Primary PCI without onsite CABG facility

PRIMARY PCI WITHOUT ONSITE CABG FACILITY

DEV PAHLAJANI MD,FACC,FSCAICHIEF OF INTERVENTIONAL CARDIOLOGY

BREACH CANDY HOSPITAL, MUMBAI

PCI WITHOUT ONSITE CABGPRE STENT ERA

• Gruntzig’s first 50 cases—10% needed emergency CABG

• NHLBI 1984—6.6% required emergency cabg

• Dropped to 3% in late 90’s

EMERGENCY CABG POST PCI-INDICATIONS

• Extensive dissection• Acute closure• Perforation, tamponade• Major side branch occlusion• Unsuccessful dilatation

Percentage of patients requiring emergency coronary artery bypass grafting (CABG) after percutaneous coronary intervention from 1979 to

2003 (n = 23,087).

JACC 2005, 46, 2006

% E

mer

genc

y of

CAB

G

Year

14

12

10

8

6

4

2

0 1979 1984 1989 1994 1999 2004

p < 0.001 for trend

Prevalence of emergency CABG after percutaneous coronary interventions from 1992 through 2000

Circulation October 2002

% E

mer

genc

y of

CAB

G

Year of Procedure

2.0

1.5

1.0

0.5

0.01992 1994 1996 1998 2000

N = 18,593 PCIsP < 0.001

Prevalence of emergency CABG in Stented and non-stented patients 1992 through 2000


6

5

4

3

2

1

0

Non-stented

Stented

p< 0.001

% E

mer

genc

y of

CAB

G

Year of Procedure

1992 1994 1996 1998 2000

Use of Stents and Platelet Glycoprotein IIb/IIIa inhibitors in all patients from 1992 through 2000


Perc

ent

Year of Procedure

100

90

80

70

60

50

40

30

20

10

0 1992 1993 1994 1995 1996 1997 1998 1999 2000

IIb/IIIa used

Stent used

Predictors for Emergency Coronary Artery BypassGrafting During the Pre-Stent Era (1979 to 1994)

Odds Ratio 95% CIPre-procedure shock 2.35 1.33-4.13Acute myocardial infarction 1.82 1.31-2.53Canadian Cardiovascular Society angina class ≥3

1.81 1.35-2.42

Angulated segment (>45) 1.66 1.27-2.17Multi-vessel coronary disease 1.55 1.18-2.04

JACC 2005;46,2006

Cl = confidence interval.

Predictors for Emergency Coronary Artery Bypass Grafting During the Stent Era (1995 to 2003)

Odds Ratio 95% CIEmergent PCI 3.77 2.02-7.02Multi-vessel coronary disease 2.40 1.44-4.0Peripheral vascular disease 2.28 1.24-4.17

Angulated segment (>45) 1.90 1.19-3.03History of smoking 1.88 1.07-3.28

JACC 2005;46,2006

In-hospital mortality rates of patients requiring emergency coronary artery bypass grafting after percutaneous coronary

intervention from 1979 to 2003 (n = 335)

1979-19941995-1999

2000-2003

0

2

4

6

8

10

12

14

16

JACC 2005, 46, 2006

Year

In-H

ospi

tal M

orta

lity

Rate

(%) p=0.83

Time Dependency?

For every 30-minute delay from onset of symptoms to primary PCI, there is an 8 percent increase in the relative risk of 1-year

mortality

Importance of time to reperfusion in patients undergoing primary percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction (STEMI). This plot is based on the pooled data from 1791 patients undergoing primary PCI for STEMI. After adjusting for baseline risk, there is a curvilinear relationship between the time elapsed from the onset of symptoms to balloon inflation and the rate of mortality at 1 year. For every 30-minute delay from onset of symptoms to primary PCI, there is an 8 percent increase in the relative risk of 1-year mortality. (From De Luca G, Suryapranata H, Ottervanger JP, et al: Time-delay to treatment and mortality in primary angioplasty for acute myocardial infarction: Every minute counts. Circulation 109:1223, 2004.)

