transradial approach in myocardial infarction · conclusions routine transradial primary pci can be...

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239 Acta Cardiol 2011; 66(2): 239-245 doi: 10.2143/AC.66.2.2071257 Address for correspondence: Wei-Hsian Yin, MD, PhD, Division of Cardiology, Cheng-Hsin General Hospital, No. 45, Cheng-Hsin Street, Pei-Tou, Taipei, Taiwan, R.O.C. E-mail: [email protected]; [email protected] Received 21 April 2010; revision accepted for publication 24 November 2010. INTRODUCTION Transradial angioplasty and stenting are safe and effective methods of percutaneous coronary intervention (PCI) when compared with conventional transfemoral intervention 1,2 . During the past decade, many reports regarding the feasibility and efficacy of transradial cor- onary intervention in the setting of acute myocardial infarction (MI) have been encouraging 3-13 . Although there is concern that the difficulties in obtaining vascular access owing to the smaller size of the radial artery and in learning the technique of trans- radial intervention lead to delay in reperfusion 2,14-18 , a Transradial approach in myocardial infarction Hsu-Lung JEN 1,2 , MD, PhD; Wei-Hsian YIN 1,3 , MD, PhD; Kuan-Chun CHEN 1,4 , MD; An-Ning FENG 1 , MD; Shih-Ping MA 1 , RN; Chin-Feng CHENG 1 , RN; Mason Shing YOUNG 1 , MD 1 Division of Cardiology, Department of Internal Medicine, Cheng-Hsin General Hospital; 2 Institute of Clinical Medicine; 3 Faculty of Medicine, and 4 Institute of Emergency and Critical Care Medicine, National Yang-Ming University, School of Medicine, Taipei, Taiwan. Objective This study investigates the feasibility, efficacy, and safety of routine primary percutaneous coronary intervention via transradial approach in patients with acute ST-elevation myocardial infarction. Methods and results From 2005 to 2007, 122 consecutive patients with acute ST-elevation myocardial infarction within 12 hours, including those experiencing cardiogenic shock, were eligible for primary transradial PCI if the radial artery pulse could be felt. Efficacy, safety, and major adverse cardiac events regarding mortality, recurrent non-fatal myocardial infarction, and revascularization were recorded. Eighty-five of 122 patients underwent transradial PCI, and 37 had transfemoral PCI. Older women, haemodynamic instability, and the presence of severe chronic kidney disease (stages 4 and 5) or end-stage renal disease were significantly related to choice of transfemoral approach (P < 0.05). Glycoprotein IIb/IIIa inhibitors were used more often in patients who underwent transradial PCI than in those who underwent transfemoral PCI (37% vs 16%; P = 0.043). The incidence of major bleeding com- plications requiring blood transfusion was significantly higher in the transfemoral group (P = 0.004). A similar procedural success rate was achieved in both groups (P = 0.737). During follow-up of 580 days, the total major adverse cardiac events were similar in both groups (P = 0.299). Conclusions Routine transradial primary PCI can be safely and successfully performed on up to 70% of acute ST-elevation myocardial infarction patients and, compared with transfemoral approach, is associated with a significantly reduced rate of major bleeding complications. Keywords Acute myocardial infarction – PCI – transradial approach – transfemoral approach. major advantage of the transradial approach in PCI is that vascular access site complications related to the use of fibrinolytic drugs, antiplatelets, and glycoprotein IIb/ IIIa inhibitors, are significantly lower than those of a transfemoral approach 19-23 . In view of the fact that the transradial approach considerably reduces vascular access site complication and is less uncomfortable for the patient, we have adopted this technique as routine for PCI in our institu- tion since November 1997. Primary PCI via the trans- radial approach has been the preferred method for all acute MI patients since 2005 when all physicians in our institution had already done transradial PCI for more than 300 cases. In this study, we retrospectively analysed our experi- ences with primary PCI in acute ST elevated MI, clas- sifying patients according to whether we used a transra- dial or a transfemoral approach from 2005 to 2007. Approximately 1000 PCI procedures were done in the hospital each year, and more than 80% of them, via a transradial approach. The efficacy, safety, and clinical outcomes of both methods were analysed accordingly.

