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Complex vs. non-complex percutaneous coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials

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Abstract

Background

Patients undergoing complex percutaneous coronary intervention (PCI) are at higher risk of adverse outcomes, but data are scarce in the era of newer-generation coronary stents.

Aim

We sought to compare the clinical outcomes after complex PCI with a bioresorbable-polymer sirolimus-eluting stent (BP-SES) versus a durable-polymer everolimus-eluting stent (DP-EES).

Methods

Patients (n = 2350) from BIOFLOW-II, -IV, and -V randomized trials were categorized into non-complex PCI vs. complex PCI. Complex PCI had at least one of the following criteria: multi-vessel PCI, ≥ 3 lesions treated, ≥ 3 stents implanted, total stent length ≥ 60 mm. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], or target lesion revascularization [TLR]) and probable/definite stent thrombosis (ST) at three years.

Results

Patients with complex PCI (n = 348) were older and presented more often with acute coronary syndrome than non-complex PCI patients (n = 2002). Complex PCI lesions were more often type B2/C and bifurcation lesions and required more pre- and post-dilatation. Complex PCI patients had higher rates of TLF (14.6% vs. 8.1%; aHR 1.89, 95% CI [1.31–2.73], p = 0.001), TV-MI (10.2% vs. 4.4%, aHR 2.17, 95% CI [1.40–3.37], p = 0.001), and ST (1.5% vs. 0.4%, p = 0.025) as compared with non-complex PCI. TLF was not lower with BP-SES as compared to DP-EES in complex PCI (12.6% vs 18.2%, p = 0.16).

Conclusion

Patients undergoing complex PCI with the newer-generation DES still sustain a higher risk of TLF, TV-MI and stent thrombosis as compared with non-complex PCI. This adverse outcome was not significantly modified by the stent platform (BP-SES vs. DP-EES).

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

References

  1. Kereiakes DJ, Sudhir K, Hermiller JB, Gordon PC, Ferguson J, Yaqub M, Sood P, Su X, Yakubov S, Lansky AJ, Stone GW (2010) Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients undergoing multilesion and multivessel intervention: the SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials. JACC Cardiovasc Interv 3(12):1229–1239. https://doi.org/10.1016/j.jcin.2010.09.014

    Article  PubMed  Google Scholar 

  2. Byrne RA, Stone GW, Ormiston J, Kastrati A (2017) Coronary balloon angioplasty, stents, and scaffolds. Lancet 390(10096):781–792. https://doi.org/10.1016/S0140-6736(17)31927-X

    Article  PubMed  Google Scholar 

  3. Mohamed MO, Polad J, Hildick-Smith D, Bizeau O, Baisebenov RK, Roffi M, Iniguez-Romo A, Chevalier B, von Birgelen C, Roguin A, Aminian A, Angioi M, Mamas MA (2020) Impact of coronary lesion complexity in percutaneous coronary intervention: one-year outcomes from the large, multicentre e-Ultimaster registry. EuroIntervention 16(7):603–612. https://doi.org/10.4244/EIJ-D-20-00361

    Article  PubMed  Google Scholar 

  4. Genereux P, Giustino G, Redfors B, Palmerini T, Witzenbichler B, Weisz G, Stuckey TD, Maehara A, Mehran R, Kirtane AJ, Stone GW (2018) Impact of percutaneous coronary intervention extent, complexity and platelet reactivity on outcomes after drug-eluting stent implantation. Int J Cardiol 268:61–67. https://doi.org/10.1016/j.ijcard.2018.03.103

    Article  PubMed  Google Scholar 

  5. Song PS, Park KT, Kim MJ, Jeon KH, Park JS, Choi RK, Song YB, Choi SH, Choi JH, Lee SH, Gwon HC, Jeong JO, Im ES, Kim SW, Chun WJ, Oh JH, Hahn JY (2019) 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. Korean Circ J 49(1):69–80. https://doi.org/10.4070/kcj.2018.0097

    Article  CAS  PubMed  Google Scholar 

  6. Kandzari DE, Mauri L, Koolen JJ, Massaro JM, Doros G, Garcia-Garcia HM, Bennett J, Roguin A, Gharib EG, Cutlip DE, Waksman R, Investigators BV (2017) Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Lancet 390(10105):1843–1852. https://doi.org/10.1016/S0140-6736(17)32249-3

    Article  CAS  PubMed  Google Scholar 

  7. Giustino G, Chieffo A, Palmerini T, Valgimigli M, Feres F, Abizaid A, Costa RA, Hong MK, Kim BK, Jang Y, Kim HS, Park KW, Gilard M, Morice MC, Sawaya F, Sardella G, Genereux P, Redfors B, Leon MB, Bhatt DL, Stone GW, Colombo A (2016) Efficacy and safety of dual antiplatelet therapy after complex PCI. J Am Coll Cardiol 68(17):1851–1864. https://doi.org/10.1016/j.jacc.2016.07.760

