1

Introduction

Transradial approach (TRA), when compared to transfemoral approach (TFA), has been shown to lower bleeding and vascular complications during percutaneous coronary intervention (PCI) . Furthermore, several studies have suggested that TRA is associated with superior clinical outcomes in specific high-risk patient populations . These findings, together with patient preferences have increased the use of TRA inside and outside of the US. However, TRA is still uncommon, especially in the US , and experienced transfemoral operators are potentially concerned about such a transition and the learning curve associated with the implementation of a TRA program.

There are limited data regarding the characteristics of a TRA learning curve, especially in an era with designated TRA equipment. In our institution, a TRA program was established at a defined date after which TRA was the default access in all procedures. Utilizing this opportunity we aimed to assess the characteristics and outcomes of TFA versus the initial steps of a TRA program and to assess the learning curve of TRA among experienced TFA operators in a high-volume PCI center.

2

Methods

The study was approved by the institutional review boards of MedStar Washington Hospital Center and the MedStar Health Research Institute. A dedicated data coordinating center performed all data management and analyses. Clinical observational analysis of consecutive patients undergoing elective or urgent PCI at MedStar Washington Hospital Center (Washington, DC) was performed.

TRA program was initiated January 2011. After that time, all patients with adequate ulnar artery perfusion were selected for TRA. Patients undergoing PCI by one of the two operators who initiated the TRA program (RL, RG) were divided into two cohorts according to vascular access approach: the last 250 patients prior to the establishment of TRA program (TFA group) and the initial 239 TRA patients following the establishment of TRA program (TRA group). In order to assess TRA learning curve characteristics, consecutive cases were chronologically ranked from January 2011 to August 2012, and stratified into the first 50 and subsequent 51–100, 101–150, 151–200, and 201–239 cases. Pre-specified clinical and laboratory data at admission and during hospitalization were obtained from hospital charts and were reviewed by independent research personnel unaware of the study objectives.

Operators’ experience with TRA was limited, and was comprised of approximately 10 annual TRA cases in the preceding years, most of which were diagnostic. Both operators participated in a TRA course prior to initiating the TRA program.

All procedures were performed in accordance with the American College of Cardiology/American Heart Association PCI guidelines. Prior to the procedure all patients planned for TRA underwent ulnar artery patency assessment using both the modified Allen’s test and the Barbeau test, both of which required a response grade of A–C in order to qualify for TRA. Patients were pre-medicated with diazepam 5 mg and diphenhydramine 50 mg by mouth. In all patients, midazolam 1 mg and fentanyl 50 mcg intravenous doses were administered prior to arterial access. The right radial artery was preferentially selected unless a left internal mammary artery graft was present. The wrist was prepared and stabilized in a mild dorsiflexion and placed on the catheterization table. Local subcutaneous infiltration of lidocaine hydrochloride 2% and nitroglycerine were administered over the radial artery immediately prior to puncture. Using manual palpation, a 21-gauge needle (Cook Medical, Bloomington, IN) was inserted into the radial artery and a .018″ diameter, 40-cm-long J-tipped wire (Cook Medical) was advanced into the artery. A 5- or 6-French, 100-mm, Glidesheath Basic (Terumo, Somerset, NJ) was introduced over the wire. The dilator was removed and 500-mcg nicardipine hydrochloride was administered intra-arterially via the arterial sheath. A J-tip .035″ guidewire (Medtronic, Minneapolis, MN) or .035″ floppy tip Wholey guidewire (Covidien, Plymouth, MN) was used for advancing the coronary catheters. Typically, for the diagnostic part of the procedure, a 5-French radial TIG (Terumo) was used and for PCI, 5- or 6-French Launcher EBU or Hockey stick guiding catheters (Medtronic) were used. A total of 60-70 units/kg of heparin were administered intravenously after gaining arterial access and additional anticoagulation regimens during PCI were used according to the operator’s discretion. Finally, prior to removal of the radial sheath, 500-mcg nicardipine hydrochloride was administered intra-arterially via the arterial sheath. Post-procedural antiplatelet therapy consisted of aspirin (81 mg/day orally and continued indefinitely after the procedure) and either clopidogrel (75 mg/day), prasugrel (10 mg/day) or ticagrelor (180 mg/day) for at least 3 months after PCI depending on the stent type used.

