Vascular access site complications after PCI:
An update and trans-radial approach in perspective

Martial Hamon
Department of Cardiology, University Hospital of Caen,
Caen, France

Address for correspondence:
Dr Martial Hamon, MD, FESC, Cardiology Department,
University Hospital of Caen, Avenue Côte de Nacre,
14033 Caen Cedex, Normandy, France.
Tel: +33-2-31-06-51-19 Fax: + 33-2-31-06-44-18
Email: hamon-m@chu-caen.fr


Abstract
Major bleeding, currently the most common non-cardiac complication after percutaneous coronary intervention (PCI) has been associated with an increased risk of long term mortality, and this relationship may be causal. Therefore, reducing the frequency of bleeding events, while maintaining efficacy is an important goal in the management of PCI patients. In this perspective, optimisation of antithrombotic regimen during PCI is a key issue and direct thrombin inhibitors non inferior to the standard treatment for reduction of composite ischaemic endpoints have been shown to significantly reduce major bleeding leading to better net clinical outcome. On the other hand, available evidence supported by several randomised studies suggests that the radial approach is associated with fewer bleeding events and transfusions compared to femoral approach. Bleeding and vascular access site complications are virtually eliminated. This clearly is a major advantage, in the current era of intensive anticoagulant and antiplatelet therapy. As recently stressed, this drastic reduction in the vascular access site complication rate is immediately associated with a significant reduction in hospital stay and has related economic savings. It remains to be seen whether the reduction of vascular access site complications observed with the radial approach can be translated to mortality reduction in future trials.

Vascular complications: Current status
Major bleeding is currently the most common non-cardiac complication of therapy for patients with coronary artery disease who have undergone percutaneous coronary intervention (PCI) [1]. PCI-related bleeding - in the setting of acute coronary syndromes in particular - occurs mainly at the arterial puncture site and is consistently associated with a much higher risk of death during clinical follow-up, as reported in many contemporary pharmacoinvasive trials and registries [2,3]. In the USA, more than 5% of patients who undergo PCI require transfusion, and a further 13% (approximately) experience minor bleeding [4]. In this perspective, reduction of vascular access site complications is a critical challenge in PCI procedures. In recent years, several strategies have been developed to reach this goal.

Changing anticoagulation therapy:
Searching for newantithrombin agents
The combination of antithrombotic therapies used in the past two decades has substantially decreased the risk of a myocardial infarction following PCI procedures but has also been associated with a significant increase in bleeding risk [2,5]. Therefore, therapies or strategies that maintain the benefits of currently available antithrombotic therapies, but which produce less bleeding, are of great clinical importance. In this perspective, two contemporary trials - the OASIS 5 trial, comparing fondaparinux and low molecular weight heparin; and the STEEPLE trial, comparing low molecular weight heparin and unfractionated heparin (UFH) - give us interesting, up-to-date data in the setting of PCI for non-ST-segment elevation acute coronary syndromes and planned PCI, respectively [6,7]. In the first study (20,000 patients), the primary end-point of major adverse cardiac events at nine days was similar in the two groups, but both major bleeding complications and vascular access site complications were reduced significantly using fondaparinux (although vascular access site complications remained at 3.3%). In the second study (3528 patients, femoral access PCI), once again there was no difference for ischaemic end-points but there was significant reduction (from 8.7% to 6%) in bleeding complications.

It can be seen that bleeding complications still exist, mainly in relation to the vascular access site, and are responsible for a non-negligible rate of patient complaints. These bleeding complications and the necessary related transfusions - identified as independent predictors of poor outcome [4,5] - may principally influence the quadruple end-point, including both efficacy and safety end-points. Further attempts to reduce bleeding and vascular access site complications are warranted. In this perspective, bivalirudin, a direct thrombin inhibitor (with both anticoagulant and antiplatelet properties), has been shown to be superior to UFH for reduction of ischaemic end-points (death, AMI) [8]. Furthermore, in intermediate-risk PCI, bivalirudin is non-inferior to the association of UFH plus GPIIb/IIIa inhibitors and is also able to reduce the risk of bleeding complications in a similar proportion to those observed in the two abovementioned trials [9]. These promising results have also been confirmed in higher-risk patients in the ACUITY trial with bivalirudin, once again alone non-inferior to the association of UFH plus GPIIb/IIIa inhibitors for reduction of composite ischaemic end-points and superior for reduction of bleeding complications. Multivariable analysis confirmed that radial access was an independent predictor of decreased major bleeding (OR 95%CI 0.52 [0.3-0.9] p<0.03), as was the use of bivalirudin alone in PCI patients (OR 95%CI 0.46 [0.3-0.6] p<0.0001).

