Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100584

Original Research

Long-Term Outcomes of Chronic Total Occlusion Percutaneous Coronary

Intervention Among Medicare Beneficiaries
Zaid I. Almarzooq, MBBCh, MPH a, b, Hector Tamez, MD, MPH a, Yongfei Wang, MS c, d,
Jeptha P. Curtis, MD c, d, Ajay J. Kirtane, MD, SM e, Eric A. Secemsky, MD, MSc a,
Linda R. Valsdottir, MS a, Robert W. Yeh, MD, MSc a, *
a
Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston,
Massachusetts; b Division of Cardiology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts; c Center for Outcomes Research
and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut; d Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University
School of Medicine, New Haven, Connecticut; e Columbia University Medical Center/NewYork-Presbyterian Hospital, Cardiovascular Research Foundation,
New York, New York

A B S T R A C T

Background: Chronic total occlusion (CTO) percutaneous coronary interventions (PCIs) represent 4% of all PCIs for stable angina in the United States and
have been associated with lower success and higher in-hospital event rates compared with non-CTO PCIs. We aimed to examine long-term outcomes of
CTO PCI compared with non-CTO PCI, including prespecified subgroups of high-risk non-CTO PCI (atherectomy/saphenous vein graft/unprotected left
main).
Methods: Among 551,722 patients in the National Cardiovascular Data Registry CathPCI Registry linked to Medicare (July 2009-December 2016), we
evaluated in-hospital events and long-term major adverse cardiovascular events of CTO PCIs (N ¼ 29,407) compared with non-CTO PCIs (N ¼ 522,315). We
then evaluated similar outcomes between CTO PCIs and high-risk non-CTO PCIs (N ¼ 53,662). We excluded patients with ST-elevation myocardial infarction
and non–ST-elevation myocardial infarction.
Results: Patients undergoing CTO PCI were more likely to be younger and male. CTO PCI was associated with a higher risk of in-hospital events compared
with non-CTO PCI (7.0% vs 4.2%; P <.001) and high-risk non-CTO PCI (7.0% vs 6.5%; P ¼.008). In addition, CTO PCI was associated with a slightly higher risk
of long-term repeat revascularization compared with non-CTO PCI (adjusted hazard ratio [aHR], 1.09; 95% CI, 1.05-1.13). However, compared with high-risk
non-CTO PCIs, CTO PCIs were associated with a slightly lower risk of long-term major adverse cardiovascular events (aHR, 0.87; 95% CI, 0.84-0.90) and
readmission (aHR, 0.87; 95% CI, 0.84-0.90).
Conclusions: In this study, CTO PCI was associated with higher risk of both in-hospital and out-of-hospital events but a slightly lower risk of long-term events
compared with high-risk non-CTO PCIs. These findings shed light on the complexity of various PCI procedures that can inform clinicians and patients of
expected outcomes.

Introduction PCIs represent a small proportion (~4%) of the PCIs performed for
stable angina in the United States.4
Chronic total occlusions (CTOs) are present in 14.7% to 52% of Observational studies have demonstrated angina relief, improved
patients undergoing coronary angiography depending on the under- exercise tolerance, increased left ventricular ejection fraction, and in
lying cohort.1,2 The presence of a CTO is associated with angina, some cases, improved survival associated with successful CTO PCI.5-8
decreased quality of life, and even depression.3 However, in part However, these results, particularly with regard to “hard” end points,
because of the technical challenges associated with percutaneous have not been replicated in the small number of randomized clinical
coronary intervention (PCI) of CTO lesions in addition to the lower trials conducted to date.9,10 In addition, the differences in techniques
success rate, uncertain benefit, and a higher rate of complications, CTO between CTO and non-CTO PCI, including extraplaque navigation,

Abbreviations: aHR, adjusted hazard ratio; CABG, coronary artery bypass grafting; CTO, chronic total occlusion; MACE, major adverse cardiovascular event; MI, myocardial
infarction; PCI, percutaneous coronary intervention; SVG, saphenous vein graft; ULM, unprotected left main.
Keywords: atherectomy; chronic total occlusion; left main coronary artery; outcomes; percutaneous coronary intervention; saphenous vein graft.
* Corresponding author: [email protected] (R.W. Yeh).

https://doi.org/10.1016/j.jscai.2023.100584
Received 31 July 2022; Received in revised form 27 December 2022; Accepted 2 January 2023
Available online 26 January 2023
2772-9303/© 2023 The Author(s). Published by Elsevier Inc. on behalf of the Society for Cardiovascular Angiography and Interventions Foundation. This is an open access article under
the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
2 Z.I. Almarzooq et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100584

longer total stent length, and other procedural factors, also raise (death, urgent coronary artery bypass graft surgery [CABG], stroke, or
questions about long-term outcomes and patency even after successful cardiac tamponade), MI based on biomarker assessment, intra-
CTO PCI. Thus, it is critical to understand the long-term outcomes procedure and postprocedural cardiogenic shock as defined in the
postdischarge after CTO PCI compared with non-CTO PCI. American College of Cardiology NCDR CathPCI Registry, heart failure,
In addition, although outcomes of CTO PCIs have been compared stroke (ischemic and hemorrhagic), cardiac tamponade, new require-
with non-CTO PCIs, comparative outcomes relative to high-risk non- ment for dialysis, other vascular complications requiring treatment,
CTO PCIs, such as those requiring atherectomy, unprotected left main bleeding event within 72 hours (with subtypes), and in-hospital death.
(ULM) PCI, or saphenous vein graft (SVG) PCI, have been limited. A The primary outcome was major adverse cardiovascular event
single-center study suggested that patients undergoing CTO PCI had (MACE), which was defined as the composite of death from any cause
higher procedural complications but similar long-term outcomes after discharge, repeat revascularization (any vessel), and MI. Secondary
compared with high-risk non-CTO PCIs.11 However, these findings have outcomes included the individual components of the primary com-
not been validated in a large multicenter study. posite outcome and readmission, including MI or stroke-related read-
In this study, we examined the in-hospital and long-term outcomes mission. These were identified using previously validated International
after CTO PCI in the American College of Cardiology National Car- Classification of Diseases, Ninth Revision, Clinical Modification and
diovascular Data Registry (NCDR) CathPCI Registry and compared the Procedure Coding System codes for MI, stroke, and revascularization
outcomes with other forms of high-risk non-CTO PCI procedures, such (Supplemental Table S1).13-16 Deaths were ascertained using vital status
as rotational atherectomy, ULM interventions, and SVG interventions. information in the Master Beneficiary Summary files and was complete
for all individuals. Readmission was defined as any inpatient admission
following the index PCI. Readmission related to MI or stroke was
Methods defined as the presence of an inpatient readmission with an Interna-
tional Classification of Diseases code for MI or stroke in the principal
Study population position.

