Late Clinical Events After Drug-eluting Stents: Is There a Problem?
Late Clinical Events After Drug-eluting Stents: Is There a Problem?
Recent presentations at the joint meeting of the European Society of Cardiology and World Congress of Cardiology in Barcelona, Spain, highlighted the potential problem of very late stent thrombosis and increased non-cardiac death occurring in drug-eluting stents (DES) (see pages 31718). The presentations received major publicity, not least because of the comments of the designated discussant Professor Salim Yusuf (McMaster University, Hamilton, Canada) at one of the conference Hot Line sessions.
These presentations and their content need careful assessment and debate. The manner in which the information was communicated also merits discussion. Finally, the interventional community should scientifically decide whether this is a major problem and, if so, what is required to solve it.
Two presentations at the Hot Line session concentrated on all-cause mortality, the incidence of death and Q-wave myocardial infarction (MI) (a surrogate end-point for stent thrombosis) following DES placement. These data were for randomised trials with the first-generation Cypher® (sirolimus-eluting) and Taxus® (paclitaxel-eluting) stents. The first presentation (the Nordmann meta-analysis) suggested an increase in non-cardiac deaths with DES compared to bare-metal stents (BMS) and implied this was because of increased cancer rates. The second presentation (the Camenzind meta-analysis) suggested a statistically significant increase in death and Q-wave MI (and by inference stent thrombosis) in DES, specifically with the Cypher® stent rather than the Taxus® stent, compared to BMS.
This led to Professor Yusuf commenting: "as clinicians we seem to have lost our clinical judgement, let alone our ability to view data and evidence. The whole field of angioplasty has been led astray by a preoccupation with restenosis for which study after study has shown, has no prognostic value". In addition, he suggested that angioplasty was being overused in stable angina and that there was an unhealthy relationship between interventionalists, money and industry (reported on www.theheart.org). All of these comments led to Professor Yusuf appearing on the front pages of much of the medical press.
These data require and deserve careful analysis. The interventional community understands that stent thrombosis is a major, recognised, complication of any stenting (DES or BMS) procedure. In addition, if an increase in non-cardiac mortality is the ‘price' of a DES, this would have major consequences.
Recent presentations at the joint meeting of the European Society of Cardiology and World Congress of Cardiology in Barcelona, Spain, highlighted the potential problem of very late stent thrombosis and increased non-cardiac death occurring in drug-eluting stents (DES) (see pages 31718). The presentations received major publicity, not least because of the comments of the designated discussant Professor Salim Yusuf (McMaster University, Hamilton, Canada) at one of the conference Hot Line sessions.
These presentations and their content need careful assessment and debate. The manner in which the information was communicated also merits discussion. Finally, the interventional community should scientifically decide whether this is a major problem and, if so, what is required to solve it.
Two presentations at the Hot Line session concentrated on all-cause mortality, the incidence of death and Q-wave myocardial infarction (MI) (a surrogate end-point for stent thrombosis) following DES placement. These data were for randomised trials with the first-generation Cypher® (sirolimus-eluting) and Taxus® (paclitaxel-eluting) stents. The first presentation (the Nordmann meta-analysis) suggested an increase in non-cardiac deaths with DES compared to bare-metal stents (BMS) and implied this was because of increased cancer rates. The second presentation (the Camenzind meta-analysis) suggested a statistically significant increase in death and Q-wave MI (and by inference stent thrombosis) in DES, specifically with the Cypher® stent rather than the Taxus® stent, compared to BMS.
This led to Professor Yusuf commenting: "as clinicians we seem to have lost our clinical judgement, let alone our ability to view data and evidence. The whole field of angioplasty has been led astray by a preoccupation with restenosis for which study after study has shown, has no prognostic value". In addition, he suggested that angioplasty was being overused in stable angina and that there was an unhealthy relationship between interventionalists, money and industry (reported on www.theheart.org). All of these comments led to Professor Yusuf appearing on the front pages of much of the medical press.
These data require and deserve careful analysis. The interventional community understands that stent thrombosis is a major, recognised, complication of any stenting (DES or BMS) procedure. In addition, if an increase in non-cardiac mortality is the ‘price' of a DES, this would have major consequences.
