Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS in AMI)

Carlo Di Mario, Leonardo Bolognese, Luc Maillard, Dariusz Dudek, Giampaolo Gambarati, Antonio Manari, Vincenzo Guiducci, Giampiero Patrizi, Luigi Cesare Rusconi, Giancarlo Piovaccari, Agnes Ricard Hibon, Vanessa Belpomme, Ciro Indolfi, Zoran Olivari, Giuseppe Steffenino, Krzysztof Zmudka, Flavio Airoldi, Rita Panzarasa, Marcus Flather, Philippe Gabriel Steg

Research output: Contribution to journalArticle

37 Citations (Scopus)

Abstract

Background Most patients with acute myocardial infarction (AMI) are admitted to hospitals without percutaneous transluminal coronary angioplasty (PTCA) facilities or are initially managed in a prehospital mobile unit. Thrombolysis remains the most readily available reperfusion treatment in those settings, but the optimal subsequent strategy in those patients is unclear. If a mechanical recanalization is likely to be performed in an emergency, it is probably desirable that the patient receives abciximab, the glycoprotein IIb/IIIa antagonist with the strongest evidence of benefit for angioplasty in AMI. Objective The aim of this trial is to compare the effects on clinical outcome and cost-effectiveness of 2 strategies after immediate treatment with abciximab and half-dose reteplase for ST-elevation AMI: to manage the patients conservatively (referring them for rescue PTCA only if needed) or to immediately send all patients for emergency coronary angioplasty. Methods The Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction (CARESS in AMI) is an open, prospective, randomized, multicenter clinical trial conducted in patients with high-risk ST-segment elevation AMI treated within 12 hours from symptom onset in hospitals without PTCA facilities or in a prehospital mobile intensive care unit. Apart from contraindications to thrombolysis, the main exclusion criteria are age ≥75 years and a past history of CABG surgery or a percutaneous coronary intervention procedure involving the infarct-related artery. Enrollment will be performed in hospitals without PTCA facilities or directly in the ambulance if a dedicated system is in place for prehospital diagnosis and treatment of AMI. Patients will receive half-dose reteplase and full-dose abciximab and will subsequently be randomized to conventional medical therapy (with referral for emergency rescue PTCA allowed in selected cases) or emergency angioplasty. The primary end point is the 30-day combined incidence of mortality, reinfarction, and refractory ischemia. In order to obtain a 95% power (2-sided) to detect a 42% reduction in the primary end point, 900 patients are required in each arm of the study. Secondary end points include the 1-year composite end point of mortality, reinfarction, refractory ischemia, and hospital readmission because of heart failure; resource use at 30 days and 1 year; and the incidence of inhospital stroke and bleeding complications in the 2 groups. Results Seventy-four patients have been randomized (as of March 10, 2004); results are expected in June 2005. Conclusion This study will establish whether angioplasty must be started as soon as possible in all patients who receive combined pharmacologic reperfusion with the glycoprotein IIb/IIIa inhibitor abciximab and half-dose thrombolysis or whether it can be postponed or skipped in patients with signs of successful reperfusion, with obvious organizational advantages.

Original languageEnglish
Pages (from-to)378-385
Number of pages8
JournalAmerican Heart Journal
Volume148
Issue number3
DOIs
Publication statusPublished - Sep 2004

Fingerprint

Stents
Myocardial Infarction
Coronary Balloon Angioplasty
Angioplasty
Emergencies
Reperfusion
Platelet Glycoprotein GPIIb-IIIa Complex
abciximab
reteplase
Ischemia
Patient Readmission
Ambulances
Mortality
Incidence
Percutaneous Coronary Intervention
Therapeutics
Multicenter Studies
Cost-Benefit Analysis
Intensive Care Units
Referral and Consultation

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Di Mario, C., Bolognese, L., Maillard, L., Dudek, D., Gambarati, G., Manari, A., ... Steg, P. G. (2004). Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS in AMI). American Heart Journal, 148(3), 378-385. https://doi.org/10.1016/j.ahj.2004.03.038

Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS in AMI). / Di Mario, Carlo; Bolognese, Leonardo; Maillard, Luc; Dudek, Dariusz; Gambarati, Giampaolo; Manari, Antonio; Guiducci, Vincenzo; Patrizi, Giampiero; Rusconi, Luigi Cesare; Piovaccari, Giancarlo; Hibon, Agnes Ricard; Belpomme, Vanessa; Indolfi, Ciro; Olivari, Zoran; Steffenino, Giuseppe; Zmudka, Krzysztof; Airoldi, Flavio; Panzarasa, Rita; Flather, Marcus; Steg, Philippe Gabriel.

In: American Heart Journal, Vol. 148, No. 3, 09.2004, p. 378-385.

Research output: Contribution to journalArticle

Di Mario, C, Bolognese, L, Maillard, L, Dudek, D, Gambarati, G, Manari, A, Guiducci, V, Patrizi, G, Rusconi, LC, Piovaccari, G, Hibon, AR, Belpomme, V, Indolfi, C, Olivari, Z, Steffenino, G, Zmudka, K, Airoldi, F, Panzarasa, R, Flather, M & Steg, PG 2004, 'Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS in AMI)', American Heart Journal, vol. 148, no. 3, pp. 378-385. https://doi.org/10.1016/j.ahj.2004.03.038
Di Mario C, Bolognese L, Maillard L, Dudek D, Gambarati G, Manari A et al. Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS in AMI). American Heart Journal. 2004 Sep;148(3):378-385. https://doi.org/10.1016/j.ahj.2004.03.038
Di Mario, Carlo ; Bolognese, Leonardo ; Maillard, Luc ; Dudek, Dariusz ; Gambarati, Giampaolo ; Manari, Antonio ; Guiducci, Vincenzo ; Patrizi, Giampiero ; Rusconi, Luigi Cesare ; Piovaccari, Giancarlo ; Hibon, Agnes Ricard ; Belpomme, Vanessa ; Indolfi, Ciro ; Olivari, Zoran ; Steffenino, Giuseppe ; Zmudka, Krzysztof ; Airoldi, Flavio ; Panzarasa, Rita ; Flather, Marcus ; Steg, Philippe Gabriel. / Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS in AMI). In: American Heart Journal. 2004 ; Vol. 148, No. 3. pp. 378-385.
@article{64dab9171f804cff80359a1bd64d4879,
title = "Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS in AMI)",
abstract = "Background Most patients with acute myocardial infarction (AMI) are admitted to hospitals without percutaneous transluminal coronary angioplasty (PTCA) facilities or are initially managed in a prehospital mobile unit. Thrombolysis remains the most readily available reperfusion treatment in those settings, but the optimal subsequent strategy in those patients is unclear. If a mechanical recanalization is likely to be performed in an emergency, it is probably desirable that the patient receives abciximab, the glycoprotein IIb/IIIa antagonist with the strongest evidence of benefit for angioplasty in AMI. Objective The aim of this trial is to compare the effects on clinical outcome and cost-effectiveness of 2 strategies after immediate treatment with abciximab and half-dose reteplase for ST-elevation AMI: to manage the patients conservatively (referring them for rescue PTCA only if needed) or to immediately send all patients for emergency coronary angioplasty. Methods The Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction (CARESS in AMI) is an open, prospective, randomized, multicenter clinical trial conducted in patients with high-risk ST-segment elevation AMI treated within 12 hours from symptom onset in hospitals without PTCA facilities or in a prehospital mobile intensive care unit. Apart from contraindications to thrombolysis, the main exclusion criteria are age ≥75 years and a past history of CABG surgery or a percutaneous coronary intervention procedure involving the infarct-related artery. Enrollment will be performed in hospitals without PTCA facilities or directly in the ambulance if a dedicated system is in place for prehospital diagnosis and treatment of AMI. Patients will receive half-dose reteplase and full-dose abciximab and will subsequently be randomized to conventional medical therapy (with referral for emergency rescue PTCA allowed in selected cases) or emergency angioplasty. The primary end point is the 30-day combined incidence of mortality, reinfarction, and refractory ischemia. In order to obtain a 95{\%} power (2-sided) to detect a 42{\%} reduction in the primary end point, 900 patients are required in each arm of the study. Secondary end points include the 1-year composite end point of mortality, reinfarction, refractory ischemia, and hospital readmission because of heart failure; resource use at 30 days and 1 year; and the incidence of inhospital stroke and bleeding complications in the 2 groups. Results Seventy-four patients have been randomized (as of March 10, 2004); results are expected in June 2005. Conclusion This study will establish whether angioplasty must be started as soon as possible in all patients who receive combined pharmacologic reperfusion with the glycoprotein IIb/IIIa inhibitor abciximab and half-dose thrombolysis or whether it can be postponed or skipped in patients with signs of successful reperfusion, with obvious organizational advantages.",
author = "{Di Mario}, Carlo and Leonardo Bolognese and Luc Maillard and Dariusz Dudek and Giampaolo Gambarati and Antonio Manari and Vincenzo Guiducci and Giampiero Patrizi and Rusconi, {Luigi Cesare} and Giancarlo Piovaccari and Hibon, {Agnes Ricard} and Vanessa Belpomme and Ciro Indolfi and Zoran Olivari and Giuseppe Steffenino and Krzysztof Zmudka and Flavio Airoldi and Rita Panzarasa and Marcus Flather and Steg, {Philippe Gabriel}",
year = "2004",
month = "9",
doi = "10.1016/j.ahj.2004.03.038",
language = "English",
volume = "148",
pages = "378--385",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
number = "3",

