34 results on '"Armstrong, Paul W."'
Search Results
2. Relationship of incorrect dosing of fibrinolytic therapy and clinical outcomes
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Mehta, Rajendra H., Alexander, John H., Pieper, Karen S., Werf, Frans Van de, Califf, Robert M., Garg, Jyotsna, Armstrong, Paul W., and Granger, Christopher B.
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Tissue plasminogen activator -- Dosage and administration ,Tissue plasminogen activator -- Complications and side effects - Abstract
An attempt is made to determine whether the association between incorrect dosing of altepase and adverse outcomes is related to cause and effect or to confounding. Results revealed that relationship between incorrect dosing and patient outcome in ASSENT-2 is primarily due to confounding factors rather than incorrect dosing itself.
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- 2005
3. Relationship of blood transfusion and clinical outcomes in patients with acute coronary syndromes
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Rao, Sunil V., Harrington, Robert A., Newby, L. Kristin, Moliterno, David J., Topol, Eric J., Armstrong, Paul W., Granger, Christopher B., Pieper, Karen, Lindblad, Lauren, Califf, Robert M., and Stamler, Jonathan S.
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Coronary heart disease -- Research ,Blood transfusion -- Patient outcomes ,Blood transfusion -- Research - Abstract
The association between blood transfusion and mortality among patients with acute coronary syndromes who develop bleeding, anemia or both during their hospital course are determined. It was found that blood transfusion in the setting of acute coronary syndromes is associated with higher mortality and this relationship persists after adjustment for other predictive factors and timing of events.
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- 2004
4. Mortality at 1 year with combination platelet glycoprotein IIb/IIIa inhibition and reduced-dose fibrinolytic therapy vs conventional fibrinolytic therapy for acute myocardial infarction: GUSTO V randomized trial
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Lincoff, A. Michael, Califf, Robert M., Van de Werf, Frans, Willerson, James T., White, Harvey D., Armstrong, Paul W., Guetta, Victor, Gibler, W. Brian, Hochman, Judith S., Bode, Christoph, Vahanian, Alec, Steg, P. Gabriel, Ardissino, Diego, Savonitto, Stefano, Bar, Frist, Sadowski, Zygmunt, Betriu, Amadeo, Booth, Joan E., Wolski, Kathy, Waller, Michael, and Topol, Eric J.
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Heart attack -- Drug therapy ,Thrombolytic therapy -- Evaluation ,Anticoagulants (Medicine) -- Evaluation - Abstract
Combining an anticoagulant with a thrombolytic drug does not reduce long-term death rates in heart attack patients compared to a thrombolytic drug alone. This was the conclusion of a study of 16,453 heart attack patients who received a thrombolytic drug only or a thrombolytic and an anticoagulant. Thrombolytic drugs break down blood clots whereas anticoagulants prevent blood from clotting.
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- 2002
5. Better outcomes for patients treated at hospitals that participate in clinical trials
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Majumdar, Sumit R., Roe, Matthew T., Peterson, Eric D., Chen, Anita Y., Gibler, W. Brian, and Armstrong, Paul W.
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Outcome and process assessment (Health Care) -- Research ,Clinical trials -- Reports ,Human experimentation in medicine -- Patient outcomes ,Human experimentation in medicine -- Reports ,Self-experimentation in medicine -- Patient outcomes ,Self-experimentation in medicine -- Reports ,Health - Published
- 2008
6. Variations in patient management and outcomes for acute myocardial infarction in the United States and other countries: results from the GUSTO trial
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Van de Werf, Frans, Topol, Eric J., Lee, Kerry L., Woodlief, Lynn H., Granger, Christopher B., Armstrong, Paul W., Barbash, Gabriel I., Hampton, John R., Guerci, Alan, Simes, R. John, Ross, Allan M., and Califf, Robert M.
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Heart attack -- Care and treatment ,Thrombolytic therapy -- Usage - Abstract
The aggressive management of heart attack patients in the U.S. does not appear to substantially reduce short-term mortality rates. Researchers analyzed data from 41,021 heart attack patients in the GUSTO study. This study examined the use of various thrombolytic drugs to treat heart attacks, including streptokinase and recombinant tissue plasminogen activator (rt-PA). Fifty-six percent of the patients were U.S. residents and the rest resided in 14 other countries. In both U.S. and non-U.S. patients, an accelerated dose of rt-PA lowered mortality rates when compared to streptokinase treatment. Blood flow in coronary arteries was restored in more patients receiving accelerated rt-PA. U.S. patients were more likely to be treated with angioplasty, anti-arrhythmic drugs, and calcium channel blockers, but this aggressive management did not result in significantly lower mortality rates when compared to mortality rates in non-U.S.patients., Objective.--To examine differences in outcomes and patient management between patients in the United States and outside the United States undergoing thrombolysis for acute myocardial infarction. Design, Setting, and Patients.--Patients in the United States (n=23 105) and 14 other countries (n=17916) were randomized to receive streptokinase plus either subcutaneous or intravenous (IV) heparin, accelerated recombinant tissue-type plasminogen activator (rt-PA) plus IV heparin, or combined streptokinase and rt-PA plus IV heparin. Outcome Measures.--Differences in 30-day mortality and patient management were compared among treatments and between US and non-US patients. Treatment-by-country interactions were assessed by logistic regression analyses. Expected mortality of US and non-US patients was estimated using a predictive model and was compared with observed mortality. Results.--Mortality reduction with accelerated rt-PA vs streptokinase was greater in the United States (1.2% absolute decrease vs 0.7% elsewhere), but the test for treatment-by-country interaction against streptokinase was not significant (P=.30). Benefits of accelerated rt-PA over combination therapy were observed in the United States, but not in other countries (P=.02). Despite differences in baseline characteristics and patient management, 30-day mortality was not significantly different: 6.8% in the United States vs 7.2% elsewhere (P=.09). After adjustment for baseline differences, observed vs predicted outcomes were slightly better in the United States (6.8% vs 7.0%) than elsewhere (7.2% vs 7.0%), indicating that enrollment in the United States was a marginally significant predictor of better survival (P=.047). Conclusions.--No significant evidence for a differentially greater benefit of accelerated rt-PA over streptokinase was found in US vs non-US patients. However, increased procedure and treatment use in the United States was associated with only a small decrease in short-term mortality. Long-term follow-up is required to clarify the relationship between survival and the more intensive US management approach. (JAMA. 1995; 273:1586-1591)
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- 1995
7. Comparison of the appropriateness of coronary angiography and coronary artery bypass graft surgery between Canada and New York State
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McGlynn, Elizabeth A., Naylor, C. David, Anderson, Geoffrey M., Leape, Lucian L., Park, Rolla Edward, Hilborne, Lee H., Bernstein, Steven J., Goldman, Bernard S., Armstrong, Paul W., Keesey, Joan W., McDonald, Laurie, Pinfold, S. Patricia, Damberg, Cheryl, Sherwood, Marjorie J., and Brook, Robert H.
