GRACE and SCAAR add to the debate about stents

Questions about the safety of drug-eluting stents (DES) versus bare metal stents (BMS) persisted after 2 studies presented at the European Society of Cardiology (ESC) Congress 2007 in Vienna, Austria, demonstrated varying effects of DES and BMS on long-term mortality.

Key Points

Questions about the safety of drug-eluting stents (DES) versus bare metal stents (BMS) persisted after 2 studies presented at the European Society of Cardiology (ESC) Congress 2007 in Vienna, Austria, demonstrated varying effects of DES and BMS on long-term mortality.

According to 6-month and 2-year data from the Global Registry of Acute Coronary Events (GRACE), the use of DES in patients with ST-elevation myocardial infarction (STEMI) is associated with higher rates of mortality than the use of BMS in this patient population. The results were presented by Gabriel Steg, MD, FACC, professor of cardiology and director of the coronary care unit, Hopital Bichat-Claude Bernard, Paris, France.

GRACE is an ongoing observational registry of patients with acute coronary syndrome (ACS) hospitalized in 14 countries on 4 continents.

Postdischarge survival analysis was virtually identical for patients receiving DES and those receiving BMS during the first 6 months. However, from 6 months to 2 years, the mortality rate was 8.6% with DES use compared with 1.6% with BMS use (P=.001).

"This survival difference, which persists after statistical adjustment for the differences in baseline characteristics between the 2 types of patients, suggests that DES should be used with caution in patients with acute myocardial infarction, at least until more evidence is accumulated on their long term safety from large studies with long-term follow-up," Dr Steg said.

"Personally, I never implant DES in an ST-elevation MI patient nowadays," Dr Steg said.

The results of GRACE were compared with the results from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), which did not demonstrate an overall increase in the risk of death with DES compared with BMS.

SCAAR is a registry of 13,786 patients who received DES and 21,480 who received BMS. A 3-year analysis of SCAAR (N Engl J Med. 2007;356:1009–1019) demonstrated higher mortality rates among patients who received DES compared with patients who received BMS. However, the 4-year data, which were presented at the ESC Congress 2007, did not demonstrate differences between the 2 stent groups in terms of overall death, death or MI, and MI alone.

According to Stefan James, MD, PhD, University of Uppsala, Sweden, greater awareness of late stent thrombosis may have led to a longer duration of dual antiplatelet therapy in patients who received DES, and that may account for the lack of difference in mortality between patients who received DES and those who received BMS. Use of higher balloon pressures and more accurate stent sizing may also have contributed to the result, he said.

The 4-year data for patients enrolled in SCAAR who received only 1 stent at the index revascularization (n=18,967) demonstrated an absolute reduction in the rate of restenosis of 3.5% with DES compared with BMS.

Dr Steg and Dr James agreed that patient selection could be important to achieve optimal results with stents. Dr Steg said that DES would be appropriate in elective percutaneous coronary interventions (PCIs), in patients at high risk of restenosis, and in patients with a low risk of bleeding. Dr James said that patients with bifurcation lesions or with lesions longer than 8 mm and patients with diabetes are candidates for DES, whereas BMS would be more appropriate in patients with large vessels or an increased risk of bleeding and in those who may not comply with antiplatelet therapy.