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Page 1: Transradial approach in myocardial infarction · Conclusions Routine transradial primary PCI can be safely and successfully performed on up to 70% of acute ST-elevation myocardial

239Acta Cardiol 2011; 66(2): 239-245 doi: 10.2143/AC.66.2.2071257

Address for correspondence:

Wei-Hsian Yin, MD, PhD, Division of Cardiology, Cheng-Hsin General Hospital, No. 45, Cheng-Hsin Street, Pei-Tou, Taipei, Taiwan, R.O.C. E-mail: [email protected]; [email protected]

Received 21 April 2010; revision accepted for publication 24 November 2010.

INTRODUCTION

Transradial angioplasty and stenting are safe and effective methods of percutaneous coronary intervention (PCI) when compared with conventional transfemoral intervention1,2. During the past decade, many reports regarding the feasibility and efficacy of transradial cor-onary intervention in the setting of acute myocardial infarction (MI) have been encouraging3-13.

Although there is concern that the difficulties in obtaining vascular access owing to the smaller size of the radial artery and in learning the technique of trans-radial intervention lead to delay in reperfusion2,14-18, a

Transradial approach in myocardial infarction

Hsu-Lung JEN1,2, MD, PhD; Wei-Hsian YIN1,3, MD, PhD; Kuan-Chun CHEN1,4, MD; An-Ning FENG1, MD; Shih-Ping MA1, RN; Chin-Feng CHENG1, RN; Mason Shing YOUNG1, MD1Division of Cardiology, Department of Internal Medicine, Cheng-Hsin General Hospital; 2Institute of Clinical Medicine; 3Faculty of Medicine, and 4Institute of Emergency and Critical Care Medicine, National Yang-Ming University, School of Medicine, Taipei, Taiwan.

Objective This study investigates the feasibility, effi cacy, and safety of routine primary percutaneous coronary intervention via transradial approach in patients with acute ST-elevation myocardial infarction.

Methods and results From 2005 to 2007, 122 consecutive patients with acute ST-elevation myocardial infarction within 12 hours, including those experiencing cardiogenic shock, were eligible for primary transradial PCI if the radial artery pulse could be felt. Effi cacy, safety, and major adverse cardiac events regarding mortality, recurrent non-fatal myocardial infarction, and revascularization were recorded. Eighty-fi ve of 122 patients underwent transradial PCI, and 37 had transfemoral PCI. Older women, haemodynamic instability, and the presence of severe chronic kidney disease (stages 4 and 5) or end-stage renal disease were signifi cantly related to choice of transfemoral approach (P < 0.05). Glycoprotein IIb/IIIa inhibitors were used more often in patients who underwent transradial PCI than in those who underwent transfemoral PCI (37% vs 16%; P = 0.043). The incidence of major bleeding com-plications requiring blood transfusion was signifi cantly higher in the transfemoral group (P = 0.004). A similar procedural success rate was achieved in both groups (P = 0.737). During follow-up of 580 days, the total major adverse cardiac events were similar in both groups (P = 0.299).

Conclusions Routine transradial primary PCI can be safely and successfully performed on up to 70% of acute ST-elevation myocardial infarction patients and, compared with transfemoral approach, is associated with a signifi cantly reduced rate of major bleeding complications.

Keywords Acute myocardial infarction – PCI – transradial approach – transfemoral approach.

major advantage of the transradial approach in PCI is that vascular access site complications related to the use of fibrinolytic drugs, antiplatelets, and glycoprotein IIb/IIIa inhibitors, are significantly lower than those of a transfemoral approach19-23.

In view of the fact that the transradial approach considerably reduces vascular access site complication and is less uncomfortable for the patient, we have adopted this technique as routine for PCI in our institu-tion since November 1997. Primary PCI via the trans-radial approach has been the preferred method for all acute MI patients since 2005 when all physicians in our institution had already done transradial PCI for more than 300 cases.

In this study, we retrospectively analysed our experi-ences with primary PCI in acute ST elevated MI, clas-sifying patients according to whether we used a transra-dial or a transfemoral approach from 2005 to 2007. Approximately 1000 PCI procedures were done in the hospital each year, and more than 80% of them, via a transradial approach. The efficacy, safety, and clinical outcomes of both methods were analysed accordingly.

