Clinical outcomes of second- versus first-generation drug-eluting stents in patients with acute myocardial infarction: a meta-analysis of randomized controlled trials

Introduction

It remains unclear whether the clinical outcomes of patients with acute myocardial infarction (AMI) receiving second- and first-generation drug-eluting stents (DES) are identical. The study aimed to investigate the differences in clinical utility between the two generations of DES in these specific subjects by a meta-analysis.

Material and methods

We systemically searched PubMed and EMBASE databases and the Cochrane Library up until January 2013. Randomized trials, which compared clinical outcomes of second-generation DES (everolimus- (EES) or zotarolimus-eluting stents (ZES)) with first-generation DES (sirolimus- or paclitaxel-eluting stents) in patients with AMI were included.

Results

Five trials with 1720 AMI subjects were included in the meta-analysis. Pooled analysis demonstrated a trend toward lower incidence of stent thrombosis with the second-generation DES relative to the first-generation one (risk ratio (RR), 0.53; 95% confidence intervals (CI): 0.25–1.13; p = 0.10). However, the second-generation DES did not offer a significant advantage over the first-generation DES in reducing the incidence of target lesion revascularization (TLR) (RR = 1.73; 95% CI: 0.83–3.64; p = 0.15), major adverse cardiac events (MACEs) (RR = 0.97; p = 0.90), or all-cause death (RR = 1.00; p = 1.0). In addition, in elderly patients the second-generation DES seemed to reduce the occurrence of MACEs (RR = 0.65; p = 0.10) and stent thrombosis (RR = 0.40; p = 0.08), and the second-generation EES showed a potential benefit in lowering the MACE rate (RR = 0.55; p = 0.06).

Conclusions

The second-generation DES appeared to lower the risk of stent thrombosis in AMI patients. There might be a lower incidence of MACEs associated with the second-generation EES.     

Comparison of Full Lesion Coverage versus Spot Drug-Eluting Stent Implantation for Coronary Artery Stenoses

Purpose

The aim of this study was to evaluate and compare the long-term clinical outcomes of the spot drug-eluting stent (DES) implantation strategy, which is used to minimize implanted stent length and the number of stents, versus full lesion coverage for treatment of coronary artery stenoses.

Materials and Methods

We evaluated 1-year clinical outcomes of 1619 patients with stent implantation for a single coronary lesion. They were divided into two groups: those treated by full lesion coverage (n=1200) and those treated with the spot stenting strategy (n=419). The combined occurrence of 1-year target vessel failure (TVF), including cardiac death, target-vessel related myocardial infarction, or ischemia-driven target-vessel revascularization was evaluated.

Results

The spot DES implantation group had a shorter stent length (23.14±9.70 mm vs. 25.44±13.24 mm, respectively; p<0.001) and a fewer number of stents (1.09±0.30 vs. 1.16±0.41, respectively; p<0.001), even though the average lesion length was similar to the full lesion coverage group (21.36±10.30 mm vs. 20.58±10.97 mm, respectively; p=0.206). Spot DES implantation was superior to full DES coverage with respect to 1-year TVF (1.4% vs. 3.3%, p=0.044). Cox proportional hazard model analysis showed that the risk for 1-year TVF was almost 60% lower among patients who received spot DESs compared to those who received full DES coverage after adjustment for other risk factors (HR=0.40, 95% confidence interval=0.17-0.98; p=0.046).

Conclusion

Minimizing stent length and the number of stents with overlapping by spot DES implantation may result in reduced rates of 1-year TVF, compared with full DES coverage.     

Comparison of optical coherence tomographic assessment between first- and second-generation drug-eluting stents

Purpose

There is a lack of sufficient data in comparison of optical coherence tomographic (OCT) findings between first- and second-generation drug-eluting stents (DES). Compared to first-generation (i.e., sirolimus- or paclitaxel-eluting stents), second-generation DESs (i.e., everolimus- or biolinx-based zotarolimus-eluting stents) might have more favorable neointimal coverage.

Materials and Methods

Follow-up OCT findings of 103 patients (119 lesions) treated with second-generation DESs were compared with those of 139 patients (149 lesions) treated with first-generation DESs. The percentage of uncovered or malapposed struts, calculated as the ratio of uncovered or malapposed struts to total struts in all OCT cross-sections, respectively, was compared between the two groups.

