The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform

Gianluca Campo - One of the best experts on this subject based on the ideXlab platform.

  • is Bare Metal Stent implantation still justifiable in high bleeding risk patients undergoing percutaneous coronary intervention a pre specified analysis from the zeus trial
    Jacc-cardiovascular Interventions, 2016
    Co-Authors: Sara Ariotti, Athanasios Patialiakas, Attila Thury, Salvatore Colangelo, Carlo Briguori, Gianluca Campo, Matteo Tebaldi, Marianna Adamo, Francesco Costa, Imre Ungi
    Abstract:

    Abstract Objectives This study sought to investigate the ischemic and bleeding outcomes of patients fulfilling high bleeding risk (HBR) criteria who were randomized to zotarolimus-eluting Endeavor Sprint Stent (E-ZES) or Bare-Metal Stent (BMS) implantation followed by an abbreviated dual antiplatelet therapy (DAPT) duration for stable or unstable coronary artery disease. Background DES instead of BMS use remains controversial in HBR patients, in whom long-term DAPT poses safety concerns. Methods The ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates) is a multinational, randomized single-blinded trial that randomized among others, in a stratified manner, 828 patients fulfilling pre-defined clinical or biochemical HBR criteria—including advanced age, indication to oral anticoagulants or other pro-hemorrhagic medications, history of bleeding and known anemia—to receive E-ZES or BMS followed by a protocol-mandated 30-day DAPT regimen. The primary endpoint of the study was the 12-month major adverse cardiovascular event rate, consisting of death, myocardial infarction, or target vessel revascularization. Results Compared with patients without, those with 1 or more HBR criteria had worse outcomes, owing to higher ischemic and bleeding risks. Among HBR patients, major adverse cardiovascular events occurred in 22.6% of the E-ZES and 29% of the BMS patients (hazard ratio: 0.75; 95% confidence interval: 0.57 to 0.98; p = 0.033), driven by lower myocardial infarction (3.5% vs. 10.4%; p  Conclusions Among HBR patients with stable or unstable coronary artery disease, E-ZES implantation provides superior efficacy and safety as compared with conventional BMS. (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS]; NCT01385319 )

  • randomized comparison of zotarolimus eluting endeavor sprint versus Bare Metal Stent implantation in uncertain drug eluting Stent candidates rationale design and characterization of the patient population for the zotarolimus eluting endeavor sprint s
    American Heart Journal, 2013
    Co-Authors: Marco Valgimigli, Athanasios Patialiakas, Attila Thury, Salvatore Colangelo, Imre Ungi, Gianluca Campo, Matteo Tebaldi, Stefano Tondi, Marco Roffi, Alberto Menozzi
    Abstract:

    Background The use of drug-eluting Stent (DES) instead of Bare-Metal Stent (BMS) in patients at high Stent thrombosis or bleeding risk as well as in those at low restenosis risk (ie, uncertain DES candidates) remains a matter of debate. Zotarolimus-Eluting Endeavor Sprint Stent (E-ZES) (Santa Rosa, CA) is a hydrophilic polymer-based second-generation device with unique drug fast-release profile, which may allow for a shorter dual antiplatelet therapy (DAPT) duration without safety concerns. Hypothesis The primary objective is to assess whether E-ZES implantation followed by a shorter than currently recommended course of DAPT will decrease the incidence of 12-month major adverse cardiovascular events as compared with BMS in undefined DES recipients. Actual duration of DAPT regimen will be dictated by patients' characteristics and not by Stent type and, as such, can be as short as 30 days after intervention in both Stent groups. Study Design The ZEUS study is an open-label randomized clinical trial conducted at 20 clinical sites in Italy, Switzerland, Portugal, and Hungary. With 1,600 individuals, this study will have 85% power to detect a 33% difference in the primary end point consisting of the composite of death, nonfatal myocardial infarction, or target vessel revascularization. Summary The ZEUS trial aims to assess whether the use of E-ZES, followed by a DAPT duration regimen based on patients' characteristics and not by Stent type, is superior to conventional BMS implantation in undefined DES recipients who qualify for the presence of high thrombosis, bleeding, or low restenosis risk criteria.

  • three year follow up of the multicentre evaluation of single high dose bolus tirofiban versus abciximab with sirolimus eluting Stent or Bare Metal Stent in acute myocardial infarction study multistrategy
    International Journal of Cardiology, 2013
    Co-Authors: Marco Valgimigli, Salvatore Colangelo, Gianluca Campo, Alfredo E Rodriguez, Leonardo Bolognese, Nicoletta De Cesare, Stefania Gambetti, Flavio Ribichini, Filippo Russo, Raul Moreno
    Abstract:

    Abstract Background The Multicentre Evaluation of Single high-dose Bolus TiRofiban versus Abciximab with Sirolimus-eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study [MULTISTRATEGY]) randomised 745 patients with ST-elevation myocardial infarction to receive high-dose bolus (HDB) tirofiban or abciximab infusion and sirolimus-eluting (SES) or uncoated-Stent (BMS) implantation. Tirofiban was non-inferior to abciximab in terms of ST-segment resolution after intervention, whereas 8 month-major adverse cardiac events occurred in 14.5% in the BMS and 7.8% in the SES groups ( P =0.0039), reflecting a reduction of reintervention rates (10.2% vs. 3.2%). A three-year follow-up was performed to extend previous short- to mid-term findings. Methods and results Complete data at 3years was available for 736 patients (99%). All-cause mortality was 6.7% in the tirofiban and 7.8% in the abciximab ( P =0.56) and 7.5% in the BMS vs 7.0 in the SES groups, P =0.79. The composite of all-cause death or MI was identical at 12.9% in tirofiban and abciximab groups, P =0.99 and it occurred in 13.2% in the BMS vs. 12.6% in the SES groups ( P =0.83). The need for reintervention remained more than twice as common with BMS (13.7%; versus 6.2%, P =0.0006). The cumulative rate of Stent thrombosis (ST) did not differ. This is inspite of a higher very late definite, probable or possible ST thrombosis rate in the SES group. Conclusions The 3-year follow-up of MULTISTRATEGY demonstrated comparable outcomes with HDB Tirofiban or abciximab and a sustained efficacy of SES to reduce reintervention with no difference in death, repeat MI or ST.

