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Outcomes of patients treated with a biodegradable-polymer sirolimus-eluting stent versus durable-polymer everolimus-eluting stents after rotational atherectomy

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Abstract

Objective

To compare Orsiro biodegradable-polymer sirolimus-eluting stent (Orsiro BP-SES) with durable-polymer everolimus-eluting stent (DP-EES) regarding target lesion failure (TLF) after rotational atherectomy (RA), with a focus on small stents (diameter ≤ 3 mm) where Orsiro BP-SES has 60 µm strut thickness, while DP-EES remains with 81 µm strut thickness.

Background

New-generation drug-eluting stent (DES) is superior to early-generation DES in all percutaneous coronary intervention (PCI) settings including RA. Recently, the Orsiro BP-SES was superior to a DP-EES in an all comer’s population.

Methods

Among patients who underwent RA at a single center, 121 were treated with Orsiro BP-SES and 164 with DP-EES (Promus and Xience). Those treated with other stent types, presenting with acute myocardial infarction or had a chronic total occlusion were excluded. Incidence of TLF was assessed.

Results

After 2 years, the TLF rate in Orsiro BP-SES and DP-EES groups was 10% and 18%, respectively (adjusted HR 0.55, 95%CI 0.26–1.16, p = 0.115). The rate of TLF was significantly lower in small Orsiro BP-SES with ultra-thin struts as compared to DP-EES with the same diameters (adjusted HR 0.19, 95% CI 0.04–0.87, p = 0.032), driven by lower rates of clinically driven target lesion revascularization (log-rank p = 0.022). Age (p = 0.035), total stent length (p = 0.007) and diabetes mellitus (p = 0.011) emerged as independent predictors of TLF in the whole population.

Conclusion

In the whole cohort, Orsiro BP-SES and DP-EES had comparable rates of long-term TLF after RA. In the small stent subgroup, the Orsiro BP-SES with ultra-thin struts showed significant lower rate of TLF at 2 years.

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Data availability

The deidentified participant data will be shared on a request basis. Please directly contact the corresponding author to request data sharing.

Code availability

Data analysis was performed using SPSS V.24.0 (IBM Corp., New York, USA).

Abbreviations

BMI:

Body mass index

CABG:

Coronary artery bypass graft

CAC:

Coronary artery calcification

CTO:

Chronic total occlusion

DES:

Drug-eluting stent

DP-EES:

Durable-polymer everolimus-eluting stent

GFR:

Glomerular filtration rate

LVEF:

Left ventricular ejection fraction

MACE:

Major adverse cardiac events

MI:

Myocardial infarction

Orsiro BP-SES:

Orsiro biodegradable-polymer sirolimus-eluting stent

PCI:

Percutaneous coronary intervention

RA:

Rotational atherectomy

ST:

Stent thrombosis

TLF:

Target lesion failure

TLR:

Target-lesion revascularization

TV-MI:

Target vessel myocardial infarction

UFH:

Unfractionated heparin

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Funding

The authors did not receive support from any organization for the submitted work.

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Authors and Affiliations

  1. Heart Center, Segeberger Kliniken GmbH, Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg, Am Kurpark 1, 23795, Bad Segeberg, Germany

    Nader Mankerious, Rayyan Hemetsberger, Hussein Traboulsi, Ralph Toelg, Gert Richardt & Abdelhakim Allali

  2. Cardiology Department, Heart Center Leipzig, University of Leipzig, Leipzig, Germany

    Mohamed Abdel-Wahab

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  1. Nader Mankerious
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  2. Rayyan Hemetsberger
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  3. Hussein Traboulsi
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  4. Ralph Toelg
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  5. Mohamed Abdel-Wahab
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  6. Gert Richardt
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  7. Abdelhakim Allali
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Correspondence to Nader Mankerious.

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Conflict of interest

Dr. Hemetsberger received speaker’s honoraria from Boston Scientific. Dr. Richardt received an Institutional Research Grant from Boston Scientific. Dr. Allali is a proctor for Boston Scientific. The other authors have no relevant financial or non-financial interests to disclose.

Ethics approval

The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments. The present study was approved by the Ethics Committee of Schleswig–Holstein Medical Syndicate. Reference Number: 168-11.

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Informed consent was obtained from all individual participants included in the study.

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Patients signed informed consent regarding publishing their data.

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392_2021_1852_MOESM1_ESM.tif

Online resource Fig. 1 Study Flow-chart MI, myocardial infarction; CTO, chronic total occlusion; Orsiro BP-SES, Orsiro biodegradable-polymer sirolimus-eluting stent; DP-EES, durable-polymer evorolimus eluting stent

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Mankerious, N., Hemetsberger, R., Traboulsi, H. et al. Outcomes of patients treated with a biodegradable-polymer sirolimus-eluting stent versus durable-polymer everolimus-eluting stents after rotational atherectomy. Clin Res Cardiol 110, 1574–1585 (2021). https://doi.org/10.1007/s00392-021-01852-9

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