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ABSTRACT: PURPOSE: To identify factors associated with attrition in a longitudinal study of cardiovascular prevention. METHODS: Demographic, clinical, and psychosocial variables potentially associated with attrition were investigated in 1841 subjects enrolled in the southwestern Pennsylvania Heart Strategies Concentrating on Risk Evaluation study. Attrition was defined as study withdrawal, loss to follow-up, or missing 50% or more of study visits. RESULTS: Over 4 years of follow-up, 291 subjects (15.8%) met criteria for attrition. In multivariable regression models, factors that were independently associated with attrition were black race (odds ratio [OR], 2.21; 95% confidence interval [CI], 1.55-3.16; P < .001), younger age (OR per 5-year increment, 0.88; 95% CI, 0.79-0.99; P < .05), male gender (OR, 1.79; 95% CI, 1.27-2.54; P < .05), no health insurance (OR, 2.04; 95% CI, 1.20-3.47; P < .05), obesity (OR, 1.80; 95% CI, 1.07-3.02; P < .05), CES-D depression score 16 or higher (OR, 2.02; 95% CI, 1.29-3.19; P < .05), and higher ongoing life events questionnaire score (OR, 1.09; 95% CI, 1.04-1.13; P < .001). Having a spouse/partner participating in the study was associated with lower odds of attrition (OR, 0.60; 95% CI, 0.37-0.97; P < .05). A synergistic interaction was identified between black race and depression. CONCLUSIONS: Attrition over 4 years was influenced by sociodemographic, clinical, and psychological factors that can be readily identified at study entry. Recruitment and retention strategies targeting these factors may improve participant follow-up in longitudinal cardiovascular prevention studies.
Annals of epidemiology 03/2013; · 2.95 Impact Factor
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Heart Lung & Circulation 01/2013; · 1.20 Impact Factor
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Suresh R Mulukutla,
Oscar C Marroquin,
Helen A Vlachos,
Faith Selzer,
Catalin Toma, Kevin E Kip,
J Dawn Abbott,
Elizabeth Holper,
Joon S Lee,
Sameer Khandhar,
Michael Kutcher,
Sheryl Kelsey,
Conrad Smith,
David Faxon,
David O Williams
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ABSTRACT: The optimal duration of dual-antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is an important, unanswered question. This study was designed to evaluate the association of varying durations of DAPT on clinical outcomes after DES implantation for the treatment of coronary artery disease. Using the National Heart, Lung, and Blood Institute Dynamic Registry, patients enrolled in the last 2 waves after index percutaneous coronary intervention with DES and who were event free at the time of landmark analysis were included. Landmark analysis was performed 12 and 24 months after percutaneous coronary intervention, and patients were stratified according to continued use of DAPT or not. Subjects were evaluated for rates of death, myocardial infarction, and stent thrombosis at 4 years from their index procedures. The numbers of evaluable patients were 2,157 and 1,918 for the 12- and 24-month landmarks, respectively. In both landmark analyses, there was a significantly lower 4-year rate of death or myocardial infarction in the group that continued DAPT compared to the group that did not (12 months: 10.5% vs 14.5%, p = 0.01; 24 months: 5.7% vs 8.6%, p = 0.02). Beneficial differences in the group that continued on DAPT were preserved after multivariate and propensity adjustment. There were no significant differences in definite stent thrombosis in either landmark analysis. In conclusion, at 12 and 24 months after DES implantation, continued use of DAPT was associated with lower 4-year risk for death and myocardial infarction.
