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Your search keyword '"Leiva-Pons, Jose L."' showing total 7 results
Start Over Author "Leiva-Pons, Jose L." Topic acute coronary syndrome
7 results on '"Leiva-Pons, Jose L."'

1. Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.

Author

Windecker S, Lopes RD, Massaro T, Jones-Burton C, Granger CB, Aronson R, Heizer G, Goodman SG, Darius H, Jones WS, Aschermann M, Brieger D, Cura F, Engstrøm T, Fridrich V, Halvorsen S, Huber K, Kang HJ, Leiva-Pons JL, Lewis BS, Malaga G, Meneveau N, Merkely B, Milicic D, Morais J, Potpara TS, Raev D, Sabaté M, de Waha-Thiele S, Welsh RC, Xavier D, Mehran R, and Alexander JH

Subjects
Acute Coronary Syndrome complications, Acute Coronary Syndrome surgery, Aged, Anticoagulants adverse effects, Atrial Fibrillation complications, Combined Modality Therapy, Disease Management, Drug Therapy, Combination, Elective Surgical Procedures, Female, Fibrinolytic Agents adverse effects, Hemorrhage chemically induced, Hemorrhage epidemiology, Hospitalization, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors adverse effects, Proportional Hazards Models, Prospective Studies, Purinergic P2Y Receptor Antagonists adverse effects, Purinergic P2Y Receptor Antagonists therapeutic use, Treatment Outcome, Vitamin K antagonists & inhibitors, Acute Coronary Syndrome drug therapy, Anticoagulants therapeutic use, Aspirin therapeutic use, Atrial Fibrillation drug therapy, Cardiovascular Agents therapeutic use, Fibrinolytic Agents therapeutic use, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors therapeutic use, Pyrazoles therapeutic use, Pyridones therapeutic use
Abstract

Background: The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI., Methods: Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y 12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI., Results: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; P interaction =0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54-0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74-1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72-1.04]; P interaction =0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups ( P interaction =0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; P interaction =0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization ( P interaction =0.787) and death and ischemic events ( P interaction =0.710)., Conclusions: An antithrombotic regimen consisting of apixaban and a P2Y 12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400.

Published
2019
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2. Effect of prior clopidogrel use on outcomes in medically managed acute coronary syndrome patients.

Author

Chin CT, Boden WE, Roe MT, Neely B, Neely ML, Leiva-Pons JL, Corbalán R, Gottlieb S, Dalby AJ, Armstrong PW, Prabhakaran D, Fox KA, White HD, Ohman EM, Winters KJ, and Schiele F

Subjects
Acute Coronary Syndrome complications, Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome mortality, Aged, Aspirin administration & dosage, Clopidogrel, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Hemorrhage chemically induced, Hospitalization, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction etiology, Platelet Aggregation Inhibitors adverse effects, Prasugrel Hydrochloride administration & dosage, Proportional Hazards Models, Risk Assessment, Risk Factors, Stroke etiology, Ticlopidine administration & dosage, Ticlopidine adverse effects, Time Factors, Treatment Outcome, Acute Coronary Syndrome drug therapy, Platelet Aggregation Inhibitors administration & dosage, Ticlopidine analogs & derivatives
Abstract

Objective: We investigated whether prior clopidogrel influenced long-term ischaemic and bleeding risks and modified the randomised treatment effect of clopidogrel versus prasugrel among medically managed patients with acute coronary syndromes (ACS) treated with dual antiplatelet therapy., Methods: Medically managed patients with ACS in the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trial were randomised to clopidogrel versus prasugrel (plus aspirin), stratified by prior clopidogrel use. From the analysis population (n=8927), we compared two groups: 'clopidogrel in-hospital (n=6513)' (clopidogrel started ≤72 h of presentation for index ACS event) and 'prior-clopidogrel (n=2414)' (on clopidogrel ≥5 days before index hospitalisation). Treatment-related differences in ischaemic (all-cause death, cardiovascular (CV) death, myocardial infarction (MI), stroke and the composite of CV death/MI/stroke) and bleeding outcomes (severe/life-threatening or moderate bleeding events based on Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria) through 30 months were analysed between patients in the two groups., Results: Compared with 'clopidogrel in-hospital,' 'prior clopidogrel' patients were younger (median 64 years vs 66 years, p<0.001), more likely to have prior CV events/revascularisation, and had a higher frequency of CV death, MI or stroke through 30 months (20.8% vs 18.2%, p=0.002), with no difference in bleeding events (2.3% vs 3.4%, p=0.50). Randomised treatment effect (prasugrel vs clopidogrel) was similar for ischaemic and bleeding outcomes in both groups (all pinteraction>0.05)., Conclusions: Patients receiving clopidogrel before admission for ACS and subsequently treated only medically are at higher risk for CV events versus those not previously receiving clopidogrel. More potent antiplatelet inhibition with prasugrel versus clopidogrel did not significantly reduce this risk., Trial Registration Number: NCT00699998., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Published
2016
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3. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization.

