1. David R. Holmes, MD Mayo Clinic Rochester, MN
The 5 Best Trials from that may Impact my Practice CRT 2012 Washington, DC February 2012
David R. Holmes, MD Mayo Clinic Rochester, MN

2. I have no real or apparent conflicts of interest to report.
David R. Holmes, MD
I have no real or apparent conflicts of interest to report.

3. So much data, so little time…

5. TAVR

6. Clinical Documents in Development
Societal Overview of TVT by ACCF and STS
(July 2011)
ACCF,STS,AATS, SCAI led expert consensus document on pre- and post-procedural issues, including patient selection
(Jan 2012)
SCAI, AATS, ACCF, STS led competence statement addressing institutional and operator requirements
(First Quarter 2012)
ACCF led update guideline on Valvular Heart Disease
(TBD)
All multi-societal efforts involving physician stakeholders

7. Consensus Recommendations ACC and STS
Focus TAVR Programs
Specialized Heart Centers
Multidisciplinary teams
Expert surgeons and interventionalists and imagers
Expertise with high risk and structural heart disease patients
Ancillary personnel
Optimal facilities
Protocol development
Patient selection
Procedural details
Complication management

8. Consensus Recommendations ACC and STS
TAVR Programs
Participate in TVT Registry
Track appropriate use
Patient selection
Outcomes – risk benefit ratio
Development of post procedural protocols
Development of communication strategies

11. 2007: STS Quality Measurement Task Force developed a multidimensional composite quality measure for isolated CABG – 11 process and outcome measures in 4 quality domains
: In collaboration with Consumers Union, STS published isolated CABG composite’s cores. Public Reporting Initiative
Rating system:
Below average
Average
Above average
Shahian DM et al:Ann Thorac Surg 92:S12-S23, 2011

12. Other Performance Metrics
Safety – fewer adverse hospital events and medical errors
Timeliness – reduced waiting time
Equity – reduce racial and ethnic disparities
Effectiveness – treatment results are superior to alternatives, including no treatment
Efficiency – minimize waste, maximize quality/ cost ratio
Patient-centricity – respect patient preferences and goals
Shahian DM et al:Ann Thorac Surg 92:S12-S23, 2011

13. ACC Website(s)
Consumer Reports
Hospital/Compare
USNWR

15. Depends on whether you are the one bleeding or not
Moderate Bleeding
Depends on whether you are the one bleeding or not

16. Cumulative hazard rates
Major Bleeding
Warfarin
Dabigatran 150
Cumulative hazard rates
Dabigatran 110
Follow-up (yr)
No. at risk
6,015 5,835 5,640 4,510 2,872 1,349
6,076 5,839 5,638 4,557 2,928 1,366
6,022 5,801 5,600 4,474 2,797 1,269

17. Major Bleeding ISTH Definition
Warfarin
31% RRR
Event (%)
Apixaban
Apixaban 327 patients, 2.13% per year
Warfarin 462 patients, 3.09% per year
HR 0.69 (95% CI, ); P<0.001
Month
No. at risk
Apixaban
Warfarin

18. Medication Safety Alert Dabigatran January 12, 2012
Launched in 2010
First quarter 2011
932 serious adverse events reported
120 deaths
25 permanent disability
543 repeat hospitalization
505/932 involved hemorrhage
120 of which indicted hemorrhagic stroke+
+ Warfarin ranked second – 176 episodes of hemorrhage

19. Disappearing LAA Thrombus Resulting in Stroke
Parekh A, Ezekowitz M et al: Circ 114:e513, 2006

20. Left Atrial Function
Single-center study of 150 patients undergoing Maze procedure using radiofrequency and cryo-ablation for AF
Sustained Sinus rhythm during follow-up
Goal: assess LA mechanical contraction post-op and determine if it imposes increased risk of stroke
Endpoint: ischemic stroke felt secondary to T/E event
Buber J, J Am Coll Cardiol 58: , 2011

21. Left Atrial Function 3 Months 1 Year Absent LAMC Absent LAMC 31% 31%
69%
69%
Present LAMC
Present LAMC
Buber J, J Am Coll Cardiol 58: , 2011

