It remains undefined if transradial coronary angiography from a right or left radial arterial approach differs in real-world practice. To address this issue, we performed a subanalysis of the PREVAIL study. The PREVAIL study was a prospective, multicenter, observational survey of unselected consecutive patients undergoing invasive cardiovascular procedures over a 1-month observation period, specifically aimed at assessing the outcomes of radial approach in the contemporary real world. The choice of arterial approach was left to the discretion of the operator. Prespecified end points of this subanalysis were procedural characteristics. Of 1,052 patients consecutively enrolled, 509 patients underwent transradial catheterization, 304 with a right radial and 205 with a left radial approach. Procedural success rates were similar between the 2 groups. Compared to the left radial group, the right radial group had longer procedure duration (46 ± 29 vs 33 ± 24 minutes, p <0.0001) and fluoroscopy time (765 ± 787 vs 533 ± 502, p <0.0001). At multivariate analysis, including a parsimonious propensity score for the choice of left radial approach, duration of procedure (beta coefficient 11.38, p <0.001) and total dose–area product (beta coefficient 11.38, p <0.001) were independently associated with the choice of the left radial artery approach. The operator’s proficiency in right/left radial approach did not influence study results. In conclusion, right and left radial approaches are feasible and effective to perform percutaneous procedures. In the contemporary real world, however, the left radial route is associated with shorter procedures and lower radiologic exposure than the right radial approach, independently of an operator’s proficiency.
Radial artery access provides very significant decreases in local access site complications compared to brachial or femoral access, and—in experienced hands—it offers a decrease in hard end point including mortality compared to other arterial access sites. However, limited evidence and conflicting trials have been reported in previous comparisons of right versus left radial access in patients undergoing coronary procedures. Recently, it has been suggested that the right radial approach may encounter more technical difficulties than the left approach, a finding recently confirmed in an updated meta-analysis of randomized trials. One should consider, however, that all previous data have been obtained in randomized comparisons of right versus left radial access in selected subgroups of patients who were referred to tertiary referral centers. Conversely, it remains undefined if the right and left radial artery approaches are really different in real-world practice. To address this issue, we performed a prespecified subanalysis of the Prospective Registry of Vascular Access in Interventions in Lazio Region (PREVAIL) study, a prospective trial performed over a short period in a large unselected population of consecutive patients at 9 Italian hospitals representing actual real-world care. The study was specifically designed to control for possible confounders and appraise arterial access-related clinical outcomes across different centers and with different operators after interventional and diagnostic procedures.
Methods
Detailed methods of the PREVAIL study have been previously published. Concisely, the study was the first large prospective observational study specifically aimed at assessing arterial access outcomes in percutaneous cardiovascular procedures. The study was performed in a short time frame (1 month) in the Lazio region, an Italian region with >5 million inhabitants. The study encompassed 9 centers that were selected according to their volume of activity: 3 were defined as high-volume centers (i.e., >2,000 procedures/year), 3 as moderate-volume centers (1,000 to 2,000 procedures/year), and 3 as low-volume centers (<1,000 procedures/year). Procedural activities of each center were recorded before the enrollment phase.
Among those centers, 5 of 9 (55%) usually performed radial artery access in their everyday practice. Overall, 42 operators participated in the study, of whom 16 (38%) reported a high volume of radial procedures (e.g., performing >65% of their caseload by radial artery access in the year preceding the study).
All consecutive patients who underwent an invasive procedure requiring arterial access in the catheterization laboratory were suitable for the study. All patients included in the main PREVAIL study were also included in this prespecified analysis. Patients were excluded from enrollment in PREVAIL only if they were enrolled in other research protocols requiring specific therapy or a specific arterial access site. Choice of arterial access site and technique employed were decided by individual practitioners based on their usual practice. The protocol was approved by all local hospital ethics committee, and informed consent was obtained from all patients. Data on percutaneous coronary procedures were collected prospectively using a case-report form and thereafter transferred to an electronic database.
The prespecified goals of this subanalysis were to compare feasibility and procedural characteristics between left and right radial access. Specifically, the beginning (i.e., insertion of sheath) and ending (i.e., removal of catheters) of the procedures were recorded to derive procedural duration.
To assess global puncture-related safety, hemorrhage was classified as “major” or “minor” according to previously published definitions that underline the need for wide definitions of bleeding to avoid underestimating the incidence of clinically significant hemorrhages. Also, incidence of postprocedure or in-hospital death or myocardial infarction/reinfarction, defined according to the universal definition, were considered.
