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Holger Thiele - One of the best experts on this subject based on the ideXlab platform.
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1 year outcomes with Intracoronary abciximab in diabetic patients undergoing primary percutaneous coronary intervention
Journal of the American College of Cardiology, 2016Co-Authors: Raffaele Piccolo, Ingo Eitel, Gennaro Galasso, Alberto Dominguezrodriguez, Allan Iversen, Pedro Abreugonzalez, Stephan Windecker, Holger Thiele, Federico PiscioneAbstract:Abstract Background Diabetic patients are at increased risk for future cardiovascular events after ST-segment elevation myocardial infarction (STEMI). Administration of an Intracoronary abciximab bolus during primary percutaneous coronary intervention (PCI) may be beneficial in this high-risk subgroup. Objectives This study sought to report the 1-year clinical outcomes and cardiac magnetic resonance (CMR) findings in STEMI patients with and without diabetes randomized to Intracoronary or intravenous abciximab bolus at the time of primary PCI. Methods Patient-level data from 3 randomized trials were pooled. The primary endpoint was the composite of death or reinfarction. Comprehensive CMR imaging was performed in 1 study. Results Of 2,470 patients, 473 (19%) had diabetes and 1,997 (81%) did not. At 1 year, the primary endpoint was significantly reduced in diabetic patients randomized to Intracoronary abciximab compared with those randomized to intravenous bolus (9.2% vs. 17.6%; hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.28 to 0.83; p = 0.009). The Intracoronary abciximab bolus did not reduce the primary endpoint in patients without diabetes (7.4% vs. 7.5%; HR: 0.95; 95% CI: 0.68 to 1.33; p = 0.77), resulting in a significant interaction (p = 0.034). Among diabetic patients, Intracoronary versus intravenous abciximab bolus was associated with a significantly reduced risk of death (5.8% vs. 11.2%; HR: 0.51; 95% CI: 0.26 to 0.98; p = 0.043) and definite/probable stent thrombosis (1.3% vs. 4.8%; HR: 0.27; 95% CI: 0.08 to 0.98; p = 0.046). At CMR (n = 792), the myocardial salvage index was significantly increased only in diabetic patients randomized to Intracoronary compared with intravenous abciximab (54.4; interquartile range: 35.1 to 78.2 vs. 39.0, interquartile range: 24.7 to 61.7; p = 0.011; p for interaction vs. no diabetes = 0.016). Conclusions In diabetic patients with STEMI, the administration of Intracoronary abciximab improved the effectiveness of primary PCI compared with the intravenous bolus.
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Intracoronary versus intravenous bolus abciximab administration in patients undergoing primary percutaneous coronary intervention with acute st elevation myocardial infarction a pooled analysis of individual patient data from five randomised controlled trials
Eurointervention, 2014Co-Authors: Raffaele Piccolo, Ingo Eitel, Alberto Dominguezrodriguez, Allan Iversen, Pedro Abreugonzalez, Holger Thiele, Bart J.g.l. De ,smet, Karim D Mahmoud, Federico PiscioneAbstract:Aims: In recent years, Intracoronary bolus abciximab has emerged as an alternative to the standard intravenous route in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The aim of the current study was to perform an individual patient-level pooled analysis of randomised trials, comparing Intracoronary versus intravenous abciximab bolus use in STEMI patients undergoing primary PCI. Methods and results: Individual data of 3,158 patients enrolled in five trials were analysed. Reperfusion endpoints were: post-procedural Thrombolysis in Myocardial Infarction (TIMI) 3 flow, myocardial blush grade (MBG) 2/3 and complete ST-segment resolution. The primary clinical endpoint of interest was the composite of death and reinfarction at 30 days. Compared with the intravenous route, Intracoronary abciximab bolus administration did not improve TIMI 3 flow (odds ratio [OR] 1.19; 95% confidence interval [CI]: 0.90-1.59; p=0.23) and complete ST-segment resolution (OR 1.22, 95% CI: 0.92-1.63, p=0.17), but increased MBG 2/3 occurrence (OR 1.83, 95% CI: 1.05-3.18, p=0.03). At 30-day follow-up, Intracoronary bolus abciximab did not reduce the risk of death and reinfarction (OR 0.78, 95% CI: 0.55-1.10, p=0.16), death (OR 0.77, 95% CI: 0.51-1.17, p=0.22), reinfarction (OR 0.79, 95% CI: 0.46-1.33, p=0.38) and stent thrombosis (OR 0.77, 95% CI: 0.43-1.35, p=0.36) as compared with intravenous administration. Conclusions: In STEMI patients undergoing primary PCI, Intracoronary abciximab does not provide additional benefits as compared with standard intravenous treatment and, therefore, it should not be recommended as the default route of administration in this setting.
