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James E Tcheng - One of the best experts on this subject based on the ideXlab platform.
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complementary effects of thienopyridine pretreatment and platelet glycoprotein iib iiia integrin blockade with eptifibatide in coronary stent intervention results from the esprit trial
Catheterization and Cardiovascular Interventions, 2007Co-Authors: Jeanpierre Dery, Mina Madan, Thaddeus R Tolleson, J C Oshea, C. M. Gibson, J Mathias, Karen S Pieper, Robert A. Harrington, M. E. Campbell, James E TchengAbstract:Objectives: This analysis sought to investigate the complementary effect of thienopyridine pretreatment and platelet glycoprotein (GP) IIb/IIIa integrin blockade in coronary stent intervention. Background: Definitive evidence supporting combined antiplatelet therapy consisting of thienopyridine pretreatment and GP IIb/IIIa receptor blockade in patients undergoing percutaneous coronary intervention (PCI) with stent implantation is limited. Methods: We retrospectively analyzed clinical outcomes by thienopyridine use in the 2,040 patients randomized to eptifibatide or placebo who underwent PCI in the ESPRIT trial. Results: A total of 901 patients received a loading dose of thienopyridine before PCI (group 1), 123 received thienopyridine pretreatment without a loading dose (group 2), and 1,016 were not treated with thienopyridine before PCI (group 3). The composite incidence of death or myocardial infarction at 30 days was significantly lower in group 1 than in groups 2 and 3 combined (OR, 0.71 [95%CI, 0.52–0.99]; P = 0.0417). A similar trend was seen for the composite of death, myocardial infarction, or urgent target vessel revascularization (unadjusted OR, 0.77 [0.57–1.05]; P = 0.1025). After adjusting for baseline characteristics, these differences were no longer significant. No interactions were identified with eptifibatide assignment for any of the group comparisons. Conclusions: Pretreatment with a loading dose of thienopyridine lowers the rate of ischemic complications regardless of treatment with a GP IIb/IIIa inhibitor. Conversely, the efficacy of eptifibatide is maintained whether or not a loading dose of a thienopyridine is administered. Optimal outcomes are achieved in patients receiving thienopyridine pretreatment along with platelet GP IIb/IIIa inhibitor therapy. © 2007 Wiley-Liss, Inc.
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complementary effects of thienopyridine pretreatment and platelet glycoprotein iib iiia integrin blockade with eptifibatide in coronary stent intervention results from the esprit trial
Catheterization and Cardiovascular Interventions, 2007Co-Authors: Jeanpierre Dery, Mina Madan, Thaddeus R Tolleson, J C Oshea, C. M. Gibson, J Mathias, Karen S Pieper, Robert A. Harrington, M. E. Campbell, James E TchengAbstract:Objectives: This analysis sought to investigate the complementary effect of thienopyridine pretreatment and platelet glycoprotein (GP) IIb/IIIa integrin blockade in coronary stent intervention. Background: Definitive evidence supporting combined antiplatelet therapy consisting of thienopyridine pretreatment and GP IIb/IIIa receptor blockade in patients undergoing percutaneous coronary intervention (PCI) with stent implantation is limited. Methods: We retrospectively analyzed clinical outcomes by thienopyridine use in the 2,040 patients randomized to eptifibatide or placebo who underwent PCI in the ESPRIT trial. Results: A total of 901 patients received a loading dose of thienopyridine before PCI (group 1), 123 received thienopyridine pretreatment without a loading dose (group 2), and 1,016 were not treated with thienopyridine before PCI (group 3). The composite incidence of death or myocardial infarction at 30 days was significantly lower in group 1 than in groups 2 and 3 combined (OR, 0.71 [95%CI, 0.52–0.99]; P = 0.0417). A similar trend was seen for the composite of death, myocardial infarction, or urgent target vessel revascularization (unadjusted OR, 0.77 [0.57–1.05]; P = 0.1025). After adjusting for baseline characteristics, these differences were no longer significant. No interactions were identified with eptifibatide assignment for any of the group comparisons. Conclusions: Pretreatment with a loading dose of thienopyridine lowers the rate of ischemic complications regardless of treatment with a GP IIb/IIIa inhibitor. Conversely, the efficacy of eptifibatide is maintained whether or not a loading dose of a thienopyridine is administered. Optimal outcomes are achieved in patients receiving thienopyridine pretreatment along with platelet GP IIb/IIIa inhibitor therapy. © 2007 Wiley-Liss, Inc.