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Angiography -- Evaluation ,Coronary artery bypass -- Evaluation ,Heart diseases ,Canada -- Health aspects ,New York -- Health aspects - Abstract
Coronary angiography and coronary artery bypass graft (CABG) surgery tend to be used appropriately in heart disease patients in Canada and the U.S. Researchers reviewed medical records of 1866 coronary angiography patients, 533 treated in Canada and 1333 treated in New York, and 1892 CABG patients, 556 treated in Canada and 1336 treated in New York. Investigators assessed the appropriateness and short-term outcome of the procedure in each patient. Results revealed that coronary angiography was used inappropriately in 5% of Canadians and 4% of New Yorkers according to U.S. criteria. CABG was used inappropriately in 3% in Canadians and 2% of New Yorkers according to U.S. criteria. Both procedures were performed less often in Canadian patients over age 75 than in their New York counterparts. Patient outcome after coronary angiography revealed that more New Yorkers had less significant blockage of their arteries than Canadians. During CABG, more Canadians had a heart attack than New Yorkers., Objective.--To compare the appropriateness of coronary angiography and coronary artery bypass graft (CABG) use between the United States and Canada. Design.--Retrospective randomized medical record review. Setting.--All hospitals performing coronary angiography and/or CABG surgery in two Canadian provinces (Ontario and British Columbia); in New York State, 15 randomly selected hospitals that provide coronary angiography and 15 randomly selected hospitals that provide CABG surgery. Patients.--All patients were randomly selected. For coronary angiography, 533 patients in Canada and 1333 patients in New York were selected; for CABG, 556 patients in Canada and 1336 patients in New York were selected. Main Outcome Measures.--Percentage of patients in each country who had coronary angiography or CABG for necessary, appropriate, uncertain, or inappropriate indications as rated by criteria developed separately in each country and the complications of those procedures. Results.--For coronary angiography, 9% of Canadian cases and 10% of New York cases were rated inappropriate using Canadian criteria compared with 5% and 4%, respectively, using US criteria. For CABG, 4% of Canadian cases and 6% of New York cases were rated inappropriate by Canadian criteria compared with 3% and 2%, respectively, using US criteria. A lower proportion of procedures were performed on persons aged 75 years or older in Canada than in New York for both coronary angiography (5% vs 11%; P
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- 1994
8. Impact of Sex on Long-term Mortality from Acute Myocardial Infarction vs Unstable Angina
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Chang, Wei-Ching, Kaul, Padma, Westerhout, Cynthia M., Graham, Michelle, Fu, Yuling, Chowdhury, Tapan, and Armstrong, Paul W.
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Unstable angina -- Research ,Heart attack -- Research ,Sex -- Analysis ,Mortality -- Analysis ,Health - Published
- 2003
9. Clinical Outcomes and Response to Vericiguat According to Index Heart Failure Event: Insights From the VICTORIA Trial.
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Lam, Carolyn S. P., Giczewska, Anna, Sliwa, Karen, Edelmann, Frank, Refsgaard, Jens, Bocchi, Edimar, Ezekowitz, Justin A., Hernandez, Adrian F., O'Connor, Christopher M., Roessig, Lothar, Patel, Mahesh J., Pieske, Burkert, Anstrom, Kevin J., and Armstrong, Paul W.
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- 2021
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10. Influence of Clinical Trials of Acute Coronary Syndrome Beyond the Primary Hypothesis: A Systematic Review.
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Luoma, Leiah M., Westerhout, Cynthia M., Granger, Christopher B., and Armstrong, Paul W.
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- 2020
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11. Effect of Vericiguat vs Placebo on Quality of Life in Patients With Heart Failure and Preserved Ejection Fraction: The VITALITY-HFpEF Randomized Clinical Trial.
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Armstrong, Paul W., Lam, Carolyn S. P., Anstrom, Kevin J., Ezekowitz, Justin, Hernandez, Adrian F., O'Connor, Christopher M., Pieske, Burkert, Ponikowski, Piotr, Shah, Sanjiv J., Solomon, Scott D., Voors, Adriaan A., She, Lilin, Vlajnic, Vanja, Carvalho, Francine, Bamber, Luke, Blaustein, Robert O., Roessig, Lothar, Butler, Javed, and VITALITY-HFpEF Study Group
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ENZYME metabolism , *RESEARCH , *EXERCISE tolerance , *HETEROCYCLIC compounds , *ORAL drug administration , *REGRESSION analysis , *MEDICAL cooperation , *TREATMENT failure , *RANDOMIZED controlled trials , *QUALITY of life , *BLIND experiment , *HOSPITAL care , *STROKE volume (Cardiac output) , *STATISTICAL sampling , *HEART failure - Abstract
Importance: Patients with heart failure and preserved ejection fraction (HFpEF) are at high risk of mortality, hospitalizations, and reduced functional capacity and quality of life.Objective: To assess the efficacy of the oral soluble guanylate cyclase stimulator vericiguat on the physical limitation score (PLS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ).Design, Setting, and Participants: Phase 2b randomized, double-blind, placebo-controlled, multicenter trial of 789 patients with chronic HFpEF and left ventricular ejection fraction 45% or higher with New York Heart Association class II-III symptoms, within 6 months of a recent decompensation (HF hospitalization or intravenous diuretics for HF without hospitalization), and with elevated natriuretic peptides, enrolled at 167 sites in 21 countries from June 15, 2018, through March 27, 2019; follow-up was completed on November 4, 2019.Interventions: Patients were randomized to receive vericiguat, up-titrated to 15-mg (n = 264) or 10-mg (n = 263) daily oral dosages, compared with placebo (n = 262) and randomized 1:1:1.Main Outcomes and Measures: The primary outcome was change in the KCCQ PLS (range, 0-100; higher values indicate better functioning) after 24 weeks of treatment. The secondary outcome was 6-minute walking distance from baseline to 24 weeks.Results: Among 789 randomized patients, the mean age was 72.7 (SD, 9.4) years; 385 (49%) were female; mean EF was 56%; and median N-terminal pro-brain natriuretic peptide level was 1403 pg/mL; 761 (96.5%) completed the trial. The baseline and 24-week KCCQ PLS means for the 15-mg/d vericiguat, 10-mg/d vericiguat, and placebo groups were 60.0 and 68.3, 57.3 and 69.0, and 59.0 and 67.1, respectively, and the least-squares mean changes were 5.5, 6.4, and 6.9, respectively. The least-squares mean difference in scores between the 15-mg/d vericiguat and placebo groups was -1.5 (95% CI, -5.5 to 2.5; P = .47) and between the 10-mg/d vericiguat and placebo groups was -0.5 (95% CI, -4.6 to 3.5; P = .80). The baseline and 24-week 6-minute walking distance mean scores in the 15-mg/d vericiguat, 10-mg/d vericiguat, and placebo groups were 295.0 m and 311.8m , 292.1 m and 318.3 m, and 295.8 m and 311.4 m, and the least-squares mean changes were 5.0 m, 8.7 m, and 10.5 m, respectively. The least-squares mean difference between the 15-mg/d vericiguat and placebo groups was -5.5 m (95% CI, -19.7 m to 8.8 m; P = .45) and between the 10-mg/d vericiguat and placebo groups was -1.8 m (95% CI, -16.2 m to 12.6 m; P = .81), respectively. The proportions of patients who experienced symptomatic hypotension were 6.4% in the 15-mg/d vericiguat group, 4.2% in the 10-mg/d vericiguat group, and 3.4% in the placebo group; those with syncope were 1.5%, 0.8%, and 0.4%, respectively.Conclusions and Relevance: Among patients with HFpEF and recent decompensation, 24-week treatment with vericiguat at either 15-mg/d or 10-mg/d dosages compared with placebo did not improve the physical limitation score of the KCCQ.Trial Registration: ClinicalTrials.gov Identifier: NCT03547583. [ABSTRACT FROM AUTHOR]- Published
- 2020
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12. Transition from meeting abstract to full-length journal article for randomized controlled trials
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Toma, Mustafa, McAlister, Finlay A., Bialy, Liza, Adams, Denise, Vandermeer, Ben, and Armstrong, Paul W.
