Browsing by Author "Armstrong, Paul W."

Now showing 1 - 9 of 9
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    Cardiovascular clinical research in South America
    (2013) Nicolau, Jose C.; Corbalan, Ramon; Diaz, Rafael; Bahit, Cecilia; Armstrong, Paul W.; Granger, Christopher B.; Lopes, Renato D.
    In recent years, international clinical trials have increasingly included large numbers of patients and research sites from developing countries. In South America particularly, enrollment in randomized clinical trials has increased substantially. Despite this significant growth of late, there has been little systematic assessment of the role of this region in cardiovascular clinical trials. South America has several strengths with respect to conducting and participating in clinical trials. These include a large population, a high prevalence of cardiovascular diseases, reliable quality of data, a track record of important contributions to previous clinical trials, and good patient adherence and retention in trials. Labor costs also tend to be lower than those in high-income countries. On the other hand, clinical research in this region of the world faces limitations posed by a relatively small clinical trials network with limited operations expertise, as well as prolonged regulatory approval timelines, diversity in health care systems, limited training opportunities in clinical research, and a low patient level of education. Thus, there are many opportunities to improve the conduct of clinical research in South America, but strategies and systems must be developed to overcome barriers in this economically growing region and to establish a robust infrastructure for clinical trials, including high-quality investigator networks.
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    Concomitant proton-pump inhibitor use, platelet activity, and clinical outcomes in patients with acute coronary syndromes treated with prasugrel versus clopidogrel and managed without revascularization : insights from the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial
    (2015) Nicolau, Jose Carlos; Bhatt, Deepak L.; Roe, Matthew T.; Lokhnygina, Yuliya; Neely, Benjamin; Corbalán Herreros, Ramón; Leiva-Pons, José L.; Martinez, Felipe; Goodman, Shaun G.; Winters, Kenneth J.; Verheugt, Freek W.A.; Armstrong, Paul W.; White, Harvey D.; Fox, Keith A. A.; Prabhakaran, Dorairaj; Ohman, E. Magnus
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    Global variation in quality of care among patients hospitalized with acute heart failure in an international trial: Findings from the Acute Study Clinical Effectiveness of Nesiritide in Decompensated Heart Failure Trial (ASCEND-HF)
    (2013) Howlett, Jonathan G.; Ezekowitz, Justin A.; Podder, Mohua; Hernández, Adrián F.; Díaz, Rafael; Dickstein, Kenneth; Dunlap, Mark E.; Corbalán Herreros, Ramón; Armstrong, Paul W.; Starling, Randall C.; O'Connor, Christopher M.; Califf, Robert M.; Fonarow, Gregg C .; ASCEND-HF Investigators
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    Half-Dose Tenecteplase or Primary Percutaneous Coronary Intervention in Older Patients With ST-Elevation Myocardial Infarction: STREAM-2 1-Year Mortality Follow-Up
    (Lippincott Williams & Wilkins, 2024) Sinnaeve, Peter R.; Welsh, Robert C.; Arias Mendoza, Alexandra; Ristic, Arsen D.; Averkov, Oleg V.; Lambert, Yves; Kerr Saraiva, José F.; Sepúlveda Varela, Pablo Andrés; Rosell-Ortiz, Fernando; French, John K.; Music, Ljilja B.; Vandenberghe, Katleen; Bogaerts, Kris; Danays, Thierry; Bainey, Kevin R.; Armstrong, Paul W.; Van de Werf, Frans
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    Lipoprotein-associated phospholipase A2 activity is a marker of risk but not a useful target for treatment in patients with stable coronary heart disease
    (2016) Wallentin, Lars; Held, Claes; Armstrong, Paul W.; Cannon, Christopher P.; Davies, Richard Y.; Granger, Christopher B.; Hagstrom, Emil; Harrington, Robert A.; Corbalán Herreros, Ramón
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    Pharmaco-Invasive Strategy With Half-Dose Tenecteplase in Patients With STEMI: Prespecified Pooled Analysis of Patients Aged ≥75 Years in STREAM-1 and 2
    (American Heart Association, 2024) Bainey, Kevin R.; Welsh, Robert C.; Zheng, Yinggan; Arias-Mendoza, Alexandra; Ristic, Arsen D.; Averkov, Oleg V.; Lambert, Yves; Kerr Saraiva, Jose F.; Sepúlveda Varela, Pablo Andrés; Rosell-Ortiz, Fernando; French, John K.; Music, Ljilja B.; Temple, Tracy; Ly, Eric; Bogaerts, Kris; Sinnaeve, Peter R.; Danays, Thierry; Westerhout, Cynthia M.; van de Werf, Frans; Armstrong, Paul W.
