Research

JAMA Cardiology | Original Investigation

Contemporary Use and Trends in Unprotected Left Main

Coronary Artery Percutaneous Coronary Intervention
in the United States
An Analysis of the National Cardiovascular Data Registry
Research to Practice Initiative
Javier A. Valle, MD, MSCS; Hector Tamez, MD, MPH; J. Dawn Abbott, MD; Issam D. Moussa, MD; John C. Messenger, MD;
Stephen W. Waldo, MD; Kevin F. Kennedy, MS; Frederick A. Masoudi, MD, MSPH; Robert W. Yeh, MD, MSc

Supplemental content
IMPORTANCE Recent data support percutaneous revascularization as an alternative to coronary
artery bypass grafting in unprotected left main (ULM) coronary lesions. However, the relevance
of these trials to current practice is unclear, as patterns and outcomes of ULM percutaneous
coronary intervention (PCI) in contemporary US clinical practice are not well studied.

OBJECTIVE To define the current practice of ULM PCI and its outcomes and compare these
with findings reported in clinical trials.

DESIGN, SETTING, AND PARTICIPANTS This cross-sectional multicenter analysis included data
collected from 1662 institutions participating in the National Cardiovascular Data Registry
(NCDR) CathPCI Registry between April 2009 and July 2016. Data were collected from
33 128 patients undergoing ULM PCI and 3 309 034 patients undergoing all other PCI.
Data were analyzed from June 2017 to May 2018.

MAIN OUTCOMES AND MEASURES Patient and procedural characteristics and their temporal
trends were compared between ULM PCI and all other PCI. In-hospital major adverse clinical
events (ie, death, myocardial infarction, stroke, and emergent coronary artery bypass
grafting) were compared using hierarchical logistic regression. Characteristics and outcomes
were also compared against clinical trial cohorts.

RESULTS Of the 3 342 162 included patients, 2 223 570 (66.5%) were male, and the mean
(SD) age was 64.2 (12.1) years. Unprotected left main PCI represented 1.0% (33 128 of
3 342 162) of all procedures, modestly increasing from 0.7% to 1.3% over time. The mean
(SD) annualized ULM PCI volume was 0.5 (1.5) procedures for operators and 3.2 (6.1)
procedures for facilities, with only 1808 of 10 971 operators (16.5%) and 892 of 1662 facilities Author Affiliations: Rocky Mountain
(53.7%) performing an average of 1 or more ULM PCI annually. After adjustment, major Veterans Affairs Medical Center,
Aurora, Colorado (Valle, Waldo);
adverse clinical events occurred more frequently with ULM PCI compared with all other PCI
University of Colorado School of
(odds ratio, 1.46; 95% CI, 1.39-1.53). Compared with clinical trial populations, patients in Medicine, Aurora (Valle, Messenger,
the CathPCI Registry were older with more comorbid conditions, and adverse events were Waldo, Masoudi); Richard and Susan
more frequent. Smith Center for Outcomes Research
in Cardiology, Beth Israel Deaconess
Medical Center, Boston,
CONCLUSIONS AND RELEVANCE Use of ULM PCI has increased over time, but overall use Massachusetts (Tamez, Yeh); Warren
remains low. These findings suggest that ULM PCI occurs infrequently in the United States Alpert Medical School, Brown
University, Providence, Rhode Island
and in an older and more comorbid population than that seen in clinical trials.
(Abbott); Robert Wood Johnson
Medical School, New Brunswick,
New Jersey (Moussa); Saint Luke’s
Health System, Kansas City, Missouri
(Kennedy).
Corresponding Author: Javier A.
Valle, MD, MSCS, Rocky Mountain
Veterans Affairs Medical Center,
1700 N Wheeling St,
JAMA Cardiol. doi:10.1001/jamacardio.2018.4376 Aurora, CO 80045
Published online January 2, 2019. (javier.valle3@va.gov).