    Article  CAS  PubMed  Google Scholar 

  8. Dangas G, Baber U, Sharma S, Giustino G, Mehta S, Cohen DJ, Angiolillo DJ, Sartori S, Chandiramani R, Briguori C, Dudek D, Escaned J, Huber K, Collier T, Kornowski R, Kunadian V, Kaul U, Oldroyd K, Sardella G, Shlofmitz R, Witzenbichler B, Ya-Ling H, Pocock S, Gibson CM, Mehran R (2020) Ticagrelor with or without aspirin after complex PCI. J Am Coll Cardiol 75(19):2414–2424. https://doi.org/10.1016/j.jacc.2020.03.011

    Article  CAS  PubMed  Google Scholar 

  9. Serruys PW, Takahashi K, Chichareon P, Kogame N, Tomaniak M, Modolo R, Chang CC, Komiyama H, Soliman O, Wykrzykowska JJ, de Winter RJ, Ferrario M, Dominici M, Buszman P, Bolognese L, Tumscitz C, Benit E, Stoll HP, Hamm C, Steg PG, Onuma Y, Juni P, Windecker S, Vranckx P, Colombo A, Valgimigli M (2019) Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention: insights from the Global Leaders trial. Eur Heart J 40(31):2595–2604. https://doi.org/10.1093/eurheartj/ehz453

    Article  CAS  PubMed  Google Scholar 

  10. Chandrasekhar J, Baber U, Sartori S, Aquino M, Kini AS, Rao S, Weintraub W, Henry TD, Farhan S, Vogel B, Sorrentino S, Ge Z, Kapadia S, Muhlestein JB, Weiss S, Strauss C, Toma C, DeFranco A, Effron MB, Keller S, Baker BA, Pocock S, Dangas G, Mehran R (2018) Associations between complex PCI and prasugrel or clopidogrel use in patients with acute coronary syndrome who undergo PCI: from the PROMETHEUS study. Can J Cardiol 34(3):319–329. https://doi.org/10.1016/j.cjca.2017.12.023

    Article  PubMed  Google Scholar 

  11. Azzalini L, Baber U, Johal GS, Farhan S, Barman N, Kapur V, Hasan C, Vijay P, Jhaveri V, Mehran R, Kini AS, Sharma SK (2020) One-year outcomes of patients undergoing complex percutaneous coronary intervention with three contemporary drug-eluting stents. Catheter Cardiovasc Interv. https://doi.org/10.1002/ccd.28996

    Article  PubMed  Google Scholar 

  12. Windecker S, Haude M, Neumann FJ, Stangl K, Witzenbichler B, Slagboom T, Sabate M, Goicolea J, Barragan P, Cook S, Piot C, Richardt G, Merkely B, Schneider H, Bilger J, Erne P, Waksman R, Zaugg S, Juni P, Lefevre T (2015) Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomized BIOFLOW-II trial. Circ Cardiovasc Interv 8(2):e001441. https://doi.org/10.1161/CIRCINTERVENTIONS.114.001441

    Article  CAS  PubMed  Google Scholar 

  13. Saito S, Toelg R, Witzenbichler B, Haude M, Masotti M, Salmeron R, Witkowski A, Uematsu M, Takahashi A, Waksman R, Slagboom T (2019) BIOFLOW-IV, a randomised, intercontinental, multicentre study to assess the safety and effectiveness of the Orsiro sirolimus-eluting stent in the treatment of subjects with de novo coronary artery lesions: primary outcome target vessel failure at 12 months. EuroIntervention 15(11):e1006–e1013. https://doi.org/10.4244/EIJ-D-18-01214

    Article  PubMed  Google Scholar 

  14. Coughlan JJ, Aytekin A, Ndrepepa G, Schupke S, Bernlochner I, Mayer K, Neumann FJ, Menichelli M, Richardt G, Wohrle J, Witzenbichler B, Gewalt S, Xhepa E, Kufner S, Sager HB, Joner M, Ibrahim T, Fusaro M, Laugwitz KL, Schunkert H, Kastrati A, Cassese S (2021) Ticagrelor or prasugrel in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention. Circ Cardiovasc Interv 14(7):e010565. https://doi.org/10.1161/CIRCINTERVENTIONS.121.010565

    Article  CAS  PubMed  Google Scholar 

  15. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW, Academic Research C (2007) Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 115(17):2344–2351. https://doi.org/10.1161/CIRCULATIONAHA.106.685313

    Article  Google Scholar 

  16. Piccolo R, Giustino G, Mehran R, Windecker S (2015) Stable coronary artery disease: revascularisation and invasive strategies. Lancet 386(9994):702–713. https://doi.org/10.1016/S0140-6736(15)61220-X

