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Achieving rapid reperfusion with primary percutaneous
coronary intervention remains a challenge: Insights
from American Heart Association's Get With the
Guidelines program
Rajendra H. Mehta, MD, MS,a Vincent J. Bufalino, MD,b Wenqin Pan, PhD,a Adrian F. Hernandez, MD,a
Christopher P. Cannon, MD,c Gregg C. Fonarow, MD,d and Eric D. Peterson, MD, MPHa on behalf of the American
Heart Association Get With the Guidelines Investigators Durham, NC; Lombard, IL; Boston, MA; and Los Angeles, CA
Background The speed of reperfusion (door-to-balloon [D2B] time) is a well established performance metric for
patients with ST-elevation myocardial infarction. Although preferably D2B times should be ≤90 minutes, it is unclear how
consistently this is achieved in community practice, particularly in women, elderly people, and minorities.
Methods We used the American Heart Association Get With the Guidelines database to study D2B times at 254
participating United States sites (2002-2006). Median D2B time and percentage of compliance with goal (percutaneous
coronary interventions [PCI] ≤90 minutes) were assessed overall, over time, and among patient subgroups associated with
the greatest delay in this time (older patients, women, and minorities). Standard generalized estimating equation was used
to assess continuous trend, percentage of compliance (PCI ≤90 minutes) over time, and disparities in care based on race,
sex, and age.
Results Over the study period, 10 965 patients with ST-elevation myocardial infarction who met eligibility criteria received
primary PCI (36% aged ≥65 years, 27% female, and 17% nonwhite). The overall median D2B time was 96 minutes
(interquartile range [IQR] 69-140 minutes). Only 44.8% of cases had D2B ≤90 minutes. Median D2B time improved over
the study period (108 minutes at baseline [fourth quarter of 2002] to 82 minutes by the last study quarter [third quarter of
2006], adjusted P = .001). The percentage achieving D2B ≤90 minutes also improved (36.2%-58.8%, adjusted P = .003).
Relative to their peers, patients aged ≥65 years (103 [IQR 74-153] vs 93 [IQR 67-133] minutes), women (103 [IQR 73-154]
vs 94 [IQR 68-135] minutes), and minorities (108 [IQR 77-162] vs 95 [IQR 68-136] minutes) had significantly longer median
D2B times. These subgroup disparities in the D2B persisted over the study period as compared with their peers.
Conclusion
The median D2B times with primary PCI have improved modestly in hospitals participating in the
American Heart Association Get With the Guidelines program over the last few years but remain below ideal levels. The
D2B times are particularly delayed in the elderly people, women, and minority populations; an issue that has persisted
over time. These results highlight the ongoing need for national myocardial infarction quality improvement initiatives.
(Am Heart J 2008;0:1-9.)
Primary percutaneous coronary interventions (PCI) has
been shown to be the more effective reperfusion strategy
than fibrinolytic therapy for patients with ST-elevation
From the aDuke Clinical Research Institute and Duke University Medical Center, Durham,
NC, bMidwest Heart Specialists, Lombard, IL, cBrigham and Women's Hospital, Boston,
MA, and dUCLA Medical Center, Los Angeles, CA.
Funding source: Get With the Guidelines-CAD is sponsored by the American Heart
Association with funding in part from an unrestricted education grant from the MerckSchering Plough Partnership.
Submitted November 12, 2007; accepted January 17, 2008.
Reprint requests: Vincent Bufalino, MD, 801 S Washington 4th Floor, Edward Heart
Hospital, Naperville, IL 60540.
E-mail: [email protected]
0002-8703/$ - see front matter
© 2008, Published by Mosby, Inc.
doi:10.1016/j.ahj.2008.01.010
myocardial infarction (STEMI), when performed rapidly
by experienced operators and in a timely fashion.1 Shorter
door-to-balloon (D2B) times have been associated with
significantly lower mortality among patients undergoing
primary PCI,2,3 leading the American College of Cardiology/American Heart Association (ACC/AHA) guidelines
to designate the rapid performance of primary PCI,
preferably with D2B ≤90 minutes, as a class IA recommendation.4 In addition, D2B time has been incorporated
as one of the core quality metric collected and reported
publicly by the Centers for Medicare and Medicare
Services and the Joint Commission highlighting its
significance. However, multiple logistic challenges often
prevent timely reperfusion in routine clinical practice as
compared with that seen in randomized clinical
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American Heart Journal
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2 Mehta et al
Figure 1
Study population flow chart.
trials. 1,2,5-8 As a result, many institutions and professional
societies have focused their attention on improving this
established performance metric for patients undergoing
primary PCI. 9-14
The Get With the Guidelines (GWTG) program of the
AHA is a national quality improvement initiative that
focuses on improving compliance with a number of
evidenced-based therapies. 10-12 There was no specific
focus in GWTG program on improving D2B times. Data
from GWTG provide a unique opportunity to examine
national trends in D2B times supplementing other
national registries such as National Registry on Myocardial
Infarction (NRMI) 2,5-8 and the ACC–National Cardiovascular Database Registry. 15 The main objectives of this
study were to evaluate temporal changes in overall D2B
times among patients undergoing primary PCI at GWTG
between 2001 and 2006. We also sought to determine
whether D2B performance metrics varied among elderly,
women, and minority populations and whether any
identified gaps in care had narrowed over time in these at
risk populations.
ment Tool (PMT) (Outcome, Cambridge, MA), which were
pilot-tested in 24 Massachusetts hospitals by the AHA and the
Massachusetts Quality Improvement Organization with the
support of multiple organizations in Massachusetts. The
collaborative learning model includes interactive learning
sessions, teleconference, and electronic communication
between multidisciplinary teams from hospitals in a variety
of settings to facilitate the transfer of the “how-to” necessary
to produce system-wide change. The PMT aids in concurrent
data collection and decision support and also provides realtime online reporting features. After the success of the initial
pilot phase in a diverse group of Massachusetts hospitals,
the AHA adopted GWTG as a national program with
introduction in Southern California followed by a phased
introduction across the United States.
The GWTG is similar but more contemporary as compared
with NRMI. 2,5-8 Furthermore, unlike in NRMI, which focused on
patients with acute myocardial infarction, the GWTG program
focuses on improving the quality of care of all patients with
coronary artery disease. In contrast to these 2 registries, the
ACC–National Cardiovascular Database Registry 15 includes only
those patients that underwent a cardiac catheterization and/or
PCI. Clearly, hospitals participating in these 3 registries differ
with some overlap.
Methods
Patient population
The GWTG program
Details of GWTG have been previously published. 10-12 In brief,
the AHA launched the GWTG initiative focused on the redesign
of hospital systems of care to improve the quality of care of
patients with coronary artery disease. The GWTG is based on a
collaborative model and the Internet-based Patient Manage-
The GWTG-coronary artery disease database includes
248 915 patients enrolled between January 2, 2000, and
September 20, 2006, from the 492 hospitals participating in
GWTG–coronary artery disease initiative that had the capability
of performing primary PCI and includes teaching and
nonteaching, rural and urban, large and small hospitals from all
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American Heart Journal
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Mehta et al 3
Table I. Baseline characteristics
Characteristics
N
Demographics
Age, median (IQR), y
Table II. Performance measures
Overall
D2B time
≤90 min
D2B time
>90 min
10 965
4912
6053
59
(51-70)
36.1
27.4
16.9
27.9
(25-32)
58
(50-68)
31.9
24.5
13.8
28.0
(25-31)
60
(52-72)
39.4
29.8
19.4
28.0
(25-32)
b.0001
3.5
8.2
.2281
.2650
Age ≥65 years (%)
Female sex (%)
Nonwhite (%)
Body mass index,
median (IQR),
kg/m2
Medical history
Atrial fibrillation (%)
3.3
3.0
Chronic obstructive
7.9
7.6
pulmonary
disease (%)
Diabetes (%)
23.1
20.0
Congestive heart
4.2
3.1
failure (%)
Hypertension (%)
56.8
53.0
Hyperlipidemia (%)
45.7
45.1
Prior myocardial
14.3
13.5
infarction (%)
Peripheral vascular
3.6
3.0
disease (%)
Stroke (%)
3.8
3.2
Renal
3.0
2.2
insufficiency (%)
Renal dialysis (%)
0.7
0.5
Smoking (%)
43.7
46.8
Anemia (%)
0.1
0.1
Alcohol (%)
4.5
4.4
LV ejection fraction
22.2
19.9
b40% (%)
133
131
Systolic blood
(113, 153) (113, 150)
pressure at