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Intracoronary versus intravenous bolus abciximab during primary percutaneous coronary intervention in patients with acute st elevation myocardial infarction a randomised trial
The Lancet, 2012Co-Authors: Holger Thiele, Jochen Wohrle, Petra Neuhaus, Oana Brosteanu, Peter Sick, Ralf Birkemeyer, Rainer Hambrecht, Harald Rittger, Bernward Lauer, Marcus WiemerAbstract:Summary Background Intracoronary administration of an abciximab bolus during a primary percutaneous coronary intervention results in a high local drug concentration, improved perfusion, and reduction of infarct size compared with intravenous bolus application. However, the safety and efficacy of Intracoronary versus standard intravenous bolus application in patients with ST-elevation myocardial infarction (STEMI) undergoing this intervention has not been tested in a large-scale clinical trial. Methods The AIDA STEMI trial was a randomised, open-label, multicentre trial. Patients presenting with STEMI in the previous 12 h with no contraindications for abciximab were randomly assigned in a 1:1 ratio by a central web-based randomisation system to Intracoronary versus intravenous abciximab bolus (0·25 mg/kg bodyweight) during percutaneous coronary intervention with a subsequent 12 h intravenous infusion 0·125 μg/kg per min (maximum 10 μg/min). The primary endpoint was a composite of all-cause mortality, recurrent infarction, or new congestive heart failure within 90 days of randomisation. Secondary endpoints were the time to occurrence of the primary endpoint, each individual component of that endpoint, early ST-segment resolution, thrombolysis in myocardial infarction (TIMI) flow grade, and enzymatic infarct size. A masked central committee adjudicated the primary outcome and its components. Treatment allocation was not concealed from patients and investigators. This trial is registered with ClinicalTrials.gov, NCT00712101. Findings Between July, 2008, and April, 2011, 2065 patients were randomly assigned Intracoronary abciximab (n=1032) or intravenous abciximab (n=1033). Intracoronary, as compared with intravenous abciximab, resulted in a similar rate of the primary composite clinical endpoint at 90 days in 1876 analysable patients (7·0% vs 7·6%; odds ratio [OR] 0·91; 95% CI 0·64–1·28; p=0·58). The incidence of death (4·5% vs 3·6%; 1·24; 0·78–1·97; p=0·36) and reinfarction (1·8% vs 1·8%; 1·0; 0·51–1·96; p=0·99) did not differ between the treatment groups, whereas less patients in the Intracoronary group had new congestive heart failure (2·4% vs 4·1%; 0·57; 0·33–0·97; p=0·04). None of the secondary endpoints or safety measures differed significantly between groups. Interpretation In patients with STEMI undergoing primary percutaneous coronary intervention, Intracoronary as compared to intravenous abciximab did not result in a difference in the combined endpoint of death, reinfarction, or congestive heart failure. Since Intracoronary abciximab bolus administration is safe and might be related to reduced rates of congestive heart failure the Intracoronary route might be preferred if abciximab is indicated. Funding Lilly, Germany. University of Leipzig—Heart Centre. University of Leipzig, Clinical Trial Centre Leipzig, supported by the Federal Ministry of Education and Research (BMBF).
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clinical impact of Intracoronary abciximab in patients undergoing primary percutaneous coronary intervention an individual patient data pooled analysis of randomised studies
Heart, 2012Co-Authors: Raffaele Piccolo, Ingo Eitel, Alberto Dominguezrodriguez, Allan Iversen, Pedro Abreugonzalez, Holger Thiele, Bart J.g.l. De ,smet, Karim D Mahmoud, Federico PiscioneAbstract:Objectives The aim of this study was to perform an individual patient-level pooled analysis of randomised trials, comparing Intracoronary versus intravenous abciximab bolus use in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Background Abciximab represents a cornerstone in the treatment of STEMI patients undergoing primary PCI. Intracoronary abciximab bolus administration has been proposed as an alternative strategy to the standard intravenous route. However, whether Intracoronary abciximab effectively improves clinical outcomes compared with standard route remains unknown. Methods Individual data of 1198 patients enrolled in five trials were entered into the pooled analysis. The primary endpoint of the study was the occurrence of all-cause death and reinfarction at 30-day follow-up. Secondary endpoints were all-cause death, reinfarction and target-vessel revascularisation (TVR). Results No significant heterogeneity was found across trials. Compared with the intravenous route, Intracoronary abciximab administration significantly reduced the risk of the composite of death and reinfarction (HR 0.52, 95% CI 0.29 to 0.94; p=0.03), death (HR 0.44, 95% CI 0.20 to 0.95; p=0.04) and TVR (HR 0.53, 95% CI 0.29 to 0.99; p=0.045), without a significant impact on the risk of reinfarction (HR 0.54, 95% CI 0.24 to 1.21; p=0.13). However, after correction for baseline differences, only the composite of death/reinfarction and death remained significant. Conclusions In STEMI patients undergoing primary PCI, Intracoronary abciximab administration, when compared with the intravenous standard route, can improve short-term clinical outcomes mainly by reducing the risk of death.
