European Heart Journal Advance Access originally published online on June 7, 2006
European Heart Journal 2006 27(14):1757; doi:10.1093/eurheartj/ehl071
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Guidelines for percutaneous coronary interventions
Division of Cardiology
Department of Internal Medicine
University Hospital Rostock
E.-Heydemann Street 8
18057 Rostock
Germany
Tel: +49 381 494 7700
Fax: +49 381 494 7702
E-mail address: christoph.nienaber{at}med.uni-rostock.de
The recently published guidelines for PCI1 by the European task force were set out to mark a timely milestone, but missed this goal unfortunately as a result of unbalanced statements. Various peculiarities make it difficult to follow those guidelines for various reasons.
First, statements and findings from the Taxus VI trial were utilized for the paper,2 although the stent utilized in Taxus VI has never been marketed and is not available while results from other trials are neglected.
Secondly, results from RCTs on various interesting subsets of patients with focus on in-stent restenosis, diabetes, and small vessels have not been taken into consideration; nevertheless, the authors of the guidelines are demanding such RCTs even at a time when ARTS II and TROPICAL could not use bare metal controls, but rather had to compare with historical controls for ethical reason.3,4
Thirdly, the authors' conclusion of equipotential effects of sirolimus and paclitaxel coated stents only on the basis on the small TAXI trial is likely to be oversimplified and more than courageous5; justified is only that the hypothesis of 6% MACE with sirolimus and 14% with paclitaxel were not met.
Finally, although the preamble to those guidelines claims both to present all relevant evidence on a particular issue and to be developed by an unquestionable decision-making process, none of those standards have been met. It is already late for an update.
References
- Silber S, Albertsson P, Avilés FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W. Task Force per le Procedure Coronariche Percutanee della Societa Europea di Cardiologia. (2005) Guidelines for percutaneous coronary interventions. The Task Force for percutaneous coronary interventions of the European Society of Cardiology. Eur Heart J 26:804–847.
[Free Full Text] - Dawkins KD, Grube E, Guagliumi G, Banning AP, Zmudka K, Colombo A, Thuesen L, Hauptman K, Marco J, Wijns W, Popma JJ, Koglin J, Russell ME. TAXUS VI Investigators. (2005) Clinical efficacy of polymer based paclitaxel eluting stents in the treatment of complex, long coronary artery lesions from a multicentre, randomised trial: support for the use of drug eluting stents in contemporary clinical practice (TAXUS VI). Circulation 112:3306–3313.
[Abstract/Free Full Text] - Serruys PW, Ong ATL, Morice MC, De Bruyne B, Colombo A, Macaya C, Richardt G, Fajadet J, Hamm C, Dawkins K, O_Malley J, Bressers M, Donohoe D. on behalf of the ARTS II Investigators. (2005) Arterial Revascularisation Therapies Study Part II—Sirolimus-eluting stents for the treatment of patients with multivessel de novo coronary artery lesions (ARTS II). EuroInterv 2:147–156.
- Neumann FJ, Desmet W, Grube E, Brachmann J, Presbitero P, Rubartelli P, Mugge A, Di Pede F, Fullgraf D, Aengevaeren W, Spedicato L, Popma JJ. (2005) Effectiveness and safety of sirolimus-eluting stents in the treatment of restenosis after coronary stent placement. Circulation 111:2107–2111.
[Abstract/Free Full Text] - Goy JJ, Stauffer JC, Siegenthaler M, Benoit A, Seydoux C. (2005) A prospective randomized comparison between paclitaxel and sirolimus stents in the real world of interventional cardiology: the TAXI trial. J Am Coll Cardiol 45:308–311.
[Abstract/Free Full Text]
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