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Company systems management ,Clinical trials -- Information management ,Medical publishing -- Methods - Abstract
Randomized controlled trials (RCTs) abstracts presented in late-breaking trials sessions are compared to those presented at other sessions at a major scientific meeting and the subsequent full-length publications in each case are compared. While late-breaking trials were observed to be larger and more likely to be preceded by a design paper, they were less likely to report positive results than RCTs presented at other sessions.
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- 2006
13. Toleration of High Doses of Angiotensin-Converting Enzyme Inhibitors in Patients With Chronic Heart Failure: Results From the ATLAS Trial
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Massie, Barry M., Armstrong, Paul W., Cleland, John G. F., Horowitz, John D., Packer, Milton, Poole-Wilson, Philip A., and Ryden, Lars
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ACE inhibitors -- Dosage and administration ,Heart failure -- Drug therapy ,Lisinopril -- Dosage and administration ,Health - Abstract
Background: Treatment with angiotensin-converting enzyme (ACE) inhibitors reduces mortality and morbidity in patients with chronic heart failure (CHF), but most affected patients are not receiving these agents or are being treated with doses lower than those found to be efficacious in trials, primarily because of concerns about the safety and tolerability of these agents, especially at the recommended doses. The present study examines the safety and tolerability of high- compared with low-dose lisinopril in CHF. Methods: The Assessment of Lisinopril and Survival study was a multicenter, randomized, double-blind trial in which patients with or without previous ACE inhibitor treatment were stabilized receiving medium-dose lisinopril (12.3 or 15.0 mg once daily [OD]) for 2 to 4 weeks and then randomized to high- (35.0 or 32.5 mg OD) or low-dose (5.0 or 2.5 mg OD) groups. Patients with New York Heart Association classes II to IV CHF and left ventricular ejection fractions of no greater than 0.30 (n = 3164) were randomized and followed up for a median of 46 months. We examined the occurrence of adverse events and the need for discontinuation and dose reduction during treatment, with a focus on hypotension and renal dysfunction. Results: Of 405 patients not previously receiving an ACE inhibitor, doses in only 4.2% could not be titrated to the medium doses required for randomization because of symptoms possibly related to hypotension (2.0%) or because of renal dysfunction or hyperkalemia (2.3%). Doses in more than 90% of randomized patients in the high- and low-dose groups were titrated to their assigned target, and the mean doses of blinded medication in both groups remained similar throughout the study. Withdrawals occurred in 27.1% of the high- and 30.7% of the low-dose groups. Subgroups presumed to be at higher risk for ACE inhibitor intolerance (blood pressure, [is less than] 120 mm Hg; creatinine, [is greater than or equal to] 132.6 [micro]mol/L [[is greater than or equal to] 1.5 mg/dL]; age, [is greater than or equal to] 70 years; and patients with diabetes) generally tolerated the high-dose strategy. Conclusions: These findings demonstrate that ACE inhibitor therapy in most patients with CHF can be successfully titrated to and maintained at high doses, and that more aggressive use of these agents is warranted. Arch Intern Med. 2001;161:165-171
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- 2001
14. Association Between Sitagliptin Use and Heart Failure Hospitalization and Related Outcomes in Type 2 Diabetes Mellitus.
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McGuire, Darren K., de Werf, Frans Van, Armstrong, Paul W., Standl, Eberhard, Koglin, Joerg, Green, Jennifer B., Bethel, M. Angelyn, Cornel, Jan H., Lopes, Renato D., Halvorsen, Sigrun, Ambrosio, Giuseppe, Buse, John B., Josse, Robert G., Lachin, John M., Pencina, Michael J., Garg, Jyotsna, Lokhnygina, Yuliya, Holman, Rury R., and Peterson, Eric D.
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- 2016
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15. Sudden Cardiac Death After Non-ST-Segment Elevation Acute Coronary Syndrome.
