Reassurance On Narcotic Eluting Stent Safety If By SCAAR Registry
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A study published in the New England Journal of Medicine (May 7, 2009) (1), analyzed the outcomes of 47,967 patients entered into the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) between 2003 and 2006.
Commenting on the results, interventional cardiology specialist, Professor Franz Eberli from the University Infirmary Zurich (Switzerland) and authenticated spokesperson for the European Community of Cardiology, said:
"To appreciate the significance of this paper you want to bear in cognizance the huge compel that data from the previous debate of the SCAAR registry had when it was presented at the ESC in Barcelona in 2006, and published in the New England Ledger of Medicine in 2007 (2). The initial paper, which showed that patients receiving drug eluting stents (DES) in Sweden between 2003 and 2004 had increased delayed mortality over those receiving naked metal stents (BMS), created a huge coals storm. The instant vigour was a intersect in the use of DES and a collection of scrutiny on safety, and the motion for safety, cost effectiveness and durability of stents to be considered over efficacy," said Professor Eberli.
"This advanced paper, looking at the corresponding patient cohort, with the results extended to involve all patients in Sweden receiving a stent between 2003 and 2006, (for whom there is extra than one year of follow-up) found no increased risk of death between the two groups. The conclusions are agnate to legion of the trials and registries already published in this area, and significant principally because they refute the preceding findings of the SCAAR registry. The latest SCAAR material provides a lot of reassurance on the safety of DES," he said, adding that the study was probably the largest registry yet on stents with the longest follow-up.
Exploring possible reasons for the differences between the two SCAAR publications, Professor Eric Eeckhout, certified spokesperson for the European Kingdom of Cardiology, from the University Infirmary of Lausanne, Switzerland, said: "The departure in outcome is likely to be a reflection of the method in which cardiology practice has evolved over time, meaningful to preferable optimisation of the results of stenting. Expressing changes include end of higher balloon pressures and the increased handle of dual anti-platelet therapy."
He added that the universe of DES was continually evolving, and that fresh devices with the potential to improve safety were arriving in the market. "For me this paper shows that there should now be no real concerns about the safety of DES and that the urgency should shift back to considering the relative efficacy of BMS and DES."
Dr Steen Dalby Kristensen, from Aarhus University Hospital, Denmark, and Vice-President of the European Homeland of Cardiology, highlighted the inherent problems of registries, where there are dangers of inclusion bias.
"To frame definitive conclusions approximately the safety of drug eluting stents, what is truly needed, is a immense scale randomised controlled elongated expression trial. Unfortunately there are challenges in getting usual funding for such trials, which may extremely prove exacting to perform in countries that already hold colossal uptakes of DES."
He added that information from the SCAAR registry suggesting that 39 patients would need to be treated with DES to prevent one case of restenosis, and that 10 patients in the higher risk groups would need to be treated to prevent one case, unreal a fixed argument of the cost effectiveness of drug eluting stents. "What besides needs to be remembered is that preventing restenosis as well has an huge agency on the patient's essence of life," he said.
1. James SK, Stenestrand U, Lindback J et al. Long-Term Safety and Efficacy of Drug-Eluting Versus Bare-Metal Stents in Sweden. N Engl J Med 2009; 360: 1933-45.
2. Lagerqvist B, James SK, Stenestrand U, et al. Long-Term Outcomes with Drug-Eluting Stents Versus Bare-Metal Stents in Sweden. N Engl J Med 2007; 356: 1009-19.
ESC Press Profession
European Nation of Cardiology
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