the serosa-lined tunnel due to incontinence. Twelve months postoperatively, 95% (92/97) patients were continent. A limitation is the retrospective analysis from prospectively assessed data. This could limit the generalisability of these findings, as selection bias cannot be excluded. CONCLUSIONS: The heterotopic continent cutaneous cross-folded ileal reservoir achieves good functional results. Complications associated with the serosa-lined tunnel occur in about half of the patients but generally are easy to manage. As a result, patient satisfaction is high. PATIENT SUMMARY: In patients who do not qualify for an orthotopic bladder substitute, a heterotopic continent cutaneous cross-folded ileal reservoir offers a viable alternative with good postoperative functional results and high patient satisfaction.

Routine Preoperative Bone Scintigraphy Has Limited Impact on the Management of Patients with Invasive Bladder Cancer.

BACKGROUND: According to current guidelines, bone scintigraphy is not routinely indicated in patients with invasive bladder cancer prior to radical cystectomy unless specific symptoms are present. These guidelines, however, are based on sparse data of low quality. OBJECTIVE: To assess the clinical impact of routine staging bone scintigraphy on further patient management. DESIGN, SETTING, AND PARTICIPANTS: A retrospective, single-center study of 1287 consecutive patients, who were scheduled to undergo radical cystectomy due to invasive bladder cancer between January 2000 and December 2017, was conducted. All patients were prospectively followed up according to our institutional protocol. INTERVENTION: Bone scintigraphy as staging imaging prior to radical cystectomy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the change in intended patient management. Secondary endpoints were the need for additional imaging, the diagnostic performance of baseline bone scintigraphy, and the association between clinical and radiological findings on bone metastases and survival. Logistic and Cox regression models were used for univariate and multivariate analyses. RESULTS AND LIMITATIONS: Of 1287 patients scheduled for radical cystectomy, 1148 (89%) underwent bone scintigraphy as staging imaging. Overall, baseline bone scintigraphy led to a change in the intended management in 19/1148 (1.7%) patients. Additional imaging was performed in 44/1148 (4%) patients. Although positive bone scintigraphy findings were associated with the occurrence/development of bone metastases, the diagnostic performance of baseline bone scintigraphy was generally poor (positive predictive value, negative predictive value, sensitivity, and specificity were 56%, 89%, 27%, and 96%, respectively). Higher clinical tumor stage and the nonperformance of cystectomy had negative impacts on cancer-specific survival and overall survival, while positive bone scintigraphy was associated with worse cancer-specific survival. This study was limited by its retrospective nature and the lack of follow-up bone scintigraphy in all patients. CONCLUSIONS: These results demonstrate the limited value of bone scintigraphy in the staging of invasive bladder cancer and do not support its routine use. PATIENT SUMMARY: In this study, we looked at the clinical impact of bone scintigraphy on the diagnostics of patients with invasive bladder cancer. We found that routine staging bone scintigraphy had limited impact on further patient management. We conclude that bone scintigraphy should not be part of routine staging in patients with invasive bladder cancer.

[Overview of ureteral stone management]. / Prise en charge de la lithiase urétérale.

Ureteral stones are a major health concern with a worldwide rising prevalence. In countries with a high standard of living, the prevalence urolithiasis is notably high with over 10%. Ureteral stones formed in the kidney and then descending the ureter commonly manifest themselves as renal colic. The treatment of ureteral stones includes conservative treatment, medical expulsion therapy, interventional stone treatment such as ureteral stenting, ureteroscopy and extracorporeal shock wave lithotripsy as well as (oral) chemolysis in selected cases. This article presents a comprehensive overview on the treatment of ureteral stones and an outlook on advancements in treatment.

La maladie lithiasique est un problème de santé majeur en augmentation. Dans les pays industrialisés, la prévalence de la maladie lithiasique est particulièrement élevée, plus de 10 %. Les lithiases sont formées dans le rein, puis elles migrent dans l'uretère où elles se manifestent couramment par des coliques néphrétiques. La prise en charge des lithiases urétérales comprend les traitements conservateur, médical expulsif, interventionnels comme la pose de stent urétéral, l'urétéroscopie ou la lithotripsie extracorporelle, ainsi que la chimiolyse orale dans certains cas. Cet article présente un résumé de la prise en charge de la lithiase urétérale ainsi que les progrès réalisés en matière de traitement.