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Hess, Paul L., Wojdyla, Daniel M., Al-Khatib, Sana M., Lokhnygina, Yuliya, Wallentin, Lars, Armstrong, Paul W., Roe, Matthew T., Ohman, E. Magnus, Harrington, Robert A., Alexander, John H., White, Harvey D., Van de Werf, Frans, Piccini, Jonathan P., Held, Claes, Aylward, Philip E., Moliterno, David J., Mahaffey, Kenneth W., and Tricoci, Pierluigi
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- 2016
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16. Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy : primary results of the SYNERGY randomized trial
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UCL - MD/MINT - Département de médecine interne, UCL - (SLuc) Service de pathologie cardiovasculaire, Ferguson, James J., Califf, Robert M., Antman, Elliott M., Cohen, Marc, Grines, Cindy L., Goodman, Shaun, Kereiakes, Dean J., Langer, Anatoly, Mahaffey, Kenneth W., Nessel, Christopher C., Armstrong, Paul W., Avezum, Alvaro, Aylward, Phil, Becker, Richard C., Biasucci, Luigi, Borzak, Steven, Col, Jacques, Frey, Marty J., Fry, Ed, Gulba, Dietrich C., Guneri, Sema, Gurfinkel, Enrique, Harrington, Robert, Hochman, Judith S., Kleiman, Neal S., Leon, Martin B., Lopez-Sendon, Jose Luis, Pepine, Carl J., Ruzyllo, Witold, Steinhubl, Steven R., Teirstein, Paul S., Toro-Figueroa, Luis, White, Harvey, SYNERGY Trial Investigators, UCL - MD/MINT - Département de médecine interne, UCL - (SLuc) Service de pathologie cardiovasculaire, Ferguson, James J., Califf, Robert M., Antman, Elliott M., Cohen, Marc, Grines, Cindy L., Goodman, Shaun, Kereiakes, Dean J., Langer, Anatoly, Mahaffey, Kenneth W., Nessel, Christopher C., Armstrong, Paul W., Avezum, Alvaro, Aylward, Phil, Becker, Richard C., Biasucci, Luigi, Borzak, Steven, Col, Jacques, Frey, Marty J., Fry, Ed, Gulba, Dietrich C., Guneri, Sema, Gurfinkel, Enrique, Harrington, Robert, Hochman, Judith S., Kleiman, Neal S., Leon, Martin B., Lopez-Sendon, Jose Luis, Pepine, Carl J., Ruzyllo, Witold, Steinhubl, Steven R., Teirstein, Paul S., Toro-Figueroa, Luis, White, Harvey, and SYNERGY Trial Investigators
- Abstract
Enoxaparin has demonstrated advantages over unfractionated heparin in low- to moderate-risk patients with non-ST-segment elevation acute coronary syndromes (ACS) treated with a conservative strategy. To compare the outcomes of patients treated with enoxaparin vs unfractionated heparin and to define the role of enoxaparin in patients with non-ST-segment elevation ACS at high risk for ischemic cardiac complications managed with an early invasive approach. The Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial was a prospective, randomized, open-label, multicenter, international trial conducted between August 2001 and December 2003. A total of 10 027 high-risk patients with non-ST-segment elevation ACS to be treated with an intended early invasive strategy were recruited. Subcutaneous enoxaparin (n = 4993) or intravenous unfractionated heparin (n = 4985) was to be administered immediately after enrollment and continued until the patient required no further anticoagulation, as judged by the treating physician. The primary efficacy outcome was the composite clinical end point of all-cause death or nonfatal myocardial infarction during the first 30 days after randomization. The primary safety outcome was major bleeding or stroke. The primary end point occurred in 14.0% (696/4993) of patients assigned to enoxaparin and 14.5% (722/4985) of patients assigned to unfractionated heparin (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.86-1.06). No differences in ischemic events during percutaneous coronary intervention (PCI) were observed between enoxaparin and unfractionated heparin groups, respectively, including similar rates of abrupt closure (31/2321 [1.3%] vs 40/2364 [1.7%]), threatened abrupt closure (25/2321 [1.1%] vs 24/2363 [1.0%]), unsuccessful PCI (81/2281 [3.6%] vs 79/2328 [3.4%]), or emergency coronary artery bypass graft surgery (6/2323 [0.3%] vs 8/2363 [0.3%]). More bleeding was observe
- Published
- 2004
17. Extent, location, and clinical significance of non-infarct-related coronary artery disease among patients with ST-elevation myocardial infarction.
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Park, Duk-Woo, Clare, Robert M, Schulte, Phillip J, Pieper, Karen S, Shaw, Linda K, Califf, Robert M, Ohman, E Magnus, Van de Werf, Frans, Hirji, Sameer, Harrington, Robert A, Armstrong, Paul W, Granger, Christopher B, Jeong, Myung-Ho, and Patel, Manesh R
- Abstract
Importance: Little information exists about the anatomical characteristics and clinical relevance of non-infarct-related artery (IRA) disease among patients with ST-segment elevation myocardial infarction (STEMI).Objectives: To investigate the incidence, extent, and location of obstructive non-IRA disease and compare 30-day mortality according to the presence of non-IRA disease in patients with STEMI.Design, Setting, and Participants: Retrospective study of patients pooled from a convenience sample of 8 independent, international, randomized STEMI clinical trials published between 1993 and 2007. Follow-up varied from 1 month to 1 year. Among 68,765 patients enrolled in the trials, 28,282 patients with valid angiographic information were included in this analysis. Obstructive coronary artery disease was defined as stenosis of 50% or more of the diameter of a major epicardial artery. To assess the generalizability of trial-based results, external validation was performed using observational data for patients with STEMI from the Korea Acute Myocardial Infarction Registry (KAMIR) (between November 1, 2005, and December 31, 2013; n = 18,217) and the Duke Cardiovascular Databank (between January 1, 2005, and December 31, 2012; n = 1812).Main Outcomes and Measures: Thirty-day mortality following STEMI.Results: Overall, 52.8% (14,929 patients) had obstructive non-IRA disease; 29.6% involved 1 vessel and 18.8% involved 2 vessels. There was no substantial difference in the extent and distribution of non-IRA disease according to the IRA territory. Unadjusted and adjusted rates of 30-day mortality were significantly higher in patients with non-IRA disease than in those without non-IRA disease (unadjusted, 4.3% vs 1.7%, respectively; risk difference, 2.7% [95% CI, 2.3% to 3.0%], P < .001; and adjusted, 3.3% vs 1.9%, respectively; risk difference, 1.4% [95% CI, 1.0% to 1.8%], P < .001). The overall prevalence and association of non-IRA disease with 30-day mortality was consistent with findings from the KAMIR registry (adjusted, 3.6% for patients with non-IRA disease vs 2.5% in those without it; risk difference, 1.1% [95% CI, 0.6% to 1.7%]; P < .001), but not with the Duke database (adjusted, 4.7% with non-IRA disease vs 4.3% without it; risk difference, 0.4% [95% CI, -1.4% to 2.2%], P = .65).Conclusions and Relevance: In a retrospective pooled analysis of 8 clinical trials, obstructive non-IRA disease was common among patients presenting with STEMI, and was associated with a modest statistically significant increase in 30-day mortality. These findings require confirmation in prospectively designed studies, but raise questions about the appropriateness and timing of non-IRA revascularization in patients with STEMI. [ABSTRACT FROM AUTHOR]- Published
- 2014
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18. Extent, Location, and Clinical Significance of Non--Infarct-Related Coronary Artery Disease Among Patients With ST-Elevation Myocardial Infarction.
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Duk-Woo Park, Clare, Robert M., Schulte, Phillip J., Pieper, Karen S., Shaw, Linda K., Califf, Robert M., Ohman, E. Magnus, Van deWerf, Frans, Hirji, Sameer, Harrington, Robert A., Armstrong, Paul W., Granger, Christopher B., Myung-Ho Jeong, and Patel, Manesh R.
