logy 137 (2009) 199–205www.elsevier.com/locate/ijcard

International Journal of Cardio

Transradial access compared with femoral puncture closure devices inpercutaneous coronary procedures

Alessandro Sciahbasi a,⁎, Dionigi Fischetti b, Amedeo Picciolo b, Roberto Patrizi a,Isabella Sperduti c, Giuseppe Colonna b, Francesco Summaria a,

Antonio Montinaro b, Ernesto Lioy a

a U.O. Cardiologia, Policlinico Casilino, ASL RMB, Rome, Italyb Divisione di Emodinamica, Ospedale Vito Fazzi, Lecce, Italy

c Biostatistics Unit, Regina Elena Institute for Cancer Research, Rome, Italy

Received 29 January 2008; received in revised form 2 May 2008; accepted 1 June 2008Available online 8 August 2008

Abstract

Background: Transradial access (RA) is associated with less complications and is preferred by patients. Vascular closure devices (VCDs) mayimprove discomfort and may reduce complications associated with transfemoral access. Aim was to evaluate complications and discomfortassociated with percutaneous coronary procedures employing RA or VCDs.Methods: We enrolled 1492 consecutive patients who underwent percutaneous coronary procedures with RA (604 procedures), femoralapproach with manual compression (MC) (276 procedures), or with either Angioseal™ (311 procedures) or Starclose™ (301 procedures)closure device. Discomfort was assessed using procedure-specific questions. Major vascular complications were evaluated duringhospitalization.Results: RA significantly reduced major complications (0.7%) compared to either the MC (2.9%, p=0.03) or the VCDs (Starclose™ 2.7%,Angioseal™ 3.9%, p=0.003). There were no significant differences in major complications between MC and either the Angioseal™ or theStarclose™. At multivariate analysis the RA was predictor of reduced complications (OR 0.26, 95% CI 0.08–0.85, p=0.03 vs MC, and OR0.19, 95% CI 0.07–0.57, p=0.003 vs VCDs). The RA was associated with a significant reduction in procedural discomfort with 44.2% ofpatients referring no discomfort (pb0.0001). Starclose™ and Angioseal™ were better tolerated than MC (27.8%, 29.3% and 8.9% patientsrespectively without discomfort, pb0.0001).Conclusions: RA is associated with a significant reduction in major vascular complications compared to femoral approach even if twodifferent VCDs are employed. VCDs are better tolerated than MC but the RA was associated with the lowest discomfort.© 2008 Elsevier Ireland Ltd. All rights reserved.

Keywords: Radial; Vascular closure device; Angioseal; Starclose

1. Introduction

Transradial approach (RA) of cardiac catheterization is acommon alternative to transfemoral access for diagnosticcoronary angiography and percutaneous coronary interven-tions (PCI) [1]. The RA reduces access bleeding complica-

⁎ Corresponding author. UOC Cardiologia, Policlinico Casilino-ASLRMB, Rome, Italy. Tel.: +39 06 23188256; fax: +39 06 23188408.

E-mail address: alessandro.sciahbasi@fastwebnet.it (A. Sciahbasi).

0167-5273/$ - see front matter © 2008 Elsevier Ireland Ltd. All rights reserved.doi:10.1016/j.ijcard.2008.06.045

tions [2] and reduces the procedural discomfort of thepatients [3] mostly due to the prolonged vascular compres-sion time and bed rest length associated with the transfe-moral access. However, RA is more demanding for theoperator with longer learning curve [4], increased fluoro-scopy time [5,6] and reduced possibility to perform coronaryinterventions with 7 or 8 French catheters [7].

Vascular closure devices (VCDs) have been developed toreduce bed rest and vascular complications after PCIperformed through femoral access [8]. When compared to

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manual compression these devices facilitate patient mobili-zation, decrease length of hospital stay and improve patientsatisfaction level [9,10]. However the role of VCDscompared to RA in terms of patient discomfort is stillundetermined.

The Angioseal™ is an extensively used VCD, with over5 million devices used up to now, that provide rapid and easyvascular closure following diagnostic and interventionalprocedures. The device is composed of a collagen spongeand a specially designed adsorbable polymer which ensurean endovascular arteriotomy closure. A large meta-analysis[11] showed a reduced trend toward less complications withAngioseal compared to manual compression.

