Positive outcomes from Chinese CREATE trial questioned as underreporting

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CHICAGO—The real-world use of the Excel sirolimus-eluting stent (SES) coated with a biodegradable polymer is associated with good clinical outcomes, according to one-year data from the China-based CREATE study in a late-breaking clinical trials session presented on Monday by Yaling Han, MD, at the SCAI-ACCi2 Summit at the American College of Cardiology (ACC) Scientific Sessions. However, the study's results were questioned by John Ormiston, MD, who suggested that the investigators did not include some of the adverse outcomes in their final results.

The Excel stent has biodegradable polymer coated SES, “which can be fully dissolved within six months of implantation,” Han said. The Excel stent is manufactured by Ji Wei in Weihai, China.

Han of the Shenyang Northern Hospital in 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 new device with a biodegradable polymer coating. Of these, 369 (17.8 percent) underwent primary stenting within 24 hours of having a heart attack, Han said.

After stenting, all patients were prescribed both clopidogrel and aspirin for six months, according to Han, who also reported that on average, patients continued to take clopidogrel for 199 days.

Han said that the 12-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), Han reported. Death from any cause occurred in 34 patients (1.64 percent), including 11 noncardiac deaths, according to Han, who also reported that 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, according to the researchers.

Based on their reported findings, 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.

In his response commentary, Ormiston from Mercy Hospital in Auckland, New Zealand, said the investigators were underreporting the adverse events of the Excel stent.

“Based on the conclusions provided, we don’t know how they were chosen for angiographic follow-up,” Ormiston noted. He attributed this exclusion to underreporting.

Comparing to the 12-month MACE rate of the SPIRIT trial, which enrolled high-risk patients, how come adverse events outcomes are lower for CREATE even though they enlisted higher risk patients, Ormiston questioned.

As a result, he said that “the CREATE trial under-reported on events.”

Ormiston questioned whether data collection was complete.

In his final comments on CREATE, he said that there were a relatively small size of participants and there is evidence of underreporting of events, so the results need to be further investigated.