What is the clinical evidence from this study?

Study design: Observational. Population: Complex percutaneous coronary intervention (PCI) (n=1145). Intervention: Biodegradable polymer-biolimus-eluting stents (BP-BES) vs. Durable polymer-everolimus-eluting stents (DP-EES). Primary outcome: Target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization at 2 years (HR 0.578, 95% CI 0.246-1.359, p=0.209).

What does this research mean for the field?

Biodegradable polymer-biolimus-eluting stents provide comparable 2-year clinical outcomes, including target lesion failure rates, compared to durable polymer-everolimus-eluting stents in patients undergoing complex percutaneous coronary intervention. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

August 27, 2018Sunhwan'giOpen Access

Safety and Efficacy of Biodegradable Polymer-biolimus-eluting Stents (BP-BES) Compared with Durable Polymer-everolimus-eluting Stents (DP-EES) in Patients Undergoing Complex Percutaneous Coronary Intervention

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Key result

BP-BES shows no significant difference in target lesion failure vs. DP-EES in complex PCI.

HR 0.578
95% CI 0.246-1.359
P=0.209
n=1,145

Why the study?

There are no data comparing clinical outcomes of complex PCI between biodegradable polymer-biolimus-eluting stents and durable polymer-everolimus-eluting stents.

Does the use of biodegradable polymer-biolimus-eluting stents (BP-BES) improve target lesion failure compared to durable polymer-everolimus-eluting stents (DP-EES) in patients undergoing complex PCI?

Study Design

Type

Observational (n=1,145)

Multicenter

Yes

Structured PICO

Does the use of biodegradable polymer-biolimus-eluting stents (BP-BES) improve target lesion failure compared to durable polymer-everolimus-eluting stents (DP-EES) in patients undergoing complex PCI?

Population

1,145 patients undergoing complex percutaneous coronary intervention, with a median age of 65 years and 30.9% female, followed for a median of 2 years.

Exposure

Biodegradable polymer-biolimus-eluting stents (BP-BES)

Comparator

Durable polymer-everolimus-eluting stents (DP-EES)

Outcome

Target lesion failure (TLF), defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI), or target lesion revascularization (TLR) at 2 years of follow-upcomposite

Main Result

Hazard Ratio: 0.578 (95% CI 0.246–1.359)

Absolute Event Rate: 3.8% vs 5.2%

p-value: p=0.209

In patients undergoing complex PCI, biodegradable polymer-biolimus-eluting stents demonstrated comparable 2-year safety and efficacy to durable polymer-everolimus-eluting stents.

Limitations

Procedural complexity definition was arbitrary and based on available variables, lacking some important variables like SYNTAX score.
Non-randomized, observational, and post-hoc design may be subject to unmeasured confounding factors despite propensity score matching.
Low event rates resulted in inadequate statistical power to draw definite conclusions, especially for stent thrombosis.
2-year follow-up may be insufficient to assess long-term safety and efficacy after complete polymer degradation.
Procedural complexity definition was arbitrary and site-reported without angiographic core laboratory review
Non-randomized, observational, post-hoc design subject to unmeasured confounding
Low event rates leading to inadequate power, especially for stent thrombosis
2-year follow-up may be insufficient to assess long-term safety and efficacy of biodegradable polymers

Discussion

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Implication

May support interchangeable BP-BES or DP-EES selection in complex PCI; leaves open need for randomized confirmation.

Cite This Study

Song et al. (2018) conducted an observational in Complex percutaneous coronary intervention (PCI) (n=1,145). Biodegradable polymer-biolimus-eluting stents (BP-BES) vs. Durable polymer-everolimus-eluting stents (DP-EES) was evaluated on Target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization at 2 years (HR 0.578, 95% CI 0.246-1.359, p=0.209). Biodegradable polymer-biolimus-eluting stents showed comparable 2-year rates of target lesion failure to durable polymer-everolimus-eluting stents (3.8% vs. 5.2%; HR 0.578, p=0.209) in patients undergoing complex percutaneous coronary intervention.

synapsesocial.com/papers/6abe007fd8bdd63c9fc1f491 https://doi.org/10.4070/kcj.2018.0097

Topics

Percutaneous coronary intervention Chronic total occlusion PCI

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Safety and Efficacy of Biodegradable Polymer-biolimus-eluting Stents (BP-BES) Compared with Durable Polymer-everolimus-eluting Stents (DP-EES) in Patients Undergoing Complex Percutaneous Coronary Intervention

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

Topics

Safety and Efficacy of Biodegradable Polymer-biolimus-eluting Stents (BP-BES) Compared with Durable Polymer-everolimus-eluting Stents (DP-EES) in Patients Undergoing Complex Percutaneous Coronary Intervention

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

Also Consider

Topics

Also Consider