Whether bivalirudin is superior to unfractionated heparin in patients with stable or unstable angina who undergo percutaneous coronary intervention (PCI) after pretreatment with clopidogrel is ...unknown.
We enrolled 4570 patients with stable or unstable angina (with normal levels of troponin T and creatine kinase MB) who were undergoing PCI after pretreatment with a 600-mg dose of clopidogrel at least 2 hours before the procedure; 2289 patients were randomly assigned in a double-blind manner to receive bivalirudin, and 2281 to receive unfractionated heparin. The primary end point was the composite of death, myocardial infarction, urgent target-vessel revascularization due to myocardial ischemia within 30 days after randomization, or major bleeding during the index hospitalization (with a net clinical benefit defined as a reduction in the incidence of the end point). The secondary end point was the composite of death, myocardial infarction, or urgent target-vessel revascularization.
The incidence of the primary end point was 8.3% (190 patients) in the bivalirudin group as compared with 8.7% (199 patients) in the unfractionated-heparin group (relative risk, 0.94; 95% confidence interval CI, 0.77 to 1.15; P=0.57). The secondary end point occurred in 134 patients (5.9%) in the bivalirudin group and 115 patients (5.0%) in the unfractionated-heparin group (relative risk, 1.16; 95% CI, 0.91 to 1.49; P=0.23). The incidence of major bleeding was 3.1% (70 patients) in the bivalirudin group and 4.6% (104 patients) in the unfractionated-heparin group (relative risk, 0.66; 95% CI, 0.49 to 0.90; P=0.008).
In patients with stable and unstable angina who underwent PCI after pretreatment with clopidogrel, bivalirudin did not provide a net clinical benefit (i.e., it did not reduce the incidence of the composite end point of death, myocardial infarction, urgent target-vessel revascularization, or major bleeding) as compared with unfractionated heparin, but it did significantly reduce the incidence of major bleeding. (ClinicalTrials.gov number, NCT00262054.)
Despite the demonstrated safety of the same-day discharge (SDD) after percutaneous coronary intervention (PCI), uptake of this program has been relatively poor in the United States. We evaluated the ...temporal trends and variations in the utilization of SDD after PCI during the contemporary era. In addition, we evaluated the predictors of SDD (compared with next-day discharge) and the causes of readmission in these 2 patient cohorts.
Data were extracted from State Ambulatory Surgical Database and State Inpatient Database from Florida and New York ranging from 2009 to 2013. All adults undergoing PCI in an outpatient setting were included. Data were merged with the directory available from the American Hospital Association to obtain detailed information on hospital-related characteristics. Unplanned readmissions within 7 and 30 days constituted the coprimary outcomes. There was modest increase in the proportion of SDD after PCI from 2.5% in 2009 to 7.4% in 2013 (
-trend <0.001). SDD was more frequently used among male and younger patients with fewer comorbidities. There were considerable differences in the discharge practices among the different hospital types. Larger hospitals, teaching hospitals, and high PCI volume hospitals had higher utilization of SDD compared with their respective counterparts. SDD and next-day discharge cohorts had similar rates of unplanned readmissions, in-hospital mortality, and acute myocardial infarction during follow-up. Furthermore, uninsured patients had significantly lower odds of SDD along with higher incidence of unplanned readmission within 30 days after PCI compared with insured patients.
During 2009 to 2013, there has been a modest increase in SDD after PCI. Several demographic and clinical characteristics play critical role in determination of SDD after PCI. There were significant disparities in discharge practices between different sex, racial, and insurance-based strata.
Treatment for severe symptomatic aortic stenosis has changed significantly in recent years due to advances in transcatheter aortic valve replacement (TAVR). Recent studies with the CoreValve ...prosthesis have demonstrated superior results compared with surgical aortic valve replacement in patients at increased risk for surgery, but there are limited data on gender-related differences in patient characteristics and outcomes with this device. We compared baseline characteristics and clinical outcomes in women and men undergoing TAVR with the CoreValve prosthesis. A total of 3,687 patients (1,708 women and 1,979 men) were included. At baseline, women tended to be slightly older and to have increased frailty, but they had fewer cardiac co-morbidities, higher left ventricular systolic function, less coronary artery disease, and fewer previous strokes. All-cause mortality was 5.9% for women and 5.8% for men at 30 days (p = 0.87) and 24.1% and 21.3%, respectively, at 1 year (p = 0.08). The incidence of stroke was 5.7% in women and 4.0% in men at 30 days (p = 0.02) and 9.3% and 7.7%, respectively, at 1 year (p = 0.05). Women had a higher incidence of bleeding, including more life-threatening bleeds, and a greater incidence of major vascular complications than men at 30 days. Device success was achieved in 86.9% of women and 86.1% of men (p = 0.50). In conclusion, although there were significant baseline differences and procedure-related complications between women and men undergoing TAVR with the CoreValve prosthesis, this analysis found no significant difference in 30-day or 1-year mortality.