The American journal of cardiology 12/2012; · 3.58 Impact Factor
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Cecile A Lengacher,
Melissa M Shelton,
Richard R Reich,
Michelle K Barta,
Versie Johnson-Mallard,
Manolete S Moscoso,
Carly Paterson,
Sophia Ramesar,
Pinky Budhrani,
Irina Carranza,
Jean Lucas,
Paul B Jacobsen,
Matthew J Goodman, Kevin E Kip
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ABSTRACT: To investigate the mechanism(s) of action of mindfulness based stress reduction (MBSR(BC)) including reductions in fear of recurrence and other potential mediators. Eighty-two post-treatment breast cancer survivors (stages 0-III) were randomly assigned to a 6-week MBSR(BC) program (n = 40) or to usual care group (UC) (n = 42). Psychological and physical variables were assessed as potential mediators at baseline and at 6 weeks. MBSR(BC) compared to UC experienced favorable changes for five potential mediators: (1) change in fear of recurrence problems mediated the effect of MBSR(BC) on 6-week change in perceived stress (z = 2.12, p = 0.03) and state anxiety (z = 2.03, p = 0.04); and (2) change in physical functioning mediated the effect of MBSR(BC) on 6-week change in perceived stress (z = 2.27, p = 0.02) and trait anxiety (z = 1.98, p = 0.05). MBSR(BC) reduces fear of recurrence and improves physical functioning which reduces perceived stress and anxiety. Findings support the beneficial effects of MBSR(BC) and provide insight into the possible cognitive mechanism of action.
Journal of Behavioral Medicine 11/2012; · 3.10 Impact Factor
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ABSTRACT: BACKGROUND:: Heart rate recovery (HRR) after exercise cessation is thought to reflect the rate of reestablishment of parasympathetic tone. Relatively little research has focused on improved HRR in women after completing cardiac rehabilitation (CR) exercise training. OBJECTIVE:: We examined the influence of exercise training on HRR in women completing a traditional CR program and in women completing a CR program tailored for women. METHODS:: A 2-group randomized clinical trial compared HRR between 99 women completing a traditional 12-week CR program and 137 women completing a tailored CR program. Immediately upon completion of a symptom-limited graded exercise test, HRR was measured at 1 through 6 minutes. RESULTS:: Compared with baseline, improvement in 1-minute HRR (HRR1) was similar (P = 0.777) between the tailored (mean [SD], 17.5 [11] to 19.1 [12]) and the traditional CR program (15.7 [9.0] to 16.9 [9.5]). The amount of change in the 2-minute HRR (HRR2) for the tailored (30 [13] to 32.8 [14.6]) and traditional programs (28.3 [12.8] to 31.2 [13.7]) also was not different (P = 0.391). Similar results were observed for HRR at 3 through 6 minutes. Given these comparable improvements of the 2 programs, in the full cohort, the factors independently predictive of post-CR HRR1, in rank order, were baseline HRR1 (part correlation, 0.35; P < 0.001); peak exercise capacity, estimated as metabolic equivalents (METs; 0.24, P < 0.001); anxiety (-0.17, P = 0.001); and age (-0.13, P = 0.016). The factors independently associated with post-CR HRR2 were baseline HRR2 (0.44, P < 0.001), peak METs (0.21, P < 0.001), and insulin use (-0.10, P = 0.041). CONCLUSIONS:: One to 6 minutes after exercise cessation, HRR was significantly improved among the women completing both CR programs. The modifiable factors positively associated with HRR1 included peak METs and lower anxiety, whereas HRR2 was associated with insulin administration and peak METs. Additional research on HRR after exercise training in women is warranted.
The Journal of cardiovascular nursing 11/2012; · 1.43 Impact Factor
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Richard Sheppard,
Paul J Mather,
Jeffrey D Alexis,
Randall C Starling,
John P Boehmer,
Vinay Thohan,
Daniel F Pauly,
David W Markham,
Mark Zucker, Kevin E Kip,
Dennis M McNamara
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ABSTRACT: Given the potential for recovery in recent onset nonischemic cardiomyopathy (ROCM), the timing and need for implantable cardioverter-defibrillator (ICDs) remains controversial. We examined the utilization of ICDs and the impact on survival for subjects with ROCM.
