Comparison of 3-year clinical outcomes after transradial versus transfemoral percutaneous coronary...

ORIGINAL ARTICLE

Comparison of 3-year clinical outcomes after transradialversus transfemoral percutaneous coronary intervention

Masahiro Natsuaki • Takeshi Morimoto • Yutaka Furukawa •

Yoshihisa Nakagawa • Kazushige Kadota • Masashi Iwabuchi •

Satoshi Shizuta • Hiroki Shiomi • Takeshi Kimura

Received: 13 December 2011 / Accepted: 25 January 2012 / Published online: 28 February 2012

� Japanese Association of Cardiovascular Intervention and Therapeutics 2012

Abstract Transradial approach is an established proce-

dure in percutaneous coronary intervention (PCI). How-

ever, long term clinical outcomes of transradial PCI

compared to transfemoral PCI have not been fully eluci-

dated. Among 13087 patients undergoing first PCI in the

CREDO-Kyoto registry Cohort-2 from January 2005 to

December 2007, we identified 2736 patients with trans-

radial approach and 4092 patients with transfemoral

approach, excluding patients with acute myocardial

infarction, patients on dialysis and patients treated with

transbrachial approach. Using propensity score methodol-

ogy, 2701 patients with transfemoral approach were ran-

domly matched to 2701 patients with transradial approach

based on clinical, angiographic, and procedural character-

istics. The rates for procedural success of PCI were high in

both transradial and transfemoral PCI (99 vs. 98%,

P = 0.57). At 30 days, there was no significant difference

in the incidence of all-cause death between the 2 groups

(radial group 0.2% vs. femoral group 0.2%, P = 0.73).

Incidence of bleeding event tended to be lower in the radial

group than in the femoral group (1.0 vs. 1.6%, P = 0.09),

and incidence of puncture site bleeding was significantly

lower in the radial group than in the femoral group (0.2 vs.

0.6%, P = 0.005). Through 3-year follow up, cumulative

incidence of all-cause death was not significantly different

between the 2 groups (5.6 vs. 6.7%, hazard ratio 0.90 (95%

confidence interval 0.71–1.13), P = 0.35]. In conclusion,

transradial PCI reduced 30-day puncture site bleeding

event compared to transfemoral PCI, with similar PCI

success rates. In contrast, 3-year mortality rate was com-

parable between transradial and transfemoral PCI.

Keywords Transradial � Transfemoral � Approach

Introduction

Percutaneous coronary intervention (PCI) has been tradi-

tionally performed via the femoral artery. However, fem-

oral approach is associated with significant risk of bleeding

complications [1]. Radial artery is one of the access sites

for coronary procedure. Diagnostic coronary angiography

via radial artery was first performed by Campeau [2].

On behalf of the CREDO-Kyoto PCI/CABG Registry Cohort-2

Investigators.

Electronic supplementary material The online version of thisarticle (doi:10.1007/s12928-012-0098-z) contains supplementarymaterial, which is available to authorized users.

M. Natsuaki � S. Shizuta � H. Shiomi � T. Kimura (&)

Department of Cardiovascular of Medicine,

Graduate School of Medicine, Kyoto University,

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan

e-mail: [email protected]

T. Morimoto

Center for Medical Education and Clinical Epidemiology Unit,

Graduate School of Medicine, Kyoto University, Kyoto, Japan

Y. Furukawa

Department of Cardiovascular Medicine,

Kobe City Medical Center General Hospital, Kobe, Japan

Y. Nakagawa

Division of Cardiology, Tenri Hospital, Tenri, Japan

K. Kadota

Division of Cardiology, Kurashiki Central Hospital,

Kurashiki, Japan

M. Iwabuchi

Division of Cardiology, Kokura Memorial Hospital,

Kitakyushu, Japan

123

Cardiovasc Interv and Ther (2012) 27:84–92

DOI 10.1007/s12928-012-0098-z

http://dx.doi.org/10.1007/s12928-012-0098-z

Subsequently, Kiemeneij and Laarman [3] performed cor-

onary stent implantation through radial artery in 1993.