The Starclose™ is a newer VCD that provides extra-vascular hemostasis by a star-shaped nitinol clip. A recentstudy [12] did not demonstrate significant differences inmajor complications compared to the Angioseal™ VCD.However there are no studies comparing the risk ofcomplications with these two VCDs and the risk associatedwith the transradial access.

Aim of this dual center observational study, TransradialAccess compared with femoRAl puNcture closure devices inpercuTAneous coronary procedures (TARANTA study), wasto compare the procedural risk of vascular complicationsassociated with the RA compared with the use of twodifferent VCDs for femoral closure and to evaluate thepatient discomfort associated with the use of VCDs or theRA.

2. Methods

2.1. Patient population

From January 2006 to March 2007, we prospectivelyenrolled consecutive patients referred for cardiac catheter-ization or percutaneous coronary intervention in twodifferent hospitals (Policlinico Casilino, Rome, Italy andVito Fazzi Hospital, Lecce, Italy). Of the 2744 patients whounderwent percutaneous coronary procedures, 1492 wereincluded in the study: patients were excluded for knownvascular disease precluding arterial access, ischemic Allentest, ST-segment elevation acute myocardial infarction, needto use arterial sheaths other than 6 French in diameter,angiographic contraindication to vascular closure device,history of bleeding diathesis, emergency catheterization, lackof informed consent, patients unable to answer our quality oflife questionnaire (patients intubated, dementia) or patientsreferred from department other than cardiology.

Procedures were performed by 8 different interventionalcardiologists and patients underwent coronary procedures inaccordance with the routine practice of the single operator.Three operators performed systematic radial approach, twooperators systematic femoral approach followed by manualcompression, three operators systematic femoral approachwith either Angioseal™ VIP (St. Jude Medical, St. Paul,Minnesota, US) closure device or Starclose™ (Abbott

Vascular, Redwood City, California, US) closure device.Each operator performed at least 300 procedure per year.

The study has been approved by Institutional EthicalCommittee and written informed consent was obtained totake part of the study.

2.2. Procedure

A 6 French artery sheath was utilised in all cases. Only inthe RA group, the Allen test was performed prior to theprocedure and patients with ischemic results (7% of screenedpatients) were excluded from the study. The radial arteryapproach was performed using an hydrophilic guidewire andhydrophilic sheath (Radifocus™, Introducer II, TerumoCorporation, Tokyo, Japan). After sheath insertion, 2.5 mg ofverapamil were injected directly into the radial artery and5000 units of unfractioned heparin were administratedintravenous to all patients. Additional units of unfractionedheparin were given prior to the interventional procedureunder activated clotting time guidance (250–300 s or 200–250 s if glycoprotein IIb/IIIa inhibitors were used).

In the femoral approach a 6 French non-hydrophilicsheath was utilised and unfractioned heparin was given onlyprior to an interventional procedure according to theactivated clotting time results (250–300 s or 200–250 s ifglycoprotein IIb/IIIa inhibitors were used).

The activated clotting time was monitored after theprocedure only in the manual compression group.

Most patients underwent coronary angiography followedby coronary intervention in the same procedure: if thecoronary intervention needed the use of catheters bigger than6 French, the patient was excluded from the study.

2.3. Sheath management

In the radial group, the radial artery sheath wasimmediately removed at the end of the procedure (eitherdiagnostic or interventional) and hemostasis was obtainedusing an inflatable wrist band (TR-BAND™, TerumoCorporation, Tokyo, Japan). The compression device wasprogressively deflated and completely removed within 6–8 h. Patients were allowed to ambulate within 1 h after theprocedure unless contraindicated by their clinical conditions.

In the manual compression group, the femoral sheath wasremoved immediately after the procedure (in case ofdiagnostic exam) or when the activated clotting time wasless than 180 s (in case of interventional procedure).Hemostasis was obtained by manual compression, lastingat least 20 min, and subsequent femoral bandage. Thesepatients had to rest in bed overnight and were allowed towalk the following morning unless their clinical status didnot advise early mobilization.

In the Angioseal™ VIP and Starclose™ group the arterialclosure was performed in the cardiac catheterization laboratoryat the end of the procedure. Patients were allowed to ambulatewithin 3 h unless contraindicated by clinical status.

Table 1Clinical and procedural characteristics of patients.

