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Harvey D White,
Harmony R Reynolds,
Antonio C Carvalho,
Camille A Pearte,
Li Liu,
C Edwin Martin, Genell L Knatterud,
Vladimír Džavík,
Mariusz Kruk,
Philippe Gabriel Steg,
Warren J Cantor,
Venu Menon,
Gervasio A Lamas,
Judith S Hochman
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ABSTRACT: The OAT study randomized 2,201 patients with a totally occluded infarct-related artery on days 3 to 28 (>24 hours) after myocardial infarction (MI) to percutaneous coronary intervention (PCI) or medical treatment (MED). There was no difference in the primary end point of death, reinfarction, or heart failure at 2.9 or 6-year mean follow-up. However, in patients randomized to PCI, there was a trend toward a higher rate of reinfarction.
We analyzed the characteristics and types of reinfarction according to the universal definition. Independent predictors of reinfarction were determined using Cox proportional hazard models with follow-up up to 9 years.
There were 169 reinfarctions: 9.4% PCI vs 8.0% MED, hazard ratio 1.31, 95% CI 0.97-1.77, P = .08. Spontaneous reinfarction (type 1) occurred with similar frequency in the groups: 4.9% PCI vs 6.7% MED, hazard ratio 0.78, 95% CI 0.53-1.15, P = .21. Rates of type 2 (secondary) and 3 (sudden death) MI were similar in both groups. There was an increase in type 4a reinfarctions (related to protocol or other PCI) (0.8% PCI vs 0.1% MED, P = .01) and type 4b reinfarctions (stent thrombosis) (2.7% PCI vs 0.6% MED, P < .001). Multivariate predictors of reinfarction were history of PCI before study entry (P = .001), diabetes (P = .005), and absence of new Q waves with the index infarction (P = .01).
There was a trend for reinfarctions to be more frequent with PCI. Opening an occluded infarct-related artery in stable patients with late post-MI may expose them to a risk of subsequent reinfarction related to reocclusion and stent thrombosis.
American heart journal 04/2012; 163(4):563-71. · 4.65 Impact Factor
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Judith S Hochman,
Gervasio A Lamas,
Christopher E Buller,
Vladimir Dzavik,
Harmony R Reynolds,
Staci J Abramsky,
Sandra Forman,
Witold Ruzyllo,
Aldo P Maggioni,
Harvey White, [......],
Jamie M Rankin,
Jean P Renkin,
P Gabriel Steg,
Alice M Mascette,
George Sopko,
Matthias E Pfisterer,
Jonathan Leor,
Viliam Fridrich,
Daniel B Mark, Genell L Knatterud
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ABSTRACT: It is unclear whether stable, high-risk patients with persistent total occlusion of the infarct-related coronary artery identified after the currently accepted period for myocardial salvage has passed should undergo percutaneous coronary intervention (PCI) in addition to receiving optimal medical therapy to reduce the risk of subsequent events.
We conducted a randomized study involving 2166 stable patients who had total occlusion of the infarct-related artery 3 to 28 days after myocardial infarction and who met a high-risk criterion (an ejection fraction of <50% or proximal occlusion). Of these patients, 1082 were assigned to routine PCI and stenting with optimal medical therapy, and 1084 were assigned to optimal medical therapy alone. The primary end point was a composite of death, myocardial reinfarction, or New York Heart Association (NYHA) class IV heart failure.
The 4-year cumulative primary event rate was 17.2% in the PCI group and 15.6% in the medical therapy group (hazard ratio for death, reinfarction, or heart failure in the PCI group as compared with the medical therapy group, 1.16; 95% confidence interval [CI], 0.92 to 1.45; P=0.20). Rates of myocardial reinfarction (fatal and nonfatal) were 7.0% and 5.3% in the two groups, respectively (hazard ratio, 1.36; 95% CI, 0.92 to 2.00; P=0.13). Rates of nonfatal reinfarction were 6.9% and 5.0%, respectively (hazard ratio, 1.44; 95% CI, 0.96 to 2.16; P=0.08); only six reinfarctions (0.6%) were related to assigned PCI procedures. Rates of NYHA class IV heart failure (4.4% vs. 4.5%) and death (9.1% vs. 9.4%) were similar. There was no interaction between treatment effect and any subgroup variable (age, sex, race or ethnic group, infarct-related artery, ejection fraction, diabetes, Killip class, and the time from myocardial infarction to randomization).
