JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY VOL. 67, NO.

24, 2016

2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION ISSN 0735-1097/$36.00

PUBLISHED BY ELSEVIER

Letters

identify components of the ATRIA score: anemia

HAS-BLED Versus ATRIA (285.9), end-stage renal disease (585.6), age >65
Risk Scores for Intracranial years, prior hemorrhage (998.11) and hypertension
(401, 405). ICH events were identied using codes
Hemorrhage in Patients 430 to 432. For the purpose of simplicity in risk
Receiving Thrombolytics assessment, the variables were dichotomized. Stan-
dard receiver-operating characteristic curves were
for Pulmonary Embolism constructed to evaluate the ability of the HAS-BLED
and the ATRIA risk scores to predict ICH in PE
Intracranial hemorrhage (ICH) is one of the dreaded patients receiving thrombolytic agents. Model cali-
complications of thrombolytic therapy for acute pul- bration was assessed with multiple bootstrapping
monary embolism (PE) (1). Prior registries such as the with replacement.
RIETE registry (Computerized Registry of Patients From 2011 to 2012, 2,727 patients received
with Venous Thromboembolism) and the Interna- thrombolytic therapy for PE; the prevalence of
tional Cooperative Pulmonary Embolism Registry intracerebral hemorrhage was 48 (1.8%). Patients
(ICOPER) have noted risk of major bleeding including
ICH at 2.4% and 3%, respectively (1), indicating need
for identifying the same accurately. We identied
patients with PE treated with thrombolytic therapy T A B L E 1 Baseline Characteristics of Patients With PE Receiving
Thrombolytic Agents With and Without ICH
who may be at relatively high risk of ICH from an
administrative database, and compared the ability of No ICH ICH
(n 2,679) (n 48) p Value
2 commonly used bleeding risk scores used for risk
Age in years at 58.0 (46.070.0) 61.0 (53.074.0) 0.073
prediction in anticoagulation-treated patients to admission
accurately predict ICH. Female 1,381 (51.5) 24 (50.0) 0.12
We used data from patients discharged from short- Length of stay 7.0 (4.011.0) 14.0 (5.522.0) <0.001
(cleaned)
stay hospitals in the United States from 2011 to 2012
AMI 117 (4.4) 3 (6.3) 0.53
with PE (ICD-9 diagnosis codes 415.1, 415.11, 415.13,
PVD 46 (1.7) 1 (2.1) 0.85
and 415.19) who received thrombolytic therapy (ICD-9
CEVD 77 (2.9) 29 (60.4) <0.001
procedure code 99.10) and the proportion with ICH Dementia 3 (0.1) 0 (0.0) 0.82
from the Nationwide Inpatient Sample (Healthcare COPD 237 (8.8) 3 (6.3) 0.53
Cost and Utilization Project, Agency for Healthcare Rheumatoid disease 41 (1.5) 0 (0.0) 0.39
Research and Quality), which includes 20% of all PUD 14 (0.5) 0 (0.0) 0.62

hospital discharges in the United States (2). Pre- Mild LD 6 (0.2) 0 (0.0) 0.74
Diabetes 262 (9.8) 5 (10.4) 0.88
existing medical conditions were identied using
Diabetes 31 (1.2) 0 (0.0) 0.45
the Deyo modication of the Charlson comorbidity complications
index (3). Two commonly used bleeding risk scores HP/PAPL 29 (1.1) 11 (22.9) <0.001
used for assessing bleeding risk in patients on anti- RD 139 (5.2) 3 (6.3) 0.74
coagulationthe HASBLED (4), and ATRIA (5)were Cancer 128 (4.8) 3 (6.3) 0.64