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 Research Original Investigation Use and Trends in Unprotected Left Main Coronary Artery Percutaneous Coronary Intervention
L
eft main coronary artery stenosis has traditionally been
considered a surgical disease, with clinical practice
guidelines recommending coronary artery bypass graft-
ing (CABG) as the preferred treatment.1,2 At the same time,
revascularization via percutaneous coronary intervention (PCI)
of unprotected left main (ULM) coronary artery stenosis has
remained necessary for patients at prohibitive or high risk for
surgical intervention,3 representing a small but clinically im-
portant population.4 Subsequent data implied that with im-
provements in technology and procedural techniques, the
efficacy of PCI for left main coronary artery revascularization
may approach that seen with surgery.5-7 Accordingly, random-
ized clinical trials have been conducted to address this hy-
pothesis. While producing conflicting results, the recent pub-
lications of the Evaluation of XIENCE Versus Coronary Artery
Bypass Surgery for Effectiveness of Left Main Revasculariza-
tion (EXCEL) trial8 and the Coronary Artery Bypass Grafting
Versus Drug Eluting Stent Percutaneous Coronary Angio-
plasty in the Treatment of Unprotected Left Main Stenosis
(NOBLE) trial9 portend a possible paradigm shift in the man-
agement of obstructive left main lesions. Despite these devel-
opments, to our knowledge, there has not been an assess-
ment of the contemporary practice of ULM PCI in the United
States in nearly a decade.4,10 While the results of the EXCEL
and NOBLE trials8,9 may have significant implications for
coronary revascularization, their applicability to current prac-
tice is unclear.
Accordingly, we studied the patient and procedural char-
acteristics associated with ULM PCI in the National Cardio-
vascular Data Registry (NCDR) CathPCI Registry as well as
the clinical outcomes of patients undergoing ULM PCI com-
pared with patients undergoing PCI to other coronary seg-
ments as well as with findings reported in recent clinical
trials. Understanding current practice for ULM PCI will aid
clinicians as they seek to incorporate data from clinical trials
into their practices.
Methods
Cohort
The cohort was derived from the NCDR CathPCI Registry, which
collects data on patients undergoing PCI at more than 1600
institutions and accounts for greater than 90% of PCI-
capable hospitals in the United States.11,12 Registry data ele-
ments were prospectively defined (http://cvquality.acc.org/
ncdr-home). In the CathPCI Registry, each procedure is linked
to both the operator and the institution. Data are entered at
each institution using a standardized interface and exported
to a central repository, where they undergo regular auditing
to ensure optimal data integrity.13 Institutional review board
approval was waived for this analysis, as data were derived from
a national quality registry. Informed consent was not obtained,
as data were deidentified.
We identified all PCI procedures performed at an institu-
tion participating in the NCDR CathPCI Registry from April
2009 to July 2016 (CathPCI version 4.0 and later). Proce-
dures were excluded if patients had a history of CABG (pro-
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Key Points
Question Does management of unprotected left main coronary
artery stenoses in contemporary clinical practice reflect that
reported in clinical trials?
Findings In this analysis of National Cardiovascular Data Registry
CathPCI Registry data including 3.3 million patients, unprotected left
main percutaneous coronary intervention (PCI) represented less than
1% of all PCI in clinical practice and was characterized by low operator
and institutional volumes, older and more comorbid patients than
trial populations, and a higher frequency of adverse events.
Meaning Trials of unprotected left main PCI do not reflect
contemporary practice, although it is possible that case selection
and procedural inexperience influence the observed discrepancies;
further study is needed to determine if case selection refinement
and increasing experience may improve outcomes.
viding protection to the left main coronary artery via left-
sided bypass grafts) or if they presented for PCI with
cardiogenic shock or cardiac arrest, as these procedures and
patients would likely not be representative of most PCI in prac-
tice. Interventions to chronic total occlusion of the left main
coronary artery were excluded for similar reasons. Finally,
patients undergoing balloon angioplasty alone (ie, without
stenting) were excluded, as these cases could represent inter-
ventions to temporize patients for CABG.
Covariates of Interest
Baseline patient demographic, clinical, and procedural char-
acteristics were collected from the CathPCI Registry and com-
pared between patients undergoing ULM PCI and patients
undergoing all other PCI. Temporal trends of these character-
istics were compared in 2-year increments. Data were chosen
based on characteristics and comorbidities associated with PCI
outcomes and included age, sex, race/ethnicity, insurance
payer, tobacco use, comorbid medical conditions, and char-
acteristics of their presentation for PCI. Procedural risk for mor-
tality was estimated using the CathPCI risk model.14 Proce-
dural data included access site; use of mechanical circulatory
support (MCS), stratified into any kind of MCS, use of intra-
aortic balloon pump (IABP), or use of non-IABP MCS; timing
of MCS initiation; procedural medications, including glyco-
protein IIb/IIIa use and anticoagulant choice; and lesion and
intervention characteristics, including use of atherectomy, stent
type, and bifurcation status. Operator and facility data were
also collected from the CathPCI database. Trial data from the
EXCEL and NOBLE trials were abstracted directly from the
published reports.8,9
Outcomes
In-hospital outcomes were collected from the CathPCI Regis-
try. The primary outcome was in-hospital major adverse clini-
cal events (MACE), which was a composite of death, myocar-
dial infarction (MI), stroke, or emergent CABG. These outcomes
were also assessed individually. Emergent CABG was defined
as emergent or salvage or with an indication of PCI failure or
PCI complication. Outcomes from the EXCEL and NOBLE trials
were as published.8,9
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 Use and Trends in Unprotected Left Main Coronary Artery Percutaneous Coronary Intervention
Statistical Analysis
We compared patient, procedural, operator, and facility char-
