European Heart Journal Advance Access originally published online on September 30, 2008
European Heart Journal 2008 29(22):2820-2821; doi:10.1093/eurheartj/ehn430
Comment on ‘Comparison of operator radiation exposure with optimized radiation protection devices during coronary angiograms and ad hoc percutaneous coronary interventions by radial and femoral routes’
Antwerp Cardiovascular Institute Middelheim
AZ Middelheim
Lindendreef 1
2020 Antwerp
Belgium
Tel: +32 484 086933
Fax: +32 3 2306511
Email: agostonipf{at}gmail.com
Institute of Cardiology
John Radcliffe Hospital
Oxford
UK
Divison of Cardiology
University of Turin
Turin
Italy
Meta-analysis and Evidence-based Medicine Training in Cardiology (METCARDIO) members(www.metcardio.org)
We read with extreme interest the paper by Brasselet et al.1 showing an increased radiation exposure for operators performing percutaneous coronary angiographies and interventions through the radial approach in comparison to the femoral access. We believe the prospective, operator-blinded design and the careful acquisition of the radiation exposure data are major strengths of this study. However, there are limitations that in our opinion seriously undermine the conclusions of the manuscript, where the authors suggest reconsidering promptly the radial approach in light of their findings.
First, the non-randomized nature of this study is a major drawback and the authors did not do any effort to adjust statistically their results at least for the available variables collected. For example, body weight has been found to be significantly higher among patients in the radial group.1 Body weight can influence the total amount of X-rays needed to visualize properly the coronary arteries as the X-ray apparatus automatically increases or reduces the emission according to the impedance that finds from the body of the patient. An adjustment of the results according to the baseline data is needed in a study designed as a registry, and a regression analysis or a propensity matching analysis would be extremely welcome.2,3
Secondly, no mention of the possible rates of crossover from femoral to radial access or vice versa has been made or considered, and this would be also important, mainly in an intention to treat analysis.
Thirdly, it is not clear whether the procedures were performed all in one room or in different rooms. The authors mention only that the cine-angiography units were the same and were all 9 years old; however, if located in different rooms, it is possible that a different rate of use of these machines could have had an impact on the results.
Finally, safety is a comprehensive issue, and radiation safety is only a part of the whole picture. Periprocedural bleedings after percutaneous coronary procedures threaten safety.4,5 Yet, no mention of the minimization of bleeding risks by the radial access and of its potential impact on overall patient safety is made in the analysis or discussion.6
In conclusion, the radial approach has been repeatedly shown to have several benefits over the femoral access for coronary angiographies and interventions in thousands of patients.6 We believe that a single registry of 420 patients without a randomized design cannot prompt to reconsider the radial approach for these indications. On the other hand, seen the provocative results of this study and the expertise of the authors in radiation exposure measurement, we urge them to plan a prospective randomized comparison, setting radiation exposure as primary endpoint and using the results of the current pilot study to define a proper power analysis and an adequate sample size.
References
- Brasselet C, Blanpain T, Tassan-Mangina S, Deschildre A, Duval S, Vitry F, Gaillot-Petit N, Clément JP, Metz D. Comparison of operator radiation exposure with optimized radiation protection devices during coronary angiograms and ad hoc percutaneous coronary interventions by radial and femoral routes. Eur Heart J (2008) 29:63–70.
[Abstract/Free Full Text] - Harrell FE Jr, Lee KL, Mark DB. Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med (1996) 15:361–387.[CrossRef][Web of Science][Medline]
- Blackstone EH. Comparing apples and oranges. J Thorac Cardiovasc Surg (2002) 123:8–15.
[Free Full Text] - Ndrepepa G, Berger PB, Mehilli J, Seyfarth M, Neumann FJ, Schömig A, Kastrati A. Periprocedural bleeding and 1-year outcome after percutaneous coronary interventions: appropriateness of including bleeding as a component of a quadruple end point. J Am Coll Cardiol (2008) 51:690–697.
[Abstract/Free Full Text] - Manoukian SV, Feit F, Mehran R, Voeltz MD, Ebrahimi R, Hamon M, Dangas GD, Lincoff AM, White HD, Moses JW, King SB 3rd, Ohman EM, Stone GW. Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial. J Am Coll Cardiol (2007) 49:1362–1368.
[Abstract/Free Full Text] - Agostoni P, Biondi-Zoccai GG, De Benedictis ML, Rigattieri S, Turri M, Anselmi M, Vassanelli C, Zardini P, Louvard Y, Hamon M. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol (2004) 44:349–356.
[Abstract/Free Full Text]
CiteULike 
Connotea 
Del.icio.us What's this?
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||