22. Left Atrial Function Survival Free of Stroke by LAMC
Buber J, J Am Coll Cardiol 58: , 2011

24. Intent-to-Treat: All Stroke
WATCHMAN Control Rel risk Posterior probabilities*
Cohort Rate (95% CI) Rate (95% CI) (95% CI) Noninferiority Superiority
600 pt-yr 3.4 ( ) 3.6 ( ) 0.96 ( )
900 pt-yr 2.6 ( ) 3.5 ( ) 0.74 ( )
1,065 pt-yr 2.3 ( ) 3.2 ( ) 0.71 ( )
1,350 pt-yr 2.1 ( ) 2.7 ( ) 0.78 ( )
1,500 pt-yr 2.0 ( ) 2.7 ( ) 0.77 ( )
23% lower relative risk in WATCHMAN group
*No adjustment made for multiple comparisons

25. LAA Occlusion What Do We Know?
There is a strong relationship between atrial fibrillation, increasing age, increasing stroke
In patients with atrial non-valvular atrial fibrillation, embolus arises in LAA
Even with new drugs, bleeding remains an issue and increases with time
Satisfactory closure of LAA is noninferior to chronic anticoagulation in preventing stroke

26. CABG
PCI

27. MACCE to 4 Years by SYNTAX Score Tercile Low Scores (0-22)
TAXUS (N=299)
CABG (N=275)
CABG
PCI P
Death
8.9%
8.3%
0.77
CVA
4.0%
1.4%
0.059 MI
4.2%
6.6%
0.25
Death, CVA or MI
14.6%
14.4%
0.87
Revasc
13.6%
20.0%
0.04
Overall
Months Since Allocation
Cumulative Event Rate (%) 12 24 50 25 48 36
P=0.57
28.6%
26.1%
SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibit 52
Cumulative KM Event Rate ± 1.5 SE; log-rank P value
Site-reported Data; ITT population

28. MACCE to 4 Years by SYNTAX Score Tercile Intermediate Scores (23-32)
TAXUS (N=310)
CABG (N=300)
CABG
PCI P
Death
9.3%
11.1%
0.49
CVA
3.6%
2.0%
0.25 MI
9.0%
0.009
Death, CVA or MI
14.9%
17.3%
0.44
Revasc
10.9%
20.7%
0.002
Overall
Months Since Allocation
Cumulative Event Rate (%) 12 24 50 25 48 36
P=0.006
32.0%
21.5%
SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibit 54
Cumulative KM Event Rate ± 1.5 SE; log-rank P value
Site-reported Data; ITT population

29. MACCE to 4 Years by SYNTAX Score Tercile High Scores (33)
TAXUS (N=290)
CABG (N=315)
CABG
PCI P
Death
8.4%
16.1%
0.004
CVA
3.7%
3.5%
0.80 MI
3.9%
9.3%
0.01
Death, CVA or MI
14.6%
22.7%
Revasc
11.4%
28.8%
<0.001
Overall
Months Since Allocation
Cumulative Event Rate (%) 12 24 50 25 48 36
P<0.001
40.1%
23.6%
SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibit 56
Cumulative KM Event Rate ± 1.5 SE; log-rank P value
Site-reported Data; ITT population

30. Drug-Eluting Stents vs CABG Repeat Revascularization
Meta-Analysis EES vs PES
SYNTAX
HR=0.51, 95% CI
HR=2.3, 95% CI
NOTE: Weights are from random effects analysis
Overall (I-squared = 0.0%, p = 0.491)
SPIRIT III
COMPARE
SPIRIT IV
Trials
SPIRIT II
22/669
15/897
61/2458
EES
4/223
18/333
40/903
55/1229
PES
5/77
0.51 (0.39, 0.66)
0.61 (0.33, 1.12)
0.38 (0.21, 0.68)
0.55 (0.39, 0.79)
RR (95% CI)
0.28 (0.08, 1.00) 1 .1 .2 .5 2 5 10
TLR at 1 Year
Risk ratio
EES vs CABG?
PES
EES
6.9
Favors EES
Favors PES
Serruys PW et al: NEJM 2009
Kalesan, Juni – Updated 8/2011

