Studies comparing gender-specific outcomes in patients with atrial fibrillation (AF) have reported conflicting results. Gender differences in cerebrovascular accident/systemic embolism (CVA/SE) or ...major bleeding outcomes with novel oral anticoagulant (NOAC) use are not known. The goal of this analysis was to perform a systematic review and meta-analysis evaluating gender differences in residual risk of CVA/SE and major bleeding outcomes in patients with nonvalvular AF treated with either warfarin or NOAC. Sixty-four randomized studies were identified using keywords “gender,” “AF,” and “CVA.” Using the Preferred Reporting Items for Systemic Reviews and Meta-analysis method, 6 studies met criteria for inclusion in this meta-analysis. CVA/SE and major bleeding outcomes were separately analyzed in cohorts receiving warfarin and NOAC agents, comparing men with women. Women with AF taking warfarin were at a significantly greater residual risk of CVA/SE compared with men (odds ratio 1.279, 95% confidence interval 1.111 to 1.473, Z = −3.428, p = 0.001). No gender difference in residual risk of CVA/SE was noted in patients with AF receiving NOAC agents (odds ratio 1.146, 95% confidence interval 0.97 to 1.354, p = 0.109). Major bleeding was less frequent in women with AF treated with NOAC. In conclusion, women with AF treated with warfarin have a greater residual risk of CVA/SE and an equivalent major bleeding risk, whereas those treated with NOAC agents deemed superior to warfarin are at equivalent residual risk of CVA/SE and less major bleeding risk compared with men. These results suggest an increased net clinical benefit of NOAC agents compared with warfarin in treating women with AF.
Summary Background Transradial access for cardiac catheterisation results in lower bleeding and vascular complications than the traditional transfemoral access route. However, the increased radiation ...exposure potentially associated with transradial access is a possible drawback of this method. Whether transradial access is associated with a clinically significant increase in radiation exposure that outweighs its benefits is unclear. Our aim was therefore to compare radiation exposure between transradial access and transfemoral access for diagnostic coronary angiograms and percutaneous coronary interventions (PCI). Methods We did a systematic review and meta-analysis of the scientific literature by searching the PubMed, Embase, and Cochrane Library databases with relevant terms, and cross-referencing relevant articles for randomised controlled trials (RCTs) that compared radiation parameters in relation to access site, published from Jan 1, 1989, to June 3, 2014. Three investigators independently sorted the potentially relevant studies, and two others extracted data. We focused on the primary radiation outcomes of fluoroscopy time and kerma-area product, and used meta-regression to assess the changes over time. Secondary outcomes were operator radiation exposure and procedural time. We used both fixed-effects and random-effects models with inverse variance weighting for the main analyses, and we did confirmatory analyses for observational studies. Findings Of 1252 records identified, we obtained data from 24 published RCTs for 19 328 patients. Our primary analyses showed that transradial access was associated with a small but significant increase in fluoroscopy time for diagnostic coronary angiograms (weighted mean difference WMD, fixed effect: 1·04 min, 95% CI 0·84–1·24; p<0·0001) and PCI (1·15 min, 95% CI 0·96–1·33; p<0·0001), compared with transfemoral access. Transradial access was also associated with higher kerma-area product for diagnostic coronary angiograms (WMD, fixed effect: 1·72 Gy·cm2 , 95% CI −0·10 to 3·55; p=0·06), and significantly higher kerma-area product for PCI (0·55 Gy·cm2 , 95% CI 0·08–1·02; p=0·02). Mean operator radiation doses for PCI with basic protection were 107 μSv (SD 110) with transradial access and 74 μSv (68) with transfemoral access; with supplementary protection, the doses decreased to 21 μSv (17) with transradial access and 46 μSv (9) with transfemoral. Meta-regression analysis showed that the overall difference in fluoroscopy time between the two procedures has decreased significantly by 75% over the past 20 years from 2 min in 1996 to about 30 s in 2014 (p<0·0001). In observational studies, differences and effect sizes remained consistent with RCTs. Interpretation Transradial access was associated with a small but significant increase in radiation exposure in both diagnostic and interventional procedures compared with transfemoral access. Since differences in radiation exposure narrow over time, the clinical significance of this small increase is uncertain and is unlikely to outweigh the clinical benefits of transradial access. Funding None.