Stephen D. Wiviott - One of the best experts on this subject based on the ideXlab platform.
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causes of late mortality with dual antiplatelet therapy after coronary stents
European Heart Journal, 2015Co-Authors: Stephen D. Wiviott, Laura Mauri, Donald E Cutlip, Gabriel P Steg, Sammy Elmariah, Robert W Yeh, Stephan WindeckerAbstract:Aims In the dual antiplatelet therapy (DAPT) study, continued thienopyridine beyond 12 months after drug-eluting stent placement was associated with increased mortality compared with placebo. We sought to evaluate factors related to mortality in randomized patients receiving either drug-eluting or bare metal stents in the DAPT study. Methods and results Patients were enrolled after coronary stenting, given thienopyridine and aspirin for 12 months, randomly assigned to continued thienopyridine or placebo for an additional 18 months (while taking aspirin), and subsequently treated with aspirin alone for another 3 months. A blinded independent adjudication committee evaluated deaths. Among 11 648 randomized patients, rates of all-cause mortality rates were 1.9 vs. 1.5% (continued thienopyridine vs. placebo, P = 0.07), cardiovascular mortality, 1.0 vs. 1.0% ( P = 0.97), and non-cardiovascular mortality, 0.9 vs. 0.5% ( P = 0.01) over the randomized period (Months 12–30). Rates of fatal bleeding were 0.2 vs. 0.1% ( P = 0.81), and deaths related to any prior bleeding were 0.3 vs. 0.2% ( P = 0.36), Months 12–33). Cancer incidence did not differ (2.0 vs. 1.6%, P = 0.12). Cancer-related deaths occurred in 0.6 vs. 0.3% ( P = 0.02) and were rarely related to bleeding (0.1 vs. 0, P = 0.25). After excluding those occurring in patients with cancer diagnosed before enrolment, rates were 0.4 vs. 0.3% ( P = 0.16). Conclusion Bleeding accounted for a minority of deaths among patients treated with continued thienopyridine. Cancer-related death in association with thienopyridine therapy was mainly not related to bleeding and may be a chance finding. Caution is warranted when considering extended thienopyridine in patients with advanced cancer. Trial Registration clinicaltrials.gov Identifier: [NCT00977938][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00977938&atom=%2Fehj%2F37%2F4%2F378.atom
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twelve or 30 months of dual antiplatelet therapy after drug eluting stents
The New England Journal of Medicine, 2014Co-Authors: Laura Mauri, Stephen D. Wiviott, Dean J Kereiakes, Sharon-lise T. Normand, Donald E Cutlip, Eugene Braunwald, Gabriel P Steg, Robert W Yeh, Priscilla Driscollshempp, David J. CohenAbstract:0.29 [95% confidence interval {CI}, 0.17 to 0.48]; P<0.001) and major adverse cardiovascular and cerebrovascular events (4.3% vs. 5.9%; hazard ratio, 0.71 [95% CI, 0.59 to 0.85]; P<0.001). The rate of myocardial infarction was lower with thienopyridine treatment than with placebo (2.1% vs. 4.1%; hazard ratio, 0.47; P<0.001). The rate of death from any cause was 2.0% in the group that continued thienopyridine therapy and 1.5% in the placebo group (hazard ratio, 1.36 [95% CI, 1.00 to 1.85]; P = 0.05). The rate of moderate or severe bleeding was increased with continued thienopyridine treatment (2.5% vs. 1.6%, P = 0.001). An elevated risk of stent thrombosis and myocardial infarction was observed in both groups during the 3 months after discontinuation of thienopyridine treatment. Conclusions Dual antiplatelet therapy beyond 1 year after placement of a drug-eluting stent, as compared with aspirin therapy alone, significantly reduced the risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events but was associated with an increased risk of bleeding. (Funded by a consortium of eight device and drug manufacturers and others; DAPT ClinicalTrials.gov number, NCT00977938.)
