[Show abstract][Hide abstract] ABSTRACT: Coronary artery disease (CAD) is the major cause of death in patients with type 2 diabetes mellitus. Although demographic and clinical factors associated with extent of CAD in patients with diabetes mellitus have been described, genetic factors have not. We hypothesized that genetic variation in peroxisome proliferator-activated receptor (PPAR) pathway genes, important in diabetes mellitus and atherosclerosis, would be associated with extent of CAD in patients with diabetes mellitus.
We genotyped 1043 patients (702 white, 175 blacks) from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) genetic cohort for 3351 variants in 223 PPAR pathway genes using a custom targeted-genotyping array. Angiographic end points were determined by a core laboratory. In whites, a single variant (rs1503298) in TLL1 was significantly (P=5.5 × 10(-6)) associated with extent of CAD, defined as number of lesions with percent diameter stenosis ≥20%, after stringent Bonferroni correction for all 3351 single nucleotide polymorphisms. This association was validated in the diabetic subgroups of 2 independent cohorts, the Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status (TRIUMPH) post-myocardial infarction registry and the prospective Family Heart Study (FHS) of individuals at risk for CAD. TLL1rs1503298 was also significantly associated with extent of severe CAD (≥70% diameter stenosis; P=3.7 × 10(-2)) and myocardial jeopardy index (P=8.7 × 10(-4)). In general linear regression modeling, TLL1rs1503298 explained more variance of extent of CAD than the previously determined clinical factors.
We identified a variant in a single PPAR pathway gene, TLL1, that is associated with the extent of CAD independently of clinical predictors, specifically in patients with type 2 diabetes mellitus and CAD. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00006305.
[Show abstract][Hide abstract] ABSTRACT: We evaluated demographic, clinical, and angiographic factors influencing the selection of coronary artery bypass graft (CABG) surgery versus percutaneous coronary intervention (PCI) in diabetic patients with multivessel coronary artery disease (CAD) in the BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes) trial.
Factors guiding selection of mode of revascularization for patients with diabetes mellitus and multivessel CAD are not clearly defined.
In the BARI 2D trial, the selected revascularization strategy, CABG or PCI, was based on physician discretion, declared independent of randomization to either immediate or deferred revascularization if clinically warranted. We analyzed factors favoring selection of CABG versus PCI in 1,593 diabetic patients with multivessel CAD enrolled between 2001 and 2005.
Selection of CABG over PCI was declared in 44% of patients and was driven by angiographic factors including triple vessel disease (odds ratio [OR]: 4.43), left anterior descending stenosis >or=70% (OR: 2.86), proximal left anterior descending stenosis >or=50% (OR: 1.78), total occlusion (OR: 2.35), and multiple class C lesions (OR: 2.06) (all p < 0.005). Nonangiographic predictors of CABG included age >or=65 years (OR: 1.43, p = 0.011) and non-U.S. region (OR: 2.89, p = 0.017). Absence of prior PCI (OR: 0.45, p < 0.001) and the availability of drug-eluting stents conferred a lower probability of choosing CABG (OR: 0.60, p = 0.003).
The majority of diabetic patients with multivessel disease were selected for PCI rather than CABG. Preference for CABG over PCI was largely based on angiographic features related to the extent, location, and nature of CAD, as well as geographic, demographic, and clinical factors. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes [BARI 2D]; NCT00006305).
[Show abstract][Hide abstract] ABSTRACT: This report describes the baseline angiographic findings in the Bypass Angioplasty Revascularization Investigation (BARI) 2 Diabetes (BARI 2D) trial, a randomized study that was initiated after the original BARI trial (BARI 1). Unlike BARI 1, which compared coronary artery bypass graft surgery with coronary angioplasty (percutaneous coronary intervention) in patients with and without diabetes, BARI 2D is investigating early versus deferred revascularization as needed in selected patients with type 2 diabetes mellitus and significant stable coronary artery disease (CAD). This analysis included 1,773 patients without previous procedures. The intended mode of revascularization, percutaneous coronary intervention or coronary artery bypass graft surgery, was specified before randomization. Angiographic findings in those randomized to revascularization versus medical treatment were similar. Overall, the mean number of lesions >or=20% diameter stenosis was 4.6 +/- 2.3, and the myocardial jeopardy index was 46 +/- 24%. Patients selected for the coronary artery bypass graft stratum had a higher mean number of lesions >or=20% diameter stenosis (5.7 vs 4.0, p <0.0001) and a higher myocardial jeopardy index (61% vs 38%, p <0.0001) than those selected for the percutaneous coronary intervention stratum. Female gender, black race, and higher body mass index were associated with less extensive CAD, whereas a history of hypertension, age at entry, low-density lipoprotein cholesterol, and ankle-brachial index <or=0.9 were associated with more extensive CAD. In conclusion, BARI 2D patients, who by design have mild or no symptoms, demonstrate considerable variation in the extent of CAD and amount of jeopardized myocardium. Coronary arteriographic findings are consistent with the intent of the design of BARI 2D. Certain baseline and clinical features were associated with the extent of disease and myocardial jeopardy.
