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Drug-eluting stents safety - is it time to turn the page on Barcelona 2006?

Three years ago, at a session held here in Barcelona during the ESC/World Congress of Cardiology,Eduardo Camenzind initiated a public debate about the long-term outcome in patients undergoing DES implantation. This debate resulted in a substantial decrease in the use of DES in some countries, and stimulated additional clinical research aimed at the assessment of the risk of late in-stent thrombosis with DES, both in the setting of randomized trials and large registries with long follow-up times.


Today’s session provided new information on this important topic, summarizing the experience from the last three years.


Eduardo Camenzind emphasized that the use of DES resulted in a dramatic decrease in restenosis at the price of increased late stent thrombosis. He gave a critical overview of the recently published data, stressing that the problem has not been solved yet, but also drawing attention to the fact that there are many factors other than DES that can predispose to in-stent thrombosis.


Adnan Kastrati analyzed the data from randomized trials, stressing that the existing data coming from randomized clinical trials (RCTs) and meta-analyses generally confirm the efficacy and safety, also in high-risk patient groups, like those with diabetes and myocardial infarction. He remarked, however, that none of the RCTs had enough power to reliably evaluate safety of DES, and that meta-analyses of RCTs are not an optimal alternative to large specific trials on stent thrombosis with long FU. He also touched upon the evolving technology of DES, and the need to appreciate the differences between kinds of DES. He concluded that, based on recent evidence, there are good reasons for us to believe that the benefit of DES in terms of restenosis is not achieved at the expense of compromised safety.


Staffan James presented the latest data from registries, including the large SCAAR database from Sweden. Most recent data from this registry do not show a difference in death or MI in the 5-year and 6-year follow-up. Dr James also presented the data from other registries, which yielded divergent results, from DES mortality benefit, through no difference, to those showing an increase in late stent thrombosis after discontinuation of dual antiplatelet treatment. He also stressed the need for further studies on optimal time of dual antiplatelet treatment. He commented on the fact that late thrombosis rate may differ with different types of stents, and that this is true not only in relation to DES, but also to BMS. He concluded that we indeed should turn the page on Barcelona 2006 because we have learned several things from history:

  • Long term follow-up of large registries indicate a similar or lower mortality and MI risk for DES vs. BMS (on- and off label)
  • Also in high risk patients such as STEMI and diabetes long term follow-up of large registries are reassuring
  • Late stent thrombosis is rare but seems uniquely associated with DES
  • Prolongation of dual anti-platelet therapy may not solve the risk of late stent thrombosis

This also needs to be done because we need to look forward to evaluate new DES types including bio absorbable polymers and stent struts as well as more effective anti thrombotic treatments.  

David Holmes summarized the session by addressing the most relevant practical question: “Which recommendations can we give in 2009?” He said that we are not finished with addressing all the issues related to long-term DES safety. He also emphasized that DES is not the sole purveyor of stent thrombosis, there is no real class effect, DES might be used in higher risk patient subsets, and that there are advances in adjunctive care that might change the picture. Dr Holmes alluded to potential differences in patient populations included in different studies, and to the need for meticulous care with which each procedure, regardless of stent nature, has to be performed. In summary – not only stents, but also patients and operators are different.

He concluded by saying that DES definitely reduce restenosis, but they are not a panacea for prevention of cardiovascular events. Great attention should be paid to optimal antiplatelet regimen. DES should be used in those patients to whom they offer the most pronounced improvement in efficacy, and that the strategies will continue to evolve.

Dr Holmes said that we need to come back to Barcelona in 3-4 years in order to discuss this important topic again.


The chairmen took a vote, asking the audience at the beginning and at the end of the session whether they still think that DES implantation is an important clinical controversy. The vote was split on both occasions, with some change in favor of DES at the end of the session, but also with more abstentions. So, the discussion on this moving target is definitely not over.




Drug-eluting stents safety - is it time to turn the page on Barcelona 2006?

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.