Oral chemolysis is an effective, non-invasive therapy for urinary stones suspected of uric acid content.

Despite the possible benefit from avoiding stone surgery with all its possible complications, oral chemolysis is rarely performed in patients with urinary stones suspected of uric acid content. Among the reasons for its limited use is the sparse and low-quality data on its efficacy and the lack of reliable factors predicting its outcome. We thus performed a retrospective single-center cohort study of 216 patients (median patient age 63 years) with 272 renal (48%) and/or ureteral (52%) stones treated with oral chemolysis from 01/2010 to 12/2019. Patients with low urine pH (< 6), low stone density upon non-contrast enhanced computed tomography (NCCT), radiolucent urinary stones on plain radiography, and/or a history of uric acid urolithiasis were included. Potassium citrate and/or sodium/magnesium bicarbonate were used for alkalization (target urine pH 6.5-7.2). Median stone size was 9 mm, median stone density 430 Hounsfield Units. Patients with ureteral stones < 6 mm were excluded since stones this small are very likely to pass spontaneously. The stone-free status of each patient was evaluated after 3 months using NCCT. Oral chemolysis was effective with a complete and partial response rate of stones at 3 months of 61% and 14%, respectively; 25% of stones could not be dissolved. Lower stone density (OR = 0.997 [CI 0.994-0.999]; p = 0.008) and smaller stone size (OR = 0.959 [CI 0.924-0.995]; p = 0.025) significantly increased the success rate of oral chemolysis in multivariate logistic regression analysis. More precise stone diagnostics to exclude non-uric-acid stones could further improve outcome.

Results of the phase I open label clinical trial SAKK 06/14 assessing safety of intravesical instillation of VPM1002BC, a recombinant mycobacterium Bacillus Calmette Guérin (BCG), in patients with non-muscle invasive bladder cancer and previous failure of conventional BCG therapy.

Background: VPM1002BC is a modified mycobacterium Bacillus Calmette Guérin (BCG) for the treatment of non-muscle invasive bladder cancer (NMIBC). The genetic modifications are expected to result in better immunogenicity and less side effects. We report on patient safety and immunology of the first intravesical application of VPM1002BC in human. Methods: Six patients with BCG failure received a treatment of 6 weekly instillations with VPM1002BC. Patients were monitored for adverse events (AE), excretion of VPM1002BC and cytokines, respectively. Results: No DLT (dose limiting toxicity) occurred during the DLT-period. No grade ≥3 AEs occurred. Excretion of VPM1002BC in the urine was limited to less than 24 hours. Plasma levels of TNFα significantly increased after treatment and blood-derived CD4+ T cells stimulated with PPD demonstrated significantly increased intracellular GM-CSF and IFN expression. Conclusion: The intravesical application of VPM1002BC is safe and well tolerated by patients and results in a potential Th1 weighted immune response.

A treatment strategy to help select patients who may not need secondary intervention to remove symptomatic ureteral stones after previous stenting.