Continuous variables for each of the 2 subject groups, femoral and radial access, were reported as mean ± SD; categorical variables were reported as absolute number and percentage. Bivariate analysis according to right versus left radial access were performed with unpaired Gosset t test for continuous variables, Pearson chi-square test for categorical variables whenever expected counts were ≥5, and Fisher’s exact test for categorical variables whenever expected counts were ≤4. Subsequently, multivariable linear regression analyses were performed to appraise the impact of right versus left radial access on study end points by adjusting in the final entry model for all covariates found significantly associated (p <0.05) with access site at bivariate analyses. To further adjust for residual confounding and minimize the risk of biased estimates, linear regression analyses were repeated after including a parsimonious propensity score with satisfactory discrimination (c-statistic 0.865) and calibration (p = 0.955, Hosmer–Lemeshow test). Results of linear regression are reported as regression coefficient (beta) with 95% confidence interval and adjusted p value. Statistical analyses were carried out with PASW Statistics/SPSS 18.0 (IBM, Armonk, New York).
Results
Of 1,052 patients consecutively enrolled over the 1 month of observation, 509 patients underwent transradial catheterization, 304 with the right radial approach and 205 with the left radial approach. Clinical presentation ( Table 1 ) was more often stable angina pectoris in the left radial than in the right radial access group, whereas the latter was slightly more likely to have presented with an acute coronary syndrome. Also, the left radial group had a higher prevalence of diabetes mellitus and peripheral/carotid artery disease and previously more often had radial access and coronary artery bypass grafting.
| Variable | Approach | p Value | |
|---|---|---|---|
| Right | Left | ||
| (n = 304) | (n = 205) | ||
| Age (years) | 66 ± 10 | 66 ± 11 | 0.77 |
| Men | 237 (78%) | 146 (71%) | 0.08 |
| Body mass index (kg/m 2 ) | 27 ± 5 | 28 ± 4 | 0.61 |
| Active smoker | 38 (12%) | 32 (16%) | 0.06 |
| Diabetes mellitus | 54 (18%) | 50 (24%) | 0.02 |
| Peripheral artery disease | 13 (4%) | 25 (12%) | 0.0009 |
| Carotid artery disease | 7 (2%) | 24 (12%) | <0.0001 |
| Chronic renal failure | 21 (7%) | 21 (10%) | 0.18 |
| Previous radial access | 33 (11%) | 40 (19%) | 0.006 |
| Previous percutaneous coronary intervention | 64 (21%) | 56 (27%) | 0.10 |
| Previous coronary bypass | 7 (2%) | 35 (17%) | <0.0001 |
| Previous stroke | 8 (3%) | 13 (6%) | 0.039 |
| Clinical presentation | |||
| Chronic stable angina pectoris | 115 (38%) | 99 (48%) | 0.02 |
| Acute coronary syndromes | 85 (28%) | 54 (26%) | 0.69 |
| ST-segment elevation myocardial infarction | 29 (9%) | 17 (8%) | 0.63 |
| Other indications for coronary angiography | 75 (25%) | 35 (17%) | 0.13 |
As presented in Table 2 , a similar proportion of patients in the right and left radial groups underwent coronary angiography only or percutaneous coronary intervention, and no difference in urgent case prevalence was reported. Also, feasibility of radial access and percutaneous coronary intervention success rates were similar in the 2 groups. Nevertheless, compared to the left radial group, the right radial group had longer procedure duration and fluoroscopy time, whereas no differences were found in quantity of contrast injected and numbers of catheters used per procedure. Moreover, patients who underwent right radial access had a higher heparin dosage, a larger sheath size, and less frequently underwent glycoprotein IIb/IIIa inhibitor administration compared to left radial access group.