acteristics for patients undergoing ULM PCI and all other PCI,
using t tests for continuous variables and χ2 or Fisher exact tests
for categorical variables. Similar methods were used to com-
pare characteristics of ULM PCI in the CathPCI Registry with that
characteristics in the EXCEL and NOBLE trials.8,9 Patient, pro-
cedural, operator, and facility characteristics were also com-
pared for ULM PCI over time, using 1-way analysis of variance
tests for continuous variables and χ2 or Fisher exact tests for cat-
egorical variables. Multivariable regression was used to assess
characteristics associated with adverse outcomes in patients
undergoing PCI, including left main vs all other PCI. Second-
ary analyses used hierarchical logistic regression to assess the
association of annual PCI volumes with ULM PCI outcomes by
tertiles of operator and institutional PCI volume as well as the
association of MCS use with ULM PCI outcomes by tertiles of
institutional-level use of MCS. All inferences used a type I
error rate of .05, and all P values were 2-tailed. Statistical analy-
ses were performed using R version 3.2.2 (The R Foundation).
Results
Cohort
From April 2009 to July 2016, 4 715 818 patients underwent PCI
at institutions participating in the NCDR CathPCI Registry. Of
these, 844 471 patients were excluded for a history of CABG, 94
302 for cardiogenic shock, 51 272 for cardiac arrest, 130 815 for
intervention to chronic total occlusions, and 253 426 for under-
going balloon angioplasty without stenting. The final cohort con-
sisted of 3 342 162 patients who underwent PCI, of which 33 128
(1.0%) underwent ULM PCI (eFigure 1 in the Supplement).
Demographic, Clinical, Procedural,
and Institutional Characteristics
Compared with patients undergoing all other PCI, patients un-
dergoing ULM PCI were older (mean [SD] age, 71.8 [12.4] vs 64.1
[12.1] years) and had a higher burden of medical comorbidi-
ties, including history of heart failure (27.7% [9176] vs 10.0%
[330 845]), cerebrovascular disease (21.6% [7153] vs 10.6%
[351 821]), peripheral arterial disease (21.8% [7224] vs 9.7%
[320 828]), diabetes (40.4% [13 368] vs 35.0% [1 158 940]),
chronic lung disease (24.5% [8106] vs 14.3% [472 291]), and
end-stage renal disease requiring dialysis (5.6% [1849] vs 2.3%
[74 870]) (Table 1). Compared with those undergoing all other
PCI, patients undergoing ULM PCI presented more com-
monly with unstable angina or non-ST elevation MI and with
more frequent urgent procedural status. These differences were
reflected in the NCDR CathPCI predicted risk of in-hospital mor-
tality (ULM PCI: 2.3%; all other PCI: 0.8%; P < .001).
Unprotected left main PCI was performed via femoral ac-
cess more frequently than other PCI (86.2% [28 535] vs 77.9%
[2 577 738]; P < .001) and with significantly more use of MCS
(24.7% [8169] vs 1.3% [43 928]; P < .001). Intra-aortic balloon
pump counterpulsation represented slightly greater than half
of MCS used for ULM PCI (55.6% [4538 of 8169]), while IABP
use represented most of MCS used for all other PCI (83.1%
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Original Investigation Research
[36 513 of 43 928]). Atherectomy was used more commonly in
ULM PCI (9.3% [3087] vs 1.4% [46 705]; P < .001), with most
being rotational. Drug-eluting stents were used in most inter-
ventions for both ULM PCI and all other PCI (Table 2). Of 33 128
patients undergoing ULM PCI, 24 520 left main coronary ar-
tery lesions (74.0%) were considered class C, with 14 947
lesions (45.1%) involving a bifurcation. Of these bifurcation le-
sions, 6053 (40.5%) were treated with a 2-stent strategy. Mul-
tivessel PCI was performed in 15 635 ULM interventions
(47.2%), as opposed to 727 907 (22.0%) of all other PCI
(P < .001). The mean (SD) number of stents used was 2.2 (1.3),
and the mean (SD) lesion length was 51.8 (54.7) millimeters.
Annual PCI volume was higher among ULM PCI opera-
tors (mean [SD] procedures, 128.4 [91.0] vs 102.3 [68.2];
P < .001) and institutions performing ULM PCI (mean [SD] pro-
cedures, 693.9 [429.8] vs 599.3 [404.3]; P < .001) compared
with operators and institutions performing all other PCI.
Unprotected left main PCI was performed most frequently at
institutions in urban settings and with private or community
designations. Unprotected left main PCI was performed most
frequently in the South Atlantic and Pacific census divisions.
On-site surgical backup was present more frequently among
institutions performing ULM PCI (92.9% [30 763] vs 86.2%
[2 852 804]; P < .001).
Temporal Trends in ULM PCI
Unprotected left main PCI use has increased over time, from
3054 procedures between quarter 3 of 2009 and quarter 2 of
2010 (0.7% of all PCIs performed) to a peak of 6829 proce-
dures between quarter 3 of 2015 and quarter 2 of 2016 (1.3%
of all PCIs performed) (Figure 1). Age and sex were similar across
the study period between patients undergoing ULM PCI and
patients undergoing all other PCI. However, rates of medical
comorbidities increased significantly in those undergoing ULM
PCI. Estimated risk of inpatient mortality increased over time,
from 2.2% to 2.5% (P = .02) (eTable 1 in the Supplement).
Use of radial access increased from 4.7% (315 of 6696) from
2009 to 2011 to 20.3% (1383 of 6829) from 2015 to 2016 (P < .001).
Between these periods, use of MCS increased modestly (22.6%
[1511] to 29.2% [1995]; P < .001), but use of IABP declined (15.8%
[1055] to 11.8% [806]; P < .001) and use of other MCS increased
(7.9% [529] to 18.8% [1281]; P < .001). Rates of atherectomy in-
creased over the study period from 6.9% (465) to 9.4% (641)
(P < .001); atherectomy was mainly rotational but with an increas-
ing proportion of orbital atherectomy (0% to 22.5% [144 of 641]
of all atherectomy; P < .001) (eTable 2 in the Supplement).
Composite rates of in-hospital death, MI, stroke, or emergent
CABG decreased over time (2009-2011, 9.3% [620 of 6696]; 2015-
2016, 7.8% [532 of 6829]; P = .01). Individual rates of MI also
decreased over time (2009-2011, 4.5% [303]; 2015-2016, 2.5%
[169]; P < .001), while rates of death, stroke, and emergent CABG
did not differ significantly (eTable 3 in the Supplement).
Variation in Performance of ULM PCI
The mean (SD) annualized volume of ULM PCI across operators
in the CathPCI Registry was 0.5 (1.5) procedures, with only
1808 operators (16.7%) averaging 1 or more ULM PCI annually
(Figure 2A). Discounting all operators averaging less than 1 ULM
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 Research Original Investigation Use and Trends in Unprotected Left Main Coronary Artery Percutaneous Coronary Intervention

