Transcript Slide 1

JOURNAL REVIEW
RADIAL VS FEMORAL ACCESS IN PRIMARY PCI
CULPRIT VS MULTIVESSEL PCI IN PRIMARY PCI
PRIMARY PCI IN CARDIOGENIC SHOCK
Dr Sandeep.R
SR CARDIO
RADIAL VS FEMORAL ACCESS IN PRIMARY PCI
Eikelboom JW et al. Circulation 2006;114(8):774-82
AUG2005 – SEP 2008
INCLUSION :
AMI <12hrs
EXCLUSION:
CS,H/O CABG,ALLEN’S TEST –ve
NON PALPABLE RADIAL A.
N=200,( TRA =100,TFA=100)
PRIMARY OUTCOME:
30 DAY MACE ,VASCULAR COMPLCN.
HOSPITAL STAY
SECONDARY OUTCOME : INTRAPROCEDURE
CHARACTERISTICS
HOU ET AL
APRIL 2011
OBJECTIVE
To determine if Radial vs. Femoral access for coronary angiography/PCI can reduce the
composite of death, MI, stroke or non-CABG major bleeding in ACS patients
METHODOLOGY
Done in 32 countries n=7021( june 2006 – nov 2010)
Primary outcome: Death , Mi , stroke or non CABG bleeding within 30 days
Secondary outcomes Death, M. i or stroke , non-CABG-related major bleeding at 30
days, major vascular access site complications at 48 h & 30 days PCI procedural
success.
RIVAL Study Design
NSTE-ACS and STEMI
(n=7021)
Key Inclusion:
• Intact dual circulation of hand required
• Interventionalist experienced with both (minimum 50 radial
procedures in last year)
Randomization
Radial Access
(n=3507)
Femoral Access
(n=3514)
EXCL.
1) CARDIOGENIC
SHOCK
2) SEVERE POVD
3) PRIOR CABG
WITH >1 LIMA
Blinded Adjudication of Outcomes
Primary Outcome: Death, MI, stroke
or non-CABG-related Major Bleeding at 30 days
Jolly SS et al. Am Heart J. 2011;161:254-60.
Primary and Secondary Outcomes
Radial Femoral
HR
95% CI
P
4.0
0.92
0.72-1.17
0.50
3.2
3.2
0.98
0.77-1.28
0.90
0.7
0.9
0.73
0.43-1.23
0.23
(n=3507)
(n=3514)
%
%
3.7
Primary Outcome
Death, MI, Stroke,
Non-CABG Major
Bleed
Secondary Outcomes
Death, MI, Stroke
Non-CABG Major
Bleeding
Other Outcomes
Radial Femoral
Major Vascular
Access Site
Complications
(n=3507)
(n=3514)
%
%
1.4
3.7
HR
95% CI
P
0.37 0.27-0.52 <0.0001
Other Definitions of Major Bleeding
TIMI Non-CABG
Major Bleeding
0.5
0.5
1.00 0.53-1.89
ACUITY Non-CABG
Major Bleeding*
1.9
4.5
0.43 0.32-0.57 <0.0001
* Post Hoc analysis
1.00
Subgroups: Primary Outcome
Death, MI, Stroke or non-CABG major Bleed
RESULTS
Results stratified by
High*, Medium* and Low* Volume Radial Centres
High (>146 radial PCI/year/ median operator at centre), Medium (61-146), Low (≤60)
RIVAL
Outcomes stratified by STEMI vs. NSTEACS
2N
%
%
Radial Femoral
Interaction
p-value
Primary Outcome
NSTE/ACS
5063
STEMI
1958
3.8
3.1
3.5
5.2
0.025
Death, MI or stroke
NSTE/ACS
5063
STEMI
1958
3.4
2.7
2.7
4.6
0.011
5063
1958
1.2
1.3
0.8
3.2
0.001
Non CABG Major Bleed
NSTE/ACS
5063
STEMI
1958
0.6
0.8
1.0
0.9
0.56
Major Vascular Complications
NSTE/ACS
5063
1.4
STEMI
1958
1.3
3.8
3.5
0.89
Death
NSTE/ACS
STEMI
0.25
1.00
4.00
Radial better
Femoral better
Hazard Ratio(95% CI)
Conclusion
• No significant difference between radial and femoral access
in primary outcome of death, MI, stroke or non-CABG major
bleeding
• Rates of primary outcome appeared to be lower with radial
compared to femoral access in high volume radial centres &
STEMI
• Radial had fewer major vascular complications with similar
PCI success
•
•
OBJECTIVE:
Compare the usefulness, effectiveness and
procedural course of the TRA and TFA for PCI in
pt. with STEMI &compare the effects during
hospitalization
•
•
•
•
•
Small single centre RCT (N=100)
April 2005- june 2006
Inclusion criteria:
1)age 18-75
2) STEMI< 12hr
RESULTS
CONCLUSION
•No diff. in outcomes between TRA &TFA
•TRA for PCI in patients with MI is equally effective as TFA.