Manual compression (n=276) Starclose™ (n=301) Angioseal™ VIP (n=311) Transradial approach (n=604) p

ClinicalAge (years) 67.53±11.29 66.81±10.27 67.14±10.15 66.70±10.90 0.73Males (%) 66.7 67.1 65.9 67.9 0.94Weight (kg) 73.53±13.57 73.94±12.58 73.54±12.71 75.34±12.74 0.10Height (cm) 165.62±8.20 165.36±8.38 165.29±7.58 166.38±7.38 0.12Body mass index (kg/m2) 26.77±4.36 27.04±4.28 26.82±4.30 27.16±3.88 0.51ACS (%) 36.2 33.7 30.7 37.6 0.20Diabetes (%) 29.3 24.9 23.2 24.3 0.33

ProceduralPCI (%) 44.2 50.5 35.4 45.4 0.002Multivessel PCI (% of PCI) 18.1 19.2 18.1 17.1 0.87Thienopyridines (%) 94.2 73.3 61.3 91.5 b0.0001GP IIb/IIIa inhibitors (%) 17.8 6.8 5.6 18.9 b0.0001aFluoroscopy time (min) 6 (1–61) 6 (1–45) 5 (1–58) 8 (1–62) b0.0001

Results are expressed as mean and standard deviation. Discrete variables are expressed as percent.ACS: acute coronary syndromes; GP: glycoprotein; PCI: percutaneous coronary interventions.a Median and range.

Fig. 1. Differences in major vascular complications between groups. Theradial approach was associated with a significant reduction in major vascularcomplications compared with both the manual compression and the vascularclosure devices groups. There were no significant differences betweenmanual compression and vascular closure devices or between Starclose™and Angioseal™ VIP. MC: manual compression; RA: transradial approach.

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2.4. Vascular closure devices

The Starclose™ vascular closure system is composed ofan introducer sheath, dilator, guide wire and a clip applier,with a nitinol clip housed in the clip applier. When releasedfrom the clip applier, tines on the clip grasp the edges of thevascular tissue and draw them together to close thearteriotomy site. The system is designed to providemechanical closure without impinging the vessel lumen.

The Angioseal VIP™ vascular closure device is com-posed of a collagen sponge and a specially designedadsorbable polymer anchor that are connected by anadsorbable suture. The device seals the arteriotomy betweenthe anchor and the collagen sponge. The hemostasis isenhanced by the coagulation-inducing properties of thecollagen.

Femoral angiography was performed with 10 ml ofcontrast in right anterior 30° projection in all subjects beforedeploying both vascular closure devices. The followingangiographic criteria were used to guide VCD deployment:1. a femoral puncture far more than 4–5 mm from thefemoral bifurcation; 2. femoral vessel greater than 4 mm and3. absence of diffuse calcification or vascular stenosis greaterthan 40%. If the femoral artery was not suitable to VCDclosure, the patient was excluded from the study and thehemostasis was obtained by manual compression.

2.5. Definition of complications

Major complications include vascular death, pseudo-aneurysm, arteriovenous fistula, major bleeding requiringblood transfusion or surgical intervention, surgical interven-tion at the puncture site, ischemic complication of the limb,stroke or transient ischemic attack.

Minor complications include haematoma not requiringblood transfusion or vascular repair, loss of radial pulse

without ischemia of the arm, failure of the vascular closuredevice.

VCD failure was considered the inability to use the deviceor the persistence of bleeding after the deployment requiringmanual compression.

Procedural failure was considered the inability tocannulate the coronary ostia or the inadequate cathetersupport or the inability to track a device in place.

2.6. Quality of life assessment

Quality of life was assessed in all patients the day after theprocedure using a series of procedure-specific questions aspreviously documented [3]. The procedure-specific questions

Table 2Details of vascular complications.