Transradial PCI has gained increasing popularity since its

introduction and has been reported to be associated with

less bleeding or vascular complications compared to

transfemoral PCI [4–6]. However, long term clinical out-

comes after transradial PCI compared to transfemoral PCI

have not been fully elucidated [7–9]. In this study, 30-day

and 3-year clinical outcomes of patients undergoing first

PCI were compared between transradial PCI and transfe-

moral PCI in a large cohort of patients enrolled in the

CREDO-Kyoto (Coronary REvascularization Demonstrat-

ing Outcome study in Kyoto) registry cohort-2.

Methods

Study population

The CREDO-Kyoto registry cohort-2 is a multi-center reg-

istry enrolling consecutive patients undergoing first coro-

nary revascularization among 26 centers in Japan between

January 2005 and December 2007 [10]. The relevant review

boards or ethics committees in all 26 participating centers

approved the research protocol (Supplemental Appendix A).

Because of retrospective enrollment, written informed con-

sents from the patients were waived; however, we excluded

those patients who refused participation in the study when

contacted for follow-up. This strategy is concordant with the

guidelines for epidemiological studies issued by the Ministry

of Health, Labor and Welfare of Japan.

During the 3 years of enrollment period, 13144 patients

underwent PCI as the first coronary revascularization pro-

cedure. Excluding 57 patients who refused study partici-

pation, 13087 patients were enrolled in the PCI arm of the

registry. We excluded 4729 patients with acute myocardial

infarction (MI) and 397 patients on hemodialysis because

femoral approach was mostly selected in those patients. In

addition, excluding 1099 patients treated via brachial artery

and 34 patients with missing information on arterial access

site, 6828 patients were subjected to the current analysis.

In the current analysis, we compared clinical outcomes

at 30 days and through 3 years after PCI between the 2

groups of patients treated by transradial PCI (radial group

2736 patients) and transfemoral PCI (femoral group 4092

patients). Since there were marked differences in baseline

clinical, angiographic, and procedural characteristics

between the 2 groups, we used propensity score matching

methodology to adjust those differences.

Scheduled staged PCI procedures during the index hospi-

talization or performed within 3 months of the initial proce-

dure were not regarded as follow-up events, but were included

in the index procedure. In patients who underwent staged PCI

procedures, arterial access site was evaluated only at the time

of the first PCI procedure. When the initial access site was

changed to another site due to arterial puncture failure, we

recorded the final access site in the case report form. Rec-

ommended antiplatelet regimen was aspirin (C81 mg daily)

indefinitely and thienopyridine (200 mg ticlopidine or 75 mg

clopidogrel daily) for at least 3 months. Duration of anti-

platelet therapy was left to the discretion of each attending

physician. Unfractionated heparin was generally used as anti-

thrombotic agent during PCI and the dose of heparin was left

to the local site protocols in the participating centers.

Definitions

Definitions of baseline clinical characteristics were descri-

bed previously [10]. Endpoints assessed for 30-day clinical

outcome included death, MI, stroke, major adverse car-

diovascular events (MACE) (a composite of death, MI, or

stroke), bleeding, puncture site bleeding and non-puncture

site bleeding, while endpoints assessed for 3-year clinical

outcome included death, cardiac death, MI, stroke, MACE,

bleeding, target-lesion revascularization (TLR) and target-

vessel revascularization (TVR). Death was regarded as

cardiac in origin unless obvious non-cardiac causes could

be identified. Any death during the index hospitalization

was regarded as cardiac death. MI was defined according to

the definition in the Arterial Revascularization Therapy

Study [11]. Within 1 week of the index procedure, only

Q-wave MI was adjudicated as MI. Stroke during follow-up

was defined as ischemic or hemorrhagic stroke requiring

hospitalization with symptoms lasting[24 h. Bleeding was

defined according to the Global Utilization of Streptokinase

and Tissue plasminogen activator for Occluded coronary

arteries (GUSTO) classification [12]. GUSTO moderate or

severe bleeding was adjudicated as a bleeding event.