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H.-L. Jen et al.240

were done according to the standard methods. Use of thrombectomy devices and glycoprotein IIb/IIIa antag-onists was at the discretion of the physician. Cardiac markers (creatine kinase, creatine kinase MB, and tro-ponin) were analysed every 6 hours for the first 24 hours after having the PCI. Use of post-procedural heparin was discouraged. After the procedure, all patients received daily aspirin 100 mg and clopidogrel 75 mg for at least 9 months unless contraindicated.

Vascular access site haemostasis

For the transradial approach, the arterial access sheaths were removed immediately after the transradial procedures, and haemostasis was achieved by radial compression with a pressure clamp. The clamp was removed within 2 to 3 hours if haemostasis was achieved and changed to a pressure dressing. The pressure dress-ing was removed within 12 hours after the intervention.

For the transfemoral approach, the arterial access sheaths were removed 4 to 6 hours after the procedure, regardless of the use of glycoprotein IIb/IIIa inhibitors. Haemostasis was achieved by manual compression for 20 to 30 minutes, subsequently followed by a pressure bandage and sandbag application for another 8 to 12 hours. No closure devices were used in the present study.

Study endpoints and defi nitions

Endpoints were recorded from the start of the pro-cedure to at least 6 months’ follow-up. After discharge, all patients were routinely checked at regular outpatient visits. Clinical information regarding safety and efficacy endpoints was provided by the cardiologists in charge.

The primary safety endpoints of this study were defined as the incidence of major bleeding complications requiring blood transfusion, including vascular access site bleeding and other major bleeding (intracranial or gastrointestinal bleeding), and major adverse cardiac events including mortality, recurrent non-fatal MI, and any revascularization procedure during the follow-up.

The primary efficacy endpoint was defined as the procedural success rate (achievement of successful rep-erfusion). Successful reperfusion was defined as achieve-ment of a residual diameter stenosis of < 30% with Thrombolysis In Myocardial Infarction (TIMI) grade 3 flow at the end of PCI.

Data analysis

Statistical analyses were performed with SPSS software for Windows (Statistical Product and Service Solutions, version 12.0, SSPS Inc, Chicago, IL, USA). Continuous variables are expressed as mean ± SD. The

METHODS

Study population

We retrospectively reviewed 141 consecutive patients with STEMI, within 12 hours from onset of chest pain, who underwent primary PCI in Cheng-Hsin General Hospital between June 2005 and June 2007. Among them, 19 were excluded because of mechanical compli-cations, left main disease, or severe multivessel disease requiring emergency surgical intervention. The remain-ing 122 patients were recruited for the present study. The diagnosis of STEMI was made in the presence of both prolonged chest pain lasting more than 30 minutes, unresponsiveness to nitroglycerin and electrocardio-graphic (ECG) changes matching the electrocardio-graphic criteria of STEMI. Electrocardiographic criteria of STEMI are ST elevation of ≥ 1 mm in ≥ 2 contiguous ECG leads.

In our institution, all patients with acute STEMI, including those with cardiogenic shock, were considered eligible for primary transradial PCI if the radial artery pulse could be felt. Should 1 radial access fail but the vascular access time was still < 5 minutes, we usually chose the opposite radial access. However, the left and right groin sites also were prepared before the procedure in case radial approach should fail. We avoided perform-ing primary transradial PCI on those patients with a feeble or absent radial pulse, an abnormal Allen test, a small-sized radial artery that precluded the use of a 6-French introducer, an abnormality of the artery that caused coronary cannulation failure, or vascular access time > 5 minutes. If the patient was under chronic hae-modialysis or had severe chronic kidney disease (stage 4 or 5) and was considered a candidate for future hae-modialysis, we avoided the transradial approach so as to preserve the radial artery for future autogenous radi-ocephalic arteriovenous fistula. The final decision between the radial and the femoral approach was nev-ertheless left to the discretion of the physician. The ethical committee of the hospital approved the study protocol.

Primary PCI procedures, anticoagulant, and antiplatelet regimen

All patients undergoing primary PCI were pretreated with aspirin (300 mg) and clopidogrel (300 mg). In both transradial and transfemoral groups, the arterial access was done using an appropriate introducer. Subsequent to the arterial puncture and sheath insertion, heparin 5000 to 10 000 IU intravenous was administered, with a target activated clotting time of 250 to 300 seconds, or 200 to 250 seconds for patients receiving glycoprotein IIb/IIIa inhibitors. Transradial and transfemoral PCI

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Transradial approach for acute myocardial infarction 241

hospital, location of infarction, risk factors, previous stroke, previous MI, prior PCI or coronary artery bypass grafting (CABG), number of diseased vessels, peak creatine kinase levels, and baseline lipid profile between groups.

durations of follow-up are expressed by medians (25th to 75th percentiles). Categorical data are presented as a percentage frequency.

