Coronary Interventions

Postdischarge Bleeding After Percutaneous

Coronary Intervention and Subsequent Mortality
and Myocardial Infarction
Insights From the HMO Research Network-Stent Registry
Javier A. Valle, MD, MSc; Susan Shetterly, MS; Thomas M. Maddox, MD,
MSc; P. Michael Ho, MD, PhD; Steven M. Bradley, MD, MPH; Amneet Sandhu,
MD; David Magid, MD, MPH; Thomas T. Tsai, MD, MSc

Background—Bleeding after hospital discharge from percutaneous coronary intervention (PCI) is associated with increased
risk of subsequent myocardial infarction (MI) and death; however, the timing of adverse events after these bleeding
events is poorly understood. Defining this relationship may help clinicians identify critical periods when patients are at
highest risk.
Methods and Results—All patients undergoing PCI from 2004 to 2007 who survived to hospital discharge without a
bleeding event were identified from the HMO Research Network-Stent (HMORN-Stent) Registry. Postdischarge rates
and timing of bleeding-related hospitalizations, MI, and death were defined. We then assessed the association between
postdischarge bleeding–related hospitalizations with death and MI using Cox proportional hazards models. Among
8137 post-PCI patients surviving to hospital discharge without in-hospital bleeding, 391 (4.8%) had bleeding-related
hospitalization after discharge, with the highest incidence of bleeding-related hospitalizations occurring within 30 days
of discharge (n=79, 20.2%). Postdischarge bleeding–related hospitalization after PCI was associated with subsequent
death or MI (hazard ratio, 3.09; 95% confidence interval, 2.41–3.96), with the highest risk for death or MI occurring
in the first 60 days after bleeding-related hospitalization (hazard ratio, 7.16; confidence interval, 3.93–13.05).
Conclusions—Approximately 1 in 20 post-PCI patients are readmitted for bleeding, with the highest incidence occurring
within 30 days of discharge. Patients having postdischarge bleeding are at increased risk for subsequent death or MI,
with the highest risk occurring within the first 60 days after a bleeding-related hospitalization. These findings suggest a
critical period after bleeding events when patients are most vulnerable for further adverse events. (Circ Cardiovasc
Interv.
2016;9:e003519. DOI: 10.1161/CIRCINTERVENTIONS.115.003519.)
Key Words: hemorrhage ◼ myocardial infarction ◼ percutaneous coronary intervention ◼ stent ◼ survival

A
ggressive antithrombotic regimens have led to significant
reductions in thrombotic complications after percutaneous
coronary intervention (PCI),1–3 but they have exposed
patients to an increased risk of bleeding. Bleeding remains
one of the most common complications after PCI, with ≤6%
of patients experiencing a major bleeding event.4 Study of
post-PCI bleed- ing has demonstrated that these events are not
benign, with an association between bleeding and increased
risk of death and myocardial infarction (MI).5–13 Recent data
suggest that bleed- ing after hospital discharge carries
similar risks to inpatient bleeding.11–13 Although inpatient
post-PCI bleeding has been well characterized,5–10,14
comparatively little is known about the timing and prognostic
impact of postdischarge bleeding events. Significant gaps
remain in the understanding of postdischarge bleeding. First,
the sources and the timing of postdischarge
bleeding after PCI are not well characterized. Establishing
the highest risk periods for postdischarge bleeding after PCI
can inform efforts to appropriately focus preventive
measures. Second, the timing of death and MI after
postdischarge bleed- ing remains unknown. Understanding
the temporal relation- ship between postdischarge bleeding
and subsequent adverse events could identify critical periods
of patient risk after bleed- ing events. Finally, although risk
factors for inpatient bleeding are well established, they may
not overlap with risk factors for postdischarge bleeding. The
identification of distinct risk fac- tors for postdischarge
bleeding may provide opportunities to further tailor post-PCI
care for those at highest risk for events.
Accordingly, we studied patients undergoing PCI in 3
large integrated United States healthcare systems. First, we
described the timing and the sources of bleeding events after

Received December 18, 2015; accepted April 27, 2016.