PAMI VS THROMB.META ANALYSIS

PCI (n=3872) Lysis (n=3867) P

Death 270 (7%) 390 (9%) 0.0002

Death (Excluding SHOCK Trial Data)

199 (5%) 276 (7%) 0.0003

Nonfatal Reinfarction

80 (3%) 222 (7%) < 0.0001

Stroke 30(1%) 64 (2%) 0.0004

Combined Endpoint 253 (8%) 442 (14%) <0.0001

Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous therapy for acute myocardial infarction: a quantitative review of 23 randomized trials. Lancet 2003:361:13:20

Meta-Analysis of 23 Randomized Trials of Percutaneous Coronary Intervention (PCI) vs. Lysis (n=7739)

PPCI WITHOUT ONSITE CABG• HOW OFTEN IS THE NEED?

• IS IT BETTER THAN FIBRINOLYTICS?

• IS IT NON INFERIOR/BETTER THAN ONSITE CABG?

• PRECAUTIONS AND CURRENT GUIDELINES

Most of the 1,506 hospitals in the National Registry of Myocardial Infarction-2 had the capability to perform coronary angiogra phy (Cath-capable), angioplasty

(PTCA-capable) or bypass surgery (CABG-capable). CABG = coronary artery bypass graft surgery; PTCA = percutaneous transluminal coronary angioplasty.

(From Rogers et al. [20], by permission of the American College of Cardiology)

Nonivasive28%

Cath -capable25%

PTCA-capable8%

CABG-capable39%

JACC Vol. 39, No. 12, 2002

PAMI 2- Stone et al ,AJC 2000

• 982 patients underwent PPCI

• 6.1% needed CABG during index hospital

• Only 0.4% of these CABG were emergency procedures after PPCI

Randomized Trials of Primary Stenting Versus Balloon Angioplasty for Acute Myocardial Infarction : Incidence of

Emergency CABG for Failed PCI

Study (Reference) n Design Emergency CABG for Failed PCI

PAMI-STENT (2) 900 Multicenter 4 (0.4%)

Suryapranata et al. (13) 452 Single-center 1 (0.2%)

FRESCO (14) 150 Single-center 0

GRAMI (15) 104 Multicenter 1(1%)

PASTA (16) 136 Multicenter 0

STENTIM-2 (17) 211 Multicenter 0

Total 1,953 6 (0.31%)

JACC 2005;46,2006Singh et al

PPCI WITHOUT ONSITE CABG

• WHAT IS THE NEED?


• IS IT SAFE/NON INFERIOR OR BETTER THAN AT CENTERS WITH ONSITE CABG?


Thrombolytic Therapy vs Primary Percutaneous Coronary Intervention for

Myocardial Infarction in Patients Presenting to Hospitals Without On-site

Cardiac Surgery

A Randomized Controlled Trial C-PORT JAMA 2002, 287, 1943

Flow of Participants Through The TrialC-PORT

JAMA, April 17, 2002 – Vol 287, No. 15

451 Randomized

226 Assigned to Receive Thrombolytic Therapy

226 Induced in Analysis

0 Excluded From Analysis

225 Assigned to Primary Percutaneous Coronary

Intervention

225 Induced in Analysis

0 Excluded From Analysis

Primary Outcomes : Treatment-Received Analysis

No. (%)Outcome Thrombolytic Therapy (n =

211)Primary PCI

(n = 171)

P Value

6 Weeks Death 16 (7.6) 7 (4.1) .15 Recurrent Ml 20 (9.5) 7 (4.1) .04 Stroke 8 (3.8) 2 (1.2) .11 Composite 40 (19.0) 14 (8.2) .003

6 Months Death 16 (7.6) 9 (5.3) .36 Recurrent Ml 23 (10.9) 8 (4.7) .03 Stroke 8 (3.8) 3 (1.8) .24 Composite 43 (20.4) 17 (9.9) .005

CPORT JAMA 2002

CPORTCumulative 6-Week Event-Free Survival

JAMA April 17, 2002Vol. 287, No. 15

No. at RiskPercutaneous Coronary Intervention 225 206 202 202 201ThrombolyticTherapy 226 191 187 186 186Survival was significantly better (P=.03) in the group receiving thrombolytic therapy

