JOURNAL REVIEW

RADIAL VS FEMORAL ACCESS IN PRIMARY PCI

CULPRIT VS MULTIVESSEL PCI IN PRIMARY PCI

PRIMARY PCI IN CARDIOGENIC SHOCK

Dr Sandeep.RSR CARDIO

RADIAL VS FEMORAL ACCESS IN PRIMARY PCI

Eikelboom JW et al. Circulation 2006;114(8):774-82

HOU ET AL

AUG2005 – SEP 2008INCLUSION :

AMI <12hrsEXCLUSION:

CS,H/O CABG,ALLEN’S TEST –veNON PALPABLE RADIAL A.N=200,( TRA =100,TFA=100)

PRIMARY OUTCOME:30 DAY MACE ,VASCULAR COMPLCN.HOSPITAL STAY

SECONDARY OUTCOME : INTRAPROCEDURE CHARACTERISTICS

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.

NSTE-ACS and STEMI(n=7021)

Radial Access(n=3507)

Femoral Access(n=3514)

Primary Outcome: Death, MI, stroke or non-CABG-related Major Bleeding at 30 days

Randomization

RIVAL Study Design

Key Inclusion: • Intact dual circulation of hand required• Interventionalist experienced with both (minimum 50 radial

procedures in last year)

Jolly SS et al. Am Heart J. 2011;161:254-60.

Blinded Adjudication of Outcomes

EXCL.1) CARDIOGENIC

SHOCK2) SEVERE POVD3) PRIOR CABG

WITH >1 LIMA

Primary and Secondary Outcomes

Radial(n=3507)

%

Femoral (n=3514)

%HR 95% CI P

Primary Outcome

Death, MI, Stroke, Non-CABG Major Bleed

3.7 4.0 0.92 0.72-1.17 0.50

Secondary Outcomes

Death, MI, Stroke 3.2 3.2 0.98 0.77-1.28 0.90

Non-CABG Major Bleeding 0.7 0.9 0.73 0.43-1.23 0.23

Other Outcomes

Radial(n=3507)

%

Femoral (n=3514)

%HR 95% CI P

Major Vascular Access Site Complications

1.4 3.7 0.37 0.27-0.52<0.000

1

Other Definitions of Major Bleeding

TIMI Non-CABG Major Bleeding

0.5 0.5 1.00 0.53-1.89 1.00

ACUITY Non-CABG Major Bleeding*

1.9 4.5 0.43 0.32-0.57<0.000

1

* Post Hoc analysis

Death, MI, Stroke or non-CABG major Bleed Subgroups: Primary Outcome

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)

NSTE/ACSSTEMI

NSTE/ACSSTEMI

NSTE/ACSSTEMI

NSTE/ACSSTEMI

NSTE/ACSSTEMI

50631958

50631958

50631958

50631958

50631958

3.55.2

2.74.6

0.83.2

1.00.9

3.83.5

3.83.1

3.42.7

1.21.3

0.60.8

1.41.3

0.25 1.00 4.00Radial better Femoral better

Hazard Ratio(95% CI)

0.025

0.011

0.001

0.56

0.89

Interactionp-value

2N Radial Femoral% %

Primary Outcome

Death, MI or stroke

Death

Non CABG Major Bleed

Major Vascular Complications

Outcomes stratified by STEMI vs. NSTEACSR I V A L

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

CONCLUSIONS1. 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

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

Kardiologia Polska 2011; 69, 8: 763–771

Heart 2007;93:1556–1561.

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.

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

CONCLUSIONRadial 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.

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)

OBJECTIVES

CONCLUSIONIn 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

AHA – NO GUIDELINES

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

POLITI et al

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

STUDY PROTOCOL

STEMI & MVD(n=243)

Excluded 21 CS,6 LM dis.,9 previous CABG,7 VHD,4 failed

N=214N=214

CORN=84

SRN=65

CRN=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.

FOLLOW UP PERIOD 2.5 YRS

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.

JACC Vol. 58, No. 7, 2011

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 fondaparinux2)current use of warfarin3) history of bleeding diathesis, conditions predisposing to hemorrhagic risk, orrefusal to receive blood transfusions4) Stroke or TIA < 6 months or any permanent neurologic deficit5) 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, ischemia-driven TVR & stroke

RESULTS

JACC Vol. 58, No. 7, 2011

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

mortality (6.2% vs. 2.0%; HR: 3.14, 95% CI: 1.35 to 7.27, p =0.005), definite/probable

stent thrombosis (5.7% vs. 2.3%; HR: 2.49, 95% CI: 1.09 to 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.

CONCLUSION:A deferred angioplasty strategy of nonculprit lesions should remain the standard approach in patients with STEMI undergoing primary PCI, as multivessel PCI may be associated with a greater hazard for mortality and stent thrombosis.

APEX AMI TRIAL

European Heart Journal (2010) 31, 1701–1707

TYPE N INCLUSION CRITERIA

EXCLUSION CRITERIA

OUTCOME RESULTS

APEX AMI

SUBGP. STUDY 2201(2004-2006)

STEMI with high risk ecg<6hr 1)Rescue PCI

2)isolated IW MI

90-day mortality

90-daycomposite of death, CHF& CS

12.5 (NIRA)vs. 5.6%(IRA), P < 0.001 17.4(NIRA) vs. 12.0%(IRA), P = 0.020[adjusted hazard ratio 2.44, 95% CI (1.55–3.83), P < 0.001]

EuroIntervention 2012;8:456-464

STUDYTYPE

N INCLUSIONCRITERIA

EXCLUSIONCRITERIA

END PT. RESULT

JENSON ET AL

Retrospective 1174(2002-09)

STEMI<12hr cardiogenic shock, IABP

All-cause Mortality

AHA GUIDELINES 2013ESC GUIDELINE 2012

• 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 illnessMechanical or other cause of shock, Severe valvular diseaseDCMPYInability 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 medical-therapy 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 CollCardiol 2003;42:1380–6

Percutaneous Coronary Intervention for Cardiogenic Shock in the SHOCK Trial JACC Vol. 42, No. 8, 2003

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

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 -2010)

INCLUSION CRIT.1) Resuscitated from cardiac arrest,2) Satisfied the criteria for STEMI and CS3) Culprit lesion on CAG < 24 h after AMI

EXCLUSION CRIT.1)Futile on arrival at the cath lab 2)Alternative cause of shock was suspected3)Mechanical complication ofmyocardial 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 mortality2)Periprocedural Mi3)Bleeding4)CHF5)Renal failure/Stroke6)Emergent PCI or CABG

SECONDARY OUTCOME30day & 1 YR 1)All cause mortality2)Cardiac & noncardiac death3)TLR &TVR 4) MACE

RESULTS

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.

• 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.

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) Thrombolyzed2) 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

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

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

.

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