Development and validation of a risk scoring model to predict net adverse cardiovascular outcomes after primary percutaneous coronary intervention in patients pretreated with 600 mg clopidogrel: rationale and design of the RISK-PCI study.
BACKGROUND
No comprehensive primary PCI (pPCI) risk model to predict net adverse cardiovascular events (NACE) has been reported with the use of clopidogrel 600 mg, which is now considered the standard loading dose. The primary hypothesis of the RISK-PCI trial is that an accurate risk prediction may be achieved by using clinical, angiographic, and procedural variables available at the time of intervention.


METHODS
The present single-center, longitudinal, cohort study will include 1,750 consecutive patients with ST-elevation myocardial infarction (STEMI), undergoing pPCI after pretreatment with 300 mg aspirin and 600 mg clopidogrel. The primary end-points of the trial (NACE) include major adverse cardiovascular events (MACE) and major bleeding. A logistic regression model will be developed to predict 30-day and 1-year NACE after pPCI. A risk score derived from study set data will be validated using validation set data.


RESULTS
Until June 1, 2008, 1,166 patients have been enrolled. Thirty-day follow-up is available in 1,007 patients.


CONCLUSIONS
The RISK-PCI study is designed to develop an accurate risk scoring system, using variables available at the time of intervention, to predict long-term adverse outcomes after pPCI.
Mrdovic
Igor
I
Clinical Center of Serbia, Institute for Cardiovascular Diseases, Emergency Hospital, Belgrade, Serbia. igormrd@gmail.com
Savic
Lidija
L
Perunicic
Jovan
J
Asanin
Milika
M
Lasica
Ratko
R
Marinkovic
Jelena
J
Vasiljevic
Zorana
Z
Ostojic
Miodrag
M
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000706:statistics & numerical data; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000077144:Clopidogrel; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000628:therapy*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D015233:Models, Statistical; D008962:Models, Theoretical; D015999:Multivariate Analysis; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012372:ROC Curve; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin