PRAGUE-8 Study
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PRAGUE-8 Study Clopidogrel > 6 hours before elective CAG vs. a few minutes before PCI in stable angina ? P Widimský, Z Moťovská, S Šimek, P Kala & PRAGUE-8 trial Investigators Charles University Prague (Third Medical Faculty, First Medical Faculty, Medical Faculty Hradec Kralové), University Hospital Brno and Regional Hospital Liberec. Open, randomized multicenter trial. Support: Research project MSM0021620817 Charles University Prague. Nothing else to disclose, no support from industry.
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PRAGUE-8 Study C lopidogrel > 6 hours before elective CAG vs. a few minutes before PCI in stable angina ? P Widimský, Z Mo ť ovská, S Šimek , P Kala & PRAGUE-8 trial Investigators - PowerPoint PPT Presentation
Transcript of PRAGUE-8 Study
PRAGUE-8 StudyClopidogrel > 6 hours before elective CAG
vs. a few minutes before PCI in stable angina ?P Widimský, Z Moťovská, S Šimek, P Kala
& PRAGUE-8 trial InvestigatorsCharles University Prague (Third Medical Faculty, First Medical Faculty, Medical Faculty Hradec
Kralové), University Hospital Brno and Regional Hospital Liberec.
Open, randomized multicenter trial.Support: Research project MSM0021620817 Charles University Prague.Nothing else to disclose, no support from industry.
The full list of investigators.Charles University Prague - 3rd Medical Faculty and
University Hospital Kralovske Vinohrady (442 pts. enrolled): Zuzana MOTOVSKA, Petr Widimský, Robert Petr, Dana Bílková, Václav Bufka, Pavel Gregor, Radovan Jirmář, Petr Ošťádal, Tomáš Buděšínský, Jaroslav Dvořák, Viktor Kočka, Libor Lisa.
Charles University Prague – 1st Medical Faculty and General University Hospital (334 pts. enrolled): Stanislav Šimek, Hana Skalická, Jan Horák, Petr Kuchynka, Aleš Linhart, Michael Aschermann.
Masaryk University & University Hospital Brno (204 pts. enrolled): Petr Kala, Martin Poloczek, Roman Miklík, Jindřich Špinar, Lenka Kubková, Jan Maňoušek.
Charles University Prague – Medical Faculty & University Hospital Hradec Kralove (24 pts. enrolled): Lucie Horáková, Radek Pudil, Jan Vojáček, Josef Šťásek, Josef Bis, Jaroslav Dušek, Pavel Polanský, Miroslav Brtko.
Regional Hospital Liberec (24 pts. enrolled): František Holm, Zdeněk Šembera, Jiri Maly.
Background.
Clopidogrel pre-treatment before planned elective PCI reduces periprocedural complications.
Current practice: very few „planned“ PCI’s (i.e. separate procedures from CAG), but rather „ad-hoc“ PCI’s (unplanned, indicated and performed immediately after planned elective CAG).
ESC guidelines for PCI: Evidence is lacking. Expert consesnsus: clopidogrel pre-treatment to all elective CAG’s (to achieve therapeutic levels at the time of possible ad-hoc PCI).
Is this valid ??
Inclusion criteria Exclusion criteria
Planned elective CAG for suspected or proven coronary artery disease
Thienopyridine treatment in previous two weeks
Signed written informed consent
Contraindication for clopidogrel
Age ≥ 18 years Clinically significant bleeding in last 3 months
CAG scheduled less than 6 hours after potential randomization
Randomizationon the day before CAG
Group A „nonselective“ clopidogrel use
(n = 513)
clopidogrel 600 mg > 6 hours before each CAG
(mean time interval between clopidogrel loading dose and CAG was 20,6 hours)
Group B „selective“ clopidogrel use
(n = 515)
clopidogrel 600 mg in the cath-lab after CAG, only to patients, undergoing subsequent PCI
Patients baseline characteristics
N = 1028
Group A (non-selective clopidogrel before CAG)
Group B (selective clopidogrel before PCI)
P value
N = 513 515
Age 65 66 n.s.
Females 36% 39% n.s.
Stabilized ACS 13% 15% n.s.
Proven or suspected chronic stable CAD
87% 85% n.s.
Previous MI 27% 28% n.s.
Diabetes mellitus 28% 28% n.s.
Mean INR at randomization 1,06 1,05 n.s.
Mean APTT at randomization 35 s 34 s n.s.
Mean creatinine 94(22 pts. > 140)
94(24 pts. > 140)
n.s.
Mean ejection fraction (echo)
57% 58% n.s.
Primary end-point(death / periprocedural MI / stroke or TIA / re-intervention
within 7 days, %)
0,8 0,81,3
2,2
0
1
2
3
4
5
6
7
8
9
10
All study pts. Only PCI pts.
Group A(nonselective)
Group B (selective)n.s.
Periprocedural troponin elevation(% of pts. with >3x ULN after intervention)
2,7 3
8,6
11,1
-1
1
3
5
7
9
11
13
15
All study pts. Only PCI pts.
Group A(nonselective)
Group B (selective)
n.s.
Bleeding complications(clinically significant, major &
minor, %)
3,5
1,2
7,2
0,7
0
1
2
3
4
5
6
7
8
9
10
All study pts. Only PCI pts.
Group A(nonselective)
Group B (selective)p = 0,006 p = 0,02
Definitions:Major: intracranial or clinically overt bleeding with a decrease in hemoglobin > 50 g/lMinor: clinically visible with a decrease in hemoglobin ≤ 50 g/l according to the TIMI criteria
Individual end-points [n]
Events [n] Group A (non-selective clopidogrel before CAG)
Group B (selective clopidogrel before PCI)
P value
Death of any cause 1 0 n.s.
Periprocedural MI (CK-MB >3x ULN)
0 0 n.s.
Periprocedural stroke / TIA
1 2 n.s.
Reintervention 2 2 n.s.
Primary end-point 4 4 n.s.
Impairment of TIMI-flow to <3 after PCI
6 0 n.s.
Clopidogrel and early CABG (n = 28)Only 2,7% of all CAG patients underwent early
(within <7 days) CABG.
7,7 6,7
31
20
0
10
20
30
Chest re-opening for
bleeding
HB fall >50g/l
Group A Group B
Conclusion.
Routine clopidogrel pretreatment before elective CAG in stable coronary artery disease is not justified.
It increased the risk of bleeding complications, while the benefit on ischemic periprocedural complications was not significant.
Clopidogrel should be given only to patients with known CAG who undergo PCI and this can be done safely in the catheterization laboratory between the two procedures.