Among GUSTO moderate or severe bleeding, procedural

bleeding such as hematoma and retroperitoneal bleeding

was defined as puncture site bleeding, although measure-

ment of hematoma size was not conducted. TLR was

defined as either PCI or coronary artery bypass grafting due

to restenosis or thrombosis of the target lesion that included

the proximal and distal edge segments as well as the ostium

of the side branches. TVR was defined as either PCI or

coronary artery bypass grafting of the target vessel. Pro-

cedural success of PCI was defined as successful dilatation

of at least one lesion with residual stenosis\50% by visual

estimation without procedure related MI.

Data collection and follow-up

Demographic, angiographic, and procedural data were

collected from hospital charts or databases according to

pre-specified definitions in each participating center by

Outcomes of transradial intervention 85

123

experienced clinical research coordinators from the study

management center (Supplemental Appendix B). Follow-up

data were obtained from hospital charts or by contacting

patients or referring physicians. Cardiac death, MI, stroke and

bleeding were adjudicated against original source documents

by a clinical event committee (Supplemental Appendix C).

Since final data collection for follow-up events was

initiated on July 1st, 2009, follow-up events were censored

on this date. Median follow-up duration was 965 (inter-

quartile range 705–1239) days.

Statistical analysis

Categorical variables were compared with the Chi-square test.

Continuous variables were expressed as mean value ± stan-

dard deviation or median and interquartile range. Continuous

variables were compared using the Student’s t test or Wilco-

xon rank sum test based on the distribution. Cumulative

incidence was estimated by the Kaplan–Meier method and

differences were assessed with the log-rank test.

The propensity score was calculated from the 19 clini-

cally relevant factors shown in Tables 1 and 2 and ‘center’.

We selected these factors in line with the previous report

[13]. The continuous variables were dichotomized by

clinically meaningful reference values or median values.

The 35 patients with transradial approach and 26 patients

with transfemoral approach were excluded in this analysis

because of missing information of estimated glomerular

filtration rate. Using the propensity score, patients in the

femoral group were randomly matched to radial access

patients using a greedy matching strategy [13].

We used univariate Cox proportional hazard models to

estimate the risk of radial group compared to femoral group

for long-term clinical events. Proportional hazard

assumption for the comparison between the radial and

femoral approaches in all-cause death was assessed on the

plots of log (time) versus log [-log (survival)] stratified by

the approach site. The effects of the approach site (radial

compared to femoral) were expressed as hazard ratios (HR)

and their 95% confidence intervals (CI).

Statistical analyses were conducted by a physician

(Natsuaki M) and by a statistician (Morimoto T) with the

use of JMP 8.0 (SAS Institute Inc, Cary, NC, USA) and

SAS 9.2 (SAS Institute Inc, Cary, NC, USA) softwares. All

the statistical analyses were two-tailed. P values \0.05

were considered statistically significant.

Results

Baseline characteristics

The femoral group as compared with the radial group

included more patients with female gender, urgent procedure

and unstable angina. The femoral group had more comor-

bidities such as hypertension, diabetes, renal dysfunction,

heart failure, mitral regurgitation, prior MI, anemia and

thrombocytopenia. Peripheral vascular disease was more

common in the radial group. Baseline medications were also

different between the 2 groups (Table 1). In terms of

angiographic and procedural characteristics, significantly

more patients with complex characteristics were included in

the femoral group than in the radial group. Procedural suc-

cess rate was significantly higher in the radial group than in

the femoral group. Sheath size and amount of contrast were

greater in the femoral group (Table 2).

After propensity score matching, 2701 patients out of

4066 patients with transfemoral approach were randomly

matched to 2701 patients with transradial approach. In the

matched cohort, baseline characteristics were generally well

balanced except for age, ejection fraction, and prior MI.