Results

Both DES groups showed similar suppression of neointimal hyperplasia (NIH) on OCT (mean NIH cross-sectional area; second- vs. first-generation=1.1±0.5 versus 1.2±1.0 mm², respectively, p=0.547). However, the percentage of uncovered struts of second-generation DESs was significantly smaller than that of first-generation DESs (3.8±4.8% vs.7.5±11.1%, respectively, p<0.001). The percentage of malapposed struts was also significantly smaller in second-generation DESs than in first-generation DESs (0.4±1.6% vs.1.4±3.7%, respectively, p=0.005). In addition, intra-stent thrombi were less frequently detected in second-generations DESs than in first-generation DESs (8% vs. 20%, respectively, p=0.004).

Conclusion

This follow-up OCT study showed that second-generation DESs characteristically had greater neointimal coverage than first-generation DESs.     

Comparisons of the effects of stent eccentricity on the neointimal hyperplasia between sirolimus-eluting stent versus paclitaxel-eluting stent

Purpose

Previous studies suggested that asymmetric stent expansion did not affect suppression of neointimal hyperplasia (NIH) after sirolimus-eluting stents (SES) implantation. The aim of this study was to evaluate the effects of stent eccentricity (SE) on NIH between SES versus paclitaxel-eluting stents (PES) using an intravascular ultrasound (IVUS) analysis from the randomized trial.

Materials and Methods

Serial IVUS data were obtained from Post-stent Optimal Expansion (POET) trial, allocated randomly to SES or PES. Three different SE (minimum stent diameter divided by maximum stent diameter) were evaluated; SE at the lesion site with maximal %NIH area (SE-NIH), SE at the minimal stent CSA [SE-minimal stent area (SE-MSA)], and averaged SE through the entire stent (SE-mean). We classified each drug-eluting stents (DES) into the concentric (≥ mean SE) and eccentric groups (< mean SE) based on the mean value of SE.

Results

Among 301 enrolled patients, 233 patients [SES (n = 108), PES (n = 125)] underwent a follow-up IVUS. There was no significant correlation between %NIH area and SE-NIH (r = - 0.083, p = 0.391) or SE-MSA (r = - 0.109, p = 0.259) of SES. However, SE-NIH of PES showed a weak but significant correlation with %NIH area (r = 0.269, p < 0.01). As to the associations between SE-mean and NIH volume index, SES revealed no significant correlation (r = - 0.001, p = 0.990), but PES showed a weak but significant correlation (r = 0.320, p < 0.01). However, there was no difference in the restenosis rate between the eccentric versus concentric groups of both DES.

Conclusion

This study suggests that lower SE of both SES and PES, which means asymmetric stent expansion, may not be associated with increased NIH.     

Efficacy and safety of a biodegradable polymer sirolimus-eluting stent in primary percutaneous coronary intervention: a randomized controlled trial

Introduction

With long-term follow-up, whether biodegradable polymer drug-eluting stents (DES) is efficient and safe in primary percutaneous coronary intervention (PCI) remains a controversial issue. This study aims to assess the long-term efficacy and safety of DES in PCI for ST-segment elevation myocardial infarction (STEMI).

Material and methods

A prospective, randomized single-blind study with 3-year follow-up was performed to compare biodegradable polymer DES with durable polymer DES in 332 STEMI patients treated with primary PCI. The primary end point was major adverse cardiac events (MACE) at 3 years after the procedure, defined as the composite of cardiac death, recurrent infarction, and target vessel revascularization. The secondary end points included in-segment late luminal loss (LLL) and binary restenosis at 9 months and cumulative stent thrombosis (ST) event rates up to 3 years.

Results

The rate of the primary end points and the secondary end points including major adverse cardiac events, in-segment late luminal loss, binary restenosis, and cumulative thrombotic event rates were comparable between biodegradable polymer DES and durable polymer DES in these 332 STEMI patients treated with primary PCI at 3 years.

Conclusions

Biodegradable polymer DES has similar efficacy and safety profiles at 3 years compared with durable polymer DES in STEMI patients treated with primary PCI.     