From the Division of Cardiology, University of Colorado, Aurora (J.A.V, T.M.M., P.M.H., S.M.B., A.S., T.T.T.); The Institute For Health Research,
Kaiser Permanente Colorado, Denver (S.S., D.M., T.T.T.); Department of Cardiology, Veterans Affairs Eastern Colorado Health Care System, Denver
(T.M.M., P.M.H., S.M.B.); and The Colorado Cardiovascular Outcomes Research Consortium, Denver (J.A.V., T.M.M., P.M.H., S.M.B., A.S., D.M.,
T.T.T.).
The Data Supplement is available at http://circinterventions.ahajournals.org/lookup/suppl/doi:10.1161/CIRCINTERVENTIONS.115.003519/-/DC1.
Correspondence to Javier A. Valle, MD, MSc, Division of Cardiology, University of Colorado, 12361 E, 17th Ave, B130, Aurora, CO 80204. E-
mail javier.valle@ucdenver.edu
© 2016 American Heart Association, Inc.
Circ Cardiovasc Interv is available at http://circinterventions.ahajournals.org DOI: 10.1161/CIRCINTERVENTIONS.115.003519

1
2 Valle et al Outcomes of Postdischarge Bleeding After PCI
WHAT IS KNOWN
• Bleeding after percutaneous coronary intervention is
associated with increased risk of adverse events.
• This increased risk is present for both in-hospital and
postdischarge bleeding.
WHAT THE STUDY ADDS
• The risk of bleeding-related hospitalization after dis-
charge from percutaneous coronary intervention is
highest within 30 days of discharge.
• The risk of death or myocardial infarction after a
bleeding-related hospitalization is highest within the
first 60 days of the bleeding event.
• Risk factors for postdischarge bleeding are distinct
from those traditionally associated with inpatient
bleeding events.
hospital discharge from PCI. Second, we assessed the
associa- tion between postdischarge bleeding and subsequent
death or MI. Finally, we identified risk factors associated
with postdis- charge bleeding. The results of this analysis
may assist clini- cians in identifying intervals after PCI when
patients are at highest risk for adverse events.
Methods
Cohort
The HMO Research Network-Stent (HMORN-Stent) Registry cap-
tured all patients undergoing PCI with a drug-eluting stent between
January 2004 and December 2007 at 3 large integrated health
systems: Kaiser Permanente Northern California, Kaiser Permanente
Colorado, and Health Partners (Minneapolis, MN). Each of these sites
participates in the National Cardiovascular Data Registry CathPCI
Registry,15 re- cording and submitting detailed data from the PCI
procedures, includ- ing demographics, cardiac risk factors,
comorbidities, cardiac history, details of admission presentation,
preprocedural testing, diagnostic catheterization findings, PCI
procedural details, PCI procedural com- plications, and admission
and discharge medications. Each variable was prospectively defined
by a committee of the American College of Cardiology for capture
in CathPCI and captured concomitantly in the HMORN-Stent registry
during the study period. Each healthcare system also maintained
postdischarge data for each patient, including pharmaceutical
dispensing data, rehospitalizations, and vital status. Institutional
review board approval was obtained at each of the 3 sites.
All patients in the HMORN-Stent registry who underwent suc-
cessful PCI with a drug-eluting stent in ≥1 coronary artery between
January 2004 and December 2007 were considered for this analysis
(n=8371). Patients were excluded if they did not survive to discharge
(n=72), had an in-hospital bleeding event as defined by CathPCI and
HMORN-Stent covariates of bleeding at access site, retroperitoneal
bleeding, gastrointestinal bleeding, genitourinary bleeding, or other
bleeding (n=172), or if they were missing specific data on comor-
bidities or admission presentation data (n=15). Patient comorbidities
were obtained using HMORN-Stent recorded data. Medication and
pharmacy dispensation data were obtained using specific pharmacy
dispensing records, creating indicators of drug availability during the
follow-up period.
Outcomes
The primary outcome for this analysis was death or MI after bleed-
ing-related hospitalization. Deaths were derived from health plan
data sources and state death certificates. Vital status data were
avail- able post discharge for all patients through December