35. System Delay and Long-Term Mortality
System Delay (min)
Long-term Mortality
0-60
15.4%
61-120
23.3%
28.1%
30.8%
Terkelsen CJ et al: JAMA 304: , 2010

36. Care Processes RACE Initiatives
Hospital specific reperfusion protocol
ED activation of catheterization laboratory single call
Provide EMS equipment for pre-hospital ECG
Glickman SW et al: Circ Cardiovasc Qual Outcomes 4: , 2011

37. Care Processes RACE Initiatives
55 non PCI hospitals, 436 patients
Evaluate association of EMS, ED and Hospital setting with door-in-door-out time
Glickman SW et al: Circ Cardiovasc Qual Outcomes 4: , 2011

38. Care Processes Recommendations to Improve Door-In-Door-Out Times
% of Hospitals (n=55)
Before Intervention
After Intervention P
Hospital processes
Dedicated STEMI reperfusion team with committed leadership
25.5
65.4
<0.001
Hospital-specific reperfusion protocol
20.0
89.1
ED processes
System for obtaining ECGs within 10 min. of ED arrival
27.3
36.4
0.41
Single call No. to activate PCI center cardiac catheterization lab
16.4
96.2
Glickman SW et al: Circ Cardiovasc Qual Outcomes 4: , 2011

39. Care Processes Recommendations to Improve Door-In-Door-Out Times
% of Hospitals (n=55)
Before Intervention
After Intervention P
EMS processes
EMS has equipment to perform prehospital ECGs
74.5
88.2
0.12
Program for paramedics to recognize STEMI on 12-lead ECGs
45.4
80.4
<0.001
Use local ambulance to transport patients within 50 miles
34.2
56.0
0.07
Keep patient on local stretcher as part of AMI
3.9
27.5
0.02
Glickman SW et al: Circ Cardiovasc Qual Outcomes 4: , 2011

40. Care Processes RACE Initiatives
Glickman SW et al: Circ Cardiovasc Qual Outcomes 4: , 2011
Door-In-Door-Out Time (minutes)
Pre-Intervention
Post-Intervention
Changes in door-in-door-out times with the RACE intervention. Among the 436 patients in this study, median door-in-door-out times improved significantly with the RACE intervention (before: 97.0 min. [interquartile range ]; after 58.0 min. [interquartile range 35-90]; p<0.0001).

41. Care Processes RACE Initiatives
Hospital ED
EMS
Glickman SW et al: Circ Cardiovasc Qual Outcomes 4: , 2011
# of Processes
Hospital Number
Number and type of processes adopted at non-PCI hospitals. This figure displays the overall number and type of practices, including EMS, ED and hospital, adopted by non-PCI hospitals after the RACE program.

42. Care Processes Median Door-in-Door Out Times
Hospital Processes
ED Processes
Minutes
Minutes
Number
Number
Glickman SW et al: Circ Cardiovasc Qual Outcomes 4: , 2011
EMS Processes
Total Processes
Minutes
Minutes
Number
Number

43. Conclusions – Prehospital, ED, and hospital processes of care were independently associated with shorter door-in-door-out times for STEMI patients requiring transfer. Adoption of several EMS processes was associated with the largest reduction in treatment times. These findings highlight the need for an integrated, system-based approach to improving STEMI care.

44. Emergency Medical Service Transport GWTG
37,634 STEMI patients enrolled in GWTG from
Evaluate use of EMS transport vs self transport to ED
Self
40%
EMS
60%
Mathews R et al: Circulation 124: , 2011

45. Emergency Medical Service Transport GWTG
Self-Transport (n=15,049), min
EMS Transport (n=22,585), min P
Symptom-onset-to-hospital-arrival time
120 (60-285)
89 (57-163)
<0.0001
Time to ECG
8 (4-14)
5 (2-10)
Door-to-balloon time
76 (61-93)
63 (48-80)
Door-to-needle time
29 (18-51)
23 (13-36)
Mathews R et al: Circulation 124: , 2011

46. Emergency Medical Service Transport GWTG
EMS
Self
Older
Live further from hospital
Hemodynamic compromise
Younger
Male
Hispanic
Private insurance
Race, income, educational level – no significant association
Mathews R et al: Circulation 124: , 2011

47. Conclusions – Emergency medical services transportation to the hospital is underused among contemporary ST-segment-elevation myocardial infarction patients. Nevertheless, use of EMS transportation is associated with substantial reductions in ischemic time and treatment delays. Community education efforts are needed to improve the use of emergency transport as part of system-wide strategies to improve ST-segment-elevation myocardial infarction reperfusion care.

