Radial versus femoral access for elderly patients with acute coronary syndrome undergoing coronary angiography and intervention: insights from the RIVAL trial

Radial versus femoral access for elderly patients with acute coronary syndrome undergoing coronary angiography and intervention: insights from the RIVAL trial

Radial versus femoral access for elderly patients with acute coronary syndrome undergoing coronary angiography and intervention: insights from the RIV...

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Radial versus femoral access for elderly patients with acute coronary syndrome undergoing coronary angiography and intervention: insights from the RIVAL trial Warren J. Cantor, MD, a Shamir R. Mehta, MD, MSC, b Fei Yuan, MMath, b Vladimír Džavík, MD, c Matthew Worthley, MD, d Kari Niemelä, MD, PHD, e Vicent Valentin, MD, f Anthony Fung, MD, g Asim N. Cheema, MD, PHD, h Petr Widimsky, MD, i Madhu Natarajan, MD, b Barbara Jedrzejowski, MEng, b and Sanjit S. Jolly, MD, MSC b ON, BC, Canada; Adelaide, Australia; Tampere, Finland; Valencia, Spain; and Prague, Czech Republic

Background Radial access for percutaneous coronary intervention is associated with lower rates of access site complications and bleeding. However, elderly patients have more complex vascular anatomy and radial access may be more challenging in this population. There remains uncertainty regarding the role of radial access in elderly patients undergoing cardiac catheterization. Methods and Results

The RIVAL trial randomized patients with acute coronary syndromes undergoing cardiac catheterization to radial versus femoral access. In this analysis, the rates of access site complications and access site cross-over were compared across different age groups. Among the 7,021 patients, 1035 (15%) were ≥75 years of age. Across all age categories, radial access was consistently associated with higher rates of access site cross over and lower rates of major access site complications, with no significant interaction between age and access site. Radial access was associated with lower rates of major vascular access site complications in patients ≥75 years of age (3.6% vs 6.6%; P = .03) and in patients b75 years of age (1.0% vs 3.2%; P b .001; P value for interaction = .2). The rates of access site crossover were higher with radial access among patients ≥75 (12.5% vs 2.6%; P b .001) and b75 (6.7% vs 1.9%; P b .001; P value for interaction = .9). There were no significant differences in the primary composite outcome (death, myocardial infarction, stroke or non coronary artery bypass graft major bleeding) or its individual components in either age group. In patients ≥75 years of age undergoing primary percutaneous coronary intervention, there was no significant difference in procedure time (120 vs 115 minutes; P = .3).

Conclusions Consistent with the overall RIVAL trial population, elderly patients undergoing cardiac catheterization have lower rates of major bleeding or access site complications and higher rates of access site crossover with radial access compared to femoral access. (Am Heart J 2015;170:880-886.)

Elderly patients undergoing cardiac catheterization and percutaneous coronary intervention (PCI) are at increased risk for ischemic, hemorrhagic, and vascular complications. 1,2 Radial access is associated with significantly lower rates of vascular access site and bleeding complications. 3,4

However, elderly patients have increased vascular tortuosity and calcification and more complex coronary anatomy which could potentially limit the success of transradial procedures. 5,6 Elderly patients are also at higher risk for non-access site bleeding 6 which may obscure any benefit

From the aSouthlake Regional Health Centre, Newmarket, ON, Canada, bMcMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada, cPeter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada, dUniversity of Adelaide, Royal Adelaide Hospital, Adelaide, Australia, eTampere University Hospital and Heart Center, Tampere, Finland, fHospital Universitari Dr Peset, Valencia, Spain, gUniversity of British Columbia, Vancouver, BC,

Ingelheim, and AstraZeneca. Dr Džavík is a consultant to Abbott Vascular, Cordis,