The American journal of cardiology 04/2009; 103(5):632-8. · 3.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The interpretations of 156 99mtechnetium pyrophosphate myocardial scintigrams by four observers were analyzed in order to determine the reliability and reproducibility of the subjective process of reading scintigrams. The scintigrams were scored on an integral scale from 0 to 4, depending upon the degree of myocardial radionuclide accumulation, and the site and nature of uptake were specified. Exact agreement upon score was generally poor but approximate concurrence of interpretation was good (90.4 and 92.5% inter- and intra-observer agreement, respectively). There was somewhat less agreement on scintigrams with the higher scores of 3 and 4 (83.3 and 78.0%, respectively). A high level of concurrence upon the differentiation between diffuse and localized uptake, and upon the site of uptake, was found. We conclude that only approximate rather than exact agreement of individual readers' interpretations can be expected in this subjective technique, that scintigrams with higher degrees of radionuclide accumulation produce slightly greater observer disagreement, and that variability of interpretation could account for some of the diagnostic inaccuracy of 99mtechnetium pyrophosphate myocardial scintigraphy.
[Show abstract][Hide abstract] ABSTRACT: The PAS-Port device (Cardica, Redwood City, CA) allows the rapid deployment of a clampless proximal anastomosis between a vein graft and the aorta.
Fifty-four patients awaiting elective coronary artery bypass graft surgery were enrolled. Outcome variables were intraoperative device performance, early and 6- month angiographic graft patency, and 12-month clinical follow-up.
Sixty-three PAS-Port devices were deployed in 54 patients. Two deployments were unsuccessful. There were no reoperations for bleeding. Two patients died of causes unrelated to the device. Patency evaluation at discharge was performed by angiogram on 49 implants and computed tomography in 2 implants (86% follow-up). At discharge, all evaluated grafts were patent (100%) and rated Fitzgibbon A. At 6-month follow-up, there was no additional mortality; 47 implants (88% follow-up) were evaluated by angiography (Fitzgibbon O [n = 1], Fitzgibbon B [n = 1], and Fitzgibbon A [n = 45]) and 5 by computed tomography. All grafts but 1 were patent (98.1%). At 12 months, 2 additional patients died of causes unrelated to the PAS-Port implant. Forty-six of 50 alive patients (95.8%) were followed up without any reports of device-related major adverse cardiac events.
Discharge (100%) and 6-month patency (98%) are excellent; patency and 12 months' clinical follow-up compares favorably with data from historical hand-sewn controls. The PAS-Port system safely allows the clampless creation of a proximal anastomosis.
The Annals of thoracic surgery 02/2006; 81(1):90-6. · 3.45 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The C-Port System (Cardica, Inc, Redwood City, Calif) integrates in one tool all functions necessary to enable rapid automated distal coronary anastomoses. The goal of this prospective, nonrandomized, and multicenter study is to determine the safety and efficacy of this novel anastomotic system.
Five centers enrolled 133 patients awaiting elective coronary artery bypass grafting surgery. Outcome variables were intraoperative device performance, incidence of device-related adverse events, predischarge and 6-month angiographic graft patency, and 12-month clinical outcome. Independent core laboratories performed qualitative and quantitative angiographic and computed tomographic assessments.