Patients were divided into 2 groups based on their PCI approaches. Univariate comparisons of clinical char-acteristics, procedural parameters, complications, and follow-up data between the 2 groups were made with the t test or the Wilcoxon signed rank test for quantita-tive data, and with the chi-square test or Fisher exact test for qualitative data.

Kaplan-Meier analyses of cumulative event-free rates between the 2 groups were done, and the differences between their event-free curves were tested by a log-rank test. Acute MI patients were then divided into those who had major adverse cardiac events during follow-up and those who were event-free during follow-up. Multi-variable Cox proportional hazards analyses were done to determine the significance of possible adverse baseline variables, markers of severity of infarction, and proce-dural parameters as independent predictors of clinical outcomes. Data are reported as the estimated hazard ratios and 95% confidence intervals. A P value < 0.05 was considered significant.

RESULTS

Baseline patient characteristics

The baseline characteristics of the patients are given in table 1. Eighty-five patients had radial PCI (70%), and 37 underwent femoral PCI (30%). Younger age; male sex; absence of severe, chronic kidney disease; and haemodynamic stability were significantly related to the use of the radial approach (P values all < 0.05). Among the 37 patients (11%) who underwent a transfemoral PCI, the femoral approach was used in 4 patients with poor or absent radial pulse, and 12 patients (32%) were under chronic haemodialysis or had severe chronic kid-ney disease; thus, they were considered candidates for future haemodialysis. For the 17 patients (46%) with haemodynamic instability who required a second vas-cular access site for transvenous temporary pacing or intra-aortic balloon pumping (IABP), physicians also chose the transfemoral approach. Two patients (5.5%) had a radial attempt that failed owing to an unsuccessful radial puncture within 5 minutes; 2 others (5.5%) with a radial attempt that failed with marked tortuosities of brachio-subclavian artery that caused coronary can-nulation failure were later switched to the femoral approach. There were more patients with the infarct-related artery of left circumflex artery in the transradial group than in the femoral group (13% vs 0%; P = 0.033); however, there was no statistical difference regarding the times from onset of the symptoms to arrival at the

Table 1 Demographic variables, risk factors, and other parameters of the 122 study patients undergoing primary percutaneous coronary intervention

TR (N = 85) TF (N = 37) P value

Age, years 60 ± 11 68 ± 15 0.005

Male gender, n (%) 70 (82) 20 (54) 0.020

Diabetes mellitus, n (%) 23 (27) 10 (27) NS

Hypertension, n (%) 45 (53) 26 (70) NS

Hyperlipidaemia, n (%) 78 (92) 29 (78) NS

Smoking, n (%) 50 (59) 16 (43) NS

Family history of early CAD, n (%) 43 (51) 16 (43) NS

Severe chronic kidney disease, n (%) 6 (7) 12 (32) 0.001

Prior stroke, n (%) 3(4) 3 (8) NS

Prior myocardial infarction, n (%) 9 (11) 3 (8) NS

Prior CABG, n (%) 1 (1) 2 (5) NS

Prior PCI, n (%) 18 (21) 7 (19) NS

Total cholesterol, mg/dL 187 ± 35 177 ± 43 NS

LDL-cholesterol, mg/dL 126 ± 35 115 ± 40 NS

HDL-cholesterol, mg/dL 36 ± 8 38 ± 10 NS

Triglycerides, mg/dL 148 ± 89 118 ± 72 NS

Chest pain onset to arrival, hours 3.2 ± 2.3 3.9 ± 2.8 NS

Location of MI, n (%)

anterior 43 (51) 18 (49) NS

inferior/lateral 42 (49) 19 (51) NS

Infarct-related artery, n (%)

Left anterior descending 43 (51) 18 (49) NS

Left circumfl ex 11 (13) 0 (0) 0.033

Right coronary artery 31 (37) 19 (51) NS

Number of diseased vessel, n (%)

single 23 (27) 5 (14) NS

double 24 (28) 11 (30) NS

triple 38 (45) 21 (57) NS

Killip class, n (%)

I 52 (61) 12 (32) 0.006

II 29 (34) 14 (38) NS

III 1 (1) 4 (11) 0.049

IV 3 (4) 7 (19) 0.013

Peak creatine kinase, IU/L 3200 ± 2100 2474 ± 2083 NS

CABG: coronary artery bypass grafting, CAD: coronary artery disease, HDL-cholesterol: high-density lipoprotein cholesterol, LDL-cholesterol: low-density lipoprotein cholesterol, MI: myocardial infarction, PCI: percutaneous coronary intervention, TF: transfemoral group, TR: transradial group.