admission, median
(IQR), mm Hg
79
80
Diastolic blood
(66, 91)
(67, 92)
pressure at
admission, median
(IQR), mm Hg
P
b.0001
b.0001
b.0001
.9349
Performance
measures ⁎
Aspirin within 24 h (%)
Discharge aspirin (%)
Discharge β-blockers (%)
Discharge ACE inhibitors
or ARB in patients
with documented LV
systolic dysfunction (%)
Lipid-lowering agent
in patients with LDL
>100 mg/dL (%)
Smoking cessation
counseling (%)
100% compliance with
composite measures (%)
D2B
D2B
time ≤90 time >90
Overall
min
min
P
96.9
98.5
97.7
87.8
97.2
98.9
98.1
91.1
96.6
98.2
97.3
85.4
.0876
.0053
.0062
.0002
94.9
95.5
94.4
.1072
93.2
94.2
92.3
.0125
71.5
73.2
70.2
.0005
25.6
5.1
b.0001
b.0001
59.8
46.2
14.9
b.0001
.2520
.0371
4.1
.0028
4.3
3.7
.0030
b.0001
Data collection
0.8
41.2
0.1
4.7
24.0
.0688
b.0001
.5001
.5283
b.0001
Data were systematically collected for each hospitalization,
including patient demographics, medical history, symptoms
on arrival, electrocardiographic examination, inhospital treatment and events, discharge treatment and counseling, and
patient disposition.
136
(114, 155)
.1514
77
(66, 90)
.2390
LV, Left ventrical.
census regions of the United States. All patients presenting
with chest pain or ischemic symptoms and ST elevation in 2
contiguous leads or new or presumed new left bundle branch
block who had a PCI within 24 hours were eligible (n =
15 536). Patients were excluded if they were transferred from
other hospitals or emergency departments or received
fibrinolysis (n = 4394). The remaining patients constituted the
analysis sample (n = 11142, hospitals = 254). Furthermore, for
the evaluation of D2B trend over time, because very few
patients were enrolled in the last 2 quarters of 2001 and in the
first 3 quarters of 2002 (n = 177), these patients were also
excluded for this analysis. Thus, the final study sample was
composed of 10 965 patients enrolled between October 1,
2002, and September 18, 2006, at 254 sites (Figure 1). Data on
patients were collected by participating hospitals without
financial compensation. Case finding was based on clinical
ACE, Angiotensin-converting enzyme; ARB, angiotensin receptor blocker; LDL, lowdensity lipoprotein; LV, left ventrical.
⁎ In patients with appropriate indication and without any contraindications.
identification of patients with these diagnoses as well as by
retrospective International Classification of Diseases, Ninth
Revision, coding to permit the use of the PMT and other
decision support tools adapted by hospitals in the program.
Outcomes of interests
The 2 main outcomes of interest included median D2B
time and proportion of patients with D2B time ≤90 minutes.
These end points were examined in overall population as
well as in subgroups of interests that had the longest D2B
times, that is, patients aged ≥65 years versus b65 years, women
versus men, and minorities (nonwhite) versus whites.
Statistical analysis
All analyses were performed using SAS 9.1 (SAS Institute,
Research Triangle, NC). Data are presented as proportions
for categorical variables and as median and interquartile
range (IQR) for continuous variables. For univariate comparisons, we used χ2 tests for categorical variables and
Wilcoxon 2-sample test for continuous variables. The overall
linear time effect on percentage of compliance was tested
using the Cochran-Mantel-Haenszel method. The adjusted
linear time (quarter) effect was tested by fitting multivariate
logistic regression model to account for confounders and
also standard generalized estimating equation approach to
account for with inhospital clustering. Baseline patient
characteristics in the model included age, race, sex, body
mass index, insurance, past medical history (chronic
obstructive pulmonary disease, hypertension, diabetes, heart
failure, smoking status, dyslipidemia, prior myocardial
infarction, prior stroke, peripheral vascular disease, and renal
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4 Mehta et al
Figure 2
Trends in median D2B times (IQR, minutes) over consecutive calendar quarters.
Figure 3
Proportion of patients with D2B ≤90 minutes over consecutive calendar quarters.
insufficiency), and systolic blood pressure at admission.
