Utility of post-procedural anticoagulation after primary PCI for STEMI: insights from a pooled analysis of the HORIZONS-AMI and EUROMAX trials.
BACKGROUND
Many sites routinely continue anticoagulation after primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction (STEMI), despite an unclear benefit-risk ratio. We evaluated the impact of this strategy on 30-day outcomes from a pooled patient-level database of two large primary percutaneous coronary intervention trials.


METHODS
EUROMAX and HORIZONS-AMI were both multicentre, international randomised trials comparing bivalirudin to heparin with or without glycoprotein IIb/IIIa inhibitors in patients with STEMI undergoing primary percutaneous coronary intervention. Outcomes at 30 days were analysed according to the use of post-procedural anticoagulation (unfractionated or low-molecular-weight heparins or fondaparinux) outside of the catheterisation laboratory.


RESULTS
Among 5239 patients undergoing primary percutaneous coronary intervention, 2153 (41.1%) received post-procedural anticoagulation. After adjusting for differences in baseline variables, there were no differences in the 30-day rates of adverse ischaemic events between patients without versus with post-procedural anticoagulation: adjusted odds ratio for major adverse cardiac events 0.80; 95% confidence interval 0.60-1.07; P=0.14; adjusted odds ratio for stent thrombosis 0.82; 95% confidence interval 0.55-1.24; P=0.35; adjusted odds ratio for death 1.07; 95% confidence interval 0.69-1.66; P=0.77. Conversely, protocol-defined major bleeding was decreased without post-procedural anticoagulation: adjusted odds ratio 0.74; 95% confidence interval 0.58-0.94; P=0.01. Similar results were observed for Thrombolysis In Myocardial Infarction major and minor bleeding.


CONCLUSIONS
In this large STEMI database, a substantial proportion of primary percutaneous coronary intervention patients received post-procedural anticoagulation, which in turn was associated with higher bleeding rates without any reduction in ischaemic events. Therefore, routine post-procedural anticoagulation after primary percutaneous coronary intervention seems to have an unfavourable benefit-risk profile and should be avoided unless a well-established indication is present.


BACKGROUND
ClinicalTrials.gov , EUROMAX Identifier NCT01087723; HORIZONS Identifier NCT00433966.
1 Hôpital Bichat, Université Paris-Diderot, France.
Gregory
G
Ducrocq
1 Hôpital Bichat, Université Paris-Diderot, France.|2 NHLI, Imperial College, Royal Brompton Hospital, UK.
Philippe Gabriel
PG
Steg
3 Isala Klinieken, Department of Cardiology, the Netherlands.
Arnoud
A
Van't Hof
4 Klinikum Ludwigshafen and Institut für Herzinfarktforschung, Germany.
Uwe
U
Zeymer
5 Mount Sinai School of Medicine and the Cardiovascular Research Foundation, USA.
Roxana
R
Mehran
6 Kerckhoff Heart and Thoraxcenter, Germany.
Christian W
CW
Hamm
7 The Medicines Company, USA.
Debra
D
Bernstein
7 The Medicines Company, USA.
Jayne
J
Prats
7 The Medicines Company, USA.
Efthymios N
EN
Deliargyris
8 Columbia University Medical Center and the Cardiovascular Research Foundation, USA.
Gregg W
GW
Stone
D000368:Aged; D000991:Antithrombins / Q000008:administration & dosage; D017023:Coronary Angiography; D003328:Coronary Thrombosis / Q000175:diagnosis / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage; D006493:Heparin / Q000008:administration & dosage*; D006629:Hirudins / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000008:administration & dosage*; D062645:Percutaneous Coronary Intervention; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D011182:Postoperative Care / Q000706:statistics & numerical data*; D011994:Recombinant Proteins / Q000008:administration & dosage; D000072657:ST Elevation Myocardial Infarction / Q000601:surgery*; D015912:Thrombolytic Therapy / Q000706:statistics & numerical data*; D016896:Treatment Outcome
D000991:Antithrombins; D005343:Fibrinolytic Agents; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
Bivalirudin; anticoagulation; bleeding; myocardial infarction; percutaneous coronary intervention