DCB combined with provisional DES implantation in the treatment of De Novo Medina 0,1,0 or 0,0,1 left main coronary bifurcation lesions: A proof-of-concept study

Emrah Erdoğan, Zheng Li, Yong-Xiang Zhu, Vincenzo Tufaro, Si-Li Feng, Qian Li, Li Liang, Shang Chang, Ling-Tong Bu, Bing Liu, Qi-Hua Zhou, Nathan A L Yap, Christos V Bourantas, Yao-Jun Zhang, Emrah Erdoğan, Zheng Li, Yong-Xiang Zhu, Vincenzo Tufaro, Si-Li Feng, Qian Li, Li Liang, Shang Chang, Ling-Tong Bu, Bing Liu, Qi-Hua Zhou, Nathan A L Yap, Christos V Bourantas, Yao-Jun Zhang

Abstract

Objective: To investigate the safety and efficacy of a percutaneous revascularization strategy that is based on the use of drug-coated balloon for the treatment of patients with acute coronary syndrome and de novo Medina type 0,1,0 or 0,0,1 left main stem bifurcation lesions.

Methods: In this multicenter, prospective, proof-of-concept study, patients fulfilling the above criteria were enrolled and received treatment with drug-coated balloon combined with provisional drug-eluting stent implantation in the proximal major branches of the left main stem. Patients who declined this revascularization approach were treated with drug-eluting stent implantation 1-2 mm distally to the left anterior descending or left circumflex artery ostium followed by drug-coated balloon therapy for the ostial disease. The primary endpoint of the study was the calculation of percent diameter stenosis on quantitative coronary angiography post-procedure as well as event rate at 8 months follow-up.

Results: A total of 30 patients were enrolled in the study; their mean age was 60.3 ± 7.8 years, while 22 (73.3%) were male. Twenty-two patients were treated only with drugcoated balloon and provisional drug-eluting stent implantation and 8 had drug-eluting stent implantation followed by drug-coated balloon therapy of the ostium of the left main stem major branch. All the procedures were successful with no immediate complications. The percent diameter stenosis of lesion decreased significantly post-procedure from 87.5% (80.0-90.0) to 20% (17.5-30.0), P <.001. During the follow-up period, no major adverse cardiac events were reported.

Conclusions: This proof-of-concept study indicates that ostial drug-coated balloon therapy of the left main stem major branches is safe and effective. Larger clinical data and longer follow-up are needed before advocating its regular use in clinical practice.

Conflict of interest statement

Conflict of Interest: None of the other authors have a conflict of interest.

Figures

Figure 1.
Figure 1.
Study diagram of the present study. CB, cutting balloon; DCB, drug-coated balloon; OCT, optical coherence tomography; pDES, provisional drug-eluting stent; SCB, semi-compliant balloon; TIMI, thrombolysis in myocardial infarction.
Figure 2.
Figure 2.
A case example of DCB+pDES strategy. (A) Initial angiogram with LAD ostial 95% visual stenosis; (B) pre-dilation with 2.75 × 10 mm SCB; (C) result after dilation with SCB, 40% residual stenosis; (D) pre-dilation with 3.5 × 10 mm CB; (E) 20% residual stenosis with A-type dissection is observed after CB implantation; (F) treatment with 3.5 × 20 mm DCB implantation; (G) final result with 20% residual stenosis after DCB treatment; (H) 6-month follow-up angiography showed no obvious stenosis; a, pre-procedure OCT showed LAD ostium, MLA = 2.33 mm; b, localized dissection in the proximal LAD after CB, MLA = 3.07 mm; c, localized dissection in the proximal LAD after DCB treatment (white arrow), MLA = 3.91 mm; d, 6-month follow-up, endothelial repair is seen, lumen size was significantly increased, MLA = 5.01 mm. CB, cutting balloon; DCB, drug-coated balloon; LAD, left anterior descending artery; MLA, minimal luminal area; OCT, optical coherence tomography; pDES, provisional drug-eluting stent; SCB, semi-compliant balloon.
Figure 3.
Figure 3.
A case example of DES+DCB strategy. (A) Initial angiogram shows a visual 30% LM end stenosis and LAD ostial and proximal 90% stenosis; (B) pre-dilation with 2.5 × 10 mm CB; (C) pre-dilation with 2.75 × 10 mm CB; (D) X-ray angiography post-CB pre-dilatation, a type-A dissection and visually residual stenosis of >60% was observed; (E) a 2.75 × 18 mm DES was implanted, located 1-2 mm distally from the LAD ostium; (F) 3.0 × 15 mm DCB implantation covering the LAD ostium; (G) final result after DES+DCB treatment, visual residual stenosis is