| Variable | Approach | p Value | |
|---|---|---|---|
| Right | Left | ||
| (n = 304) | (n = 205) | ||
| Procedure performed in high-volume radial center | 206 (68%) | 180 (88%) | <0.0001 |
| Procedure performed by high-volume radial artery access operator | 123 (40%) | 115 (56%) | 0.0005 |
| Type of procedure | |||
| Diagnostic only | 180 (59%) | 125 (61%) | 0.69 |
| Overall interventional | 124 (41%) | 80 (39%) | 0.70 |
| Duration of procedure (min) | 46 ± 29 | 33 ± 24 | <0.0001 |
| States of Health size (French) | 5.9 ± 0.4 | 5.5 ± 0.7 | <0.0001 |
| Contrast injected (ml) | 182 ± 115 | 176 ± 112 | 0.50 |
| Fluoroscopy time (s) | 765 ± 787 | 533 ± 502 | <0.0001 |
| Total dose–area product (mGy × cm 2 ) | 45.6 ± 37.2 | 59.6 ± 35.5 | <0.0001 |
| Number of catheters used per procedure | 2.8 ± 1.1 | 2.8 ± 1.1 | 0.35 |
| Normalized heparin dosage (IU/body mass index) | 5,936 ± 2,334 | 5,219 ± 1,991 | 0.002 |
| Glycoprotein IIb/IIIa inhibitor use | 32 (10%) | 44 (21%) | 0.0007 |
| Failure of first access (with crossover to femoral or contralateral radial access) | 16 (5%) | 17 (8%) | 0.17 |
| Percutaneous coronary intervention characteristics | |||
| Multivessel procedure | 51 (17%) | 37 (18%) | 0.64 |
| Complete success | 118 (39%) | 76 (37%) | 0.57 |
| Partial success | — | 1 (0.5%) | 0 |
| Failure | 4 (3%) | 2 (1%) | 0.56 |
The 2 study groups were similar in individual complications. Per-treatment analysis revealed a very low bleeding rate in the 2 groups, namely 3 of 304 patients in the right radial group and 3 of 205 patients in the left radial group had minor hemorrhages at sites of radial artery access, although no major ischemic end points were observed in the 2 groups.
No significant associations were detected between total activity volume by radial approach of each operator and procedure duration. Also, procedure durations were significantly shorter with the left than with the right radial approach; nevertheless, operators performed >80% of their caseload by the radial approach (47 ± 28 minutes by right radial vs 32 ± 26 minutes by left radial, p <0.0001) or 65% to 80% of their caseload by the radial approach (46 ± 31 minutes by right radial vs 34 ± 19 minutes by left radial, p = 0.0099) or <65% of their caseload by the radial approach (47 ± 26 minutes by right radial vs 36 ± 26 minutes by left radial, p = 0.053). Moreover, no significant differences in quantity of injected contrast and number of catheters used per procedure were observed when controlling for overall procedural volume of operators. Surprisingly, a lower incidence of primary failure in the right radial approach than in left arterial access was observed only when comparing procedures done by operators performing <65% of their caseload by the radial approach (5 of 83 vs 7 of 26, p = 0.007). It is noteworthy that similar results were obtained when controlling for an individual operator’s 1-side volume of activity. In fact, comparison between right access by operators with a high right radial volume (n = 114) and left access by operators with a high left radial volume (n = 94) disclosed significantly shorter procedure duration, smaller sheath size, and shorter fluoroscopy time in the left radial group than in the radial artery group, although the former presented more often with acute coronary syndromes and more commonly were given glycoprotein IIb/IIIa inhibitors than the latter ( Table 3 ).
| Variable | Right Access by Operators With High Right Radial Volume | Left Access by Operators With High Left Radial Volume | p Value |
|---|---|---|---|
| (n = 114) | (n = 94) | ||
| Total duration of procedure (min) | 46 ± 27 | 34 ± 18 | <0.0001 |
| States of Health size (French) | 5.9 ± 0.3 | 5.4 ± 1.0 | 0.0009 |
| Contrast injected (ml) | 172 ± 93 | 179 ± 126 | 0.93 |
| Fluoroscopy time (s) | 713 ± 889 | 489 ± 415 | 0.03 |
| Total dose–area product (mGy × cm 2 ) | 28.3 ± 20.2 | 38.5 ± 23.7 | <0.0001 |
| Number of catheters used per procedure | 2.9 ± 1.0 | 2.6 ± 1.0 | <0.03 |
| Normalized heparin dosage (IU/body mass index) | 240 ± 97 | 210 ± 57 | 0.32 |
| Glycoprotein IIb/IIIa inhibitor use | 4 (3%) | 31 (33%) | <0.0001 |
| Chronic stable angina pectoris | 59 (52%) | 38 (40%) | 0.02 |
| Acute coronary syndromes | 27 (24%) | 37 (39%) | 0.69 |
| Overall number of percutaneous coronary interventions | 44 (39%) | 45 (48%) | 0.26 |
| Multivessel procedure | 18 (16%) | 18 (19%) | 0.79 |
| Failure of first access (with crossover to femoral or contralateral radial access) | 2 (2%) | 5 (5%) | 0.15 |
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