•Total procedure time, X-ray exposure time &contrast vol. did not differ
•TRA in PCI procedures –early ambulation
•Complications are rare in both groups.
`
Aim: To compare the results of TRA and TFA using a StarClose device for primary PCI in patients
with ST-elevation myocardial infarction (STEMI)
Methods: Patients were randomised to PCI using TRA (n = 49) or PCI using TFA and
StarClose (n = 59) - NOV 2006 – MAR 2008
Inclusion criteria were:
(1) age 18–75 years,
(2)STEMI <12 HR
Exclusion criteria were:
(1) Killip class III or IV
(2) Necessity to use an IABP or TPI
(3) patient’s height < 150 cm,
(4) history of coronary artery bypass grafting (CABG)
Kardiologia Polska 2011; 69, 8: 763–771
RESULTS
Kardiologia Polska2011; 69, 8: 763–771
Results: D to B inflation time was 67.4 ± 17.1 vs 57.5 ± 17.5 min (p = 0.009) (tra vs tfa)
There were no significant differences in the incidence of MACE or bleeding complications
between the groups: 2.1% and 8.2% in the TRA group vs 1.7% and 10.2% in the TFA group
Ambulation time comparable
CONCLUSIONS
1. Performing PCI in patients with MI -Longer D to B time in TRA vs TFA.(No impact on MACE)
2. The duration and efficacy of PCI were comparable in both groups
3. VCD after PCI in the TFA group resulted in a similar incidence of access site and bleeding
complications rates as in the TRA
4. The use of vascular closure devices allows early ambulation in TFA
Kardiologia Polska 2011; 69, 8: 763–771
Objective:
To compare bleeding complications and results of percutaneous coronary intervention
(PCI) between patients treated by radial and femoral approaches for acute myocardial
infarction (AMI,) and using abciximab and 5 French guiding-catheters
Patients: 114 consecutive patients with AMI were prospectively randomised.
Exclusion criteria H/O CABG , cardiogenic shock, AV block, and c/I to abciximab
or negative Allen test ,need for IABP /TPI
Heart 2007;93:1556–1561.
Results:
No diff in primary outcomes
Peripheral arterial complication rates & delays to patient ambulation significantly lower
in RA vs FA
A cross over necessary in the RA than in FA
CAG & FLUORO time were significantly longer in the RA VS FA but PCI duration similar
in both groups.
Heart 2007;93:1556–1561.
Objectives : The purpose of this study was to assess whether transradial access for STEMI ACS
undergoing early invasive treatment is associated with better outcome compared with conventional
transfemoral access.
METHODOLOGY: Multicenter, randomized, parallel-group study (January 2009 and July 2011)
n= 1,001 acute STEMI ACS pts< 24 hrs undergoing primary/rescue PCI were randomized to the radial
(500) or femoral (501) approach at 4 high-volume centers
The primary endpoint- 30-day rate of net adverse clinical events (NACEs), defined as a composite of
cardiac death,stroke, MI, TLR , and bleeding
Individual components of NACEs & length of hospital stay -secondary endpoints.
STUDY DESIGN
RESULTS
CONCLUSION
Radial access in patients with STEMI is associated with significant clinical benefit, in
terms of both bleeding and cardiac mortality.
Radial approach is not just a valid alternative but it should become recommended
approach in these pt.
OBJECTIVES
To compare radial vs femoral approach in primary PCI for patients with STEMI
< 12 hours in very high volume radial centers ( > 80% radial primary PCI)
CONCLUSION
In patients with STEMI <12 hrs, radial approach was associated with a significant
lower incidence of major bleeding and access site complications and a significant
better net clinical benefit.
Moreover radial approach reduced significantly ICU stay and contrast volume
compared to femoral approach.
Our results support the use of radial approach in primary PCI in high volume centers
as a first choice
META ANALYSIS
Am J Cardiol 2012;109:813–818
WHAT DOES THE GUIDELINE SAY?
ESC GUIDELINES 2013
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Conclusions: In STEMI patients undergoing primary PCI, the radial approach is
associated with favorable outcomes and should be the preferred approach for
experienced radial operators.