All patients aged 65 years who underwent PCI between July 1,
2009 and December 31, 2016 in the American College of Cardiology Statistical analysis
NCDR CathPCI Registry were included in this study.12 Data elements
are prospectively collected from the medical record using standardized Baseline patient, procedural characteristics, and in-hospital proce-
forms and definitions (Version 4). We aimed to capture outcomes dural events were obtained from the American College of Cardiology
associated with elective PCI; as such, we excluded initial presentations NCDR CathPCI Registry and compared between patients with non-CTO
of ST segment elevation myocardial infarction (MI), non-ST segment PCI and patients with CTO PCI using independent sample t tests or
elevation MI, preprocedure cardiogenic shock, and patients who Mann–Whitney U tests for continuous variables as indicated based on
experienced cardiac arrest. Patients were categorized as CTO PCI if the data normality. Categorical variables were compared using either χ2
index lesion was categorized as 100% with thrombolysis in MI score tests or Fisher exact tests as appropriate. We used the Kaplan–Meier
0 flow and coded as CTO in the CathPCI Registry. All other patients method to estimate the cumulative incidence of the primary and sec-
were classified as non-CTO PCI. In patients with >1 PCI, the first pro- ondary outcomes and the log-rank statistic to compare the differences
cedure was considered the index procedure. Using direct patient between groups. Multivariate analyses were performed using a Cox
identifiers, patients were linked to the CathPCI registry data with proportional hazards regression model that included possible con-
administrative claims data from Centers for Medicare and Medicaid founders selected a priori and listed in Table 1, which include age, sex,
Services fee for services inpatient and outpatient claims data between race, ethnicity, presence of diabetes mellitus, chronic kidney disease,
2009 and 2017 as well as the Centers for Medicare and Medicaid Ser- hypertension, hyperlipidemia, known reduced left ventricular ejection
vices beneficiary enrollment data, which provided long-term outcomes fraction, symptoms at presentation, PCI indication, presence of prior
with at least 1 year of follow-up. stent, as well as procedure and device variables (stent length and
diameter, bare metal stent vs drug-eluting stent, calcification, bifurca-
tion involvement, intra-aortic balloon pump use). To account for the
Covariates and outcomes competing risk of death when assessing the individual nonfatal com-
ponents of the primary composite outcome, we used the method
The primary exposure of interest was CTO PCI vs non-CTO PCI. described by Fine and Gray17 to estimate the subdistribution hazard
Covariates of interest in the study included demographic characteristics ratio of CTO vs non-CTO PCI for these events. A P value of 0.05 is
(including age, sex, and race/ethnicity), prior medical history (including considered statistically significant without adjustment for multiplicity.
diabetes mellitus, hypertension, current dialysis, dyslipidemia, prior MI, In order to put the results within a more clinically relevant context,
prior cerebrovascular disease, prior peripheral arterial disease, prior we performed the same analyses in prespecified subgroups comparing
heart failure, prior valve surgery/procedure, and prior revascularization), CTO PCI long-term outcomes with patients undergoing PCI of other
and procedural and lesion characteristics (including symptoms at pre- high-risk lesions (atherectomy use in PCI, ULM PCI, and SVG PCI).
sentation, cardiogenic shock at the start of the procedure [this is Statistical analyses were performed using SAS software version 9.4 (SAS
collected separately in the American College of Cardiology NCDR Institute). The institutional review board of the Beth Israel Deaconess
CathPCI Registry from intraprocedural and postprocedural cardiogenic Medical Center exempted this study from review.
shock], PCI indication, coronary anatomy, bifurcation lesion, lesion in a
graft, lesion calcification, CTO, stent type, total stent length, minimum
stent diameter, highest lesion location [using the following order: left Results
main (highest), proximal left anterior descending artery, proximal right
coronary artery, medial left anterior descending artery, and proximal Baseline characteristics
circumflex artery], and use of intra-aortic balloon pump).
We evaluated in-hospital procedural events, including procedural Of the 1,990,847 patients aged 64 years who underwent PCI be-
success rate defined as <50% angiographic stenosis with thrombolysis tween July 1, 2009 and December 31, 2016, 551,722 (27.7%) were
in MI flow grade 3 following the procedure without any major events included in the cohort (Figure 1). The main reasons for exclusion were:
 Z.I. Almarzooq et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100584 3

Table 1. Baseline characteristics of patients undergoing percutaneous coronary intervention.