}

TY - JOUR

T1 - Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS in AMI)

AU - Di Mario, Carlo

AU - Bolognese, Leonardo

AU - Maillard, Luc

AU - Dudek, Dariusz

AU - Gambarati, Giampaolo

AU - Manari, Antonio

AU - Guiducci, Vincenzo

AU - Patrizi, Giampiero

AU - Rusconi, Luigi Cesare

AU - Piovaccari, Giancarlo

AU - Hibon, Agnes Ricard

AU - Belpomme, Vanessa

AU - Indolfi, Ciro

AU - Olivari, Zoran

AU - Steffenino, Giuseppe

AU - Zmudka, Krzysztof

AU - Airoldi, Flavio

AU - Panzarasa, Rita

AU - Flather, Marcus

AU - Steg, Philippe Gabriel

PY - 2004/9

Y1 - 2004/9

N2 - Background Most patients with acute myocardial infarction (AMI) are admitted to hospitals without percutaneous transluminal coronary angioplasty (PTCA) facilities or are initially managed in a prehospital mobile unit. Thrombolysis remains the most readily available reperfusion treatment in those settings, but the optimal subsequent strategy in those patients is unclear. If a mechanical recanalization is likely to be performed in an emergency, it is probably desirable that the patient receives abciximab, the glycoprotein IIb/IIIa antagonist with the strongest evidence of benefit for angioplasty in AMI. Objective The aim of this trial is to compare the effects on clinical outcome and cost-effectiveness of 2 strategies after immediate treatment with abciximab and half-dose reteplase for ST-elevation AMI: to manage the patients conservatively (referring them for rescue PTCA only if needed) or to immediately send all patients for emergency coronary angioplasty. Methods The Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction (CARESS in AMI) is an open, prospective, randomized, multicenter clinical trial conducted in patients with high-risk ST-segment elevation AMI treated within 12 hours from symptom onset in hospitals without PTCA facilities or in a prehospital mobile intensive care unit. Apart from contraindications to thrombolysis, the main exclusion criteria are age ≥75 years and a past history of CABG surgery or a percutaneous coronary intervention procedure involving the infarct-related artery. Enrollment will be performed in hospitals without PTCA facilities or directly in the ambulance if a dedicated system is in place for prehospital diagnosis and treatment of AMI. Patients will receive half-dose reteplase and full-dose abciximab and will subsequently be randomized to conventional medical therapy (with referral for emergency rescue PTCA allowed in selected cases) or emergency angioplasty. The primary end point is the 30-day combined incidence of mortality, reinfarction, and refractory ischemia. In order to obtain a 95% power (2-sided) to detect a 42% reduction in the primary end point, 900 patients are required in each arm of the study. Secondary end points include the 1-year composite end point of mortality, reinfarction, refractory ischemia, and hospital readmission because of heart failure; resource use at 30 days and 1 year; and the incidence of inhospital stroke and bleeding complications in the 2 groups. Results Seventy-four patients have been randomized (as of March 10, 2004); results are expected in June 2005. Conclusion This study will establish whether angioplasty must be started as soon as possible in all patients who receive combined pharmacologic reperfusion with the glycoprotein IIb/IIIa inhibitor abciximab and half-dose thrombolysis or whether it can be postponed or skipped in patients with signs of successful reperfusion, with obvious organizational advantages.