Prospective and Systematic Analysis of Unexpected Requests for Non-Cardiac Surgery or Other Invasive Procedures during the First Year after Drug-Eluting Stent Implantation

Purpose

Unexpected requests for non-cardiac surgery requiring discontinuation of dual antiplatelet therapy (DAPT) frequently occur in daily clinical practice. The objectives of this study were to evaluate prevalence, timing and clinical outcomes of such unexpected requests for non-cardiac surgery or other invasive procedures during the first year after drug-eluting stents (DESs) implantation.

Materials and Methods

We prospectively investigated the prevalence, timing and clinical outcomes of unexpected requests for non-cardiac surgery or other procedures during the first year after DESs implantation in 2117 patients.

Results

The prevalence of requested non-cardiac surgery or invasive procedures was 14.6% in 310 requests and 12.3% in 261 patients. Among 310 requests, those were proposed in 11.3% <1 month, 30.0% between 1 and 3 months, 36.8% between 4 and 6 months and 21.9% between 7 and 12 months post-DES implantation. The rates of actual discontinuation of DAPT and non-cardiac surgery or procedure finally performed were 35.8% (111 of 310 requests) and 53.2% (165 of 310 requests), respectively. On multivariate regression analysis, the most significant determinants for actual discontinuation of DAPT were Endeavor zotarolimus-eluting stent implantation with 3-month DAPT (OR=5.54, 95% CI 2.95-10.44, p<0.001) and timing of request (OR=2.84, 95% CI 1.97-4.11, p<0.001). There were no patients with any death, myocardial infarction, or stent thrombosis related with actual discontinuation of DAPT.

Conclusion

Those unexpected requests with premature discontinuation of DAPT were relatively common and continuously proposed during the first year following DES implantation. No death, myocardial infarction or stent thrombosis occurred in patients with actual discontinuation of DAPT.     

Impact of Coronary Plaque Characteristics on Late Stent Malapposition after Drug-Eluting Stent Implantation

Purpose

To evaluate the impact of pre-procedural coronary plaque composition assessed by virtual histology intravascular ultrasound (VH-IVUS) on late stent malapposition assessed by optical coherence tomography (OCT) following drug-eluting stent (DES) implantation.

Materials and Methods

The study population consisted of 121 patients (121 lesions) who underwent both pre-procedural VH-IVUS and follow-up OCT after DES implantation. The association between pre-procedural plaque composition [necrotic core (NC), dense calcium (DC), fibrotic (FT), and fibro-fatty (FF) volumes] assessed by VH-IVUS and late stent malapposition (percent malapposed struts) or strut coverage (percent uncovered struts) assessed by follow-up OCT was evaluated.

Results

Pre-procedural absolute total NC, DC, FT, and FF plaque volumes were 22.9±19.0, 7.9±9.6, 63.8±33.8, and 16.5±12.4 mm³, respectively. At 6.3±3.1 months post-intervention, percent malapposed and uncovered struts were 0.8±2.5% and 15.3±16.7%, respectively. Pre-procedural absolute total NC and DC plaque volumes were positively correlated with percent malapposed struts (r=0.44, p<0.001 and r=0.45, p<0.001, respectively), while pre-procedural absolute total FT plaque volume was weakly associated with percent malapposed struts (r=0.220, p=0.015). Pre-procedural absolute total DC plaque volume was the only independent predictor of late stent malapposition on multivariate analysis (β=1.12, p=0.002). There were no significant correlations between pre-intervention plaque composition and percent uncovered struts.

Conclusion

Pre-procedural plaque composition was associated with late stent malapposition but not strut coverage after DES implantation. Larger pre-procedural absolute total DC plaque volumes were associated with greater late stent malapposition.     

Impact of Statin Treatment on Strut Coverage after Drug-Eluting Stent Implantation

Purpose

To evaluate the effect of statin treatment on strut coverage after drug-eluting stent (DES) implantation.

Materials and Methods

In this study, 60 patients were randomly assigned to undergo sirolimus-eluting stent (SES) or biolimus-eluting stent (BES) implantation, after which patients were randomly treated with pitavastatin 2 mg or pravastatin 20 mg for 6 months. The degree of strut coverage was assessed by 6-month follow-up optical coherence tomography, which was performed in 52 DES-implanted patients.

