Update from Swedish DES Registry: No Increased Risk of Death

C. Michael Gibson, M.S., M.D. September 2, 2007

Vienna, Austria - Last year, higher mortality rates associated with DES in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) led to Drug Eluting Stents being labeled the "Death Stent" in the Swedish press. However, today at the European Society of Cardiology (ESC) meeting, additional follow-up suggests that DES may not be associated with as high of a mortality risk as earlier data suggested. The release of these data come at a critical juncture when some countries such as Britain have considered withdrawal of reimbursement for DES, and as usage has fallen below 20% in other countries such as Sweden.

Additional long term data from SCAAR were presented today by Dr. Stefan James from the Academic Hospital in Uppsala, Sweden. Consistent with prior data from the SCAAR group, an additional one year of entry and follow-up of patients suggests that DES is associated with higher adverse events rates. Of note though, out to 4 years of follow-up, there was no increase risk of mortality.

Dr. James indicated that DES was associated with an increased risk of late stent thrombosis, but similar to other data from randomized trials, this did not translate into a long term mortality hazard.

One to four year follow up in 35,000 patients were included. DES was associated with a 1.25 fold increase in MI after 6 months (95% CI 1.09-1.42, p<0.05), but death was not increased after 6 months (1.09, 95% CI0.96-1.25, p=NS). The composite of death and MI was significantly increased by 1.17 fold (95% CI 1.06 to 1.29, p<0.05). These late results were balanced by a reduction in early events in the first 6 months with DES. DES was associated with a 15% reduction in Death/MI in the first 6 months (0.85, 95% CI 0.77-0.95, p<0.05).

There was a modest absolute reduction in clinical restenosis (not angiographic restenosis) of 3.5%.

At a press conference, James suggested that greater attention now being paid to long term dual antiplatelet therapy may have attenuated the long term risk of DES. He also commented that patient selection and improvements in implantation technique may be responsible.

James indicated that from his perspective DES are most appropriate in lesions at high risk for restenosis: longer, complex lesions, in small vessels.

It is unclear how these data will impact the US market where the rate of DES implantation is much higher, although still down from its peak prior to the stent thrombosis firestorm.

References: 1. 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; 356:1009-1019.