Author

Roe MT, Armstrong PW, Fox KA, White HD, Prabhakaran D, Goodman SG, Cornel JH, Bhatt DL, Clemmensen P, Martinez F, Ardissino D, Nicolau JC, Boden WE, Gurbel PA, Ruzyllo W, Dalby AJ, McGuire DK, Leiva-Pons JL, Parkhomenko A, Gottlieb S, Topacio GO, Hamm C, Pavlides G, Goudev AR, Oto A, Tseng CD, Merkely B, Gasparovic V, Corbalan R, Cinteză M, McLendon RC, Winters KJ, Brown EB, Lokhnygina Y, Aylward PE, Huber K, Hochman JS, and Ohman EM

Subjects
Aged, Aspirin therapeutic use, Cardiovascular Diseases mortality, Cardiovascular Diseases prevention & control, Clopidogrel, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction epidemiology, Piperazines adverse effects, Platelet Aggregation Inhibitors adverse effects, Prasugrel Hydrochloride, Purinergic P2 Receptor Antagonists adverse effects, Purinergic P2 Receptor Antagonists therapeutic use, Stroke epidemiology, Thiophenes adverse effects, Ticlopidine adverse effects, Ticlopidine therapeutic use, Acute Coronary Syndrome drug therapy, Angina, Unstable drug therapy, Myocardial Infarction drug therapy, Piperazines therapeutic use, Platelet Aggregation Inhibitors therapeutic use, Thiophenes therapeutic use, Ticlopidine analogs & derivatives
Abstract

Background: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated., Methods: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel., Results: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P=0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P=0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group., Conclusions: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).

Published
2012
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4. Management of acute coronary syndromes in Mexico: gaps and opportunities to improve outcomes.

Author

Leiva-Pons JL

Subjects
Acute Coronary Syndrome epidemiology, Drug Costs, Fibrinolytic Agents economics, Health Services Accessibility, Humans, Mexico epidemiology, Practice Guidelines as Topic, Treatment Outcome, Acute Coronary Syndrome drug therapy, Fibrinolytic Agents therapeutic use, Guideline Adherence statistics & numerical data
Abstract

Acute coronary syndromes (ACS) include unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI). The management of ACS has improved greatly over the last 3 decades, with an associated steady decline in mortality from this condition seen in the US. The benefits of advances in the management of ACS observed in the US have not fully extended to Mexico, as thrombolytic therapy remains the most commonly used reperfusion strategy for STEMI and new antithrombotic drugs are not widely available. However, treatment of ACS in Mexico is rapidly evolving. Dual oral antiplatelet therapy with the combination of clopidogrel and aspirin (acetylsalicylic acid) is becoming the new standard of care for the management of patients with NSTEMI and those undergoing percutaneous coronary intervention. Results from controlled clinical studies strongly support the use of early and aggressive treatment with this combination. The addition of clopidogrel to the national formulary represents an important step in the evolution of care for ACS patients in Mexico. Local and regional leadership is required to foster the widespread adoption of this highly beneficial treatment strategy. The main objectives of this review are to highlight the recommendations of the Mexican guidelines for the management of ACS and provide some perspective regarding challenges to optimal management of ACS patients in Mexico.

Published
2009
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5. Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease

Author

Lincoff, A. Michael, Nicholls, Stephen J., Riesmeyer, Jeffrey S., Barter, Philip J., Brewer, H. Bryan, Fox, Keith A. A., Gibson, C. Michael, Granger, Christopher, Menon, Venu, Montalescot, Gilles, Rader, Daniel, Tall, Alan R., McErlean, Ellen, Wolski, Kathy, Ruotolo, Giacomo, Vangerow, Burkhard, Weerakkody, Govinda, Goodman, Shaun G., Conde, Diego, McGuire, Darren K., Nicolau, Jose C., Leiva-Pons, Jose L., Pesant, Yves, Li, Weimin, Kandath, David, Kouz, Simon, Tahirkheli, Naeem, Mason, Denise, Nissen, Steven E. Del Valle M, Finnell JB, Standley J, Poi K, Croaning J, Tong YC, Guerra JL, Guasparini G, Hubert C, Ardissino D, Betteridge J, Borghi C, Bruckert E, Chiang CE, Cinteza M, Dalby AJ, Erlinge D, Fernandez-Ortiz A, Ge J, Gottlieb S, Goudev A, Gratsiansky N, Huber K, Ilavská A, Jeong MH, Jukema JW, Katus H, Keltai M, Krum H, Nielsen H, Ogawa H, Ongen Z, Parkhomenko A, Raugaliene R, Renkin J, Rynkiewicz A, Steinhubl S, White H, Widimsky P, Zhu J, Armstrong P, Ridker P, Mahaffey K, Steg G, Wittes J, Bhargava A, Chenier M, Coleman C, Cremer P, Jellis C, Lahoud R, Lappe J, Min D, Monteleone P, Newton D, Stegman B, Senn T, Katzan I, Sharma J, Uchino K, Vora N, Brown K, Fabec D, Piper P, Preston S, Colombo T, Pagel-Langenickel I, Penev P, Maixing A, Crowley K, Sarkar S, Torosyan N, Castano L, Tran D, Dena V, Blain L, Keenan G, Slade K, Quinlan E, Edwards R, Ren H, Glenny J, Maffei L, Albisu Di Gennaro J, Caccavo A, Prado A, Colombo H, Luquez H, Lobo Marquez L, Hammett C, Blombery P, Colquhoun D, Amerena J, Howes L, Cooke D, Simpson R, Horowitz J, Sullivan D, Proietto J, Yeo W, Hirschl M, Hanusch U, Drexel H, Brodmann M, Wollaert B, De Wolf L, Delforge M, Vanwelden J, Peeters A, Siqueira Bodart J, Montenegro R, Franken M, Eliaschewitz F, Parvanova Z, Raev D, Mincheva V, Kichukov K, Stoyanov M, Apostolova E, Tzekova M, Dimov B, Lazov P, Devedzhiev T, Dion D, Poirier P, Lavoie JP, Lonn E, Shukla D, Chehayeb R, Nault P, Gaudet D, Tardif JC, Beaudry Y, Bakbak A, Wong B, St-Maurice F, Labonte R, Polasek P, Sweet M, Bhargava R, Nawaz S, Pandey S, Tishler S, Peterson S, O’Keefe D, Genest J, Syan R, Leiter L, Li H, Ma W, Ma C, Xu D, Li X, Hala T, Machova V, Smejkalova O, Vodnansky P, Reichert P, Velimsky T, Matuska J, Machkova M, Jerabek O, Kuchar J, Rasmussen T, Lindgren L, Alexandersen P, Bang L, Brønnum-Schou J, Valter I, Soots M, Lanno R, Rosenthal S, Cottin Y, Elbaz M, Lafitte S, Silvain J, Coste P, Rangé G, Gosse P, Morel O, Berrouschot J, Bourhaial H, Toursarkissian N, Appel KF, Rieker W, Stellbrink C, Münzel T, Geisler T, Kadel C, Giannitsis E, Trenk D, vom Dahl J, Dorsel T, Singer O, Schäufele T, Natour M, Ozaki R, Lau E, Chan K, Yeung V, Yu C, Lakatos F, Zólyomi S, Vangel S, Merkely B, Szakal I, Sipos A, Laszloczky A, Kis E, Szocs A, Szántai G, Faludi P, Kancz S, Oroszlan T, Hamoud S, Francis A, Chorin E, Leibowitz D, Kracoff O, Weisz G, Schiff E, Bitzur R, Hussein O, Di Lorenzo L, Visona A, Mos L, De Luca G, Salvioni A, Rubba P, Imberti D, Bucci M, Saku K, Sueyoshi A, Ohshima K, Kazatani Y, Shimizu M, Fujii K, Higa N, Kawamitsu K, Shimomura H, Hoshizaki H, Tashiro H, Baden M, Ueda O, Tanabe J, Momiyama Y, Hosokawa S, Takahashi N, Kimura K, Fujinaga H, Masutani M, Kuramochi T, Higashikata T, Ichikawa S, Yamagishi M, Sakota S, Sakuragi S, Suzuki M, Taguchi S, Nakamura T, Ozaki Y, Tsujita K, Yasuda S, Ando K, Fujimoto K, Tanabe K, Fukunaga M, Kavaliauskiene R, Motiejuniene L, Slapikas R, Jarasuniene D, De los Rios Ibarra M, Alcocer Gamba M, Nevarez Ruiz L, Fajardo-Campos P, Llamas Esperon G, Violante Ortiz R, Stobschinski de Alba C, Guizar Sanchez C, Guerra Lopez A, Montano E, Miracle S, Fanghanel G, Lenderink T, Troquay R, Van Leendert R, van Eck J, Hamer B, Ronner E, Karalis I, Lok D, Magro M, Westendorp I, Stroes E, De Melker E, Verhave G, Plomp J, Bronzwaer P, Wiersma J, Kooy A, Herrman JP, Imholz B, de Groot M, Devlin G, Elliott J, Benatar J, Harding S, Hart H, Young C, Mirek-Bryniarska E, Gniot J, Broncel M, Kozina M, Kus W, Sciborski R, Lesnik J, Kawka-Urbanek T, Krzyzanowski M, Okopien B, Wierzbicka K, Dyczek A, Ochean V, Copaci I, Matei C, Pruna C, Constantinescu M, Minescu B, Stamate C, Boldueva S, Markov V, Alexeeva N, Chizhov P, Supryadkina T, Petrochenkova N, Zrazhevsky K, Barbarash O, Gurevich V, Hranai M, Gergel V, Dzupina A, Uhliar R, Vinanska D, Fazekas F, Bugan W, Saaiman J, Nortje H, Theron H, Bernhardi D, Ramlachan P, Van-Zyl L, Basson M, Venter T, Kim D, Han S, Park G, Hwang K, Rhee M, Cho B, Jeong J, Hong B, Chang K, Garcia Puig J, Fuentes Jiménez F, Nieto Iglesias LJ, Pintó Sala X, Gamez JM, Sánchez Álvarez J, Hernandez García JM, Olsson A, Mooe T, Tengmark BO, Lindholm CJ, Hansen O, Tyden P, Moccetti T, Binder R, Ueng K, Lai W, Shyu K, Hsieh I, Sheu W, Chen J, Altunkeser B, Erkan A, Karpenko O, Kaydashev I, Yagensky A, Kovalenko V, Brunskill J, Barr C, Cecil J, Cahill T, A Gorog D, Bakhai A, Coulson W, Gorog D, Loftus I, Haddad T, Hotchkiss D, Isserman S, Janik M, Weinstein D, Wilson S, Butman S, Hearne S, Khan F, Nadar V, Zelman R, Benton R, Flores E, Kahn B, Soni A, Asbill B, Singal D, Dy J, Foucauld J, Crenshaw B, Rogers W, Aslam A, Lieber I, Shah P, Durr S, Spencer R, Mahal S, Cheng S, Abadier R, Gilmore R, Staniloae C, Miller G, Seals A, Jetty P, Mathis C, Henry S, Murray A, Felten W, Navas J, Gudipati R, Singh N, West S, Sabatino K, Crater T, Amin J, Dosh K, Earl J, Z Jafar M, Gelernt M, Kutner M, Salazar J, Krantzler J, El-Ahdab F, Lader E, Zakhary B, Miller S, Madder R, Khan T, Khan M, Collis W, Evans J, Prodafikas J, Panchal V, Cohen K, Weiss R, Dietrich D, Vogel C, Mascarenhas V, Seaworth J, Teklinski A, Davalos J, Dehning M, Herzog W, Snyder H, Talano J, Donahoe S, Hunter J, Sandoval J, Batchelor W, Brautigam D, Moriarty K, Siachos A, Kereiakes D, Traboulssi M, Arif I, Kosinski E, Quadrel M, DeHart D, Miller M, Poock J, Loh I, van Cleeff M, Georgeson S, Suryanarayana