MC (n=276) Starclose™ (n=301) Angioseal™ VIP (n=311) RA (n=604)

Major complications n (%) 8 (2.9) 8 (2.7) 12 (3.9) 4 (0.7)Vascular death 0 (0) 0 (0) 0 (0) 0 (0)Bleeding requiring transfusion or vascular surgery 5 (1.8) 5 (1.7) 3 (1) 1 (0.2)Pseudoaneurysm requiring surgery 1 (0.4) 1 (0.3) 4 (1.3) 0 (0)Other surgical interventions at the puncture site 0 (0) 2 (0.7) 0 (0) 0 (0)Ischemic complications of the limb 1 (0.4) 0 (0) 4 (1.3) 0 (0)TIA 1 (0.4) 0 (0) 1 (0.3) 2 (0.3)Stroke 0 (0) 0 (0) 0 (0) 1 (0.2)

Failure of the VCD n (%) – 9 (3) 4 (1.3) –Access site failure n(%) 0 (0) 0 (0) 0 (0) 15 (2.5)Procedural failure n (%) 2 (0.7) 1 (0.3) 1 (0.3) 9 (1.5)Loss of radial pulse n (%) – – – 7 (1%)

MC: Manual compression; RA: transradial approach; TIA: transient ischemic attack; VCD: vascular closure device.

Table 3Univariate and multivariate analysis for major complications.

Univariate analysis Multivariate analysis

OR(95% CI)

p value OR(95% CI)

p value

Age (b75 vs ≥75) 0.50(0.24–1.0)

0.05 0.53(0.26–1.09)

0.08

Sex (M vs F) 0.48(0.24–0.97)

0.04 NS

BMI 0.95(0.87–1.04)

0.25

Fluoroscopy time 1.02(0.98–1.06)

0.36

Access site(Manual Compressionvs VCDs)

0.88(0.38–2.03)

0.77 0.77(0.33–1.78)

0.77

(RA vs VCD) 0.20(0.07–0.58)

0.003 0.19(0.07–0.57)

0.003

(RA vs Manualcompression)

0.22(0.07–0.75)

0.02 0.26(0.08–0.85)

0.03

ACS (yes vs no) 0.84(0.39–1.78)

0.64

GPIIb–IIIa inhibitors(yes vs no)

0.66(0.20–2.17)

0.49

Diabetes (yes vs no) 2.37(1.17–4.81)

0.02 2.11(1.03–4.35)

0.04

Thienopyridines(no vs yes)

0.85(0.32–2.23)

0.74

Procedure (Coronarographyvs PCI)

0.79(0.39–1.58)

0.50

ACS: acute coronary syndromes; BMI: body mass index; CI: Confidenceinterval; GP: glycoprotein; NS: not significant; PCI: percutaneous coronaryinterventions; OR: odds ratio; RA: transradial approach; VCD: vascularclosure device.OR and CI can only be calculated for two variables.

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used 0 to 10 visual analog scales [13] to assess overalldiscomfort, the ability to eat, the difficult to urinate, thediscomfort of the bed rest and the discomfort related to thevascular compression. The questionnaires were filled by thepatients after standardized instructions given by nurses. Weconsidered low discomfort scores ranging from 0 to 5 andhigh discomfort scores ranging from 6 to 10.

2.7. Statistical analysis

Data are presented as mean and standard deviation unlessotherwise noted. Student's t-test and Analysis of Variance(ANOVA) were used to compare mean values with theBonferroni correction employed to adjust for multiplecomparisons. A 2-tailed p value of ≤0.05 was consideredstatistically significant. The normality assumptions forANOVA were assessed with the Kolmogorov–Smirnov test.Comparisons of proportions between groups were performedusing a two-sided chi-square test, or if the number expected ofpatients was less than five, a two-sided Fisher's exact test, bothadjusted for multiple comparisons. Multivariate logisticregression analysis was performed to identify independentclinical and procedural predictors of major vascular complica-tions in all patients. The cut-off p value to be enrolled orexcluded from the model were set to 0.10 and 0.15. Results areexpressed as odds ratio (OR) with 95% Confidence Interval(CI). The SPSS (version 11.0) was used for all analysis.

3. Results

Clinical and procedural characteristics of all patientsundergoing coronary procedures (diagnostic or interven-tional) are shown in Table 1. During the 15 months of thestudy, 604 patients underwent coronary angiography or PCIthrough RA (274 PCI), 276 patients through femoral accessfollowed by manual compression (122 PCI), 301 patientsthrough femoral access closed with Starclose™ VCD (152PCI) and 311 patients through femoral access closed withAngioseal™ VIP VCD (110 PCI). All groups were well

matched for age, sex, weight, height, body mass index andhistory of diabetes. More than 30% of the patients in eachgroup were referred for an acute coronary syndrome withoutsignificant differences between groups. The number of PCIwas significantly lower in the Angioseal™VIP group and theuse of glycoprotein IIb/IIIa inhibitors and thienopyridines

Fig. 2. Odds ratio for major complications. The reduction in major complications associated with the radial approach was observed in all subgroups analysed.ACS: acute coronary syndromes; GP: glycoprotein; MC: manual compression; PCI: percutaneous coronary interventions; RA: transradial approach;VCD: vascular closure device.