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CORONARY disease ,MYOCARDIAL infarction ,HEART disease related mortality ,MYOCARDIAL revascularization ,CLINICAL trials - Abstract
IMPORTANCE Little information exists about the anatomical characteristics and clinical relevance of non--infarct-related artery (IRA) disease among patients with ST-segment elevation myocardial infarction (STEMI). OBJECTIVES To investigate the incidence, extent, and location of obstructive non-IRA disease and compare 30-day mortality according to the presence of non-IRA disease in patients with STEMI. DESIGN, SETTING, AND PARTICIPANTS Retrospective study of patients pooled from a convenience sample of 8 independent, international, randomized STEMI clinical trials published between 1993 and 2007. Follow-up varied from 1 month to 1 year. Among 68 765 patients enrolled in the trials, 28 282 patients with valid angiographic information were included in this analysis. Obstructive coronary artery disease was defined as stenosis of 50% or more of the diameter of a major epicardial artery. To assess the generalizability of trial-based results, external validation was performed using observational data for patients with STEMI from the Korea Acute Myocardial Infarction Registry (KAMIR) (between November 1, 2005, and December 31, 2013; n = 18 217) and the Duke Cardiovascular Databank (between January 1, 2005, and December 31, 2012; n = 1812). MAIN OUTCOMES AND MEASURES Thirty-day mortality following STEMI. RESULTS Overall, 52.8%(14 929 patients) had obstructive non-IRA disease; 29.6%involved 1 vessel and 18.8% involved 2 vessels. There was no substantial difference in the extent and distribution of non-IRA disease according to the IRA territory. Unadjusted and adjusted rates of 30-day mortality were significantly higher in patients with non-IRA disease than in those without non-IRA disease (unadjusted, 4.3%vs 1.7%, respectively; risk difference, 2.7%[95% CI, 2.3%to 3.0%], P < .001; and adjusted, 3.3%vs 1.9%, respectively; risk difference, 1.4% [95%CI, 1.0% to 1.8%], P < .001). The overall prevalence and association of non-IRA disease with 30-day mortality was consistent with findings from the KAMIR registry (adjusted, 3.6% for patients with non-IRA disease vs 2.5%in those without it; risk difference, 1.1%[95%CI, 0.6%to 1.7%]; P < .001), but not with the Duke database (adjusted, 4.7%with non-IRA disease vs 4.3%without it; risk difference, 0.4%[95%CI, --1.4%to 2.2%], P = .65). CONCLUSIONS AND RELEVANCE In a retrospective pooled analysis of 8 clinical trials, obstructive non-IRA disease was common among patients presenting with STEMI, and was associated with a modest statistically significant increase in 30-day mortality. These findings require confirmation in prospectively designed studies, but raise questions about the appropriateness and timing of non-IRA revascularization in patients with STEMI. [ABSTRACT FROM AUTHOR]
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- 2014
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19. Platelet Function During Extended Prasugrel and Clopidogrel Therapy for Patients With ACS Treated Without Revascularization: The TRILOGY ACS Platelet Function Substudy.
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Gurbel, Paul A., Erlinge, David, Ohman, E. Magnus, Neely, Benjamin, Neely, Megan, Goodman, Shaun G., Huber, Kurt, Chan, Mark Y., Cornel, Jan H., Brown, Eileen, Zhou, Chunmei, Jakubowski, Joseph A., White, Harvey D., Fox, Keith A. A., Prabhakaran, Dorairaj, Armstrong, Paul W., Tantry, Udaya S., and Roe, Matthew T.
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MEDICAL research ,HEALTH outcome assessment ,BLOOD platelets ,ACUTE coronary syndrome ,CLOPIDOGREL ,PRASUGREL ,BODY weight ,AGE ,DRUG dosage ,DRUG efficacy ,PATIENTS - Abstract
The article focuses on a research study in which researchers characterized the differences and evaluated the clinical outcomes associated with platelet reactivity among patients with acute coronary syndromes (ACS) treated with clopidogrel or prasugrel. In this study, the researchers administered aspirin with either prasugrel or clopidogrel to patients 75 years or older and younger than 75 years but who weighed less than 60 kilogram received a five milligram prasugrel maintenance dose. They found that prasugrel was associated with lower platelet reactivity than clopidogrel, irrespective of age, weight, and dose among patients with ACS.
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- 2012
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20. International Variation in and Factors Associated With Hospital Readmission After Myocardial Infarction.
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Kociol, Robb D., Lopes, Renato D., Clare, Robert, Thomas, Laine, Mehta, Kajendra H., Kaul, Padma, Pieper, Karen S., Hochman, Judith S., Weaver, W. Douglas, Armstrong, Paul W., Granger, Christopher B., and Patel, Manesh R.
- Subjects
PATIENT readmissions ,MYOCARDIAL infarction - Abstract
The article determines the international variation in and factors associated with hospital readmission after ST-segment elevation myocardial infarction (STEMI) and country-level care patterns in controlled patients from the U.S., Canada, Australia, New Zealand and European countries from July 13, 2004 to May 11, 2006. Findings revealed the higher readmission rates for the U.S. than other countries, and the shortest median length of hospital stay for U.S. patients and the longest for patients in Germany. Results of multivariable logistic regression analysis identified multivessel disease and U.S. location as independent predictors of readmission but not of in-hospital death or 30-day post-admission death.
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- 2012
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21. Age and Outcomes in ST-Segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention.
- Author
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Gharacholou, S. Michael, Lopes, Renato D., Alexander, Karen P., Mehta, Rajendra H., Stebbins, Amanda L., Pieper, Karen S., James, Stefan K., Armstrong, Paul W., and Granger, Christopher B.
- Subjects
MYOCARDIAL infarction ,CORONARY disease ,DISEASES in older people ,AGE ,CLINICAL trials ,MEDICAL research - Abstract
The article focuses on a study which investigated a group of elderly patients diagnosed with ST-segment elevation myocardial infarction and treated with primary percutaneous coronary intervention (PPCI) to understand and determine the influence of age on treatment and outcomes. The data of patients included in the Assessment of Pexelizumab in Acute Myocardial Infarction clinical trial conducted from July 13, 2004 to May 11, 2006 are analyzed. It also discusses the rates of medication use in hospitals and at hospital discharge.
- Published
- 2011
- Full Text
- View/download PDF
22. Resource Use in the Last 6 Months of Life Among Patients With Heart Failure in Canada.
- Author
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Kaul, Padma, McAlister, Finlay A., Ezekowitz, Justin A., Bakal, Jeffrey A., Curtis, Lesley H., Quan, Hude, Knudtson, Merril L., and Armstrong, Paul W.