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ed administration of Thienopyridines in non st segment elevation myocardial infarction results from the ncdr
American Journal of Emergency Medicine, 2013Co-Authors: Deborah B. Diercks, Dajuanicia N. Holmes, Jorge F. Saucedo, Judd E Hollander, Stephen D. Wiviott, Michael C Kontos, Bryn E Mumma, James A De LemosAbstract:Abstract Objective American Heart Association/American College of Cardiology guidelines recommend that patients with definite unstable angina or non–ST-segment elevation myocardial infarction (NSTEMI) receive dual antiplatelet therapy on presentation to the hospital when undergoing early invasive management or "as soon as possible" after admission when being managed conservatively. The guidelines do not specify whether these medications should be administered in the emergency department (ED). Our aim was to determine whether ED administration of a thienopyridine was associated with clinical outcomes among patients with NSTEMI. Methods We examined thienopyridine use in 39454 patients with NSTEMI who received a thienopyridine within 24 hours of presentation in the National Cardiovascular Data Registry's Acute Coronary Treatment and Intervention Outcomes Network–Get With The Guidelines Registry from January 2007 to June 2010. Patients who were not seen initially in the ED, were transferred in, or were missing time data were excluded. We analyzed the association between ED administration of Thienopyridines and outcomes and patient demographics. Results Of the cohort receiving a thienopyridine within 24 hours, 9534 (24.2%) received it in the ED. Emergency department administration of a thienopyridine was not associated with in-hospital major bleeding (multivariable adjusted odds ratio, 0.99; 95% confidence interval, 0.91-1.09) or in-hospital mortality (adjusted 1.02; 95% confidence interval, 0.86-1.20). Independent predictors most strongly associated with ED thienopyridine administration were elevated troponin, ED length of stay, prior percutaneous coronary intervention, and initial electrocardiogram showing ischemic changes. Conclusions There was no association between ED thienopyridine administration and in-hospital major bleeding or mortality. Emergency department length of stay, electrocardiographic changes, and elevated troponin were associated with ED thienopyridine administration.
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Abstract 12797: Characteristics and Outcomes of Emergency Department Patients Treated with Thienopyridines: Results from the NCDR(R)
Circulation, 2011Co-Authors: Deborah B. Diercks, Micheal Kontos, Dajuanicia N. Holmes, Jorge F. Saucedo, Judd E Hollander, Stephen D. Wiviott, James A De LemosAbstract:Background: Over the last 10 years the AHA/ACC guidelines have evolved to recommend that patients with definite unstable angina or Non-ST segment elevation myocardial infarction (NSTEMI) receive dual antiplatelet therapy that may include a thienopyridine on presentation . to the hospital. Determinants and outcomes associated with the administration of Thienopyridines in the emergency department (ED) have not been well characterized. Methods: We examined thienopyridine use in 39,543 patients with NSTEMI included in the NCDR’s ACTION Registry®-GWTG™ (430 US hospitals) between1/2007 and 6/2010. Patients not seen initially in the ED, transferred in, not administered Clopidogrel or Prasugrel within 24 hours of presentation, or missing time data were excluded. We analyzed the patient demographics associated with ED administration and impact of ED thienopyridine administration on in-hospital outcomes. Results: Of the cohort 9564 (24.2%) received a thienopyridine in the ED. Factors independently associated with t...
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intrinsic platelet reactivity before p2y12 blockade contributes to residual platelet reactivity despite high level p2y12 blockade by prasugrel or high dose clopidogrel results from principle timi 44
Thrombosis and Haemostasis, 2011Co-Authors: Andrew L Frelinger, Stephen D. Wiviott, Dietmar Trenk, Franzjosef Neumann, Alan D Michelson, Debra L Miller, Joseph A Jakubowski, Timothy M Costigan, Carolyn H Mccabe, Elliott M AntmanAbstract:It was the objective of this study to determine whether the intrinsic platelet response to adenosine diphosphate (ADP) before thienopyridine exposure contributes to residual platelet reactivity to ADP despite high level P2Y12 blockade by prasugrel (60 mg loading dose [LD]), 10 mg daily maintenance dose [MD]) or high-dose clopidogrel (600 mg LD, 150 mg daily MD). High residual platelet function during clopidogrel therapy is associated with poor clinical outcomes. It remains unknown whether the relationship between platelet reactivity prior to treatment with clopidogrel (300 mg LD, 75 mg daily MD) and residual on-treatment platelet reactivity is maintained after more potent P2Y12 inhibition. PRINCIPLE-TIMI 44 was a randomised, double-blind, two-phase crossover study of prasugrel compared with high-dose clopidogrel in 201 patients undergoing cardiac catheterisation for planned percutaneous coronary intervention. ADP-stimulated platelet-monocyte aggregates, platelet surface P-selectin and platelet aggregation were measured pre-treatment, during LD (6 h and 18–24 h) and MD (15 d). Correlations of pre-treatment to on-treatment values were determined by Spearman rank order. Prasugrel resulted in greater platelet inhibition than high-dose clopidogrel for each measure. However, for both drugs, pre-treatment reactivity to ADP predicted 6 h, 18–24 h and 15 day reactivity to ADP (correlations 0.24–0.62 for platelet-monocyte aggregates and P-selectin). In conclusion, a patient's intrinsic platelet response to ADP before exposure to Thienopyridines contributes to residual platelet reactivity to ADP despite high level P2Y12 blockade with high-dose clopidogrel or even higher level P2Y12 blockade with prasugrel. Patients who are hyper-responsive to ADP pre-treatment are more likely to be hyper-responsive to ADP on-treatment, which may be relevant to therapeutic strategies.