An National Heart, Lung, and Blood Institute sponsored registry enrolled 373 subjects with ROCM, all with a left ventricular ejection fraction (LVEF) ≤0.40 and ≤6 months of symptoms. The mean age was 45 ± 14 years, 38% were female, 21% black, 75% New York Heart Association II/III, and the mean LVEF was 0.24 ± 0.08. Survival was comparable for subjects with an ICD within 1 month of entry (n = 43, 1/2/3 year % survival = 97/97/92) and those with no ICD at 1 month (n = 330, % survival = 98/97/95, P = .30) and between those with and without an ICD at 6 months (ICD, n = 73, 1/2/3 year % survival = 98/98/95; no ICD, n = 300, % survival = 98/96/95, P = .95). There were only 6 sudden cardiac deaths (SCD) noted (% survival free from SCD = 99/98/97) and these occurred in 1.9% of subjects without ICD and 0.9% of those with a device (P = .50).
In a multicenter cohort of ROCM the risk of SCD was low at 1% per year. Early ICD placement did not impact survival and can be deferred while assessing potential for myocardial recovery.
Journal of cardiac failure 09/2012; 18(9):675-81. · 3.25 Impact Factor
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Rachel H Mackey,
Theresa J Fanelli,
Francesmary Modugno,
Jane A Cauley,
Kathleen M McTigue,
Maria Mori Brooks,
Rowan T Chlebowski,
Joann E Manson,
Thomas L Klug, Kevin E Kip,
J David Curb,
Lewis H Kuller
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ABSTRACT: BACKGROUND: In the Women's Health Initiative Hormone Trials (WHI-HT), breast cancer risk was increased with estrogen plus progestin (E+P) but not with unopposed estrogen (E-alone). We hypothesized that E+P would preferentially metabolize to 16α-hydroxyestrone (16α-OHE1) rather than 2-hydroxyestrone (2-OHE1), and that breast cancer risk would be associated with baseline and 1 year changes in estrogen metabolites: positively for 16α-OHE1 levels and negatively for levels of 2-OHE-1 and the 2:16 ratio.METHODS: In a prospective case-control study nested in the WHI-HT, 845 confirmed breast cancer cases were matched to 1,690 controls by age and ethnicity. Using stored serum, 2-OHE1 and 16α-OHE1 levels were measured by enzyme immunoassay at baseline, and for those randomized to active treatment (n = 1,259), at 1 year.RESULTS: The 1-year increase in 16α-OHE1 was greater with E+P than E-alone (median 55.5 pg/mL vs. 43.5 pg/mL, P < 0.001), but both increased 2-OHE1 by ∼300 pg/mL. Breast cancer risk was modestly associated with higher baseline levels of 2-OHE1 and the 2:16 ratio, and for estrogen receptor+/progesterone+ cases only, higher baseline 16α-OHE1 levels. For those randomized to active treatment, breast cancer risk was associated with greater increase in 2-OHE-1 and the 2:16 ratio, but associations were not significant.CONCLUSIONS: Although E+P modestly increased 16α-OHE1 more than E-alone, increase in 16α-OHE1 was not associated with breast cancer.Impact: Study results do not explain differences between the WHI E+P and WHI E-alone breast cancer results but metabolism of oral HT, which may explain smaller than expected increase in breast cancer compared with endogenous estrogens. Cancer Epidemiol Biomarkers Prev; 1-11. ©2012 AACR.
Cancer Epidemiology Biomarkers & Prevention 08/2012; · 4.12 Impact Factor
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ABSTRACT: Large epidemiologic studies examining differences in cardiovascular disease (CVD) risk factor profiles between European Americans and African Americans have exclusively used self-identified race (SIR) to classify individuals. Recent genetic epidemiology studies of some CVD risk factors have suggested that biogeographic ancestry (BGA) may be a better predictor of CVD risk than SIR. This hypothesis was investigated in 464 African Americans and 771 European Americans enrolled in the Heart Strategies Concentrating on Risk Evaluation (Heart SCORE) Study in March and April 2010. Individual West African and European BGA were ascertained by means of a panel of 1,595 genetic ancestry informative markers. Individual BGA varied significantly among African Americans and to a lesser extent among European Americans. In the total cohort, BGA was not found to be a better predictor of CVD risk factors than SIR. Both measures predicted differences in the presence of the metabolic syndrome, waist circumference, triglycerides, body mass index, very low density lipoprotein cholesterol, lipoprotein A, and systolic and diastolic blood pressure between European Americans and African Americans. These results suggest that for most nongenetic cardiovascular epidemiology studies, SIR is sufficient for predicting CVD risk factor differences between European Americans and African Americans. However, higher body mass index and diastolic blood pressure were significantly associated with West African BGA among African Americans, suggesting that BGA should be considered in genetic cardiovascular epidemiology studies carried out among African Americans.
