Study results on novel drug-eluting stent coated with a biodegradable polymer

"Real-world" use of a novel drug-eluting stent coated with a biodegradable polymer is associated with good clinical outcomes, according to one-year data from a large international registry.

Results of the CREATE study, which focused on the sirolimus-eluting Excel stent, are being reported today in a Late-Breaking Clinical Trials session at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit (SCAI-ACCi2) in Chicago. SCAI-ACCi2 is a scientific meeting for practicing cardiovascular interventionalists sponsored by the Society for Cardiovascular Angiography and Interventions (SCAI) in partnership with the American College of Cardiology (ACC).

For the study, Yaling Han, MD, Shenyang Northern Hospital, Shenyang, China, and colleagues recruited a total of 2,077 patients from 59 medical centers in four countries. All had stenting with the Excel stent, a novel device with a biodegradable polymer coating. Of these, 369 (17.8 percent) underwent primary stenting within 24 hours of having a heart attack.

After stenting, all patients were prescribed both clopidogrel and aspirin for six months to inhibit the action of platelets in the blood. Anti-platelet medications prevent the development of unwanted blood clots within the stent, or stent thrombosis, a serious complication that can cause heart attack or even death. On average, patients continued to take clopidogrel for 199 days.

Twelve-month follow-up data were available for 2,060 patients (99.2 percent). After 12 months, the overall rate of major cardiovascular complications was 2.77 percent, including cardiac death in 23 patients (1.12 percent), heart attack in 8 patients (0.39 percent), and repeat coronary procedure in 32 patients (1.55 percent). Death from any cause occurred in 34 patients (1.64 percent), including 11 noncardiac deaths. Overall, thrombotic complications occurred in 16 patients (0.78 percent), including six definite cases, five probable cases and five possible cases. Of these, three thrombotic complications (0.15 percent) occurred after discontinuation of clopidogrel.

The researchers concluded that the Excel stent is associated with a low incidence of cardiovascular complications, and that six months of dual-antiplatelet therapy appears to be feasible and safe.