Title: Radial approach complications and solutions
1LA PREPARAZIONE ALLA PTCA NELLE SINDROMI
CORONARICHE ACUTESTEMI Preparazione
farmacologica alla PTCA dalle Linee -Guida ai
dati degli studi e dei registri Negli ospedali
con emodinamicaMaria Rosa Conte AO Mauriziano
Torino Firenze 23 gennaio 2010
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4 Primary PCI Co-therapy
Antischemic agents Antiplatelet
co-therapy Aspirin Clopidogrel loading dose New
agents prasugrel, ticagrelor Gp IIb-IIIa
antagonist Antithrombin co-therapy UHF Bivalirudin
Fondaparinux
5www.escardio.org
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7THIENOPYRIDINES
CLASS I
CLASS II b
CLASS III
8Clopidogrel in STEMI 300 vs 600 mg loading dose
JACC 2009 54 1438-46
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10OASIS 7-CURRENT
26,087 ACS pts UA/NSTEMI 70.8 STEMI 29.2 PCI
planned ?24hrs
600 mg 150 (1 week) 75 (to 1 mo)
300 mg 75 (to 1 mo)
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15FDA approved Prasugrel in July 2009!!!
16PRASUGREL
Montalescot, Lancet 09
17GPI
CLASS II a
CLASS II b
18ESC guidelines for STEMI management 2008
Gp IIb-IIIa Inhibitors
www.escardio.org
192B or not 2B in STEMIs ??
GGGP IIb/IIIa inhibitors used in conjunction with
primary PCI result in a significant reduction at
30 days in
- GP 11b/111a inhibitors used in conjunction with
primary PCI result in a significant reduction at
30 days in - Death
- Reinfarction
- Target lesion revascularisation
-
- (ADMIRAL and ISAR 2 study) Class
1 evidence
20Only trials with pPCI
De Luca et al. JAMA 2005
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23The results of the CADILLAC study suggest that
the only advantage to the prospective use of
abciximab was a decrease in subacute stent
thrombosis that occurred in the patients treated
with stent implantation and abciximab
administration. Thus, the lesson to be drawn from
CADILLAC is apparently that stent therapy
significantly improves angiographic and clinical
outcomes, but routine use of abciximab therapy
confers no incremental benefit in patients
undergoing mechanical reperfusion therapy of
acute MI.
24Kandzari DE et al. AHJ 200414745762
25Gp IIb-IIIa inhibitors and STEMI
?
Abciximax or Small molecules ? Upstrean or
Downstream? All STEMI ? After loading dose of
Clopidogrel ( prasugrel )?
26Small molecules potential advantages
- Reversibility of IPA at the end of the infusion
- Lower incidence of Thrombocytopenia ? 2.4 vs
0.55 - Cost
1,542
358
195
JAMA 2008 299 1788-99 JACC 2009 53 1668-73
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28Multistrategy
745 AMI Patients Admission ECG with ST
Elevation within 12 hours from Symptoms Onset
Abc BMS
Abc SES
HD Tirof BMS
HD Tirof DES
- End Point
- Tirofiban non inferior vs abciximab for
cumulative ST resolution ? - proportion of Pts achieving 50 recovery at 90
- MACE death, re-MI, clinically driven TVR lt 8
months
JAMA 2008 299 1788-99
29Multistrategy 8 months, MACE-results
AbcBMS
TiroBMS
AbcSES
TiroSES
JAMA 2008 299 1788-99
30Two meta-analyses of randomized trials were
published that compared small-molecule GP
IIb/IIIa antagonists with abciximab in STEMI
patients undergoing primary PCI.6,7 In each case,
there was no statistically significant difference
in 30-day mortality, reinfarction, or major TIMI
bleeding, and there was no significant difference
in death or reinfarction at 8 months between
groups. There was also no statistically significan
t difference in postprocedural TIMI flow grade 3
or ST-segment resolution. On the basis of these
studies, the present writing group judged that
the totality of evidence indicates that the
various GP IIb/IIIa antagonists
demonstrate similar effectiveness in the setting
of primary PCI.
6. Gurm H, Tamhane U, Meier P, et al. A
comparison of abciximab and small molecule
glycoprotein IIb/IIIa inhibitors in patients
undergoing primary percutaneous coronary
intervention a meta-analysis of contemporary
randomized controlled trials. Circ Cardiovasc
Intervent. 200922306. 7. De Luca G, Ucci G,
Cassetti E, et al. Benefits from small molecule
administration as compared with abciximab among
patients with ST-segment elevation myocardial
infarction treated with primary angioplasty a
meta-analysis. J Am Coll Cardiol. 2009531668
73.