Patients in the femoral group were older and had lower

ejection fraction than those in the radial group, while patients

in the radial group included more patients with prior MI. In

terms of lesion characteristics, there were not significant

differences between the 2 groups. In terms of procedural

characteristics, the rate for procedural success was similar in

the 2 groups. Sheath size and amount of contrast were sig-

nificantly greater in the femoral group (Tables 1, 2).

Clinical outcomes at 30 days after percutaneous

coronary intervention

In the total study population, the 30-day incidences of death,

MI, stroke and MACE were not significantly different

between the radial and the femoral group (Table 3). How-

ever, the incidence of bleeding was significantly lower in the

radial group than in the femoral group (1.1 vs. 2.6%,

P \ 0.0001). Incidences of puncture site bleeding as well as

non-puncture site bleeding were significantly lower in the

radial group than in the femoral group (0.2 vs. 1.0%,

P \ 0.0001, 0.9 vs. 1.6%, P = 0.02, respectively) (Table 3).

After propensity matching, the incidences of death, MI,

stroke and MACE were similar between the 2 groups

(Table 3). However, the incidence of bleeding tended to be

lower (1.0 vs. 1.6%, P = 0.09). Puncture site bleeding was

significantly lower in the radial group than in the femoral

group (0.2 vs. 0.6%, P = 0.005), while there was no sig-

nificant difference in the incidence of non-puncture site

bleeding between the 2 groups (0.9 vs. 0.9%, P = 0.89)

(Table 3; Fig. 1).

Clinical outcomes through 3 years after percutaneous

coronary intervention

In the total study population, the 3-year incidences of all-

cause death and cardiac death were significantly lower in

86 M. Natsuaki et al.

123

Table 1 Baseline characteristics

All patients Matched cohorts

Radial (N = 2736) Femoral (N = 4092) P value Radial (N = 2701) Femoral (N = 2701) P value

