Aims Recent data from the National Cardiovascular Data Registry indicate that women with ST-segment-elevation myocardial infarction (STEMI) continue to have higher mortality and reported delays in ...treatment compared to men. We aimed to determine whether the sex difference in mortality exists when treatment disparities are reduced. Methods and Results Using a prospective regional percutaneous-coronary-intervention (PCI)-based STEMI system database with a standardized STEMI protocol, we evaluated baseline characteristics, treatment and clinical outcomes of STEMI patients stratified by sex. From March 2003 to January 2016, 4918 consecutive STEMI patients presented to the Minneapolis Heart Institute at Abbott Northwestern Hospital regional STEMI system including 1416 (28.8%) women. Compared to men, women were older (68.4 vs 60.9 years) with higher rates of hypertension (66.7 vs 55.7%), diabetes (21.7 vs 17.4%) and cardiogenic shock (11.5 vs 8.0%) (all P < .001). Pre-revascularization medications and PCI were performed with same frequencies, but women were less likely to receive statin or anti-platelet therapy at discharge. After age-adjustment, women had similar in-hospital mortality to men (5.1% vs 4.8%, P = .60), despite slightly longer door-to-balloon time (95 vs 92 mins, P = .004). Five-year follow-up confirmed absence of a sex disparity in age-adjusted survival post-STEMI. Conclusions Previously reported treatment disparities between men and women are diminished in a regional PCI-based STEMI system using a standardized STEMI protocol. No sex differences in short-term or long-term age-adjusted mortality are present in this registry despite some treatment disparities. These results suggest that STEMI healthcare disparities and mortality in women can be improved using STEMI protocols and systems.
Summary Background Dual antiplatelet therapy (DAPT) cessation increases the risk of adverse events after percutaneous coronary intervention (PCI). Whether risk changes over time, depends on the ...underlying reason for DAPT cessation, or both is unknown. We assessed associations between different modes of DAPT cessation and cardiovascular risk after PCI. Methods The PARIS (patterns of non-adherence to anti-platelet regimens in stented patients) registry is a prospective observational study of patients undergoing PCI with stent implantation in 15 clinical sites in the USA and Europe between July 1, 2009, and Dec 2, 2010. Adult patients (aged 18 years or older) undergoing successful stent implantation in one or more native coronary artery and discharged on DAPT were eligible for enrolment. Patients were followed up at months 1, 6, 12, and 24 after implantation. Prespecified categories for DAPT cessation included physician-recommended discontinuation, brief interruption (for surgery), or disruption (non-compliance or because of bleeding). All adverse events and episodes of DAPT cessation were independently adjudicated. Using Cox models with time-varying covariates, we examined the effect of DAPT cessation on major adverse events (MACE composite of cardiac death, definite or probable stent thrombosis, myocardial infarction, or target-lesion revascularisation). Incidence rates for DAPT cessation and adverse events were calculated as Kaplan-Meier estimates of time to the first event. This study is registered with ClinicalTrials.gov , number NCT00998127. Findings We enrolled 5031 patients undergoing PCI, including 5018 in the final study population. Over 2 years, the overall incidence of any DAPT cessation was 57·3%. Rate of any discontinuation was 40·8%, of interruption was 10·5%, and of disruption was 14·4%. The corresponding overall 2 year MACE rate was 11·5%, most of which (74%) occurred while patients were taking DAPT. Compared with those on DAPT, the adjusted hazard ratio (HR) for MACE due to interruption was 1·41 (95% CI 0·94–2·12; p=0·10) and to disruption was 1·50 (1·14–1.97; p=0·004). Within 7 days, 8–30 days, and more than 30 days after disruption, adjusted HRs were 7·04 (3·31–14·95), 2·17 (0·97–4·88), and 1·3 (0·97–1·76), respectively. By contrast with patients who remained on DAPT, those who discontinued had lower MACE risk (0·63 0·46–0·86). Results were similar after excluding patients receiving bare metal stents and using an alternative MACE definition that did not include target lesion revascularisation. Interpretation In a real-world setting, for patients undergoing PCI and discharged on DAPT, cardiac events after DAPT cessation depend on the clinical circumstance and reason for cessation and attenuates over time. While most events after PCI occur in patients on DAPT, early risk for events due to disruption is substantial irrespective of stent type. Funding Bristol-Myers Squibb and Sanofi-Aventis.
Summary In the coming decades, cancer will be a major clinical and public health issue in sub-Saharan Africa. However, clinical and public health infrastructure and services in many countries are not ...positioned to deal with the growing cancer burden. Pathology is a core service required to serve many needs related to cancer in sub-Saharan Africa. Cancer diagnosis, treatment, and research all depend on adequate pathology. Pathology is also necessary for cancer registration, which is needed to accurately estimate cancer incidence and mortality. Cancer registry data directly guide policy-makers' decisions for cancer control and the allocation of clinical and public health services. Despite the centrality of pathology in many components of cancer care and control, countries in sub-Saharan Africa have at best a tenth of the pathology coverage of that in high-income countries. Equipment, processes, and services are lacking, and there is a need for quality assurance for the definition and implementation of high-quality, accurate diagnosis. Training and advocacy for pathology are also needed. We propose approaches to improve the status of pathology in sub-Saharan Africa to address the needs of patients with cancer and other diseases.