The primary end points were: (1) major adverse cardiac events (MACE), defined as the composite of death, Q-wave myocardial infarction (MI), or target vessel revascularization (TVR) at 30 days; (2) fluoroscopy time; and (3) contrast volume. Secondary outcome end points included death, Q-wave MI, target lesion revascularization (TLR), TVR, and stent thrombosis according to Academic Research Consortium definitions. Q-wave MI was defined as evidence of new Q waves on the electrocardiogram at admission. Follow-up MI event was defined as a total creatinine kinase increase ≥ 2 × the upper limit of normal and/or creatinine kinase (MB fraction) ≥ 20 ng/ml, together with symptoms and/or ischemic electrocardiographic changes. TLR was defined as ischemia-driven percutaneous or surgical repeat intervention in the stent or within 5 mm proximal or distal to the stent.

Statistical analysis was performed using SAS version 9.1 (SAS Institute Inc., Cary, NC). Continuous variables and categorical variables are expressed as mean ± standard deviation and percentages, respectively. Student’s t-test was used to compare continuous variables, and the chi-square test or Fisher’s exact test was used to compare categorical variables. A p value < 0.05 was considered statistically significant.

2

Methods

The study was approved by the institutional review boards of MedStar Washington Hospital Center and the MedStar Health Research Institute. A dedicated data coordinating center performed all data management and analyses. Clinical observational analysis of consecutive patients undergoing elective or urgent PCI at MedStar Washington Hospital Center (Washington, DC) was performed.

TRA program was initiated January 2011. After that time, all patients with adequate ulnar artery perfusion were selected for TRA. Patients undergoing PCI by one of the two operators who initiated the TRA program (RL, RG) were divided into two cohorts according to vascular access approach: the last 250 patients prior to the establishment of TRA program (TFA group) and the initial 239 TRA patients following the establishment of TRA program (TRA group). In order to assess TRA learning curve characteristics, consecutive cases were chronologically ranked from January 2011 to August 2012, and stratified into the first 50 and subsequent 51–100, 101–150, 151–200, and 201–239 cases. Pre-specified clinical and laboratory data at admission and during hospitalization were obtained from hospital charts and were reviewed by independent research personnel unaware of the study objectives.

Operators’ experience with TRA was limited, and was comprised of approximately 10 annual TRA cases in the preceding years, most of which were diagnostic. Both operators participated in a TRA course prior to initiating the TRA program.

All procedures were performed in accordance with the American College of Cardiology/American Heart Association PCI guidelines. Prior to the procedure all patients planned for TRA underwent ulnar artery patency assessment using both the modified Allen’s test and the Barbeau test, both of which required a response grade of A–C in order to qualify for TRA. Patients were pre-medicated with diazepam 5 mg and diphenhydramine 50 mg by mouth. In all patients, midazolam 1 mg and fentanyl 50 mcg intravenous doses were administered prior to arterial access. The right radial artery was preferentially selected unless a left internal mammary artery graft was present. The wrist was prepared and stabilized in a mild dorsiflexion and placed on the catheterization table. Local subcutaneous infiltration of lidocaine hydrochloride 2% and nitroglycerine were administered over the radial artery immediately prior to puncture. Using manual palpation, a 21-gauge needle (Cook Medical, Bloomington, IN) was inserted into the radial artery and a .018″ diameter, 40-cm-long J-tipped wire (Cook Medical) was advanced into the artery. A 5- or 6-French, 100-mm, Glidesheath Basic (Terumo, Somerset, NJ) was introduced over the wire. The dilator was removed and 500-mcg nicardipine hydrochloride was administered intra-arterially via the arterial sheath. A J-tip .035″ guidewire (Medtronic, Minneapolis, MN) or .035″ floppy tip Wholey guidewire (Covidien, Plymouth, MN) was used for advancing the coronary catheters. Typically, for the diagnostic part of the procedure, a 5-French radial TIG (Terumo) was used and for PCI, 5- or 6-French Launcher EBU or Hockey stick guiding catheters (Medtronic) were used. A total of 60-70 units/kg of heparin were administered intravenously after gaining arterial access and additional anticoagulation regimens during PCI were used according to the operator’s discretion. Finally, prior to removal of the radial sheath, 500-mcg nicardipine hydrochloride was administered intra-arterially via the arterial sheath. Post-procedural antiplatelet therapy consisted of aspirin (81 mg/day orally and continued indefinitely after the procedure) and either clopidogrel (75 mg/day), prasugrel (10 mg/day) or ticagrelor (180 mg/day) for at least 3 months after PCI depending on the stent type used.

