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Interact CardioVasc Thorac Surg 2007;6:813-814. doi:10.1510/icvts.2007.161471 © 2007 European Association of Cardio-Thoracic Surgery
Drug eluting stents – a nightmare?European Heart Institute, European Academy of Sciences and Arts, Mönchsberg 2, 5020 Salzburg, Austria Received 23 June 2007; received in revised form 24 August 2007; accepted 27 August 2007
*Corresponding author. Tel.: +43-662-4482-3352; fax: +43-662-4482-3374.
As a contribution to the controversial discussion for the use of drug-eluting stents, the European Heart Institute of the European Academy of Sciences and Arts is emphasizing important factors: a) drug eluting stents (DES) should be used only in accordance with their on-label indications for use; b) to avoid off-label use of DES and to assure that patients are apprized of all their revascularization options, patients should have informed consent between the patient, interventionist and a cardiac surgeon; c) without informed consent, off-label use of DES may be considered a legal offence against the interventionist; d) at onset of new symptoms, patients must be informed that surgery is a viable and recommended option.
Key Words: Drug eluting stents; Coronary artery disease; Coronary artery revascularization It became publicly evident as early as August 2006 at a meeting of cardiologists in Barcelona that drug eluting stents (DES) pose a hazard to patient safety because of the long-term risk for thrombosis, myocardial infarction and death. The BASKET-Late Study [1] presented at the American College of Cardiology meeting in March 2006 — section on Late Thrombolic Events — suggested that complications such as stent thrombosis, myocardial infarction and death were more frequently encountered in DES as compared to bare metal stents (BMS). Public turmoil started after articles appeared in the New York Times [2] and in the New England Journal of Medicine [3] in 2007. Furthermore, papers by Spaulding, Stone and Lagerquist [4–6] drew similar conclusions that DES therapy carries a higher risk in the long-term in comparison to BMS. Wallentin [5] found an increased risk of death or myocardial infarction of up to 1%. These early studies stimulated further investigations and resulted in a number of ongoing randomized clinical trials comparing DES to BMS, also comparing stenting and coronary bypass surgery. The results of these studies vary, but there are new studies supporting the original BASKET-Late Study evidence that DES therapy is not superior to BMS. Other studies indicate that DES have not reached their predicted level of success in closed chest revascularization [7]. The procedural mortality in stent grafting remains high [8]. In addition, the ARTS Study [8] clearly demonstrates a superior outcome when surgery is applied in regards to major adverse cardiac events (MACE): especially for patients undergoing repeat revascularization procedures. One major criticism of randomized DES studies conducted up to date is the fact that clinical results and MACE are presented at early endpoints. However, there exist many patients who have received multiple stents during various procedures. These cases seem to be not reported on, at least absent from a host of relatively short-term studies. Eminent cardiologist E. Topol chides his colleagues about their data collection methods, the presentation of their analysis and the paucity of data from outside studies. Daily cardiosurgical experience shows that most patients are referred for revascularization surgery only after receiving multiple stents in multiple vessels. It is common for cardiac surgeons to encounter patients who present with stents reinserted into recently restenosed stents or patients with their LADs appearing as rigid tubes with closed septal side branches. A major problem with stenting is that stents are deployed directly within the diseased areas of the vessels. Histologically, bare metal stents become lined with endothelium, but in DES, the drug release causes necrosis of the endothelium, which causes thrombus formation and necessitates aggressive anticoagulation [9]. Of course, anticoagulation carries its own set of potential complications, too. Coronary artery surgery principally avoids an interaction with the diseased areas of coronary arteries by literally bypassing the diseased tissue part. Because of the favorable long-term results and a reduced need for reintervention, the ‘Gold Standard’ in coronary artery revascularization remains the use of arterial grafts, especially the internal thoracic artery. Furthermore, I am concerned that patients do not typically receive full disclosure of their revascularization options. Generally, patients are exposed only to the revascularization opinions presented by their cardiologist – who often also is their interventionist: Mark Twain told us that a man with a hammer sees only things to hammer. There are clear indications for DES intervention and they are spelled out in the products' on-label indications. An on-label indication for DES is its use for the treatment of a single stenosis in large vessels. On-label use of DES leads to a cumulative incidence of in-stent stenosis at four years, which is comparable to BMS [9]. Unfortunately, it is evident that 60–75% of DES are used off-label in patients with complex coronary lesions, small vessels and at bifurcations and also in patients presenting with co morbidities such as unstable angina pectoris and diabetes. For the reasons cited above, the European Heart Institute of the European Academy of Sciences and Arts is emphasizing:
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