Results

The percentages of uncovered struts were 19.4±14.7% in pitavastatin-treated patients (n=25) and 19.1±15.2% in pravastatin-treated patients (n=27; p=0.927). A lower percentage of uncovered struts was significantly correlated with a lower follow-up low-density lipoprotein (LDL) cholesterol level (r=0.486; p=0.009) and a greater decline of the LDL cholesterol level (r=-0.456; p=0.015) in SES-implanted patients, but not in BES-implanted patients. In SES-implanted patients, the percentage of uncovered struts was significantly lower among those with LDL cholesterol levels of less than 70 mg/dL after 6 months of follow-up (p=0.025), but no significant difference in this variable according to the follow-up LDL cholesterol level was noted among BES-implanted patients (p=0.971).

Conclusion

Lower follow-up LDL cholesterol levels, especially those less than 70 mg/dL, might have a protective effect against delayed strut coverage after DES implantation. This vascular healing effect of lower LDL cholesterol levels could differ according to the DES type.     

Relationship between Angiographic Late Loss and 5-Year Clinical Outcome after Drug-Eluting Stent Implantation

Purpose

Currently, insufficient data exist to evaluate the relationship between angiographic late loss (LL) and long-term clinical outcome after drug-eluting stent (DES) implantation. In this study, we hypothesized that angiographic LL between 0.3 and 0.6 mm correlate with favorable long-term clinical outcomes.

Materials and Methods

Patients were enrolled in the present study if they had undergone both DES implantation in single coronary vessel and a subsequent follow-up angiogram (n=634). These individuals were then subdivided into three groups based on their relative angiographic LL: group I (angiographic LL <0.3 mm, n=378), group II (angiographic LL between 0.3 and 0.6 mm, n=124), and group III (angiographic LL >0.6 mm, n=134). During a 5-year follow-up period, all subjects were tracked for critical events, defined as any cause of death or myocardial infarction, which were then compared among the three groups.

Results

Mean follow-up duration was 63.0±10.0 months. Critical events occurred in 25 subjects in group I (6.6%), 5 in group II (4.0%), and 17 in group III (12.7%), (p=0.020; group I vs. group II, p=0.293; group II vs. group III, p=0.013). In a subsequent multivariate logistic regression analysis, chronic renal failure [odds ratio (OR)=3.29, 95% confidence interval (CI): 1.48-7.31, p=0.003] and long lesion length, defined as lesion length >28 mm (OR=1.88, 95% CI: 1.02-3.46, p=0.042) were independent predictors of long-term critical events.

Conclusion

This retrospective analysis fails to demonstrate that post-DES implantation angiographic LL between 0.3 and 0.6 mm is protective against future critical events.     

Efficacy and tolerability of renzapride in irritable bowel syndrome: a meta-analysis of randomized,controlled clinical trials including 2528 patients

Introduction

By targeting different subtypes of 5-hydroxytryptamine (5HT) receptors in the gastrointestinal (GI) tract, several drugs have been introduced for the management of irritable bowel syndrome (IBS). Renzapride is a full agonist for 5HT4 receptor and an antagonist to 5HT2b and 5HT3 receptors which is thought a promising therapeutic agent for constipation predominant IBS (C-IBS) patients due to its accelerating effect on the GI tract. In this meta-analysis, our aim was to evaluate the efficacy and tolerability of renzapride in the management of IBS.

Material and methods

A search was done from 1992 to February 2013 for placebo-controlled trials that investigated the efficacy of renzapride in IBS.

Results

Relative risk (RR) for clinical efficacy in IBS patients treated for 5 weeks or less comparing renzapride to placebo was 1.07 (95% CI = 0.89–1.29, p = 0.38). This value for IBS patients treated for more than 5 weeks was 1.04 (95% CI = 0.78–1.239, p = 0.77). The RR for clinical efficacy in IBS patients treated with renzapride (4 mg) for 5 weeks or less and more than 5 weeks in comparison to placebo was 1.2 (95% CI = 0.97–1.48, p = 0.1) and 1.16 (95% CI = 0.98–1.37, p = 0.08), respectively, which were statistically non-significant but clinically important. The analysis of tolerability demonstrated that amongst different reported adverse effects, renzapride caused diarrhea more than placebo (RR = 1.61 with a 95% CI = 1.16–2.24, p = 0.004). The RR for withdrawals from renzapride compared to placebo was 1.58 (95% CI = 1.26–2.07, p = 0.0007).

Conclusions

Renzapride is not superior to placebo in relieving IBS symptoms and causes significant incidences of diarrhea and drop-outs due to adverse effects in treated patients vs. placebo. Thus, this medicine might be a cost burden to patients without providing good effectiveness.     

Sipuleucel-T immunotherapy for castration-resistant prostate cancer. A systematic review and meta-analysis

Introduction

Sipuleucel-T is a novel active cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC). It is assumed to be associated with less adverse events than conventional docetaxel-based chemotherapy.

Material and methods

A systematic review of literature published between January, 1 1966 and February, 6 2012 was performed to assess the efficacy and safety of sipuleucel-T in patients with mCRPC. Databases were searched: Medline, EMBASE, Cochrane, CancerLit as well as ASCO and ESCO websites.

Results

Three randomized clinical trials with a total of 737 participants fulfilled established criteria. The overall survival of patients who received sipuleucel-T in comparison to the control group was significantly longer with a hazard ratio (HR) of 0.73 (95% CI: 0.61-0.88; p = 0.001). Time to disease progression was not prolonged using sipuleucel-T compared to placebo, HR = 0.89 (95% CI: 0.75-1.05; p = 0.18). Relative benefit (RB) of serum PSA level reduction of at least 50% for sipuleucel-T compared to placebo did not meet statistical significance, RB = 1.97 (95% CI: 0.48-8.14; p = 0.38). The safety population consisted of 729 patients with mCRPC. Compared to the control group, the pooled relative risks (RR) of all adverse events – RR = 1.03 (95% CI: 1.00-1.05; p = 0.06), grade 3 to 5 adverse events – RR = 0.98 (95% CI: 0.79-1.22; p = 0.86) and cerebrovascular events – RR = 1.93 (95% CI: 0.73-5.09; p = 0.18) were not significantly higher for men treated with sipuleucel-T.

Conclusions

The use of sipuleucel-T prolonged the overall survival among men with mCRPC. No effect on time to disease progression was observed and the safety profile was acceptable.     

Addressing the link between paraoxonase-1 gene variants and the incidence of early onset myocardial infarction

Introduction

The enzyme paraoxonase-1 (PON1) represents an endogenous defense mechanism against vascular oxidative stress, thereby contributing to the prevention of atherosclerosis. Several polymorphisms have been reported in the PON1 gene, including Q192R. PON1 phenotype is commonly expressed as the paraoxonase/arylesterase ratio (PON/ARE). The major aim of this study was to investigate the association between PON1 Q192R polymorphism, PON1 phenotypes and the incidence of early-onset acute myocardial infarction (AMI) in Egyptians.

Material and methods

The study subjects consisted of 102 AMI patients and 72 age-matched healthy controls. Genotyping and enzyme activities were determined using PCR-RFLP and kinetic spectrophotometric assays, respectively.

Results

The genotype distribution for the PON1 gene was significantly different between AMI patients (QQ = 38.24%, QR = 49.02%, RR = 12.75%) and controls (QQ = 66.67%, QR = 25%, RR = 8.33%). Allele frequencies were also significantly different between patients (Q = 62.75%, R = 37.25%) and controls (Q = 79.17%, R = 20.83%). The genotypes QR and RR showed higher risk for AMI compared to the homozygous QQ (odds ratio (OR) = 3.231, p < 0.001). The average PON/ARE ratio in MI patients (1.187 ±0.1) did not differ significantly from controls (1.118 ±0.26). However, it showed a significant difference among different genotypes in both AMI patients (QQ = 0.91 ±0.11, QR = 1.09 ±0.11 and RR = 2.65 ±0.4) (p = 0.0002) and controls (QQ = 0.68 ±0.1, QR = 1.07 ±0.11 and RR = 4.89 ±2.84) (p < 0.0001).

Conclusions

PON1 192R allele represents an independent risk factor for early-onset AMI in Egyptians, and PON1 Q192R polymorphism modulates the paraoxonase phenotype.     

Quality of life (QOL) evaluation after acute coronary syndrome with simultaneous clopidogrel treatment

Introduction

Double antiplatelet therapy with clopidogrel and acetylsalicylic acid is a standard procedure after acute coronary syndrome. This treatment carries a higher risk of complications. The main goal of this research was to assess the patients’ quality of life after undergoing antiplatelet therapy with clopidogrel after acute coronary syndrome (ACS).