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was significantly higher in the manual compression and RAgroups compared to VCD groups (pb0.0001). The RA wasassociated with a small but significant increase in fluoroscopytime compared to manual compression and VCD groups(pb0.0001).

3.1. Complications

Major complications were significantly lower in the RAgroup (0.7%) compared both to the manual compressiongroup (2.9%, p=0.03) and to the VCD groups (2.7% forStarclose™, 3.9% for Angioseal™ VIP, p=0.003). Therewere no significant differences between manual compressionand either the Angioseal™ VIP or the Starclose™ groups in

Table 4Quality of life associated with the procedure.

Manual compression (n=276) Starclose™ (n=3

Any discomfortDifficult to urinate (%) 30.1 25.7Difficult to eat (%) 30.0 20.5Pain for compression (%) 67.3 62.9Discomfort of bed rest (%) 84.3 64.1Global discomfort (%) 91.1 72.2

High (6–10 points) discomfortDifficult to urinate (%) 14.2 0.4Difficult to eat (%) 9.7 0Pain for compression (%) 29.7 1.2Discomfort of bed rest (%) 55.8 3.1Global discomfort (%) 8.9 0.4

major complications (Fig. 1). The reduction in majorcomplications observed in the RA group was mainly drivenby less bleeding complications (Table 2).

At the univariate analysis age b75 years, male sex, theabsence of diabetes and the RA were associated with asignificant reduction in the rate of complications. However,the multivariate logistic regression analysis identified the RAas predictor of reduced rate of complications (OR 0.19, 95%CI 0.07–0.57 vs VCDs, p=0.003 and OR 0.26, 95% CI0.08–0.85 vs manual compression, p=0.03) and identifiedthe diabetes as predictor of increase rate of complications(OR 2.11, 95% CI 1.03–4.35, p=0.04), (Table 3). Moreoverthe reduction in major complications associated with the RAwas observed in all subgroups considered (Fig. 2).

01) Angioseal™ VIP (n=311) Transradial approach (n=604) p

30.0 12.8 b0.000122.1 9.5 b0.000161.8 31.6 b0.000166.5 19.4 b0.000170.7 55.8 b0.0001

1.1 3.6 b0.00010.7 3.0 b0.00011.8 7.3 b0.00014.4 6.2 b0.00010.7 0.9 b0.0001

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The rate of failure of the two different VCDs was similaraccounting for 1.3% in the Angioseal™ VIP group and 3%in the Starclose™ group (p=0.143, Table 2).

The procedural failure was very low in all groups buthigher in the RA group compared with the other groups(Table 2).

In 15 patients (2,5%) of the radial group the radial arterycould not be successfully inserted. The following day afterthe procedure the radial artery was not palpable in 7/604patients (1%) of the RA; all these patients were asympto-matic without further clinical vascular events.

3.2. Procedural discomfort

The RAwas associated with a significant reduction in allparameters of procedural discomfort compared to the othergroups (Table 4) with 44.2% of patients referring nodiscomfort for the procedure (pb0.0001). VCDs were bettertolerated than manual compression in terms of shorter lengthof bed rest and of less global discomfort (Table 4). Whendata were analysed considering low (0–5 points) and high(6–10 points) discomfort scores, all the procedures (RA,VCDs and manual compression) were well tolerated withless than 10% of patients showing high global discomfort(Table 4). However both the RA and the use of VCDs werebetter tolerated than the manual compression for all theparameters considered.

4. Discussion

This study compared the transradial approach forcoronary procedures with two different and extensivelyused vascular closure devices. The main finding of the studyis that RA is associated with less major complicationscompared to VCDs and with better patient comfort.