PCI did not reduce the occurrence of death, reinfarction, or heart failure, and there was a trend toward excess reinfarction during 4 years of follow-up in stable patients with occlusion of the infarct-related artery 3 to 28 days after myocardial infarction. (ClinicalTrials.gov number, NCT00004562 [ClinicalTrials.gov].).
New England Journal of Medicine 12/2006; 355(23):2395-407. · 53.30 Impact Factor
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Vladimír Dzavík,
Christopher E Buller,
Gervasio A Lamas,
James M Rankin,
G B John Mancini,
Warren J Cantor,
Ronald J Carere,
John R Ross,
Deborah Atchison,
Sandra Forman, [......],
Pawel Buszman,
Carlos Vozzi,
Anthony Glanz,
Eric A Cohen,
Peter Meciar,
Gerald Devlin,
Alice Mascette,
George Sopko, Genell L Knatterud,
Judith S Hochman
[show abstract]
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ABSTRACT: In the present study, we sought to determine whether opening a persistently occluded infarct-related artery (IRA) by percutaneous coronary intervention (PCI) in patients beyond the acute phase of myocardial infarction (MI) improves patency and indices of left ventricular (LV) size and function.
Between May 2000 and July 2005, 381 patients with an occluded native IRA 3 to 28 days after MI (median 10 days) were randomized to PCI with stenting (PCI) or optimal medical therapy alone. Repeat coronary and LV angiography was performed 1 year after randomization (n=332, 87%). Coprimary end points were IRA patency and change in LV ejection fraction. Secondary end points included change in LV end-systolic and end-diastolic volume indices and wall motion. PCI was successful in 92%. At 1 year, 83% of PCI versus 25% of medical therapy-only patients had a patent IRA (P<0.001). LV ejection fraction increased significantly (P<0.001) in both groups, with no between-group difference: PCI 4.2+/-8.9 (n=150) versus medical therapy 3.5+/-8.2 (n=136; P=0.47). Median change (interquartile range) in LV end-systolic volume index was -0.5 (-9.3 to 5.0) versus 1.0 (-5.7 to 7.3) mL/m2 (P=0.10), whereas median change (interquartile range) in LV end-diastolic volume index was 3.2 (-8.2 to 13.3) versus 5.3 (-4.6 to 23.2) mL/m2 (P=0.07) in the PCI (n=86) and medical therapy-only (n=76) groups, respectively.
PCI with stenting of a persistently occluded IRA in the subacute phase after MI effectively maintains long-term patency but has no effect on LV ejection fraction. On the basis of these findings and the lack of clinical benefit in the main Occluded Artery Trial, routine PCI is not recommended for stable patients with a persistently occluded IRA after MI.
Circulation 12/2006; 114(23):2449-57. · 14.74 Impact Factor
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ABSTRACT: Experimental and clinical studies have suggested that late opening of an infarct-related artery (IRA) after myocardial infarction (MI) could improve clinical outcome. However, the suggestive observational data are limited by selection biases. Indeed, most small randomized studies have not demonstrated benefit. Thus, there is no recommendation for routine late opening of the IRA in current national guidelines for management of stable post-MI patients. The OAT is designed to test the hypothesis that opening a totally occluded IRA 3 to 28 days after MI in high-risk asymptomatic patients will improve clinical outcome and be cost-effective. The primary end point is the first occurrence of recurrent MI, hospitalization/treatment of New York Heart Association class IV congestive heart failure, or death. Trial background, design, and preliminary baseline characteristics of 2027 randomized patients are presented. Eligible patients are randomly assigned in equal proportions to optimal evidence-based medical care or optimal care plus late opening of the IRA using percutaneous coronary intervention of the occluded IRA. Treatment groups will be compared using intent-to-treat analysis. The results of OAT should have broad clinical impact by defining an evidence-based approach to the asymptomatic, high-risk, post-MI patient with an occluded IRA. If the efficacy and cost-effectiveness of percutaneous coronary intervention are established, then a policy of routinely seeking and opening persistently occluded IRAs could be advocated. If not, this strategy should be avoided in this large subgroup of post-MI patients.
