Why ACTION - Clinical Trial Results

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Transcript Why ACTION - Clinical Trial Results

Acute
Coronary
Treatment and
Intervention
Outcomes
Network
“An ACC and AHA? Effort to
Improve MI Care”
Eric Peterson, MD, MPH, FACC, FAHA
Professor of Medicine
Director of CV Research
Duke Clinical Research Institute
Background
• Outcomes of STEMI and NSTEMI can be altered with
evidence-based, timely, and safe care.
• Yet, studies have shown ACS care is sub-optimal
– Gaps between guideline recommendations and
practice
– Significant care delays (reperfusion Rx in STEMI)
– Care disparities (age, gender, race, insurance)
– Paradoxical care (failure to treat those most in need)
– Safety concerns (excessive dosing)
Acute Medications
STEMI vs NSTEMI Use
100%
99% 96%
95%
91%
91%
85%
83%
80%
74%
59%
60%
46%
40%
20%
0%
ASA
Beta
Blockers
Heparin
(LMW+UHF)
STEMI
GP llb-llla
Inhibitors
Clopidogrel
NTEMI
CRUSADE DATA: July 1, 2005 – June 30, 2006 (n=31,665)
Timely Reperfusion
among STEMI Patients
100%
80%
77%
60%
47%
40%
40%
21%
20%
0%
Primary PCI
Primary PCI
<90 minutes
Thrombolytics
Thrombolytics
<30 minutes
Q2 2006 CRUSADE STEMI data
Safety Concerns: Frequency of
Excessive Antithrombotic Dosing
70
64.5
% Excessive Dose
60
50
37 38.5
40
28.7
30
20
33.1
12.5 12.5
16.5
8.5
10
0
LMW Heparin
< 65 yrs
UF Heparin
65-75 yrs
GP IIb/IIIa
>75 yrs
Alexander KA, et al. JAMA 2005;294:3108-3116
Why is ACTION Needed
• Participation in CMS Metrics is just not enough
– Fails to capture newer effective therapies (e.g, Class I
ACC/AHA guideline treatments)
– Doesn’t collect important safety information (dosing)
– Limited data on timing of therapies
– Lack patient outcomes
– Limited performance feedback
• Broad QI Interventions increasing all aspects of
ACS care is needed to improve patient outcomes
Provider Led QI Works!
• Participation in provider-led quality improvement
(QI) efforts can improve ACS care!
– ACC-GAP
– AHA GWTG
– NRMI, CRUSADE
• Means of QI
Concept
Clinical
Trials
Guidelines
Outcomes
Provider Led
Quality Improvement
– Feedback
Safe, Effective,
Long-term Use
– Motivated local champions
Measurement
– Collaborative sharing of best practices
Performance
Indicators
GAP Results: Changing Practice
**
93%
92%
100%
84%
86%
89%
80%
75%
80%
*
65%
68%
53%
60%
40%
20%
0%
(267) (406)
* p < 0.05
** p < 0.01
ASA
CHOL RX
(106) (146)
BB
PRE
(139) (173)
ACE
(159) (226)
SMOKING
POST
(112) (209)
Proportion of Patients
1
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
New England AHA GWTG Pilot Trial
12 Month Results
Baseline
4-6 Months
9-12 Months
Composite Adherence Trends
84.3%
83.0%
in CRUSADE
80.7%
79.3%
80%
77.9% 78.0%
75.2%
72.3%
73.0%
73.6%
71.0%
70%
69.6%
68.1%
60%
Q1
'02
Q4
'02
Q3
'03
Q3
'04
Q3
0'5
Q2
'06
Quarter 1, 2002 through Quarter 2, 2006
Association Between Overall
Guidelines Adherence and Mortality
% In-Hosp Mortality
7
6
5.95
6.31
5.16 5.06
5
4.97
4.63
4.16 4.15
4
3
Every 10%  in guidelines adherence 
10%  in mortality (OR=0.90, 95% CI: 0.84-0.97)
2
1
0
<=25%
25 - 50%
50 - 75%
>=75%
Hospital Composite Quality Quartiles
Adjusted
Unadjusted
Peterson et al, JAMA 2006;295:1863-1912
The ACTION Registry
• Represents the merger of the nation’s premier ACS
registries:
– NRMI (National Registry of Myocardial Infarction)
– CRUSADE
– ? Soon AHA GWTG CAD
• Unified under the leadership and support of NCDR™ :
– Guidelines, performance indictor, and data standard alignment
– Clinical/Technical/contract Support
– Training and orientation
Goals of the ACTION Registry
• The nation’s ACS surveillance system
– Assess characteristics, treatments, and outcomes of patients
hospitalized with STEMI and NSTEMI
• Optimize the care and outcomes of ACS patients
– Implement ALL evidence-based guideline recommendations in
clinical practice
– Assure that the right things are done right (safe and timely).