The benefit of transradial access for coronary interventionhas been well documented in the literature [14]: access sitebleeding complications are rare and length of hospital stay issignificantly reduced compared to the traditional femoralaccess. However, RA is considered more demanding for theinterventional cardiologist and the use of VCDs for femoralprocedures represents a good alternative in order to reducevascular complications [15] and patient discomfort [9,10]. Inaddition the recently published European Guidelines fornon-ST elevation myocardial infarction endorse the use ofclosure devices as well as the radial approach to reducebleeding complications in patients undergoing percutaneouscoronary interventions [16]. In our study similar majorcomplications were observed in the VCD and manualcompression groups, whereas the RA had the lowestincidence of vascular complications. This reduction invascular complications is attractive because it was associatedwith a reduction in bleeding complications, a known riskfactor for worse prognosis in patients with acute coronarysyndromes [17,18]. Moreover in our study the lower rate ofvascular complications in the RA group was observed

despite a significantly higher use of glycoprotein IIb/IIIainhibitors and thienopyridines compared to VCD groups andeven if vascular cerebral accidents were included amongmajor vascular complications. Cerebral accidents wereconsidered as major vascular complication on the basis ofsignificantly RA related increased incidence of cerebralaccidents and cognitive disorders reported in some studies[19].

A significant reduction in access site complications withRA compared to the use of the Perclose VCD has beenpreviously reported [5]. However in that study an earlygeneration of vascular closure device with known highercomplication rates compared to the Angioseal™ [9], wasused. Moreover high rates of patients exclusion and cross-over to standard manual compression interfered with theinterpretation of the results. Newer devices like theAngioseal™ VIP and the Starclose™ systems are associatedwith higher closure success rates and with reduced incidenceof vascular complications, and have not yet compared to RA.

Many studies have reported that patient satisfaction washigher using VCDs in comparison to manual compression[9,10]. In fact the use of VCDs was significantly bettertolerated by the patients due to reduction in bed rest length,in discomfort to urinate and to eat and with the compressionrelated pain. However to our knowledge previous studiescomparing the tolerability of VCDs to RA have not beenperformed. In our study we confirmed that VCDs are bettertolerated than manual compression; on the other hand whenVCDs are compared to RA, the latter is better toleratedparticularly because of a reduction in the discomfort relatedto bed rest.

RA is not extensively employed by interventionalcardiologists because there are some concerns about thehigher than with femoral approach procedural failures andabout the risk of post-procedural occlusion of the radialartery. In our study the procedural success with RAwas high(96%) and similar to previous studies [7]. Moreover, in ouropinion, the use of an inflatable wrist band for radialhemostasis, that ensures a progressive artery decompression,was related to a low rate of post-procedural pulse loss. Thisincidence in our study was very low (1%) and lower thanreported in other studies [19,20], although 6F sheaths and 6Fcatheters were used in all procedures. However, in our study,RA was associated with a slight but significant increase influoroscopy time as previously documented [5,6,21]. Highvolume catheterization labs have to consider specialprecautions in order to improve the X-ray protection duringcoronary procedures via the RA.

In other studies [22,23] RA has also been employed toperform primary percutaneous interventions in the setting ofacute ST-elevation myocardial infarction with comparableresults to the femoral approach. However in our study weexcluded patients with ST-elevation myocardial infarctionfor two reasons: a. to avoid confounding results evaluatingthe periprocedural quality of life assessment and b. to avoid aselection bias in a non-randomised trial because in such high

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risk procedures the RA might not be the preferred techniquefor all patients.

The choice of the access site was not determined in arandomized way and this may limit the results of our study.However in the comparison of different vascular accessesperformed by operators who routinely employ a particulartechnique (RA or VCDs), we excluded the complicationsthat may be observed during operator learning curves, orrelated to a reduced skill both with RA and the use of VCDs.Other limitations of our study consist in the short in hospitalfollow-up and in the diagnosis of vascular complicationsbased on clinical data rather than guided by image studies.

In conclusion our study shows a reduction in majorvascular complications with transradial approach comparedto femoral approach, even if two different vascular closuredevices are employed. The transradial approach is alsoassociated with better patient tolerability. Vascular closuredevices seem to be a good option alternative to manualcompression in terms of better patient comfort, although thecomplications rates are similar.

Acknowledgement

The authors of this manuscript have certified that theycomply with the Principles of Ethical Publishing in theInternational Journal of Cardiology [24].

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