  • sex specific benefits of sirolimus eluting Stent on long term outcomes in patients with st elevation myocardial infarction undergoing primary percutaneous coronary intervention insights from the multicenter evaluation of single high dose bolus tirofi
    American Heart Journal, 2012
    Co-Authors: Giuseppe Ferrante, Salvatore Colangelo, Gianluca Campo, Alfredo E Rodriguez, Leonardo Bolognese, Nicoletta De Cesare, Patrizia Presbitero, Elena Corrada, Corrado Vassanelli, E Bramucci
    Abstract:

    Objectives We assessed the relation between female sex and sirolimus-eluting Stent (SES) use on long-term outcomes in acute myocardial infarction. Background There are no data on sex-specific differences in long-term benefit of SES use compared with Bare-Metal Stent (BMS) use among patients undergoing primary percutaneous coronary interventions. Methods We performed a post hoc analysis of the MULTISTRATEGY trial. Hazard ratios (HRs) of events with 95% CI for sex and Stent type were computed using Cox proportional regression with adjustment for confounders. Results A total of 744 patients, 64 years old (55-73 years old), 179 (24.1%) women, were enrolled. After a follow-up of 1,080 days, SES use was associated with a significant reduction of major adverse cardiovascular events, that is, the composite of all-cause death, reinfarction, or clinically driven target vessel revascularization (TVR) (13.9% vs 23.6%, adjusted HR 0.62, 95% CI 0.41-0.94, P = .026) and of TVR (6.1% vs 15.1%, adjusted HR 0.35, 95% CI 0.19-0.63, P P = .59; TVR 6.6% vs 9.1%, adjusted HR 0.62, 95% CI 0.17-2.21, P = .46). Conclusions In this analysis, the clinical benefit of SES use, over BMS, at 3-year follow-up was restricted to men and was not observed among women.

  • two year clinical follow up after sirolimus eluting versus Bare Metal Stent implantation assisted by systematic glycoprotein iib iiia inhibitor infusion in patients with myocardial infarction results from the strategy study
    Journal of the American College of Cardiology, 2007
    Co-Authors: Marco Valgimigli, Chiara Arcozzi, Dario Barbieri, Patrizia Malagutti, Roberto Carletti, Gianluca Campo, Gianfranco Percoco, Fabrizio Ferrari, Giovanni Parrinello, Roberto Ferrari
    Abstract:

    Objectives We sought to investigate whether the previously reported midterm clinical benefit of planned sirolimus-eluting Stent (SES) implantation in patients with ST-segment elevation myocardial infarction (STEMI) was maintained over a 24-month time period. Moreover, the distribution of clinical events in relation to thienopyridine discontinuation was thoroughly investigated. Background No randomized data are currently available on the safety/benefit profile of SES in this subset of patients beyond 12 months. Methods Between March 2003 and April 2004, 175 patients with STEMI were randomly allocated to tirofiban infusion followed by SES or abciximab plus Bare-Metal Stent (BMS). Complete follow-up information up to 720 days was available for all patients. Results The cumulative incidence of death, myocardial infarction (MI), or target vessel revascularization (TVR) remained lower in the tirofiban-SES compared with the abciximab-BMS group at 2 years (24.2% vs. 38.6%, respectively; hazard ratio [HR] 0.56 [95% confidence interval (CI) 0.33 to 0.98]; p = 0.038). The composite of death/MI was similar in the tirofiban-SES (16.1%) and the abciximab-BMS groups (20.5%, HR 0.77 [95% CI 0.38 to 1.55]; p = 0.43) while the need for TVR was markedly reduced (9.8% vs. 25.5%, respectively; HR 0.34 [95% CI 0.16 to 0.77]; p = 0.01) in the tirofiban-SES arm. The rate of confirmed, probable, or possible Stent thrombosis did not differ in the 2 groups, nor the incidence of death/MI after thienopyridine discontinuation. Conclusions The midterm clinical benefit of planned SES implantation assisted by tirofiban infusion in STEMI patients was mainly carried over after 2 years with no overall excess of late adverse events after thienopyridine discon-tinuation.

Salvatore Colangelo - One of the best experts on this subject based on the ideXlab platform.

  • is Bare Metal Stent implantation still justifiable in high bleeding risk patients undergoing percutaneous coronary intervention a pre specified analysis from the zeus trial
    Jacc-cardiovascular Interventions, 2016
    Co-Authors: Sara Ariotti, Athanasios Patialiakas, Attila Thury, Salvatore Colangelo, Carlo Briguori, Gianluca Campo, Matteo Tebaldi, Marianna Adamo, Francesco Costa, Imre Ungi
    Abstract:

    Abstract Objectives This study sought to investigate the ischemic and bleeding outcomes of patients fulfilling high bleeding risk (HBR) criteria who were randomized to zotarolimus-eluting Endeavor Sprint Stent (E-ZES) or Bare-Metal Stent (BMS) implantation followed by an abbreviated dual antiplatelet therapy (DAPT) duration for stable or unstable coronary artery disease. Background DES instead of BMS use remains controversial in HBR patients, in whom long-term DAPT poses safety concerns. Methods The ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates) is a multinational, randomized single-blinded trial that randomized among others, in a stratified manner, 828 patients fulfilling pre-defined clinical or biochemical HBR criteria—including advanced age, indication to oral anticoagulants or other pro-hemorrhagic medications, history of bleeding and known anemia—to receive E-ZES or BMS followed by a protocol-mandated 30-day DAPT regimen. The primary endpoint of the study was the 12-month major adverse cardiovascular event rate, consisting of death, myocardial infarction, or target vessel revascularization. Results Compared with patients without, those with 1 or more HBR criteria had worse outcomes, owing to higher ischemic and bleeding risks. Among HBR patients, major adverse cardiovascular events occurred in 22.6% of the E-ZES and 29% of the BMS patients (hazard ratio: 0.75; 95% confidence interval: 0.57 to 0.98; p = 0.033), driven by lower myocardial infarction (3.5% vs. 10.4%; p  Conclusions Among HBR patients with stable or unstable coronary artery disease, E-ZES implantation provides superior efficacy and safety as compared with conventional BMS. (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS]; NCT01385319 )