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32Early vs Late Gp IIb-IIIa inhibitors EGYPT
Abciximab
De De Luca et al. Heart
2008 94 1548-50 . 11 trials
1662pz early arms better St resolution .
Mortality NS except for abcximab p0.026
33Ortolani et al. Eur Heart J 2009 30 33-43
34FINESSE
500 AMI Patients Admission ECG with ST
Elevation within 12 hours from Symptoms Onset
PPCI
Combo-Facil-PCI Abc1/2 dose Reteplase
Abc-Facil-PCI
Primary End Point Death, VF (gt48h), Cardiogenic
shock, CHF at 90 days
N Engl J Med 2008 358 2205-17
35FINESSE conclusion
Neither facilitation of PCI with reteplase plus
abciximab nor facilitation with abciximab alone
significantly improved clinical outcomes as
compared with abciximab given at the time of
PCI Limitation of the study Slow recruitment
rates and variability in center experience and
skills
N Engl J Med 2008 358 2205-17
36FINESSE3 arms -Abcximab ½ dose
retaplase-Abcximab alone-placebo (abcximab
downstream if PCI )NO difference in 3 groups
in primary composite end point of mortality VF48
h, shock, C HF at 90 days.ST resolution better
in facilatated group more bleeding in
facilitated group
37FINESSE
Treatment was initiated lt3h after symptom onset
only in 60 pts
N Engl J Med 2008 358 2205-17
38- No advantage for facilitated abciximab ?
fibrinolitic therapy vs abciximab at the time of
primary PCI - More bleeding in pts assigned to facilitated
therapies
39Abciximab and survival in pts with AMI
complicated by cardiogenic shock
P lt 0.02
42
18
Antoniucci et al. Am J Cardiol 2002 90 353
40Mean difference in infarct size size between
treatment groups in various subgroups (Brave 3
Study)
41Acute MI - Risk Stratification
The GUSTO Pyramid - 30 Day Mortality Model
Number in parentheses represents proportion of
risk of 30 day mortality explained by
characteristics
HX CV Disease (0.4)
HTN (0.6)
Prior CABG (0.8)
Accel t-PA (0.8)
Smoker (0.8)
Weight (0.8)
Diabetes (1)
Time-to-Rx (1)
Age x Killip (1.3)
Height (1.1)
Prior MI (2.8)
90 of risk
MI Location (6)
Killip Class (15.3)
Heart Rate (12)
Systolic Blood Pressure (24)
Age (31.2)
Cardiologia Treviso
Lee et al. Circulation 1995911659-1668
42 No differences in death, recurrent MI, IRA
revascularization or stroke
43BRAVE 3 Limitation
Recruitment period relatively long 4.5 years AMI
lt 24 hrs Symptom onset to PPCI gt 300 min
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45GPI for STEMI New considerations
- Early trials performed in era without DAT
- Recent emphasis on time to PCI creates a
different substrate - Value of GPI uncertain in different settings,
potentially questionable - RECENT TRIALS BRAVE-3, On-TIME-2, HORIZONS-AMI
- Comparison of GPI MULTISTRATEGY
- Timing of GPI-
46ANTICOAGULATION
CLASS I
CLASS II a
47Fondaparinux in STEMIOASIS 6 Trial (12096pts)
Fondaparinux vs UHFcathether -related
thrombosisi plt0.001 and more coronary
complications in the arm of fondaparinux
Primary Endpoint of Death or MI in PCI Cohort
6,1
Guiding Catheter Thrombosis plt0.001
5,1
p0.19
Fondaparinux
Control
48LMWH in STEMIExTRACT-TIMI 25 trial
(20506 pts)Enoxaparin vs UFH primary end
point death/non fatal MI at 30 days was lower
plt0.001 with enoxaparin lower incidence of
major bleeding plt0.001 (duration of treatment
different 7days with enoxaparin and 48h with
UFH)
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50MACE or major bleeding
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54Bivalirudin in Patients with Heparin-induced Throm
bocytopenia Undergoing Percutaneous
Coronary Intervention Kevin R. Campbell, MD,
Kenneth W. Mahaffey, MD, Bruce E. Lewis, MD,
Jeffrey I. Weitz, MD, Scott D. Berkowitz, MD, E.
Magnus Ohman, MD, Robert M. Califf, MD. The Duke
Clinical Research Institute, Durham NC (KRC, KWM,
SDB, EMO, RMC) Loyola University Medical Center,
Maywood, IL (BEL) McMaster University and
Hamilton Civic Hospitals Research Centre,
Hamilton, Ontario (JIW).
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58Take home message
- Aspirin
- Clopidogrel 600 mg
- UFH
- Fondaparinux Class III
- Gp IIb-IIIa early and in hig risk
ptsprobably better - Bivalirudin , Prasugrel ...
- Intra coronary abcximab .?
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