Material and methods

In the questionnaire research 3220 patients after ACS and treated with clopidogrel were included. The evaluation was carried out with the quality of life questionnaire SF-12.

Results

37.9% of the interviewees experienced ACS-ST-elevation myocardial infarction (STEMI), 62.1% non-ST-elevation myocardial Infarction (NSTEMI), on average within 23 ±42 weeks (p < 0.05). 7.2% of the interviewees were receiving non-invasive treatment and in 2.4% cases it was fibrinolysis. 90.4% were treated with primary angioplasty and stenting. In 53.8% of cases a covered stent (DES) was implanted. 95.6% of the patients received, besides clopidogrel, acetylsalicylic acid. The lowest quality of life was observed after non-invasive treatment or fibrinolytic only (p < 0.05). The quality of life in those patients who underwent angioplasty and stent implantation was similar (p < 0.05). With time, a progressive improvement of all assessed quality of life aspects was observed (p < 0.05). The improvement was noted regardless of the ACS treatment method (p < 0.001). The differences between the patients were smaller at each successive evaluation (p < 0.05). In the case of vitality, emotional and psychic condition, they disappeared completely (p < 0.05).

Conclusions

The quality of life rises along with time passed after acute coronary syndrome. Invasive methods provide better quality of life than fibrinolysis and non-invasive treatment in the acute coronary syndrome patients.     

Interaction of cerebrovascular disease and contralateral carotid occlusion in prediction of shunt insertion during carotid endarterectomy

Introduction

To assess the possible role and the interaction of cerebrovascular disease and vascular stenosis on the necessity of shunt insertion during carotid endarterectomy (CEA).

Material and methods

Eighty consecutive patients undergoing CEA under regional anaesthesia were prospectively enrolled. Patients were divided into two groups depending on whether they were shunted or not. The measured end-points were co-morbidities degree of contralateral and carotid stenosis and other intra- and postoperative outstanding parameters. ANOVA, Student''s t and χ² tests were used (p<0.05). Variables differing significantly between groups and potential confounders were used in backward stepwise logistic regression to estimate the relative risk (RR, 95% CI) of shunt. In addition Wald''s test (p<0.05) with and without adjustments for potential confounders was used with various different multivariate analysis models.

Results

Contralateral stenosis and cerebral vascular accidents (CVA) were more frequently observed in shunted patients. The RR for patients with contralateral stenosis ≥ 50% was 1.3 (95% CI 1.0-1.5) and for patients with previous CVA was 1.2 (95% CI 1.0-1.4). For contralateral stenosis and CVA together the RR increased to 7.7 (95% CI 1.0-14.4). A model based on contralateral stenosis and CVA was found to be statistically significant (p=0.003) for shunt (RR=1.1, 95% CI 1.0-2.1). Relative excess risk due to interaction of both factors was 6.2.

Conclusions

The findings suggest that patients with contralateral stenosis ≥ 50% and previous CVA have a higher risk of requiring shunt use during CEA than patients with these risk factors separately.     

Prognostic role of SPARC expression in gastric cancer: a meta-analysis

Introduction

Secreted protein acidic and rich in cysteine (SPARC) is involved in regulating cell adhesion, proliferation, migration, and tissue remodeling. We performed a meta-analysis to evaluate the association between SPARC expression and the clinicopathologic features and outcomes of gastric cancer patients.

Material and methods

Publications that assessed the clinical or prognostic significance of SPARC in gastric cancer up to October 2013 were identified. A meta-analysis was performed to clarify the association between SPARC expression and clinical outcomes.

Results

Ten studies, including 1417 cases, met the inclusion criteria. The data were analyzed and the results show that SPARC is not significantly associated with the depth of gastric cancer invasion (odds ratio (OR) = 1.17, 95% confidence interval (CI): 0.60–2.29, Z = 0.47, p = 0.64) or tumor differentiation (OR = 0.59, 95% CI: 0.22–1.58, Z = 1.06, p = 0.29). Moreover, SPARC was not significantly correlated with lymph node metastasis (OR = 0.72, 95% CI: 0.37–1.41, Z = 0.96, p = 0.34). However, SPARC overexpression was highly correlated with reduced overall survival (relative risk (RR) = 1.78, 95% CI: 1.52–2.09, Z = 7.10, p = 0.43).

