What question did this study set out to answer?

To compare late-term 3-year clinical safety and efficacy outcomes between patients treated with ultrathin-strut bioresorbable-polymer sirolimus-eluting stents and thin-strut durable-polymer everolimus-eluting stents.

June 1, 2020JACC: Cardiovascular InterventionsOpen Access

Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization

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Why the study?

Comparative studies show improved safety and efficacy with ultrathin-strut drug-eluting stents, but limited insight exists regarding late-term outcomes compared with thin-strut durable-polymer stents.

Do ultrathin-strut bioresorbable-polymer sirolimus-eluting stents reduce target lesion failure at 3 years compared to thin-strut durable-polymer everolimus-eluting stents 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 BP SES vs thin-strut DP EES

Design

International prospective randomized multicenter trial

Follow-up

3 years

Authors

DKDavid E. KandzariInterventional Cardiology JKJacques KoolenInterventional Cardiology GDGheorghe DorosVascular Medicine

Discussion

Member takes

Implication

May support ultrathin BP SES preference; leaves open confirmation in randomized settings before practice change.

Key Points

To compare late-term 3-year clinical safety and efficacy outcomes between patients treated with ultrathin-strut bioresorbable-polymer sirolimus-eluting stents and thin-strut durable-polymer everolimus-eluting stents.
International randomized clinical trial (BIOFLOW V; NCT02389946) evaluating patients undergoing coronary revascularization for up to three de novo or restenotic coronary artery lesions.
A total of 1,334 patients were randomized to receive ultrathin bioresorbable-polymer sirolimus-eluting stents (n = 884) or durable-polymer everolimus-eluting stents (n = 450) with pre-specified 3-year clinical follow-up.
The 3-year rate of target lesion failure was significantly lower with bioresorbable-polymer stents compared to durable-polymer stents (8.2% vs. 13.6%; p = 0.002).
Bioresorbable-polymer stents significantly reduced target vessel myocardial infarction (5.0% vs. 9.2%; p = 0.003), clinically driven target lesion revascularization (3.2% vs. 6.7%; p = 0.006), and definite/probable late or very late stent thrombosis (0.1% vs. 1.2%; p = 0.018).
Composite rates of cardiac death or myocardial infarction were 7.7% with bioresorbable-polymer stents versus 11.7% with durable-polymer stents (p = 0.017).

Structured PICO

Population

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

Intervention

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

Comparator

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

Outcome

Target lesion failure at 3 years (pre-specified analysis of the original 12-month primary endpoint)composite

Ultrathin-strut bioresorbable-polymer sirolimus-eluting stents demonstrate superior 3-year clinical outcomes, including lower target lesion failure and stent thrombosis, compared to thin-strut durable-polymer everolimus-eluting stents.

Cite This Study

Kandzari et al. (2020) studied this question.

synapsesocial.com/papers/6a6fd9cc75498292b70939bd https://doi.org/10.1016/j.jcin.2020.02.019

Topics

Percutaneous coronary intervention Coronary artery disease Chronic total occlusion PCI

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Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Topics

Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

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Topics

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