CULPRIT VS MULTIPCI INPPCI
AIM: To compare long-term outcomes of three different strategies during primary PCI in
patients with STEMI and MVD; culprit vessel-only angioplasty; angioplasty of IRA followed by
an elective procedure for the treatment of other lesions & simultaneous treatment of IRA &
non-IRA
METHODOLOGY:n=263 Study period Jan 2003 –Dec 2007 , follow up of 2.5 yr
Inclusion crit. : AMI < 12 hr
Exclusion crit. : Cardiogenic shock, left main coronary disease (>50% diameter stenosis),
previous CABG, severe valvular heart disease & failed procedures
POLITI et al
STUDY PROTOCOL
STEMI & MVD
(n=243)
Excluded 21 CS,6 LM dis.,9 previous CABG,7 VHD,4 failed
FOLLOW UP PERIOD
2.5 YRS
N=214
N=214
COR
N=84
SR
N=65
CR
N=65
The primary endpoint of the study was the incidence of MACE defined as cardiac
or non-cardiac death, inhospital death, re-infarction, re-hospitalisation for ACS and
repeat coronary revascularisation.
RESULTS
Results:
• During a mean follow-up of 2.5 years, 42 (50.0%) patients in the COR group
experienced at least one MACE, 13 (20.0%) in SR group & 15 (23.1%) in the CR
group, p<0.001.
•Inhospital death, repeat revascularisation and rehospitalisation occurred more
frequently in the COR group (all p<0.05), whereas there was no significant
difference in re-infarction among the three groups.
•Survival free of MACE was significantly reduced in the COR group but was similar in
the CR and SR groups
CONCLUSION:
•COR associated with the highest rate of long-term MACE compared with multivessel
treatment.
•Patients scheduled for staged revascularisation experienced a similar rate of MACE
to patients undergoing complete simultaneous treatment of non-IRA.
AIM: To compare a one-time primary PCI of the culprit and nonculprit lesions with PCI of
only the culprit lesion and staged nonculprit PCI at a later date in patients with STEMI and
MVD
METHODOLOGY:HORIZONS-AMI study was a prospective, open-label, randomized,
multicenter trial in which 3,602 patients with STEMI <12hrs
INCLUSION CRIT. STEMI< 12HRS
EXCLUSION CRIT:
1)prior administration of fibrinolytic therapy, bivalirudin, GPI, LMWH, or fondaparinux
2)current use of warfarin
3) history of bleeding diathesis, conditions predisposing to hemorrhagic risk, or
refusal to receive blood transfusions
4) Stroke or TIA < 6 months or any permanent neurologic deficit
5) Recent or known platelet count <100,000 cells/mm3 or Hb< 10 g/dl
JACC Vol. 58, No. 7, 2011
The study endpoints :1-year MACE and its components-death, reinfarction, ischemiadriven TVR & stroke
JACC Vol. 58, No. 7, 2011
RESULTS
JACC Vol. 58, No. 7, 2011
RESULTS:
•Single versus staged PCI was associated with higher 1-year mortality (9.2% vs. 2.3%;
hazard ratio [HR]: 4.1, 95% confidence interval [CI]: 1.93 to 8.86, p < 0.0001), cardiac
CONCLUSION:A deferred angioplasty strategy of nonculprit lesions should remain the
mortality
(6.2% vs.in2.0%;
HR:with
3.14,STEMI
95% CI:
1.35 to 7.27,
p =0.005),
standard
approach
patients
undergoing
primary
PCI, asdefinite/probable
multivessel PCI may
bestent
associated
with (5.7%
a greater
hazardHR:
for2.49,
mortality
and1.09
stent
thrombosis
vs. 2.3%;
95% CI:
tothrombosis.
5.70, p = 0.02), and a trend
toward greater MACE (18.1% vs. 13.4%; HR: 1.42, 95% CI: 0.96 to 2.1, p = 0.08)
• The mortality advantage favoring staged PCI was maintained in a subgroup of patients
undergoing truly elective multivessel PCI.
•Staged PCI strategy was independently associated with lower all-cause mortality at 30
days and at 1 year.
JACC Vol. 58, No. 7, 2011
APEX AMI TRIAL
TYPE
APEX
AMI
SUBGP. STUDY
N
2201
(20042006)
INCLUSION
CRITERIA
EXCLUSION
CRITERIA
OUTCOME
RESULTS
STEMI with high
risk ecg<6hr
1)Rescue PCI
90-day mortality
12.5 (NIRA)vs. 5.6%(IRA), P <
0.001
2)isolated IW MI
90-day
composite of death,
CHF& CS
17.4(NIRA) vs. 12.0%(IRA), P =
0.020
[adjusted hazard ratio 2.44,
95% CI (1.55–3.83), P < 0.001]
European Heart Journal (2010) 31, 1701–1707
STUDY
TYPE
JENSON ET
AL
Retrospective
N
1174
(2002-09)
INCLUSION
CRITERIA
EXCLUSION
CRITERIA
END PT.