  • randomized comparison of zotarolimus eluting endeavor sprint versus Bare Metal Stent implantation in uncertain drug eluting Stent candidates rationale design and characterization of the patient population for the zotarolimus eluting endeavor sprint s
    American Heart Journal, 2013
    Co-Authors: Marco Valgimigli, Athanasios Patialiakas, Attila Thury, Salvatore Colangelo, Imre Ungi, Gianluca Campo, Matteo Tebaldi, Stefano Tondi, Marco Roffi, Alberto Menozzi
    Abstract:

    Background The use of drug-eluting Stent (DES) instead of Bare-Metal Stent (BMS) in patients at high Stent thrombosis or bleeding risk as well as in those at low restenosis risk (ie, uncertain DES candidates) remains a matter of debate. Zotarolimus-Eluting Endeavor Sprint Stent (E-ZES) (Santa Rosa, CA) is a hydrophilic polymer-based second-generation device with unique drug fast-release profile, which may allow for a shorter dual antiplatelet therapy (DAPT) duration without safety concerns. Hypothesis The primary objective is to assess whether E-ZES implantation followed by a shorter than currently recommended course of DAPT will decrease the incidence of 12-month major adverse cardiovascular events as compared with BMS in undefined DES recipients. Actual duration of DAPT regimen will be dictated by patients' characteristics and not by Stent type and, as such, can be as short as 30 days after intervention in both Stent groups. Study Design The ZEUS study is an open-label randomized clinical trial conducted at 20 clinical sites in Italy, Switzerland, Portugal, and Hungary. With 1,600 individuals, this study will have 85% power to detect a 33% difference in the primary end point consisting of the composite of death, nonfatal myocardial infarction, or target vessel revascularization. Summary The ZEUS trial aims to assess whether the use of E-ZES, followed by a DAPT duration regimen based on patients' characteristics and not by Stent type, is superior to conventional BMS implantation in undefined DES recipients who qualify for the presence of high thrombosis, bleeding, or low restenosis risk criteria.

  • three year follow up of the multicentre evaluation of single high dose bolus tirofiban versus abciximab with sirolimus eluting Stent or Bare Metal Stent in acute myocardial infarction study multistrategy
    International Journal of Cardiology, 2013
    Co-Authors: Marco Valgimigli, Salvatore Colangelo, Gianluca Campo, Alfredo E Rodriguez, Leonardo Bolognese, Nicoletta De Cesare, Stefania Gambetti, Flavio Ribichini, Filippo Russo, Raul Moreno
    Abstract:

    Abstract Background The Multicentre Evaluation of Single high-dose Bolus TiRofiban versus Abciximab with Sirolimus-eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study [MULTISTRATEGY]) randomised 745 patients with ST-elevation myocardial infarction to receive high-dose bolus (HDB) tirofiban or abciximab infusion and sirolimus-eluting (SES) or uncoated-Stent (BMS) implantation. Tirofiban was non-inferior to abciximab in terms of ST-segment resolution after intervention, whereas 8 month-major adverse cardiac events occurred in 14.5% in the BMS and 7.8% in the SES groups ( P =0.0039), reflecting a reduction of reintervention rates (10.2% vs. 3.2%). A three-year follow-up was performed to extend previous short- to mid-term findings. Methods and results Complete data at 3years was available for 736 patients (99%). All-cause mortality was 6.7% in the tirofiban and 7.8% in the abciximab ( P =0.56) and 7.5% in the BMS vs 7.0 in the SES groups, P =0.79. The composite of all-cause death or MI was identical at 12.9% in tirofiban and abciximab groups, P =0.99 and it occurred in 13.2% in the BMS vs. 12.6% in the SES groups ( P =0.83). The need for reintervention remained more than twice as common with BMS (13.7%; versus 6.2%, P =0.0006). The cumulative rate of Stent thrombosis (ST) did not differ. This is inspite of a higher very late definite, probable or possible ST thrombosis rate in the SES group. Conclusions The 3-year follow-up of MULTISTRATEGY demonstrated comparable outcomes with HDB Tirofiban or abciximab and a sustained efficacy of SES to reduce reintervention with no difference in death, repeat MI or ST.

  • sex specific benefits of sirolimus eluting Stent on long term outcomes in patients with st elevation myocardial infarction undergoing primary percutaneous coronary intervention insights from the multicenter evaluation of single high dose bolus tirofi
    American Heart Journal, 2012
    Co-Authors: Giuseppe Ferrante, Salvatore Colangelo, Gianluca Campo, Alfredo E Rodriguez, Leonardo Bolognese, Nicoletta De Cesare, Patrizia Presbitero, Elena Corrada, Corrado Vassanelli, E Bramucci
    Abstract:

    Objectives We assessed the relation between female sex and sirolimus-eluting Stent (SES) use on long-term outcomes in acute myocardial infarction. Background There are no data on sex-specific differences in long-term benefit of SES use compared with Bare-Metal Stent (BMS) use among patients undergoing primary percutaneous coronary interventions. Methods We performed a post hoc analysis of the MULTISTRATEGY trial. Hazard ratios (HRs) of events with 95% CI for sex and Stent type were computed using Cox proportional regression with adjustment for confounders. Results A total of 744 patients, 64 years old (55-73 years old), 179 (24.1%) women, were enrolled. After a follow-up of 1,080 days, SES use was associated with a significant reduction of major adverse cardiovascular events, that is, the composite of all-cause death, reinfarction, or clinically driven target vessel revascularization (TVR) (13.9% vs 23.6%, adjusted HR 0.62, 95% CI 0.41-0.94, P = .026) and of TVR (6.1% vs 15.1%, adjusted HR 0.35, 95% CI 0.19-0.63, P P = .59; TVR 6.6% vs 9.1%, adjusted HR 0.62, 95% CI 0.17-2.21, P = .46). Conclusions In this analysis, the clinical benefit of SES use, over BMS, at 3-year follow-up was restricted to men and was not observed among women.