- Subjects
MEDICAL care research ,HEART failure patients ,MEDICAL fees ,MEDICAL care costs ,DRUG prices ,TERMINAL care - Abstract
The article presents a research study on health care resources used by patients in Canada who are dying of heart failure. There were 33,144 patients covered in the study, at 65 years of age and above, living in Alberta. Data showed 75% increase in outpatient costs, 49% increase in physician costs and 42% increase in drug cost. A decrease in the number of patients who died in acute care hospitals was also observed. Issue on the inadequacy of alternative venues for continuing care is tackled as well as the increase cost for end-of-life care.
- Published
- 2011
- Full Text
- View/download PDF
23. Incidence of and Outcomes Associated With Ventricular Tachycardia or Fibrillation in Patients Undergoing Primary Percutaneous Coronary Intervention.
- Author
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Mehta, Rajendra H., Starr, Aijing Z., Lopes, Renato D., Hochman, Judith S., Widimsky, Petr, Pieper, Karen S., Armstrong, Paul W., and Granger, Christopher B.
- Subjects
HEALTH outcome assessment ,VENTRICULAR fibrillation ,VENTRICULAR tachycardia ,ARRHYTHMIA ,CARDIAC surgery patients ,CATHETERIZATION - Abstract
The article reports on the results of research which was conducted in an effort to Objective To evaluate the association of sustained ventricular tachycardia or ventricular fibrillation and its timing on the outcomes of patients presenting for primary percutaneous coronary intervention (PCI). Researchers found that the occurrence of ventricular tachycardia or ventricular fibrillation before or after the end of cardiac catheterization in patients presenting for primary PCI was associated with increased 90-day mortality.
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- 2009
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24. Pexelizumab for Acute ST-Elevation Myocardial Infarction in Patients Undergoing Primary Percutaneous Coronary Intervention.
- Author
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Armstrong, Paul W., Granger, Christopher B., Abrams, Peter X., Hamm, Christian, Holmes Jr., David, O'Neil, William W., Todaro, Thomas G., Vahanian, Alec, Van de Werf, Frans, Al-Khalidi, Hussein, Ardissino, Diego, Aylward, Phil, Betriu, Amadeo, Hochman, Judith, Huber, Kurt, James, Stefan, Lee, Kerry, Mahaffey, Kenneth W., Moliterno, David, and Montalescot, Gilles
- Subjects
- *
THERAPEUTIC use of monoclonal antibodies , *RANDOMIZED controlled trials , *CLINICAL medicine research , *MEDICAL experimentation on humans , *HEALTH outcome assessment , *PLACEBOS , *DRUG efficacy ,MYOCARDIAL infarction-related mortality - Abstract
This article focuses on a placebo-controlled phase 3 study of the effectiveness of the drug, pexelizumab, as an adjunct to percutaneous transliminal coronary intervention (PCI) in the treatment of patients with acute ST-elevation myocardial infarction. Patients received either placebo or pexelizumab prior to PCI. The main outcome measures were all-cause mortality up to the 30th day, death up to the 90th day and either death, cardiogenic shock or congestive heart failure through days 30 and 90. This study determined that mortality was low in the subjects studied and the administration of pexelizumab did not affect mortality rate.
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- 2007
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25. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial.
- Author
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APEX AMI (Assessment of Pexelizumab in Acute Myocardial Infarction) Investigators, APEX AMI Investigators, Armstrong, Paul W, Granger, Christopher B, Adams, Peter X, Hamm, Christian, Holmes, David Jr, O'Neill, William W, Todaro, Thomas G, Vahanian, Alec, and Van de Werf, Frans
- Abstract
Context: Reperfusion with percutaneous transluminal coronary intervention (PCI) is effective at improving outcomes in patients with acute ST-elevation myocardial infarction (STEMI). However, in patients without prompt reestablishment of brisk coronary flow and tissue perfusion, mortality remains high, providing an opportunity for novel treatments, including anti-inflammatory agents.Objective: To evaluate the effectiveness of pexelizumab, a humanized monoclonal antibody that binds the C5 component of complement, as an adjunct to PCI in improving 30-day mortality from STEMI.Design, Setting, and Patients: This trial was a prospective, multicenter, double-blind, placebo-controlled, phase 3 study of the intravenous administration of pexelizumab in conjunction with primary PCI in STEMI with prespecified high-risk electrocardiographic findings. The trial was intended to enroll 8500 patients, but in conjunction with the US Food and Drug Administration enrollment was modified to 5745 patients presenting from 296 hospitals in 17 countries from July 13, 2004, to May 11, 2006.Interventions: Two thousand eight hundred eighty-five patients were randomly assigned to receive placebo and 2860 to receive pexelizumab given as a 2-mg/kg intravenous bolus prior to PCI followed by 0.05-mg/kg per hour infusion over the subsequent 24 hours. Patients were randomized within 6 hours of symptom onset.Main Outcome Measures: The primary end point was all-cause mortality through day 30. Secondary end points were death through day 90 and the composite of death, cardiogenic shock, or congestive heart failure through days 30 and 90.Results: No difference in mortality through day 30 was observed between the pexelizumab and placebo treatment groups, with 116 patients (4.06%) and 113 patients (3.92%) who died in the respective groups (hazard ratio [HR], 1.04; 95% confidence interval [CI], 0.80-1.35; log-rank P = .78). The composite end points of death, shock, or heart failure were also similar with 257 patients (8.99%) receiving pexelizumab and 265 patients (9.19%) receiving placebo at 30 days (HR, 0.98; 95% CI, 0.83-1.16; P = .81) and 293 patients (10.24%) receiving pexelizumab and 293 patients (10.16%) receiving placebo at 90 days (HR, 1.01; 95% CI, 0.86-1.19; P = .91).Conclusion: In this large clinical trial of patients treated with primary PCI for STEMI, mortality was low and unaffected by administration of pexelizumab.Trial Registration: clinicaltrials.gov Identifier: NCT00091637. [ABSTRACT FROM AUTHOR]- Published
- 2007
- Full Text
- View/download PDF
26. Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial.