CTO PCI Non-CTO PCI P Standardized differences

N 29,407 522,315
Demographics
Age, y, mean  SD 73.7  6.5 74.5  6.6 <.001 11.85
>70 y 18,244 (62.0%) 348,084 (66.6%) <.001 9.75
Female 8954 (30.5%) 192,570 (36.9%) <.001 13.34
Race/ethnicity <.001 .
White 26,781 (91.1%) 478,035 (91.5%) 1.62
Black 1447 (4.9%) 27,565 (5.3%) 1.60
Other 1179 (4.0%) 16,715 (3.2%) 4.57
Comorbidities
BMI, kg/m2, mean  SD 29.3  5.9 29.2  5.9 .223 0.73
Prior MI 9856 (33.5%) 144,128 (27.6%) <.001 13.21
Prior heart failure 4843 (16.5%) 82,683 (15.8%) .004 1.75
Cerebrovascular disease 4538 (15.4%) 88,266 (16.9%) <.001 3.92
Peripheral arterial disease 4675 (15.9%) 86,011 (16.5%) .010 1.54
Prior valve surgery/procedure 591 (2.0%) 12,030 (2.3%) .001 1.96
Prior revascularization
Prior PCI 11,856 (40.3%) 209,294 (40.1%) .401 0.50
Prior CABG 7331 (24.9%) 123,780 (23.7%) <.001 2.89
Family history of premature CAD 5640 (19.2%) 104,705 (20.1%) <.001 2.17
Diabetes mellitus 10,779 (36.7%) 192,869 (36.9%) .348 0.56
IDDM 3728 (12.7%) 66,850 (12.8%) .636 0.36
Hypertension 25,565 (86.9%) 464,537 (88.9%) <.001 6.36
Dyslipidemia 24,962 (84.9%) 444,730 (85.2%) .220 0.73
Current use of tobacco 3600 (12.2%) 59,586 (11.4%) <.001 2.62
GFR, mean  SD 70.1  27.3 70.8  28.9 <.001 2.48
Currently on dialysis 585 (2.0%) 11,406 (2.2%) .026 1.33
Chronic lung disease 4671 (15.9%) 93,107 (17.8%) <.001 5.09
Cath laboratory visit
CAD presentation <.001
No symptom, no angina 3025 (10.3%) 53,390 (10.2%) 0.20
Symptom unlikely to be ischemic 1290 (4.4%) 24,844 (4.8%) 1.74
Stable angina 7887 (26.8%) 126,217 (24.2%) 6.19
Unstable angina 17,196 (58.5%) 317,687 (60.8%) 4.81
Anginal classification within 2 wk <.001
No symptoms 3836 (13.0%) 67,338 (12.9%) 0.45
CCS I 1610 (5.5%) 31,408 (6.0%) 2.27
CCS II 6570 (22.3%) 116,259 (22.3%) 0.20
CCS III 12,624 (42.9%) 226,017 (43.3%) 0.69
CCS IV 4689 (16.0%) 79,970 (15.3%) 1.76
NYHA class within 2 wk <.001
Class I 364 (1.2%) 6386 (1.2%) 3.42
Class II 1118 (3.8%) 19,272 (3.7%) 0.14
Class III 1646 (5.6%) 25,633 (4.9%) 0.59
Class IV 696 (2.4%) 10,840 (2.1%) 3.18
Antianginal medications within 2 wk 22,534 (76.6%) 398,059 (76.2%) .101 2.04
Heart failure within 2 wk 3833 (13.0%) 62,321 (11.9%) <.001 3.39
Cardiomyopathy or left ventricular systolic dysfunction 4612 (15.7%) 63,093 (12.1%) <.001 10.99
IABP 400 (1.4%) 2317 (0.4%) <.001 13.10
Diagnostic cath procedure
Diagnostic cath status <.001
Elective 16,314 (55.5%) 302,849 (58.0%) 5.07
Urgent 8012 (27.3%) 149,879 (28.7%) 3.21
Emergency 763 (2.6%) 3798 (0.7%) 20.65
Salvage 6 (<0.1%) 26 (<0.1%) -2.03
Coronary anatomy
Left main 1692 (5.8%) 32,528 (6.2%) <.001 1.40
LAD 16,929 (57.6%) 295,215 (56.5%) <.001 5.05
Circ 13,695 (46.6%) 212,178 (40.6%) <.001 14.51
RCA 17,880 (60.8%) 262,284 (50.2%) <.001 22.78
PCI procedure
PCI status <.001
Elective 18,356 (62.4%) 326,596 (62.5%) 0.22
Urgent 10,114 (34.4%) 191,420 (36.7%) 4.68
Emergency 895 (3.0%) 4021 (0.8%) 24.23
Salvage 22 (<0.1%) 88 (<0.1%) 4.11
Pre-PCI left ventricular ejection fraction, %, mean  SD 51.1  13.0 54.4  12.2 <.001 23.33
Cardiogenic shock at start of the procedure 193 (0.7%) 1822 (0.4%) <.001 5.10
PCI indication <.001
PCI for unstable angina 14,903 (50.7%) 270,838 (51.9%) 2.35
Staged PCI 1785 (6.1%) 26,335 (5.0%) 4.67
PCI for stable CAD 12,713 (43.2%) 224,929 (43.1%) 0.34
(continued on next page)
4 Z.I. Almarzooq et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100584

Table 1. (continued )

CTO PCI Non-CTO PCI P Standardized differences

High-risk PCI groups 3053 (10.4%) 54,413 (10.4%) -

Atherectomy 778 (2.7%) 11,612 (2.2%) <.001 5.93
ULM PCI 251 (0.9%) 4833 (0.9%) .210 0.75
SVG PCI 2024 (6.9%) 37,968 (7.3%) .013 1.49
High-risk lesion (SCAI lesion class) <.001
Class I 0 (0%) 258,668 (49.5%) 101.80
Class II 0 (0%) 263,647 (50.5%) 103.76
Class III 6745 (22.9%) 0 (0%) 236.31
Class IV 22,662 (77.1%) 0 (0%) 793.95
Highest lesion location <.001
pRCA/mLAD/pCIRC 11,465 (39.0%) 210,528 (40.3%) 2.69
pLAD 12,540 (42.6%) 202,766 (38.8%) 7.84
Left main 4458 (15.2%) 90,654 (17.4%) 5.82
Other 863 (2.9%) 16,867 (3.2%) 1.67
Access site .0032
Radial 4688 (15.9%) 87,826 (16.8%) 2.34
Femoral 24,615 (83.7%) 432,527 (82.8%) 2.38
Brachial 81 (0.3%) 1559 (0.3%) 0.42
Discharge location
Home 27,847 (94.7%) 503,435 (96.4%) <.001 8.95
Extended care/TCU/rehabilitation 680 (2.3%) 9264 (1.8%) 4.05
Other acute care hospital 160 (0.5%) 1415 (0.3%) 5.12
Nursing home 330 (1.1%) 4923 (0.9%) 1.85
Hospice 43 (0.2%) 471 (0.1%) 1.84
Other 31 (0.1%) 470 (0.1%) 0.51
Left against medical advice 27 (0.1%) 381 (0.1%) 0.69
Follow-up, d, mean  SD 1478  796.7 1546  787.1 <.001 8.7
Follow-up, d, median [IQR] 1533 [1411] 1634 [1367] <.001 8.7

Values are n (%) unless otherwise specified.

BMI, body mass index; CABG, coronary bypass grafting; CAD, coronary artery disease; CTO, chronic total occlusion; GFR, glomerular filtration rate; IDDM, insulin
dependent diabetes mellitus; IQR, interquartile range; LAD, left anterior descending artery; MI, acute myocardial infarction; mLAD, medial left anterior descending
artery; PCI, percutaneous coronary intervention; pCIRC, proximal circumflex; pLAD, proximal left anterior descending artery; pRCA, proximal right coronary artery; RCA,
right coronary artery; SD, standard deviation; SVG, saphenous vein graft; TCU, transitional care unit; ULM, unprotected left main.