(A) Clinical characteristics

Age (years) 68.4 ± 10.3 68.6 ± 10.3 0.35 68.4 ± 10.3 69.1 ± 10.3 0.01

Age C75 yearsa 31% 31% 0.52 31% 35% 0.004

Malea 75% 69% \0.0001 75% 73% 0.06

BMI 24.0 ± 3.4 23.9 ± 3.4 0.42 24.0 ± 3.5 23.8 ± 3.2 0.16

BMI \25.0a 66% 65% 0.33 66% 67% 0.49

Urgent procedurea 4.1% 9.7% \0.0001 4.0% 4.2% 0.73

Unstable angina pectorisa 7.1% 13% \0.0001 7.0% 8.3% 0.07

Hypertensiona 83% 85% 0.04 83% 85% 0.12

Diabetes mellitus 38% 40% 0.03 38% 37% 0.48

On insulin therapya 7.9% 8.8% 0.16 7.9% 7.4% 0.51

Heart failurea 11% 15% \0.0001 11% 9.8% 0.30

NYHA IVa 5.0% 9.4% \0.0001 1.4% 0.9% 0.052

Prior myocardial infarctiona 11% 18% \0.0001 11% 9.1% 0.02

Peripheral vascular diseasea 10% 7.1% \0.0001 10% 10% 0.62

eGFR 67.1 ± 18.8 65.0 ± 28.1 0.0008 67.1 ± 18.8 66.5 ± 18.9 0.23

eGFR \60, not on dialysisa 34% 39% \0.0001 34% 35% 0.69

Anemia (Hb \11 g/dl)a 7.8% 11% \0.0001 7.8% 6.7% 0.13

Platelet \100a109/La 0.8% 1.3% 0.05 0.9% 0.6% 0.34

EF 63.3 ± 11.4 59.9 ± 13.1 \0.0001 63.3 ± 11.4 62.5 ± 12.2 0.02

EF B40% 5.0% 9.4% \0.0001 5.0% 6.5% 0.03

Prior stroke 11% 12% 0.63 14% 13% 0.36

Atrial fibrillation 7.7% 7.8% 0.87 7.8% 7.4% 0.64

Shock at presentation 0% 0.1% 0.52 0% 0% 1.0

Mitral regurgitation grade 3/4 3.1% 4.5% 0.004 3.2% 3.2% 0.94

COPD 3.7% 4.3% 0.25 3.7% 3.9% 0.72

Current smoking 26% 28% 0.24 26% 26% 0.90

Liver cirrhosis 2.3% 2.5% 0.69 2.4% 2.9% 0.27

Malignancy 10% 10% 0.66 10% 11% 0.72

(B) Baseline medication

Medication at hospital discharge

Antiplatelet therapy

Thienopyridine 98% 98% 0.09 98% 98% 0.13

Ticlopidine 87% 91% \0.0001 86% 90% \0.0001

Clopidogrel 13% 9.1% \0.0001 14% 10% \0.0001

Aspirin 98% 99% 0.07 98% 99% 0.21

Cilostazole 9.1% 11% 0.004 9.0% 11% 0.02

Other medications

Statins 51% 54% 0.04 51% 56% 0.0006

Beta-blockers 23% 28% \0.0001 23% 24% 0.16

ACE-I/ARB 48% 53% \0.0001 48% 51% 0.06

Nitrates 37% 41% 0.0003 37% 38% 0.26

Calcium channel blockers 52% 50% 0.12 52% 52% 0.59

Nicorandil 19% 26% \0.0001 19% 23% 0.003

Warfarin 6.9% 7.3% 0.53 7.0% 5.7% 0.05

Proton pump inhibitors 19% 22% 0.009 19% 19% 0.81


123

the radial group than in the femoral group. There were not

significant differences in the incidences of MI and stroke

between the 2 groups. Incidences of MACE, bleeding, TLR

and TVR were significantly lower in the radial group than

in the femoral group (Table 4).

After propensity matching, there was no significant

difference in 3-year all-cause mortality between the radial

and the femoral groups (Table 4; Fig. 2a). There were also

no significant differences in the incidences of cardiac

death, MI, stroke, MACE, bleeding, TLR and TVR

between the 2 groups (Table 4; Fig. 2b, c, d).

The 3-year incidence of all-cause death in patients with

puncture site bleeding was remarkably higher compared to

those without bleeding (30 vs. 6.3%, P \ 0.0001).

Discussion

The main findings of the current analysis are as follows: (1)

Transradial PCI was associated with lower incidence of

30-day puncture site bleeding compared to transfemoral

PCI with very high rate of procedure success; (2) The risk

Table 2 Lesion and procedural characteristics



Multi vessel diseasea 51% 62% \0.0001 52% 50% 0.13

Target of proximal LADa 57% 62% \0.0001 57% 56% 0.41

Target of unprotected LMCAa 2.3% 4.4% \0.0001 2.3% 2.9% 0.20

Target of CTOa 6.9% 24% \0.0001 6.8% 6.7% 0.87

Target of bifurcationa 32% 38% \0.0001 32% 33% 0.23

Side-branch stenting 4.4% 6.7% \0.0001 4.4% 5.3% 0.10

Number of target lesions 1 (1–2) 1 (1–2) \0.0001 1 (1–2) 1 (1–2) 0.66

1.42 ± 0.70 1.54 ± 0.81 1.43 ± 0.70 1.43 ± 0.73

Total number of stents 1 (1–2) 2 (1–3) \0.0001 1 (1–2) 1 (1–2) 0.53

1.80 ± 1.18 2.06 ± 1.38 1.80 ± 1.18 1.82 ± 1.17

Total stent length (mm) 28 (18–48) 35 (20–59) \0.0001 28 (18–49) 28 (18–49) 0.86

38.4 ± 28.5 44.7 ± 33.1 38.4 ± 28.3 38.4 ± 28.0

Total stent length [28 mm 47% 56% \0.0001 47% 48% 0.39

Minimum stent size (mm) 3 (2.5–3.0) 2.75 (2.5–3.0) \0.0001 3 (2.5–3.0) 3 (2.5–3.0) 0.14

