CardioExchange Archive

RACE II: Van Gelder et al. randomized 614 patients with AF to either strict rate control (resting heart rate < 80 bpm and heart rate during moderate exercise <110 bpm) or lenient rate control (resting heart rate < 80 bpm). The results were presented at the ACC in Atlanta and published simultaneously in the New England Journal of Medicine. After 3 years, the combined rate of CV death, hospitalization for HF, stroke, systemic embolism, bleeding, and life-threatening arrhythmic events was 12.9% in the lenient-control group compared to 14.9% in the strict control group. The difference between the two groups  met the prespecified noninferiority margin. As might be expected, more patients reached their target heart rate in the lenient-control group than in the strict-control group, and they required fewer total visits. The investigators concluded that “for both patients and health care providers, lenient rate control is more convenient, since fewer outpatient visits and examinations are needed.”
In an accompanying editorial Paul Dorian said that the RACE II investigators “have made an important contribution to our understanding of the potential benefits and risks of the current guideline-recommended approach to ventricular rate control in patients with persistent atrial fibrillation.”

SORT OUT III– Investigators in Denmark randomized randomized 2332 PCI patients to receive either a zotarolimus-eluting stent (ZES) or sirolimus-eluting stent (SES). The rate of major adverse cardiac events at 9 months was 6% in the ZES arm versus 3% in the SES arm (HR 2·15, 95% CI 1·43–3·23; p=0·0002). This difference remained significant at 18 month followup. At 18 months, but not at 9 months, there was a significant difference in mortality in favor of SES (4% vs 3%; 1·61, 1·03–2·50; p=0·035).

The trial was presented at the ACC and published online in the Lancet. The authors concluded that “the sirolimus-eluting stent is superior to the zotarolimus-eluting stent for patients receiving routine clinical care.”

Dual Antiplatelet Therapy: Korean investigators combined data from two trials, REAL-LATE and ZEST-LATE, that randomized 2701 DES patients to receive either dual antiplatelet therapy or aspirin monotherapy. There was no difference at two years in the rate of MI or cardiac death (1.8% with dual therapy versus 1.2% with aspirin monotherapy, HR 1.65, CI 0.80-3.36, p=0.17). The trial was presented at the ACC in Atlanta and published in the New England Journal of Medicine.
In an accompanying editorial, Peter Berger asks: “Can this study inform physicians’ practice with any degree of confidence? Sadly, no. It is an interim analysis of two ongoing, underpowered studies…”