Background The benefit of transradial access (TRA) in patients with cardiogenic shock (CS) is uncertain. We sought to determine the benefits of TRA in patients with CS undergoing coronary ...angiography/intervention. Methods MEDLINE, Embase, Cochrane Central, and electronic databases were searched for studies that assessed the following: (1) patients with CS who underwent percutaneous coronary intervention (PCI) and (2) the association between choice of arterial access, 30-day all-cause mortality, and 30-day major adverse cardiac and cerebral events (MACCEs) using random-effects model. Results From 3,652 retrieved citations, 8 studies involving 8,131 patients with CS undergoing PCI (via TRA: 2,321 patients, via TFA: 5,810 patients) were included. Transradial access was associated with significantly reduced risk for all-cause mortality (unadjusted: risk ratio RR 0.60, 95% CI 0.52-0.71, P < .001, I2 = 29%, 8 included studies; adjusted: RR 0.55, 95% CI 0.46-0.65, P < .001, I2 = 0%, 6 included studies) and MACCE (unadjusted: RR 0.68, 95% CI 0.63-0.73, P < .001, I2 = 0%, 6 included studies; adjusted: RR 0.63, 95% CI 0.52-0.75, P < .001, I2 = 0%, 4 included studies) at 30 days when compared with TFA. Conclusions Transradial access is associated with reduced mortality and MACCE at 30 days in patients with CS undergoing PCI. Considering the possible influence of selection bias on the effect estimate in our analysis, randomized controlled trials are needed to better assess this association.
Characteristics of long-term survivors in EGFR-mutant (EGFRm) NSCLC are not fully understood. This retrospective analysis evaluated a multi-institution cohort of patients with EGFRm NSCLC treated in ...the pre-osimertinib era and sought to describe characteristics of long-term survivors.
Clinical characteristics and outcomes were abstracted from the electronic medical records of patients with EGFRm metastatic NSCLC who started first-line therapy before 2015. Demographics and comutations were compared between greater than or equal to 5-year survivors and less than 5-year survivors. Multivariable Cox proportional hazard and logistic regression models were used to evaluate factors associated with survival and the odds of death within 5 years, respectively.
Overall, 133 patients were greater than or equal to 5-year survivors; 127 were less than 5-year survivors. Burden of pathogenic comutations including TP53 and PIK3CA was similar between greater than or equal to 5-year survivors and less than 5-year survivors. Receipt of first-line chemotherapy rather than EGFR tyrosine kinase inhibitor was similar between the groups (22% of <5-y versus 31% of ≥5-y). Baseline brain metastasis and history of smoking were associated with higher odds of death within 5 years (odds ratio = 2.16, p = 0.029 and odds ratio = 1.90, p = 0.046, respectively). Among patients without baseline brain metastases, cumulative incidence of brain metastases at 5 years was 42.3%. Both baseline and post-baseline brain metastasis were associated with worse overall survival compared with no brain metastasis (hazard ratio = 3.26, p < 0.001 and hazard ratio = 4.99, p < 0.001, respectively).
Within patients treated for EGFRm metastatic NSCLC before 2015, absence of brain metastasis and nonsmoking status were predictive of 5-year survival. Our findings help to define a subset of patients with EGFRm NSCLC with excellent survival outcomes who may not require intensification of initial therapy.
We performed a systematic review and meta-analysis comparing the all-cause mortality outcomes of successful percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs) with ...unsuccessful CTO-PCI, using a stent-based strategy. Multiple studies comparing successful CTO-PCI with unsuccessful CTO-PCI have reported variable outcomes. No systematic review or meta-analysis has been performed after stenting became the default strategy for CTO-PCI. Searching major electronic databases, 64 studies were identified using the keywords “CTO,” “PCI,” and “mortality.” Using the Preferred Reporting Items for Systematic Reviews and Meta-analyses method, 13 studies met the criteria for inclusion in the present meta-analysis. The short-term (≤30 days) and long-term (≥1 year) mortality outcomes were analyzed comparing successful CTO-PCI and unsuccessful CTO-PCI. Coronary perforation and its association with CTO-PCI success was analyzed. A significant reduction in short-term mortality was noted with successful CTO-PCI compared to unsuccessful CTO-PCI (odds ratio 0.218, 95% confidence interval 0.095 to 0.498, Z = −3.61, p <0.001). A similar, significant reduction in long-term mortality was noted with successful CTO-PCI compared to unsuccessful CTO-PCI (odds ratio 0.391, 95% confidence interval 0.311 to 0.493, Z = −7.957, p <0.001). A significant association was present between coronary perforation and unsuccessful CTO-PCI (odds ratio 0.168, 95% confidence interval 0.104 to 0.271, Z = −7.333, p <0.001). In conclusion, successful CTO-PCI using a predominantly stent-based strategy is associated with a significant reduction in short- and long-term mortality compared to unsuccessful CTO-PCI. Coronary perforation was associated with CTO-PCI failure.
