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DOI: 10.1002/ccd.27490
ORIGINAL STUDIES
1
Lankenau Heart Institute, Wynnewood,
Pennsylvania
Abstract
2
Center for Outcomes Research and Objectives: This study was designed to examine the association between adopting the transradial
Evaluation, Yale-New Haven Hospital, New
approach for percutaneous coronary intervention (PCI) and rates of vascular complications follow-
Haven, Connecticut
3
ing transfemoral PCI.
Section of Cardiovascular Medicine,
Department of Internal Medicine, Yale Background: Recent studies raised concerns that operators adopting the transradial approach may
University School of Medicine, New Haven,
lose their transfemoral access skills and experience increased rates of vascular complications.
Connecticut
Methods: Retrospective analysis of data from the NCDR CathPCI Registry to examine the rates of
Correspondence
vascular complications among physicians who were femoral operators (>90% of cases) in 2010–
Marwan Badri, MBChB, Lankenau Heart
Institute, 100 Lancaster Avenue, 2011 and later adopted the transradial approach to PCI among low-, intermediate-, or high-level
Wynnewood, PA 19096. adopters (33%, 34–66%, and >66%, respectively) in 2014–2015. Propensity score matching was
Email: marwanbadri@gmail.com used to control for confounding factors.
Funding information Results: A total of 1,704,708 procedures performed by 4,697 operators were included. Most oper-
American College of Cardiology ators were low-level adopters (80.7%), followed by intermediate (15.7) and high-level adopters
Foundation’s (ACCF) National
(3.6%). Compared to the preadoption period, vascular complications of transfemoral PCIs following
Cardiovascular Data Registry (NCDR)
transradial adoption increased among low-level adopters (1.29%–1.59%, adjusted OR [95% CI]:
1.24[1.20–1.28], P < 0.001), intermediate-level adopters (1.37%–1.92%, adjusted OR 1.40[1.29–
1.53], P < 0.001), and high-level adopters (1.54%–1.93%, adjusted OR 1.26[1.00–1.58], P 5 0.053).
In the post-adoption period, there was increase in access site bleeding that is likely due to change
in registry definition. There was no increase in hematomas, retroperitoneal bleeding or other vas-
cular complications.
Conclusions: Adoption of the transradial approach for PCI is not associated with clinically mean-
ingful increase in rates of vascular complications of transfemoral PCIs.
KEYWORDS
brachial, catheterization, complications, coronary artery disease, percutaneous coronary interven-
tion, radial, ulnar, vascular complications
the femoral approach, resulting in higher rates of vascular complica- period, along with procedures performed by operators with <20 PCIs
tions [8,9]. Femoral access is needed in patients with anatomic arterial per year during the early or late periods. Finally, procedures by opera-
variants that exist in 5% of patients and in patients with occluded radial tors who did not perform PCI in both study periods were excluded.
arteries [10,11]. Moreover, transradial PCI may not be feasible when a The remaining 1,704,708 procedures were included in the analysis
procedure requires larger access than what can be accommodated by (Figure 1)
the radial artery. Hence, competency in performing transfemoral PCI is
required by all interventional cardiologists. Accordingly, this study was
2.3 | Study end points and definitions
designed to test the hypothesis that increased adoption of the transra-
dial approach is associated with increased rates of vascular complica- The primary study end point was the occurrence of vascular complica-
tions following transfemoral PCI. tions following transfemoral PCI diagnosed within the same hospitaliza-
tion during or after the procedure. Vascular complications included
bleeding at access site, hematoma at access site, retroperitoneal bleed-
2 | METHODS
ing, and other vascular complications requiring treatment. Based on the
2.1 | Data source CathPCI registry definitions, in order for hematoma and retroperitoneal
bleeding to qualify as complications they needed to be associated with
The American College of Cardiology’s National Cardiovascular Data
either a hemoglobin drop of 3 g/dl, blood transfusion, or need for a
Registry (NCDR) CathPCI Registry is the largest cardiovascular data
surgical or endovascular intervention to treat the complication. In
registry in the United States, with over 85% of institutions performing
2012, the CathPCI registry definition of complications was modified so
PCI procedures electing to participate in the CathPCI Registry [12]. The
if any of the three parameters (hemoglobin drop 3 g/dl, transfusion,
CathPCI Registry prospectively collects data on patient characteristics
or intervention to treat a vascular complication) is documented without
and clinical features, including demographics, comorbid conditions, car-
a specific complication to explain them then that was considered an
diac status, coronary lesion, intracoronary device utilization, and
access-site bleeding event. Other vascular complications included
adverse event rates. Trained data abstractors use standardized defini-
access site occlusion, peripheral embolization, dissection, pseudoaneu-
tions to extract data, and quality checks are performed by the NCDR
rysm, and arteriovenous fistulas. The definitions of each of those com-
to ensure that over 95% completeness of specific data elements is
plications are available online [14]. A secondary analysis was performed
obtained, as described in greater detail elsewhere [12].
using the same components of the primary endpoint analysis but fol-
lowing all PCIs (transradial and transfemoral).