American heart journal 11/2005; 150(4):627-42. · 4.65 Impact Factor
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Genell L. Knatterud
07/2005; , ISBN: 9780470011812
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Juliana Barnard,
Cecile Rose,
Lee Newman,
Martha Canner,
John Martyny,
Chuck McCammon,
Eddy Bresnitz,
Milt Rossman,
Bruce Thompson,
Benjamin Rybicki, [......],
Louis DePalo,
Robert P Baughman,
Michael C Iannuzzi,
Marc A Judson, Genell L Knatterud,
Alvin S Teirstein,
Henry Yeager,
Carol J Johns,
David L Rabin,
Reuben Cherniack
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ABSTRACT: To determine whether specific occupations and industries may be associated with sarcoidosis.
A Case Control Etiologic Study of Sarcoidosis (ACCESS) obtained occupational and environmental histories on 706 newly diagnosed sarcoidosis cases and matched controls. We used Standard Industrial Classification (SIC) and Standard Occupational Classification (SOC) to assess occupational contributions to sarcoidosis risk.
Univariable analysis identified elevated risk of sarcoidosis for workers with industrial organic dust exposures, especially in Caucasian workers. Workers for suppliers of building materials, hardware, and gardening materials were at an increased risk of sarcoidosis as were educators. Work providing childcare was negatively associated with sarcoidosis risk. Jobs with metal dust or metal fume exposures were negatively associated with sarcoidosis risk, especially in Caucasian workers.
In this study, we found that exposures in particular occupational settings may contribute to sarcoidosis risk.
Journal of Occupational and Environmental Medicine 04/2005; 47(3):226-34. · 2.06 Impact Factor
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ABSTRACT: Diabetes is a leading cause of morbidity and mortality. The purpose of this study is to assess the associations between diabetes complications and mortality in the Early Treatment Diabetic Retinopathy Study (ETDRS).
We examined demographic, clinical, and laboratory characteristics of the 3,711 subjects enrolled in the ETDRS, a randomized controlled clinical trial designed to evaluate the role of laser photocoagulation and aspirin therapy for diabetic retinopathy. The outcome assessed was all-cause mortality. Multivariable Cox proportional hazards regression was used to assess associations between diabetes complications and mortality for type 1 and type 2 diabetes separately.
The 5-year estimates of all-cause mortality were 5.5 and 18.9% for patients with type 1 and type 2 diabetes, respectively. In patients with type 1 diabetes, amputation (hazard ratio [HR] 5.08 [95% CI 2.06-12.54]) and poor visual acuity (1.74 [1.10-2.75]) remained significantly associated with mortality, after adjusting for other diabetes complications and baseline characteristics. In patients with type 2 diabetes, macrovascular disease and worsening levels of nephropathy, neuropathy, retinopathy, and visual acuity are associated with progressively increasing risks of mortality, after controlling for other baseline risk factors.
Amputation is the strongest predictor for mortality in patients with type 1 diabetes. All complications independently predict mortality in patients with type 2 diabetes. There is an increased risk for mortality as the degree of each complication worsens. Additional studies are needed to investigate the effectiveness of tertiary prevention to decrease mortality in these patients.