Objectives The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS). Background Clinical outcomes of diabetic ...patients after BVS implantation have been unreported. Methods This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System, SPIRIT II A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System, SPIRIT III Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS), SPIRIT IV Clinical Trial Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up. Results The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group). Conclusions In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up. (ABSORB Clinical Investigation, Cohort B; NCT00856856 ; ABSORB EXTEND Clinical Investigation; NCT01023789 ; Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System SPIRIT FIRST; NCT00180453 ; A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System SPIRIT II; NCT00180310 ; Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System EECSS SPIRIT III; NCT00180479 ; Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System SPIRIT IV Clinical Trial; NCT00307047 ).
Systemic anticoagulation decreases the risk of radial artery occlusion (RAO) after transradial catheterization and standard occlusive hemostasis. We compared the efficacy and safety of provisional ...heparin use only when the technique of patent hemostasis was not achievable to standard a priori heparin administration after radial sheath introduction. Patients referred for coronary angiography were randomized in 2 groups. In the a priori group, 200 patients received intravenous heparin (50 IU/kg) immediately after sheath insertion. In the provisional group, 200 patients did not receive heparin during the procedure. After sheath removal, hemostasis was obtained using a TR band (Terumo corporation, Tokyo, Japan) with a plethysmography-guided patent hemostasis technique. In the provisional group, no heparin was given if radial artery patency could be obtained and maintained. If radial patency was not achieved, a bolus of heparin (50 IU/kg) was given. Radial artery patency was evaluated at 24 hours (early RAO) and 30 days after the procedure (late RAO) by plethysmography. Patent hemostasis was obtained in 67% in the a priori group and 74% in the provisional group (p = 0.10). Incidence of RAO remained similar in the 2 groups at the early (7.5% vs 7.0%, p = 0.84) and late (4.5% vs 5.0%, p = 0.83) evaluations. Women, patients with diabetes, patients having not received heparin, and patients without radial artery patency during hemostasis had more RAO. By multivariate analysis, patent radial artery during hemostasis (odds ratio OR 0.03, 95% confidence interval CI 0.004 to 0.28, p = 0.002) and diabetes (OR 11, 95% CI 3 to 38,p <0.0001) were independent predictors of late RAO, whereas heparin was not (OR 0.45 95% CI 0.13 to 1.54, p = 0.20). In conclusion, our results suggest that maintenance of radial artery patency during hemostasis is the most important parameter to decrease the risk of RAO. In selected cases, provisional use of heparin appears feasible and safe when patent hemostasis is maintained.
Background The worldwide prevalence of metabolic syndrome is increasing and has been associated with chronic kidney disease. Kidney pathological findings in patients with metabolic syndrome have not ...been well described, as was explored in this study. Study Design Cross-sectional study. Setting & Participants We retrospectively screened clinical information for 146 patients who underwent elective nephrectomy for renal cell carcinoma between January 2005 and March 2007 at Brigham and Women's Hospital, Boston, MA. Twelve patients with metabolic syndrome were identified. Twelve age- and sex-matched patients who did not have any of the criteria for metabolic syndrome were used as controls. Predictor Presence of metabolic syndrome defined by using Adult Treatment Panel III criteria. Outcomes Histological characteristics in each group, decrease in kidney function at 1-year follow-up. Measurements Two pathologists blinded to the clinical diagnosis independently evaluated nephrectomy specimens using Banff criteria to objectively assess histological characteristics. Results Baseline characteristics were similar between the 2 groups. On histopathologic examination, patients with metabolic syndrome compared with controls had a greater prevalence of tubular atrophy ( P = 0.006), interstitial fibrosis ( P = 0.001), and arterial sclerosis ( P = 0.001), suggesting microvascular disease. Patients with metabolic syndrome had greater global ( P = 0.04) and segmental glomerulosclerosis ( P = 0.05). Glomerular volume and cross-sectional surface area were not different. The combined end point of tubular atrophy greater than 5%, interstitial fibrosis greater than 5%, and presence of arterial sclerosis was more prevalent in patients with metabolic syndrome ( P = 0.003; odds ratio, 33; confidence interval, 2.9 to 374.3) than controls. After 1 year, estimated glomerular filtration rate was significantly lower in patients with metabolic syndrome compared with controls ( P = 0.03). Limitations Small sample size, retrospective design. Conclusions We report a high prevalence of microvascular disease in patients with metabolic syndrome. There was a steeper decrease in kidney function over time in patients with metabolic syndrome, suggesting limited renal reserve. Aggressive screening and management may be warranted in patients with metabolic syndrome to protect kidney function.