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Intracoronary compared with intravenous bolus abciximab application during primary percutaneous coronary intervention design and rationale of the abciximab Intracoronary versus intravenously drug application in st elevation myocardial infarction aida stemi trial
American Heart Journal, 2010Co-Authors: Holger Thiele, Jochen Wohrle, Petra Neuhaus, Oana Brosteanu, Peter Sick, Roland Prondzinsky, Ralf Birkemeyer, Marcus Wiemer, Sebastian Kerber, Helmut SchuehlenAbstract:Background Intravenous abciximab reduces major adverse cardiac events in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Intracoronary abciximab bolus application during PCI results in high local drug concentration, improved perfusion, reduction of infarct size, and less microvascular obstruction. The hypothesis of this trial is that abciximab bolus Intracoronary in comparison to standard intravenous application will improve the outcome of patients undergoing primary PCI in STEMI. Study design The Abciximab Intracoronary versus intravenously Drug Application in STEMI (AIDA STEMI) study is a 1,912-patient, prospective, multicenter, randomized, open-label, controlled trial. The study is designed to compare the efficacy and safety of Intracoronary versus intravenous bolus abciximab administration during primary PCI with subsequent intravenous infusion for 12 hours. Patients will be randomized in a 1:1 fashion to 1 of the 2 treatments. The primary efficacy end point of AIDA STEMI is the composite of all-cause mortality, recurrent MI, or new congestive heart failure within 90 days of randomization. The primary safety outcome assessment will be major bleeding. Conclusions The AIDA STEMI study addresses important questions regarding the efficacy and safety of Intracoronary abciximab bolus administration during primary PCI in patients with STEMI, potentially optimizing the route of administration of glycoprotein IIb/IIIa inhibitors in the catheterization laboratory.
Ingo Eitel - One of the best experts on this subject based on the ideXlab platform.
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1 year outcomes with Intracoronary abciximab in diabetic patients undergoing primary percutaneous coronary intervention
Journal of the American College of Cardiology, 2016Co-Authors: Raffaele Piccolo, Ingo Eitel, Gennaro Galasso, Alberto Dominguezrodriguez, Allan Iversen, Pedro Abreugonzalez, Stephan Windecker, Holger Thiele, Federico PiscioneAbstract:Abstract Background Diabetic patients are at increased risk for future cardiovascular events after ST-segment elevation myocardial infarction (STEMI). Administration of an Intracoronary abciximab bolus during primary percutaneous coronary intervention (PCI) may be beneficial in this high-risk subgroup. Objectives This study sought to report the 1-year clinical outcomes and cardiac magnetic resonance (CMR) findings in STEMI patients with and without diabetes randomized to Intracoronary or intravenous abciximab bolus at the time of primary PCI. Methods Patient-level data from 3 randomized trials were pooled. The primary endpoint was the composite of death or reinfarction. Comprehensive CMR imaging was performed in 1 study. Results Of 2,470 patients, 473 (19%) had diabetes and 1,997 (81%) did not. At 1 year, the primary endpoint was significantly reduced in diabetic patients randomized to Intracoronary abciximab compared with those randomized to intravenous bolus (9.2% vs. 17.6%; hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.28 to 0.83; p = 0.009). The Intracoronary abciximab bolus did not reduce the primary endpoint in patients without diabetes (7.4% vs. 7.5%; HR: 0.95; 95% CI: 0.68 to 1.33; p = 0.77), resulting in a significant interaction (p = 0.034). Among diabetic patients, Intracoronary versus intravenous abciximab bolus was associated with a significantly reduced risk of death (5.8% vs. 11.2%; HR: 0.51; 95% CI: 0.26 to 0.98; p = 0.043) and definite/probable stent thrombosis (1.3% vs. 4.8%; HR: 0.27; 95% CI: 0.08 to 0.98; p = 0.046). At CMR (n = 792), the myocardial salvage index was significantly increased only in diabetic patients randomized to Intracoronary compared with intravenous abciximab (54.4; interquartile range: 35.1 to 78.2 vs. 39.0, interquartile range: 24.7 to 61.7; p = 0.011; p for interaction vs. no diabetes = 0.016). Conclusions In diabetic patients with STEMI, the administration of Intracoronary abciximab improved the effectiveness of primary PCI compared with the intravenous bolus.
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Intracoronary versus intravenous bolus abciximab administration in patients undergoing primary percutaneous coronary intervention with acute st elevation myocardial infarction a pooled analysis of individual patient data from five randomised controlled trials
Eurointervention, 2014Co-Authors: Raffaele Piccolo, Ingo Eitel, Alberto Dominguezrodriguez, Allan Iversen, Pedro Abreugonzalez, Holger Thiele, Bart J.g.l. De ,smet, Karim D Mahmoud, Federico PiscioneAbstract:Aims: In recent years, Intracoronary bolus abciximab has emerged as an alternative to the standard intravenous route in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The aim of the current study was to perform an individual patient-level pooled analysis of randomised trials, comparing Intracoronary versus intravenous abciximab bolus use in STEMI patients undergoing primary PCI. Methods and results: Individual data of 3,158 patients enrolled in five trials were analysed. Reperfusion endpoints were: post-procedural Thrombolysis in Myocardial Infarction (TIMI) 3 flow, myocardial blush grade (MBG) 2/3 and complete ST-segment resolution. The primary clinical endpoint of interest was the composite of death and reinfarction at 30 days. Compared with the intravenous route, Intracoronary abciximab bolus administration did not improve TIMI 3 flow (odds ratio [OR] 1.19; 95% confidence interval [CI]: 0.90-1.59; p=0.23) and complete ST-segment resolution (OR 1.22, 95% CI: 0.92-1.63, p=0.17), but increased MBG 2/3 occurrence (OR 1.83, 95% CI: 1.05-3.18, p=0.03). At 30-day follow-up, Intracoronary bolus abciximab did not reduce the risk of death and reinfarction (OR 0.78, 95% CI: 0.55-1.10, p=0.16), death (OR 0.77, 95% CI: 0.51-1.17, p=0.22), reinfarction (OR 0.79, 95% CI: 0.46-1.33, p=0.38) and stent thrombosis (OR 0.77, 95% CI: 0.43-1.35, p=0.36) as compared with intravenous administration. Conclusions: In STEMI patients undergoing primary PCI, Intracoronary abciximab does not provide additional benefits as compared with standard intravenous treatment and, therefore, it should not be recommended as the default route of administration in this setting.
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Intracoronary compared with intravenous bolus abciximab application during primary percutaneous coronary intervention in st segment elevation myocardial infarction cardiac magnetic resonance substudy of the aida stemi trial
Journal of the American College of Cardiology, 2013Co-Authors: Ingo Eitel, Jochen Wohrle, Ralf Birkemeyer, Sebastian Kerber, Bernward Lauer, Henning Suenkel, Josephine Meissner, Matthias Pauschinger, Christoph Axthelm, R ZimmermannAbstract:Objectives The aim of the AIDA STEMI (Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction) cardiac magnetic resonance (CMR) substudy was to investigate potential benefits of Intracoronary versus intravenous abciximab bolus administration on infarct size and reperfusion injury in ST-segment elevation myocardial infarction. Background The AIDA STEMI trial randomized 2,065 patients to Intracoronary or intravenous abciximab and found similar rates of major adverse cardiac events at 90 days with significantly less congestive heart failure in the Intracoronary abciximab group. CMR can directly visualize myocardial damage and reperfusion injury, thereby providing mechanistic and pathophysiological insights. Methods We enrolled 795 patients in the AIDA STEMI CMR substudy. CMR was completed within 1 week after ST-segment elevation myocardial infarction. Central core laboratory–masked analyses for quantified ventricular function, volumes, infarct size, microvascular obstruction, hemorrhage, and myocardial salvage were performed. Results The area at risk (p = 0.97) and final infarct size (16% [interquartile range: 9% to 25%] versus 17% [interquartile range: 8% to 25%], p = 0.52) did not differ significantly between the Intracoronary and the intravenous abciximab groups. Consequently, the myocardial salvage index was similar (52 [interquartile range: 35 to 69] versus 50 [interquartile range: 29 to 69], p = 0.25). There were also no differences in microvascular obstruction (p = 0.19), intramyocardial hemorrhage (p = 0.19), or ejection fraction (p = 0.95) between both treatment groups. Patients in whom major adverse cardiac events occurred had significantly larger infarcts, less myocardial salvage, and more pronounced ventricular dysfunction. Conclusions This largest multicenter CMR study in ST-segment elevation myocardial infarction patients to date demonstrates no benefit of Intracoronary versus intravenous abciximab administration on myocardial damage and/or reperfusion injury. Infarct size determined by CMR was significantly associated with major adverse cardiac events. (Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction [AIDA STEMI]; NCT00712101 )
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platelet inhibition and gp iib iiia receptor occupancy by Intracoronary versus intravenous bolus administration of abciximab in patients with st elevation myocardial infarction
Clinical Research in Cardiology, 2012Co-Authors: Steffen Desch, Annelie Siegemund, Ute Scholz, Natalie Adam, Ingo Eitel, Suzanne De Waha, Georg Furnau, Philipp Lurz, Sabrina Wetzel, Gerhard SchulerAbstract:In patients with ST-elevation myocardial infarction (STEMI), direct Intracoronary bolus administration of the glycoprotein (GP) IIb/IIIa receptor antagonist abciximab is associated with a reduction in infarct size, better myocardial salvage, less microvascular obstruction and improved myocardial blush grade as compared to intravenous bolus injection, presumably caused by higher local drug concentrations leading to a more pronounced inhibition of platelet aggregation. We investigated whether there are differences in the degree of GP IIb/IIIa receptor occupancy and platelet inhibition in blood drawn from the coronary sinus (CS) shortly after Intracoronary versus intravenous abciximab bolus administration. A total of 16 patients with acute STEMI undergoing primary percutaneous coronary intervention within 12 h of symptom onset underwent blood sampling from the CS before, immediately after and 30 min after abciximab bolus administration (Intracoronary bolus: n = 8 patients; intravenous bolus: n = 8 patients). Immediately after bolus application, GP IIb/IIIa receptor occupancy in CS blood was significantly higher in patients who received direct Intracoronary bolus injection compared to administration via a peripheral vein (Intracoronary bolus: 93.5% [IQR 92.7–95.4]; intravenous bolus: 74.0% [IQR 17.6–94.0], p = 0.04). The degree of platelet inhibition was also markedly higher with Intracoronary compared to intravenous dosing. At late sampling after 30 min no significant differences were found between groups for both platelet reactivity and GP IIb/IIIa receptor occupancy. Acutely, direct Intracoronary bolus injection resulted in a more pronounced local inhibition of platelet function and a higher degree of GP IIb/IIIa receptor occupancy as compared to standard intravenous bolus injection.