P, Cohn J, Schmedtje J, Lamas G, DeSantis J, Stahl L, Prashad R, Schuchard T, Schramm E, Rao V, Deen C, Soufer J, Gurbel P, Vazquez-Tanus J, Srivastava S, Ballantyne C, Lotun K, Younis L, Gupta D, Yeoman G, Zebrack J, Knutson T, Whitaker J, Appel M, Koren M, Muneer B, Fairlamb J, Aviles R, Kozlowski L, Rees A, Stephens M, Mays M, Downey H, Almassi H, Peichert D, Rocco M, French W, Bhatia P, Hoch J, Peart B, Carmichael P, Acheatel R, Vo A, Kirtane A, Bhagwat R, Gilchrist I, Labroo A, Pollock S, Bacon J, Karunaratne H, Moursi M, Doshi A, Sethi P, Treasure C, Marple R, Goodwin T, Zayas-Torres C, Loussararian A, Korn D, Paster R, Albirini A, Moretto T, Guarnieri T, White L, Kramer J, Shortal B, Maynard K, Raikhel M, Rohatgi A, Melucci M, Masri B, Krichmar P, Morris F, Canto J, Wali A, Comerota A, Ellison W, Degregorio M, Chandrika Parameswaran A, Goldscher D, George W, Mulkay A, Maynard R, Ziada K, Strain J, Hermiller J, Ennis B, Desai V, Al-Joundi B, Azocar J, Claudio J, Perez Vargas E, Loy J, Albert M, Chandler G, Maislos F, Graf R, Rama P, Studeny M, Gimple L, Pytlewski G, Simon H, Islam A, Dillon W, Shah S, Geohas C., Lincoff, Am, Nicholls, Sj, Riesmeyer, J, Barter, Pj, Brewer, Hb, Fox, Kaa, Gibson, Cm, Granger, C, Menon, V, Montalescot, G, Rader, D, Tall, Ar, Mcerlean, E, Wolski, K, Ruotolo, G, Vangerow, B, Weerakkody, G, Goodman, Sg, Conde, D, Mcguire, Dk, Nicolau, Jc, Leiva-Pons, Jl, Pesant, Y, Li, W, Kandath, D, Kouz, S, Tahirkheli, N, Mason, D, Nissen, Se, Del Valle, M, Finnell, Jb, Standley, J, Poi, K, Croaning, J, Tong, Yc, Guerra, Jl, Guasparini, G, Hubert, C, Ardissino, D, Betteridge, J, Borghi, C, Bruckert, E, Chiang, Ce, Cinteza, M, Dalby, Aj, Erlinge, D, Fernandez-Ortiz, A, Ge, J, Gottlieb, S, Goudev, A, Gratsiansky, N, Huber, K, Ilavská, A, Jeong, Mh, Jukema, Jw, Katus, H, Keltai, M, Krum, H, Nielsen, H, Ogawa, H, Ongen, Z, Parkhomenko, A, Raugaliene, R, Renkin, J, Rynkiewicz, A, Steinhubl, S, White, H, Widimsky, P, Zhu, J, Armstrong, P, Ridker, P, Mahaffey, K, Steg, G, Wittes, J, Bhargava, A, Chenier, M, Coleman, C, Cremer, P, Jellis, C, Lahoud, R, Lappe, J, Min, D, Monteleone, P, Newton, D, Stegman, B, Senn, T, Katzan, I, Sharma, J, Uchino, K, Vora, N, Brown, K, Fabec, D, Piper, P, Preston, S, Colombo, T, Pagel-Langenickel, I, Penev, P, Maixing, A, Crowley, K, Sarkar, S, Torosyan, N, Castano, L, Tran, D, Dena, V, Blain, L, Keenan, G, Slade, K, Quinlan, E, Edwards, R, Ren, H, Glenny, J, Maffei, L, Albisu Di Gennaro, J, Caccavo, A, Prado, A, Colombo, H, Luquez, H, Lobo Marquez, L, Hammett, C, Blombery, P, Colquhoun, D, Amerena, J, Howes, L, Cooke, D, Simpson, R, Horowitz, J, Sullivan, D, Proietto, J, Yeo, W, Hirschl, M, Hanusch, U, Drexel, H, Brodmann, M, Wollaert, B, De Wolf, L, Delforge, M, Vanwelden, J, Peeters, A, Siqueira Bodart, J, Montenegro, R, Franken, M, Eliaschewitz, F, Parvanova, Z, Raev, D, Mincheva, V, Kichukov, K, Stoyanov, M, Apostolova, E, Tzekova, M, Dimov, B, Lazov, P, Devedzhiev, T, Dion, D, Poirier, P, Lavoie, Jp, Lonn, E, Shukla, D, Chehayeb, R, Nault, P, Gaudet, D, Tardif, Jc, Beaudry, Y, Bakbak, A, Wong, B, St-Maurice, F, Labonte, R, Polasek, P, Sweet, M, Bhargava, R, Nawaz, S, Pandey, S, Tishler, S, Peterson, S, O’Keefe, D, Genest, J, Syan, R, Leiter, L, Li, H, Ma, W, Ma, C, Xu, D, Li, X, Hala, T, Machova, V, Smejkalova, O, Vodnansky, P, Reichert, P, Velimsky, T, Matuska, J, Machkova, M, Jerabek, O, Kuchar, J, Rasmussen, T, Lindgren, L, Alexandersen, P, Bang, L, Brønnum-Schou, J, Valter, I, Soots, M, Lanno, R, Rosenthal, S, Cottin, Y, Elbaz, M, Lafitte, S, Silvain, J, Coste, P, Rangé, G, Gosse, P, Morel, O, Berrouschot, J, Bourhaial, H, Toursarkissian, N, Appel, Kf, Rieker, W, Stellbrink, C, Münzel, T, Geisler, T, Kadel, C, Giannitsis, E, Trenk, D, vom Dahl, J, Dorsel, T, Singer, O, Schäufele, T, Natour, M, Ozaki, R, Lau, E, Chan, K, Yeung, V, Yu, C, Lakatos, F, Zólyomi, S, Vangel, S, Merkely, B, Szakal, I, Sipos, A, Laszloczky, A, Kis, E, Szocs, A, Szántai, G, Faludi, P, Kancz, S, Oroszlan, T, Hamoud, S, Francis, A, Chorin, E, Leibowitz, D, Kracoff, O, Weisz, G, Schiff, E, Bitzur, R, Hussein, O, Di Lorenzo, L, Visona, A, Mos, L, De Luca, G, Salvioni, A, Rubba, P, Imberti, D, Bucci, M, Saku, K, Sueyoshi, A, Ohshima, K, Kazatani, Y, Shimizu, M, Fujii, K, Higa, N, Kawamitsu, K, Shimomura, H, Hoshizaki, H, Tashiro, H, Baden, M, Ueda, O, Tanabe, J, Momiyama, Y, Hosokawa, S, Takahashi, N, Kimura, K, Fujinaga, H, Masutani, M, Kuramochi, T, Higashikata, T, Ichikawa, S, Yamagishi, M, Sakota, S, Sakuragi, S, Suzuki, M, Taguchi, S, Nakamura, T, Ozaki, Y, Tsujita, K, Yasuda, S, 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Subjects
Male, 0301 basic medicine, Cardiovascular Outcome, Cholesterol Ester Transfer Protein, Myocardial Ischemia, 030204 cardiovascular system & hematology, Coronary artery disease, cholesteryl ester transfer protein inhibitor, Benzodiazepines, chemistry.chemical_compound, 0302 clinical medicine, Cardiovascular Disease, Anticholesteremic Agent, Intracranial Arteriosclerosi, Treatment Failure, Evacetrapib, Peripheral Vascular Diseases, Benzodiazepine, biology, Medicine (all), Anticholesteremic Agents, Diabetes Mellitu, General Medicine, Middle Aged, Intracranial Arteriosclerosis, High-Risk Vascular Disease, Editorial, Cardiovascular Diseases, Cardiology, Female, lipids (amino acids, peptides, and proteins), Human, Risk, medicine.medical_specialty, Acute coronary syndrome, 03 medical and health sciences, Double-Blind Method, Internal medicine, Diabetes mellitus, Cholesterylester transfer protein, Diabetes Mellitus, Journal Article, medicine, Humans, Aged, Cholesterol, Vascular disease, business.industry, Cholesterol, HDL, Biomarker, Cholesterol, LDL, medicine.disease, Cholesterol Ester Transfer Proteins, Surgery, 030104 developmental biology, Peripheral Vascular Disease, chemistry, biology.protein, business, Biomarkers, Lipoprotein
Abstract