    BACKGROUND: In STREAM-1 (Strategic Reperfusion Early After Myocardial Infarction), excess intracranial hemorrhage occurred in patients aged >= 75 years receiving full-dose tenecteplase as part of a pharmaco-invasive strategy, whereas no further intracranial hemorrhage occurred after halving the tenecteplase dose. In STREAM-2 (Second Strategic Reperfusion Early After Myocardial Infarction), half-dose tenecteplase was an effective and safe pharmaco-invasive strategy in older patients with ST-segment-elevation myocardial infarction presenting within <3 hours, compared with primary percutaneous coronary intervention (PCI). We prespecified evaluating the efficacy and safety of a half-dose versus full-dose pharmaco-invasive strategy and compared the half-dose pharmaco-invasive strategy to primary PCI in patients aged >= 75 years. METHODS: We pooled data sets in patients aged >= 75 years from STREAM-1 and STREAM-2 receiving a pharmaco-invasive strategy versus primary PCI. Resolution of ST-segment-elevation after fibrinolysis and angiography was assessed, as was the relative risk of the primary composite of 30-day all-cause death, myocardial infarction, heart failure, and shock, along with bleeding. RESULTS: A total of 390 patients were included: 42 patients were randomized to full-dose pharmaco-invasive treatment, 205 patients to half-dose pharmaco-invasive treatment, and 143 patients to primary PCI. Half-dose versus full-dose pharmaco-invasive treatment resulted in similar proportions of patients achieving >= 50% ST-segment resolution posttenecteplase (63.2% versus 62.6%), with reduced intracranial hemorrhage (7.1% versus 0%, respectively). Half-dose pharmaco-invasive treatment and primary PCI also had similar proportions of patients with >= 50% ST-segment resolution postangiography (77.9% versus 72.4%; P=0.277) and comparable composite end points (23.4% versus 28.0%; relative risk, 0.90 [95% CI, 0.62-1.30]; P=0.567) without occurrence of intracranial hemorrhage. CONCLUSIONS: Comparable efficacy exists between half- and full-dose tenecteplase pharmaco-invasive treatments with improved safety in patients with ST-segment-elevation myocardial infarction aged >= 75 years. Half-dose pharmaco-invasive therapy is a legitimate therapeutic option for elderly patients with ST-segment-elevation myocardial infarction unable to access timely primary PCI.
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    Prasugrel versus Clopidogrel for Acute Coronary Syndromes without Revascularization
    (MASSACHUSETTS MEDICAL SOC, 2012) Roe, Matthew T.; Armstrong, Paul W.; Fox, Keith A. A.; White, Harvey D.; Prabhakaran, Dorairaj; Goodman, Shaun G.; Cornel, Jan H.; Bhatt, Deepak L.; Clemmensen, Peter; Martinez, Felipe; Ardissino, Diego; Nicolau, Jose C.; Boden, William E.; Gurbel, Paul A.; Ruzyllo, Witold; Dalby, Anthony J.; McGuire, Darren K.; Leiva Pons, Jose L.; Parkhomenko, Alexander; Gottlieb, Shmuel; Topacio, Gracita O.; Hamm, Christian; Pavlides, Gregory; Goudev, Assen R.; Oto, Ali; Tseng, Chuen Den; Merkely, Bela; Gasparovic, Vladimir; Corbalan, Ramon; Cinteza, Mircea; McLendon, R. Craig; Winters, Kenneth J.; Brown, Eileen B.; Lokhnygina, Yuliya; Aylward, Philip E.; Huber, Kurt; Hochman, Judith S.; Ohman, E. Magnus; TRILOGY ACS Investigators
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    STREAM-2: Half-Dose Tenecteplase or Primary Percutaneous Coronary Intervention in Older Patients With ST-Segment-Elevation Myocardial Infarction: A Randomized, Open-Label Trial
    (2023) Van de Werf, Frans; Ristic, Arsen D.; Averkov, Oleg V.; Arias-Mendoza, Alexandra; Lambert, Yves; Saraiva, Jose F. Kerr; Sepúlveda Varela, Pablo Andrés; Rosell-Ortiz, Fernando; French, John K.; Music, Ljilja B.; Vandenberghe, Katleen; Bogaerts, Kris; Westerhout, Cynthia M.; Pages, Alain; Danays, Thierry; Bainey, Kevin R.; Sinnaeve, Peter; Goldstein, Patrick; Welsh, Robert C.; Armstrong, Paul W.