2007. MIs were identified from administrative claims data, using
International Classification of Disease, Ninth Revision, Clinical
Diagnosis Codes (codes 410.XX) for events after discharge from the
initial hospitaliza- tion. Hospitalizations outside of the hospital
systems were similarly captured via administrative claims data as
submitted for payment. Bleeding-related hospitalizations were
identified by the presence of a hospital admission for a primary
discharge diagnosis of a bleeding event, or a secondary discharge
diagnosis of a bleeding event and evidence of blood transfusion.16
Bleeding events were obtained by review of the International
Classification of Disease, Ninth Revision codes for billed diagnoses
occurring after discharge from the index PCI hospitalization.
International Classification of Disease, Ninth Revision bleeding
diagnoses included gastrointestinal hemorrhage (International
Classification of Disease, Ninth Revision codes
455–578), intracranial hemorrhage (430–432), hemarthrosis (719.2),
hemopericardium (423), hematuria (599.7), hemoptysis (786.3), vag-
inal bleeding (623.8–626.2), epistaxis (784.7), and hemorrhage not
otherwise specified or other bleeding (459). Bleeding, death, and MI
events were captured for the duration of follow-up (either healthcare
plan disenrollment or December 2007).
To evaluate the association between bleeding and risk of death
and MI, we constructed Cox proportional hazards models17,18 with
postdischarge bleeding–related hospitalization as a time-varying ex-
posure. Covariates for adjustment were chosen from previous vali-
dated in-hospital bleeding models14 and clinical judgment to include
age, sex, medical and cardiac history (history of bleeding event, MI,
cerebrovascular disease, congestive heart failure, diabetes mellitus,
peripheral arterial disease, chronic lung disease, chronic kidney dis-
ease [CKD] with or without need for dialysis, hypertension, PCI,
coronary artery bypass surgery, and dyslipidemia), admission history
(presence of cardiogenic shock, acute coronary syndrome, and type
versus stable angina or atypical chest pain syndrome), and postdis-
charge medications. Peripheral arterial disease and dyslipidemia
were defined by the definitions used in CathPCI.19 CKD was
defined in the HMORN-Stent registry using CathPCI data elements
(history of renal failure requiring dialysis) as well as review of the
patient record for a documented history of renal failure or serum
creatinine level of
>2.0 mg/dL. To most accurately represent outpatient medication use
at the time of follow-up events, we measured postdischarge medi-
cations as time-varying covariates using pharmacy prescription and
refill claims data, with methods previously described by Tsai et al.16
Specific medications were chosen based on presumed modification
of bleeding risk and included clopidogrel, warfarin, proton pump
inhibi- tors (PPI), and histamine receptor antagonists (H2 blocker).
As part of a secondary analysis, prescription and refill data on 3-
hydroxy-
3-methylglutaryl-coenzyme A reductase inhibitors (statins) were
also abstracted. To further evaluate the timing of death or MI from
the postdischarge bleeding–related hospitalization, we estimated risk
of death or MI in specific time intervals (0–60, 61–120, 121–180,
181–
365, and >365 days) from the bleeding-related hospital admission.
To examine the risk factors for postdischarge bleeding, we again
constructed Cox models,17,18 using time-varying medication avail-
ability and the covariates listed above in our models. All statistical
analysis was performed using SAS version 9.2.
Results
There were 8371 patients who received a drug-eluting stent
from January 2004 through December 2007 across the 3
sites. A total of 218 patients were excluded from the analy-
sis because of a major in-hospital bleeding event (n=146) and
in-hospital mortality (n=72). Fifteen patients were excluded
for missing data on key comorbidity, admission, or presen-
tation covariates, resulting in a final cohort of 8137 patients
(Figure 1). Baseline characteristics of the study population
are presented in Table 1. Mean postdischarge follow-up was
547 days (SD 218) with a median of 665 days (interquartile