    Article  PubMed  Google Scholar 

  17. Foin N, Lee RD, Torii R, Guitierrez-Chico JL, Mattesini A, Nijjer S, Sen S, Petraco R, Davies JE, Di Mario C, Joner M, Virmani R, Wong P (2014) Impact of stent strut design in metallic stents and biodegradable scaffolds. Int J Cardiol 177(3):800–808. https://doi.org/10.1016/j.ijcard.2014.09.143

    Article  PubMed  Google Scholar 

  18. Hemetsberger R, Gori T, Toelg R, Byrne R, Allali A, El-Mawardy M, Rheude T, Weissner M, Sulimov DS, Robinson DR, Richardt G, Abdel-Wahab M (2021) Optical coherence tomography assessment in patients treated with rotational atherectomy versus modified balloons: PREPARE-CALC OCT. Circ Cardiovasc Interv 14(3):e009819. https://doi.org/10.1161/CIRCINTERVENTIONS.120.009819

    Article  CAS  PubMed  Google Scholar 

  19. Raber L, Mintz GS, Koskinas KC, Johnson TW, Holm NR, Onuma Y, Radu MD, Joner M, Yu B, Jia H, Meneveau N, de la Torre Hernandez JM, Escaned J, Hill J, Prati F, Colombo A, Di Mario C, Regar E, Capodanno D, Wijns W, Byrne RA, Guagliumi G (2018) Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. EuroIntervention 14 (6):656–677. https://doi.org/10.4244/EIJY18M06_01

  20. Kawamoto H, Panoulas VF, Sato K, Miyazaki T, Naganuma T, Sticchi A, Figini F, Latib A, Chieffo A, Carlino M, Montorfano M, Colombo A (2015) Impact of strut width in periprocedural myocardial infarction: a propensity-matched comparison between bioresorbable scaffolds and the first-generation sirolimus-eluting stent. JACC Cardiovasc Interv 8(7):900–909. https://doi.org/10.1016/j.jcin.2015.02.011

    Article  PubMed  Google Scholar 

  21. Bangalore S, Toklu B, Patel N, Feit F, Stone GW (2018) Newer-generation ultrathin strut drug-eluting stents versus older second-generation thicker strut drug-eluting stents for coronary artery disease. Circulation 138(20):2216–2226. https://doi.org/10.1161/CIRCULATIONAHA.118.034456

    Article  CAS  PubMed  Google Scholar 

  22. Giustino G, Baber U, Aquino M, Sartori S, Stone GW, Leon MB, Genereux P, Dangas GD, Chandrasekhar J, Kimura T, Salianski O, Stefanini GG, Steg PG, Windecker S, Wijns W, Serruys PW, Valgimigli M, Morice MC, Camenzind E, Weisz G, Smits PC, Kandzari DE, Galatius S, Von Birgelen C, Saporito R, Jeger RV, Mikhail GW, Itchhaporia D, Mehta L, Ortega R, Kim HS, Kastrati A, Chieffo A, Mehran R (2016) Safety and efficacy of new-generation drug-eluting stents in women undergoing complex percutaneous coronary artery revascularization: from the WIN-DES collaborative patient-level pooled analysis. JACC Cardiovasc Interv 9(7):674–684. https://doi.org/10.1016/j.jcin.2015.12.013

    Article  PubMed  Google Scholar 

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Funding

The BIOFLOW trials were funded by BIOTRONIK.

Author information

Authors and Affiliations

  1. Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany

    Rayyan Hemetsberger, Ralph Toelg, Nader Mankerious, Karim Elbasha, Abdelhakim Allali & Gert Richardt

  2. Department of Cardiology, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum, Bochum, Germany

    Rayyan Hemetsberger

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

    Hector M. Garcia-Garcia & Ron Waksman

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

    Serdar Farhan

  7. Inselspital (University Hospital), Bern, Switzerland

    Stephan Windecker

  8. Hospital Privé Jaques Cartier, Massy, France

    Thierry Lefèvre

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

    Shigeru Saito

  10. Piedmont Heart Institute, Atlanta, GA, USA

    David Kandzari

Authors
  1. Rayyan Hemetsberger
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  2. Mohammad Abdelghani
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  3. Ralph Toelg
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  4. Hector M. Garcia-Garcia
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  9. Stephan Windecker
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  10. Thierry Lefèvre
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  11. Shigeru Saito
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  12. David Kandzari
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  13. Ron Waksman
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  14. Gert Richardt
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Corresponding author

Correspondence to Rayyan Hemetsberger.

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Conflict of interest

Dr. Hemetsberger has received speakers’ honoraria from Boston Scientific. Dr. Abdelghani has nothing to declare. Dr. Toelg has received speakers’ honoraria from Biotronik. Dr. Garcia-Garcia has received institutional research/grant support from Biotronik. Dr. Farhan, Dr. Mankerious, 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., Abdelghani, M., Toelg, R. et al. Complex vs. non-complex percutaneous coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials. Clin Res Cardiol 111, 795–805 (2022). https://doi.org/10.1007/s00392-022-01994-4

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