Conclusions

The SPARC may play an important role in the progression of gastric cancer, and SPARC overexpression is closely correlated with poor patient survival. The SPARC is a potential clinical marker for the survival of gastric cancer patients; however, well-designed prospective studies are needed to confirm these findings.     

The place of antibiotics in management of irritable bowel syndrome: a systematic review and meta-analysis

Introduction

Irritable bowel syndrome (IBS) is a prevalent gastrointestinal disease with an obscure pathophysiology. Current treatments for IBS have modest efficacy at best and the need for a robust therapy for IBS remains unmet. As small intestinal bacterial overgrowth has been proposed to be involved in pathogenesis of IBS, antibacterial agents might be efficacious in treatment of this condition.

Material and methods

PubMed, Embase, Scopus, Google Scholar, Web of Science, and Cochrane Central Register of Controlled Trials were searched for studies comparing the efficacy of antibiotics in the management of IBS and/or IBS type symptoms. Data were collected from 1966 to April 2009. Clinical response was considered as our key outcome of interest.

Results

Of five trials that evaluated the effect of antibiotics in IBS, two randomized placebo-controlled trials met the inclusion criteria for the meta-analysis. This meta-analysis included 234 patients with IBS-type symptoms of whom 181 met the Rome criteria for IBS. The pooled relative risk (RR) for “clinical response in IBS” was 2.04 (95% confidence interval [CI] of 1.23-3.40, p = 0.0061). The pooled RR for “clinical response in IBS-type symptoms” was 2.06 (95% CI of 1.3-3.27, p = 0.002).

Conclusions

Although antibiotics have a statistically significant effect on IBS and bloating, given the evidence for the presence of publication bias, methodological variability of the trials and lack of a precise scientific explanation for the role of bacterial overgrowth in the pathophysiology of IBS, use of antibiotics on a regular basis in IBS patients is not recommended.     

Serum p-cresyl sulfate predicts cardiovascular disease and mortality in elderly hemodialysis patients

Introduction

Previous studies have shown that serum p-cresyl sulfate (PCS) and indoxyl sulfate (IS) were significantly related to clinical outcomes in patients on hemodialysis (HD). However, evidence for the relationship in elderly HD patients remains scarce. We explore whether the two toxins can predict clinical outcomes in elderly HD patients.

Material and methods

Fifty stable HD patients more than 65 years old were enrolled from a single medical center. Serum total and free PCS, IS levels and biochemistry were measured concurrently. The clinical outcomes including cardiovascular events and all-cause mortality were analyzed after 38-month follow-up.

Results

Univariate Cox proportional hazard ratio analysis revealed that cardiovascular events were associated with gender (p = 0.02), diabetes (p < 0.01), calcium (p = 0.01), total PCS (p < 0.01), free PCS (p < 0.01) and total IS (p = 0.05). Multivariate analysis showed that diabetes (p = 0.01), total PCS (p = 0.01) and free PCS (p = 0.04) were related to cardiovascular events. For all-cause mortality, only total PCS (p = 0.01) reached significance after adjusting other confounding factors. However, Kaplan-Meier analysis indicated that free PCS (p = 0.02) and total PCS (p < 0.01) were significantly associated with cardiovascular events and total PCS (p = 0.048) was related to all-cause mortality during 38-month follow-up.

Conclusions

Our results indicate that total PCS is a valuable marker in predicting cardiovascular event and all-cause mortality in elderly HD patients.     

Comparison of coronary artery bypass grafting with percutaneous coronary intervention for unprotected left main coronary artery disease

Purpose

Coronary artery bypass grafting (CABG) is the optimal treatment option for left main coronary artery disease (LMCAD). However, LMCAD remains a constant topic of discussion between cardiac surgeons and interventional cardiologists. The aim of this study was to assess the efficacy of LMCAD treatments by comparing the mid-term outcomes of CABG and percutaneous coronary intervention (PCI) using bare metal stents or drug-eluting stents (DESs).