Figure 1. Study cohort derivation.
range, 375–730). Of the 69 patients who had a follow-up of
≤30 days, 5 patients (7%) had procedures in December 2007
and 12 disenrolled from the health plan (17%). The
remainder (n=52, 75%) died within the follow-up time
period.
Postdischarge Bleeding–Related Hospitalizations
During the follow-up period, 391 post-PCI patients (4.8%)
experienced a postdischarge bleeding–related hospitalization.
Of these 391 patients, 286 (73.1%) had bleeding as a princi-
pal discharge diagnosis, and the remaining 107 (27.2%) had a
secondary discharge diagnosis with an evidence of
transfusion during the hospitalization. The majority of
bleeding events were gastrointestinal (n=228, 58.3%),
hemorrhage not other- wise specified (n=69, 17.6%), or
urogenital (n=50, 12.8%). Bleeding events occurred most
frequently in the first 30 days post discharge (79 bleeding
events and 20.2% of all events), with an incidence of 11.9
bleeds per 100 patient-years, with the incidence of
bleeding decreasing over time (Figure 2; Table I in the
Data Supplement).
Before adjustment, patients who experienced bleed-
ing events tended to be older with a higher body mass index
and more comorbid conditions. They were more likely to be
female, and they were more likely to be receiving warfarin
and either a PPI or histamine receptor antagonist on
discharge. Although previous coronary artery bypass surgery
was more common in patients who had bleeding-related
hospitaliza- tions (Table 1), previous PCI was not associated
with bleeding events post discharge.
Death and MI
Death or MI occurred in 746 patients during the study period.
There were 400 deaths with 75 occurring in patients who had
a post-PCI bleeding-related hospitalization. There were 416
MIs during the study period, with 55 occurring in patients
who had a post-PCI bleeding-related hospitalization. The tim-
ing of death after a post-PCI bleeding-related hospitalization
ranged from 0 to 688 days. The median time to death after a
postdischarge bleeding–related hospitalization was 71 days,
with 46.7% occurring within 60 days of the bleeding event.
The timing of MI after a post-PCI bleeding-related hospital-
ization ranged from 0 to 373 days. The median time to MI
after a post-PCI bleeding-related hospitalization was 28 days,
with 67.9% occurring within 60 days (Figure 3; Table I in the
Data Supplement).
Death or MI Related to Bleeding
After adjustment, post-PCI bleeding-related hospitalizations
were significantly associated with higher rates of death or MI
(adjusted hazard ratio [HR], 3.09; 95% confidence interval
[CI], 2.42–3.96; Figure 4) compared with patients without
bleeding events. The highest rates of death or MI were seen
within the first 60 days after a bleeding-related
hospitalization (Figure 3). In patients having a bleeding-
related hospitaliza- tion, the HR for death or MI was 7.16
(95% CI, 3.93–13.05) within the first 60 days when
compared with those patients without bleeding events. After
60 days from the bleeding- related hospitalization, the HR of
death or MI decreased to between 2.87 and 3.21 (61–90 days:
HR, 3.06; 95% CI, 0.74–
12.64; 91–180 days: HR, 3.92; 95% CI, 1.99–7.75; 181–365
days: HR, 3.80; 95% CI, 2.39–6.04; and >365 days: HR,
3.54; 95% CI, 2.44–5.14) when compared with those patients
without a bleeding-related hospitalization. Postdischarge
bleeding–related hospitalization was the second most potent
independent predictor of death or MI in this population, only
following a history of CKD requiring dialysis (HR, 3.58;
95% CI, 2.74–4.67; Table II in the Data Supplement).
Risk Factors for Post-PCI Bleeding-Related
Hospitalizations
After multivariable adjustment, the strongest risk factor
associ- ated with post-PCI bleeding-related hospitalization
was filled prescriptions for warfarin (HR, 3.24; 95% CI, 2.45–
4.28). Filling prescriptions for clopidogrel was also
associated with a higher risk of bleeding-related
hospitalization (HR, 1.28;
95% CI, 1.01–1.63). Primary historical and demographic fac-
tors associated with post-PCI bleeding-related hospitalizations
included age, history of congestive heart failure, previous
bleeding event within the last year, peripheral vascular
disease, diabetes mellitus, and CKD with or without dialysis.
Among these historical and demographic variables, history of
CKD requiring dialysis (HR, 1.67; 95% CI, 1.02–2.71),
congestive heart failure (HR, 1.61; 95% CI, 1.24–2.09), CKD
without dialysis (HR, 1.55; 95% CI, 1.08–2.23), and
peripheral vascu- lar disease (HR, 1.48; 95% CI, 1.15–1.91)
were associated with the highest rates of bleeding-related
hospitalization (Table 2). Bleeding was not associated with
time-varying use of PPI or H2 blocker (HR, 1.16; CI, 0.93–
1.45). After adjustment, sex was not significantly associated
with bleeding, nor were previ- ous revascularization (coronary
artery bypass surgery or PCI), PCI indication, or the presence
of cardiogenic shock. Indepen- dent factors associated with
postdischarge bleeding are shown in Table 2. Dyslipidemia
was associated with a decreased event rate of postdischarge
bleeding after adjustment (HR, 0.76; CI,
0.59–0.99). Because dyslipidemia is associated with statin
therapy, and statin therapy has been associated with decreased
rates of inpatient bleeding,20 a secondary analysis was per-
formed to evaluate for association between statin use and
bleeding risk. This secondary analysis of time-varying statin
use did not show any significant association between statin
use and risk of postdischarge bleeding (HR, 0.97; CI, 0.79–
1.20).
 Table 1. Demographics and Clinical Characteristics at the Table 1. Continued
Time of PCI
Postdischarge No Postdischarge
Postdischarge No Postdischarge Bleeding–Related Bleeding–Related
Bleeding–Related Bleeding–Related Hospitalization, Hospitalization,
Hospitalization, Hospitalization, n=391 n=7746 P Value
n=391 n=7746 P Value
Clopidogrel post
97.7% 96.9% 0.35
Mean age, y (SD) 70.0 (11.1) 63.7 (11.5) <0.001 discharge