Diabetes Care 04/2005; 28(3):617-25. · 8.09 Impact Factor
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Lee S Newman,
Cecile S Rose,
Eddy A Bresnitz,
Milton D Rossman,
Juliana Barnard,
Margaret Frederick,
Michael L Terrin,
Steven E Weinberger,
David R Moller,
Geoffrey McLennan, [......],
Michael C Iannuzzi,
Marc A Judson, Genell L Knatterud,
Bruce W Thompson,
Alvin S Teirstein,
Henry Yeager,
Carol J Johns,
David L Rabin,
Benjamin A Rybicki,
Reuben Cherniack
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ABSTRACT: Past research suggests that environmental factors may be associated with sarcoidosis risk. We conducted a case control study to test a priori hypotheses that environmental and occupational exposures are associated with sarcoidosis. Ten centers recruited 706 newly diagnosed patients with sarcoidosis and an equal number of age-, race-, and sex-matched control subjects. Interviewers administered questionnaires containing questions regarding occupational and nonoccupational exposures that we assessed in univariable and multivariable analyses. We observed positive associations between sarcoidosis and specific occupations (e.g., agricultural employment, odds ratio [OR] 1.46, confidence interval [CI] 1.13-1.89), exposures (e.g., insecticides at work, OR 1.52, CI 1.14-2.04, and work environments with mold/mildew exposures [environments with possible exposures to microbial bioaerosols], OR 1.61, CI 1.13-2.31). A history of ever smoking cigarettes was less frequent among cases than control subjects (OR 0.62, CI 0.50-0.77). In multivariable modeling, we observed elevated ORs for work in areas with musty odors (OR 1.62, CI 1.24-2.11) and with occupational exposure to insecticides (OR 1.61, CI 1.13-2.28), and a decreased OR related to ever smoking cigarettes (OR 0.65, CI 0.51-0.82). The study did not identify a single, predominant cause of sarcoidosis. We identified several exposures associated with sarcoidosis risk, including insecticides, agricultural employment, and microbial bioaerosols.
American Journal of Respiratory and Critical Care Medicine 01/2005; 170(12):1324-30. · 11.08 Impact Factor
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ABSTRACT: To classify and describe clinically meaningful classes of color vision defects using pretreatment Farnsworth-Munsell 100-hue results from the Early Treatment Diabetic Retinopathy Study (ETDRS) patients using standard statistical techniques.
The ETDRS was a randomized trial investigating retinal photocoagulation and oral aspirin in diabetic retinopathy.
Farnsworth-Munsell (FM) 100-hue test was successfully administered before initiation of study treatment in each eye of 2701 of the 3711 ETDRS patients. Test results were converted into a Fourier series, classified by cluster analysis in the deferred-treatment group of eyes, and verified in the immediate-treatment group of eyes as separate samples.
Cluster analysis uncovered thirteen distinct patterns. Pattern A (51% or 1366 of the eyes) showed unimpaired hue discrimination and was comprised of younger patients with no or little macular edema. Pattern B eyes (10% or 262) showed generalized impairment of hue discrimination with no main axis defect. Patterns C (C1, C2, C3), comprising 26% (or 698) of the eyes, showed increasing severity of the yellow-blue diabetic retinopathy defect, associated with increasing mean age and increasing macular edema severity. Patterns D (D1, D2), comprising 6% (or 164) of the eyes, were similar to the C patterns but showed a stronger yellow-blue defect. Patterns E (E1, E2, E3), or approximately 2% (or 38) of the eyes and predominantly male, exhibited the expected pattern for congenital protan defect. Patterns F, G, and H, approximately 6% (or 153) of the eyes, showed distinct patterns of one-sided axes. The nomenclature is arbitrary.
Cluster analysis of FM 100-hue test results has found 13 patterns of impaired hue discrimination, helpful in understanding color vision defects in diabetes mellitus.
American Journal of Ophthalmology 08/2004; 138(1):119-24. · 4.22 Impact Factor
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Ruth Lindquist,
Gilles Dupuis,
Michael L Terrin,
Byron Hoogwerf,
Susan Czajkowski,
J Alan Herd,
Franca B Barton,
Mary Fran Tracy,
Donald B Hunninghake,
Diane Treat-Jacobson,
Sally Shumaker,
Steve Zyzanski,
Irvin Goldenberg, Genell L Knatterud
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ABSTRACT: Women undergoing coronary artery bypass graft (CABG) surgery have a worse medical condition and fewer social and financial resources than men. Some studies have found that women recover less well than men after CABG, whereas others have found women's outcomes comparable to those of men. Past studies of health-related quality of life after CABG have too few women for adequate comparison with men and have not included patients whose data are not available at baseline (eg, emergency CABG), limiting generalizability.