Abstract The objective of this study was to compare outcomes in women following surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) utilizing a ...self-expanding prosthesis in patients with severe aortic stenosis who were at high risk for surgical AVR. Although registries and meta-analyses have suggested that TAVR is of considerable benefit in women, perhaps even more so than in men, a rigorous evaluation of TAVR with a self-expanding valve versus SAVR in women from a randomized trial has not been performed. Patients with severe aortic stenosis were randomized 1:1 to either TAVR or SAVR. Outcomes at 1 year are reported. Treatment was attempted in a total of 353 women (183 TAVR and 170 SAVR). Baseline characteristics and predicted risk of the 2 groups were comparable, although the frequency of diabetes mellitus was lower in TAVR patients (33.3% versus 45.3%; P = 0.02). TAVR-treated patients experienced a statistically significant 1-year survival advantage compared to SAVR patients (12.7% versus 21.8%; P = 0.03). The composite all-cause mortality or major stroke rate also favored TAVR (14.9% vs. 24.2%; P = 0.04). Quality of life (QoL), as measured by the Kansas City Cardiomyopathy Questionnaire summary score, for both the TAVR and SAVR groups increased significantly from baseline to 1 year. In conclusion, female TAVR patients had lower 1-year mortality and lower 1-year all-cause mortality or major stroke compared to females undergoing SAVR, with both cohorts experiencing improved QoL. Further studies specifically in women are warranted to validate these findings.
Purpose of Review
Spontaneous coronary artery dissection (SCAD) is an increasingly recognized cause of acute coronary syndrome (ACS), particularly among women < 50 years of age. Here, we aim to ...review the pathogenesis of SCAD, discuss SCAD as an initial manifestation of systemic arterial disease, and highlight invasive strategies as well as unique challenges in the care of women with SCAD.
Recent Findings
A paradigm shift has occurred in the care of SCAD patients in the past decade as recommendations for conservative management have become widespread. Invasive interventions are reserved for patients with hemodynamic compromise or active ischemia due to increased periprocedural complications and failure rates. Certain patient populations have been identified for larger territory infarcts and proximal disease including patients with known connective tissue disease, premenopausal women, and patients with pregnancy-associated SCAD (P-SCAD).
Summary
Current recommended management of SCAD is conservative. Despite a growing awareness of SCAD and its known association with systemic arteriopathies in women, evidence-based data remains scarce. Future studies focused on identifying genetic factors, optimal medical therapy after SCAD, and techniques to minimize interventional complications are needed.
There is growing interest in “minimalist” transcatheter aortic valve implantation (M-TAVI), performed with conscious sedation instead of general anesthesia (GA-TAVI). We assessed the impact of M-TAVI ...on procedural efficiency, long-term safety, and quality of life (QoL) in 477 patients with severe aortic stenosis (82 years, women 50%, STS 5.0), who underwent M-TAVI (n = 278) or GA-TAVI (n = 199). M-TAVI patients were less likely to have NYHA Class ≥3, valve-in-valve TAVI, and receive self-expanding valves. M-TAVI was completed without conversion to GA in 269 (97%) patients. M-TAVI was more efficient that GA-TAVI including shorter lengths of stay (2 vs 3 days, p <0.0001), higher likelihood of being discharged home (87% vs 72%, p <0.0001), less use of blood transfusions (10% vs 22%, p = 0.0008), inotropes (13% vs 32%, p <0.0001), contrast volume (50 vs 90 ml, p <0.0001), fluoroscopy time (20 vs 24 minute, p <0.0001), and need for >1 valves (0.4 vs 5.5%, p = 0.0004). At 1-month, death/stroke (M-TAVI vs GA-TAVI 4.0 vs 6.5%) and a “safety composite” end point (death, stroke, transient ischemic attack, myocardial infarction, new dialysis, major vascular complication, major or life-threatening bleeding, and new pacemaker: 17.6% vs 21.1%) were similar (p = NS for both). At a median follow-up of 365 days, survival curves showed similar incidence of death/stroke as well as the safety composite end point between the groups. QoL scores were similar at baseline and 1-month after TAVI. In multivariable analyses, M-TAVI showed significant improvements in all parameters of procedural efficiency. In conclusion, M-TAVI is more efficient than GA-TAVI, with similar safety at 1-month and long-term, and similar QoL scores at 1 month.
Recent studies have identified cardiomyocytes of extracardiac origin in transplanted human hearts, but the exact origin of these myocyte progenitors is currently unknown.
Hearts of female subjects ...(n=4) who had undergone sex-mismatched bone marrow transplantation (BMT) were recovered at autopsy and analyzed for the presence of Y chromosome-positive cardiomyocytes. Four female gender-matched BMT subjects served as controls. Fluorescence in situ hybridization (FISH) for the Y chromosome was performed on paraffin-embedded sections to identify cells of bone marrow origin with concomitant immunofluorescent labeling for alpha-sarcomeric actin to identify cardiomyocytes. A total of 160 000 cardiomyocyte nuclei were analyzed approximating 20 000 nuclei per patient. The mean percentage of Y chromosome-positive cardiomyocytes in patients with sex-mismatched BMT was 0.23+/-0.06%. Not a single Y chromosome-positive cardiomyocyte was identified in any of the control patients. Immunofluorescent costaining for laminin and chromosomal ploidy analysis with FISH showed no evidence of either pseudonuclei or cell fusion in any of the chimeric cardiac myocytes identified.
These data establish for the first time human bone marrow as a source of extracardiac progenitor cells capable of de novo cardiomyocyte formation.
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