Male sex 63.4% 71.5% <0.001 Warfarin post discharge 31.2% 9.1% <0.001

Bleed within year PPI/H2 antagonist post

4.1% 1.3% <0.001 74.4% 44.5% <0.001
preceding PCI discharge
ACS indicates
History of MI acute coronary syndrome;
32.5% CKD, chronic 26.2%
kidney disease; 0.006
NYHA, New York Heart Association; PCI, percutaneous coronary intervention; PPI, proton
pump inhibitor; and STEMI, ST-segment–elevation myocardial infarction.
Cerebrovascular
disease
16.1% 8.2% <0.001 Discussion
Patients are most likely to have bleeding-related hospitaliza-
Peripheral vascular
22.0% 10.2% <0.001 tions during the first 30 days after PCI, with the majority of
disease
bleeding events being gastrointestinal in origin, and the inci-
Diabetes mellitus 40.4% 30.4% <0.001 dence of bleeding-related hospitalization decreasing over
CKD <0.001 time. Bleeding-related hospitalizations after PCI were signifi-
cantly associated with death and MI, with a 3-fold increased
CKD 9.2% 4.0%
hazard of death or MI during the duration of follow-up and a
CKD requiring >7-fold hazard of death or MI within the first 60 days after
4.9% 1.9%
dialysis the bleeding event. Independent risk factors for postdischarge
Chronic lung disease 21.5% 14.8% <0.001 bleeding differed from inpatient models, with acute coronary
Congestive heart failure 24.3% 9.4% <0.001 syndrome or cardiogenic shock presentation at the time of
PCI, previous PCI, and sex not associated with risk of bleed-
Hypertension 83.6% 76.3% 0.001 ing events. These findings suggest a risk profile for those
Dyslipidemia 79.3% 82.0% 0.18 post- PCI patients most likely to bleed after discharge, the
History of PCI 20.7% 21.2% 0.82 time of greatest vulnerability for postdischarge bleeding, and
should draw clinicians’ attention to the extraordinarily high
History of coronary risk for adverse outcomes in the 60 days after a bleeding
25.8% 17.1% <0.001
artery bypass grafting
event.
Cardiogenic shock 2.6% 1.6% 0.15 This study expands the growing body of literature evalu-
PCI presentation 0.009 ating post-PCI bleeding. Previous work has established a
relationship between bleeding and increased major adverse
No symptoms/angina 7.7% 5.5%
cardiovascular events during the initial hospitalization for
Atypical chest pain 3.3% 5.1% PCI,6,8–10,12,21 and increasing data support a similar relationship
Stable angina 12.5% 17.0% in the outpatient arena, after discharge.11–13,21 Our findings of
a relationship between postdischarge bleeding and increased
ACS: unstable angina 28.6% 29.9%
risk of death and MI are consistent with previous analyses,
ACS: Non-STEMI 34.0% 27.9% with an overall HR for death and MI similar to that found
ACS: STEMI 13.8% 14.7% by Ko et al11 and consistent with the findings of Kazi et al.13
The source for these bleeding events seems to be consistent
NYHA class 0.13
across analyses, with a majority coming from gastrointesti-
Class 1 26.6% 32.0% nal sources and the highest incidence occurring in the earliest
Class 2 14.8% 13.5% period after discharge.11 Finally, our study suggests that there
is some overlap between traditional risk factors for inpatient
Class 3 31.7% 31.4%
bleeding of CKD, peripheral vascular disease, age, and those
Class 4 26.9% 22.9% for postdischarge bleeding, but that factors related to
Missing 0% 0.2% presenta- tion and sex carry less impact for risk after
discharge.4,11
Current smoker 0.07
Our study has several novel contributions to the literature.
No 86.5% 82.0% First, this is the first study to evaluate the timing of adverse
Yes 13.6% 17.9% events after a postdischarge bleeding event. We demonstrate
that although post-PCI patients are at high risk for death or MI
Missing 0% 0.1%
at any time after a bleeding-related hospitalization, the period
Mean body mass of highest risk seems to be within the first 60 days after a
28.2 (5.9) 29.0 (5.7) 0.007 )
(Continued
index (SD)
bleed. These findings are consistent with hypotheses of major
bleed- ing events and transfusions resulting in a prothrombotic
milieu
Figure 2. Incidence of bleeding-related hospitalizations after discharge from percutaneous coronary intervention (PCI), overall and by
bleeding source.
that can precipitate adverse events.22,23 The fact that highest resulting in immediate ischemia24), but may represent
risk of death and MI continues out to 60 days would suggest continued perturbation in a patient’s hemostatic balance.
that the mediator for death and MI is not just the bleeding These findings may also represent the higher mortality and MI
event itself (ie, hypovolemia and reduced oxygen delivery to risks of a sicker population, and selection bias for those
tissues, patients healthy enough