A longitudinal study of symptoms and health-related quality of life was conducted among patients from four clinical centers enrolling both men (n = 405) and women (n = 269) in the Post CABG Biobehavioral Study in the United States and Canada.
After 6 weeks from CABG (average 81 days), both men and women had less anxiety and symptoms related to depression than before surgery (P <.001). After 6 months (average 294 days), both men and women improved in physical and social functioning (P <.001). Although changes in scale scores were similar for men and women at each time point, women scored lower than men on these domains (P <.001, adjusted for baseline medical and sociodemographic differences) and had more symptoms related to depression through 1 year after CABG (P =.003).
Both male and female patients improve in physical, social, and emotional functioning after CABG, and recovery over time is similar in men and women. However, women's health-related quality-of-life scale scores remained less favorable than men's through 1 year after surgery.
American heart journal 01/2004; 146(6):1038-44. · 4.65 Impact Factor
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Marc A Judson,
Robert P Baughman,
Bruce W Thompson,
Alvin S Teirstein,
Michael L Terrin,
Milton D Rossman,
Henry Yeager,
Geoffrey McLennan,
Eddy A Bresnitz,
Louis DePalo, [......],
Michael C Iannuzzi,
Carol J Johns,
David R Moller,
Lee S Newman,
David L Rabin,
Cecile Rose,
Benjamin A Rybicki,
Steven E Weinberger, Genell L Knatterud,
Reuben Cherniak
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ABSTRACT: A cohort of 215 sarcoidosis patients from the ACCESS study underwent a clinical evaluation at study enrollment and two years later. Approximately 80% of subjects had an improved or stable FVC, FEV1, chest radiograph determined by Scadding stage, and dyspnea scale. African-Americans had less improvement in FVC than Caucasians (p = 0.04). Patients with erythema nodosum at presentation were more likely to have improvement in the chest radiograph at two-year follow-up (p = 0.007). Patients with a lower annual family income were more likely to worsen with respect to dyspnea (p = 0.01) and more likely to have new organ involvement at two-year follow-up (p = 0.045). The development of new organ involvement over the two year follow-up period was more common in African-Americans compared to Caucasians (p = 0.002) and more likely in those with extrapulmonary involvement at study entry (p = 0.003). There was an excellent concordance between changes in FVC and FEV1 over the two-year period. However, changes in FVC alone were inadequate to describe the change in pulmonary status of the patients, as changes in chest radiographic findings or the level of dyspnea did often but not always move in the same direction as FVC. In conclusion, data from this heterogeneous United States sarcoidosis population indicate that sarcoidosis tends to improve or remain stable over two years in the majority of patients. Several factors associated with improved or worse outcome over two years were identified.
Sarcoidosis, vasculitis, and diffuse lung diseases: official journal of WASOG / World Association of Sarcoidosis and Other Granulomatous Disorders 11/2003; 20(3):204-11. · 1.27 Impact Factor
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Genell L Knatterud,
Carl White,
Nancy L Geller,
Lucien Campeau,
Sandra A Forman,
Michael Domanski,
James S Forrester,
Fredarick L Gobel,
J Alan Herd,
Ann Hickey,
Byron J Hoogwerf,
Donald B Hunninghake,
Michael L Terrin,
Yves Rosenberg
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ABSTRACT: Previous studies have suggested that angiographic evidence of disease progression in coronary arteries increases the risk of subsequent coronary clinical events. This study ascertained whether patients enrolled in the Post Coronary Artery Bypass Graft Clinical Trial (POST CABG) who had substantial progression of atherosclerosis in >or=1 saphenous vein grafts (on the basis of assessment of baseline and follow-up angiograms obtained 4-5 years after study entry), but who had not reported clinical symptoms before follow-up angiography, were at a higher risk of subsequent events than patients who did not have substantial progression of atherosclerosis (decrease >or=0.6 mm in lumen diameter at site of greatest change from baseline).