The C-Port was used to perform a vein-to-coronary anastomosis in 130 patients. Intraoperative conversion to a hand-sewn anastomosis was necessary in 11 patients because of inadequate target site preparation, inappropriate target vessel selection, or both. Inadequate blood flow related to poor runoff required conversion in 3 additional patients. Three patients died before discharge of causes unrelated to the device. At discharge, 113 patients had a C-Port implant in place, and 104 C-Port anastomoses were studied by means of angiography, resulting in 100 FitzGibbon A, 3 FitzGibbon B, and 1 FitzGibbon 0 classifications. At 6 months, one additional patient died of a device-unrelated cause, and 98 patients were evaluated by means of angiography (n = 89). Overall patency (FitzGibbon A) was 92.1%. Three C-Port anastomoses were rated FitzGibbon B, and 4 were rated FitzGibbon 0. At 12 months, 107 (98.2%) of 109 alive patients were followed up, without any reports of device-related major adverse cardiac events.
The C-Port System allows for a rapid, reliable, and compliant distal anastomosis and yields favorable 6-month angiographic and 12-month clinical results when compared with published studies.
The Journal of thoracic and cardiovascular surgery 01/2006; 130(6):1645-52. · 3.41 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Coronary angiograms obtained five years following revascularization were examined to assess the extent of compromise in myocardial perfusion due to failure of revascularization versus progression of native disease.
The Bypass Angioplasty Revascularization Investigation (BARI) randomized revascularization candidates between bypass surgery and angioplasty. Entry and five-year angiograms from 407 of 519 (78%) patients at four centers were analyzed.
Analysis of the distribution of coronary vessels and stenoses provided a measure of myocardial jeopardy that correlates with presence of angina. The extent to which initial benefits of revascularization were undone by failed revascularization versus native disease progression was assessed.
Myocardial jeopardy fell following initial revascularization, from 60% to 17% for percutaneous coronary intervention (PCI)-treated patients compared with 60% to 7% for coronary artery bypass graft (CABG) surgery patients (p < 0.001), rebounding at five years to 25% for PCI and 20% for surgery patients (p = 0.01). Correspondingly, angina prevalence was higher at five years in PCI-treated patients than in surgery-treated patients (28% vs. 18%; p = 0.03). However, myocardial jeopardy at five years, and not initial treatment (PCI vs. surgery), was independently associated with late angina. Increased myocardial jeopardy from entry to five-year angiogram occurred in 42% of PCI-treated patients and 51% of CABG-treated patients (p = 0.06). Among the increases in myocardial jeopardy, two-thirds occurred in previously untreated arteries.
Native coronary disease progression occurred more often than failed revascularization in both PCI- and CABG-treated patients as a cause of jeopardized myocardium and angina recurrence. These results support intensive postrevascularization risk-factor modification.
Journal of the American College of Cardiology 08/2004; 44(4):766-74. · 14.09 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Abnormal glucose tolerance (AGT; diabetes or impaired glucose tolerance) is associated with increased risk of cardiovascular disease, especially in women. Cardiovascular disease rates in women increase after menopause. The Women's Health Initiative found that postmenopausal hormone therapy (PHT) increased the risk of cardiovascular disease and that effects in diabetic women did not differ from those in women without diabetes. In this study, we hypothesized that PHT would have a worse effect on disease among women with AGT.
We randomly assigned 423 postmenopausal women with angiographically defined atherosclerosis (321 women had exit angiograms) with (n=140) or without (n=181) AGT to receive estrogen, estrogen plus progestin, or a placebo for 2.8+/-0.9 years. LDL was lower and HDL and triglycerides were higher after PHT in non-AGT and AGT women, but more adverse changes occurred in C-reactive protein and fibrinogen in women with AGT (P=0.11 and P=0.02 for interactions). PHT had no effect on fasting glucose or insulin concentrations in women without AGT, but in women with AGT, fasting glucose levels, insulin concentration, and insulin resistance as assessed by the HOMA (homeostasis model) calculation decreased slightly (P=0.28, P=0.25, P=0.14 for interaction, respectively). Atherosclerotic progression was greater in women with AGT. Atherosclerotic progression in previously nondiseased segments was enhanced by PHT to a greater extent in women with AGT (P=0.11 for interaction).
PHT is associated with a worsening of coronary atherosclerosis and exacerbation of the profile of inflammatory markers in women with AGT. Therefore, PHT is not warranted for use in diabetic women. Further study is needed to explore the improvement in insulin resistance and glycemia that appears to occur with PHT in women with AGT.
[Show abstract][Hide abstract] ABSTRACT: To evaluate the safety and effectiveness of a self-closing surgical clip with an interrupted technique in left internal thoracic artery to left anterior descending artery bypass grafting.