STEMI<12hr
cardiogenic
shock, IABP
All-cause
Mortality
EuroIntervention 2012;8:456-464
RESULT
ESC
GUIDELINE
2012
AHA GUIDELINES 2013
• PRIMARY PCI IN CARDIOGENIC SHOCK
s
•
•
•
•
•
OBJECTIVE : To compare the effects of early
revascularization ( PCI & CABG) on 30 day
& 1yr survival in patients who present with
cardiogenic shock after AMI vs initial
medical stabilizn
30 centre ( APR 1993-NOV 1998)
The primary end point - overall mortality
30 days after randomization.
Secondary end point -overall mortality 6 &
12 months after infarction
INCLUSION : AMI with shock < 36hr of MI
EXCLUSION:
Severe systemic illness
Mechanical or other cause of shock,
Severe valvular disease
DCMPY
Inability to gain access for catheterization & unsuitability for revascrln.
RESULTS
CONCLUSION:
Overall mortality at 30 days did not differ significantly between the revascularization
and medical-therapy groups (46.7 % and 56.0 %, respectively; difference, -9.3 %; 95
% confidence interval for the difference, -20.5 to 1.9 percent; P=0.11)
Six-month mortality was lower in the revascularization group than in the medicaltherapy group (50.3 percent vs. 63.1 percent, P=0.027)
•However, early revascularization resulted in lower mortality from all causes at six
months
• Hence, early revascularization be strongly considered for patients with acute
myocardial infarction complicated by cardiogenic shock.
SUB GROUP ANALYSIS
J Am Coll
Cardiol 2003;42:1380–6
Conclusion.
• Successful early restoration of coronary blood flow is a major predictor of survival and an
important therapeutic goal.
• Benefit of reperfusion appears to extend > accepted 12-h post-MI window.
•Surgery - in shock patients with severe MR or multivessel disease
Percutaneous Coronary Intervention for Cardiogenic Shock in the SHOCK Trial JACC Vol. 42, No. 8, 2003
Aim :
To compare a strategy of early intervention when appropriate vs initial medical management
in shock pt. due to primary pump failure < 48hrs AMI
METHODOLOGY: Multicentre ( nine centres) RCT ,1992-1996 ,30 day &1 yr survival studied
N= 55 patients ( 32 invasive & 23 medical) .Of the 32 patients in the invasive group, 30 (94%)
underwent early angiography, 27 (84%) PTCA, and one (4%) CABG.
Primary end-point: the main study end-point was mortality from all causes (cardiac and
non-cardiac) 30 days after randomization.
Secondary end-points:
(1) need for non-emergency PTCA and/or CABG during hospital stay
(2) (CCS) angina and (NYHA) heart failure class at discharge from hospital;
(3) Mortality, cardiac events and functional status at 1 year.
CONCLUSION : Failed to demonstrate that emergency PTCA significantly
improves survival in patients with AMI & early cardiogenic shock.
As the study was stopped prematurely, due to an insufficient patient inclusion
rate, a clinically meaningful benefit of early reperfusion may have been missed
Objectives: To assess the impact of multivessel (MV) primary percutaneous coronary
intervention (PCI) on clinical outcomes in patients with ST-segment elevation
myocardial infarction (STEMI) presenting with cardiogenic shock (CS) and
resuscitated cardiac arrest (CA)
Background :The safety and efficacy of MV primary PCI in patients with STEMI and
refractory CS is unknown
METHODOLOGY : Multicentre observational study done in 5 french centres (1998 EXCLUSION CRIT.
2010)
1)Futile on arrival at the cath lab
INCLUSION CRIT.
2)Alternative cause of shock was
1) Resuscitated from cardiac arrest,
suspected
2) Satisfied the criteria for STEMI and CS
3) Culprit lesion on CAG < 24 h after AMI 3)Mechanical complication of
myocardial infarction (MI) determined
before PCI
The primary outcome measure of the study was 6-month survival
Secondary endpoints included death due to CS, recurrent cardiac arrest, and a
composite of these endpoints
Results. Patients with SVD (36.5% had increased 6-month survival compared to those
with MVD (29.6% vs. 42.3%, p - 0.032).
However, 6-month survival was significantly greater in patients who underwent MV PCI
(43.9% vs. 20.4%, p -0.0017).
