This document summarizes data on primary percutaneous coronary intervention (PCI) performed at hospitals without on-site coronary artery bypass grafting (CABG) surgery capabilities. The need for emergency CABG after primary PCI has decreased over time, from around 10% in the 1970s to less than 1% currently due to improvements in techniques and equipment. Several studies have found primary PCI performed at centers without on-site CABG to have similar or better outcomes compared to fibrinolytic therapy, with lower mortality, reinfarction and stroke rates. While transfer times to PCI centers without on-site CABG are longer, studies have found primary PCI at these centers to be safe when performed by experienced operators, with low rates of emergency

1. PRIMARY PCI WITHOUT ONSITE
CABG FACILITY
DEV PAHLAJANI MD,FACC,FSCAI
CHIEF OF INTERVENTIONAL CARDIOLOGY
BREACH CANDY HOSPITAL, MUMBAI

2. PCI WITHOUT ONSITE CABG
PRE 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

3. EMERGENCY CABG POST PCI-
INDICATIONS
• Extensive dissection
• Acute closure
• Perforation, tamponade
• Major side branch occlusion
• Unsuccessful dilatation

4. Percentage of patients requiring emergency coronary artery bypass
grafting (CABG) after percutaneous coronary intervention from 1979 to
2003 (n = 23,087).
14
p < 0.001 for trend
12
% Emergency of CABG
10
8
6
4
2
0 1979 1984 1989 1994 1999 2004
Year
JACC 2005, 46, 2006

5. Prevalence of emergency CABG after percutaneous
coronary interventions from 1992 through 2000
2.0
N = 18,593 PCIs
P < 0.001
% Emergency of CABG
1.5
1.0
0.5
0.0
1992 1994 1996 1998 2000
Year of Procedure
Circulation October 2002

6. Prevalence of emergency CABG in Stented and
non-stented patients 1992 through 2000
6
Non-stented
% Emergency of CABG
5 Stented
4
p< 0.001
3
2
1
0
1992 1994 1996 1998 2000
Year of Procedure
Circulation October 2002

7. Use of Stents and Platelet Glycoprotein IIb/IIIa
inhibitors in all patients from 1992 through 2000
100
90 IIb/IIIa used
80 Stent used
70
Percent
60
50
40
30
20
10
0 1992 1993 1994 1995 1996 1997 1998 1999 2000
Year of Procedure
Circulation October 2002

8. Predictors for Emergency Coronary Artery Bypass
Grafting During the Pre-Stent Era (1979 to 1994)
Odds Ratio 95% CI
Pre-procedure shock 2.35 1.33-4.13
Acute myocardial infarction 1.82 1.31-2.53
Canadian Cardiovascular Society 1.81 1.35-2.42
angina class ≥3
Angulated segment (>45) 1.66 1.27-2.17
Multi-vessel coronary disease 1.55 1.18-2.04
Cl = confidence interval.
JACC 2005;46,2006

9. Predictors for Emergency Coronary Artery Bypass
Grafting During the Stent Era (1995 to 2003)
Odds Ratio 95% CI
Emergent PCI 3.77 2.02-7.02
Multi-vessel coronary disease 2.40 1.44-4.0
Peripheral vascular disease 2.28 1.24-4.17
Angulated segment (>45) 1.90 1.19-3.03
History of smoking 1.88 1.07-3.28
JACC 2005;46,2006

10. In-hospital mortality rates of patients requiring emergency
coronary artery bypass grafting after percutaneous coronary
intervention from 1979 to 2003 (n = 335)
16
p=0.83
14
In-Hospital Mortality Rate (%)
12
10
8
6
4
2
0
1979-1994
1995-1999
2000-2003
Year
JACC 2005, 46, 2006

11. Time Dependency?

12. 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.)

13. PAMI VS THROMB.META ANALYSIS
Meta-Analysis of 23 Randomized Trials of Percutaneous Coronary
Intervention (PCI) vs. Lysis (n=7739)
PCI (n=3872) Lysis (n=3867) P
Death 270 (7%) 390 (9%) 0.0002
Death (Excluding 199 (5%) 276 (7%) 0.0003
SHOCK Trial Data)
Nonfatal 80 (3%) 222 (7%) < 0.0001
Reinfarction
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

14. 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

15. 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)
CABG- Nonivasive
capable 28%
39%
Cath -capable
25%
PTCA-capable
8%
JACC Vol. 39, No. 12, 2002

16. 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

17. 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;46,2006
Singh et al

18. PPCI WITHOUT ONSITE CABG
• WHAT IS THE NEED?
• IS IT BETTER THAN FIBRINOLYTICS?
• IS IT SAFE/NON INFERIOR OR BETTER THAN AT
CENTERS WITH ONSITE CABG?
• PRECAUTIONS AND CURRENT GUIDELINES

19. 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

20. Flow of Participants Through The Trial
C-PORT
451
Randomized
225 Assigned to
226 Assigned to Primary
Receive Percutaneous
Thrombolytic Coronary
Therapy Intervention
226 Induced in 225 Induced in
Analysis Analysis
0 Excluded From 0 Excluded From
Analysis Analysis
JAMA, April 17, 2002 – Vol 287, No. 15

21. Primary Outcomes : Treatment-Received
Analysis
No. (%)
Outcome Thrombolytic Therapy (n = Primary PCI P Value
211) (n = 171)
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

22. CPORT
Cumulative 6-Week Event-Free Survival
1.0
Cumulative Event-Free Survival
Percutaneous Coronary
Intervention
0.9
Thrombolytic Therapy
0.8
0.7
No. at Risk
Percutaneous 0
Coronary 0 10 20 30 40
Intervention 225 206 202 202 201
Thrombolytic
Therapy 226 191 187 186 186
Survival was significantly better (P=.03) in the group receiving
thrombolytic therapy
JAMA April 17, 2002
Vol. 287, No. 15