Finally, to examine if participation in the GWTG program
had any influence on the trend in D2B over consecutive
calendar quarters, we adjusted for quarter of enrollment of
the sites in GWTG.
We also evaluated interactions between D2B time over
consecutive quarters with age or sex or race. An interaction
term was considered to be insignificant if its P value was >.10.
Odds ratios (ORs) and 95% confidence intervals (CIs) were
calculated to estimate the likelihood posed by subgroups of
interest on compliance with D2B time ≤90 minutes. All P values
are 2-sided, with P b .05 considered statistically significant.
Results
Patient characteristics and performance measures
The baseline demographics of the overall study
population (N = 10 965) as well as that stratified
according to D2B time ≤90 minutes are shown in Table I.
Approximately, 36% of patients were aged ≥65 years,
27% were women, and 17% were nonwhite. Patients
with longer D2B time were more likely to be older,
female, and nonwhite. Most comorbid conditions were
also significantly higher in this cohort and included
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Table III. Independent correlate of longer D2B times in patients
undergoing primary PCI
Variable
Age ≥65 y
Female sex
Minority
Calendar quarter
of enrollment
Body mass index
Chronic lung
disease
Diabetes mellitus
Congestive
heart failure
Hypertension
Hyperlipidemia
Prior myocardial
infarction
Peripheral vascular
disease
Renal insufficiency
Prior stroke
Smoker
Systolic blood
pressure
OR
95% CI,
lower limit
95% CI,
upper limit
P
0.815
0.836
0.760
1.044
0.735
0.763
0.686
1.025
0.903
0.916
0.842
1.063
b.0001
.0001
b.0001
b.0001
0.998
0.999
0.990
0.854
1.005
1.170
.5560
.9922
0.886
0.763
0.840
0.619
0.993
0.942
.0060
.0116
0.892
0.972
0.915
0.812
0.893
0.806
0.979
1.057
1.038
.0159
.5028
.1677
0.710
0.546
0.924
.0109
0.810
0.905
1.145
0.998
0.651
0.731
1.042
0.993
1.009
1.121
1.258
1.002
.0597
.3627
.0047
.3507
diabetes, hypertension, prior myocardial infarction,
peripheral vascular disease, stroke, congestive heart
failure, and renal insufficiency. Only history of smoking
was less common in patients with longer D2B. Left
ventricular ejection fraction b40% was also more
prevalent among patients with longer D2B. Compliance
with most performance measures was lower for patients
with longer D2B (Table II).
Door-to-balloon time
Overall, the median D2B was 96 minutes (IQR
69-140 minutes). Only 44.8% of patients had D2B ≤90
minutes. Median D2B time improved significantly
between the fourth quarter of year 2002 and the third
quarter of year 2006 (Figure 2) from 108 to 82
minutes (P b .0001). The most impressive improvement in this measure occurred in the final 4 quarters
as compared with the first 4 quarters (median time
100 minutes [IQR 71-145 minutes] vs 90 minutes
[IQR 66-127] for last 4 quarters vs first 4 quarters,
P = .0056). In addition, the variability in this measure
across sites also decreased over time (P value using F
test b.0001; Figure 2). As a result, the proportion of
patients with D2B time ≤90 minutes increased over
time (from 101 [36.2%] of 279 to 146 [58.2%] of 251,
P for trend b.0001; Figure 3). Thus, relatively 62.4%
more patients were treated with D2B times ≤90 minutes
in the last quarter as compared with the first quarter
(absolute increase 22.6%). Again, the proportion of
patients treated ≤90 minutes of arrival to the hospital
was higher in the last 4 quarters (50.0%) as compared
with the first 4 quarters (42.7%) (P b .0001). Even after
accounting for differences in case mix as well as for
within-site correlation, the overall linear trend over
time for improvement remained significant (P b .0001
for improvement in median D2B time and P b .0001 for
increase in proportion of patients with this time
≤90 minutes). Finally, linear trend for improvement in
D2B persisted even after adjustment for the enrollment
specific quarter of the sites in the GWTG program
(P = .0011 for improvement in median D2B time and
P = .0028 for increase in proportion of patients with
D2B ≤90 minutes).