All 1351 patients enrolled in the trial underwent baseline angiography; only the 961 patients who had follow-up angiography and no coronary events before the follow-up study were included in this analysis. The clinical center staff contacted patients to ascertain the events that had occurred after follow-up angiography (approximately 3.4 years later).
Sixty-nine patients had died; 870 patients or relatives were interviewed, and 22 patients could not be contacted. Univariable estimates of relative risk associated with substantial progression ranged from 2.2 (P <.001) for cardiovascular death or nonfatal myocardial infarction to 3.3 (P <.001) for revascularization. Multivariable and univariable estimates of risk were similar.
The findings provide evidence that patients who had substantial progression of atherosclerosis in vein grafts are at an increased risk for subsequent coronary events and suggest that angiographic changes in vein grafts are appropriate surrogate measures for clinical outcomes.
American heart journal 03/2003; 145(2):262-9. · 4.65 Impact Factor
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ABSTRACT: Trials comparing primary percutaneous coronary intervention (PCI) and thrombolytic therapy for treatment of acute myocardial infarction (MI) suggest primary PCI is the superior therapy, although they differ with respect to the durability of benefit. Because PCI is often limited to hospitals that have on-site cardiac surgery programs, most acute MI patients do not have access to this therapy.
To determine whether treatment of acute MI with primary PCI is superior to thrombolytic therapy at hospitals without on-site cardiac surgery and, if so, whether superiority is durable.
The Atlantic Cardiovascular Patient Outcomes Research Team (C-PORT) trial, a prospective, randomized trial conducted from July 1996 through December 1999.
Eleven community hospitals in Massachusetts and Maryland without on-site cardiac surgery or extant PCI programs.
Four hundred fifty-one thrombolytic-eligible patients with acute MI of less than 12 hours' duration associated with ST-segment elevation on electrocardiogram.
After a formal primary PCI development program was completed at all sites, patients were randomly assigned to receive primary PCI (n = 225) or accelerated tissue plasminogen activator (bolus dose of 15 mg and an infusion of 0.75 mg/kg for 30 minutes followed by 0.5 mg/kg for 60 minutes; n = 226). After initiation of assigned treatment, all care was determined by treating physicians.
Six-month composite incidence of death, recurrent MI, and stroke; median hospital length of stay.
The incidence of the composite end point was reduced in the primary PCI group at 6 weeks (10.7% vs 17.7%; P =.03) and 6 months (12.4% vs 19.9%; P =.03) after index MI. Six-month rates for individual outcomes were 6.2% vs 7.1% for death (P =.72), 5.3% vs 10.6% for recurrent MI (P =.04), and 2.2% vs 4.0% for stroke (P =.28) for primary PCI vs thrombolytic therapy, respectively. Median length of stay was also reduced in the primary PCI group (4.5 vs 6.0 days; P =.02).
Compared with thrombolytic therapy, treatment of patients with primary PCI at hospitals without on-site cardiac surgery is associated with better clinical outcomes for 6 months after index MI and a shorter hospital stay.
JAMA The Journal of the American Medical Association 05/2002; 287(15):1943-51. · 30.03 Impact Factor
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Genell L Knatterud
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ABSTRACT: In preparing to undertake a clinical trial, it may be helpful to keep in mind Fredrickson's description of clinical trials (31): "Field trials are indispensable. They will continue to be an ordeal. They lack glamour, they strain our resources and patience, and they protract the moment of truth to excruciating limits. Still, they are among the most challenging tests of our skills. I have no doubt that when the problem is well chosen, the study is appropriately designed, and that when all the populations concerned are made aware of the route and the goal, the reward can be commensurate with the effort. If, in major medical dilemmas, the alternative is to pay the costs of perpetual uncertainty, have we really any choice?"