Background Benign biliary strictures (BBS) have been endoscopically managed with placement of multiple plastic stents. Uncovered metal stents have been associated with mucosal hyperplasia and ...partially covered self-expandable metal stents with migration. Recently, fully covered self-expandable metal stents (CSEMSs) with anchoring fins have become available. Objective Our purpose was to analyze the efficacy and complication rates of CSEMSs in the treatment of BBS. Design CSEMSs (10-mm diameter) were placed in 44 patients with BBS. CSEMSs were left in place until adequate biliary drainage was achieved, confirmed by resolution of symptoms, normalization of liver function tests, and imaging. Setting Tertiary care center with long-standing experience with metal stents. Patients A total of 44 patients with BBS (28 men, median age 53.5 years) were included. The preprocedure diagnoses included chronic pancreatitis (n = 19), gallstone-related strictures (n = 14), post liver transplant (n = 9), autoimmune pancreatitis (n = 1), and primary sclerosing cholangitis (n = 1). Intervention ERCP with temporary CSEMS placement. Removal of CSEMSs was performed with a snare or rat tooth. Main Outcome Measurements Stricture resolution and morbidity. Results The median time of CSEMS placement was 3.3 months (interquartile range 3.0-4.8). Resolution of the BBS was confirmed in 34 of 41 patients (83%) after a median postremoval follow-up time of 3.8 months (interquartile range 1.2-7.7). Complications were observed in 6 (14%) patients after CSEMS placement and in 4 (9%) after CSEMS removal. Limitation Pilot study from a single center. Conclusion Temporary placement of CSEMSs for BBS may offer an alternative to plastic stenting. Further investigation is required to further assess safety and long-term efficacy.
Abstract Background Dual-antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention reduces the risk for coronary thrombotic events (CTEs) at the expense of increasing ...risk for major bleeding (MB). Metrics to accurately predict the occurrence of each respective event and inform clinical decision making are lacking. Objectives The aim of this study was to develop and validate separate models to predict risks for out-of-hospital thrombotic and bleeding events after percutaneous coronary intervention with drug-eluting stents. Methods Using data from 4,190 patients treated with drug-eluting stents and enrolled in the PARIS (Patterns of Non-Adherence to Anti-Platelet Regimen in Stented Patients) registry, separate risk scores were developed to predict CTE (defined as the composite of stent thrombosis or myocardial infarction) and MB (defined as the occurrence of a Bleeding Academic Research Consortium type 3 or 5 bleed). External validation was performed in the ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) registry. Results Over 2 years, CTEs occurred in 151 patients (3.8%) and MB in 133 (3.3%). Independent predictors of CTEs included acute coronary syndrome, prior revascularization, diabetes mellitus, renal dysfunction, and current smoking. Independent predictors of MB included older age, body mass index, triple therapy at discharge, anemia, current smoking, and renal dysfunction. Each model displayed moderate levels of discrimination and adequate calibration. Conclusions Simple risk scores of baseline clinical variables may be useful to predict risks for ischemic and bleeding events after PCI with DES, thereby facilitating clinical decisions surrounding the optimal duration of DAPT. (Patterns of Non-Adherence to Anti-Platelet Regimen in Stented Patients PARIS; NCT00998127 )
Background Data on the effect of bile duct injuries (BDI) on health-related quality of life (HRQOL) are not well defined. We sought to assess long-term HRQOL after BDI repair in a large cohort of ...patients spanning a 23-year period. Study Design We identified and mailed HRQOL questionnaires to all patients treated for major BDI after laparoscopic cholecystectomy between January 1, 1990 and December 31, 2012 at Johns Hopkins Hospital. Results We identified 167 patients alive at the time of the study who met the inclusion criteria. Median age at BDI was 42 years (interquartile range 31 to 54 years); the majority of patients were female (n = 131 78.4%) and of white race (n = 137 83.0%). Most patients had Bismuth level 2 (n = 56 33.7%) or Bismuth level 3 (n = 40 24.1%) BDI. Surgical repair most commonly involved a Roux-en-Y hepaticojejunostomy (n = 142 86.1%). Sixty-two patients (37.1%) responded to the HRQOL questionnaire. Median follow-up was 169 months (interquartile range 125 to 222 months). At the time of BDI, mental health was most affected, with patients commonly reporting a depressed mood (49.2%) or low energy level (40.0%). These symptoms improved significantly after definitive repair (both p < 0.05). Limitations in physical activity and general health remained unchanged before and after surgical repair (both p > 0.05). Conclusions Mental health concerns were more commonplace vs physical or general health issues among patients with BDI followed long term. Optimal multidisciplinary management of BDI can help restore HRQOL to preinjury levels.