American journal of epidemiology 07/2012; 176(2):146-55. · 5.59 Impact Factor
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ABSTRACT: Data on the potential effect of metformin on the risk of liver cancer are limited and inconsistent.
The objective of this study was to review the evidence currently available to examine the potential role of metformin in chemoprevention for liver cancer in patients with type 2 diabetes.
The data sources of the study included the PubMed and SciVerse Scopus databases.
Selection included studies that assessed the effect of metformin therapy on the risk of liver cancer in patients with type 2 diabetes.
Summary effect estimates were derived using a random-effects meta-analysis model.
A database was developed on the basis of five studies consisting of approximately 105,495 patients with type 2 diabetes. In meta-analyses, metformin was associated with an estimated 62% reduction in the risk of liver cancer among patients with type 2 diabetes (odds ratio 0.38, 95% confidence interval 0.24, 0.59; P < 0.001). The effect estimates were heterogeneous across the five included studies (P for heterogeneity = 0.001; I(2) = 78%). When restricting the analysis to the four studies related to hepatocellular carcinoma, metformin was again associated with a significantly lower cancer risk (odds ratio 0.30, 95% confidence interval 0.17, 0.52; P < 0.001), and there was evidence of significant heterogeneity between these four studies (P for heterogeneity = 0.03; I(2) = 67%).
Metformin appears to be associated with a lower risk of liver cancer in patients with type 2 diabetes. Further investigation, including mechanistic studies, well-designed cohort studies, and possibly controlled trials, is needed.
The Journal of clinical endocrinology and metabolism 04/2012; 97(7):2347-53. · 6.50 Impact Factor
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Cecile A Lengacher, Kevin E Kip,
Michelle Barta,
Janice Post-White,
Paul B Jacobsen,
Maureen Groer,
Brandy Lehman,
Manolete S Moscoso,
Rajendra Kadel,
Nancy Le,
Loretta Loftus,
Craig A Stevens,
Mokenge P Malafa,
Melissa Molinari Shelton
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ABSTRACT: Purpose: To investigate whether a mindfulness-based stress reduction program for cancer (MBSR-C) improved psychological and physical symptoms, quality of life (QOL), and stress markers among advanced-stage cancer patients and caregivers. Design: A pilot within-subject design was used. Method: Patients previously diagnosed with advanced-stage breast, colon, lung, or prostate cancer and on treatment were recruited from the Moffitt Cancer Center and Research Institute. Twenty-six patient-caregiver dyads completed a modified 6-week, self-study MBSR-C program based on the Kabat-Zinn model. Psychological and physical symptoms and QOL were compared pre- and post-MBSR-C sessions. Salivary cortisol and interleukin-6 were assessed pre- and post-MBSR-C session at 1, 3, and 6 weeks. Findings: Following the 6-week MBSR program, patients showed improvements in stress and anxiety (p < .05); caregivers' psychological and QOL also improved but were not statistically significant. Both patients and caregivers had decreases in cortisol at Weeks 1 and 3 (p < .05) but not at Week 6. Similar to cortisol levels at Week 6, salivary interleukin-6 levels were lower overall (before/after an MBSR-C session), compared with Week 1 for patients and caregivers. Conclusions: MBSR-C may be a beneficial intervention for reducing stress, anxiety, cortisol levels, and symptoms in advanced-stage cancer patients and may also benefit caregivers.
Journal of Holistic Nursing 03/2012; 30(3):170-85.
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Journal of the American College of Cardiology 02/2012; 59(8):776-7. · 14.16 Impact Factor
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ABSTRACT: Sleep apnea has been implicated as an independent risk factor for atherosclerotic coronary artery disease (CAD). An association between the severity of sleep apnea and total cholesterol levels has previously been reported. However, the association with small dense low density lipoprotein (LDL) cholesterol concentration (subclass B), one of the strongest predictors of atherosclerosis, is unknown. We examined the relationship between sleep apnea and LDL subclass B, considering body size.