Epidemiologic Reviews 02/2002; 24(1):12-25. · 7.58 Impact Factor
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ABSTRACT: OBJECTIVESThe study was done to assess patients in the Post-Coronary Artery Bypass Graft (Post-CABG) trial to determine prognostic factors for atherosclerosis progression.BACKGROUNDSaphenous vein grafts (SVGs) are effective in relieving angina and, in certain patient subsets, in prolonging life. However, the progression of atherosclerosis in many of these grafts limits their usefulness.METHODSThe Post-CABG trial studied moderate versus aggressive lipid-lowering and low-dose warfarin versus placebo in patients with a history of coronary artery bypass surgery and found that more aggressive lipid lowering was effective in preventing progression of atherosclerosis in SVGs, but warfarin had no effect. Using variables measured at baseline, we sought the independent prognostic factors for atherosclerosis progression in SVGs, employing the statistical method of generalized estimating equations with a logit-link function.RESULTSTwelve independent prognostic factors for atherosclerosis progression were found. In the order of their importance they were: maximum stenosis of the graft at baseline angiography; years post-SVG placement; the moderate low-density lipoprotein–cholesterol (LDL-C) lowering strategy; prior myocardial infarction; high triglyceride level; small minimum graft diameter; low high-density lipoprotein–cholesterol (HDL-C); high LDL-C; high mean arterial pressure; low ejection fraction; male gender; and current smoking.CONCLUSIONSThis study identified Post-CABG patient and SVG characteristics associated with saphenous vein graft atherosclerosis progression. These data provide a basis for rational risk factor management to prevent progression of SVG atherosclerosis.
Journal of the American College of Cardiology 12/2000; · 14.16 Impact Factor
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ABSTRACT: Objectives.We report mortality, infarction, revascularization and repeat hospital admission events for 1 year after enrollment and randomization in the Thrombolysis in Myocardial Ischemia (TIMI) IIIB clinical trial.Background.The purpose of this trial was to investigate the role of a thrombolytic agent added to conventional medical therapies and to compare an early invasive management strategy to a more conservative early strategy in patients with unstable angina and non-Q wave myocardial infarction.Methods.There were 1,473 patients enrolled, and they received conventional anti-ischemic medical therapies. They were randomized to therapy with either tissue-type plasminogen activator (t-PA) or placebo and also to an early invasive management strategy with coronary arteriography at 18 to 48 h, followed by revascularization as soon as possible if appropriate, or, alternatively, to an early conservative strategy with arteriography and revascularization reserved for failure of initial therapy to prevent recurrent ischemia. The primary end point was a composite outcome variable and was assessed at 42 days. Patients were then managed entirely at the discretion of their treating physician. Follow-up contacts were made at 1 year.Results.The incidence of death or nonfatal infarction for the t-PA— and placebo-treated groups was similar after 1 year (12.4% vs. 10.6%, p = 0.24). The incidence of death or nonfatal infarction was also similar after 1 year for the early invasive and early conservative strategies (10.8% vs. 12.2%, p = 0.42). A trial of this size should be able to detect differences in relative risk for death or infarction ≥1.81 with a power of 80% at a significance level (alpha) of 0.01. Revascularization by 1 year was common, but was slightly more common with the early invasive than the early conservative strategy (64% vs. 58%, p < 0.001). This result was related entirely to a small difference in angioplasty rates (39% vs. 32%, p < 0.001) inasmuch as rates of bypass grafting by 1 year were equivalent (30% in each group, p = 0.50). The high rate of revascularization in both strategies was accompanied by comparable clinical status at the 1-year follow-up contact.Conclusions.In this large study of unstable angina and non-Q wave myocardial infarction, the incidence of death and nonfatal infarction or reinfarction was low but not trivial after 1 year (4.3% mortality, 8.8% nonfatal infarction). An early invasive management strategy was associated with slightly more coronary angioplasty procedures but equivalent numbers of bypass surgery procedures than a more conservative early strategy of catheterization and revascularization only for signs of recurrent ischemia. The incidence of death or nonfatal infarction, or both, did not differ after 1 year by strategy assignment, but fewer patients in the early invasive strategy group underwent later repeat hospital admission (26% vs. 33%, p < 0.001). Either strategy is appropriate for patient management; differences in hospital admissions and revascularization procedures, with their attendant costs, are likely to be minimal.