PURPOSE: This study aimed at evaluating whether removal of the ureteral stent the day before scheduled secondary intervention facilitates spontaneous ureteral stone passage and thus can spare the pre-stented patient this surgery. METHODS: Retrospective analysis of a single-centre consecutive series of 216 patients after previous stenting due to a symptomatic ureteral stone from 01/2013 to 01/2018. Indwelling stents were removed under local anaesthesia. Patients were told to filter their urine overnight. Multivariate analysis was performed to assess predictive factors for spontaneous stone passage. RESULTS: 34% (74/216) of patients had spontaneous stone passage while the stent was indwelling. Of the remaining 142 patients, 41% (58/142) had spontaneous stone passage within 24 h after stent removal. Only 84/216 (39%) patients needed secondary intervention. Multivariate logistic regression analysis of all 216 patients showed a significant association between spontaneous stone passage and smaller stone size (p < 0.001), distal stone location (p = 0.046) and stent dwell time (p = 0.02). Predictive factors for spontaneous stone passage after stent removal were smaller size (p < 0.001), distal location (p = 0.001), and stone movement while the stent was indwelling (p = 0.016). A treatment strategy was established that helps select patients suitable for conservative management. CONCLUSIONS: The majority (61%) of ureteral stones passed spontaneously after pre-stenting; 34% while the stent was indwelling, 27% within 24 h after stent removal. Besides distal stone location, stone size (< 6 mm) and stone movement (≥ 5 cm) while the stent is indwelling indicate patients who are likely to pass their ureteral stone spontaneously after stent removal. The treatment strategy (decision tree) presented here helps identify those patients. TRIAL REGISTRATION: https://doi.org/10.1186/ISRCTN12112914 .

Complication reporting with the Bern Comprehensive Complication Index CCI after open radical prostatectomy: A longitudinal long-term single-center study.

OBJECTIVE: To impartially optimize complication reporting in patients after open radical prostatectomy (ORP) and pelvic lymph node dissection (PLND) by adopting the modified Bern Comprehensive Complication Index (CCI). ORP and PLND are associated with relevant postoperative morbidity. The CCI-ranging from 0 (no complications) to 100 (death)-is a tool that aims to integrate all complications occuring within 90 days postoperatively weighted by severity in a single formula. METHODS: In an observational single-center cohort, 90-day postoperative complications of 1,123 consecutive patients undergoing standardized ORP and PLND between 1996 and 2017 were evaluated. Prospectively collected complications were graded according to the Clavien-Dindo Classification. Grade I to II complications were defined as minor and grade IIIa to V as major. Finally, the recently developed modified Bern CCI using an exponential function, which transforms the sum of the weights into a value between 0 and 100 and the original CCI for each patient were extracted and compared. The correlation between the modified Bern and original CCI values was depicted graphically. RESULTS: The complication rate was 42%, with 18% minor and 24% major complications. With the original CCI, the threshold of 100 was exceeded in 1 patient who had a maximal index value of 101 within 90d postoperatively. The maximal value of the Bern CCI was 97.5. Mean Bern and original CCI scores and standard deviations were 6.2 (11.3) and 7.6 (12.2) at 30 days, and 9.3 (13.9) and 10.7 (14.2) at 90 days. CONCLUSIONS: The Bern CCI provides a more precise depiction of postoperative morbidity and represents the burden in patients with >1 complication after ORP and PLND more accurately than the original CCI allowing for a more reliable evaluation of quality of care and recovery. It therefore warrants consideration for standardized reporting of complications after ORP and PLND.

Comparison of the Diagnostic Performance of Contrast-enhanced Ultrasound with That of Contrast-enhanced Computed Tomography and Contrast-enhanced Magnetic Resonance Imaging in the Evaluation of Renal Masses: A Systematic Review and Meta-analysis.

CONTEXT: Contrast-enhanced ultrasound (CEUS) has the potential to be a valuable alternative to contrast-enhanced computed tomography (CECT) and contrast-enhanced magnetic resonance imaging (CEMR), the current gold standards in characterisation of renal masses. OBJECTIVE: To systematically review all available evidence on the qualitative diagnostic performance of CEUS versus that of CECT and CEMR in the evaluation of benign and malignant cystic and solid renal masses. EVIDENCE ACQUISITION: The review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. EVIDENCE SYNTHESIS: After screening 1483 articles, six cohort studies and 10 descriptive studies were included. Pooling data from included studies with final diagnosis of benign or malignant renal masses by pathology showed a significant difference in the sensitivity of CEUS (0.96; 95% confidence interval [CI] 0.94-0.98) versus that of CECT (0.90; 95% CI 0.86-0.93). Pooling data from included studies with final diagnosis by pathology report or reaffirmed diagnosis by follow-up imaging without pathology report showed significant difference in the sensitivity of CEUS (0.98; 95% CI 0.94-1.0) versus that of CEMR (0.78; 95% CI 0.66-0.91). CONCLUSIONS: Preliminary data imply that CEUS may perform at least as well as or better than CECT and CEMR in the diagnosis of renal masses. However, the evidence base is limited, and more high-quality, well-designed, adequately powered, and sampled studies are needed to reach definitive conclusions. PATIENT SUMMARY: Early data suggest that contrast-enhanced ultrasound is a promising option for the evaluation of renal masses, but more reliable evidence is required.

