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Patients with higher-atherothrombotic risk vs. lower-atherothrombotic risk undergoing coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials

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Abstract

Background

Patients with atherothrombotic risk are at high hazard of ischemic events. Preventive medicine plays a major role in modifying their outcomes. Whether the choice of a BP-SES or DP-EES can contribute to the occurrence of events remains unclear. We sought to investigate the outcomes of patients with higher atherothrombotic risk (H-ATR) versus lower atherothrombotic risk (L-ATR) undergoing percutaneous coronary intervention (PCI) with either bioresorbable-polymer sirolimus-eluting stent (BP-SES) or durable-polymer everolimus-eluting stent (DP-EES).

Methods

Patients (n = 2361) from BIOFLOW-II, -IV, and -V randomized trials were categorized into H-ATR vs. L-ATR. L-ATR patients had ≤ 1 and H-ATR ≥ 2 of the following criteria: presentation in ACS, diabetes mellitus, previous myocardial infarction, previous PCI/CABG, or previous stroke. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], target lesion revascularization [TLR]) and stent thrombosis (ST) at three years.

Results

H-ATR patients (n = 1023) were more morbid than L-ATR patients (n = 1338). TLF rate was significantly higher in H-ATR patients as compared with L-ATR (11.6% vs. 7.0%; HR 1.67, 95% CI 1.27–2.20, p < 0.0001). With BP-SES TLF rates were numerically lower as compared with DP-EES in H-ATR (10.5% vs. 13.5%; HR 0.78, 95% CI 0.54–1.14, p = 0.20) and significantly lower in L-ATR (5.6% vs. 9.8%; HR 0.57, 95% CI 0.38–0.85, p = 0.006).

Conclusion

In the era of newer-generation DES, patients with H-ATR still are at hazard for ischemic events. Patients with BP-SES had lower TLF rates as compared with DP-EES, most consistent in L-ATR whereas in H-ATR patients most probably secondary preventive strategies are of higher value.

Clinical trial registration

Clinicaltrial.gov. NCT01356888, NCT01939249, NCT02389946. https://clinicaltrials.gov/show/NCT01356888, https://clinicaltrials.gov/show/NCT01939249, https://clinicaltrials.gov/show/NCT02389946.

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Abbreviations

BP-SES:

Bioresorbable-polymer sirolimus-eluting stent

DES:

Drug-eluting stent

DP-EES:

Durable-polymer everolimus-eluting stent

PCI:

Percutaneous coronary intervention

ST:

Stent thrombosis

TLF:

Target lesion failure

TLR:

Target lesion revascularization

TV-MI:

Target-vessel myocardial infarction

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Authors and Affiliations

  1. Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Währinger Gürtel 18–20, 1090, Vienna, Austria

    Rayyan Hemetsberger

  2. Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Bad Segeberg, Germany

    Nader Mankerious, Ralph Toelg & Gert Richardt

  3. Cardiology Department, Al-Azhar University, Cairo, Egypt

    Mohammad Abdelghani

  4. Cardiology Department, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands

    Mohammad Abdelghani

  5. Icahn School of Medicine at Mount Sinai, The Zena and Michael A. Wiener Cardiovascular Institute, New York, NY, USA

    Serdar Farhan

  6. Interventional Cardiology, Medstar Washington Hospital Center, Washington, DC, USA

    Hector M. Garcia-Garica & Ron Waksman

  7. Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany

    Abdelhakim Allali

  8. Inselspital (University Hospital), Bern, Switzerland

    Stephan Windecker

  9. Hospital Privé Jaques Cartier, Massy, France

    Thierry Lefèvre

  10. Okinawa Tokushukai Shonan Kamakura General Hospital, Kamakura, Japan

    Shigeru Saito

  11. Piedmont Heart Institute, Atlanta, GA, USA

    David Kandzari

Authors
  1. Rayyan Hemetsberger
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  2. Nader Mankerious
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  3. Ralph Toelg
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  13. Gert Richardt
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Corresponding author

Correspondence to Rayyan Hemetsberger.

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Conflict of interest

This study was sponsored by Biotronik. Dr. Toelg has received speakers’ honoraria from Biotronik. Dr. Garcia-Garcia has received institutional research/grant support from Biotronik. Dr. Hemetsberger, Dr. Mankerious, Dr. Abdelghani, Dr. Farhan, Dr. Elbasha, Dr. Allali have nothing to declare. Dr. Windecker reports research and educational grants to the institution from Abbott, Amgen, Astra Zeneca, BMS, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi-Aventis, Sinomed, Terumo, V-Wave. SW serves as unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers, He is also member of the steering/excecutive committee group of several investigated-initiated trials that receive funding by industry without impact on his personal remuneration. Stephan Windecker is an unpaid member of the Pfizer Research Award selection committee in Switzerland. Dr Lefèvre has received consultant fees from Biotronik and Abbott and Honoraria from Abbott, Terumo, Boston and Edwards. Dr. Saito has nothing to declare. Dr. Kandzari has received institutional research/grant support from Biotronik, Boston Scientific, Medinol, Medtronic, and Orbus Neich, and personal consulting honoraria from Boston Scientific, Cardiovascular Systems, Inc., and Medtronic. Dr Waksman reports consultant fees from Abbott Vascular, Amgen, Biosensors, Biotronik, Boston Scientific, Corindus, Lifetech Medical, Medtronic, and Philips Volcano; advisory board for Abbott Vascular, Amgen, Boston Scientific, Medtronic, and Philips Volcano; grant support from Abbott Vascular, Biosensors, Biotronik, Boston Scientific, and Edwards Lifesciences; and speakers bureau from AstraZeneca. Dr. Richardt has received institutional research grants from St. Jude Medical, Biotronik, and Medtonic.

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Hemetsberger, R., Mankerious, N., Toelg, R. et al. Patients with higher-atherothrombotic risk vs. lower-atherothrombotic risk undergoing coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials. Clin Res Cardiol 112, 1278–1287 (2023). https://doi.org/10.1007/s00392-023-02205-4

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