Journal of the American College of Cardiology 01/1996; · 14.16 Impact Factor
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ABSTRACT: Objectives. This report describes the survival and reinfarction rates for 2- and 3-year follow-up in the Thrombolysis in Myocardial Infarction (TIMI) Phase II clinical trial.Background. Patients enrolled in TIMI II were randomly assigned to an invasive (1,681 patients) or a conservative (1,658 patients) management strategy to follow receipt of intravenous recombinant tissue-type plasminogen activator for acute myocardial infarction.Methods. Eligibility required presentation within 4 h of onset of symptoms and at least 1-mV ST segment elevation in two contiguous electrocardiographic leads. The invasive strategy group underwent cardiac catheterization 18 to 48 h after study entry and, when appropriate, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting. In the conservative strategy group these diagnostic and revascularization procedures were reserved for recurrent spontaneous ischemia or ischemia on low level exercise at the time of hospital discharge.Results. Complete 2-year follow-up data are available for 3,187 patients (95.4%). Cumulative life-table rates of death or reinfarction were 17.6% for the invasive strategy group and 17.9% for the conservative strategy group (p = NS) and mortality was 8.9% and 8.7% (p = NS), respectively. Complete data are available for 1,959 (90.1%) of the 2,174 patients enrolled for 3 years. Rates of death or reinfarction were 21.0% for the invasive strategy group and 20.0% for the conservative strategy group (p = NS), with mortality of 11.5% and 11.0% (p = NS), respectively. In this cohort, the mortality was 1.3% in the 2nd year and 1.7% in the 3rd year from study entry.Conclusions. TIMI II invasive and conservative strategies resulted in similar favorable outcomes after 2 and 3 years. Mortality and reinfarction rates in the two strategies were comparable. Deaths were infrequent in the 2nd and 3rd years from study entry.
Journal of the American College of Cardiology.
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ABSTRACT: The post-Coronary Artery Bypass Graft (Post-CABG) trial has shown that aggressive compared to moderate lowering of low-density lipoprotein cholesterol (LDL-C) delayed the progression of obstructive disease in aortocoronary saphenous vein grafts and in the left main coronary artery. Patients had been allocated to high-and low-dose lovastatin therapy for a 4-5 year period. The present study evaluated the effect of LDL-C lowering and the role of cardiovascular risk factors on the progression of arteriosclerosis in the distal abdominal aorta and common iliac arteries. From one of the participating centers of the post-CABG trial, 145 patients who had adequate imaging of the aortoiliac arteries at baseline and follow-up were included. Angiographic outcomes, presumed to reflect progression of arteriosclerosis and obtained from lumen diameter (LD) measurements using quantitative cineangiography, were as follows: significant decrease of the minimum lumen diameter (LD) and increase of the maximum LD, percent lumen stenosis, and percent lumen dilatation. These outcomes were not significantly less frequent in patients randomly allocated to aggressive compared to moderate LDL-C lowering. Of 9 cardiovascular risk factors, only 2 were significantly related to progression of aortoiliac arteriosclerosis. Current smoking predicted both percent lumen stenosis increase and, to a lesser degree, percent lumen dilatation increase (p = 0.010 and p = 0.055, respectively). Abnormally high body mass index (BMI > or = 25 kg/m2) correlated with percent lumen dilatation increase (p = 0.006). Aggressive compared to moderate LDL-C lowering did not prevent or delay the progression of aortoiliac arteriosclerosis. Smoking predicted both lumen narrowing and dilatation presumably caused by arteriosclerosis. Abnormally high BMI, reflecting overweight or obesity, was strongly associated with vessel dilatation.
Angiology 56(2):191-9. · 1.51 Impact Factor