This is a cross-sectional observational cohort of participants enrolled in a cardiovascular health study. Sleep apnea was assessed with a validated portable monitor. Lipid panels included total cholesterol, triglycerides, high density lipoprotein cholesterol, LDL cholesterol, and LDL subclasses A, B, and A/B. Sleep apnea was analyzed categorically using the apnea hypopnea index (AHI).
A total of 519 participants were evaluated. Mean age was 58.7 ± 7.4 years; BMI was 29.6 ± 5.7; 65% were female; 59% were Caucasian, and 37% were African American. Among participants with abnormal waist circumference by ATP III criteria, moderate to severe sleep apnea (AHI ≥ 25) was not independently associated with LDL subclass B. In contrast, among participants with normal waist circumference, moderate to severe sleep apnea was associated with 4.5-fold odds of having LDL subclass B.
Sleep apnea is independently associated with an atherogenic phenotype (LDL subclass B) in non-obese individuals. The association between sleep apnea and LDL subclass B in those with normal waist circumference may account, in part, for the increased risk of atherosclerosis and subsequent vascular events.
Journal of clinical sleep medicine: JCSM: official publication of the American Academy of Sleep Medicine 01/2012; 8(2):155-61. · 3.23 Impact Factor
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ABSTRACT: Percutaneous coronary intervention (PCI) for protected left main coronary artery (PLM) disease is complex because of patient and lesion factors; however, limited data exist on the outcomes of drug-eluting stent (DES) use for this indication. DEScover is a prospective observational study that enrolled consecutive patients with PCI in 2005. In-hospital and 1-year statuses were analyzed for 6,172 patients treated with DES according to LM and coronary artery bypass grafting (CABG) statuses (PLM, n = 93; previous CABG native vessel non-LM, n = 722; no previous CABG, n = 5,357). Cumulative event rates were calculated by the Kaplan-Meier method. Cox proportional hazards regression was used for multivariable analysis of adverse events. Baseline clinical, angiographic, and procedural variables differed significantly among groups, with patients with previous CABG, PLM, and non-LM having higher risk characteristics. In patients with previous CABG, after adjustment with CABG non-LM as a reference group, there were no significant differences in 1-year risk of any adverse event except a trend toward a greater risk of myocardial infarction (MI) in patients with PLM (adjusted hazard ratio 2.4, confidence interval 0.95 to 6.2, p = 0.06). However, patients after CABG (PLM and non-LM) compared to patients without previous CABG had a similar adjusted risk of death, MI, and stent thrombosis; an increased risk of target lesion revascularization (adjusted hazard ratio 1.79, confidence interval 1.2 to 2.6, p = 0.003), target vessel revascularization and death/MI/target vessel revascularization; and a lower risk of CABG (adjusted hazard ratio 0.25, confidence interval 0.09 to 0.67, p = 0.006). In conclusion, status after CABG rather than PLM location increases the risk of repeat revascularization with PCI in DES-treated patients.