Percutaneous Coronary Intervention

Thrombolytic Therapy

Cu

mu

lati

ve E

ven

t-F

ree

Su

rviv

al

1.0

0.9

0.8

0.7

00 10 20 30 40






Primary Angioplasty Without Cardiac Surgery In-Hospital Outcomes in Patients

Undergoing % of Patients

Outcome Total(n=489)

InitialCardiogenic

Shock(n = 56)

Without Shock

(n=433)

Death 5.3 % 23.2% 3.0 %Reinfarction 2.5 % 1.8 % 2.5 %Reocclusion 3.3 % 1.8 % 3.5 %Stroke or TIA (none hemorrhagic)

0.4 % 1.8 % 0.2 %

Wharton et alJACC Vol. 33, No. 5 1999

Primary Angioplasty Without Cardiac Surgery

Median Time from ED arrival to Reperfusion

Successful PTCA

Reinfarction

Stroke / TIA

Death (In-Hospital)

0 10 20 30 40 50 60 70 80 90 100

Wharton et alJACC Vol. 33 No. 5, 1999

102min

124min

99 %92 %

3.0%3%

0.4%

1%

3.9%

4%

Outcomes of 335 Primary Angioplasty Procedures

Outcome Mean Value ± SD or % of Procedures

Post-PTCA TIMI flow grade 0-1 4.8%2 0.9% 3 94.3% Post PTCA % stenosis 23 ± 22 PTCA success 94.3%In-hospital mortality 6.6%Presenting with cardiogenic shock (n = 44)

25.0%

Presenting without shock (n = 291)

3.8%

Wharton et al.JACC Vol. 33 No. 5 1999

Time to Treatment in the Air PAMI-No SOS Study

Time Intervals (min) Transfer for PAMedian

(25 th, 75th)

On-Site PAMedian

(25 th, 75th)

p Value

Chest pain onset to emergency center arrival

90 (45,170) 87 (45,167) 0.77

Emergency center arrival to angiography

155 (119,194) 81 (60,115) <0.0001

Emergency center arrival to balloon inflation

166 (131, 240) 105 (80,139) <0.0001

Chest pain onset to reperfusion (balloon inflation)

270 (202, 362) 201 (148, 326) 0.017

Wharton et alJACC 2004;43,1943

Wharton et al JACC 2004, 43, 1943

Hospital Stay0

5

10

15

20

Day

s

Death reMI Disabling CVA MACE0

1

2

3

4

5

6

7

8

9

10

8.5

1.4

0

8.5

3.4

0.21

5

Transfer for PA (n=71) On-Site PA (n=499

p=.10

p=0.54

p=.24p=1.00

p=0.2738%

6.1±4.35.2±4.0

30

-Da

y E

ve

nts

Percutaneous Coronary Interventions In Facilities Without Cardiac Surgery On Site : A Report From the National Cardiovascular Data Registry (NCDR)

Michael A. Kutcher, MD et alJACC, 2009, 54, 1, 16

NCDR –JACC 2009• Data from jan 2004-march 2009

• 308161 patients

• 465 PCI capable centers

• 8736 patients 60 centers with no onsite CABG

• 299425 PCI at onsite CABG centers

Pie charts showing the relative distribution of myocardial infarction (Ml) presentation within centers with on- or off-site surgical backup. Off-Site Backup N=8,736 patients

Blue areas indicate no Ml; purple areas indicate non-ST-segment elevation myocardial infarction (non-STEMI); yellow areas indicate STEMI. p < 0.001.

JACC Vol. 54, No. 1, 2009NCDR Offsite PCI

51281442

2166

212806

44896

41723

Off-Site Backup N=8,736 patients On-Site Backup N=299,425 patients

(59 %)(17 %)

(25 %)(14%)

(15%)

(71%)