Table 1. Patient Demographic and Clinical Characteristics

No. (%)
Total ULM PCI All Other PCI
Characteristic (N = 3 342 162) (n = 33 128) (n = 3 309 034) P Value
Demographic Characteristics
Age, mean (SD), y 64.2 (12.1) 71.8 (12.4) 64.1 (12.1) <.001
Male 2 223 570 (66.5) 19 875 (60.0) 2 203 695 (66.6) <.001
Race
White 2 898 809 (86.7) 28 595 (86.3) 2 870 214 (86.7)
African American 294 311 (8.8) 2413 (7.3) 291 898 (8.8) <.001
Asian 89 073 (0.6) 1278 (3.9) 87 795 (2.7)
Other 28 018 (0.8) 401 (1.2) 27 617 (0.8)
Hispanic ethnicity 190 753 (5.7) 1859 (5.6) 188 894 (5.7) .47
Insurance payor
None 228 461 (6.8) 939 (2.8) 227 522 (6.9)
Private 2 154 816 (64.5) 20 945 (63.2) 2 133 871 (64.5)
Medicare 1 623 926 (48.6) 23 113 (69.8) 1 600 813 (48.4) <.001
Medicaid 343 952 (10.3) 3930 (11.9) 340 022 (10.3)
Military 97 397 (2.9) 1100 (3.3) 96 297 (2.9)
Other 59 060 (1.8) 502 (1.4) 58 558 (1.8)
History
Current tobacco use 963 078 (28.8) 6447 (19.5) 956 631 (28.9) <.001
Hypertension 2 677 875 (80.1) 28 497 (86.0) 2 649 378 (80.1) <.001
Dyslipidemia 2 523 393 (75.6) 26 847 (81.2) 2 496 546 (75.5) <.001
Family history of CAD 766 160 (22.9) 5318 (16.1) 760 842 (23.0) <.001
Prior MI 822 618 (24.6) 11 262 (34.0) 811 356 (24.5) <.001
Prior heart failure 340 021 (10.2) 9176 (27.7) 330 845 (10.0) <.001
Prior PCI 1 181 763 (35.4) 12 402 (37.4) 1 169 361 (35.3) <.001
ESRD on dialysis 76 719 (2.3) 1849 (5.6) 74 870 (2.3) <.001
GFR, mean (SD) 73.1 (17.6) 73.1 (17.6) 73.1 (17.5) <.001
Cerebrovascular disease 358 974 (10.7) 7153 (21.6) 351 821 (10.6) <.001
Peripheral arterial disease 328 052 (9.8) 7224 (21.8) 320 828 (9.7) <.001
Chronic lung disease 480 397 (14.4) 8106 (24.5) 472 291 (14.3) <.001
Diabetes 1 172 308 (35.1) 13 368 (40.4) 1 158 940 (35.0) <.001
Presentation Characteristics
PCI status
Elective 1 291 227 (38.6) 11 495 (34.7) 1 279 732 (38.7)
Urgent 1 432 072 (42.9) 18 091 (54.6) 1 413 981 (42.7) <.001
Emergent 615 190 (18.4) 3265 (9.9) 611 925 (18.5)
Salvage 2487 (0.1) 263 (0.8) 2224 (0.1)
CAD presentation
No symptoms 225 269 (6.7) 3274 (9.9) 221 995 (6.7)
Unlikely ischemic 78 680 (2.4) 860 (2.6) 77 820 (2.4)
Stable angina 476 713 (14.3) 4419 (13.3) 472 294 (14.3) <.001
Unstable angina 1 265 483 (37.9) 13 881 (41.9) 1 251 602 (37.8)
Non-STEMI 725 678 (21.7) 8364 (25.3) 717 314 (21.7)
STEMI 569 498 (17.0) 2321 (7.0) 567 177 (17.1)
CCS class (2 wk)
0 338 201 (10.1) 4509 (13.6) 333 692 (10.1)
1 131 133 (3.9) 912 (2.8) 130 221 (3.9)
<.001 Abbreviations: CAD, coronary artery
2 490 974 (14.7) 3734 (11.3) 487 240 (14.8)
disease; CCS, Canadian
3 1 170 340 (35.1) 11 557 (34.9) 1 158 783 (35.1)
Cardiovascular Society;
4 1 204 445 (36.1) 12 357 (37.4) 1 192 088 (36.1) ESRD, end-stage renal disease;
Antianginal medications (2 wk) 2 304 937 (69.0) 26 667 (80.5) 2 278 270 (68.9) <.001 GFR, glomerular filtration rate;
Heart failure medications (2 wk) 325 063 (9.7) 9816 (29.6) 315 247 (9.5) <.001 MI, myocardial infarction;
PCI, percutaneous coronary
Cardiomyopathy 313 623 (9.4) 7855 (23.7) 305 768 (9.2) <.001
intervention; STEMI, ST-elevation
CathPCI Registry Procedural risk, 0.8 (2.6) 2.3 (7.7) 0.8 (2.5) <.001 myocardial infarction;
mean (SD), % ULM, unprotected left main.

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 Use and Trends in Unprotected Left Main Coronary Artery Percutaneous Coronary Intervention Original Investigation Research