This survival advantage was mediated by a reduction in the composite of recurrent CA
and death due to shock (p - 0.024) in MV PCI patients
Conclusions:The results of this study suggest that in STEMI patients with MVD
presenting with CS and CA, MV primary PCI may improve clinical outcome.
AIM:To evaluate the clinical characteristics, lesion features, procedural details, and clinical
outcomes of elderly pts >75 years old compared with pts <75 years old undergoing PCI for
acute MI complicated by CS in a large, contemporary multicenter PCI registry.
BACKGROUND :Although benefits of early PCI have been shown in younger groups only
few studies have reported on clinical outcomes in elderly shock patients using current PCI
techniques
METHODOLOGY: 145 pts ( n=45 >75yr & n=98 <75yr) ( AMI &CS) from the Melbourne
Interventional Group registry between 2004 and 2007 were analyzed
Primary outcome:
1)All cause mortality
2)Periprocedural Mi
3)Bleeding
4)CHF
5)Renal failure/Stroke
6)Emergent PCI or CABG
SECONDARY OUTCOME
30day & 1 YR
1)All cause mortality
2)Cardiac & noncardiac death
3)TLR &TVR
4) MACE
RESULTS
•Elderly patients were more likely to be female (46.7% vs. 22.4%, p = 0.01) ,
Hypertensive(77.8% vs. 46.4%, p = 0.01), previous MI (31.1% vs. 15.5%, p =0.03), renal
failure (24.4% vs. 11.3%, p = 0.05) and MVD (93.1% vs. 68.3%, p = 0.01)
In-hospital, 30-day, and 1-year mortality in the elderly group versus the younger group
were 42.2% vs. 33.7% (p = 0.32), 43.2% vs. 36.1% (p =0.42), and 52.6% vs. 46.8%
(p=0.56), respectively.
CONCLUSION:
•1-year survival of elderly patients with AMI complicated by CS undergoing PCI
using contemporary techniques was comparable with survival rates of younger
patients.
•Elderly patients presenting with CS may benefit from selective use of early
revascularization and merits further investigation.
AIM:To evaluate predictors of in-hospital mortality of a large cohort of consecutive
patients with cardiogenic shock treated with primary PCI
METHODOLOGY: Data collected from PCI registry of 80 centres in germany from July
1994- Mar 2001
INCLUSION CRIT.: All patients with AMI with shock <24 hrs
EXCLUSION : pt who were lysed before PCI
SAMPLE SIZE:A total of 9422 procedures were registered, of these 1333 (14.2%)
were performed in patients with cardiogenic shock
RESULTS
RESULTS
RESULTS
• Total in-hospital mortality was 46.1% and was dependent on TIMI flow grade after
PCI
•In a multivariate analysis left main disease, TIMI <3 flow after PCI, older age, TVD
and longer time-intervals between symptom onset &PCI -independent predictors
of mortality
• Significant decrease in mortality over the years (P for trend 0.02)
CONCLUSION:
•Younger age, absence of TVD, shorter time between symptom-onset and PCI, and the
achievement of TIMI 3 flow - best predictors of an improved in-hospital mortality.
•The decision for interventional therapy in the elderly (>75 years) to be individualized
Objectives. This prospective observational study was conducted to examine the apparent impact
of a systematic direct PTCA strategy on mortality in a series of 66 consecutive patients with AMI
complicated by CS, and to analyze the predictors of outcome after successful direct PTCA.
INCLUSION CRITERIA :
1)STEMI< 6 HRS of symptom onset 2) STEMI with ongoing ischaemia 6-24 hrs
EXCLUSION CRIT.:
1) Thrombolyzed
2) Angiographic exclusion criteria for direct PTCA were
a) infarct-related artery diameter stenosis ,70%,
b) inability to identify the infarct-related artery.
3) Patients with septal or papillary muscle rupture
RESULTS
Results.:
In patients with CS, direct PTCA had a success rate of 94%; optimal angiographic result was achieved in
85%; primary stenting of the IRA was accomplished in 47%; and the in hospital mortality rate was 26%.
•Univariate analysis showed that patient age, chronic coronary occlusion and completeness of
revascularization were significantly related to in-hospital mortality.
The mean follow-up period was 16 months.
•Survival rate at 6 months was 71%.
•Comparison of event-free survival in patients with a stented or nonstented infarct-related artery suggests
an initial and long-term benefit of primary stenting
CONCLUSION:
Systematic direct PTCA, including stent supported PTCA, can establish a Thrombolysis in Myocardial
Infarction (TIMI) 3 flow in majority of patients presenting with AMI and early CS
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