2.90 ± 0.44 2.85 ± 0.42 2.90 ± 0.44 2.92 ± 0.45

Minimum stent size \3.0 mm 45% 50% \0.0001 45% 44% 0.49

Procedural success of PCI 99% 96% \0.0001 99% 98% 0.57

DES use 67% 65% 0.25 67% 65% 0.19

Sheath size (french) 6.11 ± 0.44 6.73 ± 0.58 \0.0001 6.11 ± 0.44 6.68 ± 0.60 \0.0001

Sheath size [6 french 15% 69% \0.0001 15% 63% \0.0001

Contrast amount (ml) 150 (106–200) 190 (135–260) \0.0001 150 (106–200) 180 (125–240) \0.0001

Contrast amount [175 ml 38% 56% \0.0001 38% 52% \0.0001

Staged PCI 16% 23% \0.0001 16% 17% 0.48

LAD left anterior descending artery, LMCA left main coronary artery, CTO chronic total occlusion, PCI percutaneous coronary intervention, DESdrug eluting stenta Variables selected for propensity analysis

Table 1 continued



H2-blockers 23% 22% 0.38 23% 22% 0.49

BMI body mass index, NYHA IV New York Heart Association class IV, eGFR estimated glomerular filtration rate, Hb hemoglobin, EF ejection

fraction, COPD chronic obstructive pulmonary disease, ACE-I angiotensin converting enzyme inhibitors, ARB angiotensin receptor blockersa Variables selected for propensity analysis


123

for 3-year mortality and other clinical outcomes were

comparable between transradial PCI and transfemoral PCI.

Traditionally, femoral approach has been the preferred

approach for PCI, but it is associated with a higher risk of

bleeding complications [1]. Observational and meta-anal-

ysis of randomized studies reported that transradial PCI

reduces PCI-related hemorrhagic complications compared

to transfemoral PCI [4, 5]. This study, in concordance with

those reports, confirmed that the 30-day bleeding event

tended to be lower and puncture site bleeding was signif-

icantly lower after transradial PCI than after transfemoral

PCI. As post-PCI bleeding as well as post-PCI transfusion

is reported to be associated with adverse prognosis [14–

21], radial approach would be recommended to reduce

bleeding complications especially in those patients with

high bleeding risks. Crude analysis of this study also

showed that patients with puncture site bleeding had

remarkably worse prognosis compared to those without

bleeding. Furthermore, post-PCI bleeding is also an

important endpoint in the clinical trials of anti-thrombotic

agents. We should take arterial access site into consider-

ation when interpreting these trial results.

Several previous observational studies suggested better

long-term survival or cardiovascular outcomes after trans-

radial PCI compared to transfemoral PCI. Sciahbasi et al.

[7] reported that the radial approach was associated with a

significantly lower rate of 1-year death or recurrent

infarction. Arzamendi et al. [8] reported that the radial

approach was associated with a decreased risk of major

Table 3 Event rates at 30 days after PCI



Death 5 (0.2%) 18 (0.4%) 0.07 5 (0.2%) 4 (0.2%) 0.73

MI 34 (1.3%) 39 (1.0%) 0.25 33 (1.2%) 28 (1.0%) 0.52

Stroke 6 (0.2%) 21 (0.5%) 0.06 6 (0.2%) 3 (0.1%) 0.31

Death/MI/stroke 41 (1.5%) 73 (1.8%) 0.37 40 (1.5%) 35 (1.3%) 0.56

Bleeding 29 (1.1%) 104 (2.6%) \0.0001 28 (1.0%) 42 (1.6%) 0.09

Puncture site bleeding 5 (0.2%) 41 (1.0%) \0.0001 4 (0.2%) 17 (0.6%) 0.005

Non-puncture site bleeding 24 (0.9%) 63 (1.6%) 0.02 24 (0.9%) 25 (0.9%) 0.89

PCI percutaneous coronary intervention, MI myocardial infarction

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

Bleeding Puncture site bleeding Non-puncture sitebleeding

Inci

denc

e

P=0.005 P=0.89

P=0.09 radialfemoral

Fig. 1 Incidence of 30-day bleeding after propensity score matching:

radial versus femoral patients

Table 4 Event rates at 3 years after PCI


Radial

(N = 2736)