assessed to identify ability to accurately identify risk Moderate/severe LD 4 (0.1) 0 (0.0) 0.79
Metastatic cancer 77 (2.9) 1 (2.1) 0.74
of ICH in PE patients receiving thrombolytic therapy.
AIDS 4 (0.1) 0 (0.0) 0.79
The individual components of the HAS-BLED score
Shock 160 (6.0) 1 (2.1) 0.26
were identied from administrative codes: hyper-
tension (ICD-9 codes 401, 405), abnormal renal func- Values are median (interquartile range) or n (%).
AIDS acquired immune deciency syndrome; AMI acute myocardial infarc-
tion (codes 585), abnormal liver function (codes 571,
tion; COPD chronic obstructive pulmonary disease; CEVD cerebrovascular
573.9), stroke (438), bleeding (459), coagulopathy disease; HP hemiplegia; ICH intracranial hemorrhage; LD liver disease;
PAPL paraplegia; PE pulmonary embolism; PUD peptic ulcer; PVD
(286.9), elderly (age >65 years), and alcohol (303.9)/ peripheral vascular disease; RD renal disease.
drug use (304.9). Similar methodology was used to
JACC VOL. 67, NO. 24, 2016
JUNE 21, 2016:290411
who developed ICH tended to be older, had a higher
prevalence of prior history of cerebrovascular disor-
ders and paralysis, and had a longer length of hos-
pital stay (Table 1), although other comorbidities
were comparable. Both the HASBLED and the ATRIA
scores predicted in-hospital ICH risk (p < 0.001 for
both), (receiver-operating characteristic: 0.57 [95%
condence interval: 0.55 to 0.59] and 0.53 [95%
condence interval: 0.51 to 0.55], respectively), but
cannot be considered adequate for risk prediction,
even if statistically signicant. There was no signif-
icant difference in discrimination between the
scores.
Currently available bleeding scores are only
able to moderately predict the risk of ICH after
thrombolytic agent use in PE, thus identifying an
urgent need for more precise risk prediction tools,
acknowledging limitations of using an administrative
dataset, and dichotomizing predictor variables for
deriving the same.
*Saurav Chatterjee, MD
Gregory Y.H. Lip, MD
Jay Giri, MD, MPH
*Cardiovascular Medicine
Mount Sinai St. Lukes-Roosevelt Hospitals
1111 Amsterdam Avenue
New York, New York 10025
E-mail: sauravchatterjeemd@gmail.com
http://dx.doi.org/10.1016/j.jacc.2016.03.577
Please note: Dr. Chatterjee had full access to all the data in the study and takes
responsibility for the integrity of the data and the accuracy of the data analysis.
Dr. Lip is a consultant for Bayer/Jensen J&J, Astellas, Merck, Sano, BMS/Pzer,
Biotronik, Medtronic, Portola, Boehringer Ingelheim, Microlife, and Daiichi-
Sankyo; and is a speaker for Bayer, BMS/Pzer, Medtronic, Boehringer Ingel-
heim, Microlife, Roche, and Daiichi-Sankyo. Dr. Giri has reported that he has no
relationships relevant to the contents of this paper to disclose. P.K. Shah, MD,
served as Guest Editor for this paper.
REFERENCES
1. Chatterjee S, Chakraborty A, Weinberg I, et al. Thrombolysis for pulmonary
embolism and risk of all-cause mortality, major bleeding, and intracranial
hemorrhage: a meta-analysis. JAMA 2014;311:241421.
2. Healthcare Cost and Utilization Project (HCUP). HCUP Databases. July
2008. Rockville, MD: Agency for Healthcare Research and Quality; 2008.
Available at: http://www.hcup-us.ahrq.gov/nisoverview.jsp. Accessed
September 1, 2015.
3. Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for
use with ICD-9-CM administrative databases. J Clin Epidemiol 1992;45:
6139.
4. Pisters R, Lane DA, Nieuwlaat R, et al. A novel user-friendly score (HAS-
BLED) to assess one-year risk of major bleeding in atrial brillation patients:
the Euro Heart Survey. Chest 2010;138:1093100.
5. Fang MC, Go AS, Chang Y, et al. A new risk scheme to predict
warfarin-associated hemorrhage: the ATRIA (Anticoagulation and
Risk Factors in Atrial Fibrillation) study. J Am Coll Cardiol 2011;58:
395401.
Letters 2905
The Contemporary Pulse of
Bioresorbable-Scaffold
Thrombosis Among
Expert Operators
Fully bioresorbable scaffolds (BRS) represent a
promising new technological frontier in percutaneous
revascularization. BRS provide scaffolding properties
and controlled release of antiproliferative agents
followed by complete resorption of the backbone. The
bioresorbable vascular scaffold (BVS) (Absorb BVS,
Abbott Vascular, Santa Clara, California) has been the
rst BRS available for clinical use.
In 2014, we performed a survey (1) seeking to
understand opinions and use of this technology. The
fear for scaffold thrombosis was one of the most
interesting ndings of the surveyrelated at least in
part to the GHOST-EU (Gauging coronary Healing
with biOresorbable Scaffolding plaTforms in EUrope)
registry ndings (2). The survey highlighted how
scientic experts (operators with scientic reputation
but <20 BVS implantations) had less condence with
BVS use in complex settings as compared with tech-
nical experts (operators with >20 BVS implantations).
Notably, technical experts expressed more concerns
for scaffold thrombosis (3).
During the last 2 years, operator experience with
BVS has increased and additional data has become
available. A comprehensive meta-analysis showed a
higher risk of denite/probable device thrombosis
with BVS compared with drug-eluting stents (DES) at
1 yearwith most events occurring during the rst
month after implantation (4). Conversely, a patient-
level meta-analysis of randomized trials including
stable patients with at least 1 year of follow-up
showed comparable efcacy and safety between BVS
and DES (5).
Against this background, we conducted a follow-
up survey of expertsdened as operators with
at least 1 publication on BVS as rst/corresponding
author, or with documented experience of $50
BVS implantations. A list of centers using BVS
was provided by the manufacturer, and a list of
scientic experts was obtained through a PubMed
search. Overall, 225 experts were identied, and an
e-mail invitation was sent in September 2015. In
case of no response, 2 additional reminders were
sent 15 and 30 days after the initial invitation.
Overall, 152 (67.6%) experts responded to the
questionnaire.