Data comparing the effect of renal denervation (RD) with those of maximal medical therapy (MMT) have shown conflicting results. Also, effect of RD on pulse pressure (PP) has not been evaluated. The ...aim of this meta-analysis was to compare the effect of RD with that of MMT on blood pressure (BP) and PP at 6-month follow-up in patients with resistant hypertension. Randomized controlled trials and nonrandomized controlled trials reporting systolic BP, diastolic BP, and PP results in RD and MMT groups at 6-month follow-up in patients with resistant hypertension were systematically reviewed, and eligible citations were pooled using a random-effects model. Five studies (3 randomized controlled trials, 2 nonrandomized controlled trials, n = 800) met the inclusion criteria. In the pooled analysis, RD was associated with a significant decrease in systolic BP (weighted mean difference −19.4 mm Hg, 95% confidence interval −32.8 to −5.9, p = 0.005), diastolic BP (weighted mean difference −6.4 mm Hg, 95% confidence interval −10.7 to −2.0 mm Hg, p = 0.004), and PP (weighted mean difference −12.7 mm Hg, 95% confidence interval −22.3 to −3.1 mm Hg, p = 0.009) compared with MMT at 6-month follow-up. Sensitivity analysis limited to randomized controlled trials showed a borderline significant difference in lowering systolic BP, a significant difference in lowering diastolic BP, and a nonsignificant difference in lowering PP when RD was compared with MMT. In conclusion, this meta-analysis shows that RD is superior to MMT in lowering BP, but heterogeneity among study populations in this pooled sample is high, and further data are needed to better compare these treatment strategies.
Background Iron deficiency anemia is a common complication in patients with chronic kidney disease (CKD). Currently available intravenous (IV) iron replacement therapies have either inconvenient ...regimens of administration or adverse event profiles that limit their utility in the outpatient setting. Ferumoxytol is a novel, semisynthetic, carbohydrate-coated, superparamagnetic iron oxide nanoparticle that is administered IV as an injection. The main objective of this study was to assess the safety of ferumoxytol for the treatment of patients with CKD stages 1 to 5 and 5D. Study Design Phase 3, randomized, double-blind, placebo-controlled, crossover, multicenter study of a single 510-mg dose of ferumoxytol versus saline as placebo. Setting & Participants 750 patients with CKD stages 1 to 5 and 5D. Intervention An IV injection of either 17 mL of ferumoxytol or saline placebo over 17 seconds on day 0 and the alternate agent on day 7. Outcomes & Measurements Descriptive comparison of adverse events, laboratory tests, and vital signs. Results Of 750 randomly assigned patients with CKD, 60% were not on dialysis therapy. 713 patients received ferumoxytol, and 711 received placebo. There were 420 adverse events reported; 242 in 152 patients (21.3%) with ferumoxytol and 178 in 119 patients (16.7%) with placebo. The incidence of related adverse events was 5.2% with ferumoxytol and 4.5% with placebo. The most common related adverse events after each treatment included symptoms related to the injection/infusion site, dizziness, pruritus, headache, fatigue, and nausea. Serious adverse events occurred in 21 patients (2.9%) after ferumoxytol and 13 patients (1.8%) after placebo. Serious related adverse events were observed in 1 patient (0.1%) after each treatment. There was no meaningful decrease in blood pressure after administration of ferumoxytol or placebo. Limitations Follow-up was 7 days after each study treatment. Conclusions Ferumoxytol is well tolerated and has a safety profile similar to placebo in anemic patients with CKD stages 1 to 5 and 5D.
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