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clinical impact of Intracoronary abciximab in patients undergoing primary percutaneous coronary intervention an individual patient data pooled analysis of randomised studies
Heart, 2012Co-Authors: Raffaele Piccolo, Ingo Eitel, Alberto Dominguezrodriguez, Allan Iversen, Pedro Abreugonzalez, Holger Thiele, Bart J.g.l. De ,smet, Karim D Mahmoud, Federico PiscioneAbstract:Objectives The aim of this study was to perform an individual patient-level pooled analysis of randomised trials, comparing Intracoronary versus intravenous abciximab bolus use in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Background Abciximab represents a cornerstone in the treatment of STEMI patients undergoing primary PCI. Intracoronary abciximab bolus administration has been proposed as an alternative strategy to the standard intravenous route. However, whether Intracoronary abciximab effectively improves clinical outcomes compared with standard route remains unknown. Methods Individual data of 1198 patients enrolled in five trials were entered into the pooled analysis. The primary endpoint of the study was the occurrence of all-cause death and reinfarction at 30-day follow-up. Secondary endpoints were all-cause death, reinfarction and target-vessel revascularisation (TVR). Results No significant heterogeneity was found across trials. Compared with the intravenous route, Intracoronary abciximab administration significantly reduced the risk of the composite of death and reinfarction (HR 0.52, 95% CI 0.29 to 0.94; p=0.03), death (HR 0.44, 95% CI 0.20 to 0.95; p=0.04) and TVR (HR 0.53, 95% CI 0.29 to 0.99; p=0.045), without a significant impact on the risk of reinfarction (HR 0.54, 95% CI 0.24 to 1.21; p=0.13). However, after correction for baseline differences, only the composite of death/reinfarction and death remained significant. Conclusions In STEMI patients undergoing primary PCI, Intracoronary abciximab administration, when compared with the intravenous standard route, can improve short-term clinical outcomes mainly by reducing the risk of death.
Federico Piscione - One of the best experts on this subject based on the ideXlab platform.
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1 year outcomes with Intracoronary abciximab in diabetic patients undergoing primary percutaneous coronary intervention
Journal of the American College of Cardiology, 2016Co-Authors: Raffaele Piccolo, Ingo Eitel, Gennaro Galasso, Alberto Dominguezrodriguez, Allan Iversen, Pedro Abreugonzalez, Stephan Windecker, Holger Thiele, Federico PiscioneAbstract:Abstract Background Diabetic patients are at increased risk for future cardiovascular events after ST-segment elevation myocardial infarction (STEMI). Administration of an Intracoronary abciximab bolus during primary percutaneous coronary intervention (PCI) may be beneficial in this high-risk subgroup. Objectives This study sought to report the 1-year clinical outcomes and cardiac magnetic resonance (CMR) findings in STEMI patients with and without diabetes randomized to Intracoronary or intravenous abciximab bolus at the time of primary PCI. Methods Patient-level data from 3 randomized trials were pooled. The primary endpoint was the composite of death or reinfarction. Comprehensive CMR imaging was performed in 1 study. Results Of 2,470 patients, 473 (19%) had diabetes and 1,997 (81%) did not. At 1 year, the primary endpoint was significantly reduced in diabetic patients randomized to Intracoronary abciximab compared with those randomized to intravenous bolus (9.2% vs. 17.6%; hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.28 to 0.83; p = 0.009). The Intracoronary abciximab bolus did not reduce the primary endpoint in patients without diabetes (7.4% vs. 7.5%; HR: 0.95; 95% CI: 0.68 to 1.33; p = 0.77), resulting in a significant interaction (p = 0.034). Among diabetic patients, Intracoronary versus intravenous abciximab bolus was associated with a significantly reduced risk of death (5.8% vs. 11.2%; HR: 0.51; 95% CI: 0.26 to 0.98; p = 0.043) and definite/probable stent thrombosis (1.3% vs. 4.8%; HR: 0.27; 95% CI: 0.08 to 0.98; p = 0.046). At CMR (n = 792), the myocardial salvage index was significantly increased only in diabetic patients randomized to Intracoronary compared with intravenous abciximab (54.4; interquartile range: 35.1 to 78.2 vs. 39.0, interquartile range: 24.7 to 61.7; p = 0.011; p for interaction vs. no diabetes = 0.016). Conclusions In diabetic patients with STEMI, the administration of Intracoronary abciximab improved the effectiveness of primary PCI compared with the intravenous bolus.
