- Email: [email protected]
Radial versus femoral access in acute coronary syndromes
Correspondence
I declare that I have no conflicts of interest.
Christian Pristipino [email protected]
In the RIVAL trial (April 23, p 1409), Sanjit Jolly and colleagues identified a similar incidence of net adverse clinical endpoints in patients randomised to a radial-access versus femoral-access approach to coronary angiography and possible intervention, and an average 7·6% radial-access failure rate. However, radial access yielded fewer net adverse clinical endpoints in patients with STelevation myocardial infarction and at centres with the highest annual volume of radial-access procedures, despite all operators being “radial experts”. In our multicentre prospective study to assess outcomes with different arterial accesses in the real world (PREVAIL),2 we showed that the volume of radial-access procedures done is pivotal for the success of this approach. High-volume operators who used the radial approach for more than 85% of their caseload had a six times higher success rate than did counterparts who used the radial approach just 25–50% of the time,3 similar to the 40% average of RIVAL operators.1 Moreover, in the PREVAIL study, we did not detect any threshold above which the volume of radial-access procedures was no longer associated with enhanced success or outcomes,2,3 suggesting that the greater an operator’s volume of radialaccess procedures, the better his or her outcomes. Considering these studies together, one can infer that: (1) randomised studies to assess the safety or efficacy of the radial-access approach should select only operators who do high volumes of radial-access procedures; and (2) to enhance outcomes, patients with ST-elevation myocardial infarction should undergo emergency procedures via radial access, with all operators striving to achieve proficiency by adopting radial-access procedures in most emergent and non-emergent procedures. 1
www.thelancet.com Vol 378 August 20, 2011
Department of Cardiology, San Filippo Neri Hospital, 00189 Rome, Italy 1
2
3
Jolly SS, Yusuf S, Cairns J, et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet 2011; 377: 1409–20. Pristipino C, Trani C, Nazzaro MS, et al. Major improvement of percutaneous cardiovascular procedure outcomes with radial artery catheterisation: results from the PREVAIL study. Heart 2009; 95: 476–82. Pristipino C, Roncella A, Trani C, et al. Identifying factors that predict the choice and success rate of radial artery catheterisation in contemporary real world cardiology practice: a sub-analysis of the PREVAIL study data. EuroIntervention 2010; 6: 240–46.
The strength of the RIVAL1 study lies with the high volume of percutaneous coronary interventions (PCIs) per operator. However, this aspect also makes the study outcome less generalisable to most operators. The study supports the notion that, if one was not already a transradial expert, then transfemoral access is equally safe, since the excess vascular complications did not translate into more frequent blood transfusions or death. Additionally, although fluoroscopy time is longer in the transradial group, PCI procedural time was not. It might be that additional fluoroscopy time is accounted for during catheter introduction, and, although the difference was significant, the skin dose might not be so clinically, since the dose is not delivered to a single location. The most important point of the study is that, although transradial access reduces access-site bleeding, non-access-site bleeding remains a problem. In predominantly transfemoral PCI trials,2 bivalirudin reduced bleeding by about 40%, and one wonders whether, had the RIVAL trial been done with bivalirudin as the default anticoagulant, the difference in bleeding and vascular complications would have been less impressive. The “transradial movement” has made substantial contributions to
the PCI world, drawing attention to radiation exposure and accesssite complications. But it is time to concentrate on bleeding as a whole. What eventually drives the preferred access route might be patients’ preference and length of hospital stay, but what will drive mortality will be the choice of procedural anticoagulant and pharmacotherapy in addition to timely intervention.
Science Photo Library
Radial versus femoral access in acute coronary syndromes
I declare that I have no conflicts of interest.
Aun-Yeong Chong [email protected] Sandwell General Hospital, Lyndon, West Bromwich B71 4HJ, UK 1
2
Jolly SS, Yusuf S, Cairns J, et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet 2011; 377: 1409–20. Verheugt FWA, Steinhubl SR, Harmon M, et al. Incidence, prognostic impact, and influence of antithrombotic therapy on access and nonaccess site bleeding in percutaneous coronary intervention. J Am Coll Cardiol Cardiovasc Intervent 2011; 4: 191–97.
Authors’ reply Christian Pristipino refers to the observation that increasing radial volume by individual operators was associated with lower access-site crossover in a multicentre registry.1 As a result, he suggests that all future trials of radial versus femoral access should only use high-volume radial operators. The RIVAL trial was a pragmatic trial involving high-volume operators who were experienced with both procedures. We found a decrease in access-site crossover with increased radial volume at both the operator level and centre level. However, the results of the RIVAL trial suggest that radial centre volume might be more important given the observed interaction for the primary outcome in the highvolume radial centres (hazard ratio for highest-tertile centres 0·49, 95% CI 0·28–0·87, interaction p=0·021), with no interaction noted at the operator level (highest-tertile operators 0·79, 0·48–1·28, interaction p=0·54).2 These findings are consistent with those of
Submissions should be made via our electronic submission system at http://ees.elsevier.com/ thelancet/
661
I declare that I have no conflicts of interest.