48. EMT Activation of Cath Labs
False Positives
False Negatives
Door to Balloon Time

49. EMT Activation Approaches
Monitor vital signs and transport
Obtain ECGs
Transmit
Local ER
Regional clearing house ED
Interventional cardiologist
Participate in interpretation
Provide in the field lytic therapy under supervision

50. Pre hospital ECG Programs
“The central challenge for health care providers is not to simply perform PH ECG, but to use and integrate the diagnostic information from a PH ECG with systems of care.”
AHA

51. EMT Activation of Cath Labs Issues
False positives
University hospital in Michigan: 30% to 50% false positive activations
Acceptable ceiling in private practice?
Mayo Clinic: 15%
Washington State: 15%
North Carolina: 20% (ED physicians: 5%)

52. EMT Activation of Cath Labs Issues
False negatives

53. Pre hospital ECG Protocol
Prospective observational study of systems of care
Evaluate implementation of pre hospital ECG program on patients with STEMI
Nestler DM. Circ Cardiovasc Qual
Outcomes. 4:640-46, 2011

54. Pre hospital ECG Protocol System
PH ECG acquisition
Emergency medical service, interpretation without PHECG transmission
Pre hospital activation of cardiac cath team
Bypass ED
Nestler DM. Circ Cardiovasc Qual
Outcomes. 4:640-46, 2011

55. Prehospital ECGs & Activation Protocol
Nestler DM et al: Circ Cardiovasc Qual Outcomes 4: , 2011

56. Prehospital ECGs & Activation
Pre-implementation (n=50)
Post-implementation (n=82)
PH STEMI Activation (n=38)
Pre-implementation (n=50)
Post-implementation (n=82)
PH STEMI Activation (n=38)
Minutes
Nestler DM et al: Circ Cardiovasc Qual Outcomes 4: , 2011

57. Prehospital ECGs & Activation
All Pre-implementation (n=50)
All Post-implementation (n=82) P
Post- implementation PH STEMI Activation (n=38)
Median DTB, min (interquartile range)
59 (47, 76)
57 (36, 72)
0.28
32 (27, 55)
<0.001
Median FMCTB, min (interquartile range)
90 (78, 111)
88 (63, 114)
0.87
58 (51, 87)
0.001
Nestler DM et al: Circ Cardiovasc Qual Outcomes 4: , 2011

58. Prehospital ECGs & Activation Conclusions
An EMS-based PH ECG protocol involving prehospital interpretation without physician oversight, direct cardiac catheterization laboratory activation, and ED bypass resulted in significant reductions in median DTB and FMCTB intervals for those identified as STEMI in the prehospital setting.
Nestler DM et al: Circ Cardiovasc Qual Outcomes 4: , 2011

60. Futility versus Frailty

61. Futility versus Frailty
All who drink of this remedy recover in a short time, except those whom it does not help, who all die. Therefore, it is obvious that it fails only in incurable cases….Galen
Futility: treatment that does not accomplish its intended goal. May result from several factors –
Lack of medical efficacy
Lack of meaningful survival (patient)
Despite absolute 20% survival advantage with TAVR in PARTNER B, there is still a 30% mortality rate at one year

62. All-cause mortality (%)
Primary Endpoint
 at 1 yr = 20.0% NNT = 5.0 pt
HR (95% CI) = 0.51 (0.38, 0.68) Log rank P<0.001
50.7%
Std Rx
All-cause mortality (%)
TAVR
30.7%
Months
Std Rx
TAVR

