Steady long-term risk of late events with first-generation DES
medwireNews: Patients with first-generation drug-eluting coronary stents (DES) remain at risk for late adverse events, say researchers who report the 10-year outcomes of the Danish all-comer SORT OUT II trial.
“Although there is no need for extraordinary medical attention for these patients, the absence of declines in annual event rates calls for continuous surveillance,” they write in the Journal of the American College of Cardiology.
However, the team notes that the risk was comparable regardless of whether patients received sirolimus- or paclitaxel-eluting stents.
During follow-up, the primary endpoint of a major cardiac adverse event (MACE) – a composite of cardiac death, myocardial infarction, and target vessel revascularization – occurred in 32.5% of 1065 patients randomly assigned to receive a sirolimus-eluting stent and 33.1% of the 1033 given a paclitaxel-eluting stent, giving a nonsignificant hazard ratio of 0.96.
Of note, the annual rate of MACE remained steady at 2.6% in the sirolimus-eluting stent group and at 2.5% in the paclitaxel-eluting stent group throughout the follow-up period.
The incidence of the individual components of the composite endpoint did not differ significantly between stent types, neither did all-cause mortality, with corresponding rates of 27.4% and 26.3%.
Definite, probable, and possible stent thrombosis occurred in an identical proportion of patients in either group, at 13.3%, and again, the annual rate from year 1 to 10 remained constant at 1.2% and 1.3% among patients given sirolimus- and paclitaxel-eluting stents, respectively.
Lead author Anders Galløe (Zealand University Hospital, Roskilde, Denmark) and colleagues reiterate that “[t]he steady annual late event rates and the absence of decline are curious and worrying, and we encourage a debate on the appropriateness of intensified surveillance of patients who have a first-generation implanted DES.”
Given that 73.1% of the study participants were alive after a decade, “we feel obliged to continue surveillance and would recommend that this approach should be expanded to all new stent brands to ensure detection of surprising changes in event rates that could call for enhanced medical attention,” they continue.
David Moliterno and Khaled Ziada, both from the University of Kentucky in Lexington, USA, note in an accompanying commentary that “[t]here is no unique surveillance or preventive strategy that can reduce the risk of very late events with first-generation DES.”
Nonetheless, “it is imperative to continue secondary prevention measures to limit disease progression and reduce the risk of non–stent-related events,” the commentators add.
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