Table 2. Procedural and Institutional Characteristics

No. (%)
Total ULM PCI All Other PCI
Characteristic (N = 3 342 162) (n = 33 128) (n = 3 309 034) P Value
Procedural Characteristics
Arterial access site
Femoral 2 606 273 (78.0) 28 535 (86.2) 2 577 738 (77.9)
Brachial 8529 (0.3) 180 (0.5) 8349 (0.3) <.001
Radial 724 499 (21.7) 4323 (13.1) 720 176 (21.8)
Other 1778 (0.1) 81 (0.2) 1697 (0.1)
MCS 52 097 (1.6) 8169 (24.7) 43 928 (1.3) <.001
Before PCI 7278 (0.2) 1722 (5.2) 5556 (0.2) <.001
During or after PCI 36 554 (1.1) 3442 (10.4) 33 112 (1.0) <.001
IABP 41 051 (1.2) 4538 (13.7) 36 513 (1.1) <.001
Before PCI 4459 (0.1) 1095 (3.3) 3364 (0.1) <.001
During or after PCI 26 825 (0.8) 68 (0.2) 26 757 (0.8) <.001
Other MCS 12 630 (0.4) 4023 (12.1) 8607 (0.3) <.001
Before PCI 2894 (0.1) 648 (2.0) 2246 (0.1) <.001
During or after PCI 9729 (0.3) 3374 (10.2) 6355 (0.2) <.001
Contrast volume, mean (SD), mL 185.1 (83.6) 216.9 (114.1) 184.8 (83.1) <.001
Fluoroscopy time, mean (SD), min 13.5 (10.4) 23.0 (16.4) 13.4 (10.3) <.001
Lesion Characteristics
Class C lesion 1 855 009 (55.7) 24 520 (74.0) 1 830 489 (55.5) <.001
LMCA bifurcation NA 14 947 (45.1) NA NA
1 Stent NA 8871 (26.8) NA NA
>1 Stent NA 6053 (18.3) NA NA
Missing NA 23 (0.1) NA NA
Lesion treated previously 310 066 (9.3) 2909 (8.8) 307 157 (9.3) <.001
Restenosis 263 664 (7.9) 2464 (7.4) 261 200 (7.9) .001
Stent thrombosis 42 790 (1.3) 231 (0.7) 42 559 (1.3) <.001
Lesion length, mean (SD), mm 30.1 (27.8) 51.8 (54.7) 29.9 (27.3) <.001
No. of lesions treated, mean (SD) 1.4 (0.6) 2.0 (1.1) 1.3 (0.6) <.001
Multivessel PCI 743 542 (22.2) 15 635 (47.2) 727 907 (22.0) <.001
PCI Characteristics
Atherectomy
Laser 4734 (0.1) 135 (0.4) 4599 (0.1)
<.001
Orbital 6353 (0.2) 303 (0.9) 6050 (0.2)
Rotational 38 705 (1.2) 2649 (8.0) 36 056 (1.1)
Thrombectomy
Aspiration 136 864 (4.1) 530 (1.6) 136 334 (4.1) <.001
Mechanical 14 041 (0.4) 117 (0.4) 13 924 (0.4) .06
Cutting or scoring balloon 133 315 (4.0) 3409 (10.3) 129 906 (3.9) <.001
No. of stents, mean (SD) 1.5 (0.8) 2.2 (1.3) 1.5 (0.8) <.001
BMS 619 169 (18.5) 4831 (14.6) 614 338 (18.6) <.001
DES 2 756 071 (82.5) 29 226 (88.2) 2 726 845 (82.4) <.001
Stent type
Cobalt chromium EES 1 264 395 (45.9) 12 662 (43.3) 1 251 733 (45.9)
Platinum chromium EES 581 530 (21.1) 7059 (24.2) 574 471 (21.1)
ZES 602 324 (21.9) 5636 (19.3) 596 688 (21.9)
PES 168 608 (6.1) 1207 (4.1) 167 401 (6.1) <.001
SES 61 284 (2.2) 427 (1.5) 60 857 (2.2)
Bioabsorbable DES 519 (0.0) 0 519 (0.0)
Other DES 515 (0.0) 6 (0.0) 509 (0.0)
>1 DES type 76 896 (2.8) 2229 (7.6) 74 667 (2.7)
Operator annual PCI volume, 102.6 (68.5) 128.4 (91.0) 102.3 (68.2) <.001
mean (SD)

(continued)

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 Research Original Investigation Use and Trends in Unprotected Left Main Coronary Artery Percutaneous Coronary Intervention

Table 2. Procedural and Institutional Characteristics (continued)

No. (%)
Total ULM PCI All Other PCI
Characteristic (N = 3 342 162) (n = 33 128) (n = 3 309 034) P Value
Institutional Characteristics
Institutional location
Rural 437 460 (13.1) 2882 (8.7) 434 578 (13.1)
<.001
Suburban 1 029 765 (30.8) 8319 (25.1) 1 021 446 (30.9)
Urban 1 874 937 (56.1) 21 927 (66.2) 1 853 010 (56.0)
Institutional designation
Government 36 827 (1.1) 320 (0.7) 36 507 (1.1)
<.001
Private/community 2 901 604 (86.8) 25 645 (77.4) 2 875 959 (86.9)
University 403 731 (12.1) 7163 (21.6) 396 568 (12.0)
Teaching institution 1 624 038 (48.6) 20 634 (62.3) 1 603 404 (48.5) <.001
Institutional census division
E North Central 620 265 (18.6) 5524 (16.7) 614 741 (18.6)
E South Central 283 289 (8.5) 1817 (5.5) 281 472 (8.5)
Middle Atlantic 400 730 (12.0) 3842 (11.6) 396 888 (12.0)
Abbreviations: BMS, bare-metal
Mountain 164 696 (4.9) 1494 (4.5) 163 202 (4.9) stent; DES, drug-eluting stent;
<.001
New England 138 721 (4.2) 1552 (4.7) 137 169 (4.1) EES, everolimus-eluting stent;
Pacific 366 298 (11.0) 5804 (17.5) 360 494 (10.9) IABP, intra-aortic balloon pump;
LMCA, left main coronary artery;
South Atlantic 767 927 (23.0) 6420 (19.4) 761 507 (23.0) MCS, mechanical circulatory
W North Central 282 283 (8.4) 3785 (11.4) 278 498 (8.4) support; NA, not applicable;
W South Central 317 887 (9.5) 2890 (8.7) 314 997 (9.5) PCI, percutaneous coronary
intervention; PES, paclitaxel-eluting
Institutional annual PCI volume, 600.3 (404.6) 693.9 (429.8) 599.3 (404.3) <.001
mean (SD) stent; SES, sirolimus-eluting stent;
ULM, unprotected left main;
On-site surgical back-up 2 883 567 (86.3) 30 763 (92.9) 2 852 804 (86.2) <.001
ZES, zotarolimus-eluting stent.

Figure 1. Temporal Trends in Unprotected Left Main (ULM) Percutaneous Coronary Intervention (PCI)

7000 2.0

6000
1.5
5000
ULM PCI Rate, %
ULM PCIs, No.

4000
1.0
3000

2000
0.5
1000

0 0
2009 Q3- 2010 Q3- 2011 Q3- 2012 Q3- 2013 Q3- 2014 Q3- 2015 Q3-
2010 Q2 2011 Q2 2012 Q2 2013 Q2 2014 Q2 2015 Q2 2016 Q2 Use of ULM PCI over time in
Period aggregate and as a proportion of all
other PCI. Q indicates quarter.