2.2 | Study data
Based on the availability of data in the CathPCI registry (versions 4.3.1 2.4 | Statistical analysis
and 4.4), data for the early period were obtained from 2010 to 2011
Baseline demographic, clinical, and procedural characteristics were
and data for the late period were obtained from 2014 to 2015. To
examined overall and compared between the early and late periods
examine the impact of transradial adoption on femoral operators, the
using the Chi-square test for categorical variables and t tests for con-
operators included in the early period had to have performed more
tinuous variables. Counts and percentages were used to present cate-
than 90% of their annual procedures in the early period through the
gorical variables and means with standard deviations were used to
femoral approach. We then stratified operators into three groups based
on the percentage of the transradial PCIs they performed in the late
period (postradial adoption): low-level transradial adopters (33%),
intermediate-level transradial adopters (34%–66%), and high-level
transradial adopters (>66%). To examine the association of adopting
the transradial approach to PCI with vascular complications of transfe-
moral and all (transradial and transfemoral) PCIs, we compared the
rates of vascular complications in each of these three groups with the
rates of complications of procedures performed by the same operators
in the early (preadoption) period. We used National Provider Identifiers
(NPI) to link physicians between the two time periods.
Out of 2,710,698 PCIs available for analysis, we excluded proce-
dures in which access site was neither transradial nor transfemoral. We
also excluded procedures in which mechanical support was used
(including intra-aortic balloon pump) as these procedures are associated
with higher rates of complications [13]. Procedures for which no opera-
tor NPI was available were also excluded. Then we excluded proce-
dures performed by operators with <90% transfemoral PCI in the early FIGURE 1 Study procedure selection flowchart
BADRI ET AL. | 3
Race <0.001
White 1,495,041 (87.70) 769,955 (88.18) 725,086 (87.20)
Black 143,003 (8.39) 71,609 (8.20) 71,394 (8.59)
Other 66,664 (3.91) 31,581 (3.62) 35,083 (4.22)
Diabetes <0.001
Noninsulin treated 359,883 (21.11) 185,916 (21.29) 173,967 (20.92)
Insulin treated 246,791 (14.48) 116,860 (13.38) 129,931 (15.62)
Peripheral arterial disease 208,910 (12.25) 107,899 (12.36) 101,011 (12.15) <0.001
Cardiogenic shock within 24 h 18,858 (1.11) 8,427 (0.97) 10,431 (1.25) <0.001
Cardiac arrest within 24 h 25,824 (1.51) 11,838 (1.36) 13,986 (1.68) <0.001
present continuous variables. To balance the patients’ characteristics the early period and a procedure in the late period for each physician
for the comparison of vascular complications, we first performed a in the same type of access site (femoral or radial). The variables
logistic regression model with an indicator of post period (1 5 late included in the model were age, female sex, black race, other race, prior
period and 0 5 early period) as dependent variables to generate the MI, prior heart failure, prior valve surgery, non-insulin-treated diabetes,
propensity scores for each procedure and then matched a procedure in insulin-treated diabetes, dialysis, cerebrovascular disease, peripheral
4 | BADRI ET AL.
T AB LE 2 Vascular complications following transfemoral PCIs in the early and late periods
arterial disease, chronic lung disease, hypertension, smoking, dyslipide- Most patients were hypertensive (82.6%) and dyslipidemic (79.1%).
mia, family history of premature CAD, prior PCI, prior CABG, thrombo- Compared to patients undergoing PCI in the early period, those treated
lytics, heart failure within 2 weeks, cardiogenic shock within 24 h, in the late period were older and more likely to have prior myocardial
cardiac arrest within 24 h, CAD presentation (symptoms unlikely ische- infarction, end-stage renal disease on dialysis, cardiogenic shock, and
mic, stable angina, unstable angina, NSTEMI, STEMI), undergoing other cardiac arrest within 24 h of the procedure (P < 0.01). In addition,
procedures, catheterization status (elective, urgent, emergent), PCI sta- higher proportions of patients in the late period presented with acute
tus (urgent, emergent, salvage), cardiogenic shock at the start of PCI, myocardial infarction (both ST elevation and non-ST elevation) and
PCI for high-risk NSTEMI or unstable angina, and procedure medica- lower proportions presented with stable coronary syndromes. The
tions (aspirin, P2Y12 inhibitors, anticoagulants, direct thrombin inhibi- remaining baseline demographic, clinical, and procedural characteristics
tors, and GP IIb/IIIa inhibitors). With the matched procedures, we then of patients undergoing the procedures are listed in Table 1.