• Facilitate efforts to improve ACS care quality & safety via novel
QI improvement methods
Facilities
Registry
• No charge for participation
• Support provided by
– Genentech
– BMS and Sanofi
– Schering Plough
• Data elements
– Consistent w AHA/ACC
• Data submission
– EDC system
– Soon multivendor
ACTION Registry Participantst
300
250
200
150
290
223
100
50
0
38
50
Jan-07
Feb-07
93
100
Mar-07
Mar-07
120
132
Mar-07
Apr-07
May-07
Sep-07
Current ACTION Site Distribution
Active Sites = 290
WA
(12)
VT (0)
ND
(1)
MT
(1)
MI
WY
(0)
UT
(0)
CA
(15)
AZ
(3)
CO
(7)
IL
(18)
OK
(2)
OH
(22)
AR
(1)
AL
(3)
CT (2)
NJ (6)
DE (0)
WV
(1)
VA
(11)
MD (11)
DC (0)
NC
(17)
TN
(8)
MS
(5)
TX
(11)
PA
(26)
KY
(2)
MO
(8)
KS
(5)
NM
(0)
IN
(12)
MA (1)
RI (0)
MI
(14)
IA
(7)
NE
(4)
NV
(0)
NY
(10)
WI
(6)
SD
(1)
ID
(1)
NH (1)
MN
(5)
OR
(6)
ME
(1)
SC
(3)
GA
(8)
LA
(2)
FL
(9)
AK
(1)
HI (0)
Last updated: 1/4/07
ACTION 2007 Cumulative Data
Submission
24319
25000
Number of records
20355
20000
16201
15000
11960
10000
5000
7956
4169
0
Jan-07
Feb-07
Mar-07
Apr-07
May-07
Jun-07
Complexity of ACS Patients
STEMI vs. NSTEMI
Variable
Mean age + SD (yrs)
Female sex
Diabetes mellitus
Prior MI
Prior CHF
Prior PCI
Prior CABG
STEMI
(n=11,854)
62 + 12
30%
23%
18%
5%
18%
7%
NSTEMI
(n=26,956)
69 + 14
39%
33%
28%
16%
23%
18%
ACTION/CRUSADE DATA: July 1, 2006 – June 30, 2007
In-Hospital Outcomes
STEMI vs. NSTEMI
Variable
Death
Re-infarction
CHF
Cardiogenic Shock
Stroke
RBC Transfusion
STEMI
(n=11,854)
6.0%
1.2%
6.6%
7.1%
0.8%
6.2%
NSTEMI
(n=26,956)
3.9%
1.4%
7.1%
2.5%
0.7%
8.8%
*Transfusion among non-CABG patients
ACTION/CRUSADE DATA: July 1, 2006 – June 30, 2007
Acute Medications
STEMI vs NSTEMI
100%
98%
97%
96%
93%
93%
90%
84%
75%
80%
59%
60%
52%
40%
20%
0%
ASA
STEMI
Beta Blockers
NSTEMI
Heparin
(LMW+UFH)
GP llb-llla
Inhibitors
Clopidogrel
ACTION/CRUSADE DATA: July 1, 2006 – June 30, 2007
STEMI (n=11,854)
NSTEMI (n=26,956)
STEMI – Timing of Reperfusion
80%
60%
60%
40%
40%
20%
5%
0%
DTB <= 90 min Non-Transfer In
DTB <= 90 min Transfer In
DTN <= 30 min - All
ACTION/CRUSADE DATA: July 1, 2006 – June 30, 2007 (n=11,854)
DTB = 1st Door to Balloon
DTN = 1st Door to Needle for Lytics
100%
99%
97%
Discharge Medications
STEMI vs NSTEMI
97% 95%
91%
89%
86%
76%
80%
90%
74%
60%
40%
20%
0%
ASA
STEMI
Beta Blockers
NSTEMI
ACE-I or ARB*
Statins
Clopidogrel
* Ideal Patients
ACTION/CRUSADE DATA: July 1, 2006 – June 30, 2007
STEMI (n=11,854)
NSTEMI (n=26,956)
Discharge Interventions
STEMI vs. NSTEMI
100%
96%
92%
93%
87%
81%
80%
77%
72%
67%
60%
40%
20%
0%
Exercise
Counseling
STEMI
NSTEMI
Dietary
Modification
Cardiac Rehab
Referral
Smoking
Cessation
ACTION/CRUSADE DATA: July 1, 2006 – June 30, 2007
STEMI (n=11,854)
NSTEMI (n=26,956)
ACTION QI Tool Development
•
•
•
•
•
•
•
•
Quarterly Feedback reports
Individualized Gap analysis
On-line Real time summaries
QI tool kits
D2B tool kits
Monthly Web-casts
Regional Group Meetings
TAKE ACTION™ Campaign
How to Join
• Download the enrollment file from www.
ncdr.com
• Complete your enrollment packet and submit
the materials to the NCDR
• Receive Welcome Kit
• Complete online tool tutorial
Questions:
Call 800-257-4737
Email [email protected]
Thanks
Questions???