# Geographic Variations on the Safety and Efficacy of the Supreme Biodegradable Polymer DES: Results From PIONEER III

## TL;DR

This study found that the Supreme biodegradable polymer stent had consistent safety and effectiveness across different regions, including North America, Europe, and Japan.

## Contribution

The study demonstrates the generalizability of the Supreme DES outcomes across diverse geographic locations and site recruitment volumes.

## Key findings

- Target lesion failure rates were consistent across North America, Europe, and Japan.
- Clinical outcomes were similar between low- and high-recruiting sites.
- European patients had higher rates of non–ST-segment elevation myocardial infarction.

## Abstract

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.

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.

From October 2017 to July 2019, 1629 patients were recruited in North America (816, 50.1%), Europe (650, 39.9%), and Japan (163, 10%). Procedural success was achieved in 1556 of 1611 procedures (96.6%), with no difference by the geographic location. Target lesion failure at 12 months for combined groups was observed in 84 of 1629 patients (5.2%), with no significant geographic differences (4.7%, 6.5%, and 2.5%, respectively; P =.08), with similar results in the Supreme DES group alone (4.4%, 6.8%, and 3.7%, respectively, P =.20). Cardiac death at 12 months occurred in 0.4%, 0.2%, and 0.0% (P =.79), target vessel–related myocardial infarction occurred in 2.2%, 4.7%, and 3.7%, (P =.10), and clinically driven target lesion revascularization was required in 2.1%, 3.1%, and 0%, respectively (P =.15). 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.

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.

•European patients had higher rates of non–ST-segment elevation myocardial infarction.•Target lesion failure was consistent irrespective of geography.•1-Year target lesion failure was consistent in low- and high-recruiting sites.

European patients had higher rates of non–ST-segment elevation myocardial infarction.

Target lesion failure was consistent irrespective of geography.

1-Year target lesion failure was consistent in low- and high-recruiting sites.