Femoral

(N = 4092)

HR (95% CI) P Radial

(N = 2701)

Femoral

(N = 2701)

HR (95% CI) P

All-cause

death

124 (5.6%) 265 (7.6%) 0.72 (0.59–0.88) 0.001 124 (5.6%) 151 (6.7%) 0.90 (0.71–1.13) 0.35

Cardiac

death

47 (2.0%) 124 (3.5%) 0.57 (0.41–0.78) 0.0006 47 (2.1%) 50 (2.0%) 1.00 (0.68–1.46) 0.98

MI 78 (3.3%) 109 (3.1%) 1.03 (0.77–1.36) 0.85 76 (3.3%) 74 (3.1%) 1.06 (0.77–1.45) 0.74

Stroke 78 (3.5%) 148 (4.2%) 0.81 (0.62–1.05) 0.11 78 (3.6%) 102 (4.6%) 0.84 (0.63–1.11) 0.23

Death/MI/

stroke

251 (11.1%) 456 (12.8%) 0.83 (0.72–0.96) 0.01 250 (11.2%) 277 (11.8%) 0.97 (0.82–1.14) 0.68

Bleeding 137 (5.8%) 292 (7.9%) 0.71 (0.58–0.86) 0.0006 136 (5.8%) 163 (6.8%) 0.86 (0.69–1.07) 0.18

TLR 427 (17.1%) 733 (19.3%) 0.84 (0.74–0.94) 0.003 419 (17.0%) 419 (16.4%) 0.99 (0.87–1.13) 0.91

TVR 528 (21.3%) 894 (23.6%) 0.85 (0.77–0.95) 0.003 518 (21.1%) 519 (20.4%) 0.99 (0.87–1.11) 0.81

PCI percutaneous coronary intervention, MI myocardial infarction, TLR target lesion revascularization, TVR target vessel revascularization, HRhazard ratio, CI confidence interval


123

adverse cardiac events (cardiac death, MI, or TLR) at

1-year. In contrast, Saito et al. [9] reported there were not

significant differences in 9-month cardiovascular outcomes

between radial and femoral groups in their randomized

controlled trial. However, follow-up periods of these

reports were shorter and numbers of patients were smaller

compared to those of our study. The current study with

3-year follow-up demonstrated that the incidences of all-

cause death, cardiac death, MACE, bleeding, TLR and

TVR through 3 years were significantly lower in the radial

0

10

20

30

0 365 730 1095

All-cause Death

Days after Stent implantation

Cu

mu

lati

ve In

cid

ence

(%)

radial

femoral

Log-rank P=0.35

Interval 0 day 30 days 1 year 2 years 3 yearsfemoral group

N of events 4 72 114 151N of patients at risk 2701 2688 2565 2047 1140Incidence 0.2% 2.7% 4.5% 6.7%

radial groupN of events 5 47 97 124N of patients at risk 2701 2667 2558 1923 960Incidence 0.2% 1.8% 3.9% 5.6%

0 365 730 1095

Death/ MI/ Stroke


Cu

mu

lati

ve In

cid

ence

(%)

radial

femoral

Log-rank P=0.68




30

20

10

0

0 365 730 1095

Bleeding


Cu

mu

lati

ve In

cid

ence

(%)

radial

femoral

Log-rank P=0.18




30

20

10

00 365 730 1095

TLR


Cu

mu

lati

ve In

cid

ence

(%)

radial

femoral

Log-rank P=0.91




30

20

10

0

A B

C D

Fig. 2 a Cumulative incidence of all-cause death after propensity

score matching: radial versus femoral patients. b Cumulative inci-

dence of death/MI/stroke after propensity score matching: radial

versus femoral patients. MI myocardial infarction. c Cumulative

incidence of bleeding after propensity score matching: radial versus

femoral patients. d Cumulative incidence of target lesion revascular-

ization after propensity score matching: radial versus femoral

patients. TLR target lesion revascularization


123

group than in the femoral group in the crude analysis.

