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Bernard R Chaitman,
Pamela M Hartigan, David C Booth,
Koon K Teo,
G B John Mancini,
William J Kostuk,
John A Spertus,
David J Maron,
Marcin Dada,
Robert A O'Rourke,
William S Weintraub,
Daniel S Berman,
Leslee J Shaw,
William E Boden
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ABSTRACT: The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial enrolled patients from 3 distinct healthcare systems (HCSs) in North America. The primary aim of this study was to determine whether there is a treatment difference in cardiovascular outcomes by HCS.
The study population included 968 patients from the US Department of Veterans Affairs (VA), 386 from the US non-VA, and 931 from Canada with different comorbidities and prognoses. The primary outcome was all-cause mortality or nonfatal myocardial infarction (MI) during the median 4.6-year follow-up. Baseline demographics were similar between percutaneous coronary intervention and optimal medical therapy treatment groups within each HCS. After follow-up, the primary end point of total mortality and nonfatal MI was not statistically significant between percutaneous coronary intervention and optimal medical therapy, regardless of HCS: VA, 22.3% versus 21.9% (hazard ratio, 1.05; 95% CI, 0.80-1.38; P=0.95); US non-VA, 15.8% versus 21.8% (hazard ratio, 0.70; 95% CI, 0.43-1.12; P=0.24); Canadian HCS, 17.3% versus 13.5% (hazard ratio, 1.30; 95% CI, 0.93-1.83; P=0.17). The interaction between HCSs and treatment was not statistically significant. Long-term mortality was significantly higher in the VA system as a result of significantly greater comorbidity and worse left ventricular function.
In the COURAGE trial, addition of percutaneous coronary intervention to optimal medical therapy did not improve 5-year survival or reduce MI or other major adverse cardiovascular events regardless of whether patients were Canadian or American or US veterans or non-veterans. Outcome differences were largely explained by differences in baseline characteristics known to affect long-term prognosis.
Circulation Cardiovascular Quality and Outcomes 09/2010; 3(5):476-83. · 4.91 Impact Factor
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The American journal of medicine 09/2007; 120(8):671-2. · 4.47 Impact Factor
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William E Boden,
Robert A O'Rourke,
Koon K Teo,
Pamela M Hartigan,
David J Maron,
William J Kostuk,
Merril Knudtson,
Marcin Dada,
Paul Casperson,
Crystal L Harris, [......],
Shah Nawaz,
Lawrence M Title,
Gerald Gau,
Alvin S Blaustein, David C Booth,
Eric R Bates,
John A Spertus,
Daniel S Berman,
G B John Mancini,
William S Weintraub
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ABSTRACT: In patients with stable coronary artery disease, it remains unclear whether an initial management strategy of percutaneous coronary intervention (PCI) with intensive pharmacologic therapy and lifestyle intervention (optimal medical therapy) is superior to optimal medical therapy alone in reducing the risk of cardiovascular events.
We conducted a randomized trial involving 2287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.S. and Canadian centers. Between 1999 and 2004, we assigned 1149 patients to undergo PCI with optimal medical therapy (PCI group) and 1138 to receive optimal medical therapy alone (medical-therapy group). The primary outcome was death from any cause and nonfatal myocardial infarction during a follow-up period of 2.5 to 7.0 years (median, 4.6).
There were 211 primary events in the PCI group and 202 events in the medical-therapy group. The 4.6-year cumulative primary-event rates were 19.0% in the PCI group and 18.5% in the medical-therapy group (hazard ratio for the PCI group, 1.05; 95% confidence interval [CI], 0.87 to 1.27; P=0.62). There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%; hazard ratio, 1.05; 95% CI, 0.87 to 1.27; P=0.62); hospitalization for acute coronary syndrome (12.4% vs. 11.8%; hazard ratio, 1.07; 95% CI, 0.84 to 1.37; P=0.56); or myocardial infarction (13.2% vs. 12.3%; hazard ratio, 1.13; 95% CI, 0.89 to 1.43; P=0.33).
As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy. (ClinicalTrials.gov number, NCT00007657 [ClinicalTrials.gov].).
New England Journal of Medicine 05/2007; 356(15):1503-16. · 53.30 Impact Factor
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ABSTRACT: End-stage renal disease (ESRD) patients on chronic dialysis are at heightened risk for target vessel revascularization (TVR) after coronary stenting. However, ESRD patients were excluded from the trials that demonstrated the superiority of drug-eluting stents (DES) over bare metal stents (BMS) in reducing TVR. We sought to identify the impact of stent type (DES versus BMS) on TVR and other cardiac adverse events in ESRD patients.