References

    1. Kornowski R. The complexity of stenting in bifurcation coronary lesions. JACC Cardiovasc Intv United States. 2013;6(7):696 697. 10.1016/j.jcin.2013.04.005)
    1. Behan MW, Holm NR, de Belder al. Coronary bifurcation lesions treated with simple or complex stenting: 5-year survival from patient-level pooled analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. Eur Heart J. 2016;37(24):1923 1928. 10.1093/eurheartj/ehw170)
    1. Kwan TW, James D, Huang Y, Liou M, Wong S, Coppola J. Perfection of precise ostial stent placement. J Invasive Cardiol. 2012;24(7):354 358.
    1. Rigatelli G, Zuin M, Baracca al. Long-term clinical outcomes of isolated ostial left anterior descending disease treatment: ostial stenting Versus left main cross-over stenting. Cardiovasc Revasc Med. 2019;20(12):1058 1062. 10.1016/j.carrev.2019.01.030)
    1. Capranzano P, Sanfilippo A, Tagliareni al. Long-term outcomes after drug-eluting stent for the treatment of ostial left anterior descending coronary artery lesions. Am Heart J. 2010;160(5):973 978. 10.1016/j.ahj.2010.07.002)
    1. Burzotta F, Talarico GP, Trani al. Frequency-domain optical coherence tomography findings in patients with bifurcated lesions undergoing provisional stenting. Eur Heart J Cardiovasc Imaging. 2014;15(5):547 555. 10.1093/ehjci/jet231)
    1. Jeger RV, Eccleshall S, Wan Ahmad al. Drug-coated balloons for coronary artery disease: third report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020;13(12):1391 1402. 10.1016/j.jcin.2020.02.043)
    1. Liu Y, Zhang YJ, Deng al. 12-month clinical results of drug-coated balloons for de novo coronary lesion in vessels exceeding 3.0 mm. Int J Cardiovasc Imaging. 2019;35(4):579 586. 10.1007/s10554-018-1505-z)
    1. Her AY, Ann SH, Singh al. Serial morphological changes of side-branch ostium after paclitaxel-coated balloon treatment of de novo coronary lesions of main vessels. Yonsei Med J. 2016;57(3):606 613. 10.3349/ymj.2016.57.3.606)
    1. Kleber FX, Rittger H, Ludwig al. Drug eluting balloons as stand alone procedure for coronary bifurcational lesions: results of the randomized multicenter PEPCAD-BIF trial. Clin Res Cardiol. 2016;105(7):613 621. 10.1007/s00392-015-0957-6)
    1. Vaquerizo B, Fernández-Nofreiras E, Oategui al. Second-generation drug-eluting balloon for ostial side branch lesions (001-bifurcations): mid-term clinical and angiographic results. J Interv Cardiol. 2016;29(3):285 292. 10.1111/joic.12292)
    1. Her AY, Shin ES, Bang al. Drug-coated balloon treatment in coronary artery disease: recommendations from an Asia-pacific consensus group. Cardiol J. 2021;28(1):136 149. 10.5603/CJ.a2019.0093)
    1. Lansky A, Wijns W, Xu al. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET all comers): a multicentre, open-label, randomised non-inferiority trial. Lancet. 2018;392(10153):1117 1126. 10.1016/S0140-6736(18)31649-0)
    1. Valgimigli M, Bueno H, Byrne al. ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: the Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European. Eur Heart J. 2017;39:213 260.
    1. Vranckx P, Cutlip DE, Mehran al. Myocardial infarction adjudication in contemporary all-comer stent trials: balancing sensitivity and specificity. Addendum to the historical MI definitions used in stent studies. EuroIntervention J Eur Collab Work Gr Interv Cardiol Eur Soc Cardiol. 2010;5:871 874.
    1. Burzotta F, Lassen JF, Lefèvre al. Percutaneous coronary intervention for bifurcation coronary lesions: the 15th consensus document from the European Bifurcation Club. EuroIntervention. 2021;16(16):1307 1317. 10.4244/EIJ-D-20-00169)
    1. Çayli M, Elbasan Z, Gür al. Modified flower petal technique in the treatment of Medina type 0,0,1 or 0,1,0 lesions. EuroIntervention. 2015;11(7):772 779. 10.4244/EIJV11I7A154)
    1. Medina A, Martín P, Suárez de Lezo al. Vulnerable carina anatomy and ostial lesions in the left anterior descending coronary artery after floating-stent treatment. Rev Esp Cardiol. 2009;62(11):1240 1249. 10.1016/s1885-5857(09)73351-1)
    1. Murasato Y, Shibao K, Meno K, Takenaka K. A case of very late stent thrombosis on the protruded struts at the left main coronary bifurcation. J Cardiol Cases. 2020;22(1):40 43. 10.1016/j.jccase.2020.04.007)
    1. Mehran R, Baber U, Sharma al. Ticagrelor with or without aspirin in high-risk patients after PCI. N Engl J Med. 2019;381(21):2032 2042. 10.1056/NEJMoa1908419)
    1. Kim BK, Hong SJ, Cho al. Effect of ticagrelor monotherapy vs ticagrelor with aspirin on major bleeding and cardiovascular events in patients with acute coronary syndrome: the TICO randomized clinical trial. JAMA. 2020;323(23):2407 2416. 10.1001/jama.2020.7580)

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