Objectives Cell therapy is a novel experimental treatment modality for patients with critical limb ischemia (CLI) of the lower extremities and no other established treatment options. This study was ...conducted to assess the safety and clinical efficacy of intramuscular injection of autologous tissue repair cells (TRCs). Methods A prospective, randomized double-blinded, placebo controlled, multicenter study (RESTORE-CLI) was conducted at 18 centers in the United States in patients with CLI and no option for revascularization. Enrollment of 86 patients began in April 2007 and ended in February 2010. For the prospectively planned interim analysis, conducted in February 2010, 33 patients had the opportunity to complete the trial (12 months of follow-up), and 46 patients had completed at least 6 months of follow-up. The interim analysis included analysis of both patient populations. An independent physician performed the bone marrow or sham control aspiration. The aspirate was processed in a closed, automated cell manufacturing system for approximately 12 days to generate the TRC population of stem and progenitor cells. An average of 136 ± 41 × 106 total viable cells or electrolyte (control) solution were injected into 20 sites in the ischemic lower extremity. The primary end point was safety as evaluated by adverse events, and serious adverse events as assessed at multiple follow-up time points. Clinical efficacy end points included major amputation-free survival and time to first occurrence of treatment failure (defined as any of the following: major amputation, death, de novo gangrene, or doubling of wound size), as well as major amputation rate and measures of wound healing. Results There was no difference in adverse or serious adverse events between the two groups. Statistical analysis revealed a significant increase in time to treatment failure (log-rank test, P = .0053) and amputation-free survival in patients receiving TRC treatment, (log-rank test, P = .038). Major amputation occurred in 19% of TRC-treated patients compared to 43% of controls ( P = .14, Fisher exact test). There was evidence of improved wound healing in the TRC-treated patients when compared with controls at 12 months. Conclusions Intramuscular injection of autologous bone marrow-derived TRCs is safe and decreases the occurrence of clinical events associated with disease progression when compared to placebo in patients with lower extremity CLI and no revascularization options.
Abstract Objectives The aim of this study was to examine the frequency and clinical impact of different cessation patterns of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention ...with drug-eluting stents among patients with and those without diabetes mellitus (DM). Background Early DAPT suspension after percutaneous coronary intervention increases the risk for major adverse cardiac events. However, temporal variability in risk and relation to DAPT cessation patterns among patients with DM remain unclear. Methods Using data from the PARIS (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients) registry, 1,430 patients with DM (34%) and 2,777 without DM (66%) treated with drug-eluting stents were identified. DAPT cessation modes were classified as temporary interruption (<14 days), disruption because of bleeding or poor compliance, and physician-recommended discontinuation. Results During 2-year follow-up, DM was associated with an increased risk for thrombotic events but a similar risk for bleeding. The cumulative incidence of DAPT cessation was significantly lower in patients with versus those without DM (50.1% vs. 55.4%; p < 0.01), driven largely by less frequent physician-guided discontinuation beyond 1 year. In contrast, 2-year rates of interruption and disruption were similar between groups. When DAPT was interrupted or discontinued under physician guidance, the risk for major adverse cardiac events was unchanged compared with patients with DM on uninterrupted DAPT. Conversely, when DAPT was disrupted, the risk for major adverse cardiac events increased compared with uninterrupted DAPT, regardless of diabetic status, with no evidence of statistical interaction. Conclusions DAPT cessation patterns vary according to diabetic status, with less frequent physician-guided discontinuation among patients with DM. The presence of DM does not emerge as a modifier of cardiovascular risk after DAPT cessation.
Anemic patients remain at increased risk of ischemic and bleeding events. Whether or not the effects of hemoglobin levels on thrombotic and bleeding risk are independent of platelet reactivity on ...clopidogrel, however, remains unknown. Patients from the Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) study were categorized by the presence of anemia at baseline, defined according the World Health Organization criteria. Platelet reactivity was measured with VerifyNow assay; high platelet reactivity (HPR) on clopidogrel was defined as platelet reactive units value >208. Out of 8413 patients included in the study cohort, 1816 (21.6%) had anemia. HPR was more prevalent in patients with anemia (58.3% vs 38.4%; p<0.001), an association that persisted following multivariable adjustment. Patients with anemia had higher 2-year rates of major adverse cardiac events (MACE; 9.5% vs 5.6%; p<0.0001), major bleeding (11.8% vs 7.7%; p<0.0001), and all-cause mortality (4.0% vs 1.4%; p<0.0001); however, following adjustment for baseline clinical confounders, including HPR, anemia was no longer associated with MACE (adjusted hazard ratio HR: 1.22; 95% confidence interval CI: 0.98–1.51; p=0.07), but was still significantly associated with all-cause mortality (adjusted HR: 1.61; 95% CI: 1.23–2.12; p<0.0001) and major bleeding (adjusted HR: 1.42; 95% CI: 1.20–1.68; p<0.0001). In conclusion, anemia independently correlated with HPR. After PCI with drug-eluting stents, anemia at baseline was significantly associated with higher 2-year hemorrhagic and mortality risk; conversely, its association with ischemic risk was attenuated following multivariable adjustment, including HPR.
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