The study included 89 consecutive ESRD patients who underwent coronary stenting and were followed for greater than or equal to 9 months. TVR was the primary endpoint, and the secondary endpoint was a composite of death, myocardial infarction (MI) and TVR. Multivariate logistic regression models were used to adjust for differences in clinical and procedural characteristics.
DES were used in 24 and BMS in 65 patients. The stent diameter was smaller (p = 0.008), but the stent length was longer (p = 0.006) in the DES group. TVR was required in 1 (4%) of DES and 17 (26%) BMS patients, while 8 (33%) DES and 39 (60%) BMS patients met the secondary endpoint. By multivariate logistic regression, DES use was associated with a significant reduction in TVR (OR 0.07, 95% CI 0.006-0.844; p = 0.036) and a significant reduction in death, MI and TVR (OR 0.11, 95% CI 0.022-0.513; p = 0.005).
A high rate of ischemic events was noted for ESRD patients, regardless of stent type. However, in ESRD patients undergoing coronary revascularization, DES use is effective in reducing 9-month TVR and the composite of death, MI and TVR.
The Journal of invasive cardiology 10/2006; 18(9):405-8. · 1.84 Impact Factor
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Journal of The American College of Cardiology - J AMER COLL CARDIOL. 01/1990; 15(2).
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ABSTRACT: The purpose of this study was to evaluate whether the degree of valvular regurgitation could be reliably estimated by digital subtraction angiography using a 0 to 4+ scale of measurement identical to that applied in conventional cineangiography. Thirty-seven sets of angiograms, each consisting of a digital subtraction angiogram (DSA) and a cineangiogram (CINE) were obtained from 33 patients. Twenty-three angiogram sets were obtained from the ventricles, while 14 were performed in the ascending aorta. Both DSA and CINE images were analyzed for regurgitation by two independent observers. A weighted kappa statistical analysis, carried out to determine the extent to which the two observers agreed on DSA and CINE assessments, demonstrated excellent agreement. The degree of atrioventricular valve regurgitation manifested by DSA was not significantly different from that determined on CINE for either Observer A or B (1.8 ± 1.2 by CINE vs 2.1 ± 1.5 by DSA, 2.1 ± 1.4 vs 2.5 ± 1.0, respectively). However, occasional exceptions occurred in which the degree of atrioventricular valve regurgitation was overestimated by DSA as compared to CINE. Conversely, in 12 cases with aortic regurgitation, DSA overestimated the grade of regurgitation compared to CINE, 2.3 ± 1.1 by CINE vs 3.2 ± 0.8 by DSA (p < 0.01) for Observer A and 2.1 ± 1.2 vs 3.0 ± 1.0 (p < 0.01) for Observer B. The phenomenon which best explains these data is the occurrence of digital enhancement of myocardial opacification produced by coronary perfusion radiocontrast during angiography. Thus, although DSA generally yielded results comparable to conventional CINE in the quantitation of mitral regurgitation, this technique resulted in a systematic overestimation of the severity of aortic regurgitation.
American Heart Journal.
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ABSTRACT: This study was designed to elucidate the operator- and patient-dependent variables inherent in clinical application of quantitative coronary arteriography. Digital arteriograms from 25 consecutive patients undergoing diagnostic catheterization were analyzed by four experienced angiographers utilizing an automated coronary edge detection system to measure percent area stenosis.The identification of potentially significant lesions for quantitation constituted a major source of variability, with unanimous agreement on the presence of a ≥50% stenosis occurring at 38 (29%) of the 130 reported sites. Selection of an optimal frame for quantitative analysis resulted in disagreement for every lesion reported. Frame selection by the operator, as opposed to measurement of preselected frames, increased the interobserver variability from 5% to 7% for automated geometric analysis (p < 0.01), and from 8% to 10.5% for automated densitometric analysis (p < 0.01).Fully automatic arterial border detection was possible for only 20 (52.5%) of the 38 unanimously identified stenoses. The 18 failures involved one or more of the following factors: 1) stenosis at a bifurcation (13 [72%]); 2) diffuse, severe disease (8 [44%]); 3) excessive vessel tortuosity or overlap or both (4 [22%]); and 4) poor image quality (5 [28%]). In contrast, the same automated border detection algorithm successfully traced all 15 preselected frames of discrete stenoses referred for coronary angioplasty.Automated quantitative coronary arteriography performs well when carefully selected, discrete stenoses are presented to the computer for analysis. However, quantitative analysis of routine clinical coronary arteriograms is limited by operator-dependent variability in stenosis identification and frame selection, as well as by complex coronary anatomy and suboptimal image quality. These limitations make automated quantitative coronary arteriography impractical for routine clinical use.
Journal of the American College of Cardiology.