Eighty-two patients were enrolled and treated (February 2000 through August 2001) in a prospective, nonrandomized, multicenter trial. Left internal thoracic artery to left anterior descending artery anastomoses were performed in 60 off-pump coronary artery bypasses (73%), 12 conventional coronary artery bypass grafting (15%), and 10 minimally invasive direct coronary artery bypass (12%) procedures. Angiograms (64 to 383 days, mean 200 days) were obtained on 63 patients (77%). Qualitative and quantitative angiographic assessment was performed by an independent core laboratory.
The self-closing surgical clip was used for 82 left internal thoracic artery to left anterior descending artery interrupted anastomoses without the requirement for knot tying or primary suture management. Minimum left internal thoracic artery to left anterior descending artery anastomosis time was 3 minutes. There was one perioperative and one late death (both not heart related) and one reexploration for bleeding unrelated to the anastomotic site. FitzGibbon grades were as follows: A (n = 60, 95.2%), B (n = 3, 4.8%) including one kinked left internal thoracic artery, and O (n = 0, 0%). Quantitative analysis (n = 57) showed mean lumen diameters of left internal thoracic artery proximal to the anastomosis of 2.1 mm, at anastomosis of 2.0 mm, and in the left anterior descending artery distal to the anastomosis of 1.9 mm. The average ratio of the anastomosis to the left anterior descending artery diameter was 1.14 (0.45 to 1.93). Anastomotic stenosis as a percentage of average left internal thoracic artery to left anterior descending artery diameter was -2.3%, comparing favorably with results (23% to 24%) reported from the Patency, Outcomes, Economics, Minimally invasive direct coronary artery (POEM) bypass study.
The interrupted technique, facilitated by a self-closing anastomotic clip, yields favorable 6-month angiographic results when compared with other published studies.
Journal of Thoracic and Cardiovascular Surgery 08/2003; 126(1):168-77; discussion 177-8. · 3.53 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: LDLs include particle subclasses that have different mobilities on polyacrylamide gradient gels: LDL-I (27.2 to 28.5 nm), LDL-IIa (26.5 to 27.2 nm), LDL-IIb (25.6 to 26.5 nm), LDL-IIIa (24.7 to 25.6 nm), LDL-IIIb (24.2 to 24.7 nm), LDL-IVa (23.3 to 24.2 nm), and LDL-IVb (22.0 to 23.3 nm in diameter). We hypothesized that the association between smaller LDL particles and coronary artery disease (CAD) risk might involve specific LDL subclasses.
Average 4-year onstudy lipoprotein measurements were compared with annualized rates of stenosis change from baseline to 4 years in 117 men with CAD. The percentages of total LDL and HDL occurring within individual subclasses were measured by gradient gel electrophoresis. Annual rate of stenosis change was related concordantly to onstudy averages of total cholesterol (P=0.04), triglycerides (P=0.05), VLDL mass (P=0.03), total/HDL cholesterol ratio (P=0.04), LDL-IVb (P=0.01), and HDL(3a) (P=0.02) and inversely to HDL(2)-mass (P=0.02) and HDL(2b) (P=0.03). The average annual rate in stenosis change was 6-fold more rapid in the fourth quartile of LDL-IVb (>or=5.2%) than in the first quartile (<2.5%, P=0.03). Stepwise multiple regression analysis showed that LDL-IVb was the single best predictor of stenosis change.
LDL-IVb was the single best lipoprotein predictor of increased stenosis, an unexpected result, given that LDL-IVb represents only a minor fraction of total LDL.
[Show abstract][Hide abstract] ABSTRACT: The Women's Angiographic Vitamin and Estrogen trial was a randomized, double-blind, placebo-controlled study designed to test the efficacy of estrogen replacement and antioxidant vitamins for preventing angiographic progression of coronary artery disease. Postmenopausal women with one or more angiographically documented coronary stenoses of 15-75% at baseline were assigned in a 2 x 2 factorial randomization to active hormone replacement therapy (conjugated estrogens for women who had had a hysterectomy or conjugated estrogens with medroxyprogesterone for women with intact uteri) or placebo and to active vitamins E and C or their placebos. Seven clinical centers, five in the United States and two in Canada, randomized 423 women between July 1997 and July 1999. Quantitative coronary angiography was performed at baseline and repeated after projected mean follow-up of 3 years.