Canada, hSt. Michael's Hospital, Toronto, ON, Canada, and iCharles University, Hospital Kralovske Vinohrady, Prague, Czech Republic. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT01014273 Disclosures: Dr Cantor has received consulting fees/honoraria (modest) from AstraZeneca, Roche Canada and Daiichi Sankyo. Dr Mehta has received consulting fees/honoraria (modest) from Abbott Vascular, Sanofi-Aventis, Eli Lilly, and AstraZeneca. Dr Jolly has received an institutional research grant (to PHRI) from Medtronic; and consulting fees (modest) from Sanofi-Aventis, GlaxoSmithKline, Boehringer

and Johnson & Johnson. Funding Sources: RIVAL was funded by a grant from the Canadian Network and Centre for Trials Internationally (CANNECTIN), an initiative of the Canadian Institutes of Health Research. RIVAL began as an investigator-initiated substudy of the CURRENT OASIS 7 trial, which was funded by a grant to the Population Health Research Institute (PHRI) from Sanofi and Bristol-Myers Squibb. RCT# NCT01014273 Submitted May 22, 2015; accepted August 8, 2015. Reprint requests: Warren J. Cantor, MD, Southlake Regional Health Center, 581 Davis Drive, Newmarket, Ontario, Canada, L3Y 2P6. E-mail: [email protected] 0002-8703 © 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ahj.2015.08.011

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of radial access in reducing access site bleeding. Most of the previous studies documenting the feasibility, safety and efficacy of the transradial approach included mainly younger patients. 3 It is therefore uncertain whether radial access carries the same advantages over femoral access in elderly patients as it does in younger patients. The benefits and potential risks of radial access for elderly patients are particularly relevant for patients with ST-elevation myocardial infarction (STEMI). Elderly patients may have higher rates of access site crossover with radial access than younger patients, and the additional delay to reperfusion may offset any benefits of radial access for elderly STEMI patients undergoing primary PCI. We performed a subgroup analysis of the RIVAL randomized trial to compare radial and femoral access in elderly patients with acute coronary syndrome (ACS) undergoing cardiac catheterization and PCI. A secondary analysis was performed for elderly patients with STEMI. We also performed an exploratory analysis to evaluate the relationship between access site cross-over rates and radial PCI volume for both elderly and younger patients.

Methods The details of the RIVAL trial have been previously published. 7,8 Patients with ACS including STEMI undergoing cardiac catheterization were randomized to radial or femoral access. Patients had to be suitable for either access route and have a normal Allen’s test. Patients were excluded if they had cardiogenic shock, severe peripheral vascular disease or previous coronary bypass surgery with more than one internal mammary arterial graft. The cardiologist performing the procedure had to have expertise in both radial and femoral access, including at least 50 radial procedures within the last year. For the purpose of this analysis, elderly patients were defined as patients ≥75 years of age. The outcomes of interest for this analysis included the primary endpoint of the overall trial (death, myocardial infarction [MI], stroke or non coronary artery bypass graft major bleeding) and its components, access site cross-over, major vascular access site complications, ACUITY major bleeding and transfusion. Centers were divided into tertiles according to the median radial PCI volume of their operators: (low [60 radial PCI/year/operator], intermediate [61 to 146 radial PCI/ year/operator], and high [N146 radial PCI/year/operator]). 9 Interaction P values were reported for age subgroups. Analyses were performed using intention to treat, at a statistical significance level of .05. Baseline characteristics were compared between two age groups (age b75 vs age ≥75) and access sites (femoral vs radial). Statistical methods, including Wilcoxon rank sum tests, χ 2 tests and logistic regression were used for comparison and for testing interactions. In addition, effects on clinical outcomes were examined using Cox proportional hazards models. Hazard ratios, 95% CIs and interaction were evaluated. No

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adjustments were made for multiple comparisons. Statistical software (SAS 9.2) was used for all statistical analyses. RIVAL was funded by a grant from the Canadian Network and Centre for Trials Internationally, an initiative of the Canadian Institutes of Health Research. RIVAL began as an investigator-initiated substudy of the CURRENT OASIS 7 trial, which was funded by a grant to the Population Health Research Institute (PHRI) from Sanofi and Bristol-Myers Squibb. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the manuscript, and its final contents.