Figure 3. Timing of death or myocardial infarction

(MI) after bleeding-related hospitalization.
 Figure 4. Risk of death or myocardial infarction
(MI) after bleeding-related hospitalization.

to tolerate ongoing dual antiplatelet therapy after a bleeding bleeding events occur early on and carry substantial risk.
event. However, the significant increase in risk of death or MI There is an opportunity
in the period extending from immediately after a bleeding
event to
60 days raises suspicion for a pathophysiologic mechanism
out- side of a patient’s inherent risk. Finally, the association
between ongoing clopidogrel use and decreased rates of death
or MI after bleeding-related hospitalization suggests that there
may still be a role for intensive antiplatelet therapy after
bleeding events. These findings may represent a need for
increased scru- tiny and more precise tailoring of clinical
decisions surrounding the discontinuation of P2Y12
antagonists after a bleed.
Another novel finding is in the review of risk factors for
postdischarge bleeding–related hospitalizations. Although
our study found that many inpatient risk factors were also
relevant to postdischarge bleeding, we did not find sex or
type of pre- sentation for PCI to be significantly associated
with bleeding risk. This is inconsistent with the literature on
inpatient bleed- ing, which has identified female sex and
acute coronary syn- drome or cardiogenic shock presentation
at the time of PCI as potent risk factors for inpatient
bleeding. This lack of asso- ciation may emphasize a
difference between the evaluation of inpatient and the
postdischarge bleeding events: a departure from procedural
and PCI presentation factors as influential on outcome, rather
focusing on intrinsic patient factors and post- discharge
medications that can modulate risk. We did find an
association between dyslipidemia and decreased bleeding risk
that was not explained by a secondary analysis of time-vary-
ing statin use, and offers an avenue for future study. In addi-
tion, we did not find any association between H2 blocker or
PPI use and bleeding events. The lack of relationship
between the use of gastroprotective agents, such as PPIs and
H2 block- ers is novel, especially given the majority of
bleeds are from a gastrointestinal source. However, this
finding may represent confounding by indication, with those
patients deemed to be at highest bleeding risk receiving
gastrointestinal prophylaxis.
The findings of this analysis add to the data surrounding
post-PCI bleeding, and again demonstrate the need for
caution with patients at risk for bleeding. Post-PCI bleeding is
associ- ated with increased rates of death and MI, even if the
bleed- ing occurs after hospital discharge. Patients at risk for
bleeding merit close follow-up and evaluation, as their
for further exploration into possible targets for prevention of
bleeding events after the identification and substantiation of
known bleeding events. Among those patients on
warfarin, it is possible that closer monitoring of international
normal- ized ratios post-PCI may minimize time in
supratherapeutic ranges that can place patients at risk for
bleeding. Furthermore, data from the WOEST (What is the
Optimal Antiplatelet and Anticoagulant Therapy in Patients
With Oral Anticoagulation and Coronary Stenting Trial) and
ISAR-TRIPLE (Duration of Triple Therapy in Patients
Requiring Anticoagulation After Drug-Eluting Stent
Implantation) studies offer the possibility of alternative
management strategies to either redefine therapy for post-PCI
anticoagulation or to at least limit the duration of risk.25,26
Ongoing evaluations with novel anticoagulants and
antiplatelet agents may also offer alternatives to current prac-
tice with warfarin and clopidogrel.27,28
There are several limitations to our work. First, as with
any retrospective analysis, there is risk of residual confound-
ing and bias. Through multivariable adjustment for known
bleeding risk factors, we attempted to minimize the residual
confounding that may be present. We also excluded patients
who had a bleeding event as inpatients or who did not sur-
vive to discharge, to accurately isolate postdischarge bleed-
ing events. We made this decision in the belief that inpatient
and outpatient bleeds are different events, which is supported
by our findings of different risk profiles for inpatient and
postdischarge bleeding. A second limitation is the analysis of
medications as a variable. With any retrospective analysis of
