Fast track — ArticlesImmediate angioplasty versus standard therapy with rescue angioplasty after thrombolysis in the Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS-in-AMI): an open, prospective, randomised, multicentre trial
Introduction
Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI).1, 2 However, a review of consecutive admissions for STEMI in 365 US hospitals in 2005 found that most patients do not receive primary angioplasty within 90 min.3 Even with an optimum network of community hospitals, tertiary referral centres with 24 h immediate PCI availability, and a technically advanced ambulance service using electrocardiogram (ECG) telediagnosis and helicopters, most patients from rural areas do not qualify for primary angioplasty.4, 5, 6 The attempt to extend to these patients the benefit of mechanical revascularisation using initial thrombolysis followed by PCI has been hampered by a higher frequency of both bleeding and ischaemic events after the intervention.
One study showed a deleterious effect of early PCI after tenecteplase compared with primary angioplasty.7 In most cases, patients are still managed conservatively at non-PCI centres, with initial thrombolytic therapy followed by transfer for PCI only if there is no evidence of reperfusion or the patient develops haemodynamic instability. We postulated that early pharmacological reperfusion at a non-PCI centre, addressing the need for a rapid and powerful platelet inhibition that overcomes the initial activation induced by thrombolytics, could be safely followed by immediate transfer for PCI. We expected this strategy to be better than the current standard management with selective late transfer for rescue PCI.
The Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction (CARESS-in-AMI) was a multicentre trial that randomly assigned high-risk patients with STEMI admitted to non-PCI hospitals to immediate transfer for PCI or to standard treatment with rescue PCI if needed.
Section snippets
Patients and procedures
The design features of CARESS-in-AMI have been published previously8 and the amended protocol, modified in its sample size but with no change in endpoints or any other aspect, has been registered on the ClinicalTrials.gov website (number 00220571).
The study involved networks of non-PCI (so-called spoke) centres and specialist PCI (hub) centres in Poland (14 spoke and three hub sites), Italy (21 spokes and 12 hubs), and France (six spokes and five hubs) that worked together to manage patients in
Results
Between December, 2002, and February, 2007, 600 patients were randomly assigned to either immediate PCI (299 patients) or standard care/rescue PCI (301 patients, figure 1). Baseline clinical characteristics were well balanced between the two groups (table 1). Time from symptom onset to admission was 120 (IQR 75–196) min and time from admission to reteplase administration 42 (30–61) min. The distribution of time from symptom onset to administration of reteplase was well balanced between the two
Discussion
Our study shows that in patients 75 years or younger with large STEMI admitted to centres without PCI facilities, a strategy of immediate transfer for PCI after a combination of half-dose reteplase plus abciximab is better than continuing standard management at the same centre. The driving component of the composite endpoint was refractory ischaemia, since death and reinfarction were lower but not significantly different in the immediate PCI group. The late rise in reinfarction and refractory
References (33)
- et al.
Combined abciximab reteplase stent study in acute myocardial infarction (CARESS in AMI)
Am Heart J
(2004) - et al.
Thrombolysis in myocardial infarction (TIMI) trial—phase I: hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue activator and streptokinase
J Am Coll Cardiol
(1988) - et al.
Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials
Lancet
(2003) - et al.
Facilitated angioplasty: paradise lost
Lancet
(2006) - et al.
Comparison of primary and facilitated percutaneous coronary interventions for ST-elevation myocardial infarction: quantitative review of randomised trials
Lancet
(2006) - et al.
Routine invasive strategy within 24 hours of thrombolysis versus ischaemia-guided conservative approach for acute myocardial infarction with ST-segment elevation (GRACIA-1): a randomised controlled trial
Lancet
(2004) - et al.
Combined angioplasty and pharmacological intervention versus thrombolysis alone in acute myocardial infarction (CAPITAL AMI study)
J Am Coll Cardiol
(2005) - et al.
Beneficial effects of immediate stenting after thrombolysis in acute myocardial infarction
J Am Coll Cardiol
(2003) - et al.
ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction
Circulation
(2004) - et al.
Management of acute myocardial infarction in patients presenting with acute ST elevation. The task force on the management of acute myocardial infarction of the European Society of Cardiology
Eur Heart J
(2003)
Strategies for reducing the door-to-balloon time in acute myocardial infarction
N Engl J Med
A regional system to provide timely access to percutaneous coronary intervention for ST-elevation myocardial infarction
Circulation
Regional systems of care to optimize timeliness of reperfusion therapy for ST-elevation myocardial infarction: the Mayo Clinic STEMI protocol
Circulation
Implementation of reperfusion therapy in acute myocardial infarction. A policy statement from the European Society of Cardiology
Eur Heart J
Primary versus tenecteplase-facilitated percutaneous coronary intervention in patients with ST-segment elevation acute myocardial infarction (ASSENT-4 PCI): randomised trial
Lancet
Coronary intervention for persistent occlusion after myocardial infarction
N Engl J Med
Cited by (374)
Impact of out-of-hospital presentation remote areas of patients with myocardial infarction with ST segment elevation : From the Nord-Alpin Emergency Network [RENAU]
2023, Annales de Cardiologie et d'Angeiologie2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
2022, Journal of the American College of CardiologyFive years of Stent for Life in Portugal
2021, Revista Portuguesa de CardiologiaManagement and outcomes of uncomplicated ST-segment elevation myocardial infarction patients transferred after fibrinolytic therapy
2020, International Journal of CardiologyModern Management of ST-Segment Elevation Myocardial Infarction
2020, Current Problems in CardiologyAn analysis of randomized controlled trials underpinning ST-elevation myocardial infarction management guidelines
2019, American Journal of Emergency Medicine
- ‡
Investigators and committees listed at end of paper