Results Among the 7,021 patients enrolled in the RIVAL trial, 1035 (15%) were ≥75 years of age. Baseline characteristics of patients b75 and ≥75 years of age are shown in Table I. The elderly patients were more likely to be women, European and to present with unstable angina. They were more likely to be non-smokers and to have hypertension, diabetes, previous MI, or revascularization. The procedural characteristics and pharmacotherapy of patients b75 and ≥75 years of age are shown in Table II. The rates of access site crossover and major bleeding for the radial and femoral treatment groups across various age categories are shown in Figures. 1–3. Radial access was consistently associated with higher rates of access site cross over and lower rates of ACUITY major bleeding, with no significant interaction between age and access for these outcomes. The major bleeding rates using the RIVAL definition were low with no significant differences between radial and femoral access. The efficacy and safety outcomes for radial and femoral access among the patients ≥75 years of age are shown in Table III. Radial access was associated with significantly lower rates of major vascular access site complications in patients ≥75 years of age (3.6% vs 6.6%; P = .03) and in patients b75 years of age (1.0% vs 3.2%; P b .001; P value for interaction = .2). The difference in access site complications was driven mainly by a lower rate of large hematomas. The rates of access site crossover were higher with radial access among patients ≥75 (12.5% vs 2.6%; P b .001) and b75 (6.7% vs 1.9%; P b .001; P value for interaction = .9). There were no significant differences in the primary composite outcome or its individual components in either age group. The clinical outcomes for STEMI patients ≥75 years of age are shown in Table IV. Radial access was associated with significantly lower rates of the primary endpoint in elderly STEMI patients (4.9% vs 14.2%; P = .02) but the differences were not significant for younger STEMI patients (2.9% vs 4.1%; P = .17; P value for interaction = .13). There were significantly lower rates of death or reinfarction with radial access among elderly STEMI patients (4.9% vs 13.2%; P = .036) and a trend for lower rates among younger STEMI patients (2.0% vs 3.6%; P =

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Table I. Baseline characteristics for patients b75 and ≥75 years of age Age b75 (n = 5985)

Age Female Initial Unstable Angina Initial Non-ST MI Initial ST-Elevation MI Current Smoker Hypertension Diabetes Previous MI Previous PCI Previous CABG Peripheral Arterial Disease Baseline Creatinine

Age ≥75 (n = 1035)

Femoral (N = 2985)

Radial (N = 3000)

P

59 (52, 66) 734 (24.6) 1297 (43.5) 791 (26.5) 897 (30.1) 1055 (35.3) 1678 (56.2) 591 (19.8) 495 (16.6) 307 (10.3) 50 (1.7) 64 (2.1) 82 (71, 97)

60 (52, 66) 693 (23.1) 1285 (42.8) 883 (29.4) 832 (27.7) 1051 (35.0) 1733 (57.8) 657 (21.9) 548 (18.3) 356 (11.9) 58 (1.9) 58 (1.9) 82 (71, 97)

.23 .18 .64 .01 .05 .81 .23 .05 .09 .05 .50 .58 .33

Femoral (N = 529) 79 219 309 114 106 42 398 131 127 101 25 18 89

(77, 82) (41.4) (58.4) (21.6) (20.0) (7.9) (75.2) (24.8) (24.0) (19.1) (4.7) (3.4) (74, 112)

Radial (N = 506) 79 215 269 114 123 31 385 124 110 75 21 33 88

(77, 82) (42.5) (53.2) (22.5) (24.3) (6.1) (76.1) (24.5) (21.7) (14.8) (4.2) (6.5) (74, 106)

P

P for age b75 vs age ≥75

.25 .75 .09 .71 .10 .28 .77 .94 .42 .07 .76 .02 .29

NA b.00001 b.00001 .00007 .00001 b.00001 b.00001 .006 .00003 b.00001 b.00001 b.00001 b.0001

MI = Myocardial infarction; PCI = percutaneous coronary intervention; CABG = coronary artery bypass graft surgery; NA = not applicable

Table II. Procedural characteristics & pharmacotherapy of patients b75 and ≥75 years of age Age b75 (n = 5985)

IV Unfractionated Heparin Fondaparinux Low molecular weight heparin Bivalirudin Prasugrel or ticagrelor Angiography only PCI CABG Intra-aortic balloon pump Any stent overall Vascular closure device Arterial Sheath ≤5 Arterial sheath=6 Arterial sheath ≥7 GP IIb/IIIa inhibitor

Femoral (N = 2985) N (%)

Radial (N = 3000) N (%)

933 (31.3) 307 (10.3) 1539 (51.6) 91 (3.1) 52 (1.7) 954 (32.0) 2024 (67.8) 229 (7.7) 27 (0.9) 1935 (95.6) 770 (25.9) 188 (6.3) 2390 (80.3) 197 (6.6) 734 (24.6)

993 (33.1) 304 (10.1) 1524 (50.8) 62 (2.1) 37 (1.2) 1006 (33.5) 1989 (66.3) 246 (8.2) 23 (0.8) 1888 (94.9) 110 (3.7) 431 (14.4) 2316 (77.4) 33 (1.1) 773 (25.8)