23. PPCI WITHOUT ONSITE CABG
• WHAT IS THE NEED?
• IS IT BETTER THAN FIBRINOLYTICS?
• IS IT SAFE/NON INFERIOR OR BETTER THAN
AT CENTERS WITH ONSITE CABG?
• PRECAUTIONS AND CURRENT GUIDELINES

24. Primary Angioplasty Without Cardiac
Surgery In-Hospital Outcomes in Patients
Undergoing
% of Patients
Outcome Total Initial Without
(n=489) Cardiogenic Shock
Shock (n=433)
(n = 56)
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 0.4 % 1.8 % 0.2 %
hemorrhagic)
Wharton et al
JACC Vol. 33, No. 5 1999

25. Primary Angioplasty Without Cardiac
Surgery
124
min 4%
Death (In-Hospital)
3.9%
102
min 1%
Stroke / TIA
0.4%
3%
Reinfarction
3.0%
92 %
Successful PTCA
99 %
0 10 20 30 40 50 60 70 80 90 100
Median Time from ED arrival to
Reperfusion
Wharton et al
JACC Vol. 33 No. 5, 1999

26. 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 25.0%
(n = 44)
Presenting without shock 3.8%
(n = 291)
Wharton et al.
JACC Vol. 33 No. 5 1999

27. Time to Treatment in the
Air PAMI-No SOS Study
Time Intervals (min) Transfer for PA On-Site PA p Value
Median Median
(25 th, 75th) (25 th, 75th)
Chest pain onset to emergency 90 (45,170) 87 (45,167) 0.77
center arrival
Emergency center arrival to 155 (119,194) 81 (60,115) <0.0001
angiography
Emergency center arrival to balloon 166 (131, 240) 105 (80,139) <0.0001
inflation
Chest pain onset to reperfusion 270 (202, 362) 201 (148, 326) 0.017
(balloon inflation)
Wharton et al
JACC 2004;43,1943

28. Transfer for PA (n=71)
On-Site PA (n=499
20
10
9 8.5 8.5
15 8
7
6.1 4.3
5.2 4.0 p=0.54
30-Day Events
6
Days
10 5
5
4 3.4 p=0.27
p=.24 38%
3
5 p=1.00
2
1.4
p=.10
1
1
0.2
0
0
0
Death reMI Disabling CVA MACE
Hospital Stay
Wharton et al
JACC 2004, 43, 1943

29. Percutaneous Coronary Interventions
In Facilities Without Cardiac Surgery
On Site : A Report From the National
Cardiovascular Data Registry (NCDR)
Michael A. Kutcher, MD et al
JACC, 2009, 54, 1, 16

30. 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

31. 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.
Off-Site Backup N=8,736 patients On-Site Backup N=299,425 patients
41723
2166 (14%)
(25 %)
44896
(15%)
5128
1442 (59 %) 212806
(17 %) (71%)
No MI Non-STEMI STEMI
JACC Vol. 54, No. 1, 2009
NCDR Offsite PCI

32. 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.
Outcome Total N Total N Off-Sit
Favors Favors On-Site Odd Ratio (95% CI) p-value
Mortality –– overall
Mortality overall 308,120
308,120 0.90 (0.72 – 1.14)
0.90 (0.72 – 1.14) 0.388
0.388
Mortality –– primary PCI pts
Mortality primary PCI pts 33,008
33,008 0.97 (0.75 – 1.25))
0.97 (0.75 – 1.25) 0.807
Mortality –– non-primary PCI pts 275,098
Mortality non-primary PCI pts 275,098 0.86 (0.63 – 1.16)
0.86 (0.63 – 1.16) 0.319
0.319
Emergency CABG
Emergency CABG 308,121
308,121 0.60 (0.37 – 0.98))
0.60 (0.37 – 0.98) 0.042
0.042
Mortality –– pts not requiring
Mortality pts not requiring 306,962
306,962 0.93 (0.73 – 1.17)
0.93 (0.73 – 1.17) 0.533
0.533
emergency CABG
emergency CABG
Sensitive Analysis
Sensitive Analysis
Mortality – impute to YesYes
Mortality – impute to 308,161
308,161 1.21 (0.95 – 1.54)
1.21 (0.95 – 1.54) 0.120
0.120
for for Off-site
Off-site
Mortality – impute to No No
Mortality – impute to 308,161
308,161 0.88 (0.70 –– 1.11)
0.88 (0.70 1.11) 0.281
0.281
for for Off-site
Off-site
0.1 1 10
JACC Vol. 54, No. 1, 2009
NCDR Offsite CI

33. Physician Volume and Outcome of Primary PCI
Average Mortality by Physician and Hospital
Volume
Physician 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

34. Volume-Outcome Relationship
for Hospitals and Physicians
15
% Risk Adjusted Mortality
6
% Risk Adjusted Mortality
10
4
State-wide mortality
5
2
State-wide mortality
0 0
0 50 100 150 200
0 10 20 30 ≥36
Annual Hospital Volume (per year) Annual Physician Volume (per year)
52 43 33 25 21 11 22 15 7 8 8 4 2 2 0 2 4 7
No. of Physicians
Srinivas et al JACC 2009, 53, 574

35. PPCI WITHOUT ONSITE CABG
• WHAT IS THE NEED?
• IS IT BETTER THAN FIBRINOLYTICS?
• IS IT SAFE/NON INFERIOR OR BETTER THAN AT
CENTERS WITH ONSITE CABG?
• PRECAUTIONS AND CURRENT GUIDELINES

36. 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.

37. 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

38. PPCI WITHOUT ONSITE CABG
• 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