Dr Ronen Jaffe from the Lady Davis Carmel Medical Centre in Haifa, Israel - who is also speaking at the session on the "safety of drugeluting stents two years after Barcelona" - agrees. “We're seeing the pendulum swing back in favour of DES,” he says.
DES were pilloried at the ESC Congress in Barcelona in 2006 after a study pooling data from four randomised controlled trials (RAVEL, SIRIUS, E-SIRIUS and C-SIRIUS) showed a rate of total death and Q-wave MI of 6.3% in the cypher group, compared to 3.9% in the control group receiving a bare metal stents (BMS) (P=0.03).
Since then, criticisms of the study (by Edoardo Camenzind) have noted that the meta-analysis only included four studies from a possible ten, that the studies were published at different time points of follow-up and that the investigators used total death and Q-wave MI as the endpoints, disregarding non-Q-wave MI incidences, which were substantially lower in the cypher group.
However, the bad press for DES continued with publication of the Swedish Coronary Angiography and Angioplasty Registry (SCARR) data evaluating 6033 patients treated with DES and 13,738 with BMS in 26 centres across Sweden between 2003 and 2004. The study showed 12 more events per 1000 patients per year in people given DES than in those given BMS.
But the tide started to turn when data from an additional year's worth of patients and events from SCARR, which were presented at the ESC Congress in Vienna last year, showed no overall increased risk of death in patients treated with DES compared to BMS.
A meta-analysis of eight randomised controlled trials comparing both sirolimus and paclitaxel eluting DES with BMS in 2786 patients with acute ST-segment elevation MI, undertaken by Kastrati and colleagues, showed that the difference in instent thrombosis was not statistically significant, but that DES significantly reduced the risk of reinterventions (p<0.001). A second meta-analysis - following 18,023 patients in 38 trials for four years - found the mortality associated with DES and BMS to be similar. “Taken together these studies show there's no increased risk for death or MI with DES compared to BMS,” says Kastrati.
The issue of whether the stent itself or the artery is responsible for in-stent thrombosis also needs addressing, says Jaffe: “With DES, people are treating complex lesions that previously no one treated with stents. It might be that complex anatomy is associated with poorer outcomes."