Laura Mauri - One of the best experts on this subject based on the ideXlab platform.
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myocardial infarction after late discontinuation of thienopyridine therapy in the randomized dapt study
Journal of the American College of Cardiology, 2016Co-Authors: Ralph B Dagostino, Ada Stefanescu, Laura Mauri, Donald E CutlipAbstract:Background —Thienopyridine plus aspirin beyond one year after coronary stenting (PCI) reduces myocardial infarction (MI) risk and increases bleeding risk compared with aspirin alone. The hazard associated with late thienopyridine discontinuation and risk factors for MI after discontinuation are poorly defined. Methods —In the Dual Antiplatelet Therapy (DAPT) Study, after PCI and 12 months of thienopyridine (clopidogrel or prasugrel) plus aspirin, eligible patients remained on aspirin and were randomized to continued thienopyridine vs. placebo for 18 months. At 30 months, patients stopped study drug and were observed for 3 months. Cumulative incidence of MI was assessed over 3 months after randomization (months 12-15) and 3 months after study drug discontinuation (months 30-33). The MI hazard for each of these periods was assessed across randomized treatment arms and by DAPT Score values < or ≥2. Results —Among the 11648 randomized patients, the monthly cumulative incidence of MI was lower with continued thienopyridine vs. placebo at 12-15 months (0.12% vs. 0.37%, p<0.001 in all patients; 0.13% vs. 0.27%, p=0.02, in patients not treated with paclitaxel-eluting stents, PES), and higher at 30-33 months (0.30% vs. 0.15%, p=0.013, in all patients; in patients without PES, 0.18% vs. 0.17%, p=0.91). The majority of MIs in both time periods (74% and 76%) were not related to stent thrombosis (ST). After multivariable adjustment, treatment arm independently predicted MI at months 12-15 (p<0.001) and 30-33 (p=0.011). During months 12-15, patients with DAPT Scores < or ≥2 both had lower rates of MI with continued thienopyridine (MI monthly incidence 0.16% vs. 0.51%, p<0.001, for scores ≥2; 0.08% vs. 0.24%, p=0.012, for scores<2, interaction p=0.064). Conclusions —Discontinuing thienopyridine after either 12 or 30 months is associated with an early increase in MI risk, mainly unrelated to ST; the magnitude of risk is highest in the earlier time frame, and lower in patients not treated with PES. While higher DAPT Scores identify patients with greater absolute ischemic benefit (relative to bleeding harm) with continued thienopyridine therapy, discontinuation at 12 months increases MI hazard regardless of DAPT score group. Clinical Trial Registration — https://clinicaltrials.gov Identifier: [NCT00977938][1] [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00977938&atom=%2Fcirculationaha%2Fearly%2F2017%2F02%2F22%2FCIRCULATIONAHA.116.024835.atom
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causes of late mortality with dual antiplatelet therapy after coronary stents
European Heart Journal, 2015Co-Authors: Stephen D. Wiviott, Laura Mauri, Donald E Cutlip, Gabriel P Steg, Sammy Elmariah, Robert W Yeh, Stephan WindeckerAbstract:Aims In the dual antiplatelet therapy (DAPT) study, continued thienopyridine beyond 12 months after drug-eluting stent placement was associated with increased mortality compared with placebo. We sought to evaluate factors related to mortality in randomized patients receiving either drug-eluting or bare metal stents in the DAPT study. Methods and results Patients were enrolled after coronary stenting, given thienopyridine and aspirin for 12 months, randomly assigned to continued thienopyridine or placebo for an additional 18 months (while taking aspirin), and subsequently treated with aspirin alone for another 3 months. A blinded independent adjudication committee evaluated deaths. Among 11 648 randomized patients, rates of all-cause mortality rates were 1.9 vs. 1.5% (continued thienopyridine vs. placebo, P = 0.07), cardiovascular mortality, 1.0 vs. 1.0% ( P = 0.97), and non-cardiovascular mortality, 0.9 vs. 0.5% ( P = 0.01) over the randomized period (Months 12–30). Rates of fatal bleeding were 0.2 vs. 0.1% ( P = 0.81), and deaths related to any prior bleeding were 0.3 vs. 0.2% ( P = 0.36), Months 12–33). Cancer incidence did not differ (2.0 vs. 1.6%, P = 0.12). Cancer-related deaths occurred in 0.6 vs. 0.3% ( P = 