AB - Background Most patients with acute myocardial infarction (AMI) are admitted to hospitals without percutaneous transluminal coronary angioplasty (PTCA) facilities or are initially managed in a prehospital mobile unit. Thrombolysis remains the most readily available reperfusion treatment in those settings, but the optimal subsequent strategy in those patients is unclear. If a mechanical recanalization is likely to be performed in an emergency, it is probably desirable that the patient receives abciximab, the glycoprotein IIb/IIIa antagonist with the strongest evidence of benefit for angioplasty in AMI. Objective The aim of this trial is to compare the effects on clinical outcome and cost-effectiveness of 2 strategies after immediate treatment with abciximab and half-dose reteplase for ST-elevation AMI: to manage the patients conservatively (referring them for rescue PTCA only if needed) or to immediately send all patients for emergency coronary angioplasty. Methods The Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction (CARESS in AMI) is an open, prospective, randomized, multicenter clinical trial conducted in patients with high-risk ST-segment elevation AMI treated within 12 hours from symptom onset in hospitals without PTCA facilities or in a prehospital mobile intensive care unit. Apart from contraindications to thrombolysis, the main exclusion criteria are age ≥75 years and a past history of CABG surgery or a percutaneous coronary intervention procedure involving the infarct-related artery. Enrollment will be performed in hospitals without PTCA facilities or directly in the ambulance if a dedicated system is in place for prehospital diagnosis and treatment of AMI. Patients will receive half-dose reteplase and full-dose abciximab and will subsequently be randomized to conventional medical therapy (with referral for emergency rescue PTCA allowed in selected cases) or emergency angioplasty. The primary end point is the 30-day combined incidence of mortality, reinfarction, and refractory ischemia. In order to obtain a 95% power (2-sided) to detect a 42% reduction in the primary end point, 900 patients are required in each arm of the study. Secondary end points include the 1-year composite end point of mortality, reinfarction, refractory ischemia, and hospital readmission because of heart failure; resource use at 30 days and 1 year; and the incidence of inhospital stroke and bleeding complications in the 2 groups. Results Seventy-four patients have been randomized (as of March 10, 2004); results are expected in June 2005. Conclusion This study will establish whether angioplasty must be started as soon as possible in all patients who receive combined pharmacologic reperfusion with the glycoprotein IIb/IIIa inhibitor abciximab and half-dose thrombolysis or whether it can be postponed or skipped in patients with signs of successful reperfusion, with obvious organizational advantages.

UR - http://www.scopus.com/inward/record.url?scp=4644318789&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=4644318789&partnerID=8YFLogxK

U2 - 10.1016/j.ahj.2004.03.038

DO - 10.1016/j.ahj.2004.03.038

M3 - Article

VL - 148

SP - 378

EP - 385

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 3

ER -