[Cisplatin-based chemotherapy in muscle-invasive bladder cancer: soon outdated†?] / Chimiothérapie néoadjuvante à base de cisplatine du cancer de la vessie†: bientôt dépassée†?

For more than 30 years, cisplatin-based neoadjuvant chemotherapy (NAC) has been administered to patients with muscle-invasive bladder cancer (MIBC). However, the benefit is modest. With the advent of modern immunotherapies, new therapeutic strategies are also opening up to bladder cancer. Unfortunately, the initial results in the neoadjuvant context show a response rate of only 20-35 %. Other therapeutic strategies, such as Pan-FGFR inhibitors, do not show better response. Due to the high genetic variability of bladder cancer, a «â€…one drug fits all ¼ concept is not an ideal solution. Patient selection based on the probability of response appears to be a promising strategy to improve this modest benefit of each treatment. In this context, the NAC will also continue to play an important role.

Depuis plus de 30 ans, la chimiothérapie néoadjuvante (CNA) à base de cisplatine est administrée aux patients atteints d'un cancer de la vessie à invasion musculaire. Cependant, l'avantage est modeste. Avec l'avènement des immunothérapies modernes, de nouvelles stratégies thérapeutiques s'ouvrent. Malheureusement, les résultats initiaux montrent un taux de réponse de seulement 20-35 %. D'autres stratégies thérapeutiques, comme les Pan-FGFR inhibiteurs, ne montrent pas de meilleure réponse. En raison de la grande variabilité génétique du cancer de la vessie, un concept one drug fits all n'est pas une solution idéale. La sélection des patients en fonction de la probabilité de réponse semble être prometteuse pour améliorer cet avantage modeste de chaque traitement. Dans ce contexte, la CNA continuera également à jouer un rôle important.

Markers of plaque instability in the early diagnosis and risk stratification of acute myocardial infarction.

BACKGROUND: Plaque erosion and plaque rupture occur early in the pathophysiology of acute myocardial infarction (AMI). We hypothesized that markers of plaque instability might be useful in the early diagnosis and risk stratification of AMI. METHODS: In this multicenter study, we examined 4 markers of plaque instability, myeloperoxidase (MPO), myeloid-related protein 8/14 (MRP-8/14), pregnancy-associated plasma protein-A (PAPP-A), and C-reactive protein (CRP) in 398 consecutive patients presenting to the emergency department with acute chest pain and compared them to normal and high-sensitivity cardiac troponin T (cTnT and hs-cTnT). The final diagnosis was adjudicated by 2 independent cardiologists. Primary prognostic end point was death during a median follow-up of 27 months. RESULTS: The adjudicated final diagnosis was AMI in 76 patients (19%). At emergency department presentation, concentrations of all 4 biomarkers of plaque instability were significantly higher in patients with AMI than in patients with other diagnoses. However, their diagnostic accuracy as quantified by the area under the ROC curve (AUC) was low (MPO 0.63, MRP-8/14 0.65, PAPP-A 0.62, CRP 0.59) and inferior to both normal and high-sensitivity cardiac troponin T (cTnT 0.88, hs-cTnT 0.96; P<0.001 for all comparisons). Thirty-nine patients (10%) died during follow-up. Concentrations of MPO, MRP-8/14, and CRP were higher in nonsurvivors than in survivors and predicted all-cause mortality with moderate accuracy. CONCLUSIONS: Biomarkers of plaque instability do not seem helpful in the early diagnosis of AMI but may provide some incremental value in the risk stratification of patients with acute chest pain.