  • two by two factorial comparison of high bolus dose tirofiban followed by standard infusion versus abciximab and sirolimus eluting versus Bare Metal Stent implantation in patients with acute myocardial infarction design and rationale for the multi str
    American Heart Journal, 2007
    Co-Authors: Marco Valgimigli, Salvatore Colangelo, Gianluca Campo, Alfredo E Rodriguez, Leonardo Bolognese, Maurizio Anselmi, Nicoletta De Cesare, David J Cohen, Imad Sheiban, Giampaolo Pasquetto
    Abstract:

    Background Current treatment standards for patients undergoing primary percutaneous coronary intervention support early infusion of abciximab, followed by Bare-Metal Stent (BMS) implantation. Whether the use of sirolimus-eluting Stent (SES) would result in a further improvement of clinical outcomes remains to be proven. Similarly, whether tirofiban administered at high-bolus dose (HBD) followed by standard infusion is a valuable alternative to abciximab in the setting of ST-segment elevation myocardial infarction remains uncertain. Study Design Multicentre evaluation of single high-bolus dose tirofiban versus abciximab and sirolimus-eluting versus Bare Metal Stent in acute myocardial infarction (MULTI-STRATEGY) is a phase III, open-label, multinational investigator-driven clinical trial evaluating, with a 2-by-2 factorial design, the safety/efficacy profile of 4 interventional strategies of reperfusion: tirofiban given at HBD (bolus of 25 μg/kg over 3 minutes), followed by an infusion of 0.15 μg/kg per minute for 18 to 24 hours versus abciximab and SES, as compared to BMS implantation in primary percutaneous coronary intervention. The coprimary objectives are (i) the evaluation of the effect of SES versus BMS on the incidence of major adverse cardiac events within 8 months of the index procedure and (ii) the degree of ST-segment resolution obtained after the mechanical intervention for the comparison of HBD tirofiban versus abciximab. The protocol mandates clinical follow-up for 5 years. Conclusions MULTI-STRATEGY will evaluate the role of SES and HBD tirofiban versus BMS and abciximab in the acute management of patients presenting with ST-segment elevation myocardial infarction.

Marco Valgimigli - One of the best experts on this subject based on the ideXlab platform.

  • randomized comparison of zotarolimus eluting endeavor sprint versus Bare Metal Stent implantation in uncertain drug eluting Stent candidates rationale design and characterization of the patient population for the zotarolimus eluting endeavor sprint s
    American Heart Journal, 2013
    Co-Authors: Marco Valgimigli, Athanasios Patialiakas, Attila Thury, Salvatore Colangelo, Imre Ungi, Gianluca Campo, Matteo Tebaldi, Stefano Tondi, Marco Roffi, Alberto Menozzi
    Abstract:

    Background The use of drug-eluting Stent (DES) instead of Bare-Metal Stent (BMS) in patients at high Stent thrombosis or bleeding risk as well as in those at low restenosis risk (ie, uncertain DES candidates) remains a matter of debate. Zotarolimus-Eluting Endeavor Sprint Stent (E-ZES) (Santa Rosa, CA) is a hydrophilic polymer-based second-generation device with unique drug fast-release profile, which may allow for a shorter dual antiplatelet therapy (DAPT) duration without safety concerns. Hypothesis The primary objective is to assess whether E-ZES implantation followed by a shorter than currently recommended course of DAPT will decrease the incidence of 12-month major adverse cardiovascular events as compared with BMS in undefined DES recipients. Actual duration of DAPT regimen will be dictated by patients' characteristics and not by Stent type and, as such, can be as short as 30 days after intervention in both Stent groups. Study Design The ZEUS study is an open-label randomized clinical trial conducted at 20 clinical sites in Italy, Switzerland, Portugal, and Hungary. With 1,600 individuals, this study will have 85% power to detect a 33% difference in the primary end point consisting of the composite of death, nonfatal myocardial infarction, or target vessel revascularization. Summary The ZEUS trial aims to assess whether the use of E-ZES, followed by a DAPT duration regimen based on patients' characteristics and not by Stent type, is superior to conventional BMS implantation in undefined DES recipients who qualify for the presence of high thrombosis, bleeding, or low restenosis risk criteria.

  • three year follow up of the multicentre evaluation of single high dose bolus tirofiban versus abciximab with sirolimus eluting Stent or Bare Metal Stent in acute myocardial infarction study multistrategy
    International Journal of Cardiology, 2013
    Co-Authors: Marco Valgimigli, Salvatore Colangelo, Gianluca Campo, Alfredo E Rodriguez, Leonardo Bolognese, Nicoletta De Cesare, Stefania Gambetti, Flavio Ribichini, Filippo Russo, Raul Moreno
    Abstract:

    Abstract Background The Multicentre Evaluation of Single high-dose Bolus TiRofiban versus Abciximab with Sirolimus-eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study [MULTISTRATEGY]) randomised 745 patients with ST-elevation myocardial infarction to receive high-dose bolus (HDB) tirofiban or abciximab infusion and sirolimus-eluting (SES) or uncoated-Stent (BMS) implantation. Tirofiban was non-inferior to abciximab in terms of ST-segment resolution after intervention, whereas 8 month-major adverse cardiac events occurred in 14.5% in the BMS and 7.8% in the SES groups ( P =0.0039), reflecting a reduction of reintervention rates (10.2% vs. 3.2%). A three-year follow-up was performed to extend previous short- to mid-term findings. Methods and results Complete data at 3years was available for 736 patients (99%). All-cause mortality was 6.7% in the tirofiban and 7.8% in the abciximab ( P =0.56) and 7.5% in the BMS vs 7.0 in the SES groups, P =0.79. The composite of all-cause death or MI was identical at 12.9% in tirofiban and abciximab groups, P =0.99 and it occurred in 13.2% in the BMS vs. 12.6% in the SES groups ( P =0.83). The need for reintervention remained more than twice as common with BMS (13.7%; versus 6.2%, P =0.0006). The cumulative rate of Stent thrombosis (ST) did not differ. This is inspite of a higher very late definite, probable or possible ST thrombosis rate in the SES group. Conclusions The 3-year follow-up of MULTISTRATEGY demonstrated comparable outcomes with HDB Tirofiban or abciximab and a sustained efficacy of SES to reduce reintervention with no difference in death, repeat MI or ST.

  • two year clinical follow up after sirolimus eluting versus Bare Metal Stent implantation assisted by systematic glycoprotein iib iiia inhibitor infusion in patients with myocardial infarction results from the strategy study
    Journal of the American College of Cardiology, 2007
    Co-Authors: Marco Valgimigli, Chiara Arcozzi, Dario Barbieri, Patrizia Malagutti, Roberto Carletti, Gianluca Campo, Gianfranco Percoco, Fabrizio Ferrari, Giovanni Parrinello, Roberto Ferrari
    Abstract:

    Objectives We sought to investigate whether the previously reported midterm clinical benefit of planned sirolimus-eluting Stent (SES) implantation in patients with ST-segment elevation myocardial infarction (STEMI) was maintained over a 24-month time period. Moreover, the distribution of clinical events in relation to thienopyridine discontinuation was thoroughly investigated. Background No randomized data are currently available on the safety/benefit profile of SES in this subset of patients beyond 12 months. Methods Between March 2003 and April 2004, 175 patients with STEMI were randomly allocated to tirofiban infusion followed by SES or abciximab plus Bare-Metal Stent (BMS). Complete follow-up information up to 720 days was available for all patients. Results The cumulative incidence of death, myocardial infarction (MI), or target vessel revascularization (TVR) remained lower in the tirofiban-SES compared with the abciximab-BMS group at 2 years (24.2% vs. 38.6%, respectively; hazard ratio [HR] 0.56 [95% confidence interval (CI) 0.33 to 0.98]; p = 0.038). The composite of death/MI was similar in the tirofiban-SES (16.1%) and the abciximab-BMS groups (20.5%, HR 0.77 [95% CI 0.38 to 1.55]; p = 0.43) while the need for TVR was markedly reduced (9.8% vs. 25.5%, respectively; HR 0.34 [95% CI 0.16 to 0.77]; p = 0.01) in the tirofiban-SES arm. The rate of confirmed, probable, or possible Stent thrombosis did not differ in the 2 groups, nor the incidence of death/MI after thienopyridine discontinuation. Conclusions The midterm clinical benefit of planned SES implantation assisted by tirofiban infusion in STEMI patients was mainly carried over after 2 years with no overall excess of late adverse events after thienopyridine discon-tinuation.

  • two by two factorial comparison of high bolus dose tirofiban followed by standard infusion versus abciximab and sirolimus eluting versus Bare Metal Stent implantation in patients with acute myocardial infarction design and rationale for the multi str
    American Heart Journal, 2007
    Co-Authors: Marco Valgimigli, Salvatore Colangelo, Gianluca Campo, Alfredo E Rodriguez, Leonardo Bolognese, Maurizio Anselmi, Nicoletta De Cesare, David J Cohen, Imad Sheiban, Giampaolo Pasquetto
    Abstract:

    Background Current treatment standards for patients undergoing primary percutaneous coronary intervention support early infusion of abciximab, followed by Bare-Metal Stent (BMS) implantation. Whether the use of sirolimus-eluting Stent (SES) would result in a further improvement of clinical outcomes remains to be proven. Similarly, whether tirofiban administered at high-bolus dose (HBD) followed by standard infusion is a valuable alternative to abciximab in the setting of ST-segment elevation myocardial infarction remains uncertain. Study Design Multicentre evaluation of single high-bolus dose tirofiban versus abciximab and sirolimus-eluting versus Bare Metal Stent in acute myocardial infarction (MULTI-STRATEGY) is a phase III, open-label, multinational investigator-driven clinical trial evaluating, with a 2-by-2 factorial design, the safety/efficacy profile of 4 interventional strategies of reperfusion: tirofiban given at HBD (bolus of 25 μg/kg over 3 minutes), followed by an infusion of 0.15 μg/kg per minute for 18 to 24 hours versus abciximab and SES, as compared to BMS implantation in primary percutaneous coronary intervention. The coprimary objectives are (i) the evaluation of the effect of SES versus BMS on the incidence of major adverse cardiac events within 8 months of the index procedure and (ii) the degree of ST-segment resolution obtained after the mechanical intervention for the comparison of HBD tirofiban versus abciximab. The protocol mandates clinical follow-up for 5 years. Conclusions MULTI-STRATEGY will evaluate the role of SES and HBD tirofiban versus BMS and abciximab in the acute management of patients presenting with ST-segment elevation myocardial infarction.