compared the vascular complications between early and late period for The proportion of PCIs performed using the transradial approach
each of the three groups using the McNemar’s test for the matched increased from 1.3% in the early period to 17.8% in the late period.
pairs and conditional logistic regression to examine the effect of the Among 4697 operators who were primarily femoral operators (>90%
late versus early period on vascular complications. Numbers and per- of PCIs) in the 2010–2011 early period, the majority 3790 (80.7%)
centage of the vascular complications among the matched pairs and remained low-level adopters in the late (2014–2015) period, whereas
the odds ratio for post period versus the early period were reported. 738 (15.7%) were intermediate-level adopters and 169 (3.6%) were
high-level adopters.
3 | RESULTS Among patients matched by operator and access site, the primary
endpoint of access-site related vascular complications following trans-
A total of 1,704,708 PCI procedures were performed across the two femoral PCIs performed by all operators increased from 1.30%
study periods (early period: 873,145; late period: 831,563). The mean to 1.64% (adjusted OR [95% CI]: 1.26 [1.22–1.30], P < 0.001). Findings
age of patients was 65.0 years and 32.0% of patients were women. were similar across groups stratified by physician adoption of
BADRI ET AL. | 5
T AB LE 3 scular complications following all PCIs in the early and late periods
Complications among high-level (>66%) transradial adopters 134 (1.41) 167 (1.76) 0.05 1.25 (0.99–1.57) 0.055
Total 47 (0.50) 84 (0.89) 0.001
Access site bleeding 69 (0.73) 55 (0.58) 0.20
Access site hematoma 16 (0.17) 23 (0.24) 0.26
Retroperitoneal bleeding 49 (0.52) 42 (0.44) 0.46
Other vascular complications
study with higher rates of patients with acute coronary syndromes, car- interventions on an increasingly complex patient population without
diogenic shock, cardiac arrest, and end-stage renal disease in the late significant increase in access-site related complications.
compared to the early period. Although these factors were controlled
for and included in the logistic regression model, there may be unmeas- ACKNOWLE DGME NT
ured factors that increase the risk of periprocedural bleeding that likely
This study was supported by the American College of Cardiology
coexist in the same group of high-risk patients.
Foundation’s (ACCF) National Cardiovascular Data Registry (NCDR).
Several studies have demonstrated a significant reduction of
access-site vascular complications when PCI is performed through the
DISC LOSUR E
transradial approach [16,17]. In many studies this reduction in compli-
Drs Minges and Curtis receive salary support under contract with the
cations was associated with reduced adverse events including mortality
National Cardiovascular Data Registry to provide analytic services. Dr
[2,3]. Transradial PCI also offers significant cost savings related to
Curtis has ownership interest in Medtronic. There were no other dis-
reduction in the rates of complications, shorter lengths of stay and
closures to report.
reduced nursing workload [18,19]. Nevertheless, the skills required to
perform emergent and nonemergent transfemoral procedures remain
essential for all interventional cardiologists. Hence, the potential adverse ORC ID
impact of adopting the transradial approach on femoral skills seen in Marwan Badri MBChB http://orcid.org/0000-0003-0159-6670
two single-center studies would have significant implications for both Jeptha P. Curtis MD http://orcid.org/0000-0002-6872-0501
practicing interventionists and fellows in training [8,9]. The lack of asso- William A. Gray MD http://orcid.org/0000-0003-4676-2839
ciation we observed between operators’ adoption of transradial PCI and
clinically significant femoral complications despite an increasingly com- RE FE RE NC ES
plex patient population seen in our study is therefore reassuring. Fur- [1] Jolly SS, Yusuf S, Cairns J, Niemelä K, Xavier D, Widimsky P, Budaj
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Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR. Radial versus
level between adoption of the transradial approach at PCI centers and
femoral access for coronary angiography and intervention in
vascular complications following transfemoral procedures [20]. The find-
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between transradial adoption and vascular complications, it has several Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial ver-
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5 | CONCLUSIONS of ST-elevation myocardial infarction: A report of the American Col-
lege of Cardiology Foundation/American Heart Association Task
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in access site bleeding, adopting the transradial approach as the default [6] Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Col-
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BADRI ET AL. | 7