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Intracoronary versus intravenous bolus abciximab administration in patients undergoing primary percutaneous coronary intervention with acute st elevation myocardial infarction a pooled analysis of individual patient data from five randomised controlled trials
Eurointervention, 2014Co-Authors: Raffaele Piccolo, Ingo Eitel, Alberto Dominguezrodriguez, Allan Iversen, Pedro Abreugonzalez, Holger Thiele, Bart J.g.l. De ,smet, Karim D Mahmoud, Federico PiscioneAbstract:Aims: In recent years, Intracoronary bolus abciximab has emerged as an alternative to the standard intravenous route in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The aim of the current study was to perform an individual patient-level pooled analysis of randomised trials, comparing Intracoronary versus intravenous abciximab bolus use in STEMI patients undergoing primary PCI. Methods and results: Individual data of 3,158 patients enrolled in five trials were analysed. Reperfusion endpoints were: post-procedural Thrombolysis in Myocardial Infarction (TIMI) 3 flow, myocardial blush grade (MBG) 2/3 and complete ST-segment resolution. The primary clinical endpoint of interest was the composite of death and reinfarction at 30 days. Compared with the intravenous route, Intracoronary abciximab bolus administration did not improve TIMI 3 flow (odds ratio [OR] 1.19; 95% confidence interval [CI]: 0.90-1.59; p=0.23) and complete ST-segment resolution (OR 1.22, 95% CI: 0.92-1.63, p=0.17), but increased MBG 2/3 occurrence (OR 1.83, 95% CI: 1.05-3.18, p=0.03). At 30-day follow-up, Intracoronary bolus abciximab did not reduce the risk of death and reinfarction (OR 0.78, 95% CI: 0.55-1.10, p=0.16), death (OR 0.77, 95% CI: 0.51-1.17, p=0.22), reinfarction (OR 0.79, 95% CI: 0.46-1.33, p=0.38) and stent thrombosis (OR 0.77, 95% CI: 0.43-1.35, p=0.36) as compared with intravenous administration. Conclusions: In STEMI patients undergoing primary PCI, Intracoronary abciximab does not provide additional benefits as compared with standard intravenous treatment and, therefore, it should not be recommended as the default route of administration in this setting.
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clinical impact of Intracoronary abciximab in patients undergoing primary percutaneous coronary intervention an individual patient data pooled analysis of randomised studies
Heart, 2012Co-Authors: Raffaele Piccolo, Ingo Eitel, Alberto Dominguezrodriguez, Allan Iversen, Pedro Abreugonzalez, Holger Thiele, Bart J.g.l. De ,smet, Karim D Mahmoud, Federico PiscioneAbstract:Objectives The aim of this study was to perform an individual patient-level pooled analysis of randomised trials, comparing Intracoronary versus intravenous abciximab bolus use in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Background Abciximab represents a cornerstone in the treatment of STEMI patients undergoing primary PCI. Intracoronary abciximab bolus administration has been proposed as an alternative strategy to the standard intravenous route. However, whether Intracoronary abciximab effectively improves clinical outcomes compared with standard route remains unknown. Methods Individual data of 1198 patients enrolled in five trials were entered into the pooled analysis. The primary endpoint of the study was the occurrence of all-cause death and reinfarction at 30-day follow-up. Secondary endpoints were all-cause death, reinfarction and target-vessel revascularisation (TVR). Results No significant heterogeneity was found across trials. Compared with the intravenous route, Intracoronary abciximab administration significantly reduced the risk of the composite of death and reinfarction (HR 0.52, 95% CI 0.29 to 0.94; p=0.03), death (HR 0.44, 95% CI 0.20 to 0.95; p=0.04) and TVR (HR 0.53, 95% CI 0.29 to 0.99; p=0.045), without a significant impact on the risk of reinfarction (HR 0.54, 95% CI 0.24 to 1.21; p=0.13). However, after correction for baseline differences, only the composite of death/reinfarction and death remained significant. Conclusions In STEMI patients undergoing primary PCI, Intracoronary abciximab administration, when compared with the intravenous standard route, can improve short-term clinical outcomes mainly by reducing the risk of death.
Raffaele Piccolo - One of the best experts on this subject based on the ideXlab platform.
