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Prof. Stefan James,
SCAAR - Long term mortality after drug eluting stents in Sweden, an additional year of follow-up
Related News article: Drug-eluting stents: study shows no increased mortality.
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The Swedish Coronary Angiography and Angioplasty registry (SCAAR) has recently indicated a slight increase in long-term mortality in the Swedish patients receiving either Drug eluting stents (DES) or bare metal stents (BMS). The objective of the present study was to investigate whether the observed difference was sustained with longer follow-up.
All Swedish patients with a coronary intervention from 2003 to 2006 with a minimum follow-up of one year were included. The outcome analyses covered a period of up to 4 years and were based on 2957 deaths and 4160 myocardial infarctions and were adjusted for differences in baseline characteristics using propensity score methods.
The studied population consisted of 13785 patients who had received at least one DES, and 21477 patients who received only bare metal stents. There was no difference in the primary endpoint of death or myocardial infarction (risk ratio (RR) 1.01 (95% confidence interval 0.94-1.09) or in myocardial infarction, RR 1.01 (95%CI 0.91-1.11) or mortality RR 1.03 (95%CI 0.94-1.14) alone. In a prespecified landmark analysis, there was a lower adjusted composite event rate RR 0.95 (95%CI 0.77-0.95) at 6 months, which was compensated by a higher event rate after 6 months, RR 1.17 (95%CI 1.06-1.29). In the DES group, there was an absolute reduction of restenosis by 4% at three years follow-up and there was a sustained crude rate of stent thrombosis of 0.5 % annually.
With inclusion of one additional year, thereby doubling the number of DES treated patients and outcome events, the previously reported increase in mortality with drug eluting stents can no longer be observed. Still there remains a slightly raised risk of late stent thrombosis and reinfarction after 6 months, which is however compensated by a lower event rate during the first 6 months. The reduction of clinically relevant restenosis is lower than in randomized trials with mandated angiography at follow-up and amounts only to 4%.
Clinical Trial Update I
Stefan James 1,Jörg Carlsson 2, Johan Lindbäck, Tage Nilsson 3, Ulf Stenestrand 4, Lars Wallentin 1 and Bo Lagerqvist 1 for the SCAAR Study Group Uppsala clinical research center and Dept. of Cardiology in Uppsala 1, Kalmar 2, Karlstad 3, Linköping 4
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