medication use, compliance is a concern. We performed our
analysis with the medication use as a time-varying exposure
based on medication prescription refills, attempting to cap-
ture as much variability in compliance as possible with retro-
spective data. Third, this study pre-dates the introduction of
newer antiplatelet and anticoagulant options,29–33 and so our
findings do not reflect the use of these agents. However,
clop- idogrel and warfarin remain the dominant antiplatelet
and anticoagulant medications used in the United States,34,35
sug- gesting that our results remain applicable to a large
number of patients undergoing PCI. Fourth, our analysis
does not iden- tify readily modifiable risk factors for
postdischarge bleed- ing. Identifying such risk factors
remains an area that requires further study. However, our
findings can aid clinicians in
 Table 2. Cox Proportional Hazard Ratios of Demographic, Clinical, and Medication Variables
for Postdischarge Bleeding–Related Hospitalizations
Hazard Ratio for Bleeding-
Related Hospitalization
95% Confidence Interval P Value
Age (per 10 y)* 1.44 1.30 1.59 <0.0001
Male sex 1.17 0.94 1.44 0.15
Bleed in year before PCI 1.96 1.18 3.28 0.01
History of MI 0.95 0.74 1.21 0.67
Cerebrovascular disease 1.31 0.99 1.73 0.062
Congestive heart failure 1.61 1.24 2.09 0.0003
Diabetes mellitus 1.30 1.05 1.62 0.017
Peripheral vascular disease 1.48 1.15 1.91 0.003
Chronic lung disease 1.17 0.92 1.50 0.21
Chronic kidney disease 1.55 1.08 2.23 0.018
Chronic kidney disease requiring dialysis 1.67 1.02 2.71 0.040
Hypertension 1.14 0.86 1.52 0.37
Previous PCI 0.90 0.69 1.18 0.45
Previous coronary artery bypass grafting 1.24 0.96 1.59 0.097
Cardiogenic shock 1.25 0.66 2.39 0.50
Dyslipidemia 0.76 0.59 0.99 0.04
PCI presentation
Atypical chest pain 0.72 0.38 1.40 0.34
Stable angina 0.86 0.54 1.37 0.53
ACS: unstable angina 1.01 0.67 1.53 0.96
ACS: Non-STEMI 1.21 0.81 1.81 0.36
ACS: STEMI 1.22 0.75 1.95 0.40
Postdischarge time-varying warfarin use 3.24 2.45 4.28 <0.0001
Postdischarge time-varying clopidogrel use 1.28 1.01 1.63 0.042
Postdischarge time-varying PPI/H2 use 1.16 0.93 1.45 0.20
Postdischarge time-varying statin use 0.97 0.79 1.20 0.78
ACS indicates acute coronary syndrome; MI, myocardial infarction; PCI, percutaneous coronary intervention; PPI,
proton pump inhibitor; and STEMI, ST-segment–elevation myocardial infarction.
*All table variables are categorical and binary with the exception of age and PCI presentation.
refining the profile of patients at highest risk as well as comorbid conditions including CKD, diabetes mellitus, and
defin- ing time periods of highest vulnerability after PCI and heart failure, with higher rates of warfarin use. Bleeding-
bleed- ing events. Fifth, we were unable to identify other related hospitalizations occur early after PCI and are
recognized risk factors for bleeding, such as the presence of associated with higher rates of subsequent death and MI,
malignancy or inflammatory conditions, as these are which is most pro- nounced in the first 60 days after the
challenging to obtain from administrative data and bleeding event. Clinicians should be aware of this vulnerable
retrospective data sets. However, we did include a broad period after a postdischarge bleed. It is possible that focusing
range of covariates for risk adjustment, chosen from
resources and increasing vigi- lance during this critical period
established bleeding models as well as clinical judgment.
may improve patient outcomes.
Finally, the size of our cohort may be a limitation for our
analysis of death or MI after bleeding events. However,
despite the smaller cohort, a statistically significant Sources of Funding
relationship was still observed between postdis- charge Drs Valle and Sandhu are supported by National Institutes of Health
bleeding and death or MI. (NIH) T32 training grants at the University of Colorado, Aurora,
CO.
In summary, bleeding-related hospitalization is a major
risk for death or MI in patients after PCI. Patients at risk for
bleeding-related hospitalizations tend to be older, with more Disclosures
None.
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 Postdischarge Bleeding After Percutaneous Coronary Intervention and Subsequent
Mortality and Myocardial Infarction: Insights From the HMO Research Network-Stent
Registry
Javier A. Valle, Susan Shetterly, Thomas M. Maddox, P. Michael Ho, Steven M. Bradley,
Amneet Sandhu, David Magid and Thomas T. Tsai