63. Cumulative Event Rate (%) Months Since Allocation
Cardiac Death to 4 Years
TAXUS (N=903)
CABG (N=897)
Before 1 year*
2.1% vs 3.7%
P=0.0503
1-2 years*
0.6% vs 0.8%
P=0.62
2-3 years*
0.9% vs 1.6%
P=0.22
3-4 years*
0.8% vs 1.6%
P=0.13 25 50
P=0.004
Cumulative Event Rate (%)
1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 1
2-Year_Randomized_ doc Exhibit 2 (binary interval rate)
SYNTAX 3-Year Report_Randomized_12JUL10.doc Exhibit 2 (binary interval rate)
SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibits 1 (KM rate on right sidea) and exhibit 2 (binary interval rate in white box)
7.6%
4.3% 12 48 24 36
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates
ITT population 86

64. Myocardial Infarction to 4 Years
TAXUS (N=903)
CABG (N=897)
Before 1 year*
3.3% vs 4.8%
P=0.11
1-2 years*
0.1% vs 1.2%
P=0.008
2-3 years*
0.3% vs 1.2%
P=0.03
3-4 years*
0.3% vs 1.5%
P=0.01 25 50
P<0.001
Cumulative Event Rate (%)
1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 1
2-Year_Randomized_ doc Exhibit 2 (binary interval rate)
SYNTAX 3-Year Report_Randomized_12JUL10.doc Exhibit 2 (binary interval rate)
SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibits 1 (KM rate on right sidea) and exhibit 2 (binary interval rate in white box)
8.3%
3.8% 12 48 24 36
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates
ITT population 87

65. Cumulative Event Rate (%) Months Since Allocation
CVA to 4 Years
TAXUS (N=903)
CABG (N=897)
Before 1 year*
2.2% vs 0.6%
P=0.003
1-2 years*
0.6% vs 0.7%
P=0.82
2-3 years*
0.5% vs 0.6%
P=1.00
3-4 years*
0.4% vs 0.2%
P=0.68 25 50
P=0.06
Cumulative Event Rate (%)
1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 1
2-Year_Randomized_ doc Exhibit 2 (binary interval rate)
SYNTAX 3-Year Report_Randomized_12JUL10.doc Exhibit 2 (binary interval rate)
SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibits 1 (KM rate on right sidea) and exhibit 2 (binary interval rate in white box)
3.7%
2.3% 12 48 24 36
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates
ITT population 88

66. All-Cause Death/CVA/MI to 4 Years
TAXUS (N=903)
CABG (N=897)
Before 1 year*
7.7% vs 7.6%
P=0.98
1-2 years*
2.2% vs 3.5%
P=0.11
2-3 years*
2.5% vs 3.8%
P=0.14
3-4 years*
2.7% vs 4.6%
P=0.051 25 50
P=0.07
Cumulative Event Rate (%)
18.0%
1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 1
2-Year_Randomized_ doc Exhibit 2 (binary interval rate)
SYNTAX 3-Year Report_Randomized_12JUL10.doc Exhibit 2 (binary interval rate)
SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibits 1 (KM rate on right sidea) and exhibit 2 (binary interval rate in white box)
14.6% 12 48 24 36
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates
ITT population 89

67. Repeat Revascularization to 4 Years
TAXUS (N=903)
CABG (N=897)
Before 1 year*
5.9% vs 13.5%
P<0.001
1-2 years*
3.7% vs 5.6%
P=0.06
2-3 years*
2.5% vs 3.4%
P=0.33
3-4 years*
1.6% vs 4.2%
P=0.002 25 50
P<0.001
Cumulative Event Rate (%)
23.0%
1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 1
2-Year_Randomized_ doc Exhibit 2 (binary interval rate)
SYNTAX 3-Year Report_Randomized_12JUL10.doc Exhibit 2 (binary interval rate)
SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibits 1 (KM rate on right sidea) and exhibit 2 (binary interval rate in white box)
11.9% 12 48 24 36
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates
ITT population 90