The American journal of cardiology 11/2011; 109(4):466-70. · 3.58 Impact Factor
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Cecile A Lengacher, Kevin E Kip,
Janice Post-White,
Shirley Fitzgerald,
Cathy Newton,
Michelle Barta,
Paul B Jacobsen,
Melissa M Shelton,
Manolete Moscoso,
Versie Johnson-Mallard,
Eleanor Harris,
Loretta Loftus,
Charles Cox,
Nancy Le,
Matthew Goodman,
Julie Djeu,
Raymond H Widen,
Barry B Bercu,
Thomas W Klein
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ABSTRACT: Objectives. This randomized controlled trial was conducted to examine immune recovery following breast cancer (BC) therapy and evaluate the effect of mindfulness-based stress reduction therapy (MBSR) on immune recovery with emphasis on lymphocyte subsets, T cell activation, and production of T-helper 1 (Th1; interferon [IFN]-γ) and T-helper 2 (Th2; interleukin-4 [IL-4]) cytokines. Method. Participants who completed the study consisted of 82 patients diagnosed with Stage 0-III BC, who received lumpectomy and adjuvant radiation ± chemotherapy. Patients were randomized into an MBSR(BC) intervention program or a control (usual care) group. Immune cell measures were assessed at baseline and within 2 weeks after the 6-week intervention. The numbers and percentages of lymphocyte subsets, activated T cells, and Th1 and Th2 cells in peripheral blood samples were determined by immunostaining and flow cytometry. Results. Immune subset recovery after cancer treatment showed positive associations with time since treatment completion. The B and natural killer (NK) cells were more susceptible than T cells in being suppressed by cancer treatment. Women who received MBSR(BC) had T cells more readily activated by the mitogen phytohemagglutinin (PHA) and an increase in the Th1/Th2 ratio. Activation was also higher for the MBSR(BC) group if <12 weeks from the end of treatment and women in MBSR(BC) <12 weeks had higher T cell count for CD4(+). Conclusion. MBSR(BC) promotes a more rapid recovery of functional T cells capable of being activated by a mitogen with the Th1 phenotype, whereas substantial recovery of B and NK cells after completion of cancer treatment appears to occur independent of stress-reducing interventions.
Biological Research for Nursing 11/2011; · 1.28 Impact Factor
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ABSTRACT: Both in vitro and in vivo studies indicate that metformin inhibits cancer cell growth and reduces cancer risk. Recent epidemiological studies suggest that metformin therapy may reduce the risks of cancer and overall cancer mortality among patients with type 2 diabetes. However, data on its effect on colorectal cancer are limited and inconsistent. We therefore pooled data currently available to examine the association between metformin therapy and colorectal cancer among patients with type 2 diabetes.
The PubMed and SciVerse Scopus databases were searched to identify studies that examined the effect of metformin therapy on colorectal cancer among patients with type 2 diabetes. Summary effect estimates were derived using a random-effects meta-analysis model.
The analysis included five studies comprising 108,161 patients with type 2 diabetes. Metformin treatment was associated with a significantly lower risk of colorectal neoplasm (relative risk [RR] 0.63 [95% CI 0.50-0.79]; P < 0.001). After exclusion of one study that investigated colorectal adenoma, the remaining four studies comprised 107,961 diabetic patients and 589 incident colorectal cancer cases during follow-up. Metformin treatment was associated with a significantly lower risk of colorectal cancer (0.63 [0.47-0.84]; P = 0.002). There was no evidence for the presence of significant heterogeneity between the five studies (Q = 4.86, P = 0.30; I(2) = 18%).
From observational studies, metformin therapy appears to be associated with a significantly lower risk of colorectal cancer in patients with type 2 diabetes. Further investigation is warranted.
Diabetes care 10/2011; 34(10):2323-8. · 8.09 Impact Factor
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ABSTRACT: We sought to determine clinical and demographic predictors of recovery of left ventricular function for subjects with recent onset cardiomyopathy (ROCM).
Although ROCM is a frequent reason for consultation and transplantation referral, its prognosis and natural history on contemporary therapy are unknown.
In the multicenter IMAC (Intervention in Myocarditis and Acute Cardiomyopathy)-2 study, subjects with a left ventricular ejection fraction (LVEF) of ≤0.40, fewer than 6 months of symptom duration, and an evaluation consistent with idiopathic dilated cardiomyopathy or myocarditis were enrolled. LVEF was reassessed at 6 months, and subjects were followed up for 4 years. LVEF and event-free survival were compared by race, sex, and clinical phenotype.
The cohort of 373 persons was 38% female and 21% black, with a mean age of 45 ± 14 years. At entry, 91% were receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and 82% were receiving beta-blockers, which increased to 92% and 94% at 6 months. LVEF was 0.24 ± 0.08 at entry and 0.40 ± 0.12 at 6 months (mean increase: 17 ± 13 ejection fraction units). Transplant-free survival at 1, 2, and 4 years was 94%, 92%, and 88%, respectively; survival free of heart failure hospitalization was 88%, 82%, and 78%, respectively. In analyses adjusted for sex, baseline LVEF, and blood pressure, LVEF at 6 months was significantly lower in blacks than in nonblacks (p = 0.02). Left ventricular end-diastolic diameter at presentation was the strongest predictor of LVEF at 6 months (p < 0.0001).