[Show abstract][Hide abstract] ABSTRACT: Context
Hormone replacement therapy (HRT) and antioxidant vitamins are widely
used for secondary prevention in postmenopausal women with coronary disease,
but no clinical trials have demonstrated benefit to support their use.Objective
To determine whether HRT or antioxidant vitamin supplements, alone or
in combination, influence the progression of coronary artery disease in postmenopausal
women, as measured by serial quantitative coronary angiography.Design, Setting, and Patients
The Women's Angiographic Vitamin and Estrogen (WAVE) Trial, a randomized,
double-blind trial of 423 postmenopausal women with at least one 15% to 75%
coronary stenosis at baseline coronary angiography. The trial was conducted
from July 1997 to January 2002 in 7 clinical centers in the United States
Patients were randomly assigned in a 2 × 2 factorial design to
receive either 0.625 mg/d of conjugated equine estrogen (plus 2.5 mg/d of
medroxyprogesterone acetate for women who had not had a hysterectomy), or
matching placebo, and 400 IU of vitamin E twice daily plus 500 mg of vitamin
C twice daily, or placebo.Main Outcome Measure
Annualized mean (SD) change in minimum lumen diameter (MLD) from baseline
to concluding angiogram of all qualifying coronary lesions averaged for each
patient. Patients with intercurrent death or myocardial infarction (MI) were
imputed the worst rank of angiographic outcome.Results
The mean (SD) interval between angiograms was 2.8 (0.9) years. Coronary
progression, measured in mean (SD) change, worsened with HRT by 0.047 (0.15)
mm/y and by 0.024 (0.15) mm/y with HRT placebo (P =
.17); and for antioxidant vitamins by 0.044 (0.15) mm/y and with vitamin placebo
by 0.028 (0.15) mm/y (P = .32). When patients with
intercurrent death or MI were included, the primary outcome showed an increased
risk for women in the active HRT group (P = .045),
and suggested an increased risk in the active vitamin group (P = .09). Fourteen patients died in the HRT group and 8 in the HRT
placebo group (hazard ratio [HR], 1.8; 95% confidence interval [CI], 0.75-4.3),
and 16 in the vitamin group and 6 in the vitamin placebo group (HR, 2.8; 95%
CI, 1.1-7.2). Death, nonfatal MI, or stroke occurred in 26 HRT patients vs
15 HRT controls (HR, 1.9; 95% CI, 0.97-3.6) and in 26 vitamin patients and
18 vitamin controls (HR, 1.5; 95% CI, 0.80-2.9). There was no interaction
between the 2 treatment interventions.Conclusion
In postmenopausal women with coronary disease, neither HRT nor antioxidant
vitamin supplements provide cardiovascular benefit. Instead, a potential for
harm was suggested with each treatment.
Figures in this Article
In numerous observational studies over the past 30 years, postmenopausal
estrogen replacement therapy, with or without a progestin, has been consistently
associated with a reduced risk of coronary events, both in women with and
without evidence of coronary disease.1- 5 Estrogen
exerts beneficial effects on blood lipids, low-density lipoprotein (LDL) oxidation,
vascular function, and on some aspects of the coagulation system.6 Yet hormone replacement therapy (HRT) was not shown
to be beneficial in the only 2 randomized, placebo-controlled trials of postmenopausal
women with coronary disease.7- 9 Furthermore,
the only large primary prevention trial of HRT reported to date, the Women's
Health Initiative, was stopped prematurely because overall risk exceeded benefit,
including an increased risk of nonfatal myocardial infarction (MI) and coronary
death, which was the study's primary outcome.10 As
a result of this discrepancy between clinical trial results and other evidence,
guidelines do not offer consistent, explicit recommendations for the use of
this therapy in postmenopausal women.11
Like HRT, antioxidant consumption, either dietary or in the form of
vitamin supplements, has been associated with a reduced risk of coronary disease
in epidemiological studies.12- 16 In
a coronary angiographic trial, participants who took supplemental vitamin
E (not as part of the trial) demonstrated less lesion progression.17 Theoretically, antioxidants inhibit a key component
of atherogenesis (oxidation of LDL cholesterol within the vessel wall), and
other mechanisms have been demonstrated in animal experiments, including preservation
of nitric oxide activity, inhibition of leukocyte adhesion, reduction of cellular
oxidative injury, and inhibition of platelet adhesion.18
Five randomized, placebo-controlled trials of vitamin E in patients
with or at risk for coronary disease have been completed,19- 23 and
all but the smallest and shortest20 reported
no benefit. Although the antioxidant effects of vitamins E and C may be synergistic,
vitamin C was combined with vitamin E in only 1 of these trials.23 In
addition to inhibiting LDL oxidation through a variety of mechanisms, vitamin
C also exhibits other anti-atherosclerotic effects in animal models.24
To study possible benefits left unexplored by previous studies, the
Women's Angiographic Vitamin and Estrogen (WAVE) Trial tested the combination
of relatively high doses of vitamins E and C. Patients were randomized to
HRT and/or antioxidant vitamins in a placebo-controlled 2 × 2 factorial
design. The study population consisted of postmenopausal women with documented
coronary disease, and the end point was the change in minimum lumen diameter
(MLD) of qualifying coronary lesions.