PCI annually over the study period, the trimmed operator mean
(SD) annual volume was 2.5 (2.8) ULM PCI per year (Figure 2B).
Among operators performing any left main PCI, the median an-
nualized ULM PCI volume was 1.75 ULM PCI per year. The mean
(SD) annualized volume of ULM PCI across institutions partici-
pating in the CathPCI Registry was 3.2 (6.1) procedures, with 892
institutions (53.7%) averaging 1 or more ULM PCI annually
(Figure 2C). Discounting all institutions averaging less than 1 ULM
PCI annually over the study period, the trimmed institutional
mean (SD) annual volume was 5.7 (7.4) ULM PCI per year
(Figure 2D). Among institutions performing at least 1 ULM PCI an-
nually, the median annualized volume was 3.31 ULM PCI per year.
Outcomes
Patients undergoing ULM PCI had a significantly higher rate
of MACE compared with all other PCI (9.0% [2993] vs 2.6%
[86 940]; P < .001). Unprotected left main PCI also had higher
frequency of each individual outcome, including death (5.0%
[1643] vs 0.6% [21 344]), MI (3.9% [1285] vs 1.8% [60 015]),
stroke (0.5% [176] vs 0.2% [6304]), and emergent CABG (0.7%
[224] vs 0.1% [3219]) (Table 3). After covariate adjustment, the
odds of MACE were significantly increased with ULM PCI com-
pared with all other PCI (odds ratio [OR], 1.46; 95% CI, 1.39-
1.53) (eFigure 2 in the Supplement).
Secondary Analyses
Annual PCI Volume
When stratified by tertiles of institutional annual PCI vol-
umes, lower rates of MACE occurred after ULM PCI at institu-
tions and among operators in the highest tertile of PCI vol-
ume compared with the first and second tertiles (eTable 4 in
the Supplement). After adjustment, higher tertiles of annual

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 Use and Trends in Unprotected Left Main Coronary Artery Percutaneous Coronary Intervention Original Investigation Research

Figure 2. Variation in Use of Unprotected Left Main (ULM) Percutaneous Coronary Intervention (PCI)
Across Operators and Institutions

A Annualized operator ULM PCI volume

70
60
50
ULM PCIs, No.

40
30
20
10
0

60

10 4
54

23
02
33

44
1

12
91
70

3
0

49

81

39
9

75

65

10 5
07
96

86

97
76
38
17

28

18

23
61
38
75

5
79
26

68
72
30

64
34
37
41
45

75

83
22

60

98
53
18

56

90
94
11
15

49

87
No. of Operators

B Annualized operator-trimmed ULM PCI volume

70
60
50
ULM PCIs, No.

40
30
20
10
0
99
60
9

38
1

82
1
2

48
09
70
62

21

43
3

87
5
6

65
26
4
5

04
48
42

55
61
67
73
12

36

97
85
30

91
18
24

79

10
11
10

12

16
17
17
12

13

15
14
15
14

No. of Sites

C Annualized institution ULM PCI volume

90
80
70
ULM PCIs, No.

60
50
40
30
20
10
0
45
03
7
1

5
7

19
1
9

67
25
59

61

77
7

09
3
1

93
51
5
3

35
46

98
40

52
58
63
69
11

34

92
81
29

87
17
23

75

10
11

12

15
16
11

12

15
13
14
13

No. of Operators

D Annualized institution-trimmed ULM PCI volume

90
80
70
ULM PCIs, No.

60
50
A, Variation in annualized volume of
40 ULM PCI across operators.
30 B, Variation in annualized volume of
20 ULM PCI across operators averaging
10 at least 1 ULM PCI per year.
0 C, Variation in annualized volume of
ULM PCI across institutions.
8
9
0
1

9
8

2
1
2

8
9
32

3
63

7
5
6

5
6
94

4
52
55
59
24
21

28

65
31
34

83
86
37

62

68
18

49

80
43
15

45

74
77
12

40

71

D, Variation in annualized volume of

No. of Sites ULM PCI across institutions averaging
at least 1 ULM PCI per year.

PCI volume were associated with improved outcomes at the
institutional level (tertile 2 vs tertile 1: OR, 0.90; 95% CI, 0.80-
1.01; tertile 3 vs tertile 1: OR, 0.84; 95% CI, 0.74-0.96) and op-
erator level (tertile 2 vs tertile 1: OR, 0.94; 95% CI, 0.91-0.97;
tertile 3 vs tertile 1: OR, 0.90; 95% CI, 0.87-0.93).
Mechanical Circulatory Support
When stratified by tertiles of institutional use of MCS, in-
creased rates of MACE were observed with increased use of
IABP counterpulsation in the highest tertile compared with the
first and second tertiles (eTable 4 in the Supplement). After