Christian Pristipino [email protected]
In the RIVAL trial (April 23, p 1409), Sanjit Jolly and colleagues identified a similar incidence of net adverse clinical endpoints in patients randomised to a radial-access versus femoral-access approach to coronary angiography and possible intervention, and an average 7·6% radial-access failure rate. However, radial access yielded fewer net adverse clinical endpoints in patients with STelevation myocardial infarction and at centres with the highest annual volume of radial-access procedures, despite all operators being “radial experts”. In our multicentre prospective study to assess outcomes with different arterial accesses in the real world (PREVAIL),2 we showed that the volume of radial-access procedures done is pivotal for the success of this approach. High-volume operators who used the radial approach for more than 85% of their caseload had a six times higher success rate than did counterparts who used the radial approach just 25–50% of the time,3 similar to the 40% average of RIVAL operators.1 Moreover, in the PREVAIL study, we did not detect any threshold above which the volume of radial-access procedures was no longer associated with enhanced success or outcomes,2,3 suggesting that the greater an operator’s volume of radialaccess procedures, the better his or her outcomes. Considering these studies together, one can infer that: (1) randomised studies to assess the safety or efficacy of the radial-access approach should select only operators who do high volumes of radial-access procedures; and (2) to enhance outcomes, patients with ST-elevation myocardial infarction should undergo emergency procedures via radial access, with all operators striving to achieve proficiency by adopting radial-access procedures in most emergent and non-emergent procedures. 1
www.thelancet.com Vol 378 August 20, 2011
Department of Cardiology, San Filippo Neri Hospital, 00189 Rome, Italy 1
2
3
Jolly SS, Yusuf S, Cairns J, et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet 2011; 377: 1409–20. Pristipino C, Trani C, Nazzaro MS, et al. Major improvement of percutaneous cardiovascular procedure outcomes with radial artery catheterisation: results from the PREVAIL study. Heart 2009; 95: 476–82. Pristipino C, Roncella A, Trani C, et al. Identifying factors that predict the choice and success rate of radial artery catheterisation in contemporary real world cardiology practice: a sub-analysis of the PREVAIL study data. EuroIntervention 2010; 6: 240–46.
The strength of the RIVAL1 study lies with the high volume of percutaneous coronary interventions (PCIs) per operator. However, this aspect also makes the study outcome less generalisable to most operators. The study supports the notion that, if one was not already a transradial expert, then transfemoral access is equally safe, since the excess vascular complications did not translate into more frequent blood transfusions or death. Additionally, although fluoroscopy time is longer in the transradial group, PCI procedural time was not. It might be that additional fluoroscopy time is accounted for during catheter introduction, and, although the difference was significant, the skin dose might not be so clinically, since the dose is not delivered to a single location. The most important point of the study is that, although transradial access reduces access-site bleeding, non-access-site bleeding remains a problem. In predominantly transfemoral PCI trials,2 bivalirudin reduced bleeding by about 40%, and one wonders whether, had the RIVAL trial been done with bivalirudin as the default anticoagulant, the difference in bleeding and vascular complications would have been less impressive. The “transradial movement” has made substantial contributions to
the PCI world, drawing attention to radiation exposure and accesssite complications. But it is time to concentrate on bleeding as a whole. What eventually drives the preferred access route might be patients’ preference and length of hospital stay, but what will drive mortality will be the choice of procedural anticoagulant and pharmacotherapy in addition to timely intervention.
Science Photo Library
Radial versus femoral access in acute coronary syndromes
I declare that I have no conflicts of interest.
Aun-Yeong Chong [email protected] Sandwell General Hospital, Lyndon, West Bromwich B71 4HJ, UK 1
2
Jolly SS, Yusuf S, Cairns J, et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet 2011; 377: 1409–20. Verheugt FWA, Steinhubl SR, Harmon M, et al. Incidence, prognostic impact, and influence of antithrombotic therapy on access and nonaccess site bleeding in percutaneous coronary intervention. J Am Coll Cardiol Cardiovasc Intervent 2011; 4: 191–97.
Authors’ reply Christian Pristipino refers to the observation that increasing radial volume by individual operators was associated with lower access-site crossover in a multicentre registry.1 As a result, he suggests that all future trials of radial versus femoral access should only use high-volume radial operators. The RIVAL trial was a pragmatic trial involving high-volume operators who were experienced with both procedures. We found a decrease in access-site crossover with increased radial volume at both the operator level and centre level. However, the results of the RIVAL trial suggest that radial centre volume might be more important given the observed interaction for the primary outcome in the highvolume radial centres (hazard ratio for highest-tertile centres 0·49, 95% CI 0·28–0·87, interaction p=0·021), with no interaction noted at the operator level (highest-tertile operators 0·79, 0·48–1·28, interaction p=0·54).2 These findings are consistent with those of
Submissions should be made via our electronic submission system at http://ees.elsevier.com/ thelancet/
661