38.1% had ST-elevation MI or non–ST-elevation MI on hospital pre- ventricular dysfunction (15.7% vs 12.1%; P < .001) as compared with
sentation, 0.4% had preprocedure cardiogenic shock or cardiac arrest patients undergoing non-CTO PCI (Table 1). On the other hand, patients
within 24 hours, and 33.8% were unable to be linked to Medicare. There with non-CTO PCI were more likely to have a history of cerebrovascular
were no clinically significant differences between successfully linked disease, peripheral arterial disease, chronic lung disease, and hyper-
patients and those unable to be linked (Supplemental Table S2). tension. Similar findings were noted with additional differences in
Among the 551,722 patients included in the study, 5.3% (n ¼ 29,407) baseline characteristics among patients undergoing high-risk non-CTO
underwent CTO PCI and 9.7% (n ¼ 53,662) underwent high-risk non- PCI and its subgroups (Supplemental Tables S3-S6).
CTO PCI, of which 21.6% (n ¼ 11,612) included atherectomy, 9.0% (n ¼
4833) included ULM PCI, and 70.8% (n ¼ 37,968) included SVG PCI.
Patients undergoing CTO PCI were younger, more often male, and more Procedural characteristics
likely to have a history of prior MI or prior CABG. Furthermore, patients
who underwent CTO PCI presented more often with stable angina There were several differences in procedural characteristics be-
(26.8% vs 24.2%; P <.001) and more often had a cardiomyopathy or left tween the 2 groups. Patients undergoing CTO PCI were more likely to

Figure 1.
Exclusion cascade for analytic sample in the study. We included patients aged 64 years that underwent PCI from the NCDR CathPCI and were successfully linked to claims for the
years July 2009 to December 2016. We excluded patients with STEMI or NSTEMI, preprocedure cardiogenic shock or cardiac arrest within 24 hours of PCI. NCDR, National Car-
diovascular Data Registry; NSTEMI, non-ST-elevation myocardial infarction; PCI, percutaneous coronary intervention; STEMI, ST-elevation myocardial infarction.
 Z.I. Almarzooq et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100584 5

have required an intra-aortic balloon pump (1.4% vs 0.4%; P < .001), (75.6% vs 80.0%; P < .001), it was also associated with lower in-hospital
more likely to have an emergency diagnostic catheterization (2.6% vs event rates (6.6% vs 10.5%; P < .001), driven by intraprocedural and
0.7%; P <.001), and more likely to have staged PCI. The most common postprocedural cardiogenic shock (1.0% vs 2.5%; P < .001), peri-
discharge location in both groups was home. Similar findings were procedural MI (3.2% vs 5.3%; P < .001), and bleeding within 72 hours
noted with additional differences in procedural characteristics among (2.1% vs 3.0%; P < .001) (Supplemental Table S8).
patients undergoing high-risk non-CTO PCI and its subgroups
(Supplemental Tables S3-S6).
Long-term outcomes of CTO PCI vs non-CTO PCI

After a median follow-up time of 1629 days (IQR, 1371), 48.8% of

Procedural events
the entire cohort experienced the primary MACE outcome and 28.6%
died (0.4% of deaths were in-hospital) (Table 3, Figure 2A-D). Patients
Procedural success rates were significantly lower among patients
undergoing CTO PCI were slightly more likely to experience the com-
undergoing CTO PCI compared with non-CTO PCI (76.0% vs 96.1%; P
posite outcome (49.9% vs 48.8%; P < .001), driven by repeat revascu-
< .001). Following the procedure, patients undergoing CTO PCI were
larization (24.4% vs 22.3%; P < .001). However, they were less likely to
more likely to have an in-hospital event (7.0% vs 4.2%; P <.001), driven
experience death postdischarge (27.8% vs 28.6%; P ¼ .004) and all-
by periprocedural MI based on biomarker assessment (3.4% vs 1.9%; P
cause readmission (64.0% vs 68.5%; P < .001).
< .001), bleeding within 72 hours (2.2% vs 1.3%; P < .001), intra-
After multivariable adjustment, CTO PCI was associated with no
procedural and postprocedural cardiogenic shock (1.2% vs 0.3 %; P <
significant difference in the primary MACE outcome (adjusted HR [aHR],
.001), and in-hospital death (1.0% vs 0.4%; P < .001) (Table 2). There
1.02; 95% CI, 0.99-1.15) but lower risk of death post discharge (aHR,
were also small increases in procedure-related heart failure, stroke,
0.95; 95% CI, 0.91-0.98) and all-cause readmission (aHR, 0.91; 95% CI,
tamponade, new dialysis, and other vascular complications requiring
0.89-0.94), with a higher risk of repeat revascularization (aHR 1.09; 95%
treatment among patients undergoing CTO PCI.
CI, 1.05-1.13) (Table 4, Central Illustration).
Compared with high-risk non-CTO PCI, CTO PCI was associated
with a significantly lower procedural success rate (76.0% vs 95.7%; P <
.001). This was consistent across the subgroups of high-risk non-CTO Long-term outcomes of CTO PCI vs high-risk non-CTO PCI
PCI (Supplemental Table S7). In addition, CTO PCI was associated with subgroups
a slightly higher risk of in-hospital events (7.0% vs 6.5%; P ¼ .008),
driven by intraprocedural and postprocedural cardiogenic shock (1.2% Compared with high-risk non-CTO PCI, CTO PCI was associated with
vs 0.8%; P < .001), cardiac tamponade (0.4% vs 0.2%; P < .001), and a lower risk of the primary MACE outcome (49.9% vs 63.9%; P < .001),
bleeding within 72 hours (2.2% vs 1.9%; P ¼.032). However, among the driven by death postdischarge (27.8% vs 39.2%; P < .001) and repeat
subgroups of high-risk non-CTO PCI, CTO PCI was associated with a revascularization (24.4% vs 31.1%; P < .001) (Table 3). In addition, CTO
lower risk of in-hospital events compared with non-CTO atherectomy PCI was associated with a lower risk of all-cause readmission (64.0% vs
PCI (7.0% vs 9.1%: P <.001) and non-CTO ULM PCI (7.0% vs 12.5%; P < 75.0%; P <.001), including readmission for MI (8.0% vs 15.1%; P <.001)
.001) but higher risk compared with non-CTO SVG PCI (7.0% vs 5.1%; P or stroke (5.8% vs 7.2%; P < .001). These findings were consistent in
< .001). These were primarily driven by differences in the incidence of nearly all individual subgroups of high-risk non-CTO PCI (Table 3).
periprocedural MI, intraprocedural and postprocedural cardiogenic In multivariable models comparing CTO PCI with high-risk non-CTO
shock, and bleeding within 72 hours (Supplemental Table S7). PCI (Table 4, Central Illustration), CTO PCI was associated with a
Although CTO PCI without atherectomy, ULM, and/or SVG inter- significantly lower risk of the primary MACE outcome (aHR, 0.87; 95%
vention was associated with a significantly lower procedural success CI, 0.84-0.90), death postdischarge (aHR, 0.86; 95% CI, 0.81-0.91),
rate than CTO PCI with atherectomy, ULM, and/or SVG intervention repeat revascularization (aHR, 0.89; 95% CI, 0.84-0.94), and all-cause

Table 2. In-hospital procedure-related events of patients undergoing percutaneous coronary intervention.