No MI Non-STEMI STEMI

Total N Favors Off-Sit Favors On-Site

Mortality – overall 308,120 0.90 (0.72 – 1.14) 0.388

Mortality – primary PCI pts 33,008 0.97 (0.75 – 1.25) 0.807

Mortality – non-primary PCI pts 275,098 0.86 (0.63 – 1.16) 0.319

Emergency CABG 308,121 0.60 (0.37 – 0.98) 0.042

Mortality – pts not requiring 306,962 0.93 (0.73 – 1.17) 0.533

emergency CABG

Sensitive Analysis

Mortality – impute to Yes 308,161 1.21 (0.95 – 1.54) 0.120

for Off-site

Mortality – impute to No 308,161 0.88 (0.70 – 1.11) 0.281

for Off-site

Odds ratio plot of risk-adjusted outcomes, including sensitivity analysis for missing mortality data. Odds ratio: outcomes for patients at off-site (vs. on-site) facili ties, adjusting for within site correlations and potential confounding variables. ‘Worst case scenario: all patients with missing mortality data were

considered to have died. **Best case scenario: all patients with missing mortality data were considered as alive. CABG = coronary artery bypass graft surgery; Cl = confi dence interval; PCI = percutaneous

coronary intervention; pts = patients.

JACC Vol. 54, No. 1, 2009NCDR Offsite CI

0.1 1 10

Outcome Total N

Mortality – overall 308,120

Mortality – primary PCI pts 33,008

Mortality – non-primary PCI pts 275,098

Emergency CABG 308,121

Mortality – pts not requiring 306,962

emergency CABG

Sensitive Analysis

Mortality – impute to Yes 308,161

for Off-site

Mortality – impute to No 308,161

for Off-site

Odd Ratio (95% CI) p-value

0.90 (0.72 – 1.14) 0.388

0.97 (0.75 – 1.25)) 0.807

0.86 (0.63 – 1.16) 0.319

0.60 (0.37 – 0.98)) 0.042

0.93 (0.73 – 1.17) 0.533

1.21 (0.95 – 1.54) 0.120

0.88 (0.70 – 1.11) 0.281

Physician Volume and Outcome of Primary PCIAverage Mortality by Physician and Hospital

VolumePhysician Volume Hospital Volume Patients, n Observed Mortality Risk-Adjusted

Mortality Rate

> 10/yr (n = 90) >50/yr 4,712 3.2 (0.33) 3.8 (0.42)

>10/yr (n = 36) ≤50/yr 526 3.5 (0.90) 4.8 (123)

≤10/yr (n = 140) >50/yr 1,461 4.2 (0.90) 6.5 (2.12)

≤ 10/yr (n = 97) ≤50/yr 622 6.7 (1.6) 8.4 (2.73)

>20/yr (n = 29) >50/yr 2,424 2.8 (0.40) 3.5 (4.27)

>20/yr (n = 10) ≤50/yr 106 3.0 (1.9) 2.6 (139)

≤ 20/yr (n = 201) >50/yr 3,749 4.0 (0.6) 5.7(1.50)

≤20/yr (n = 123) ≤50/yr 1,042 6.1(1.2) 6.1(1.2)

JACC Vol. 53 No. 7, 2009

Volume-Outcome Relationship for Hospitals and Physicians

Srinivas et al JACC 2009, 53, 574

State-wide mortality

Annual Hospital Volume (per year) Annual Physician Volume (per year)

State-wide mortality

% R

isk

Adju

sted

Mor

talit

y

% R

isk

Adju

sted

Mor

talit

y

15

10

5

0

6

4

2

00 50 100 150 200

0 10 20 30 ≥36

52 43 33 25 21 11 22 15 7 8 8 4 2 2 0 2 4 7

No. of Physicians






Points To Ensure

1) The risks and benefits of primary PCI versus thrombolytic therapy;

2) The risks and benefits of primary PCI versus transfer of patients to an institution with on-site cardiac surgical capabilities for those not eligible for thrombolytic therapy;

3) The outcome for patients who are treated with the intention that they will receive primary angioplasty, but who do not receive it;

4) The frequency of and indications for emergency CABG unrelated to PCI complications;

5) The management of PCI complications that may be alleviated by emergency CABG;

6) The requirements that must be met in hospitals without on-site cardiac surgical capabilities to perform primary PCI safely and effectively.

2011 ACC/AHA/SCAI GUIDELINES EXECUTIVE SUMMARY

• CLASS IIA:LEVEL OF EVIDENCE B

• PPCI is reasonable in hospital without onsite CABG provided that appropriate placing of program development has been accomplished


• CLASS III-HARM!!!

• PPCI should not be performed in hospital without a plan for rapid transport to operating room in a nearby hospital Or without proper hemodynamic support for transport

Health & Medicine

Primary PCI without onsite CABG facility