Outcomes in ROCM are favorable but differ by race. Left ventricular end-diastolic diameter by transthoracic echo at presentation was most predictive of subsequent myocardial recovery. (Genetic Modulation of Left Ventricular Recovery in Recent Onset Cardiomyopathy; NCT00575211).
Journal of the American College of Cardiology 09/2011; 58(11):1112-8. · 14.16 Impact Factor
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Sandy M Green,
Faith Selzer,
Suresh R Mulukutla,
Edward J Tadajweski,
Jamie A Green,
Robert L Wilensky,
Warren K Laskey,
Howard A Cohen,
Sunil V Rao,
Steven D Weisbord,
Joon S Lee,
Steven E Reis, Kevin E Kip,
Sheryl F Kelsey,
David O Williams,
Oscar C Marroquin
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ABSTRACT: Patients with chronic kidney disease (CKD) have a disproportionate burden of coronary artery disease and commonly undergo revascularization. The role and safety of percutaneous coronary intervention (PCI) using drug-eluting stents (DESs) verses bare-metal stents in patients with CKD not on renal replacement therapy has not been fully evaluated. This study investigated the efficacy and safety of DES in patients with CKD not on renal replacement therapy. Patients were drawn from the National Heart, Lung, and Blood Institute Dynamic Registry and were stratified by renal function based on estimated glomerular filtration rate (GFR). Of the 4,157 participants, 1,108 had CKD ("low GFR" <60 ml/min/1.73 m(2)), whereas 3,049 patients had normal renal function ("normal GFR" ≥60 ml/min/1.73 m(2)). For each stratum of renal function we compared risk of death, myocardial infarction, or repeat revascularization between subjects who received DESs and bare-metal stents at the index procedure. Patients with low GFR had higher 1-year rates of death and myocardial infarction and a decreased rate of repeat revascularization compared to patients with normal GFR. Use of DESs was associated with a decreased need for repeat revascularization in the normal-GFR group (adjusted hazard ratio 0.63, 95% confidence interval 0.50 to 0.79, p <0.001) but not in the low-GFR group (hazard ratio 0.69, 95% confidence interval 0.45 to 1.06, p = 0.09). Risks of death and myocardial infarction were not different between the 2 stents in either patient population. In conclusion, presence of CKD predicted poor outcomes after PCI with high rates of mortality regardless of stent type. The effect of DES in decreasing repeat revascularization appeared to be attenuated in these patients.
The American journal of cardiology 09/2011; 108(11):1658-64. · 3.58 Impact Factor
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Miguel Regueiro,
Sandra El-Hachem, Kevin E Kip,
Wolfgang Schraut,
Leonard Baidoo,
Andrew Watson,
Jason Swoger,
Marc Schwartz,
Arthur Barrie,
Marilyn Pesci,
David Binion
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ABSTRACT: Infliximab is effective treatment for Crohn's disease and has been associated with rare, but serious infectious complications. Emerging data suggest a benefit of infliximab in preventing postoperative Crohn's disease recurrence. It is not known whether administration of infliximab shortly after resective surgery for Crohn's disease increases postoperative complications.
To evaluate the risk of developing postoperative complications among Crohn's disease patients receiving infliximab within 4 weeks of intestinal resection.
As part of a randomized placebo-controlled infliximab postoperative prevention study, adverse events were prospectively monitored. Crohn's disease patients undergoing intestinal resection were randomized to placebo or infliximab 2-4 weeks after surgery. Study infusions were administered at 0, 2, and 6 weeks then every 8 weeks for 1 year. To evaluate whether infliximab increased postoperative complications, we analyzed all adverse events for 1 year after surgery.