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ABSTRACT: Because a previous study utilizing a combination of recombinant tissue-type plasminogen activator (rt-PA) and urokinase demonstrated reduced reocclusion rates compared with rates obtained with rt-PA alone, this study was conducted to determine whether the combination of rt-PA and streptokinase might achieve similar results at reduced cost. Forty patients with acute myocardial infarction were treated with a I h infusion of rt-PA (50 mg) and streptokinase (1.5 million U) administered within 6 h (mean 3.6 ± 1.2) of symptom onset.Emergency coronary arteriography revealed patency of the infarct-related artery in 30 (75%) of 40 patients. With the addition of coronary angioplasty in those who had unsuccessful thrombolytic reperfusion, the early patency rate was increased to 98%. In-hospital mortality rate (2.5%) and the incidence of significant bleeding requiring transfusion (15%) were low. Angiographically documented reocclusion of the infarct vessel occurred in 3 (8%) of 37 patients by day 7. Regional wall motion of the infarct zone improved by 0.9 ± 0.9 SD/chord (p < 0.0005), and ejection fraction increased 3.68% units (p < 0.05) between immediate and day 7 studies. In contrast to the price of full dose rt-PA ($2,300) or rt-PA with urokinase ($3,500), the cost of this regimen was $1,230.This pilot study demonstrates that at half the cost, a combination of half dose rt-PA with full dose streptokinase offers high infarct vessel patency, recovery of ventricular function, a low rate of reocclusion and few bleeding complications. To assess the precise comparability of this combined regimen with other thrombolytic approaches will require a large randomized prospective trial, which is ongoing.
Journal of the American College of Cardiology.
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ABSTRACT: Although coronary flow reserve is a well established measure of the physiologic significance off atherosclerotic stenosis, cumbersome methodology has prevented its widespread clinical application. This study evaluated a new simplified method of measuring coronary flow reserve based on indicator-dilution analysis of hand-injected digital coronary arteriograms. In five dogs, the circumflex artery was instrumented with an angiographic catheter, an electromagnetic flow probe and a pneumatic occluder. For each of 18 stenoses of varying severity, arteriograms were obtained under basal conditions and during papaverine-induced hyperemia. A pair of background-corrected arterial time-density curves was generated for each stenosis by off-line computer analysis of the circumflex artery arteriograms.Coronary flow reserve was calculated from the measured areas of the time-density curves and the known volume of contrast medium used to produce each curve. Angiographic flow reserve ranged from 0.9 to 6.1 (mean 2.99), whereas electromagnetic flow reserve ranged from 0.7 to 6.9 (mean 3.02). Angiographic and electromagnetic measurements of coronary flow reserve correlated well (r = 0.86).This study establishes that indicator-dilution analysis of 30 frames/s digital coronary arteriography permits the accurate determination of coronary flow reserve. The technique described employs hand injection of small doses of radiographic contrast medium using conventional catheters, and should be readily applicable to the study of human coronary artery disease.
Journal of the American College of Cardiology.
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ABSTRACT: Although the mechanism is unknown, clinical trials have suggested that intravenous beta-adrenergic blockade may prevent early cardiac rupture after myocardial infarction. Previous studies have examined effects of beta-blockers on global left ventricular function after myocardial infarction; however, few data exist regarding their immediate effects on regional function or in patients after successful reperfusion. Therefore, 65 patients in whom thrombolysis with or without coronary angioplasty achieved reperfusion at 4.6 ± 1.7 h from symptom onset were studied. Low osmolarity contrast ventriculograms were obtained immediately before and after administration of 15 mg of intravenous metoprolol (n = 54) or placebo (n = 11).Intravenous metoprolol immediately decreased heart rate (from 92 to 76 beats/min, p < 0.0001), increased left ventricular diastolic volume (from 150 to 163 ml, p < 0.0001) and systolic volume (from 72 to 77 ml, p < 0.0005) but did not change systolic and diastolic pressures. Although there was no difference in ejection fraction after metoprolol, centerline chord analysis revealed reduced noninfarct zone motion (from 0.41 to 0.12 SD/ chord, p < 0.05), improved infarct zone motion (from −3.1 to −2.9 SD/chord, p < 0.01) and smaller circumferential extent of hypokinesia (from 30 to 27 chords, p < 0.05). Patients with dyskinesia of the infarct zone had the most striking improvement in infarct zone wall motion. Because these changes occurred immediately after beta-blockade, they could not be attributed to myocardial salvage. No significant changes in heart rate, left ventricular volumes or regional wall motion were apparent in the control group.Thus, intravenous beta-blockade reduced wall motion of the noninfarct zone and enhanced infarct zone wall motion after reperfusion in humans, independent of myocardial salvage. Whether these changes are due to alteration in heart rate, reduction in ischemia or reduction in forces from the opposing hypercontractile wall will require further investigation.
Journal of the American College of Cardiology.