  • tirofiban and sirolimus eluting Stent vs abciximab and Bare Metal Stent for acute myocardial infarction a randomized trial
    JAMA, 2005
    Co-Authors: Marco Valgimigli, Fabia Merlini, Giordano Cicchitelli, Dario Barbieri, Patrizia Malagutti, Eugene P Mcfadden, Gianluca Campo, Gianfranco Percoco, Fabrizio Ferrari, L. Ansani
    Abstract:

    ContextBare-Metal Stenting with abciximab pretreatment is currently considered a reasonable reperfusion strategy for acute ST-segment elevation myocardial infarction (STEMI). Sirolimus-eluting Stents significantly reduce the need for target-vessel revascularization (TVR) vs Bare-Metal Stents but substantially increase procedural costs. At current European list prices, the use of tirofiban instead of abciximab would absorb the difference in cost between Stenting with sirolimus-eluting vs Bare-Metal Stents.ObjectiveTo evaluate the clinical and angiographic impact of single high-dose bolus tirofiban plus sirolimus-eluting Stenting vs abciximab plus Bare-Metal Stenting in patients with STEMI.Design, Setting, and PatientsProspective, single-blind, randomized controlled study (Single High Dose Bolus Tirofiban and Sirolimus Eluting Stent vs Abciximab and Bare Metal Stent in Myocardial Infarction [STRATEGY]) of 175 patients (median age, 63 [interquartile range, 55-72] years) presenting to a single referral center in Italy with STEMI or presumed new left bundle-branch block and randomized between March 6, 2003, and April 23, 2004.InterventionSingle high-dose bolus tirofiban regimen plus sirolimus-eluting Stenting (n = 87) vs standard-dose abciximab plus Bare-Metal Stenting (n = 88).Main Outcome MeasuresThe primary end point was a composite of death, nonfatal myocardial infarction, stroke, or binary restenosis at 8 months. Secondary outcomes included freedom, at day 30 and month 8, from major cardiac or cerebrovascular adverse events (composite of death, reinfarction, stroke, and repeat TVR).ResultsCumulatively, 14 of 74 patients (19%; 95% confidence interval [CI], 10%-28%) in the tirofiban plus sirolimus-eluting Stent group and 37 of 74 patients (50%; 95% CI, 44%-56%) in the abciximab plus Bare-Metal Stent group reached the primary end point (hazard ratio, 0.33; 95% CI, 0.18-0.60; P<.001 [P<.001 by Fischer exact test]). The cumulative incidence of death, reinfarction, stroke, or TVR was significantly lower in the tirofiban plus sirolimus-eluting Stent group (18%) vs the abciximab plus Bare-Metal Stent group (32%) (hazard ratio, 0.53; 95% CI, 0.28-0.92; P = .04), predominantly reflecting a reduction in the need for TVR. Binary restenosis was present in 6 of 67 (9%; 95% CI, 2%-16%) and 24 of 66 (36%; 95% CI, 26%-46%) patients in the tirofiban plus sirolimus-eluting Stent and abciximab plus Bare-Metal Stent groups, respectively (P = .002).ConclusionTirofiban-supported sirolimus-eluting Stenting of infarcted arteries holds promise for improving outcomes while limiting health care expenditure in patients with myocardial infarction undergoing primary intervention.

Gregg W Stone - One of the best experts on this subject based on the ideXlab platform.

  • safety and efficacy of drug eluting Stents in women a patient level pooled analysis of randomised trials
    The Lancet, 2013
    Co-Authors: Giulio G Stefanini, Martin B Leon, Gregg W Stone, Marieclaude Morice, William Wijns, Patrick W Serruys, Usman Baber, Stephan Windecker, Samantha Sartori, Giora Weisz
    Abstract:

    Background The safety and efficacy of drug-eluting Stents (DES) in the treatment of coronary artery disease have been assessed in several randomised trials. However, none of these trials were powered to assess the safety and efficacy of DES in women because only a small proportion of recruited participants were women. We therefore investigated the safety and efficacy of DES in female patients during long-term follow-up. Methods We pooled patient-level data for female participants from 26 randomised trials of DES and analysed outcomes according to Stent type (Bare-Metal Stents, early-generation DES, and newer-generation DES). The primary safety endpoint was a composite of death or myocardial infarction. The secondary safety endpoint was definite or probable Stent thrombosis. The primary efficacy endpoint was target-lesion revascularisation. Analysis was by intention to treat. Findings Of 43 904 patients recruited in 26 trials of DES, 11 557 (26·3%) were women (mean age 67·1 years [SD 10·6]). 1108 (9·6%) women received Bare-Metal Stents, 4171 (36·1%) early-generation DES, and 6278 (54·3%) newer-generation DES. At 3 years, estimated cumulative incidence of the composite of death or myocardial infarction occurred in 132 (12·8%) women in the Bare-Metal Stent group, 421 (10·9%) in the early-generation DES group, and 496 (9·2%) in the newer-generation DES group (p=0·001). Definite or probable Stent thrombosis occurred in 13 (1·3%), 79 (2·1%), and 66 (1·1%) women in the Bare-Metal Stent, early-generation DES, and newer-generation DES groups, respectively (p=0·01). The use of DES was associated with a significant reduction in the 3 year rates of target-lesion revascularisation (197 [18·6%] women in the Bare-Metal Stent group, 294 [7·8%] in the early-generation DES group, and 330 [6·3%] in the newer-generation DES group, p<0·0001). Results did not change after adjustment for baseline characteristics in the multivariable analysis. Interpretation The use of DES in women is more effective and safe than is use of Bare-Metal Stents during long-term follow-up. Newer-generation DES are associated with an improved safety profile compared with early-generation DES, and should therefore be thought of as the standard of care for percutaneous coronary revascularisation in women

  • meta analysis of randomized studies comparing intravascular ultrasound versus angiographic guidance of percutaneous coronary intervention in pre drug eluting Stent era
    American Journal of Cardiology, 2011
    Co-Authors: Helen Parise, Martin B Leon, Gregg W Stone, Akiko Maehara, Gary S Mintz
    Abstract:

    We conducted a formal meta-analysis of peer-reviewed, published, randomized studies comparing intravascular ultrasound (IVUS)-guidance and angiographic-guided Bare Metal Stent implantation. A total of 8 studies were identified. Because the Balloon Equivalent to Stent (BEST) study was a noninferiority trial designed to compare 2 very different percutaneous coronary intervention strategies—IVUS-guided aggressive balloon angioplasty (with bail-out Stenting) and angiographic-guided deliberate Bare Metal Stent implantation—it was eliminated. An unadjusted random-effects meta-analysis was used to compare the IVUS-guided and non–IVUS-guided Stenting in the 7 remaining studies. A total of 2,193 patients were randomized in 5 multicenter and 2 single-center studies. IVUS guidance was associated with a significantly larger postprocedure angiographic minimum lumen diameter. The mean difference was 0.12 mm (95% confidence interval [CI] 0.06 to 0.18, p

  • incidence timing and correlates of Stent thrombosis with the polymeric paclitaxel drug eluting Stent a taxus ii iv v and vi meta analysis of 3 445 patients followed for up to 3 years
    Journal of the American College of Cardiology, 2007
    Co-Authors: Stephen G Ellis, Joerg Koglin, Keith D Dawkins, Eberhard Grube, Jeffrey J Popma, Antonio Colombo, Gregg W Stone
    Abstract:

    Objectives This study sought to study Stent thrombosis with the paclitaxel-eluting Taxus Stent. Background The incidence and timing of Stent thrombosis after drug-eluting Stent placement compared with Bare-Metal Stent implantation remain unsettled, with consequent uncertainty about risk stratification and long-term recommendations for antiplatelet medications. Methods This study used a patient-based meta-analysis using the 4 principal TAXUS randomized trials (3,445 patients) with a follow-up duration of ≥1 year. Results Cumulative Stent thrombosis occurred in 1.28% ± 0.31% in the Taxus group and 0.76% ± 0.23% in the Bare-Metal Stent group at 3 years (hazard ratio 1.51 [95% confidence interval 0.73 to 3.14], p = 0.26). Hazard ratios (per 100 patients per 6 months) were similar between the Taxus Stent group (0.59 [95% confidence interval 0.22 to 0.95]) and the Bare-Metal Stent group (0.64 [95% confidence interval 0.26 to 1.02]) through 6 months during the prescribed clopidogrel period. However, from 6 months to 3 years there were more Stent thromboses in the Taxus group (hazard ratio 0.19 [95% confidence interval 0.06 to 0.32] vs. 0.02 [95% confidence interval 0.00 to 0.07], p = 0.049). Of 8 patients with Taxus-related thrombosis after 6 months, 0 were taking clopidogrel and 2 were not taking aspirin consiStently. No Taxus-related Stent thrombosis occurred after 2 years (922 patients thus far followed up for 3 years). Independent correlates of Stent thrombosis were nonuse of clopidogrel, male gender, smoking, and possibly use of multiple nonoverlapping Stents. Conclusions Approximately 0.8% of Taxus patients have Stent thrombosis in the first 6 months after Stent implantation, similar to Bare-Metal Stents. However, a modest increase in risk is present with Taxus Stents beyond 6 months, possibly because of inadequate antiplatelet drug therapy.

  • safety and efficacy of sirolimus and paclitaxel eluting coronary Stents
    The New England Journal of Medicine, 2007
    Co-Authors: Gregg W Stone, Stephen G Ellis, Keith D Dawkins, Eberhard Grube, Antonio Colombo, Jeffrey W Moses, Marieclaude Morice, Joachim Schofer, Erick Schampaert, Ajay J Kirtane
    Abstract:

    A b s t r ac t Results The 4-year rates of Stent thrombosis were 1.2% in the sirolimus-Stent group versus 0.6% in the Bare-Metal-Stent group (P = 0.20) and 1.3% in the paclitaxel-Stent group versus 0.9% in the Bare-Metal-Stent group (P = 0.30). However, after 1 year, there were five episodes of Stent thrombosis in patients with sirolimus-eluting Stents versus none in patients with Bare-Metal Stents (P = 0.025) and nine episodes in patients with paclitaxel-eluting Stents versus two in patients with Bare-Metal Stents (P = 0.028). The 4-year rates of target-lesion revascularization were markedly reduced in both the sirolimus-Stent group and the paclitaxel-Stent group, as compared with the Bare-Metal-Stent groups. The rates of death or myocardial infarction did not differ significantly between the groups with drug-eluting Stents and those with Bare-Metal Stents. Conclusions Stent thrombosis after 1 year was more common with both sirolimus-eluting Stents and paclitaxel-eluting Stents than with Bare-Metal Stents. Both drug-eluting Stents were associated with a marked reduction in target-lesion revascularization. There were no significant differences in the cumulative rates of death or myocardial infarction at 4 years.

  • impact of moderate renal insufficiency on restenosis and adverse clinical events after paclitaxel eluting and Bare Metal Stent implantation results from the taxus iv trial
    American Heart Journal, 2005
    Co-Authors: Amir Halkin, Christopher W Casey, Ray V Matthews, Hadley B Wilson, Stephen G Ellis, Mary E Russell, Paul Gordon, Martin B Leon, Roxana Mehran, Gregg W Stone
    Abstract:

    Background Mortality and restenosis may be increased in patients with mild to moderate renal insufficiency (RI) after coronary Stent implantation. Whether drug-eluting Stents safely reduce restenosis and enhance event-free survival in these patients is unknown. We sought to evaluate the impact of baseline RI on clinical and angiographic outcomes in patients undergoing elective percutaneous coronary intervention using either Bare Metal or paclitaxel-eluting Stents. Methods In the TAXUS-IV trial, 1314 patients were randomized to either the polymer-based paclitaxel-eluting TAXUS Stent or an identical-appearing Bare Metal Stent. Outcomes were stratified on the basis of the presence of RI, defined as a baseline creatinine clearance 3 /min calculated by the Cockcroft-Gault formula. Results Baseline RI was present in 223 (17.2%) patients, in whom the mean creatinine clearance was 49.6 ± 8.5 cm 3 /min. Compared with Bare Metal Stents, treatment with the TAXUS Stent resulted in lower rates of 9-month angiographic restenosis rates in both patients with (2.1% vs 20.5%, P = .009) and without (9.2% vs 27.8%, P P = .01) and without (4.7% vs 15.8%, P Conclusions The polymer-based paclitaxel-eluting TAXUS Stent safely reduces clinical and angiographic restenosis in patients with preserved as well as moderate impairment of baseline renal function.