Disparity among subgroups
Results of subgroup analysis by age, sex, and race
suggested important differences even after adjusting for
patient medical history, body mass index, and blood
pressure. Being old (≥65 years), being female, and being
minority were the most significant predictors of the
likelihood of receiving delayed primary PCI in the
multivariate analysis (Table III). Median D2B times were
10, 9, and 13 minutes longer for elderly people, women,
and nonwhites (P b .0001 for all comparisons; Figure 4).
As a result, 8.0% fewer elderly people, 6.6% fewer
women, and 9.9% fewer minorities were treated with
D2B times ≤90 minutes as compared with younger
patients, men, and whites, respectively (P b .0001 for
all comparisons; Figure 5).
This disparity in the D2B time persisted over time
among various subgroups with the elderly people,
women, and minorities continuing to have longer delay in
D2B time and significantly lower proportion of patients in
these subgroups having D2B time ≤90 minutes as
compared with younger patients, men, and whites over
time (Tables IV and V).
Discussion
Our investigation suggests that D2B times in recent
years have improved significantly among communitybased hospitals participating in the GWTG initiative.
This improving trend was accompanied by noteworthy decrease variability in D2B times over time
between these institutions. Importantly, this translated in higher proportion of patients receiving
primary PCI in compliance with the D2B standard
of ≤90 minutes set by the ACC/AHA guidelines.
Despite this, our data also show that elderly people,
women, and minorities have the greatest delay in the
D2B times as compared with younger patients, men,
and whites, respectively, even after accounting for
other comorbid conditions. Although our investigation
suggests that institutions participating in GWTG programs had increased the proportion of patients with
D2B time ≤90 minutes by 22.6% over the last 5 years,
the disparity between whites and nonwhites, between
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Figure 4
Median D2B times by age, sex, and race.
Figure 5
Proportion of patients with D2B time ≤90 minutes by age, sex, and race.
younger and older patients, and between men and
women persisted.
Comparisons with prior studies
Multiple observational studies have reported the D2B
times for patients undergoing primary PCI.16-18 These
studies have shown a wide variation in this timing. For
example, in the patients enrolled in the Global Registry
of Acute Coronary Events at sites across 6 continents
between 1999 and 2004, the median D2B time was
78 minutes (IQR 47-120 minutes).16 The National Registry
of Myocardial Infarction investigators reported a much
longer median D2B time of 111 minutes (IQR 84-152
minutes) for patients in the United States (like in the
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Mehta et al 7
Table IV. Proportion of patients with D2B time ≤90 minutes by
age, sex, and race over calendar years
Calendar year
Category
2002
(%)
2003
(%)
2004
(%)
2005
(%)
2006
(%)
Age ≥65
Age b65
Female
Male
Minority
White
27.19
42.42
33.33
37.14
11.11
36.63
39.93
45.84
38.41
45.53
36.44
44.23
40.21
43.39
38.10
43.90
35.75
43.67
37.48
46.61
38.69
45.13
33.42
45.40
44.66
55.79
45.80
53.95
44.01
53.04
GWTG program) enrolled between 1994 and 2000.17
Investigators from the German Maximal Individual
Therapies for Acute Myocardial Infarction and Myocardial
Infarction Registry noted a very short median D2B time
of 70 minutes (IQR 45-132 minutes) for patients enrolled
between 1994 and 1998.18
Despite this wide variation in D2B times, most registries
that have tracked D2B time trends over time have
shown encouraging trends toward significant reduction in
this timing. For example, median D2B time decreased by
23 minutes (from 98 to 75 minutes) in GRACE between
1999 and 200419; by 13 minutes (from 117 to 104) in NRMI
between 1994 and 200014; and by 17 minutes (from 84 to
67 minutes) in the Maximal Individual Therapies for Acute
Myocardial Infarction and Myocardial Infarction Registry
between 1994 and 1998.18 Our findings from the GWTG
are consistent with these reports. Our data also confirm
that more and more patients are receiving primary PCI in
≤90 minutes. Thus, the increasing emphasis on health
care quality and efforts by government, professional
societies, health maintenance organizations, insurance
companies, and payers; the public reporting of performance measures; and the growing awareness in general
public regarding this subject perhaps have been successful in stimulating institutions in implementing process
changing, allowing them to overcome multiple barriers
that limit timely reperfusion and have contributed
significantly to this better trend. In addition, the new
ACC/AHA STEMI guidelines published in August of 2004 4
suggested a lower D2B time of ≤90 minutes as compared
with D2B ≤120 minutes in the guidelines published
earlier in 1999. Because the ACC/AHA guidelines are
regarded as gold standard for evidence-based practice by
the cardiology community, the change in emphasis to a
lower D2B time in recent iteration of these guidelines
could also have significantly contributed to the decreasing
D2B times as well as the increase proportion of patients
receiving primary PCI within 90 minutes of their arrival to
the emergency department.