However, the femoral group generally had more comor-

bidities and more complex lesions than the radial group.

Although operators experienced in transradial approach

might not switch access site in complex cases, many

operators prefer to use femoral access in more complicated

patients. To adjust imbalances between the 2 groups, we

performed propensity matched analysis. After propensity

matching, rate of access site bleeding remained lower in

the radial group than in the femoral group, while cumula-

tive incidences of all-cause death, cardiac death, MACE,

bleeding, TLR and TVR were not different between the 2

groups. Slight but significant excess of access site bleeding

associated with transfemoral approach did not adversely

affect the long-term clinical outcomes after PCI.

Recently, the radial versus femoral access for coronary

intervention (RIVAL) trial has been published [22]. This

randomized controlled trial showed that there was not a

significant difference in primary endpoint (death, MI,

stroke, or major bleeding at 30 days) between radial and

femoral accesses. They also showed updated meta-analysis

including RIVAL trial. The updated meta-analysis revealed

that the risk of major bleeding was significantly lower in

patients with radial access compared to those with femoral

access, although significant risk reductions were not found

in death, MI and stroke. Our current study result was

consistent with these recent observations.

Although transradial PCI was suggested to be favorable

procedure in terms of reducing bleeding complications,

there are some disadvantages in this procedure. Guiding

catheter size is limited in the transradial PCI. Sheath size

was significantly larger in the femoral group than in the

radial group in this study. Large guiding catheter provides

better back-up support and also enables to use bulky device

in complex lesions, which might lead to higher prevalence

of complex lesions in the femoral group than in the radial

group. Sheath-less guiding catheter is considered to be one

of the devices to overcome this disadvantage of transradial

PCI. The rate of arterial access failure is also reported to be

higher in the radial access than in the femoral access [6,

23]. Furthermore, transradial PCI itself is also considered

to be technically more demanding than transfemoral PCI.

In RIVAL trial, radial access seemed to be beneficial

compared with femoral access in centers undertaking a

high number of radial procedures. These centers had lower

crossover rates and better outcomes, probably because of

more expertise with radial access [22]. Sufficient expertise

and experience might be important in transradial PCI. Even

so, procedural success rate of transradial PCI in this study

is high enough to recommend transradial approach in a

large proportion of patients undergoing PCI. Approach site

for PCI should be finally decided based on the patient or

lesion characteristics as well as skill of operator.

Some limitations to our study should be considered. This

study only had information on successful arterial access

and it was impossible to capture arterial access site failure.

Also, long-term patency of radial artery was not evaluated.

Moreover, only the first PCI procedure in each patient was

evaluated. Some patients with staged PCI procedures might

have undergone both transfemoral and transradial proce-

dures. This study was an observational study and had

limitations that are common to all observational studies

caused by differences in the patients’ background charac-

teristics among groups, that are basically related to selec-

tion bias by the operators. Large scale randomized control

trial may be required to obtain stronger evidence for long-

term clinical outcomes of transradial PCI compared to

transfemoral PCI.

In conclusion, transradial PCI reduced 30-day puncture

site bleeding event compared to transfemoral PCI, with

similar PCI success rates. In contrast, there was not a

significant difference in 3-year mortality between transra-

dial and transfemoral PCI. The lower risk of access site

bleeding could be a reasonable ground for choosing the

radial approach in PCI.

Acknowledgments We appreciate the support and collaboration of

the co-investigators participating in the CREDO-Kyoto PCI/CABG

Registry Cohort-2. We are indebted to the outstanding effort of the

clinical research coordinators for data collection. This study was

supported by the Pharmaceuticals and Medical Devices Agency

(PMDA) in Japan.

Conflict of interest Takeshi Kimura serves as an advisory board

member for Cordis Cardiology, Abbott Vascular and Terumo Com-

pany. The remaining authors reported no conflicts of interest.

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