Age N =75 (n = 1035)

P

Femoral (N = 529) N (%)

Radial (N = 506) N (%)

P

P for age b75 vs age ≥75

.13 .86 .57 .02 .11 .20 .22 .47 .57 .33 b.00001 b.00001 .006 b.00001 .30

177 (33.5) 74 (14.0) 280 (52.9) 18 (3.4) 4 (0.8) 202 (38.2) 325 (61.4) 62 (11.7) 10 (1.9) 298 (91.7) 130 (24.6) 49 (9.3) 421 (79.7) 15 (2.8) 110 (20.8)

175 (34.6) 79 (15.6) 281 (55.5) 14 (2.8) 0 (0.0) 183 (36.2) 321 (63.4) 62 (12.3) 8 (1.6) 298 (92.8) 13 (2.6) 74 (14.7) 392 (77.8) 2 (0.4) 114 (22.5)

.74 .48 .42 .59 .12 .52 .52 .85 .81 .66 b.00001 .01 .45 .002 .55

.2 .00001 .07 .3 .002 .005 .004 .00002 .006 .001 .5 .1 1.0 .0004 .01

IV, Intravenous; CABG, coronary artery bypass graft surgery; GP, glycoprotein

.06; P value for interaction = .3). Access site crossover rates were higher with radial access in the older STEMI patients (11.4% vs 2.9%; P = .028) and younger STEMI patients (4.4% vs 1.5%; P b .001; P value for interaction = .8). Among the older STEMI patients there was a trend to lower mortality with radial access (3.3% vs 9.5%; P = .066) and a significantly lower mortality rate for the younger STEMI patients (1.0% vs 2.5%; P = .02; P value for interaction = .9). Among the elderly STEMI patients undergoing primary PCI (N = 154), the time from randomization to completion of the PCI procedure was 120 (105, 142) minutes in the radial group and 115 (101, 133) minutes in the femoral group (P = .3).

The access site cross-over rates stratified by hospital radial PCI volume are shown in Table V. The cross-over rates were significantly higher for radial access for low-, intermediate-, and high-volume centers. However, the cross-over rates for radial access were lowest in high volume centres for both elderly and younger patients.

Discussion Consistent with the overall RIVAL trial results, the use of radial access for elderly patients was associated with similar rates of death, MI or stroke, and lower rates of bleeding or access site complications. Furthermore, among the elderly STEMI patients, radial access was

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Figure 1

Femoral

Radial P < .0001

18%

16.3%

16%

p-value for interaction = 0.2 14% 12%

P < .0001 9.5%

10%

P < .0001

P = .017 8% 6.5%

P < .0001

6% 4%

7.0%

5.2%

3.2%

3.1% 2.3%

2%

1.6%

1.2%

0% Age < 50

Age: 50 - 59

Age: 60 - 69

Age: 70 - 79

Age >= 80

Rates of access site cross-over by age category and arterial access.

Figure 2

Femoral

Radial P < .001

8%

P = .3 7.6%

7.2%

7%

p-value for interaction = 0.3 6% 5.3%

5%

P = .03 P = .001

4%

3.6% 3.3%

3%

P = .2 2.4%

2.2%

2.0%

2% 1.2% 0.9%

1%

0% Age < 50

Age: 50 - 59

Age: 60 - 69

Age: 70 - 79

Age >= 80

Rates of ACUITY major bleeding by age category and arterial access.

also associated with significantly lower rates of death or reinfarction and a trend to lower mortality. These benefits were observed despite the higher rate of access site crossover.

Numerous studies have shown that radial access is associated with significantly lower rates of bleeding and access site complications. 3,4 However, elderly patients have generally been underrepresented in the randomized

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Figure 3

Femoral

Radial

5%

4%

p-value for interaction = 0.9 P = .7 3%

2.7% 2.2%

P = .3

2%

1.4%

P = .9

P = .6 1%

P = 1.0

0.8%

0.8% 0.6%

0.6% 0.7%

0.4% 0.0%

0% Age < 50

Age: 50 - 59

Age: 60 - 69

Age: 70 - 79

Age >= 80

Rates of RIVAL major bleeding by age category and arterial access.