0.02) and were rarely related to bleeding (0.1 vs. 0, P = 0.25). After excluding those occurring in patients with cancer diagnosed before enrolment, rates were 0.4 vs. 0.3% ( P = 0.16). Conclusion Bleeding accounted for a minority of deaths among patients treated with continued thienopyridine. Cancer-related death in association with thienopyridine therapy was mainly not related to bleeding and may be a chance finding. Caution is warranted when considering extended thienopyridine in patients with advanced cancer. Trial Registration clinicaltrials.gov Identifier: [NCT00977938][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00977938&atom=%2Fehj%2F37%2F4%2F378.atom
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twelve or 30 months of dual antiplatelet therapy after drug eluting stents
The New England Journal of Medicine, 2014Co-Authors: Laura Mauri, Stephen D. Wiviott, Dean J Kereiakes, Sharon-lise T. Normand, Donald E Cutlip, Eugene Braunwald, Gabriel P Steg, Robert W Yeh, Priscilla Driscollshempp, David J. CohenAbstract:0.29 [95% confidence interval {CI}, 0.17 to 0.48]; P<0.001) and major adverse cardiovascular and cerebrovascular events (4.3% vs. 5.9%; hazard ratio, 0.71 [95% CI, 0.59 to 0.85]; P<0.001). The rate of myocardial infarction was lower with thienopyridine treatment than with placebo (2.1% vs. 4.1%; hazard ratio, 0.47; P<0.001). The rate of death from any cause was 2.0% in the group that continued thienopyridine therapy and 1.5% in the placebo group (hazard ratio, 1.36 [95% CI, 1.00 to 1.85]; P = 0.05). The rate of moderate or severe bleeding was increased with continued thienopyridine treatment (2.5% vs. 1.6%, P = 0.001). An elevated risk of stent thrombosis and myocardial infarction was observed in both groups during the 3 months after discontinuation of thienopyridine treatment. Conclusions Dual antiplatelet therapy beyond 1 year after placement of a drug-eluting stent, as compared with aspirin therapy alone, significantly reduced the risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events but was associated with an increased risk of bleeding. (Funded by a consortium of eight device and drug manufacturers and others; DAPT ClinicalTrials.gov number, NCT00977938.)
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rationale and design of the dual antiplatelet therapy study a prospective multicenter randomized double blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing percutaneous coronar
American Heart Journal, 2010Co-Authors: David J. Cohen, Stephen D. Wiviott, Laura Mauri, Dean J Kereiakes, Sripal Bangalore, Sharon-lise T. Normand, David R HolmesAbstract:Background Dual antiplatelet therapy with aspirin and Thienopyridines (clopidogrel or prasugrel) is required after placement of coronary stents to prevent thrombotic complications. Although current clinical practice guidelines recommend 12-month treatment after drug-eluting stent placement, even longer durations may prevent thrombotic events. Study Design The Dual Antiplatelet Therapy (DAPT) Study is comparing the benefits and risks of 12 versus 30 months of dual antiplatelet therapy in preventing stent thrombosis or major adverse cardiovascular and cerebrovascular events in subjects undergoing percutaneous coronary intervention (PCI) for the treatment of coronary artery obstructive lesions. The DAPT Study is a multicenter, international, randomized, double-blind, placebo-controlled trial that will enroll 15,245 subjects treated with drug-eluting stent (DES) and 5,400 subjects treated with bare-metal stents (BMS). All subjects will receive 12 months of open-label thienopyridine treatment in addition to aspirin. After 12 months, subjects who are free from death, myocardial infarction, or stroke (MACCE), repeat revascularization, and GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) moderate or severe bleeding events will be randomized to receive either 18 additional months of thienopyridine (clopidogrel or prasugrel) (30 month DAPT arm) or placebo (12 month DAPT arm) plus aspirin. Coprimary end points are MACCE and stent thrombosis. The primary safety end point is GUSTO moderate or severe bleeding. Conclusions This randomized trial is designed to define the relative safety and effectiveness of 12 versus 30 months of dual antiplatelet therapy across the broad spectrum of patients receiving coronary stents.
