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Randomized Controlled Trial
. 2023 Oct 23;19(8):676-683.
doi: 10.4244/EIJ-D-23-00330.

Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial

Lars Jakobsen  1 , Evald H Christiansen  1 , Phillip Freeman  2 , Johnny Kahlert  3 , Karsten Veien  4 , Michael Maeng  1 , Bent Raungaard  2 , Julia Ellert  4 , Anton B Villadsen  2 , Steen D Kristensen  1 , Martin K Christensen  4 , Christian J Terkelsen  1 , Jens Aaroe  4 , Troels Thim  1 , Jens Flensted Lassen  4 , Mikkel Hougaard  4 , Ashkan Eftekhari  1 , Rebekka V Jensen  1 , Nicolaj B Støttrup  1 , Jeppe G Rasmussen  2 , Anders Junker  4 , Svend E Jensen  2 , Henrik S Hansen  4 , Lisette O Jensen  4
Affiliations
Randomized Controlled Trial

Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial

Lars Jakobsen et al. EuroIntervention. .

Abstract

Background: Target lesion failure (TLF) remains an issue with contemporary drug-eluting stents. The dual-therapy sirolimus-eluting and CD34 antibody-coated COMBO stent (DTS) was designed to improve early healing.

Aims: We aimed to compare the 3-year outcomes of the DTS and the sirolimus-eluting Orsiro stent (SES) in all-comer patients treated with percutaneous coronary intervention.

Methods: The SORT OUT X trial is a prospective multicentre randomised clinical trial with a registry-based follow-up comparing DTS and SES. The primary endpoint, TLF, is a composite of cardiac death, myocardial infarction or target lesion revascularisation (TLR).

Results: A total of 3,146 patients were randomised to treatment with the DTS (1,578 patients) or the SES (1,568 patients). At 3 years, an intention-to-treat analysis showed that 155 patients (9.8%) who were assigned the DTS and 118 patients (7.5%) who were assigned the SES met the primary endpoint (incidence rate ratio for TLF=1.33, 95% confidence interval: 1.04-1.70; p=0.02). This difference was caused by a significantly higher TLF rate in the DTS group compared to the SES group within the first year, which was mainly explained by a higher incidence of TLR in the DTS group compared to the SES group. Of note, the TLF rates were almost identical from 1 year to 3 years in both stent groups.

Conclusions: At 3 years, the SES was superior to the DTS, mainly because the DTS was associated with an increased risk of TLF within the first year but not from 1 to 3 years.

Clinicaltrials: gov: NCT03216733.

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Conflict of interest statement

E.H. Christiansen has received grants from OrbusNeich and Biotronik to his institution. M. Maeng reports personal fees from AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Boston Scientific, and Novo Nordisk, outside the submitted work. S.D. Kristensen has received lecture fees from Aspen and AstraZeneca; and research grants from Dorsia. L.O. Jensen has received research grants from Biotronik, OrbusNeich, Biosensors, and Terumo to her institution; and honoraria from Biotronik. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. Time-to-event curves for major adverse cardiac events.
A) Target lesion failure, B) cardiac death, C) myocardial infarction, D) target lesion revascularisation, E) definite stent thrombosis, F) probable or definite stent thrombosis, G) target lesion failure with landmark analysis, H) target lesion revascularisation with landmark analysis. CI: confidence interval; DTS: dual-therapy CD34 antibody-covered sirolimus-eluting stent; IRR: incidence rate ratio; SES: sirolimus eluting stent; ST: stent thrombosis
Figure 2
Figure 2. Prespecified subgroup analysis for the primary endpoint at 3-year follow-up.
P-values in the forest plot are all 2-sided for interaction. CI: confidence interval; DTS: dual-therapy CD34 antibody-covered sirolimus-eluting stent; LAD; left anterior descending artery; MI: myocardial infarction; PCI: percutaneous coronary intervention; SES: sirolimus-eluting stent; STEMI: ST-elevation myocardial infarction
See this image and copyright information in PMC

References

    1. Granada JF, Inami S, Aboodi MS, Tellez A, Milewski K, Wallace-Bradley D, Parker S, Rowland S, Nakazawa G, Vorpahl M, Kolodgie FD, Kaluza GL, Leon MB, Virmani R. Development of a novel prohealing stent designed to deliver sirolimus from a biodegradable abluminal matrix. Circ Cardiovasc Interv. 2010;3:257–66. - PubMed
    1. Haude M, Lee SW, Worthley SG, Silber S, Verheye S, Erbs S, Rosli MA, Botelho R, Meredith I, Sim KH, Stella PR, Tan HC, Whitbourn R, Thambar S, Abizaid A, Koh TH, Den Heijer, Parise H, Cristea E, Maehara A, Mehran R. The REMEDEE trial: a randomized comparison of a combination sirolimus-eluting endothelial progenitor cell capture stent with a paclitaxel-eluting stent. JACC Cardiovasc Interv. 2013;6:334–43. - PubMed
    1. Jaguszewski M, Aloysius R, Wang W, Bezerra HG, Hill J, De Winter, Karjalainen PP, Verheye S, Wijns W, Lüscher TF, Joner M, Costa M, Landmesser U. The REMEDEE-OCT Study: An Evaluation of the Bioengineered COMBO Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent Compared With a Cobalt-Chromium Everolimus-Eluting Stent in Patients With Acute Coronary Syndromes: Insights From Optical Coherence Tomography Imaging Analysis. JACC Cardiovasc Interv. 2017;10:489–99. - PubMed
    1. Saito S, Krucoff MW, Nakamura S, Mehran R, Maehara A, Al-Khalidi HR, Rowland SM, Tasissa G, Morrell D, Joseph D, Okaniwa Y, Shibata Y, Bertolet BD, Rothenberg MD, Généreux P, Bezerra H, Kong DF. Japan-United States of America Harmonized Assessment by Randomized Multicentre Study of OrbusNEich’s Combo StEnt (Japan-USA HARMONEE) study: primary results of the pivotal registration study of combined endothelial progenitor cell capture and drug-eluting stent in patients with ischaemic coronary disease and non-ST-elevation acute coronary syndrome. Eur Heart J. 2018;39:2460–8. - PMC - PubMed
    1. Nardin M, Pivato CA, Cao D, Sartori S, Zhang Z, Vogel B, Nicolas J, Chiarito M, Qiu H, Chandrasekhar J, Spirito A, Abizaid A, Christiansen EH, Colombo A, de Winter, Haude M, Jakobsen L, Jensen LO, Krucoff MW, Landmesser U, Saito S, Suryapranata H, De Luca, Dangas G, Mehran R. The mega COMBO collaboration: An individual patient data pooled analysis of patients undergoing PCI with COMBO stent. Int J Cardiol. 2023;370:149–55. - PubMed

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