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Procedural results and outcomes

Procedural data and outcomes are given in table 2. The door-to-balloon time, the size of the sheaths used for PCI procedures, the reference vessel diameter, the lesion length, and the TIMI flow before and after the PCI were similar in both radial and femoral groups. Glycoprotein IIb/IIIa inhibitors were used more often in patients who underwent radial PCI than femoral PCI (37% vs 16%; P = 0.043), but the use of thrombectomy devices was similar in both groups. The stenting rate, the use of drug-eluting stent, and the mean number of stents used during each stenting procedure did not dif-fer between the groups.

Table 2 Procedural characteristics and outcomes of the 122 study patients undergoing primary percutaneous interventions

TR (N = 85) TF (N = 37) P value

Door-to-balloon time, minutes 81 ± 38 92 ± 33 NS

IABP support or temporary pacing, n (%) 14 (17) 17 (46) 0.001

Guiding catheter, n (%)

5Fr 1 (1) 0 (0) NS

6Fr 77 (91) 33 (89) NS

7Fr 6 (7) 4 (11) NS

8Fr 1 (1) 0 (0) NS

Reference vessel diameter, mm 3.1 ± 0.6 3.1 ± 0.6 NS

Lesion length, mm 23 ± 6 23 ± 12 NS

Stent used, n (%) 59 (69) 22 (60) NS

Bare metal stent 39 (46) 18 (49) NS

Drug-eluting stent 20 (24) 4 (11) NS

Stent number/patient 1.1 ± 0.2 1.1 ± 0.4 NS

Initial TIMI fl ow, n (%)      

0 76 (89) 30 (81) NS

1 6 (7) 7 (19) NS

2 3 (4) 0 (0) NS

3 0 (0) 0 (0) NS

Glycoprotein IIb/IIIa, n (%) 31 (37) 6 (16) 0.043

Thrombectomy, n (%) 16 (19) 4 (11) NS

Final TIMI fl ow, n (%)

0 0 (0) 1 (3) NS

1 0 (0) 2 (5) NS

2 6 (7) 1 (3) NS

3 79 (93) 33 (89) NS

Procedural success rate, n (%) 79 (93) 33 (89) NS

Major bleeding complications requiring blood transfusion, n (%)

1 (1) 9 (24) <0.0001

Vascular access bleeding 0 (0) 3 (8) 0.043

Gastrointestinal bleeding 1 (1) 5 (14) 0.015

Intracranial haemorrhage 0 (0) 1 (3) NS

IABP: intra-aortic balloon pumping, TF: transfemoral group, TIMI: Thrombolysis In Myocardial Infarction, TR: transradial group.

Successful reperfusion of the culprit artery (proce-dural success rate) was achieved in 93% in the transradial group and 89% in the transfemoral group (P = 0.737). Incidence of major bleeding complications requiring blood transfusion including vascular access bleeding, gastrointestinal bleeding, and intracranial bleeding, also was significantly higher in the transfemoral group, com-pared to that of the transradial group (24% vs 1%; P < .0001).

Clinical outcomes

The median follow-ups were 575 days (range, 357 to 840 days, 25th to 75th percentiles) for the transradial group and 590 days (range, 227 to 879 days, 25th to 75th percentiles) for the transfemoral group (P = .580). There was a 43% overall event rate (52 of 122) in the study population. In-hospital mortality was significantly higher in the transfemoral group, compared with the transradial group (1% vs 14%; P = 0.015). But the mortal-ity after discharge, recurrent non-fatal MI, and revascu-larization rates were similar in both groups (table 3).

Kaplan-Meier analyses of cumulative event-free rates between the transradial and transfemoral groups show that the difference in event-free survival curves for mor-tality and recurrent non-fatal MI between the 2 groups was significant (P = 0.012) (figure 1A). Event-free sur-vival curves for total major adverse cardiac events dur-ing follow-up do not differ significantly (figure 1B).