BACKGROUND: The cholesteryl ester transfer protein inhibitor evacetrapib substantially raises the high-density lipoprotein (HDL) cholesterol level, reduces the low-density lipoprotein (LDL) cholesterol level, and enhances cellular cholesterol efflux capacity. We sought to determine the effect of evacetrapib on major adverse cardiovascular outcomes in patients with high-risk vascular disease. METHODS: In a multicenter, randomized, double-blind, placebo-controlled phase 3 trial, we enrolled 12,092 patients who had at least one of the following conditions: an acute coronary syndrome within the previous 30 to 365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease. Patients were randomly assigned to receive either evacetrapib at a dose of 130 mg or matching placebo, administered daily, in addition to standard medical therapy. The primary efficacy end point was the first occurrence of any component of the composite of death from cardiovascular causes, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina. RESULTS: At 3 months, a 31.1% decrease in the mean LDL cholesterol level was observed with evacetrapib versus a 6.0% increase with placebo, and a 133.2% increase in the mean HDL cholesterol level was seen with evacetrapib versus a 1.6% increase with placebo. After 1363 of the planned 1670 primary end-point events had occurred, the data and safety monitoring board recommended that the trial be terminated early because of a lack of efficacy. After a median of 26 months of evacetrapib or placebo, a primary end-point event occurred in 12.9% of the patients in the evacetrapib group and in 12.8% of those in the placebo group (hazard ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P=0.91). CONCLUSIONS: Although the cholesteryl ester transfer protein inhibitor evacetrapib had favorable effects on established lipid biomarkers, treatment with evacetrapib did not result in a lower rate of cardiovascular events than placebo among patients with high-risk vascular disease. (Funded by Eli Lilly; ACCELERATE ClinicalTrials.gov number, NCT01687998 .).