JAMA The Journal of the American Medical Association 01/2003; 288(19):2432-2440. · 29.98 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Hormone replacement therapy (HRT) and antioxidant vitamins are widely used for secondary prevention in postmenopausal women with coronary disease, but no clinical trials have demonstrated benefit to support their use.
To determine whether HRT or antioxidant vitamin supplements, alone or in combination, influence the progression of coronary artery disease in postmenopausal women, as measured by serial quantitative coronary angiography.
The Women's Angiographic Vitamin and Estrogen (WAVE) Trial, a randomized, double-blind trial of 423 postmenopausal women with at least one 15% to 75% coronary stenosis at baseline coronary angiography. The trial was conducted from July 1997 to January 2002 in 7 clinical centers in the United States and Canada.
Patients were randomly assigned in a 2 x 2 factorial design to receive either 0.625 mg/d of conjugated equine estrogen (plus 2.5 mg/d of medroxyprogesterone acetate for women who had not had a hysterectomy), or matching placebo, and 400 IU of vitamin E twice daily plus 500 mg of vitamin C twice daily, or placebo.
Annualized mean (SD) change in minimum lumen diameter (MLD) from baseline to concluding angiogram of all qualifying coronary lesions averaged for each patient. Patients with intercurrent death or myocardial infarction (MI) were imputed the worst rank of angiographic outcome.
The mean (SD) interval between angiograms was 2.8 (0.9) years. Coronary progression, measured in mean (SD) change, worsened with HRT by 0.047 (0.15) mm/y and by 0.024 (0.15) mm/y with HRT placebo (P =.17); and for antioxidant vitamins by 0.044 (0.15) mm/y and with vitamin placebo by 0.028 (0.15) mm/y (P =.32). When patients with intercurrent death or MI were included, the primary outcome showed an increased risk for women in the active HRT group (P =.045), and suggested an increased risk in the active vitamin group (P =.09). Fourteen patients died in the HRT group and 8 in the HRT placebo group (hazard ratio [HR], 1.8; 95% confidence interval [CI], 0.75-4.3), and 16 in the vitamin group and 6 in the vitamin placebo group (HR, 2.8; 95% CI, 1.1-7.2). Death, nonfatal MI, or stroke occurred in 26 HRT patients vs 15 HRT controls (HR, 1.9; 95% CI, 0.97-3.6) and in 26 vitamin patients and 18 vitamin controls (HR, 1.5; 95% CI, 0.80-2.9). There was no interaction between the 2 treatment interventions.
In postmenopausal women with coronary disease, neither HRT nor antioxidant vitamin supplements provide cardiovascular benefit. Instead, a potential for harm was suggested with each treatment.
JAMA The Journal of the American Medical Association 12/2002; 288(19):2432-40. · 29.98 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Few studies have compared long-term status of bypass grafts between patients with and without diabetes, and uncertainty exists as to whether diabetes independently predicts poor clinical outcome after CABG.
Among 1526 patients in BARI who underwent CABG as initial revascularization, 99 of 292 (34%) with treated diabetes mellitus (TDM) (those on insulin or oral hypoglycemic agents) and 469 of 1234 (38%) without TDM had follow-up angiography. Angiograms with the longest interval from initial surgery and before any percutaneous graft intervention (mean 3.9 years) were reviewed. An average of 3.0 grafts were placed at initial CABG for patients with TDM (n=297; internal mammary artery [IMA], 33%) and 2.9 grafts for patients without TDM (n=1347; IMA, 34%). Patients with TDM were more likely than those without to have small (<1.5 mm) grafted distal vessels (29% versus 22%) and vessels of poor quality (9% versus 6%). On follow-up angiography, 89% of IMA grafts were free of stenoses > or =50% among patients with TDM versus 85% among patients without TDM (P=0.23). For vein grafts, the corresponding percentages were 71% versus 75% (P=0.40). After statistical adjustment, TDM was unrelated to having a graft stenosis > or =50% (adjusted odds ratio, 0.87; 95% CI, 0.58 to 1.32).