Shlomi Matetzky - One of the best experts on this subject based on the ideXlab platform.
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antiplatelet effect of thienopyridine clopidogrel or prasugrel pretreatment in patients undergoing primary percutaneous intervention for st elevation myocardial infarction
American Journal of Cardiology, 2013Co-Authors: Roy Beigel, Paul Fefer, Ilia Novikov, Noam Fink, Dan Elian, Nurit Rosenberg, Victor Guetta, Amit Segev, Shlomi MatetzkyAbstract:Although previous retrospective studies have suggested the clinical benefits of clopidogrel pretreatment in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI), the antiplatelet effect of Thienopyridines during a narrow door-to-balloon time frame has not been evaluated. Seventy-nine consecutive patients with STEMI were treated with either 600 mg of clopidogrel (n = 49) or 60 mg of prasugrel (n = 30) loading on admission. All patients underwent PPCI with a door-to-balloon time of 48 ± 20 minutes. Adenosine diphosphate (ADP)–induced platelet aggregation (PA) was determined by light transmission aggregometry before thienopyridine loading, at PPCI, and after 72 hours. Baseline ADP-induced PA was comparable in clopidogrel- and prasugrel-treated patients (79 ± 10% vs 76 ± 9%, p = 0.2). Although ADP-induced PA was reduced significantly in both clopidogrel- and prasugrel-treated patients (p 50% (26 of 30 [87%] vs 35 of 49 [71%], p = 0.1), suggesting better myocardial reperfusion. In conclusion, overall, prasugrel compared with clopidogrel pretreatment resulted in greater platelet inhibition at PPCI, but even with prasugrel, only
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antiplatelet effect of thienopyridine clopidogrel or prasugrel pretreatment in patients undergoing primary percutaneous intervention for st elevation myocardial infarction
American Journal of Cardiology, 2013Co-Authors: Roy Beigel, Paul Fefer, Ilia Novikov, Noam Fink, Dan Elian, Nurit Rosenberg, Victor Guetta, Amit Segev, Shlomi MatetzkyAbstract:Although previous retrospective studies have suggested the clinical benefits of clopidogrel pretreatment in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI), the antiplatelet effect of Thienopyridines during a narrow door-to-balloon time frame has not been evaluated. Seventy-nine consecutive patients with STEMI were treated with either 600 mg of clopidogrel (n = 49) or 60 mg of prasugrel (n = 30) loading on admission. All patients underwent PPCI with a door-to-balloon time of 48 ± 20 minutes. Adenosine diphosphate (ADP)–induced platelet aggregation (PA) was determined by light transmission aggregometry before thienopyridine loading, at PPCI, and after 72 hours. Baseline ADP-induced PA was comparable in clopidogrel- and prasugrel-treated patients (79 ± 10% vs 76 ± 9%, p = 0.2). Although ADP-induced PA was reduced significantly in both clopidogrel- and prasugrel-treated patients (p 50% (26 of 30 [87%] vs 35 of 49 [71%], p = 0.1), suggesting better myocardial reperfusion. In conclusion, overall, prasugrel compared with clopidogrel pretreatment resulted in greater platelet inhibition at PPCI, but even with prasugrel, only
Gabriel P Steg - One of the best experts on this subject based on the ideXlab platform.