68. Cumulative Event Rate (%) Months Since Allocation
MACCE to 4 Years
TAXUS (N=903)
CABG (N=897)
Before 1 year*
12.4% vs 17.8%
P=0.002
1-2 years*
5.7% vs 8.3%
P=0.03
2-3 years*
4.8% vs 6.7%
P=0.10
3-4 years*
4.2% vs 7.9%
P=0.002 25 50
P<0.001
33.5%
Cumulative Event Rate (%)
23.6%
1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 1
2-Year_Randomized_ doc Exhibit 2 (binary interval rate)
SYNTAX 3-Year Report_Randomized_12JUL10.doc Exhibit 2 (binary interval rate)
SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibits 1 (KM rate on right sidea) and exhibit 2 (binary interval rate in white box) 12 48 24 36
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates
ITT population 91

69. Summary and Conclusions
Four-year MACCE rates in the overall randomized cohort were significantly higher for PCI than CABG
Significant increase of cardiac death, MI and repeat revascularization in PCI vs CABG-treated patients
Composite safety (death/stroke/MI) remains not significantly different between arms at 4 years (P=0.07)
MACCE rates at 4 years were not significantly different for patients with a low baseline SYNTAX Score; for patients with intermediate or high SYNTAX Scores, MACCE was increased at 4 years in patients treated with PCI
The 4-year SYNTAX results suggest that PCI may be an acceptable alternative revascularization method to CABG when treating patients with less complex (lower SYNTAX Score) disease including LM disease 92

70. Summary: II
The 4-year SYNTAX results suggest that CABG remains the standard of care for patients with complex disease (intermediate or high SYNTAX Scores); however, PCI may be an acceptable alternative revascularization method to CABG when treating patients with less complex (lower SYNTAX Score) disease including LM disease
The 4-year MACCE rates for the CABG and PCI registry were 19.9% and 42.2% respectively
SYNTAX patients will continue to be followed for 5 years 93

71. Summary: I
In the SYNTAX randomized patients, 4-year MACCE rates (all-cause death, stroke, repeat revascularization) were significantly higher for PCI than CABG
Significant increase of cardiac death, MI and repeat revascularization in PCI vs CABG-treated patients
Composite safety (death/stroke/MI) remains not significantly different between arms at 4 years (P=0.07)
MACCE rates at 4 years were not significantly different for patients with a low (0-22) baseline SYNTAX Score
For patients with intermediate (23-32) or high SYNTAX Scores (33), MACCE was increased at 4 years in patients treated with PCI 94

72. Rates of Death or MI Outcomes
Low risk
Medium risk
High risk
P<0.01
Death or MI rate at 1 yr (%)
Classic SYNTAX score
Functional SYNTAX score
Nam et al: J Am Coll Cardiol 2011;58:1211-8

73. Rates of Major Adverse Cardiac Events (MACE) Outcomes
Low risk
Medium risk
High risk
P<0.001
P<0.01
MACE rate at 1 yr (%)
Classic SYNTAX score
Functional SYNTAX score
Nam et al: J Am Coll Cardiol 2011;58:1211-8

74. FAME : “Downgrading” Multivessel Disease with FFR
0-VD
3-VD
0-VD
2-VD
1-VD
1-VD
2-VD
86% 3VD and 57% 2VD reclassified >1 vessel
Tonino et al, JACC 2010;55:

75. ROC Analysis Death or MI
FSS SS
P=0.02
Sensitivity
AUC (95% CI) P
FSS ( ) <0.001
SS ( )
Sensitivity
Nam et al: J Am Coll Cardiol 2011;58:1211-8

76. ROC Analysis Any Revascularization
FSS
P=0.017 SS
Sensitivity
AUC (95% CI) P
FSS ( ) <0.001
SS ( )
Sensitivity
Nam et al: J Am Coll Cardiol 2011;58:1211-8

77. ROC Analysis Death/MI/MACE at One Year
FSS
P=0.329 SS
Sensitivity
AUC (95% CI) P
FSS ( ) 0.004
SS ( ) 0.020
Sensitivity
Nam et al: J Am Coll Cardiol 2011;58:1211-8

78. Conclusions
Recalculating SS by only incorporating ischemia-producing lesions as determined by FFR decreases the number of higher-risk patients and better discriminates risk for adverse events in patients with multivessel CAD undergoing PCI. (Fractional Flow Reserve versus Angiography for Multivessel Evaluations [FAME]; NCT )

85. Time Passes By