Juan Lopezmessa - One of the best experts on this subject based on the ideXlab platform.

  • role of the paclitaxel eluting Stent and tirofiban in patients with st elevation myocardial infarction undergoing postfibrinolysis angioplasty the gracia 3 randomized clinical trial
    Circulation-cardiovascular Interventions, 2010
    Co-Authors: Pedro L Sanchez, Federico Gimeno, Pablo Ancillo, Juan J Sanz, Juan Alonsobriales, Francisco Bosa, Ignacio Santos, Juan Sanchis, Armando Bethencourt, Juan Lopezmessa
    Abstract:

    Background—A catheter-based approach after fibrinolysis is recommended if fibrinolysis is likely to be successful in patients with acute ST-elevation myocardial infarction. We designed a 22 randomized, open-label, multicenter trial to evaluate the efficacy and safety of the paclitaxel-eluting Stent and tirofiban administered after fibrinolysis but before catheterization to optimize the results of this reperfusion strategy. Methods and Results—We randomly assigned 436 patients with acute ST-elevation myocardial infarction to (1) Bare-Metal Stent without tirofiban, (2) Bare-Metal Stent with tirofiban, (3) paclitaxel-eluting Stent without tirofiban, and (4) paclitaxel-eluting Stent with tirofiban. All patients were initially treated with tenecteplase and enoxaparin. Tirofiban was started 120 minutes after tenecteplase in those patients randomly assigned to tirofiban. Cardiac catheterization was performed within the first 3 to 12 hours after inclusion, and Stenting (randomized paclitaxel or Bare Stent) was applied to the culprit artery. The primary objectives were the rate of in-segment binary restenosis of paclitaxel-eluting Stent compared with that of Bare-Metal Stent and the effect of tirofiban on epicardial and myocardial flow before and after mechanical revascularization. At 12 months, in-segment binary restenosis was similar between paclitaxel-eluting Stent and Bare-Metal Stent (10.1% versus 11.3%; relative risk, 1.06; 95% confidence interval, 0.74 to 1.52; P0.89). However, late lumen loss (0.040.055 mm versus 0.270.057 mm, P0.003) was reduced in the paclitaxel-eluting Stent group. No evidence was found of any association between the use of tirofiban and any improvement in the epicardial and myocardial perfusion. Major bleeding was observed in 6.1% of patients receiving tirofiban and in 2.7% of patients not receiving it (relative risk, 2.22; 95% confidence interval, 0.86 to 5.73; P0.14). Conclusions—This trial does not provide evidence to support the use of tirofiban after fibrinolysis to improve epicardial and myocardial perfusion. Compared with Bare-Metal Stent, paclitaxel-eluting Stent significantly reduced late loss but appeared not to reduce in-segment binary restenosis. Clinical Trial Registration—URL: http://clinicaltrials.gov. Unique identifier: NCT00306228. (Circ Cardiovasc Interv. 2010;3:297-307.)

  • role of the paclitaxel eluting Stent and tirofiban in patients with st elevation myocardial infarction undergoing postfibrinolysis angioplastyclinical perspective
    Circulation-cardiovascular Interventions, 2010
    Co-Authors: Pedro L Sanchez, Federico Gimeno, Pablo Ancillo, Juan J Sanz, Juan Alonsobriales, Francisco Bosa, Ignacio Santos, Juan Sanchis, Armando Bethencourt, Juan Lopezmessa
    Abstract:

    Background— A catheter-based approach after fibrinolysis is recommended if fibrinolysis is likely to be successful in patients with acute ST-elevation myocardial infarction. We designed a 2×2 randomized, open-label, multicenter trial to evaluate the efficacy and safety of the paclitaxel-eluting Stent and tirofiban administered after fibrinolysis but before catheterization to optimize the results of this reperfusion strategy. Methods and Results— We randomly assigned 436 patients with acute ST-elevation myocardial infarction to (1) Bare-Metal Stent without tirofiban, (2) Bare-Metal Stent with tirofiban, (3) paclitaxel-eluting Stent without tirofiban, and (4) paclitaxel-eluting Stent with tirofiban. All patients were initially treated with tenecteplase and enoxaparin. Tirofiban was started 120 minutes after tenecteplase in those patients randomly assigned to tirofiban. Cardiac catheterization was performed within the first 3 to 12 hours after inclusion, and Stenting (randomized paclitaxel or Bare Stent) was applied to the culprit artery. The primary objectives were the rate of in-segment binary restenosis of paclitaxel-eluting Stent compared with that of Bare-Metal Stent and the effect of tirofiban on epicardial and myocardial flow before and after mechanical revascularization. At 12 months, in-segment binary restenosis was similar between paclitaxel-eluting Stent and Bare-Metal Stent (10.1% versus 11.3%; relative risk, 1.06; 95% confidence interval, 0.74 to 1.52; P =0.89). However, late lumen loss (0.04±0.055 mm versus 0.27±0.057 mm, P =0.003) was reduced in the paclitaxel-eluting Stent group. No evidence was found of any association between the use of tirofiban and any improvement in the epicardial and myocardial perfusion. Major bleeding was observed in 6.1% of patients receiving tirofiban and in 2.7% of patients not receiving it (relative risk, 2.22; 95% confidence interval, 0.86 to 5.73; P =0.14). Conclusions— This trial does not provide evidence to support the use of tirofiban after fibrinolysis to improve epicardial and myocardial perfusion. Compared with Bare-Metal Stent, paclitaxel-eluting Stent significantly reduced late loss but appeared not to reduce in-segment binary restenosis. Clinical Trial Registration— URL: . Unique identifier: [NCT00306228][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00306228&atom=%2Fcirccvint%2F3%2F4%2F297.atom