Complementary evidence on the performance of coronary stents generated by a randomized controlled trial and a worldwide registry.

BACKGROUND: Large-scale registries can provide valuable complementary data to randomized controlled trials (RCT) for the post-marketing evaluation of coronary stents, but their scientific relevance remains debated.

METHODS: We sought to compare the evidence on the performance of a single coronary stent platform generated by the RCT for its regulatory approval and a well-conducted international registry. Patients treated with the Ultimaster coronary stent in the CENTURY II (CII-UM) trial (n=551) were compared to patients in the real-world e-ULTIMASTER (e-UM) registry (n=35,389). All major events were adjudicated by an independent clinical event committee in both studies. Propensity weighted analysis was used to balance baseline and procedural differences between the two populations.

RESULTS: Coronary artery disease was more complex in e-UM compared to CII-UM, including more acute coronary syndromes, multivessel disease, left main, arterial or venous grafts and chronic total occlusions (p<0.005 for all). At one-year follow-up and after excluding periprocedural myocardial infarction (MI) there was no statistically significant difference between CII-UM and e-UM regarding all-cause death (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.26-1.20, p=0.14), cardiac death (HR 0.71, 95% CI 0.29-1.72, p=0.45), target lesion failure (HR 1.18, 95% CI 0.78-1.78, p=0.44), and target vessel MI (HR 0.76, 95% CI 0.24-2.38, p=0.63). However, target vessel revascularization rate was significantly higher in CII-UM than in e-UM, HR 1.78, 95% CI 1.23-2.56, p=0.002.

CONCLUSION: A well-conducted large-scale registry can provide valuable complementary evidence to RCTs on the post-market performance of new coronary stents, across a wider range of uses and various geographic areas.