After adjustment for the possible adverse baseline variables, markers of severity of infarction, and proce-dural parameters, the following independent predictors for mortality and recurrent non-fatal MI were identified:

Table 3 Incidence of major adverse cardiac events in 122 patients undergoing primary percutaneous interventions

TR (N = 85) TF (N = 37) P value

Follow-up period, days 575 (357, 840) 590 (227, 879) NS

Total major adverse cardiac events 33 (39) 19 (51) NS

Total Mortality 3 (4) 6 (16) 0.037

In-hospital mortality 1 (1) 5 (14) 0.015

Mortality after discharge 2 (2) 1 (3) NS

Recurrent non-fatal MI 1 (1) 1 (3) NS

Any Revascularization 29 (34) 12 (32) NS

Target lesion Revascularization 13 (15) 3 (8) NS

Target vessel Revascularization 1 (1) 0 (0) NS

Coronary artery bypass grafting 6 (7) 2 (5) NS

PCI for non-IRA 9 (11) 7 (19) NS

IRA: infarct-related artery, MI: myocardial infarction, PCI: percutaneous coronary intervention, TF: transfemoral group, TR: transradial group.

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significantly reducing major bleeding complications requiring blood transfusion than the transfemoral approach, despite more-frequent use of glycoprotein IIb/IIIa inhibition in the transradial group.

age; presence of severe, chronic kidney disease; end-stage renal disease; haemodynamic instability requiring tem-porary pacing or IABP; and inferior/lateral wall infarc-tion (table 4).

Stenting, presence of triple-vessel disease, haemody-namic instability requiring temporary pacing or IABP, and inferior/lateral wall infarction were significantly associated with total major adverse cardiac events. In both models, the use of either transradial or transfemo-ral approach was not an independent predictor for long-term clinical outcomes.

DISCUSSION

In acute MI, access site complications are more likely to occur when PCI is done under conditions of aggres-sive anticoagulation and antiplatelet therapy, particularly with the use of glycoprotein IIb/IIIa receptor inhibi-tors19-23. The radial artery easily can be compressed against the radius allowing easy haemostasis after tran-sradial PCI. Therefore, one of the most important ration-ales for the transradial approach in performing primary PCI is an attempt to reduce the incidence of vascular access bleeding complications, and in this regard, several studies have demonstrated the superiority of the tran-sradial approach to the transfemoral approach3-13,19-23.

Our data are consistent with those studies and indicate that primary transradial PCI performed by experien -ced physicians on a routine basis yields a comparable procedural success rate, offering more advantages by

Fig. 1 Kaplan-Meier analyses of cumulative event-free rates in the acute MI patients, stratified into 2 groups based on whether the transradial or the transfemoral approach was used. The difference in event-free survival curves for mortality and recurrent nonfatal MI between the 2 groups was significant (P = 0.012, log-rank test) (figure 1A); however, the event-free survival curves for total MACE (mortality, recurrent non-fatal MI, and any revascularization procedure after the index primary percutaneous intervention procedure) during follow-up hardly differ from one another (figure 1B).

Table 4 Predictors of major adverse cardiac events during follow-up: Multivariate Cox proportional hazard analysis*

Model Hazard ratio 95% CI P value

Model 1

Mortality and non-fatal myocardial infarction

Inferior/lateral wall myocardial infarction 0.1 0.1 - 0.96 0.049

Age 1.2 1.0 - 1.4 0.018

Severe chronic kidney disease or ESRD 174 2.8 - 10687 0.014

Required IABP or temporary pacing 67 1.0 - 4927 0.050

Model 2

Mortality, non-fatal MI, and Revascularization

Inferior/lateral wall myocardial infarction 0.4 0.2 - 0.9 0.017

Stenting 0.5 0.3 - 0.9 0.039

Triple-vessel disease 1.9 1.1 - 3.4 0.030

Required IABP or temporary pacing 3.7 1.5 - 9.0 0.026

IABP: intra-aortic balloon pumping, ESRD: end-stage renal disease, MI: myo-cardial infarction. * Multivariable Cox proportional hazards analyses were performed to determine the significant variables considered to reflect severity of coronary artery disease and acute myocardial infarction at baseline, and associated with adverse clinical events, including age, gender, risk factors, the time between onset of symptoms to hospital, door-to-balloon time, location of infarction, presence of 2- or 3-vessel diseases, haemodynamic instability requiring intra-aortic bal-loon pumping or temporary pacing, procedural data, and concomitant med-ications as independent predictors of clinical outcomes.