Total CTO PCI Non-CTO PCI High-risk P P
non-CTO PCI CTO vs CTO vs high-risk
non-CTO PCI non-CTO PCI

N 551,722 29,407 522,315 53,662 - -

Procedural success 524,357 (95.0%) 22,362 (76.0%) 501,995 (96.1%) 51,372 (95.7%) <.001 <.001
Any event 23,768 (4.3%) 2060 (7.0%) 21,708 (4.2%) 3500 (6.5%) <.001 .008
Periprocedural MI (biomarker positive) 11,134 (2.0%) 995 (3.4%) 10,139 (1.9%) 1731 (3.2%) <.001 .222
Intraprocedural and postprocedural cardiogenic shock 2055 (0.4%) 344 (1.2%) 1711 (0.3%) 440 (0.8%) <.001 <.001
Heart failure 2728 (0.5%) 246 (0.8%) 2482 (0.5%) 461 (0.9%) <.001 .735
Stroke 878 (0.2%) 74 (0.3%) 804 (0.2%) 121 (0.2%) <.001 .456
Hemorrhagic stroke 117 (<0.1%) 9 (<0.1%) 108 (<0.1%) 13 (<0.1%) .255 .589
Tamponade 576 (0.1%) 130 (0.4%) 446 (0.1%) 104 (0.2%) <.001 <.001
New requirement for dialysis 675 (0.1%) 54 (0.2%) 621 (0.1%) 122 (0.2%) .002 .190
Other vascular events requiring treatment 2349 (0.4%) 155 (0.5%) 2194 (0.4%) 311 (0.6%) .006 .333
Bleeding event within 72 h 7559 (1.4%) 635 (2.2%) 6924 (1.3%) 1041 (1.9%) <.001 .032
Bleeding at access site 2623 (0.5%) 245 (0.8%) 2378 (0.5%) 366 (0.7%) <.001 .015
Hematoma at access site 3666 (0.7%) 245 (0.8 %) 3421 (0.7%) 437 (0.8%) <.001 .774
Retroperitoneal bleeding 747 (0.1%) 47 (0.2%) 700 (0.1%) 82 (0.2%) .242 .806
Gastrointestinal bleeding 880 (0.2%) 63 (0.2%) 817 (0.2%) 126 (0.2%) .016 .552
Genital-urinary bleeding 255 (0.1%) 15 (0.1%) 240 (0.1%) 37 (0.1%) .695 .323
Other bleeding 1266 (0.2%) 169 (0.6%) 1097 (0.2%) 211 (0.4%) <.001 <.001
In-hospital death 2138 (0.4%) 286 (1.0%) 1852 (0.4%) 432 (0.8%) <.001 .013

CTO, chronic total occlusion; MI, myocardial infarction; PCI, percutaneous coronary intervention.
6 Z.I. Almarzooq et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100584

Table 3. Long-term outcomes of patients undergoing percutaneous coronary intervention.

Total CTO PCI Non-CTO PCI P

CTO PCI vs non-CTO PCI

N 551,722 29,407 522,315
MACE 269,308 (48.8%) 14,671 (49.9%) 254,637 (48.8%) <.001
Death postdischarge 157,494 (28.6%) 8,180 (27.8%) 149,314 (28.6%) .004
Readmission (all-cause) 376,582 (68.3%) 18,832 (64.0%) 357,750 (68.5%) <.001
Readmission for AMI 44,811 (8.1%) 2346 (8.0%) 42,465 (8.1%) <.001
Readmission for stroke 33,635 (6.1%) 1700 (5.8%) 31,935 (6.1%) <.001
Repeat pevascularization 123,492 (22.4%) 7163 (24.4%) 116,329 (22.3%) <.001
CTO PCI vs high-risk non-CTO PCI
N 83,069 29,407 53,662
MACE 48,968 (59.0%) 14,671 (49.9%) 34,297 (63.9%) <.001
Death postdischarge 29,197 (35.2%) 8180 (27.8%) 21,017 (39.2%) <.001
Readmission 59,082 (71.1%) 18,832 (64.0%) 40,250 (75.0%) <.001
Readmission for MI 10,454 (12.6%) 2346 (7.8%) 8108 (15.1%) <.001
Readmission for stroke 5565 (6.7%) 1700 (5.8%) 3865 (7.2%) <.001
Repeat revascularization 23,849 (28.7%) 7163 (24.4%) 16,686 (31.1%) <.001
CTO PCI vs non-CTO atherectomy PCI
N 41,019 29,407 11,612
MACE 20,951 (51.1%) 14,671 (49.9%) 6280 (54.1%) <.001
Death postdischarge 12,100 (29.5%) 8180 (27.8%) 3920 (33.8%) <.001
Readmission 26,823 (65.4%) 18,832 (64.0%) 7991 (68.8%) <.001
Readmission for MI 3340 (8.1%) 2346 (8.0%) 994 (8.6%) <.001
Readmission for stroke 2347 (5.7%) 1700 (5.8%) 647 (5.6%) <.001
Repeat revascularization 9915 (24.1%) 7163 (24.4%) 12,752 (23.7%) .161
CTO PCI vs non-CTO unprotected left main PCI
N 34,240 29,407 4833
MACE 17,667 (51.6%) 14,671 (49.9%) 2996 (62.0%) <.001
Death postdischarge 10,429 (30.5%) 8180 (27.8%) 2249 (46.5%) <.001
Readmission 22,375 (63.4%) 18,832 (64.0%) 3543 (73.3%) <.001
Readmission for MI 2811 (8.2%) 2346 (8.0%) 465 (9.6%) <.001
Readmission for stroke 1980 (5.8%) 1700 (5.8%) 280 (5.8%) <.001
Repeat revascularization 8119 (23.7%) 7163 (24.4%) 956 (19.8%) <.001
CTO PCI vs non-CTO saphenous vein graft PCI
N 67,375 29,407 37,968
MACE 40,188 (59.7%) 14,671 (49.9%) 25,517 (67.2%) <.001
Death postdischarge 23,382 (34.7%) 8180 (27.8%) 15,202 (40.0%) <.001
Readmission 48,099 (71.4%) 18,832 (64.0%) 29,267 (77.1%) <.001
Readmission for MI 9103 (13.5%) 2346 (8.0%) 6757 (17.8%) <.001
Readmission for stroke 4678 (6.9%) 1700 (5.8%) 2978 (7.8%) <.001
Repeat revascularization 20,343 (30.2%) 7163 (24.4%) 13,180 (34.7%) <.001

MACE was defined as death, MI, or repeat revascularization.