    BACKGROUND: ST-segment-elevation myocardial infarction (STEMI) guidelines recommend pharmaco-invasive treatment if timely primary percutaneous coronary intervention (PCI) is unavailable. Full-dose tenecteplase is associated with an increased risk of intracranial hemorrhage in older patients. Whether pharmaco-invasive treatment with half-dose tenecteplase is effective and safe in older patients with STEMI is unknown. METHODS: STREAM-2 (Strategic Reperfusion in Elderly Patients Early After Myocardial Infarction) was an investigator-initiated, open-label, randomized, multicenter study. Patients >= 60 years of age with >= 2 mm ST-segment elevation in 2 contiguous leads, unable to undergo primary PCI within 1 hour, were randomly assigned (2:1) to half-dose tenecteplase followed by coronary angiography and PCI (if indicated) 6 to 24 hours after randomization, or to primary PCI. Efficacy end points of primary interest were ST resolution and the 30-day composite of death, shock, heart failure, or reinfarction. Safety assessments included stroke and nonintracranial bleeding. RESULTS: Patients were assigned to pharmaco-invasive treatment (n=401) or primary PCI (n=203). Median times from randomization to tenecteplase or sheath insertion were 10 and 81 minutes, respectively. After last angiography, 85.2% of patients undergoing pharmaco-invasive treatment and 78.4% of patients undergoing primary PCI had =50% resolution of ST-segment elevation; their residual median sums of ST deviations were 4.5 versus 5.5 mm, respectively. Thrombolysis In Myocardial Infarction flow grade 3 at last angiography was approximate to 87% in both groups. The composite clinical end point occurred in 12.8% (51/400) of patients undergoing pharmaco-invasive treatment and 13.3% (27/203) of patients undergoing primary PCI (relative risk, 0.96 [95% CI, 0.62-1.48]). Six intracranial hemorrhages occurred in the pharmaco-invasive arm (1.5%): 3 were protocol violations (excess anticoagulation in 2 and uncontrolled hypertension in 1). No intracranial bleeding occurred in the primary PCI arm. The incidence of major nonintracranial bleeding was low in both groups (<1.5%). CONCLUSIONS: Halving the dose of tenecteplase in a pharmaco-invasive strategy in this early-presenting, older STEMI population was associated with electrocardiographic changes that were at least comparable to those after primary PCI. Similar clinical efficacy and angiographic end points occurred in both treatment groups. The risk of intracranial hemorrhage was higher with half-dose tenecteplase than with primary PCI. If timely PCI is unavailable, this pharmaco-invasive strategy is a reasonable alternative, provided that contraindications to fibrinolysis are observed and excess anticoagulation is avoided.
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    Time-Varying Effects of Prasugrel Versus Clopidogrel on the Long-Term Risks of Stroke After Acute Coronary Syndromes Results From the TRILOGY. ACS. Trial
    (2016) Chee Tang Chin; Neely, Benjamin; Ohman, E. Magnus; Armstrong, Paul W.; Corbalán Herreros, Ramón; White, Harvey D.; Prabhakaran, Dorairaj; Winters, Kenneth J.; Fox, Keith A. A.; Roe, Matthew T.