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transfemoral approach, because of the difficulties in obtaining vascular access owing to the smaller size of the radial artery in women, and in manipulating guiding catheters in the tortuous brachio-subclavian arteries in the elderly. Therefore, choosing an appropriate route for primary PCI in acute MI is not a matter of establishing a predetermined choice, but selecting the most-suitable arterial access, when the needs of the patients are con-sidered14-18. If the physician of 1 particular patient does not believe that the transradial and the transfemoral interventions are equally feasible, whichever arterial access the physician considers safer and more effective for the patient should be applied.

An important limitation of the present study is that because it is retrospective, certain degrees of the physi-cians’ biases based on their experiences with transradial or transfemoral procedures cannot be thoroughly elim-inated. It is also worth noting that the present study was performed by those physicians having substantial tran-sradial experiences, so no major technical limitations would pose problems in their primary PCI via the tran-sradial route; the benefits of this technique may be less apparent with inexperienced physicians. Furthermore, owing to economic considerations, we have seldom used closure devices after the transfemoral approach in our institution for they are not reimbursable by health insur-ance system in Taiwan. Otherwise, all previous reports clearly state that this named strategy can significantly reduce major access bleeding complications.

CONCLUSIONS

An increasing number of patients with STEMI are currently treated with transradial approach in our insti-tution. In the present study, primary transradial PCI performed by skilled physicians has been proved as safe and feasible as the transfemoral approach and can be successfully performed in up to 70% of the patients. There is, however, a significant number of patients who still must be treated by or crossed over to a transfemoral approach. Therefore, in real-world daily practices, the choice of access site should be based on compelling clinical and patient factors instead of merely the suitabil-ity of an artery’s access.

CONFLICT OF INTEREST: none declared.

Several drawbacks of the transradial approach in acute MI also have been noted2,14-18. One of the major concerns regarding the use of the transradial approach in the setting of acute MI is the possible delay in achiev-ing reperfusion because transradial access is more tech-nically challenging and associated with a steep learning curve and high access-site failure rate. However, all the physicians involved in this study were experienced inter-ventional cardiologists and the door-to-balloon times in this study were similar in both transradial and trans-femoral groups. This means that when performed by experienced physicians, STEMI patients can be safely treated via a transradial approach. Furthermore, the need to use devices that require guiding catheters with a caliber greater than 6-French may have a negative effect on transradial PCI (though almost all devices can be introduced through 6-French catheters). In fact, we have found that 7-French sheath and guiding catheters were compatible with the radial artery diameter in about 70% of the cases, and 8-French in 13% in our institution (unpublished data).

The difficulty in accessing a second vascular access site for IABP in cardiogenic shock and/or a transvenous temporary pacemaker can still be argued in favour of the transfemoral approach14-18. Patients with cardiogenic shock were excluded from most of the previous transra-dial PCI studies. Although our data show that physicians were prone to use the transfemoral approach for those patients with haemodynamic instability, some cardio-genic shock patients were treated successfully with the transradial approach so long as their radial artery pulses were palpable. Cardiogenic shock or haemodynamic instability, per se, cannot stand as contraindication for primary transradial PCI. According to previous studies, primary transradial PCI also can be accomplished with-out much difficulties in most cardiogenic shock patients with a detectable radial pulse9,13. Moreover, there are theoretical reasons to support why transradial PCI may actually improve door-to-balloon times in patients with cardiogenic shock or profound bradycardia, because 1 physician can cannulate the radial artery in preparation for PCI while another, the femoral artery for the IABP or femoral vein for the pacer.

Nevertheless, in our institution, there are a significant number of STEMI patients requiring treatment by or a cross-over to the transfemoral approach. In addition to those who have severe chronic kidney disease or end-stage renal disease and poor or absent radial pulse, patients with haemodynamic instability and failed radial approach comprise a significant proportion of the trans-femoral population in acute MI. Moreover, according to our findings, more older women were in the trans-femoral group. They reflect the real-world practice of physician preferring to select acute MI patients for the

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