[Assessment of drug-eluting stents]
Haute Autorité de Santé
Record ID 32016000285
Authors' objectives: The principal aim is to define the indications for which: − alternative strategies to angioplasty with DES implantation (CABG surgery and pharmacological treatments) are preferable; − DES implantation is recommended rather than angioplasty without stent implantation or with implantation of a BMS; − a particular DES should be recommended rather than another DES. The second aim is to define the use of dual antiplatelet treatment at the time of stent implantation (treatment duration and management of the treatment in the context of any type of surgery).
Authors' recomendations: In comparison to BMS, DES are of confirmed but moderate benefit in terms of reducing the incidence of restenosis and revascularisation procedures. They are not a cause of an increased risk of intrastent thrombosis, death or myocardial infarction during follow-up over up to 4 years when they are used with long-term anti platelet treatment. DES provide some clinical benefit, but this benefit is obtained at the cost of prolonged dual antiplatelet therapy, continued for a minimum of 12 months. Economic data show that the efficiency of DES varies according to the clinical characteristics of the patients and the lesions and is strongly dependent on the difference in price between DES and BMS. HAS considers that there are no benefits in implanting DES in a non-selected patient population. Whether the current recommendations for myocardial revascularisation are respected, HAS recommends to limit the use of DES to the following indications: − treatment of coronary insufficiency attributable to de novo lesions in native coronary arteries in some subgroups of patients at high risk of restenosis (lesions > 15 mm, diameter of affected vessel < 3 mm or in diabetic patients). The devices recommended are the CYPHER, TAXUS, ENDEAVOR stents as well as the XIENCE V and PROMUS stents. − some situations of coronary insufficiency require a multidisciplinary consultation involving a medical-surgical team: • treatment of total coronary occlusion (> 72 hours) in a situation where there is evidence of ischaemia and when the lesion appears accessable with a reasonable success rate. The recommended devices are the CYPHER and TAXUS stents. • treatment of the first clinical intrastent restenosis in a BMS (i.e., the reappearance of ischaemic symptoms leading to a new revascularisation of the artery). The recommended devices are the CYPHER and TAXUS stents. • treatment of some de novo multi-vessel lesions in native coronary arteries (lesions > 15 mm, diameter of affected vessel < 3 mm or in diabetic patients), which are accessible to angioplasty when the surgical risk is very high. This situation should be the object of a medical-surgical discussion about the revascularisation alternatives, taking into account the risk factors assessed (EUROSCORE and SYNTAX score). CYPHER and TAXUS stents are recommended. • treatment of unprotected left main stenosis. The recommended device is the CYPHER stent. This evaluation confirms the benefit of DES compared to BMS in some indications. The clinical benefit (reduction of new revascularisation of lesion already treated with a DES) is less than previously expected and bears a cost in the need for antiplatelet treatment using a combination of salicylic acid and clopidogrel for 1 year. Economic data demonstrate a low efficiency of DES. In other indications for angioplasty, BMS should be favoured. DES require prolonged dual antiplatelet therapy and their cost is much higher than that of BMS. In the future, it will be desirable to have data documenting more precisely the efficiency of DES according to the indications, particularly in diabetic patients.
Project Status: Completed
Year Published: 2009
URL for published report: http://www.has-sante.fr/portail/upload/docs/application/pdf/2009-10/evaluation_des_endoprotheses_coronaires_a_liberation_de_principe_actif.pdf
English language abstract: An English language summary is available
Publication Type: Not Assigned
- Angioplasty, Balloon, Coronary
- Drug-Eluting Stents
Organisation Name: Haute Autorité de Santé
Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;
Contact Name: sh.leerobin@has-Sante.fr
Contact Email: sh.leerobin@has-Sante.fr
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