Twenty-four patients were randomized to infliximab or placebo after intestinal resection for Crohn's disease. Mean time to first postoperative infusion was 20 days (range 14-25 days). Over the course of 1 year, there were 22 total adverse events, but no difference between infliximab and placebo patients (12 versus 10, respectively, P = 1.0). In the immediate postoperative period, within 8 weeks of surgery, the number of adverse events was also similar between the two groups (3 infliximab and 5 placebo patients, P = 0.68). There were no serious adverse events and no complications related to wound healing or infection.
Initiation of infliximab within 4 weeks of intestinal resection was not associated with postoperative complications.
Digestive Diseases and Sciences 06/2011; 56(12):3610-5. · 2.12 Impact Factor
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ABSTRACT: Subjective physician assessment is the cornerstone of routine ulcerative colitis (UC) management. Endoscopic and histologic assessment of UC provides objective measures of inflammatory disease activity. The level of agreement between physician impression of UC activity and endoscopic disease activity has not been evaluated. The aim was to assess the level of agreement between physician's clinical impression of UC disease activity and endoscopic and histologic findings of inflammation.
Using the Medical Archival Retrieval System at the University of Pittsburgh Medical Center, we reviewed clinical information on all UC patients between 1995 and 2008 who had clinic visits recorded prior to colonoscopy. Clinical UC disease activity was defined by the physician's clinical impression and the endoscopic and histologic activity by colonoscopy with biopsy. The level of agreement between colonoscopy assessment of UC with histologic and clinical assessment was determined by sensitivity, specificity, positive and negative predictive values, and the kappa coefficient.
There were 369 UC patients who had a clinic visit proximate to a colonoscopy. The mean age of patients was 46 ± 16 years (50% female). The performance of clinical impression in recognizing disease activity, as determined by endoscopy, was relatively poor: sensitivity = 56.0%, predictive value negative = 56.8%, kappa coefficient = 0.35. In contrast, the performance of histological evaluation in recognizing disease activity was markedly better: sensitivity = 93.5%, predictive value negative = 89.1%, kappa coefficient = 0.70.
The physician's clinical impression of UC activity shows poor agreement with endoscopy and histology, with over one-third of patients with chronic inflammation underrecognized by clinical impression. The consequences of underestimated UC activity by clinical assessment may include undertreatment of active disease and uncontrolled chronic inflammation.
Inflammatory Bowel Diseases 04/2011; 17(4):1008-14. · 4.86 Impact Factor
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ABSTRACT: We sought to examine the determinants and outcomes of direct stenting (DS) compared to predilation with drug-eluting stents (DES).
Limited data suggest that DS with DES is feasible and may reduce restenosis compared to predilation. Whether DS improves clinical outcomes in unselected patients treated with DES is unknown.
DEScover is a prospective, multicenter, observational study of percutaneous coronary intervention that enrolled patients in 2005. The analysis cohort included 4,210 patients who received a DES and had a single lesion treated with DS (n = 1,651) or predilation (n = 2,559) at the discretion of the operator. Multivariable analysis was performed for 1-year outcomes.
DS was performed in 39.2% of patients. The direct stent patients were younger, less often male, and had a lesser extent of CAD. DS was performed less often in patients presenting with an acute myocardial infarction (MI) and more often in stable angina and elective procedures. Lesion characteristics differed with DS performed less often for calcified lesions, high-grade stenoses (>90%), and bifurcation lesions. Lesion postdilation was less common in direct stent patients (42.1% vs. 50.7%, P = 0.0001). Complete procedural success was similar (99.8% vs. predilation 99.7%, P = 0.46). At 1 year, there was no difference in the adjusted hazard ratios of death (0.67, 0.44-1.04, P = 0.08), MI (1.05, 0.66-1.67, P = 0.83), stent thrombosis (0.38, 0.13-1.14, P = 0.08), TLR (0.75, 0.48-1.17, P = 0.21), TVR (0.89, 0.64-1.23, P = 0.47), and major adverse coronary event (0.88, 0.71-1.09, P = 0.24).
DS with DES is commonly performed in clinical practice and results in similar long-term outcomes as predilation.
Catheterization and Cardiovascular Interventions 03/2011; 79(1):84-9. · 2.29 Impact Factor