Circ Cardiovasc Interv. 2016;9:

doi: 10.1161/CIRCINTERVENTIONS.115.003519
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SUPPLEMENTAL MATERIALS

Supplemental Table Legends:

Supplemental Table 1. Incidence of Bleeding by Time Interval from Discharge

Supplemental Table 2. Cox Proportional Hazard Ratios of Demographic, Clinical and Medication Variables for Post-Discharge Death or

Myocardial infarction.
Supplemental Table 1. Incidence of Bleeding by Time Interval from Discharge

Any Bleeding Gastrointestinal Genitourologic Intracranial Bleeding Pulmonary Othe

Bleeding Bleeding Bleeding Nonspe
Bleed

Bleeding Incidence Bleeding Incidence Bleeding Incidence Bleeding Incidence Bleeding Incidence Bleeding I
events events events events events events
(per 100
patient-
(n) years)

≤30 days 79 11.93 46 6.93 10 1.50 7 1.05 2 0.30 14 2.11

31-60 29 2.21 22 1.67 1 0.08 3 0.23 0 0 3 0.23

61-90 25 1.28 13 0.66 3 0.15 4 0.20 1 0.05 4 0.20

91-180 69 1.82 35 0.92 7 0.18 5 0.13 1 0.03 21 0.55

181-365 92 1.33 59 0.85 14 0.20 4 0.06 3 0.04 12 0.17

>365 97 0.91 53 0.49 15 0.14 12 0.11 2 0.02 15 0.14

Total 391 228 50 35 9 69

Supplemental Table 2. Cox Proportional Hazard Ratios of Demographic, Clinical and Medication Variables for Post-Discharge Death or

Myocardial infarction.

Hazard Ratio for post-discharge

95% Confidence Interval p value
death or myocardial infarction

Post-discharge bleed (time-

3.09 2.42 3.96 <.0001
varying exposure)*

Age (per 10 years) 1.172 1.09 1.26 <.0001

Male Gender 1.20 1.03 1.40 0.020

†
Bleed in year prior to PCI 1.17 0.77 1.78 0.46

‡
History of MI 1.37 1.16 1.63 0.0003

Cerebrovascular disease 1.35 1.10 1.65 0.0034

Congestive Heart Failure 1.78 1.48 2.15 <.0001

Diabetes Mellitus 1.45 1.24 1.69 <.0001

Peripheral vascular disease 1.31 1.08 1.57 0.0049

Chronic lung disease 1.38 1.16 1.64 0.0003

Chronic Kidney disease 1.51 1.17 1.95 0.0018

Chronic Kidney disease

3.58 2.74 4.67 <.0001
requiring dialysis

Hypertension 1.18 0.96 1.46 0.12

Previous PCI 1.16 0.97 1.38 0.11

Previous Coronary Artery

1.44 1.21 1.72 <.0001
Bypass Grafting
 Cardiogenic shock 2.08 1.42 3.04 0.0002

Dyslipidemia 0.79 0.65 0.96 0.020

PCI Presentation

Atypical chest pain 0.64 0.38 1.07 0.089

Stable angina 0.92 0.65 1.29 0.62

§
ACS : Unstable Angina 0.88 0.65 1.20 0.53
||
ACS: Non-STEMI 1.60 1.19 2.14 0.0019

ACS: STEMI 1.67 1.19 2.35 0.0032

Post-discharge time-varying 1.19 0.91 1.57 0.21

warfarin use

Post-discharge time-varying 0.62 0.52 0.73 <.0001

clopidogrel use
* † ‡ §
All table variables are categorical and binary with the exception of age and PCI presentation; PCI = Percutaneous Coronary Intervention; MI = Myocardial Infarction; ACS = Acute Coronary
||
Syndrome; STEMI = ST-Elevation Myocardial Infarction