Key result
Supreme biodegradable polymer DES matches durable polymer EES for major events across regions and volumes.
Why the study?
It was unknown whether the characteristics and clinical outcomes of the Supreme DES in PIONEER III were consistent among patients by enrollment location.
Does the Supreme biodegradable polymer DES provide consistent safety and efficacy compared to a durable polymer everolimus-eluting stent across different geographic regions?
RCT
Yes
Does the Supreme biodegradable polymer DES provide consistent safety and efficacy compared to a durable polymer everolimus-eluting stent across different geographic regions?
The safety and efficacy of the Supreme biodegradable polymer DES are consistent across different geographic regions and site recruitment volumes, supporting the generalizability of the PIONEER III trial findings.
Supports Supreme DES generalizability across regions; leaves open need for randomized confirmation before practice change.
Background: The PIONEER III trial showed the 12-month safety and efficacy of the Supreme drug-eluting stent (DES) vs the durable polymer everolimus-eluting stent. We sought to assess whether the characteristics and clinical outcomes of the Supreme DES in PIONEER III were consistent among patients by enrollment location. Methods: This subgroup analysis of the PIONEER III trial compared the characteristics and outcomes of patients recruited from North America, Europe, and Japan and the relative differences in patient outcomes according to the site recruitment volume. Compared with those from high-recruiting sites, results from low-recruiting sites were similar for target lesion failure, major adverse cardiac events, stent thrombosis, and mortality, with a nonsignificant trend for higher rates of myocardial infarction. Conclusions: Despite regional differences in patient characteristics, the clinical outcomes between Supreme DES and durable polymer everolimus-eluting stent in the PIONEER III trial were not different, supporting the generalizability and robustness of the findings from this multicenter controlled trial.
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Garot et al. (2022) reported an RCT. Supreme drug-eluting stent (DES) vs. durable polymer everolimus-eluting stent was evaluated on target lesion failure, major adverse cardiac events, stent thrombosis, and mortality. The Supreme biodegradable polymer DES showed consistent clinical outcomes compared to the durable polymer everolimus-eluting stent across different geographic regions and site recruitment volumes.
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