In the Journals

Long-term MACE, stent thrombosis rates steady with first-generation DES

Ten-year data from the SORT OUT II trial revealed no late changes in annual rates of MACE or stent thrombosis in patients who received first-generation drug-eluting stents.

In SORT OUT II, researchers randomly assigned 2,098 unselected all-comer patients (mean age, 64 years; 75% men; 50% with ACS) who were residents of Denmark to a first-generation sirolimus-eluting stent (Cypher, Cordis) or a first-generation paclitaxel-eluting stent (Taxus, Boston Scientific). MACE, defined as a composite of cardiac death, MI and target vessel revascularization, was the primary endpoint. All patients were followed for 10 years or until emigration from Denmark.

Outcomes by stent similar

After 10 years, 26.9% of patients died, including 292 (27.4%) in the SES group and 272 (26.3%) in the PES group (HR = 1.05; 95% CI, 0.89-1.23). Cardiac death accounted for 34% of all deaths.

MACE occurred in 346 (32.5%) patients in the SES group and 342 (33.1%) in the PES group (HR = 0.96; 95% CI, 0.83-1.12). After the first year, annual rates of MACE remained steady at 2.6% and 2.5%, respectively, according to the data.

Target lesion revascularization occurred in 327 (15.6%) of all patients, including 158 (14.8%) in the SES group and 169 (16.4%) in the PES group (HR = 0.89; 95% CI, 0.72-1.11), with researchers noting no late increase in TLR rates.

Of the 380 patients who experienced an MI, 276 (13.2%) had one MI, 67 (3.2%) had two MIs, 26 (1.2%) had three MIs and 12 (0.6%) had at least four MIs. Acute MI primarily occurred early, and the researchers found no indication of increased late annual rates.

Definite, probable and possible stent thrombosis occurred in 142 (13.3%) patients in the SES group and 137 (13.3%) in the PES group (HR = 1; 95% CI, 0.79-1.27), with a steady annual rate of 1.3% after the first year, the researchers wrote.

Results showed no statistically significant differences between the SES and PES groups in cardiac death, MI or stent thromboses.

“There should be no apparent need for extraordinary medical attention to these patients,” the researchers wrote. “At the same time, the annual event rates did not show a diminishing trend with time. This finding is worrying and may call for continuous observation.”

Secondary prevention needed

In an accompanying editorial, David J. Moliterno, MD, and Khaled M. Ziada, MD, both from the Gill Heart Institute and the division of cardiovascular medicine at the University of Kentucky in Lexington, wrote, “There is no unique surveillance or preventive strategy that can reduce the risk of very late events with first-generation DES.

David J. Moliterno

“Certainly, it is imperative to continue secondary prevention measures to limit disease progression and reduce the risk of non-stent-related events,” they wrote. – by Melissa Foster

Disclosure: Boston Scientific and Cordis both donated unrestricted grants to conduct the study. The researchers report no relevant financial disclosures. Moliterno reports serving on the data safety monitoring board for Janssen Pharmaceuticals and receiving research grant support from AstraZeneca. Ziada reports no relevant financial disclosures.

Ten-year data from the SORT OUT II trial revealed no late changes in annual rates of MACE or stent thrombosis in patients who received first-generation drug-eluting stents.

In SORT OUT II, researchers randomly assigned 2,098 unselected all-comer patients (mean age, 64 years; 75% men; 50% with ACS) who were residents of Denmark to a first-generation sirolimus-eluting stent (Cypher, Cordis) or a first-generation paclitaxel-eluting stent (Taxus, Boston Scientific). MACE, defined as a composite of cardiac death, MI and target vessel revascularization, was the primary endpoint. All patients were followed for 10 years or until emigration from Denmark.

Outcomes by stent similar

After 10 years, 26.9% of patients died, including 292 (27.4%) in the SES group and 272 (26.3%) in the PES group (HR = 1.05; 95% CI, 0.89-1.23). Cardiac death accounted for 34% of all deaths.

MACE occurred in 346 (32.5%) patients in the SES group and 342 (33.1%) in the PES group (HR = 0.96; 95% CI, 0.83-1.12). After the first year, annual rates of MACE remained steady at 2.6% and 2.5%, respectively, according to the data.

Target lesion revascularization occurred in 327 (15.6%) of all patients, including 158 (14.8%) in the SES group and 169 (16.4%) in the PES group (HR = 0.89; 95% CI, 0.72-1.11), with researchers noting no late increase in TLR rates.

Of the 380 patients who experienced an MI, 276 (13.2%) had one MI, 67 (3.2%) had two MIs, 26 (1.2%) had three MIs and 12 (0.6%) had at least four MIs. Acute MI primarily occurred early, and the researchers found no indication of increased late annual rates.

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Definite, probable and possible stent thrombosis occurred in 142 (13.3%) patients in the SES group and 137 (13.3%) in the PES group (HR = 1; 95% CI, 0.79-1.27), with a steady annual rate of 1.3% after the first year, the researchers wrote.

Results showed no statistically significant differences between the SES and PES groups in cardiac death, MI or stent thromboses.

“There should be no apparent need for extraordinary medical attention to these patients,” the researchers wrote. “At the same time, the annual event rates did not show a diminishing trend with time. This finding is worrying and may call for continuous observation.”

Secondary prevention needed

In an accompanying editorial, David J. Moliterno, MD, and Khaled M. Ziada, MD, both from the Gill Heart Institute and the division of cardiovascular medicine at the University of Kentucky in Lexington, wrote, “There is no unique surveillance or preventive strategy that can reduce the risk of very late events with first-generation DES.

David J. Moliterno

“Certainly, it is imperative to continue secondary prevention measures to limit disease progression and reduce the risk of non-stent-related events,” they wrote. – by Melissa Foster

Disclosure: Boston Scientific and Cordis both donated unrestricted grants to conduct the study. The researchers report no relevant financial disclosures. Moliterno reports serving on the data safety monitoring board for Janssen Pharmaceuticals and receiving research grant support from AstraZeneca. Ziada reports no relevant financial disclosures.