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1 year outcomes with Intracoronary abciximab in diabetic patients undergoing primary percutaneous coronary intervention
Journal of the American College of Cardiology, 2016Co-Authors: Raffaele Piccolo, Ingo Eitel, Gennaro Galasso, Alberto Dominguezrodriguez, Allan Iversen, Pedro Abreugonzalez, Stephan Windecker, Holger Thiele, Federico PiscioneAbstract:Abstract Background Diabetic patients are at increased risk for future cardiovascular events after ST-segment elevation myocardial infarction (STEMI). Administration of an Intracoronary abciximab bolus during primary percutaneous coronary intervention (PCI) may be beneficial in this high-risk subgroup. Objectives This study sought to report the 1-year clinical outcomes and cardiac magnetic resonance (CMR) findings in STEMI patients with and without diabetes randomized to Intracoronary or intravenous abciximab bolus at the time of primary PCI. Methods Patient-level data from 3 randomized trials were pooled. The primary endpoint was the composite of death or reinfarction. Comprehensive CMR imaging was performed in 1 study. Results Of 2,470 patients, 473 (19%) had diabetes and 1,997 (81%) did not. At 1 year, the primary endpoint was significantly reduced in diabetic patients randomized to Intracoronary abciximab compared with those randomized to intravenous bolus (9.2% vs. 17.6%; hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.28 to 0.83; p = 0.009). The Intracoronary abciximab bolus did not reduce the primary endpoint in patients without diabetes (7.4% vs. 7.5%; HR: 0.95; 95% CI: 0.68 to 1.33; p = 0.77), resulting in a significant interaction (p = 0.034). Among diabetic patients, Intracoronary versus intravenous abciximab bolus was associated with a significantly reduced risk of death (5.8% vs. 11.2%; HR: 0.51; 95% CI: 0.26 to 0.98; p = 0.043) and definite/probable stent thrombosis (1.3% vs. 4.8%; HR: 0.27; 95% CI: 0.08 to 0.98; p = 0.046). At CMR (n = 792), the myocardial salvage index was significantly increased only in diabetic patients randomized to Intracoronary compared with intravenous abciximab (54.4; interquartile range: 35.1 to 78.2 vs. 39.0, interquartile range: 24.7 to 61.7; p = 0.011; p for interaction vs. no diabetes = 0.016). Conclusions In diabetic patients with STEMI, the administration of Intracoronary abciximab improved the effectiveness of primary PCI compared with the intravenous bolus.
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Intracoronary versus intravenous bolus abciximab administration in patients undergoing primary percutaneous coronary intervention with acute st elevation myocardial infarction a pooled analysis of individual patient data from five randomised controlled trials
Eurointervention, 2014Co-Authors: Raffaele Piccolo, Ingo Eitel, Alberto Dominguezrodriguez, Allan Iversen, Pedro Abreugonzalez, Holger Thiele, Bart J.g.l. De ,smet, Karim D Mahmoud, Federico PiscioneAbstract:Aims: In recent years, Intracoronary bolus abciximab has emerged as an alternative to the standard intravenous route in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The aim of the current study was to perform an individual patient-level pooled analysis of randomised trials, comparing Intracoronary versus intravenous abciximab bolus use in STEMI patients undergoing primary PCI. Methods and results: Individual data of 3,158 patients enrolled in five trials were analysed. Reperfusion endpoints were: post-procedural Thrombolysis in Myocardial Infarction (TIMI) 3 flow, myocardial blush grade (MBG) 2/3 and complete ST-segment resolution. The primary clinical endpoint of interest was the composite of death and reinfarction at 30 days. Compared with the intravenous route, Intracoronary abciximab bolus administration did not improve TIMI 3 flow (odds ratio [OR] 1.19; 95% confidence interval [CI]: 0.90-1.59; p=0.23) and complete ST-segment resolution (OR 1.22, 95% CI: 0.92-1.63, p=0.17), but increased MBG 2/3 occurrence (OR 1.83, 95% CI: 1.05-3.18, p=0.03). At 30-day follow-up, Intracoronary bolus abciximab did not reduce the risk of death and reinfarction (OR 0.78, 95% CI: 0.55-1.10, p=0.16), death (OR 0.77, 95% CI: 0.51-1.17, p=0.22), reinfarction (OR 0.79, 95% CI: 0.46-1.33, p=0.38) and stent thrombosis (OR 0.77, 95% CI: 0.43-1.35, p=0.36) as compared with intravenous administration. Conclusions: In STEMI patients undergoing primary PCI, Intracoronary abciximab does not provide additional benefits as compared with standard intravenous treatment and, therefore, it should not be recommended as the default route of administration in this setting.
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clinical impact of Intracoronary abciximab in patients undergoing primary percutaneous coronary intervention an individual patient data pooled analysis of randomised studies
Heart, 2012Co-Authors: Raffaele Piccolo, Ingo Eitel, Alberto Dominguezrodriguez, Allan Iversen, Pedro Abreugonzalez, Holger Thiele, Bart J.g.l. De ,smet, Karim D Mahmoud, Federico PiscioneAbstract:Objectives The aim of this study was to perform an individual patient-level pooled analysis of randomised trials, comparing Intracoronary versus intravenous abciximab bolus use in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Background Abciximab represents a cornerstone in the treatment of STEMI patients undergoing primary PCI. Intracoronary abciximab bolus administration has been proposed as an alternative strategy to the standard intravenous route. However, whether Intracoronary abciximab effectively improves clinical outcomes compared with standard route remains unknown. Methods Individual data of 1198 patients enrolled in five trials were entered into the pooled analysis. The primary endpoint of the study was the occurrence of all-cause death and reinfarction at 30-day follow-up. Secondary endpoints were all-cause death, reinfarction and target-vessel revascularisation (TVR). Results No significant heterogeneity was found across trials. Compared with the intravenous route, Intracoronary abciximab administration significantly reduced the risk of the composite of death and reinfarction (HR 0.52, 95% CI 0.29 to 0.94; p=0.03), death (HR 0.44, 95% CI 0.20 to 0.95; p=0.04) and TVR (HR 0.53, 95% CI 0.29 to 0.99; p=0.045), without a significant impact on the risk of reinfarction (HR 0.54, 95% CI 0.24 to 1.21; p=0.13). However, after correction for baseline differences, only the composite of death/reinfarction and death remained significant. Conclusions In STEMI patients undergoing primary PCI, Intracoronary abciximab administration, when compared with the intravenous standard route, can improve short-term clinical outcomes mainly by reducing the risk of death.