Materials and Methods

The study population was comprised of 199 consecutive patients admitted with unprotected LMCAD. All of the patients were assigned to PCI (88 patients) or CABG (111 patients). The primary clinical end point indicated death, stroke of acute coronary syndrome (ACS).

Results

Patients assigned to PCI were at higher operative risk than patients scheduled for CABG (6.49±4.09 vs. 4.81±2.67, p=0.0032). Comparison of the group that received DESs with the CABG group did not reveal any differences in major adverse cardio-cerebral events (MACCE) occurrence (21% vs. 16%, p=NS). Patients in the CABG and PCI groups died with similar frequency (11% vs. 16%, p=NS). The mortality rate in the CABG group was higher than among those treated with DES (11% vs. 3%, p=0.049). The rate of ACS was higher in the PCI group than in the CABG group (13% vs. 4%, p=0.016).

Conclusion

Despite the fact that patients treated with PCI were at higher operative risk, PCI with DES was shown to be comparable to CABG in terms of mortality, stroke and ACS. However, the frequency of repeat revascularizations remains a constant concern with PCI.     

Ovarian reserve markers in unexplained infertility patients treated with clomiphene citrate during intrauterine insemination

Introduction

The aim of this retrospective case control study was to identify predictors of ovarian response and pregnancy outcomes in intrauterine insemination (IUI).

Material and methods

One hundred women undergoing IUI cycles with clomiphene citrate were enrolled. The number of antral follicles and the total ovarian volume by ultrasound, and the basal levels of follicle-stimulating hormone (FSH), estradiol, and inhibin B on cycle day 3 were measured in groups that were divided according to ovarian response. The tests were also evaluated according to ovarian response and pregnancy outcomes. All analyses were performed using the Statistical Package for the Social Sciences, version 15.0 (SPSS, Chicago, IL, USA).

Results

The antral follicle count (AFC) was the best single predictor for ovarian response and pregnancy outcomes. The sensitivity and specificity for prediction of ovarian response were 81% and 78% for AFC at an optimum cutoff value of ≤ 13.1. Age was negatively correlated with ovarian volume (r = –0.280, p = 0.021) and AFC (r = –0.358, p = 0.003). Increasing FSH was associated with a reduction in AFC (r = –0.273, p = 0.025). The AFC was significantly correlated with ovarian volume (r = 0.660, p < 0.0001) and FSH (r = –0.273, p = 0.03).

Conclusions

Our data demonstrate that the AFC provides better prognostic information on the occurrence of ovarian response during clomiphene citrate stimulation for IUI.     

Exercise capacity as an independent risk factor for adverse cardiovascular outcomes among nondiabetic and diabetic patients

Introduction

To investigate if decreased exercise capacity is an independent risk factor for major adverse cardiovascular events (MACE) in diabetics and nondiabetics.

Material and methods

The association of decreased exercise capacity (EC) during a treadmill exercise sestamibi stress test with MACE was investigated in 490 nondiabetics and 404 diabetics. Mean follow-up was 53 months.

Results

Nondiabetics with a predicted EC < 85% had a higher prevalence of myocardial ischemia (34% vs. 19%, p = 0.0002), 2- or 3-vessel obstructive coronary artery disease (CAD) (31% vs. 13%, p = 0.016), myocardial infarction (MI) (17% vs. 7%, p = 0.0005), stroke (8% vs. 2%, p = 0.002), death (11% vs. 3%, p = 0.0002), and MI or stroke or death at follow-up (32% vs. 11%, p < 0.001) compared to nondiabetics with a predicted EC ≥ 85%. Diabetics with a predicted EC < 85% had a higher prevalence of myocardial ischemia (48% vs. 32%, p = 0.0009), 2- or 3-vessel obstructive CAD (54% vs. 28%, p = 0.001), MI (32% vs. 14%, p < 0.001), stroke (22% vs. 6%, p < 0.001), death (17% vs. 9%, p = 0.031), and MI or stroke or death at follow-up (65% vs. 27%, p < 0.001). Stepwise Cox regression analysis showed decreased EC was an independent and significant risk factor for MACE among nondiabetics (hazard ratio 3.3, p < 0.0001) and diabetics (hazard ratio 2.7, p < 0.0001).

Conclusions

Diabetics and nondiabetics with decreased EC were at increased risk for MACE with nondiabetics and decreased EC at similar risk as diabetics with normal EC.