Table III. Clinical outcomes for radial and femoral access Age b75 Femoral Radial (N = 2985) (N = 3000) N (KM rate) N (KM rate) Death/MI/stroke/ non-CABG major bleeding Total death Death/MI Death/MI/stroke Non-CABG major bleeding Acuity major bleed Major vascular access site complications Crossover to alternate route Any transfusion Pseudoaneurysm requiring closure Large hematoma

Age ≥75 Hazard ratio (95% CI)

P

87 (2.9)

0.95 (0.71-1.27)

.73

(1.1) (2.4) (2.5) (0.7) (3.7) (3.2)

24 (0.8) 62 (2.1) 76 (2.5) 15 (0.5) 42 (1.4) 31 (1.0)

0.72 0.87 1.01 0.71 0.37 0.32

56 (1.9) 64 (2.2) 17 (0.6)

202 (6.7) 64 (2.1) 2 (0.1)

3.61 (2.69-4.85) b.001 0.99 (0.70-1.40) .97 0.12 (0.03-0.51) .0041

79 (2.6)

28 (0.9)

0.35 (0.23-0.54) b.001

91 (3.0)

33 71 75 21 111 96

(0.43-1.22) .22 (0.62-1.22) .41 (0.73-1.39) .96 (0.37-1.38) .31 (0.26-0.53) b.001 (0.21-0.48) b.001

Radial Femoral (N = 529) (N = 506) N (KM rate) N (KM rate)

Hazard ratio (95% CI)

P

P for interaction

48 (9.1)

41 (8.1)

0.88 (0.58-1.34) 0.56

.78

18 36 39 12 42 35

20 (4.0) 35 (6.9) 36 (7.1) 9 (1.8) 24 (4.8) 18 (3.6)

1.16 1.02 0.96 0.78 0.59 0.54

.23 .73 .84 .83 .21 .23

14 (2.6) 34 (6.5) 6 (1.1)

63 (12.5) 35 (7.0) 5 (1.0)

4.78 (2.68-8.53) b.001 1.07 (0.67-1.71) .78 0.87 (0.27-2.86) .82

.90 .84 .056

27 (5.1)

14 (2.8)

0.54 (0.28-1.03)

.36

(3.4) (6.8) (7.4) (2.3) (8.0) (6.6)

(0.61-2.19) (0.64-1.62) (0.61-1.51) (0.33-1.85) (0.36-0.98) (0.30-0.95)

.65 .95 .87 .57 .041 .031

.062

CABG, Coronary artery bypass graft surgery, KM, Kaplan Meier.

trials 3 and it has been unclear whether the benefits of radial access also extend to elderly patients. Approximately 10% of ACS patients undergoing cardiac catheterization are ≥80 years of age. 10 Elderly patients are more likely to have smaller radial arteries, brachial and subclavian tortuosity and unfolding of the aorta, all of

which may render radial access more challenging and cross-over to femoral access more likely. 5,11–13 Less than 15% of patients ≥75 years of age undergo PCI using radial access in the United States. 14 In this analysis of the RIVAL trial, access site cross-over was higher with radial access across all age groups, with no significant interaction

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Table IV. Clinical outcomes for radial and femoral access among STEMI patients Age b75 Femoral Radial (N = 897) (N = 832) N (KM rate) N (KM rate) Death/MI/stroke/ non-CABG major bleeding Total death Death/MI Death/MI/stroke Non-CABG major bleeding Acuity major bleed Major vascular access site complications Crossover to alternate route Any transfusion Pseudoaneurysm requiring closure Large hematoma

Age ≥75 Hazard ratio (95% CI)

P

Femoral Radial (N = 106) (N = 123) N (KM rate) N (KM rate)

Hazard ratio (95% CI)

P

P for Interaction

37 (4.1)

24 (2.9)

0.70 (0.42-1.16) .17

15 (14.2)

6 (4.9)

0.33 (0.13-0.86)

.024

.13

22 (2.5) 32 (3.6) 32 (3.6) 7 (0.8)

8 17 20 6

0.39 0.57 0.67 0.92

10 (9.5) 14 (13.2) 14 (13.2) 2 (1.9)

4 6 6 2

0.34 0.36 0.36 0.86

.066 .036 .036 .88

.87 .32 .19 .95

30 (3.4) 25 (2.8)

13 (1.6) 7 (0.8)

0.46 (0.24-0.89) .021 0.30 (0.13-0.70) .0050

11 (10.5) 10 (9.5)