AMI, acute myocardial infarction; CTO, chronic total occlusion; MACE, major adverse cardiovascular event; MI, myocardial infarction; PCI, percutaneous coronary
intervention.

readmission (aHR, 0.87; 95% CI, 0.84-0.90), including readmission for repeat revascularization. The finding of lower risk of MACE and read-
MI (aHR, 0.86; 95% CI, 0.79-0.94) but no significant difference in mission persisted among all high-risk non-CTO PCI subgroups (athe-
readmission for stroke (aHR, 1.10; 95% CI, 0.98-1.24). These findings rectomy, ULM intervention, and SVG intervention). These findings
were consistent in nearly all individual subgroups of high-risk non-CTO highlight the comparative in-hospital and long-term outcomes of CTO
PCI (Table 4, Central Illustration). PCI relative to non-CTO PCI specifically among high-risk non-CTO PCI
procedures, which will inform both clinicians and patients. In addition,
the study highlights an important subgroup of non-CTO PCIs that,
Discussion similar to CTO PCI, may require special consideration to ensure optimal
outcomes.
In this large national cohort of patients undergoing PCI, we found This study builds on prior work evaluating the outcomes of CTO PCI.
that patients undergoing CTO PCI experienced lower procedural suc- In a prior analysis of the NCDR CathPCI Registry from 2009 to 2013,
cess rates and higher adverse events during the index hospitalization. CTO PCIs accounted for 3.8% of all PCIs for stable coronary artery
These differences were driven by periprocedural MI based on disease and were associated with a higher risk of in-hospital MACEs
biomarker assessment, bleeding within 72 hours of the procedure, and (1.6% vs 0.8%; P < .001).4 Procedural success was noted to be 58.5%
intraprocedural and postprocedural cardiogenic shock. However, these but was significantly higher (74.6% vs 53.1%) among operators with
differences were less evident when comparing CTO PCI with high-risk higher procedural volume (>10 CTO PCIs per year) compared with
non-CTO PCI and varied across the subgroups of high-risk non-CTO those with low volumes (<5). In addition, several predictors of lower
PCI. In addition, CTO PCI was associated with a similar long-term risk of success were identified: older age, current smoking, prior MI, prior
the primary MACE outcome compared with non-CTO PCI. Despite CABG, prior peripheral artery disease, prior cardiac arrest, and right
being associated with a slightly lower risk of death postdischarge and coronary artery CTO target vessel. In this updated analysis of the same
all-cause readmission, CTO PCI was associated with a slightly higher risk registry, we observed a higher procedural success rate using the same
of repeat revascularization. However, when compared with high-risk definition. This likely reflects advances in technique and experience as
non-CTO PCI, CTO PCI was associated with a lower risk of the pri- we report on a more contemporary CTO cohort than was previously
mary MACE outcome, death postdischarge, all-cause readmission, and described. We similarly observed that patients undergoing CTO PCI (as
 Z.I. Almarzooq et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100584 7

Figure 2.
Long-term outcomes of patient undergoing percutaneous coronary intervention. (A) Death from discharge. (B) Death from procedure. (C) Readmission. (D) Revascularization.
Cumulative outcomes of patients undergoing PCI, including MACE, death following discharge, readmission, and revascularization. CTO, chronic total occlusion; MACE, major adverse
cardiovascular events; PCI, percutaneous coronary intervention.

compared with patients undergoing non-CTO PCI) were more likely to cohort size, single-center design, shorter follow-up, and failure to adjust
develop periprocedural events, mainly periprocedural MI and bleeding for competing risk of death. In addition, procedures, such as atherec-
requiring transfusion. Because these are unadjusted outcomes, they tomy PCI, ULM PCI, and SVG PCI, may carry their own risk regardless of
likely reflect differences in patient complexity and comorbidities. CTO PCI status. Since these were included in the CTO cohort, future
However, our study also shows that these differences were less evident studies should evaluate the outcomes of CTO PCIs with and without
when comparing CTO PCI with high-risk non-CTO PCI. In addition, these high-risk procedures to better understand the role they play in
among the various subgroups of high-risk non-CTO PCI, CTO PCI was procedural risk of CTO PCIs.
associated with a lower risk of procedural events compared with The observations reported in our study shed light on an important
non-CTO ULM PCI and non-CTO atherectomy PCI, but a higher risk comparison between CTO PCIs and high-risk non-CTO PCIs, emphasizing
compared with non-CTO SVG PCI. These differences in event rates that CTO PCIs are only one type of high-risk PCI and that there are likely
reflect the risks associated with these procedures and the varied profiles other types of high-risk interventions that may benefit from similar careful
of patients undergoing them. Overall, our study builds on the findings procedural considerations. Currently, some training programs and hos-
of the prior analysis by providing longer follow-up to assess the out- pital systems provide special considerations for CTO PCI, including an
comes of CTO PCI relative to non-CTO PCI, inclusion of a broader additional of year training, specialized operators, and additional resources
definition for revascularization (PCI and CABG vs urgent CABG only) for the care of those patients. These considerations are not necessarily
and providing additional insights into various high-risk subgroups, such considered with all high-risk non-CTO PCIs, which may explain some of
as those requiring atherectomy, ULM PCI, or SVG PCI. the differences in outcomes observed in our study. The findings of rela-
The findings comparing CTO PCI with high-risk non-CTO PCI tively higher event rates associated with high-risk non-CTO PCI compared
highlight the complex nature of certain non-CTO PCI procedures. with CTO PCI emphasizes the need for careful consideration to improve
These findings, however, differ from a prior single-center study of 2396 the outcomes of these procedures. These could include measures already
patients undergoing PCI; 609 undergoing CTO PCI and 1787 under- being applied to CTO PCI with careful training considerations, specialized
going high-risk non-CTO PCI that included atherectomy, SVG PCI, and operators, and added resources for the care of these patients.
ULM PCI. Similar to our study, the authors noted that patients under-
going CTO PCI had higher incidence of procedural events and lower
success rate (74% vs 98%, P < .001). However, we show that these re- Limitations
lationships differ when looking at the various subgroups of high-risk
non-CTO PCI with both non-CTO ULM PCI and non-CTO atherec- There are several strengths to this study. First, it includes a large
tomy PCI having a higher associated risk of in-hospital events compared multicenter national cohort undergoing PCI. Second, to our knowledge,
with CTO PCIs. On the other hand, unlike in our study, the authors it is the first multicenter study providing long-term follow-up on CTO
showed no difference in long-term risk of MACEs. Several factors may PCI outcomes compared with high-risk non-CTO PCI. Third, our analysis
have contributed to the differences in results, including the difference in takes into consideration the competing risk of death. Finally, the study
8 Z.I. Almarzooq et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100584

