What question did this study set out to answer?

To compare 2-year clinical safety and efficacy outcomes between an ultrathin-strut bioresorbable polymer sirolimus-eluting stent and a thin-strut durable polymer everolimus-eluting stent.

August 25, 2026Journal of the American College of CardiologyOpen Access

Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents Versus Thin Durable Polymer Everolimus-Eluting Stents

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Coronary Artery Lesions (n=1334). Intervention: Ultrathin bioresorbable polymer sirolimus-eluting stent (BP SES) vs. Thin durable polymer everolimus-eluting stent (DP EES). Primary outcome: 2-year target lesion failure (TLF) (treatment difference -4.33%, 95% CI -8.16 to -0.91, p=0.015).

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Key result

Ultrathin bioresorbable polymer sirolimus-eluting stents cut 2-year TLF ~37% vs durable polymer everolimus-eluting stents.

treatment difference -4.33%
95% CI -8.16 to -0.91
P=0.015
n=1,334

Why the study?

Whether newer stent developments such as bioresorbable polymers, altered architecture, and new metal alloys improve long-term clinical safety and efficacy has been inconsistent in prior studies.

Does an ultrathin bioresorbable polymer sirolimus-eluting stent improve clinical outcomes compared to a thin durable polymer everolimus-eluting stent in patients undergoing coronary revascularization?

Population

1,334 patients undergoing coronary revascularization for up to three de novo or restenotic coronary artery lesions

Comparison

Ultrathin strut bioresorbable polymer SES vs thin strut durable polymer EES

Design

International randomized trial

Follow-up

2 years

Authors

DKDavid E. KandzariInterventional Cardiology JKJacques KoolenInterventional Cardiology GDGheorghe DorosVascular Medicine

Discussion

Member takes

Key expert perspectives

Captured external expert commentary on this paper, strongest first. Original sources are linked where available.

DE David E. KandzariInterventional cardiologist, Piedmont Heart Institute

“To our knowledge, this is the only trial that has demonstrated superiority [of a new stent] to the Xience drug-eluting stent in a large, randomized trial. This is a landmark in interventional cardiology that raises the bar for future comparisons”

Piedmont Heart InstituteNews Coverage

DE David E. KandzariInterventional cardiologist, Piedmont Heart Institute

“This is the first head-to-head, randomized comparison trial to show superiority over the Xience stent, which has been the benchmark for comparisons not only of novel drug-eluting stents, but also bioresorbable stents as well”

Piedmont Heart InstituteNews Coverage

JPJohn P. ReillyInterventional cardiologist, Ochsner Medical Center

“This would be a new player to the US market, which we haven't had in years.”

Ochsner Medical CenterNews Coverage

Implication

Supports the safety of ultrathin strut bioresorbable polymer stents in routine practice.

Key Points

To compare 2-year clinical safety and efficacy outcomes between an ultrathin-strut bioresorbable polymer sirolimus-eluting stent and a thin-strut durable polymer everolimus-eluting stent.
Conducted an international randomized clinical trial (BIOFLOW V, NCT02389946) evaluating patients undergoing coronary revascularization for up to three de novo or restenotic lesions.
Randomized 1,334 patients to receive either ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stents (BP SES, n = 884) or thin strut (81 μm) durable polymer everolimus-eluting stents (DP EES, n = 450).
Evaluated pre-specified 2-year clinical outcomes including target lesion failure, target vessel myocardial infarction, ischemia-driven target lesion revascularization, and stent thrombosis.
The 2-year target lesion failure rate was significantly lower with BP SES at 7.5% compared to 11.9% with DP EES (treatment difference: -4.33%, 95% CI: -8.16% to -0.91%, p = 0.015).
BP SES significantly reduced target vessel myocardial infarction (5.3% vs. 9.5%, p = 0.01) and ischemia-driven target lesion revascularization (2.6% vs. 4.9%, p = 0.04).
Rates of cardiac death or myocardial infarction (7.0% vs. 10.4%, p = 0.047) and late/very late definite stent thrombosis (0.1% vs. 1.0%, p = 0.045) were significantly lower in the BP SES arm.

Study Design

Type

RCT (n=1,334)

Randomization

randomized

Multicenter

Yes

Structured PICO

Population

1,334 patients with up to three de novo or restenotic coronary artery lesions, followed for 2 years.

Intervention

Ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent (BP SES)

Comparator

Thin strut (81 μm) durable polymer everolimus-eluting stent (DP EES)

Outcome

Target lesion failure (TLF) at 12 months (with pre-specified 2-year analysis)composite

Main Result

Mean Difference: -4.33 (95% CI -8.16–-0.91)

Absolute Event Rate: 7.5% vs 11.9%

Absolute Risk Reduction: 4.33%

p-value: p=0.015

Ultrathin bioresorbable polymer sirolimus-eluting stents significantly reduced 2-year target lesion failure and target vessel MI compared to thin durable polymer everolimus-eluting stents.

Cite This Study

Kandzari et al. (2018) conducted an RCT in Coronary Artery Lesions (n=1,334). Ultrathin bioresorbable polymer sirolimus-eluting stent (BP SES) vs. Thin durable polymer everolimus-eluting stent (DP EES) was evaluated on 2-year target lesion failure (TLF) (treatment difference -4.33%, 95% CI -8.16 to -0.91, p=0.015). Ultrathin bioresorbable polymer sirolimus-eluting stents reduced 2-year target lesion failure compared to durable polymer everolimus-eluting stents (7.5% vs 11.9%; P=0.015).

synapsesocial.com/papers/6a8e06bd5f6d68840b01bca0 https://doi.org/10.1016/j.jacc.2018.09.019

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Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents Versus Thin Durable Polymer Everolimus-Eluting Stents

Discussion

Member takes

Key expert perspectives

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents Versus Thin Durable Polymer Everolimus-Eluting Stents

Discussion

Member takes

Key expert perspectives

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Also Consider