- Author
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SYNERGY (Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors) Trial Investigators, Ferguson, James J, Califf, Robert M, Antman, Elliott M, Cohen, Marc, Grines, Cindy L, Goodman, Shaun, Kereiakes, Dean J, Langer, Anatoly, Mahaffey, Kenneth W, Nessel, Christopher C, Armstrong, Paul W, Avezum, Alvaro, Aylward, Phil, Becker, Richard C, Biasucci, Luigi, Borzak, Steven, Col, Jacques, Frey, Marty J, and Fry, Ed
- Abstract
Context: Enoxaparin has demonstrated advantages over unfractionated heparin in low- to moderate-risk patients with non-ST-segment elevation acute coronary syndromes (ACS) treated with a conservative strategy.Objectives: To compare the outcomes of patients treated with enoxaparin vs unfractionated heparin and to define the role of enoxaparin in patients with non-ST-segment elevation ACS at high risk for ischemic cardiac complications managed with an early invasive approach.Design, Setting, and Participants: The Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial was a prospective, randomized, open-label, multicenter, international trial conducted between August 2001 and December 2003. A total of 10 027 high-risk patients with non-ST-segment elevation ACS to be treated with an intended early invasive strategy were recruited.Interventions: Subcutaneous enoxaparin (n = 4993) or intravenous unfractionated heparin (n = 4985) was to be administered immediately after enrollment and continued until the patient required no further anticoagulation, as judged by the treating physician.Main Outcome Measures: The primary efficacy outcome was the composite clinical end point of all-cause death or nonfatal myocardial infarction during the first 30 days after randomization. The primary safety outcome was major bleeding or stroke.Results: The primary end point occurred in 14.0% (696/4993) of patients assigned to enoxaparin and 14.5% (722/4985) of patients assigned to unfractionated heparin (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.86-1.06). No differences in ischemic events during percutaneous coronary intervention (PCI) were observed between enoxaparin and unfractionated heparin groups, respectively, including similar rates of abrupt closure (31/2321 [1.3%] vs 40/2364 [1.7%]), threatened abrupt closure (25/2321 [1.1%] vs 24/2363 [1.0%]), unsuccessful PCI (81/2281 [3.6%] vs 79/2328 [3.4%]), or emergency coronary artery bypass graft surgery (6/2323 [0.3%] vs 8/2363 [0.3%]). More bleeding was observed with enoxaparin, with a statistically significant increase in TIMI (Thrombolysis in Myocardial Infarction) major bleeding (9.1% vs 7.6%, P =.008) but nonsignificant excess in GUSTO (Global Utilization of Streptokinase and t-PA for Occluded Arteries) severe bleeding (2.7% vs 2.2%, P =.08) and transfusions (17.0% vs 16.0%, P =.16).Conclusions: Enoxaparin was not superior to unfractionated heparin but was noninferior for the treatment of high-risk patients with non-ST-segment elevation ACS. Enoxaparin is a safe and effective alternative to unfractionated heparin and the advantages of convenience should be balanced with the modest excess of major bleeding. [ABSTRACT FROM AUTHOR]- Published
- 2004
27. The Use of β-Blockers in a Tertiary Care Heart Failure Clinic: Dosing, Tolerance, and Outcomes.
- Author
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Tandon, Puneeta, McAlister, Finlay A., Tsuyuki, Ross T., Hervas-Malo, Marilou, Dupuit, Ruth, Ezekowitz, Justin, Cujec, Bibiana, and Armstrong, Paul W.
- Subjects
HEART failure ,CARDIAC patients ,BIOCOMPATIBILITY - Abstract
Background Little is known about the dosing, tolerability, and impact of β-blockers in nontrial participants. This study was conducted to evaluate the use and outcomes of β-blockers in a tertiary care heart failure clinic. Methods Analysis of prospectively collected data from a cohort of 1041 patients with heart failure seen at the University of Alberta Heart Function Clinic, Edmonton, from September 1, 1989, through July 1, 2001, with objective measurement of ejection fraction at baseline and prospective collection of data at all subsequent clinic visits. Results Median age at baseline was 69 years; 65% were male; 75% had systolic dysfunction; mean ejection fraction was 33%; and 51% had New York Heart Association class III or IV symptoms. Median duration of follow-up was 32 months (interquartile range, 13-62 months). Overall, 46% of patients received β-blockers, but only 18% of these were ultimately prescribed the dosages achieved in the trials (mean maximum dosages achieved, 27 mg/d for carvedilol and 81 mg/d for metoprolol tartrate). Of those patients prescribed β-blockers, 74% continued to receive them during follow-up. Blood pressure, heart rate, and failure symptomatology did not change appreciably before and after β-blockers were prescribed, or during the upward titration of the dosage. Although our patients were prescribed lower dosages than those used in trials, Cox multivariate regression revealed that β-blockers were associated with improved survival, even after adjusting for potential confounders including New York Heart Association class, year of prescription, and concomitant medication use (relative risk, 0.63; 95% confidence interval, 0.50-0.81). Conclusions The benefits of β-blockers seen in randomized trials extend to nontrial participants treated in a tertiary care clinic specializing in heart failure. In our cohort of elderly patients with multiple comorbidities, β-blockers were well tolerated. [ABSTRACT FROM AUTHOR]
- Published
- 2004
- Full Text
- View/download PDF
28. Impact of Sex on Long-term Mortality From Acute Myocardial Infarction vs Unstable Angina.
- Author
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Wei-Ching Chang, Constance M., Kaul, Padma, Westerhout, Cynthia M., Graham, Michelle M., Yuling Fu, Michelle M., Chowdhury, Tapan, and Armstrong, Paul W.
- Subjects
MORTALITY -- Sex differences ,MYOCARDIAL infarction ,HEART disease related mortality ,ANGINA pectoris ,COHORT analysis - Abstract
Background: Patient sex has been shown to differentially affect mortality from unstable angina (UA) and acute myocardial infarction (AMI). However, to our knowledge, no prior population-based studies have examined both cohorts simultaneously to explain this intriguing variation. Hence, we undertook to explore and explain sex differences in 5-year mortality after UA and AMI. Methods: We used an administrative database of 22 967 patients with AMI and 8441 patients with UA discharged from acute care hospitals in Alberta between April 1, 1993, and March 31, 2000. Results: Women were older with more baseline comorbidities, more frequently had a diagnosis of UA, and had 30% lower relative odds of undergoing revascularization than men. Kaplan-Meier estimates of 5-year mortality were similar between sexes after UA (women vs men, 21.6% vs 19.5%; P = .09) but markedly higher for women after AMI (38.5% vs 26.6%, P<.001). After adjustment for baseline characteristics and revascularization, the hazard ratios (95% confidence intervals) for women vs men were 0.81 (0.72-0.92) after UA and 0.99 (0.93-1.05) after AMI. Only women younger than 65 years were at a significantly higher risk after AMI. The reasons for this difference in sex-related outcomes between UA and AMI may relate to greater disparities in the AMI cohort with respect to age, comorbidities, neighborhood incomes, and referrals to cardiovascular specialists. Conclusions: Relative to UA, AMI has a more serious impact on women than men, such that women have a survival advantage when afflicted with UA but lose that advantage with AMI. Additional investigation into the causes, treatment, and policy implications of the age-sex interaction is warranted. [ABSTRACT FROM AUTHOR]
- Published
- 2003
- Full Text
- View/download PDF
29. Toleration of High Doses of Angiotensin-Converting Enzyme Inhibitors in Patients With Chronic...
- Author
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Massic, Barry M., Armstrong, Paul W., Cleland, John G.F., Horowitz, John D., Packer, Milton, Poole-Wilson, Philip A., and Ryden, Lars
- Subjects
- *
ANGIOTENSINS , *HEART failure patients , *VOLUMETRIC analysis , *CHEMICAL inhibitors - Abstract
Focuses on toleration of high doses of angiotensin-converting enzyme inhibitors in patients with chronic heart failure. Patient disposition and characteristics; Prerandomization titration, stabilization phase and tolerability; Adverse events in high-risk groups.