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diabetes mellitus and prevention of late myocardial infarction after coronary stenting in the randomized dual antiplatelet therapy study
Circulation, 2016Co-Authors: Ian T Meredith, Dean J Kereiakes, Donald E Cutlip, Gabriel P Steg, Robert W Yeh, Jeanfrancois Tanguay, Kirk N Garratt, David P Lee, Douglas W Weaver, David R HolmesAbstract:Background—Patients with diabetes mellitus (DM) are at high risk for recurrent ischemic events after coronary stenting. We assessed the effects of continued thienopyridine among patients with DM participating in the Dual Antiplatelet Therapy (DAPT) Study as a prespecified analysis. Methods and Results—After coronary stent placement and 12 months treatment with open-label thienopyridine plus aspirin, 11 648 patients free of ischemic or bleeding events and who were medication compliant were randomly assigned to continued thienopyridine or placebo, in addition to aspirin, for 18 more months. After randomization, patients with DM (n=3391), in comparison with patients without DM (n=8257), had increased composite outcome of death, myocardial infarction (MI), or stroke (6.8% versus 4.3%, P<0.001), increased death (2.5% versus 1.4%, P<0.001), and MI (4.2% versus 2.6%, P<0.001). Among patients with DM, in a comparison of continued thienopyridine versus placebo, rates of stent thrombosis were 0.5% versus 1.1%, P=0....
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benefits and risks of extended dual antiplatelet therapy after everolimus eluting stents
Jacc-cardiovascular Interventions, 2016Co-Authors: James B Hermiller, David J. Cohen, Dean J Kereiakes, Donald E Cutlip, Gabriel P Steg, Robert W Yeh, Stephan Windecker, Mitchell W Krucoff, Joseph M Massaro, Wenhua HsiehAbstract:Abstract Objectives The purpose of this study was to characterize outcomes for everolimus-eluting stent (EES)–treated subjects according to treatment with continued thienopyridine plus aspirin versus aspirin alone 12 to 30 months after stenting. Background In the DAPT (Dual Antiplatelet Therapy) study, continued thienopyridine plus aspirin beyond 1 year after coronary stenting reduced ischemic events. Given low rates of stent thrombosis and myocardial infarction (MI) for current drug-eluting stents, we examined outcomes among EES-treated subjects in the DAPT study. Methods The DAPT study enrolled 25,682 subjects (11,308 EES-treated) after coronary stenting. Following 12 months of treatment with thienopyridine and aspirin, eligible subjects continued treatment with aspirin and 9,961 (4,703 with EES) were randomized to 18 months of continued thienopyridine or placebo. Stent type was not randomized, and the EES subset analysis was post hoc. Results Among EES-treated patients, continued thienopyridine reduced stent thrombosis (0.3% vs. 0.7%, hazard ratio [HR]: 0.38, 95% confidence interval [CI]: 0.15 to 0.97; p = 0.04) and MI (2.1% vs. 3.2%, HR: 0.63, 95% CI: 0.44 to 0.91; p = 0.01) versus placebo but did not reduce a composite of death, MI, and stroke (4.3% vs. 4.5%, HR: 0.89, 95% CI: 0.67 to 1.18; p = 0.42), and increased moderate/severe bleeding (2.5% vs. 1.3%, HR: 1.79, 95% CI: 1.15 to 2.80; p = 0.01), and death (2.2% vs. 1.1%, HR: 1.80, 95% CI: 1.11 to 2.92; p = 0.02). Death due to cancer and not related to bleeding was increased (0.64% vs. 0.17%; p = 0.01). Conclusions In EES-treated subjects, significant reductions in stent thrombosis and MI and an increase in bleeding were observed with continued thienopyridine beyond 1 year compared with aspirin alone. (The Dual Antiplatelet Therapy Study [DAPT Study]); NCT00977938 )
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causes of late mortality with dual antiplatelet therapy after coronary stents
European Heart Journal, 2015Co-Authors: Stephen D. Wiviott, Laura Mauri, Donald E Cutlip, Gabriel P Steg, Sammy Elmariah, Robert W Yeh, Stephan WindeckerAbstract:Aims In the dual antiplatelet therapy (DAPT) study, continued thienopyridine beyond 12 months after drug-eluting stent placement was associated with increased mortality compared with placebo. We sought to evaluate factors related to mortality in randomized patients receiving either drug-eluting or bare metal stents in the DAPT study. Methods and results Patients were enrolled after coronary stenting, given thienopyridine and aspirin for 12 months, randomly assigned to continued thienopyridine or placebo for an additional 18 months (while taking aspirin), and subsequently treated with aspirin alone for another 3 months. A blinded independent adjudication committee