The primary end points were: (1) major adverse cardiac events (MACE), defined as the composite of death, Q-wave myocardial infarction (MI), or target vessel revascularization (TVR) at 30 days; (2) fluoroscopy time; and (3) contrast volume. Secondary outcome end points included death, Q-wave MI, target lesion revascularization (TLR), TVR, and stent thrombosis according to Academic Research Consortium definitions. Q-wave MI was defined as evidence of new Q waves on the electrocardiogram at admission. Follow-up MI event was defined as a total creatinine kinase increase ≥ 2 × the upper limit of normal and/or creatinine kinase (MB fraction) ≥ 20 ng/ml, together with symptoms and/or ischemic electrocardiographic changes. TLR was defined as ischemia-driven percutaneous or surgical repeat intervention in the stent or within 5 mm proximal or distal to the stent.

Statistical analysis was performed using SAS version 9.1 (SAS Institute Inc., Cary, NC). Continuous variables and categorical variables are expressed as mean ± standard deviation and percentages, respectively. Student’s t-test was used to compare continuous variables, and the chi-square test or Fisher’s exact test was used to compare categorical variables. A p value < 0.05 was considered statistically significant.

3

Results

A total of 589 PCI procedures were performed by two operators. During the “TFA period,” 250 PCIs via TFA were included for the purpose of this study. During the “TRA period” a total of 339 cases were performed; of these 239 PCIs via TRA, which were analyzed in this study, and additional 100 patients who underwent TFA PCI during the “TRA period” due to unsuitability for TRA. These 100 patients were excluded from this analysis. Of note, comparison between the 239 TRA patients and the excluded 100 TFA patients showed that these two groups did not differ significantly in terms of co-morbidities and lesion complexity.

Baseline characteristics of the two groups were comparable with an average age of 64 ± 12 and 63 ± 12 years in TFA vs. TRA groups, respectively (p = 0.52), with 74% men ( Table 1 ). Ethnicity characteristics were different with a higher percentage of African Americans undergoing TRA (16% vs. 28%, p = 0.002) and a higher percentage of Caucasians undergoing TFA (77% vs. 67%, p = 0.02). No difference in the prevalence of risk factors for atherosclerotic disease was found ( Table 1 ). However, prevalence of baseline heart failure was higher with TFA compared to TRA (12% vs. 7%, p = 0.05). In terms of indication for PCI, lower rates of acute MI were performed via TFA as compared to TRA (11% vs. 23%, p < 0.001).

Procedure characteristics were similar between groups. There were few left main artery interventions, and the majority of interventions were performed on American College of Cardiology/American Heart Association (ACC/AHA) type B or C lesions. Fluoroscopy time was significantly longer during TRA procedures (18 ± 11 vs. 15 ± 8 min, respectively, p = 0.002); however, contrast use was lower during TRA procedures (161 ± 72 vs. 180 ± 63 ml, respectively, p = 0.002) ( Table 2 ). The use of bare metal and drug-eluting stents was also similar between the two approaches. Procedural complication rates were low and did not differ between the two approaches. Major bleeding rates of 1.2% and 1.8% (p = 0.62) with TFA and TRA, respectively, and a trend toward lower major vascular complications among TRA group were noted (2.4% in TFA and 0.4% in TRA, p = 0.12). Hospitalization duration did not differ between the two approaches ( Table 3 ). In-hospital outcomes were similar between the two groups with a low frequency of mortality, MI, and stent thrombosis ( Table 3 ).

Table 2

Procedural characteristics and in-hospital outcomes of PCI patients according to arterial access approach.

	Femoral (n = 250)	Radial (n = 239)	p value
Treated vessel ⁎
Left main	1/336 (0.3%)	0/321	1.0
Left anterior descending	139/336 (41%)	120/321 (37%)	0.3
Left circumflex	74/336 (22%)	64/321 (20%)	0.51
Right coronary	122/336 (36%)	137/321 (43%)	0.1
Lesion type (ACC/AHA criteria) ⁎
Type A	40/336 (12%)	40/320 (13%)	0.82
Type B	147/336 (44%)	152/320 (48%)	0.34
Type C	149/336 (44%)	128/320 (40%)	0.26
Stent type ⁎
Bare metal stent	38/336 (12%)	53/321 (17%)	0.08
Drug-eluting stent	259/336 (77%)	234/321 (73%)	0.22
Fluoroscopy time (min ± SD)	15 ± 8	18 ± 11	0.002
Contrast volume (ml ± SD)	180 ± 63	161 ± 72	0.002
Complications ⁎
Dissection	1/336 (0.3%)	4/321 (1.2%)	0.21
Abrupt closure	1/336 (0.3%)	0/321	1.0
No reflow	2/336 (0.6%)	1/321 (0.3%)	1.0

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