- Published
- 2001
- Full Text
- View/download PDF
30. Counteracting Health Misinformation: A Role for Medical Journals?
- Author
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Armstrong, Paul W. and Naylor, C. David
- Abstract
This Viewpoint discusses the rising tide of medical misinformation and its adverse effects on global health, and suggests ways in which medical journals can collaborate with health professionals, organizations, institutions, and mainstream media to counteract such misinformation. [ABSTRACT FROM AUTHOR]
- Published
- 2019
- Full Text
- View/download PDF
31. Data and Safety Monitoring Boards Academic Credit Where Credit Is Due?
- Author
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Armstrong, Paul W. and Califf, Robert M.
- Subjects
- *
CLINICAL trials monitoring , *ACADEMIC medical centers , *CLINICAL medicine , *SCHOOL credits , *MEDICAL research - Abstract
The authors discuss the role played by data and safety monitoring boards (DSMB) or data monitoring committees in the conduct of clinical trials. It mentions the lack of qualified individuals who are willing and able to service on such boards and the problem's exacerbation by financial constraints being faced by academic medical centers. The authors also argue that DSMB service should be considered a significant academic contribution deserving of appropriate considering within academic systems.
- Published
- 2013
- Full Text
- View/download PDF
32. Prognostic Importance of Ventricular Arrhythmia in Patients Treated With Percutaneous Coronary Intervention.
- Author
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Mehta, Rajendra H., Armstrong, Paul W., and Granger, Christopher B.
- Subjects
- *
LETTERS to the editor , *VENTRICULAR tachycardia - Abstract
A reply by R. H. Mehta and colleagues to a letter to the editor about their article "Incidence of and outcomes associated with ventricular tachycardia or fibrillation in patients undergoing primary percutaneous coronary intervention" in a 2009 issue is presented.
- Published
- 2009
- Full Text
- View/download PDF
33. Pexelizumab and the APEX AMI Trial.
- Author
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Armstrong, Paul W. and Granger, Christopher B.
- Subjects
- *
LETTERS to the editor , *MYOCARDIAL infarction - Abstract
This article presents a letter to the editor in response to a editorial on the study "APEX AMI Investigators. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial," by Paul Armstrong, Christopher Granger and P. X. Adams.
- Published
- 2007
- Full Text
- View/download PDF
34. Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial.
- Author
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Ferguson JJ, Califf RM, Antman EM, Cohen M, Grines CL, Goodman S, Kereiakes DJ, Langer A, Mahaffey KW, Nessel CC, Armstrong PW, Avezum A, Aylward P, Becker RC, Biasucci L, Borzak S, Col J, Frey MJ, Fry E, Gulba DC, Guneri S, Gurfinkel E, Harrington R, Hochman JS, Kleiman NS, Leon MB, Lopez-Sendon JL, Pepine CJ, Ruzyllo W, Steinhubl SR, Teirstein PS, Toro-Figueroa L, and White H
- Subjects
- Aged, Angina Pectoris mortality, Angina Pectoris therapy, Angioplasty, Balloon, Coronary, Female, Hemorrhage epidemiology, Humans, Male, Middle Aged, Myocardial Infarction epidemiology, Stroke epidemiology, Survival Analysis, Treatment Outcome, Angina Pectoris drug therapy, Enoxaparin therapeutic use, Fibrinolytic Agents therapeutic use, Heparin therapeutic use
- Abstract
Context: Enoxaparin has demonstrated advantages over unfractionated heparin in low- to moderate-risk patients with non-ST-segment elevation acute coronary syndromes (ACS) treated with a conservative strategy., Objectives: To compare the outcomes of patients treated with enoxaparin vs unfractionated heparin and to define the role of enoxaparin in patients with non-ST-segment elevation ACS at high risk for ischemic cardiac complications managed with an early invasive approach., Design, Setting, and Participants: The Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial was a prospective, randomized, open-label, multicenter, international trial conducted between August 2001 and December 2003. A total of 10 027 high-risk patients with non-ST-segment elevation ACS to be treated with an intended early invasive strategy were recruited., Interventions: Subcutaneous enoxaparin (n = 4993) or intravenous unfractionated heparin (n = 4985) was to be administered immediately after enrollment and continued until the patient required no further anticoagulation, as judged by the treating physician., Main Outcome Measures: The primary efficacy outcome was the composite clinical end point of all-cause death or nonfatal myocardial infarction during the first 30 days after randomization. The primary safety outcome was major bleeding or stroke., Results: The primary end point occurred in 14.0% (696/4993) of patients assigned to enoxaparin and 14.5% (722/4985) of patients assigned to unfractionated heparin (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.86-1.06). No differences in ischemic events during percutaneous coronary intervention (PCI) were observed between enoxaparin and unfractionated heparin groups, respectively, including similar rates of abrupt closure (31/2321 [1.3%] vs 40/2364 [1.7%]), threatened abrupt closure (25/2321 [1.1%] vs 24/2363 [1.0%]), unsuccessful PCI (81/2281 [3.6%] vs 79/2328 [3.4%]), or emergency coronary artery bypass graft surgery (6/2323 [0.3%] vs 8/2363 [0.3%]). More bleeding was observed with enoxaparin, with a statistically significant increase in TIMI (Thrombolysis in Myocardial Infarction) major bleeding (9.1% vs 7.6%, P =.008) but nonsignificant excess in GUSTO (Global Utilization of Streptokinase and t-PA for Occluded Arteries) severe bleeding (2.7% vs 2.2%, P =.08) and transfusions (17.0% vs 16.0%, P =.16)., Conclusions: Enoxaparin was not superior to unfractionated heparin but was noninferior for the treatment of high-risk patients with non-ST-segment elevation ACS. Enoxaparin is a safe and effective alternative to unfractionated heparin and the advantages of convenience should be balanced with the modest excess of major bleeding.
- Published
- 2004
- Full Text
- View/download PDF
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