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 Research Original Investigation Use and Trends in Unprotected Left Main Coronary Artery Percutaneous Coronary Intervention
Table 3. In-Hospital Outcomes
No. (%)
Total ULM PCI
Outcome (N = 3 342 162) (n = 33 128)
Death, MI, stroke, or emergent CABG 89 933 (2.7) 2993 (9.0)
Death 22 987 (0.7) 1643 (5.0)
MI (biomarker positive) 61 300 (1.8) 1285 (3.9)
Stroke 6480 (0.2) 176 (0.5)
Emergent CABG 3443 (0.1) 224 (0.7)
multivariable adjustment, higher tertiles of IABP use during
ULM PCI remained associated with increased MACE (tertile 2
vs tertile 1: OR, 1.11; 95% CI, 1.004-1.22; tertile 3 vs tertile 1: OR,
1.17; 95% CI, 1.07-1.30), while there was no difference in MACE
across institutional tertiles of non-IABP MCS use (tertile 2 vs
tertile 1: OR, 0.95; 95% CI, 0.85-1.06; tertile 3 vs tertile 1: OR,
1.07; 95% CI, 0.96-1.20).
Comparison With Clinical Trials
Compared with recent trials,8,9 patients undergoing ULM PCI
at CathPCI Registry institutions were significantly older and had
more medical comorbidities (eTable 5 in the Supplement). Mor-
tality and stroke occurred more frequently among patients in
the CathPCI Registry compared with participants of the EX-
CEL and NOBLE trials,8,9 while rates of inpatient MI were simi-
lar. While SYNTAX scores are not available for patients in this
study, other markers of anatomic complexity, such as lesion
length and number of stents, were similar to those in EXCEL
trial.8 Left main bifurcation lesions were less frequent among
patients undergoing ULM PCI (45.1% [14 947 of 33 128]) com-
pared with patients in the EXCEL trial (80.5% [763 of 948]) and
the NOBLE trial (85.8% [508 of 592]) (P < .001), but 2-stent strat-
egies were used more frequently for these lesions in patients un-
dergoing ULM PCI than in the NOBLE trial (40.5% [6053 of
14 947] vs 36.8% [187 of 508]; P < .001).9 Intravascular imaging
was used less frequently among patients undergoing ULM PCI
(39.8% [4557 of 11 437]) than patients in the EXCEL trial (76.2%
[722 of 948]) and the NOBLE trial (74.9% [430 of 574]) (P < .001),
while MCS use was nearly 5-fold higher in patients undergoing
ULM PCI compared with patients in the EXCEL trial (24.7% [8169
of 33 128] vs 5.6% [53 of 948]; P < .001).
Discussion
We describe contemporary practice of ULM PCI in the United
States, as represented in the NCDR CathPCI Registry. While use
of ULM PCI has numerically doubled over time from 2009 to
2016, it remains a small proportion of all PCI, modestly increas-
ing from 0.7% to 1.3% over the study period. Patients undergo-
ing ULM PCI were older, had more comorbid conditions than
patients undergoing all other PCI, and demonstrated high rates
of mortality, MI, stroke, and emergent CABG. These patients,
their characteristics, and outcomes stand in contrast with those
reported by clinical trials evaluating ULM PCI, demonstrating
key differences between contemporary clinical practice and trial
populations. Finally, we observed remarkably low operator and
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All Other PCI
(n = 3 309 034) P Value
86 940 (2.6) <.001
21 344 (0.6) <.001
Abbreviations: CABG, coronary artery
60 015 (1.8) <.001 bypass grafting; MI, myocardial
6304 (0.2) <.001 infarction; PCI, percutaneous
coronary intervention;
3219 (0.1) <.001
ULM, unprotected left main.
institutional volumes, with, on average, less than 1 annual ULM
PCI for operators and only 3 ULM PCI for institutions.
Our findings document a slow uptake of ULM PCI perfor-
mance in the United States despite emerging data suggesting
ULM PCI as a reasonable alternative to CABG. The 5-year
follow-up of the Synergy Between Percutaneous Coronary
Intervention With Taxus and Cardiac Surgery (SYNTAX) trial15
suggested similar outcomes for left main coronary artery PCI
vs CABG with intermediate or low SYNTAX scores, and after
the emergence of additional supporting data,16 both US and in-
ternational guidelines shifted recommendations to include
either percutaneous or surgical revascularization for ULM
stenoses in the absence of complex anatomic features.1,17 The
recent publications of the EXCEL and NOBLE trials8,9 offered
further insights. The EXCEL trial suggested equivalence in out-
comes for CABG and PCI in the treatment of ULM stenoses,8
while the NOBLE trial suggested better outcomes with CABG.9
These divergent findings have been attributed to differences
in patient populations and trial designs, particularly with re-
spect to the primary end point definitions.18,19 Professional
guidelines continue to recommend consideration of both ULM
PCI and surgical revascularization for treatment of left main
stenoses, incorporating patient and anatomic complexity into
decision making.
However, in contrast to clinical trials, the present analy-
sis demonstrates significantly worse outcomes for a contem-
porary cohort undergoing ULM PCI in the United States as well
as major differences in demographic, clinical, and procedural
characteristics. Much of this demonstrated difference in out-
comes is likely attributable to patient and procedural factors,
with age and burden of comorbidities greater among patients
in the CathPCI Registry than those reported in clinical trials,
and procedural distinctions, such as the use of intravascular
imaging. The difference in patient populations is further high-
lighted by the nearly 5-fold increase in use of MCS among pa-
tients in the CathPCI Registry compared with in clinical trials.
With a higher burden of comorbidities among patients under-
going ULM PCI, it is possible that there is significant selection
bias in management strategies wherein more clinically com-
plex patients may undergo percutaneous rather than surgical
revascularization in clinical practice.20 Additionally, these find-
ings suggest that PCI is an infrequently used management strat-
egy for ULM stenoses. The estimated prevalence of left main
disease found during diagnostic angiography is 6% in pub-
lished series.21,22 With more than 1 million coronary angio-
grams performed annually in the United States,23 the annual
number of patients undergoing ULM PCI is quite low in com-
jamacardiology.com
 Use and Trends in Unprotected Left Main Coronary Artery Percutaneous Coronary Intervention
parison to the extrapolated incidence of ULM stenoses. There-
fore, most patients with ULM stenoses are likely managed with
strategies other than PCI in contemporary practice. Despite lim-
ited use of PCI for ULM stenoses, this analysis found 1662
institutions performing at least 1 ULM PCI during the study
period, while randomized clinical trials were limited to a small
number of high-volume centers (126 centers in the EXCEL trial8
and 36 centers in the NOBLE trial9). Furthermore, there is sig-
nificant variability in the frequency of ULM PCI performance
across registry operators and institutions. Taken together, these
findings suggest that ULM PCI is performed in older patients
with high degrees of morbidity, performed with significant vari-
ability in operator and institutional procedural experience, and
represents a minority of the management of left main steno-
sis. This raises the possibility that operator and institutional
inexperience may play a role in addition to patient and proce-