Despite diabetic patients' having smaller distal vessels and vessels judged to be of poorer quality, diabetes does not appear to adversely affect patency of IMA or vein grafts over an average of 4-year follow-up. Previously observed differences in survival between CABG-treated patients with and without diabetes may be largely a result of differential risk of mortality from noncardiac causes.
[Show abstract][Hide abstract] ABSTRACT: Data are absent that compare midterm angiographic outcome between patients with and without diabetes after initial percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass graft surgery (CABG). Importantly, diabetes mellitus may differentially influence long-term survival after PTCA or CABG.
Patients with multivessel coronary disease who were previously enrolled in the Bypass Angiopathy Revascularization Investigation to compare initial PTCA versus CABG (n=1829) and who had a reduction in jeopardized myocardium after initial revascularization and at least 1 angiogram during 5-year follow-up were analyzed (n=897). This included 369 CABG-treated patients (16% with diabetes) and 528 PTCA-treated patients (18% with diabetes). The influence of diabetes on angiographic increase in percentage of jeopardized myocardium after initial revascularization with either PTCA or CABG was investigated. Among PTCA patients, the mean percentage increase in total jeopardized myocardium was significantly greater in those with diabetes than in those without at 1-year protocol-directed angiography (42% versus 24%, P=0.05) and on the first clinically performed (unscheduled) angiogram within 30 months (63% versus 50%, P=0.01) but not at 5-year protocol-directed angiography (34% versus 26%, P=0.33). This excess midterm risk associated with diabetes persisted after statistical adjustment. In contrast, among CABG patients, diabetes was not associated with percentage increase in jeopardized myocardium at any angiographic follow-up interval.
Presence of diabetes differentially influences worsening of jeopardized myocardium after initial PTCA compared with CABG. This differential effect occurs irrespective of whether follow-up angiography is undertaken for clinical or nonclinical purposes.
[Show abstract][Hide abstract] ABSTRACT: Interrupted suture technique avoids the "purse string" and puckering effects frequently seen with continuous suture techniques and should represent the standard of care in the creation of high-quality vascular anastomoses. This clinical study evaluated the safety and effectiveness of a self-closing surgical clip (Coalescent Surgical U-CLIP Anastomotic Device [U-CLIP]) designed to facilitate this interrupted technique. Left internal mammary artery (LIMA) to left anterior descending (LAD) coronary bypass grafting was studied.
Eighteen patients meeting inclusion criteria were enrolled (October 2000 through September 2001) into this prospective study. Anastomoses were performed using a beating-heart median sternotomy procedure (off-pump coronary artery bypass) in 17 cases (94%) and a minimally invasive beating-heart procedure (minimally invasive direct coronary artery bypass [MIDCAB]) in one case (6%). Six-month follow-up was completed on 18 patients (100%), with angiograms performed on 17 patients (94%) at a mean of 179 days (range, 168-191 days). Qualitative and quantitative angiographic assessment was performed by an independent core laboratory.
The U-CLIP was used for 18 LIMA-to-LAD interrupted anastomoses without the requirement for knot tying or suture management and with no device-related morbidity or mortality. Mean LIMA-to-LAD anastomosis time was 8.6 minutes (range, 5-14 minutes). All anastomoses were FitzGibbon grade A at 6 months postprocedure. Quantitative analysis showed mean luminal diameters proximal to the anastomosis of 2.32 mm, at the anastomosis of 2.25 mm, and immediately distal to anastomosis of 1.99 mm. The average ratio of anastomosis to LAD diameter was 1.17 (range, 0.93- 1.93). Anastomotic stenosis as a percentage of average LIMA/LAD diameter was a negative 4.2%, comparing favorably with the 23% to 24% reported in the POEM (Patency, Outcomes, Economics of MIDCAB) study.
The interrupted technique, facilitated by a self-closing anastomotic clip, yielded 6-month follow-up and angiographic results that compared favorably with results of other published studies.
The Heart Surgery Forum 02/2002; 5(4):319-26; discussion 327. · 0.46 Impact Factor