Published
2017

6. Effect of prior clopidogrel use on outcomes in medically managed acute coronary syndrome patients.

Author

Chee Tang Chin, Boden, William E., Roe, Matthew T., Neely, Benjamin, Neely, Megan L., Leiva-Pons, Jose L., Corbalán, Ramón, Gottlieb, Shmuel, Dalby, Anthony J., Armstrong, Paul W., Prabhakaran, Dorairaj, Fox, Keith A. A., White, Harvey D., Magnus Ohman, E., Winters, Kenneth J., Schiele, Francois, Chin, Chee Tang, and Ohman, E Magnus

Subjects
TREATMENT of acute coronary syndrome, CLOPIDOGREL, CORONARY heart disease treatment, HEART diseases, THERAPEUTICS, CARDIOVASCULAR disease treatment, ASPIRIN, COMBINATION drug therapy, CLINICAL trials, COMPARATIVE studies, DRUG administration, HEMORRHAGE, HOSPITAL care, RESEARCH methodology, MEDICAL cooperation, MYOCARDIAL infarction, RESEARCH, RISK assessment, STROKE, TICLOPIDINE, TIME, EVALUATION research, RANDOMIZED controlled trials, TREATMENT effectiveness, PROPORTIONAL hazards models, BLIND experiment, PLATELET aggregation inhibitors, ACUTE coronary syndrome, KAPLAN-Meier estimator, DISEASE complications, DIAGNOSIS
Abstract