Usage of closure devices for reduction of vascular access site complications

Summary of available evidence comparing access site complications arising from trans-radial and femoral accesses.
Figure 1. Summary of available evidence comparing access site complications arising from trans-radial and femoral accesses.

Numerous devices have been developed in recent years to obtain an efficient arteriotomy closure immediately at the end of the procedure. At present, evidence-based data are disappointing, and all randomised studies included in a recently published meta-analysis [10] confirm that, compared to manual management of the puncture site, these devices are unable to reduce complications; moreover, they sometimes induce further complications. Since they facilitate physicians’ work and reduce nursing staff workload, these devices are very attractive, but their impact on reduction of complications and cost-effectiveness is disputable. Future direction for the development of such devices should take into account the difficult cases in daily practice, e.g. calcified arteries in the elderly are treated more and more in the catheter laboratory; obese patients; and the increasing aggressiveness of the pharmacological environment, all of which makes for numerous restrictions in using these closure devices for high-risk patients.

Why is an alternative access site needed?
An attempt at zero access site complications
What are the benefits of the trans-radial approach (TRA)?
The available evidence, supported by several randomized PR=studies, suggests that the TRA is associated with fewer bleeding events and transfusions compared to the femoral approach (Figure 1) [11,12]. Bleeding and vascular access site complications are virtually eliminated. This clearly is a major advantage in the current era of intensive anticoagulant and antiplatelet therapy. Patient comfort is increased and nursing staff workload is reduced; outpatient treatment has been proposed and already has been set up by some of the pioneers [13]. As recently stated in our meta-analysis [11,12], this drastic reduction of vascular access site complication rate is immediately associated with a significant reduction in length of hospital stay and has related health-economic savings. It remains to be seen whether the reduction of vascular access site complications observed with the TRA can be translated to mortality reduction. However, since an increasing number of patients are treated by the TRA, this hypothesis can be tested easily in substudy analyses of mega-trials, such as the recently completed OASIS 5 or ACUITY trials.

Why the trans-radial technique has not been widely adopted and how clinical practice can be changed?
The relative disadvantage of the TRA relates to the operator’s learning curve: only experienced operators should attempt the TRA. Clearly, materials and procedures were not well standardised in the beginning, and the rate of failure related to radial spasm, arterial puncture failure, or failure to reach the ascending aorta were obstacles that caused operators to be reluctant to use this approach. However, dedicated materials and diffusion of the technique reduced these limitations, and success rates now are equivalent in both access routes (Figures 2, 3) [11,12]. When the benefits of the TRA for patients are recognised, there is no doubt that more and more physicians will take this approach into account in their daily practice for PCI. Most new interventional cardiologists from several parts in the world indicate their willingness to develop their practices using the TRA and, with the development of educational and comprehensive courses, a more widespread use of the technique is expected in the future.

Figure 2. Summary of available evidence comparing procedural failure rates in trans-radial and femoral approaches.
Figure 2. Summary of available evidence comparing procedural failure rates in trans-radial and femoral approaches.

Analysis of data from randomised trials showing gradual decrease in procedural failure rates.
Figure 3. Analysis of data from randomised trials showing gradual decrease in procedural failure rates.

Key Learning
  • Bleeding complications are currently the most common complication after PCI
  • Bleeding complications and transfusions, mainly related to access site complications in the setting of PCI, impact long-term patient survival
  • Strategies preserving efficacy of PCI with the ability to reduce major bleeding are of great importance
  • New antithrombin agents, in combination with the radial approach, seem to be very attractive to optimise the management of patients who undergo PCI in different clinical settings

References
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10-2006 BUY1145315/JB2356/MB002264/CMC 12th edition