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Intracoronary autologous cardiac progenitor cell transfer in patients with hypoplastic left heart syndrome the ticap prospective phase 1 controlled trial
Circulation Research, 2015Co-Authors: Shuta Ishigami, Shinichi Ohtsuki, Suguru Tarui, Daiki Ousaka, Takahiro Eitoku, Maiko Kondo, Michihiro Okuyama, Junko Kobayashi, Kenji Baba, Sadahiko AraiAbstract:Rationale: Hypoplastic left heart syndrome (HLHS) remains a lethal congenital cardiac defect. Recent studies have suggested that Intracoronary administration of autologous cardiosphere-derived cells (CDCs) may improve ventricular function. Objective: The aim of this study was to test whether Intracoronary delivery of CDCs is feasible and safe in patients with hypoplastic left heart syndrome. Methods and Results: Between January 5, 2011, and January 16, 2012, 14 patients (1.8±1.5 years) were prospectively assigned to receive Intracoronary infusion of autologous CDCs 33.4±8.1 days after staged procedures (n=7), followed by 7 controls with standard palliation alone. The primary end point was to assess the safety, and the secondary end point included the preliminary efficacy to verify the right ventricular ejection fraction improvements between baseline and 3 months. Manufacturing and Intracoronary delivery of CDCs were feasible, and no serious adverse events were reported within the 18-month follow-up. Patients treated with CDCs showed right ventricular ejection fraction improvement from baseline to 3-month follow-up (46.9%±4.6% to 52.1%±2.4%; P =0.008). Compared with controls at 18 months, cardiac MRI analysis of CDC-treated patients showed a higher right ventricular ejection fraction (31.5%±6.8% versus 40.4%±7.6%; P =0.049), improved somatic growth ( P =0.0005), reduced heart failure status ( P =0.003), and lower incidence of coil occlusion for collaterals ( P =0.007). Conclusions: Intracoronary infusion of autologous CDCs seems to be feasible and safe in children with hypoplastic left heart syndrome after staged surgery. Large phase 2 trials are warranted to examine the potential effects of cardiac function improvements and the long-term benefits of clinical outcomes. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01273857.
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Intracoronary autologous cardiac progenitor cell transfer in patients with hypoplastic left heart syndrome the ticap prospective phase 1 controlled trial
Circulation Research, 2015Co-Authors: Shuta Ishigami, Shinichi Ohtsuki, Suguru Tarui, Daiki Ousaka, Takahiro Eitoku, Maiko Kondo, Michihiro Okuyama, Junko Kobayashi, Kenji Baba, Sadahiko AraiAbstract:RATIONALE: Hypoplastic left heart syndrome (HLHS) remains a lethal congenital cardiac defect. Recent studies have suggested that Intracoronary administration of autologous cardiosphere-derived cells (CDCs) may improve ventricular function. OBJECTIVE: The aim of this study was to test whether Intracoronary delivery of CDCs is feasible and safe in patients with hypoplastic left heart syndrome. METHODS AND RESULTS: Between January 5, 2011, and January 16, 2012, 14 patients (1.8±1.5 years) were prospectively assigned to receive Intracoronary infusion of autologous CDCs 33.4±8.1 days after staged procedures (n=7), followed by 7 controls with standard palliation alone. The primary end point was to assess the safety, and the secondary end point included the preliminary efficacy to verify the right ventricular ejection fraction improvements between baseline and 3 months. Manufacturing and Intracoronary delivery of CDCs were feasible, and no serious adverse events were reported within the 18-month follow-up. Patients treated with CDCs showed right ventricular ejection fraction improvement from baseline to 3-month follow-up (46.9%±4.6% to 52.1%±2.4%; P=0.008). Compared with controls at 18 months, cardiac MRI analysis of CDC-treated patients showed a higher right ventricular ejection fraction (31.5%±6.8% versus 40.4%±7.6%; P=0.049), improved somatic growth (P=0.0005), reduced heart failure status (P=0.003), and lower incidence of coil occlusion for collaterals (P=0.007). CONCLUSIONS: Intracoronary infusion of autologous CDCs seems to be feasible and safe in children with hypoplastic left heart syndrome after staged surgery. Large phase 2 trials are warranted to examine the potential effects of cardiac function improvements and the long-term benefits of clinical outcomes.
