Article Impact Level: HIGH Data Quality: STRONG Summary of Circulation, CIRCULATIONAHA.123.065448. https://doi.org/10.1161/CIRCULATIONAHA.123.065448 Dr. Marco Valgimigli et al.
Points
- The Bioflow-DAPT Study compared biodegradable-polymer sirolimus-eluting stents with durable-polymer zotarolimus-eluting stents in high-bleeding risk patients undergoing PCI with a one-month dual antiplatelet therapy.
- The international, randomized trial spanned 52 cardiology hospitals across 18 countries from February 2020 to September 2021.
- Among 1,948 enrolled patients, the primary outcome (composite of cardiac death, myocardial infarction, or stent thrombosis at one year) occurred in 3.6% of biodegradable-polymer stent recipients and 3.4% of durable-polymer stent recipients, showing noninferiority.
- The minimal risk difference of 0.2 percentage points and tight confidence intervals confirmed the similarity in safety and effectiveness between the two stent types.
- This study suggests that in high-risk bleeding patients with only one month of post-PCI dual antiplatelet therapy, biodegradable-polymer sirolimus-eluting stents are a viable alternative to durable-polymer zotarolimus-eluting stents, offering potential benefits in personalized treatment approaches.
Summary
This study aimed to assess the safety and efficacy of two distinct stent platforms, namely biodegradable-polymer sirolimus-eluting stents and durable-polymer zotarolimus-eluting stents, in patients at high risk for bleeding who underwent percutaneous coronary intervention (PCI) and received an abbreviated one-month course of dual antiplatelet therapy. The research, known as the Bioflow-DAPT Study, was conducted at 52 interventional cardiology hospitals across 18 countries from February 24, 2020, to September 20, 2021. Patients with acute or chronic coronary syndrome and one or more high bleeding risk criteria were randomized to receive either of the two stent types, followed by one month of dual antiplatelet therapy and then continued single antiplatelet therapy.
The primary outcome assessed was a composite of cardiac death, myocardial infarction, or stent thrombosis at the one-year mark, focusing on noninferiority. The study enrolled 1,948 high-risk bleeding patients, with 969 receiving biodegradable-polymer sirolimus-eluting stents and 979 receiving durable-polymer zotarolimus-eluting stents. The results demonstrated that at one year, the primary outcome occurred in 3.6% of patients in the biodegradable-polymer sirolimus-eluting stent group and 3.4% in the durable-polymer zotarolimus-eluting stent group. Notably, the risk difference was minimal at 0.2 percentage points, with noninferiority confirmed based on both the 95% and 97.5% confidence intervals, highlighting the similar effectiveness of both stent platforms.
In conclusion, in patients at high risk for bleeding who received only one month of dual antiplatelet therapy post-PCI, the use of biodegradable-polymer sirolimus-eluting stents demonstrated noninferiority when compared to durable-polymer zotarolimus-eluting stents regarding the composite endpoint of cardiac death, myocardial infarction, or stent thrombosis. These findings provide valuable insights into tailoring stent selection for high-risk bleeding patients undergoing PCI, potentially offering a more personalized and safer approach to their treatment.
Link to the article: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.065448
References Valgimigli, M., Wlodarczak, A., Tölg, R., Merkely, B., Kelbæk, H., Legutko, J., Galli, S., Godin, M., Toth, G. G., Lhermusier, T., Honton, B., Dietrich, P. L., Stammen, F., Ferdinande, B., Silvain, J., Capodanno, D., & Cayla, G. (2023). Biodegradable-polymer or durable-polymer stents in patients at high bleeding risk: A randomized, open-label clinical trial. Circulation, CIRCULATIONAHA.123.065448. https://doi.org/10.1161/CIRCULATIONAHA.123.065448