evaluated deaths. Among 11 648 randomized patients, rates of all-cause mortality rates were 1.9 vs. 1.5% (continued thienopyridine vs. placebo, P = 0.07), cardiovascular mortality, 1.0 vs. 1.0% ( P = 0.97), and non-cardiovascular mortality, 0.9 vs. 0.5% ( P = 0.01) over the randomized period (Months 12–30). Rates of fatal bleeding were 0.2 vs. 0.1% ( P = 0.81), and deaths related to any prior bleeding were 0.3 vs. 0.2% ( P = 0.36), Months 12–33). Cancer incidence did not differ (2.0 vs. 1.6%, P = 0.12). Cancer-related deaths occurred in 0.6 vs. 0.3% ( P = 0.02) and were rarely related to bleeding (0.1 vs. 0, P = 0.25). After excluding those occurring in patients with cancer diagnosed before enrolment, rates were 0.4 vs. 0.3% ( P = 0.16). Conclusion Bleeding accounted for a minority of deaths among patients treated with continued thienopyridine. Cancer-related death in association with thienopyridine therapy was mainly not related to bleeding and may be a chance finding. Caution is warranted when considering extended thienopyridine in patients with advanced cancer. Trial Registration clinicaltrials.gov Identifier: [NCT00977938][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00977938&atom=%2Fehj%2F37%2F4%2F378.atom
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twelve or 30 months of dual antiplatelet therapy after drug eluting stents
The New England Journal of Medicine, 2014Co-Authors: Laura Mauri, Stephen D. Wiviott, Dean J Kereiakes, Sharon-lise T. Normand, Donald E Cutlip, Eugene Braunwald, Gabriel P Steg, Robert W Yeh, Priscilla Driscollshempp, David J. CohenAbstract:0.29 [95% confidence interval {CI}, 0.17 to 0.48]; P<0.001) and major adverse cardiovascular and cerebrovascular events (4.3% vs. 5.9%; hazard ratio, 0.71 [95% CI, 0.59 to 0.85]; P<0.001). The rate of myocardial infarction was lower with thienopyridine treatment than with placebo (2.1% vs. 4.1%; hazard ratio, 0.47; P<0.001). The rate of death from any cause was 2.0% in the group that continued thienopyridine therapy and 1.5% in the placebo group (hazard ratio, 1.36 [95% CI, 1.00 to 1.85]; P = 0.05). The rate of moderate or severe bleeding was increased with continued thienopyridine treatment (2.5% vs. 1.6%, P = 0.001). An elevated risk of stent thrombosis and myocardial infarction was observed in both groups during the 3 months after discontinuation of thienopyridine treatment. Conclusions Dual antiplatelet therapy beyond 1 year after placement of a drug-eluting stent, as compared with aspirin therapy alone, significantly reduced the risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events but was associated with an increased risk of bleeding. (Funded by a consortium of eight device and drug manufacturers and others; DAPT ClinicalTrials.gov number, NCT00977938.)
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efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes treated with glycoprotein iib iiia inhibitors or Thienopyridines results from the oasis 5 fifth organization to assess strategies in ischemic syndromes trial
Journal of the American College of Cardiology, 2009Co-Authors: Sanjit S Jolly, David P Faxon, Keith A A Fox, Rizwan Afzal, William E Boden, Petr Widimsky, Gabriel P Steg, Vicent Valentin, Andrez Budaj, Christopher B GrangerAbstract:Objectives This study sought to evaluate the relative safety and efficacy of fondaparinux and enoxaparin in patients with acute coronary syndromes (ACS) treated with glycoprotein (GP) IIb/IIIa inhibitors or Thienopyridines. Background The OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial showed that fondaparinux reduced major bleeding by 50% compared with enoxaparin while preserving similar efficacy. Whether this benefit is consistent in the presence or absence of concurrent antiplatelet therapy with clopidogrel and GP IIb/IIIa inhibitors is unknown. Methods Patients with ACS (n =20,078) were randomized as a part of the OASIS 5 trial to receive either fondaparinux or enoxaparin. The use of GP IIb/IIIa inhibitors or Thienopyridines was at the discretion of the treating physician. A Cox proportional hazard model was used to compare outcomes. Results Of the 20,078 patients randomized, 3,630 patients received GP IIb/IIIa and 13,531 received Thienopyridines. There was a 40% reduction in major bleeding with fondaparinux compared with enoxaparin in those treated with GP IIb/IIIa (5.2% vs. 8.3%, hazard ratio [HR]: 0.61, p Conclusions In patients receiving GP IIb/IIIa inhibitors or Thienopyridines, fondaparinux reduces major bleeding and improves net clinical outcome compared with enoxaparin.