Table 4. Long-term outcomes of patients undergoing percutaneous coronary intervention adjusted for competing risk of death (censored at 6 years).
Unadjusted HR 95% CI P Adjusted HRa 95% CI P

CTO PCI vs non-CTO PCI

MACE 1.08 1.06-1.10 <.001 1.02 0.99-1.05 .211
Death postdischarge 0.99 0.97-1.02 .507 0.95 0.91-0.98 .005
Readmission 0.91 0.89-0.92 .000 0.91 0.89-0.94 <.001
Readmission for MI 0.98 0.94-1.02 .359 1.03 0.96-1.10 .416
Readmission for Stroke 0.95 0.90-1.00 .048 1.00 0.93-1.09 .916
Repeat revascularization 1.14 1.11-1.17 <.001 1.09 1.05-1.13 <.001
CTO PCI vs high-risk non-CTO PCI
MACE 0.70 0.69-0.72 <.001 0.87 0.84-0.90 <.001
Death postdischarge 0.66 0.64-0.68 <.001 0.86 0.81-0.91 <.001
Readmission 0.75 0.74-0.76 <.001 0.87 0.84-0.90 <.001
Readmission for MI 0.50 0.48-0.52 <.001 0.86 0.79-0.94 .001
Readmission for stroke 1.11 1.05-1.18 <.001 1.10 0.98-1.24 .096
Repeat revascularization 0.77 0.74-0.79 <.001 0.89 0.84-0.94 <.001
CTO PCI vs non-CTO atherectomy PCI
MACE 0.87 0.84-0.89 <.001 0.91 0.85-0.98 .014
Death postdischarge 0.76 0.73-0.79 <.001 0.91 0.82-1.01 .063
Readmission 0.84 0.82-0.87 <.001 0.88 0.83-0.94 <.001
Readmission for MI 0.89 0.83-0.97 .004 0.90 0.76-1.08 .274
Readmission for stroke 1.24 1.13-1.36 <.001 1.21 0.96-1.51 .102
Repeat revascularization 1.02 0.98-1.07 .362 0.91 0.82-1.02 .101
CTO PCI vs non-CTO unprotected left main PCI
MACE 0.70 0.67-0.72 <.001 0.82 0.72-0.93 .003
Death postdischarge 0.48 0.46-0.50 <.001 0.80 0.67-0.96 .017
Readmission 0.72 0.70-0.75 <.001 0.76 0.67-0.86 <.001
Readmission for MI 0.78 0.70-0.86 <.001 0.82 0.59-1.15 .259
Readmission for Stroke 1.66 1.46-1.89 <.001 1.18 0.76-1.83 .462
Repeat revascularization 1.25 1.17-1.34 <.001 0.81 0.65-1.01 .060
CTO PCI vs non-CTO SVG PCI
MACE 0.66 0.64-0.67 <.001 0.88 0.84-0.92 <.001
Death postdischarge 0.66 0.64-0.67 <.001 0.88 0.82-0.94 <.001
Readmission 0.72 0.71-0.74 <.001 0.88 0.85-0.92 <.001
Readmission for MI 0.42 0.40-0.44 <.001 0.87 0.79-0.97 .009
Readmission for Stroke 1.05 0.98-1.11 .160 1.06 0.92-1.22 .450
Repeat revascularization 0.68 0.66-0.70 <.001 0.86 0.80-0.92 <.001

MACE was defined as death, MI, or repeat revascularization

HR, hazard ratio; MACE, major adverse cardiovascular events; MI, myocardial infarction; PCI, percutaneous coronary intervention; SVG, saphenous vein graft.
a
Adjusted for patient and procedural characteristics listed in Table 1.

uses a more clinically relevant reference in those undergoing PCI with participating in the registry with no core laboratory to evaluate the
high-risk non-CTO PCI, including atherectomy, ULM PCI, and SVG PCI. angiograms, and therefore, there is the risk of misclassification bias.
However, the study also has several limitations. First, the classification of Second, despite attempting to adjust for potential confounders, the
CTO PCI was dependent on local physicians from hospitals study is observational and carries the risk of residual confounding.

Central Illustration.
Long-term outcomes of patients un-
dergoing percutaneous coronary
intervention. Primary MACE
outcome of CTO PCI compared with
non-CTO PCI, high-risk non-CTO
PCI, and the various high-risk non-
CTO subgroups. MACE was defined
as death, MI, or repeat revasculari-
zation. Model was adjusted for pa-
tient and procedural characteristics
listed in Table 1. aHR, adjusted haz-
ard ratio; CTO, chronic total occlu-
sion; MACE, major adverse
cardiovascular event; MI, myocardial
infarction; PCI, percutaneous coro-
nary intervention; SVG, saphenous
vein graft; ULM, unprotected left
main.
 Z.I. Almarzooq et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100584 9