Objective: We investigated whether prior clopidogrel influenced long-term ischaemic and bleeding risks and modified the randomised treatment effect of clopidogrel versus prasugrel among medically managed patients with acute coronary syndromes (ACS) treated with dual antiplatelet therapy.Methods: Medically managed patients with ACS in the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trial were randomised to clopidogrel versus prasugrel (plus aspirin), stratified by prior clopidogrel use. From the analysis population (n=8927), we compared two groups: 'clopidogrel in-hospital (n=6513)' (clopidogrel started ≤72 h of presentation for index ACS event) and 'prior-clopidogrel (n=2414)' (on clopidogrel ≥5 days before index hospitalisation). Treatment-related differences in ischaemic (all-cause death, cardiovascular (CV) death, myocardial infarction (MI), stroke and the composite of CV death/MI/stroke) and bleeding outcomes (severe/life-threatening or moderate bleeding events based on Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria) through 30 months were analysed between patients in the two groups.Results: Compared with 'clopidogrel in-hospital,' 'prior clopidogrel' patients were younger (median 64 years vs 66 years, p<0.001), more likely to have prior CV events/revascularisation, and had a higher frequency of CV death, MI or stroke through 30 months (20.8% vs 18.2%, p=0.002), with no difference in bleeding events (2.3% vs 3.4%, p=0.50). Randomised treatment effect (prasugrel vs clopidogrel) was similar for ischaemic and bleeding outcomes in both groups (all pinteraction>0.05).Conclusions: Patients receiving clopidogrel before admission for ACS and subsequently treated only medically are at higher risk for CV events versus those not previously receiving clopidogrel. More potent antiplatelet inhibition with prasugrel versus clopidogrel did not significantly reduce this risk.Trial Registration Number: NCT00699998. [ABSTRACT FROM AUTHOR]

Published
2016
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7. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization

Author

L. Wang, T. Stys, William E. Boden, R. H. Urbano, D. M. Olinic, Karen S. Pieper, A. Kuijper, E. Soh, J. Nicolau, Jadwiga Nessler, William J. Rogers, Ernesto Rivera, R. Braam, H. Kadr, J. Csikasz, B. Boichev, Prafulla Kerkar, I. Kraiz, R. Babu, Ali Aydinlar, D. Safley, O. Nguyen-Khac, P. Chua, W. Buchanan, C. A. Morales, A. Abyankar, A. Srinivas, S. Genth-Zotz, J. Rocha Faria Neto, D. Drenning, L. Moretti, S. Varma, D. Roth, C. Matei, Jane E. Onken, H. Tumbev, P. Keeling, Xian Li, N. Ciglenecki, Shahyar M. Gharacholou, P. P. Goh, D. Sporn, M. Chang, Marcin Gruchała, R. Foreman, Bogdan Minescu, S. Nawaz, N. Alexeeva, Y. Shalev, C. Fastabend, L. van Zyl, J. F. Certic, J. Longo, J. Wang, K. Dave, Olivier Morel, F. Maatouk, Y. El Rakshy, J. Giacomini, P. Lazov, R. Marino, Dimitar Raev, M. Y. Chan, L. Z. Dextre, Y. Hao, P. Sepulveda, K. Ramshev, C. Bayron, Ameer Kabour, Alon Marmor, Luciano Moreira Baracioli, H. Marais, Rajendra H. Mehta, R. Breedveld, A. Ben Khalfallah, Kurtulus Ozdemir, I. Westendorp, J. A. Quion, Daniel J. George, D. F. Garcia, J.-P Bassand, G. Szalai, Huw Griffiths, O. Ushakov, M. Tzekova, E. Suprun, A. Mowafy, N. El Mansour, Gail V.W. Johnson, Tereshchenko Sn, W. T. Lai, Petr Widimsky, Hany Ragy, V. R. Castillo, M. Padour, Gilles Montalescot, Louie Tirador, Deepak L. Bhatt, M. Marrinan, S. Promisloff, A. Nambiar, Reginald G.E.J. Groutars, S. R. Lee, J. Cabrera, S. Zhang, András Jánosi, K. Wita, R. Sciborski, Annabelle Rodriguez, P. Sedlon, Jaroslaw D. Kasprzak, A. Faynyk, A. Romero Acuña, M. C. Ramirez, Rakesh Gupta, R. Saligrama, Jacek Gniot, Y. Ke, John H. Alexander, X. Liu, E. Baranov, R. Grzywna, Mukul Sharma, A. Linka, Jarosław Wójcik, Haroon Rashid, M. S. Sanchez, M. Gadkari, B. Rao, James S. Zebrack, Paul W. Armstrong, Francois Schiele, Gracita O. Topacio, Peter J. Casterella, A. Belhassane, P. Golino, F. Plat, P. Roberts-Thomson, K. S. Kim, Stephen D. Wiviott, Mathew T. Roe, Y. D. Chen, I. A. Khan, S. Thanvi, S. Isserman, G. Falck, R. M. Coching, S. C. Stamate, M. Ogorek, K. Danisa, Poul Anders Hansen, M. Medvegy, Amos Katz, R. K. Seerangachar, B. Farah, V. Kale, B. Kusnick, Maurice Pye, M. Mosseri, M. Vatutin, D. Weinstein, Norma Keller, A. Mihov, Ewa Mirek-Bryniarska, N. Adjei, S. Sethi, A. Irimpen, M. Broeders, T. Huynh, K. Niezgoda, P. Samardzic, D. Ziperman, Stuart J. Pocock, T. Arad, J. Lewczuk, M. Amuchastegui, R. Moscoso, B. Dimov, W. A. Ahmad, E. Dalli, P. Laothavorn, S. Shaikh, Helmut U. Klein, J. Menon, H. Colombo, L. Fattore, G. Zarrella, Dorairaj Prabhakaran, N. Viboolkitvarakul, Judith D. Goldberg, Neetika Garg, Y. Hasin, F. Rossi Dos Santos, S. J. Vigo, L. Horbach, O. Prokhorov, H. Moellmann, T. R. Vera, C. E. Botta, Domitilla Russo, M. Rossovskaya, David C. Henderson, Rebecca B. Costello, V. Shcherbak, C. J.P.J. Werter, W. Kus, I. Dobre, P. Marechal, T. Nair, H. Nielsen, J. Waites, J. B. Moraes Junior, T. Römer, J. Senior, P. Ionescu, S. Kalashetti, R. N. Ortega, Gail E. Hafley, G. A. Dan, Apur R. Kamdar, Ruth Ann Greenfield, David F. Kong, J. Bergallo, O. Barnum, Antonis S. Manolis, Sumeet Subherwal, S. Schaefer, A. Figueredo, Habib Gamra, S. Bandyopadhyay, V. Miloradovic, Imran Arif, Peter R. Carroll, M. Demirtas, S. Guidera, G. Rogelio, Naseem Jaffrani, N. Mulvihill, Marvin J. Slepian, Darren K. McGuire, Rohit Kalra, Luís A. Providência, F. Van de Werf, Andras Vertes, J. Xu, C. F. Gamio, R. G. Xuereb, R. F. Ramos, E. Kis, N. Bustros, M. De Luca, S. Zhurba, T. Connelly, S. Singhi, F. Gredler, Serdar Kucukoglu, Francesco Fedele, C. Chavez, Christoph Kadel, Antônio Carlos Sobral Sousa, S. Srimahachota, Igor Kaidashev, J. H. Garcia, I. Teodorescu, Birute Petrauskiene, O. Kracoff, Liwa T. Younis, Alain Bouchard, P. Osmancik, Y. Sun, C. Hammett, S. Sabri, William Wallace, Mehmet Yazici, L. Ermoshkina, Harish Chandna, G. Ramos-Lopez, M. Bronisz, Sergio Luiz Zimmermann, Giuseppe Ambrosio, V. Hergeldjieva, César A. Jardim, A. Rifai, H. Lui, A. Lee, J. Scholz Issa, A. Blenkhorn, P. Micale, V. Barbarich, C. Maccallum, Peter J. Grant, G. Topacio, N. Budassi, J. Yan, Keith A.A. Fox, Y. Xia, Jan H. Cornel, A. Rafael, Paul Hermany, S. Potthoff, Mohsin A.F. Khan, Pierre Coste, Neal Ready, N. T. Duda, M. Reyes, A. Chandran, I. G. Gordeev, Anne W. Beaven, B. J.B. Hamer, C. Treasure, Pravin Manga, M. R. Babarskiene, T. Devedzhiev, Alberto Menozzi, L. Lenarz, N. Llerena, Thomas F. Lüscher, Giovânio Vieira da Silva, Y. Malynovsky, L. Ramanathan, M. Belicova, M. O. Ibarra, D. Chew, R. Castillo, M. Kesselbrenner, A. H. Li, E. Baldjiev, M. El-Harari, S. H. Hur, S. Chiaramida, C. E. Chiang, Viliam Fridrich, L. R. Cartasegna, A. Yagensky, Steven E. Hearne, Gregory Pavlides, Witold Rużyłło, Y. Chandrashekhar, S. Welka, H. Petijean, Jose L. Leiva-Pons, Shaul Atar, Andrzej Lubiński, S. Zhao, János Tomcsányi, Narinder Singh, D. Banker, T. Boyek, H. Ebinc, N. Calambur, A. Mouhaffel, M. Creteanu, H. Huang, J. O. Jeong, E. Goudreau, D. 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Subjects
Male, Prasugrel, Myocardial Infarction, Kaplan-Meier Estimate, Piperazines, Purinergic P2 Receptor Antagonists, Myocardial infarction, education.field_of_study, Cardiovascular diseases [NCEBP 14], Acute Coronary Syndrome, Aged, Angina, Unstable, Aspirin, Cardiovascular Diseases, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Middle Aged, Platelet Aggregation Inhibitors, Prasugrel Hydrochloride, Stroke, Thiophenes, Ticlopidine, Medicine (all), Hazard ratio, Clopidogrel, Acute Coronary Syndromes, General Medicine, Angina, Combination, Cardiology, medicine.drug, medicine.medical_specialty, Acute coronary syndrome, Population, Unstable, Drug Therapy, General & Internal Medicine, Internal medicine, medicine, cardiovascular diseases, education, Acute coronary syndromes, Revascularisation, Unstable angina, business.industry, medicine.disease, REVASCULARIZAÇÃO MIOCÁRDICA, business
Abstract

Item does not contain fulltext BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel. RESULTS: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P=0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P=0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group. CONCLUSIONS: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).

Published
2012

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