As observed in our study, elderly people, women, and
minority populations have been consistently shown to
have greater delay in D2B times as compared with their
Table V. Adjusted estimates of compliance with D2B time ≤90
minutes in subgroups
Subgroups ⁎
OR
95% CI
P
Age ≥65 vs b65 y
Female vs male
Minorities vs whites
0.815
0.836
0.760
0.735-0.903
0.763-0.916
0.686-0.842
b.0001
b.0001
b.0001
⁎ P for interaction between age, sex, and race and calendar quarter on D2B time
≤90 minutes >0.1 for all.
peers.17,20 Thus, individuals with these characteristics
are at ‘double jeopardy’ because they are also less likely
to receive any reperfusion and other evidence-based
therapies.21 Elderly people, women, and minorities have
been also shown to be at higher risk for worse outcome
after STEMI.22-24 Previous investigations have shown that
delay in treatment, that is, longer D2B times, have a
much greater impact on outcomes in patients at high-risk
as compared with those at low-risk.25 Better understanding of the reason(s) for these features to be
associated with poorer care and longer D2B times is
therefore imperative. This may allow institutions to
design and target specific strategies in these at-risk
cohorts that may eventually improve compliance with
the D2B benchmark set by national guidelines, over all
use of evidence-based treatments and outcomes in these
high-risk patients.
Opportunities for further improvement
Although there has been a decrease in D2B times
accompanied by a reduction in variability in this time
across sites over time and an increase in the proportion
of patients with D2B times ≤90 minutes at participating
institutions in the GWTG initiative, potential for further
improvement remains. The decrease is at best modest,
and considerable variability continued to exist among
sites. By the end of the study period, the median D2B
time was just less than the ≤90-minute benchmark, with
only 58% of patients treated within this period. The
‘gap’ was even greater for elderly people, women, and
minorities as compared with their peers despite adjustment for baseline confounders including insurance
status. Finally, most troublesome was the fact that the
disparity in the time to treatment in these subgroups
as compared with their peers persisted over time. In lieu
of the close link between D2B times and outcomes,2,3
these findings call for a need to promote process
changes that specifically focus on reducing the delay in
rapid institution of primary PCI. The literature is replete
with many approaches for improving D2B times, and
some have been more successful than others in
improving this performance metric.7 Institutions
should adopt and/or customize specific tools and
processes that best suit the local culture and allow for
greater buy-in of their caregivers for maximizing their
impact on D2B times.
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8 Mehta et al
Limitations
Similar to prior investigations that have evaluated
trends in treatments of patients with acute myocardial
infarction, we lack a control group. Thus, the possibility
that the observed trend in improvement of the D2B times
may be related to a natural progression toward overall
better adherence to evidence-based therapies and
better guideline compliance including decreasing delays
in D2B time with exposure to program initiative over
time cannot be entirely ruled out. Participation in GWTG
was voluntary; therefore, these findings may not be
applicable to institutions that do not demonstrate interest
in tracking and improving their quality and outcomes.
Finally, we cannot provide any insight on the costeffectiveness of such large-scale quality improvement
initiatives. We do not have information on the mode of
transport, that is, via emergency medical services or self,
or on detailed hospital and cardiac catheterization
specific variables. Thus, we are unable to determine
the influence of these factors on D2B time.
Conclusions
The median D2B times with primary PCI have
improved modestly in hospitals participating in the AHA
GWTG program over the last few years but remain
below ideal levels. The D2B times are particularly
delayed in elderly people, women, and minority
populations and have persisted to remain longer over
time in these cohorts as compared with younger
patients, men, and whites. These results indicate
significant opportunities for improvement and the
need for ongoing efforts on the part of health care
institutions to develop internal systems and/or to
voluntarily participate in national myocardial infarction
quality improvement initiatives such as the D2B
Alliance or the AHA's ‘Mission: Lifeline’ Initiative
designed to improve D2B times.
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