dural features in the observed difference in outcomes.
There are several possibilities to explain the limited rates
of ULM PCI in contemporary practice. One is likely the com-
fort and experience that referring physicians have with CABG.
Its historical efficacy and operator and institutional experi-
ence may influence referring physicians to send patients with
ULM stenosis for coronary artery bypass surgery despite data
suggesting equivalent short-term and mid-term outcomes in
patients with lower anatomic complexity. It is also possible that
clinicians see that real-world outcomes for patients undergo-
ing ULM PCI—many of whom are older, frail, and may be de-
termined to be at prohibitive risk for surgery—compare unfa-
vorably with patients undergoing both all other PCI as well as
CABG, leaving practitioners hesitant to refer younger, healthier
patients for ULM PCI and further propagating the demon-
strated differences in case mix. Third, it is likely that high-
risk patients and procedures, like the older and comorbid pa-
tients presenting with acute coronary syndromes in this registry
population, would be less likely to be enrolled in clinical trials,
underscoring another important difference when consider-
ing trial results in the context of clinical practice. Fourth, it is
possible that through a combination of low overall use and dif-
fusion of higher-risk cases across operators and centers, op-
erators and institutions are less comfortable performing ULM
PCI compared with operators involved in randomized trials.
The observed rates of 3.2 ULM PCI per year for institutions and
0.5 ULM PCI per year for operators in clinical practice are frac-
tions of the rates published in clinical trials, with an institu-
tional average of 7.5 PCIs in the EXCEL trial,8 16.4 PCIs in the
NOBLE trial,9 and more than 20 left main coronary interven-
tions and more than 300 PCIs per year for operators included
in the recently published Double Kissing and Double Crush
Versus Provisional T Stenting Technique for the Treatment of
Unprotected Distal Left Main True Bifurcation Lesions
(DKCRUSH-V) trial. 24 Additionally, the significantly in-
creased use of MCS in the CathPCI Registry compared with
clinical trials may reflect these contrasting levels of proce-
dural inexperience as opposed to solely medical or anatomic
factors. As published data support an association of increas-
ing volumes with improved PCI outcomes, it is possible that a
similar association exists between ULM PCI volume and
outcomes.25,26 Our findings of an association of increasing
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Original Investigation Research
operator and institutional PCI volumes with lower risks of
MACE following ULM PCI would support this hypothesis. Thus,
it is perhaps unsurprising and even judicious that ULM PCI
remains infrequent, given limited operator experience and
observed poor outcomes in a high-risk patient population. Con-
centrating ULM PCI performance to experienced centers and
high-volume operators could potentially facilitate improved
outcomes. Alternatively, broadening use of ULM PCI among
lower-risk patients (more similar to those seen in clinical trials)
may augment operator and institutional volumes to attain
operator experience and comfort among patients more likely
to have successful procedures.
Study Limitations
The findings of the present analysis should be interpreted
while considering several limitations. First, as an observa-
tional analysis, residual confounding may be present and
could bias findings. Demonstrated differences in demo-
graphic and clinical characteristics between patients under-
going ULM PCI vs not undergoing ULM PCI suggest selective
use of ULM PCI in high-risk patients at participating
CathPCI Registry institutions. These differences limit com-
parison with other published studies but underscore the
restricted use of a viable treatment modality of ULM revas-
cularization. Second, use of registry data requires assump-
tions that data are reported completely and accurately.
While error in data collection or entry is possible, the NCDR
CathPCI Registry undergoes periodic auditing to ensure
optimal data integrity. Third, we were unable to ascertain
longitudinal outcomes for patients undergoing ULM PCI, as
postdischarge data are not available in the CathPCI Registry.
Fourth, we were unable to compare treatment with ULM
PCI with CABG or medical therapy. These groups are impor-
tant for understanding the entirety of management of
patients with ULM stenoses as well as clinical outcomes
and factors associated with patient, operator, or institutional
determination of treatment strategy and represent an oppor-
tunity for further study. Finally, the inability to calculate
SYNTAX scores limited our ability to define the influence
of anatomic complexity on outcomes and limited our
ability to characterize compliance with past and current
guideline recommendations.
Conclusions
Among patients treated at institutions participating in the
CathPCI Registry, ULM PCI occurs infrequently and in an
older and more comorbid population than those repre-
sented in clinical trials. While ULM PCI increased over the
study period, operator and institutional volumes remained
variable and limited, and outcomes were significantly worse
than those seen in clinical trials. These findings suggest that
randomized clinical trials demonstrating safety and efficacy
of ULM PCI do not reflect contemporary clinical practice
and suggest an opportunity to refine patient selection and
increase operator and institutional experience as potential
means to improving outcomes.
(Reprinted) JAMA Cardiology Published online January 2, 2019 E9
 Research Original Investigation
ARTICLE INFORMATION
Accepted for Publication: November 6, 2018.
Published Online: January 2, 2019.
doi:10.1001/jamacardio.2018.4376
Author Contributions: Mr Kennedy had full access
to all of the data in the study and takes
responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design: Valle, Tamez, Waldo,
Masoudi, Yeh.
Acquisition, analysis, or interpretation of data: Valle,
Tamez, Abbott, Moussa, Messenger, Waldo, Kennedy.
Drafting of the manuscript: Valle, Waldo, Kennedy.
Critical revision of the manuscript for important
intellectual content: All authors.
Statistical analysis: Valle, Tamez, Kennedy, Masoudi.
Administrative, technical, or material support: Valle,
Tamez, Messenger, Waldo, Masoudi.
Study supervision: Valle, Abbott, Moussa, Yeh.
Conflict of Interest Disclosures: Dr Abbott has
received grants from Abbott Vascular, AstraZeneca,
Biosensors International, Bristol-Myers Squibb, and
Sino Medical Sciences Technology; consulting fees
from DynaMed and UpToDate; and personal fees
from ReCor Medical for clinical trial adjudication. Dr
Waldo has received grants from Abiomed,
Cardiovascular Systems, and Merck
Pharmaceuticals and has received consulting fees
from CPC Clinical Research for clinical trial
adjudication. Dr Masoudi is the Chief Science
Officer of the National Cardiovascular Data Registry.
Dr Yeh has received grants from Abbot Vascular,
Abiomed, and Boston Scientific as well as
consulting fees from Abbott Vascular, Boston
Scientific, and Medtronic.
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