Third, the study only included Medicare beneficiaries, and therefore, a Ethics statement
third of the NCDR population was excluded, limiting the generaliz-
ability of our findings to these patients. However, the linked and non- The institutional review board of the Beth Israel Deaconess Medical
linked (ie, excluded) participants had largely similar baseline charac- Center exempted this study from review given the use of a national
teristics (Supplemental Table S2). Fourth, although we did include the registry with no direct patient identifiers.
use of intra-aortic balloon pump, we did not have information on the
use of other forms of mechanical circulatory support during the PCI,
including the Impella device. Fifth, we included patients with cardio- Supplementary material
genic shock at the start of the procedure, which is collected in the
registry differently from intraprocedural cardiogenic shock. Although To access the supplementary material accompanying this article, visit
this occurred in <1% of the cohort, we are unable to determine if this the online version of the Journal of the Society for Cardiovascular Angi-
led to higher rates of intraprocedural cardiogenic shock because these ography & Interventions at https://doi.org/10.1016/j.jscai.2023.100584.
are collected separately in the registry. Finally, we did not include pa-
tients enrolled in Medicare Advantage plans because we are unable to References
accurately capture the outcomes of interest in that population.
1. Fefer P, Knudtson ML, Cheema AN, et al. Current perspectives on coronary chronic
total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am
Coll Cardiol. 2012;59(11):991–997.
Conclusion 2. Christofferson RD, Lehmann KG, Martin GV, Every N, Caldwell JH, Kapadia SR.
Effect of chronic total coronary occlusion on treatment strategy. Am J Cardiol.
2005;95(9):1088–1091.
In conclusion, CTO PCI was associated with an overall similar risk of 3. Bruckel JT, Jaffer FA, O’Brien C, Stone L, Pomerantsev E, Yeh RW. Angina severity,
long-term outcomes compared with non-CTO PCI but lower risk when depression, and response to percutaneous revascularization in patients with chronic
compared with high-risk non-CTO PCIs. These findings shed light on total occlusion of coronary arteries. J Invasive Cardiol. 2016;28(2):44–51.
4. Brilakis ES, Banerjee S, Karmpaliotis D, et al. Procedural outcomes of chronic total
the complexity of various PCI procedures that will inform clinicians and occlusion percutaneous coronary intervention: a report from the NCDR (National
patients on the expected outcomes. In addition, it highlights an Cardiovascular Data Registry). JACC Cardiovasc Interv. 2015;8(2):245–253.
important subgroup of non-CTO PCIs that, similar to CTO PCIs, may 5. Grantham JA, Jones PG, Cannon L, Spertus JA. Quantifying the early health status
benefits of successful chronic total occlusion recanalization: results from the
require special consideration to ensure optimal outcomes. FlowCardia’s Approach to Chronic Total Occlusion Recanalization (FACTOR) Trial.
Circ Cardiovasc Qual Outcomes. 2010;3(3):284–290.
6. Finci L, Meier B, Favre J, Righetti A, Rutishauser W. Long-term results of successful
and failed angioplasty for chronic total coronary arterial occlusion. Am J Cardiol.
Declaration of competing interest 1990;66(7):660–662.
7. Joyal D, Afilalo J, Rinfret S. Effectiveness of recanalization of chronic total occlusions: a
systematic review and meta-analysis. Am Heart J. 2010;160(1):179–187.
Zaid I. Almarzooq receives research support from the Kuwait 8. Safley DM, House JA, Marso SP, Grantham JA, Rutherford BD. Improvement in
Foundation for the Advancement of Science. Jeptha P. Curtis receives survival following successful percutaneous coronary intervention of coronary
salary support from ACC as Chief Scientific Advisor for the NCDR. Ajay chronic total occlusions: variability by target vessel. JACC Cardiovasc Interv.
2008;1(3):295–302.
J. Kirtane receives institutional funding to Columbia University and/or 9. Lee SW, Lee PH, Ahn JM, et al. Randomized trial evaluating percutaneous coronary
Cardiovascular Research Foundation from Medtronic, Boston Scientific, intervention for the treatment of chronic total occlusion. Circulation. 2019;139(14):
Abbott Vascular, Amgen, CSI, Philips, ReCor Medical, Neurotronic, 1674–1683.
10. Werner GS, Martin-Yuste V, Hildick-Smith D, et al. A randomized multicentre trial to
Biotronik, Chiesi, and Bolt Medical. In addition to research grants, compare revascularization with optimal medical therapy for the treatment of chronic
institutional funding includes fees paid to Columbia University and/or total coronary occlusions. Eur Heart J. 2018;39(26):2484–2493.
Cardiovascular Research Foundation for consulting and/or speaking 11. Azzalini L, Carlino M, Bellini B, et al. Long-term outcomes of chronic total occlusion
recanalization versus percutaneous coronary intervention for complex non-occlusive
engagements in which Ajay J. Kirtane controlled the content. Ajay J.
coronary artery disease. Am J Cardiol. 2020;125(2):182–188.
Kirtane receives consulting fees from IMDS, and travel expenses/meals 12. Masoudi FA, Ponirakis A, Yeh RW, et al. Cardiovascular care facts: a report from the
from Medtronic, Boston Scientific, Abbott Vascular, CSI, Siemens, Phi- national cardiovascular data registry: 2011. J Am Coll Cardiol. 2013;62(21):1931–1947.
lips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Robert W. 13. Faridi KF, Tamez H, Butala NM, et al. Comparability of event adjudication versus
administrative billing claims for outcome ascertainment in the DAPT study:
Yeh received research grant funding and consulting fees from Abbott findings from the EXTEND-DAPT study. Circ Cardiovasc Qual Outcomes. 2021;
Vascular, Boston Scientific, and Medtronic. Hector Tamez, Yongfei 14(1):e006589.
Wang, Eric A. Secemsky, and Linda R. Valsdottir declared no potential 14. Strom JB, Zhao Y, Faridi KF, et al. Comparison of clinical trials and administrative
claims to identify stroke among patients undergoing aortic valve replacement:
conflicts of interest with respect to the research, authorship, and/or findings from the EXTEND study. Circ Cardiovasc Interv. 2019;12(11), e008231.
publication of this article. 15. Butala NM, Strom JB, Faridi KF, et al. Validation of administrative claims to ascertain
outcomes in pivotal trials of transcatheter aortic valve replacement. JACC
Cardiovasc Interv. 2020;13(15):1777–1785.
Funding sources 16. Fishman E, Barron J, Dinh J, et al. Validation of a claims-based algorithm identifying
eligible study subjects in the ADAPTABLE pragmatic clinical trial. Contemp Clin
Trials Commun. 2018;12:154–160.
This research did not receive any specific grant from funding 17. Fine JP, Gray RJ. A proportional hazards model for the subdistribution of a
agencies in the public, commercial, or not-for-profit sectors. competing risk. J Am Stat Assoc. 1999;94(446):496–509.