6 (4.9) 5 (4.1)

.13 .12

.95 .57

13 (1.5)

37 (4.4)

3.08 (1.64-5.79) .0005

3 (2.9)

14 (11.4)

12 (1.3) 3 (0.3)

8 (1.0) 0 (0.0)

0.71 (0.29-1.74) .46 NA NA

3 (2.9) 0 (0.0)

21 (2.3)

7 (0.8)

0.36 (0.15-0.84) .019

9 (8.5)

(1.0) (2.0) (2.4) (0.7)

(0.17-0.88) (0.32-1.03) (0.38-1.18) (0.31-2.74)

.023 .061 .16 .88

(3.3) (4.9) (4.9) (1.6)

(0.11-1.07) (0.14-0.94) (0.14-0.94) (0.12-6.09)

0.47 (0.17-1.26) 0.43 (0.15-1.26)

4.05 (1.16-14.10) .028

.85

3 (2.5) 1 (0.8)

0.85 (0.17-4.23) NA

.85 NA

.50 NA

4 (3.3)

0.38 (0.12-1.24)

.11

.87

Hazard ratio (95% CI)

P

P for interaction

.009

CABG, Coronary artery bypass graft surgery

Table V. Access site cross-over rates and radial PCI volume Age b75 Femoral Radial (N = 2895) (N = 3000) N (KM rate) N (KM rate) Low-volume center (n = 1920) Intermediate-volume center (n = 2846) High-volume center (n = 2255)

8 (0.9)

62 (7.3)

29 (2.5)

102 (8.7)

19 (2.0)

38 (3.9)

Hazard Ratio (95% CI)

Age ≥75

P

Femoral Radial (N = 529) (N = 506) P for interaction N (KM rate) N (KM rate)

7.87 (3.77-16.4) b.0001 .013

14 (2.7)

63 (12.5)

4.75 (2.66-8.48)

3.51 (2.32-5.30) b.0001

4 (1.5)

36 (14.6)

9.51 (3.38-26.7) b.0001

1.98 (1.14-3.43)

7 (4.6)

12 (8.2)

1.81 (0.71-4.60)

.015

between age and access site. The access site cross-over rates for radial access were lowest at centers where operators performed the most radial PCI procedures. Despite the higher cross-over rate, radial access in elderly patients resulted in a similar reduction in access site complications or major bleeding as in younger patients. These results are consistent with two smaller randomized trials comparing radial and femoral access for elderly patients undergoing cardiac catheterization. 15,16 Both trials showed a lower incidence of access site complications with radial access. A meta-analysis of trials comparing radial and femoral access showed similar reductions in major bleeding with the radial approach in the trials with mean patient age N70 as in the other trials (OR 0.18 and 0.30, P = .003 and P b .001 respectively). 3 Patients with STEMI require rapid reperfusion to improve survival. Randomized trials comparing radial and femoral access among STEMI patients have shown

.054

.21

lower mortality with radial access despite a slightly longer procedure time. 17,18 In this analysis, despite the anatomic complexities and higher access site cross-over seen with radial access in the elderly, the procedure times were not significantly different for radial and femoral access. Furthermore, we observed a significantly lower rate of death or re-infarction with radial access for elderly STEMI patients, as well as trend toward lower mortality. However, these results need to be interpreted with caution as they represent a subgroup analysis of a subgroup, and there were no significant interactions between age and outcomes among the STEMI patients. As with all subgroup analyses, the results of this analysis should be interpreted cautiously as the RIVAL trial was not powered to detect significant differences among subgroups. Nevertheless, these results were consistent with the overall RIVAL trial and smaller randomized trials focussed on elderly patients. The elderly patients that

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were enrolled into RIVAL may not be fully representative of elderly ACS patients undergoing invasive cardiac procedures in routine clinical practice. However, observational studies comparing radial and femoral access in elderly patients have found similar reductions in bleeding and access site complications with radial access. In the RIVAL trial, the cardiac catheterization and PCI procedures were performed by cardiologists experienced in both access routes, and these results may not be generalizable to centres or physicians with more limited experience with radial access.

Conclusions Elderly patients with ACS undergoing cardiac catheterization have similar rates of death, MI or stroke, lower rates of major bleeding or access site complications and higher rates of access site crossover with radial access compared to femoral access.

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