» Articles » PMID: 35346908

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

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.

Citing Articles

Composite outcomes of drug-coated balloon using in left main bifurcation lesions: a systematic review.

Cheng Y, Chen Y, Huang B, Chen M J Geriatr Cardiol. 2024; 21(11):1047-1059.

PMID: 39734648 PMC: 11672355. DOI: 10.26599/1671-5411.2024.11.001.


Stent, balloon and hybrid in PCI: could the whole be greater than the sum of its parts?.

Lim P Br J Cardiol. 2024; 30(4):37.

PMID: 39247419 PMC: 11376257. DOI: 10.5837/bjc.2023.037.


Single-Stent Double-Kissing Nano-Crush Technique for the Management of Side Branch Ostial Lesions: A Game Changer? Or Just Another Player in the Game?.

Yalta K Anatol J Cardiol. 2023; 27(10):611-612.

PMID: 37776105 PMC: 10541785. DOI: 10.14744/AnatolJCardiol.2023.3694.


Treatment of Peripheral Artery Disease Using Injectable Biomaterials and Drug-Coated Balloons: Safety and Efficacy Perspective.

Qamar S, Spahic L, Benolic L, Zivanovic M, Filipovic N Pharmaceutics. 2023; 15(7).

PMID: 37514000 PMC: 10385947. DOI: 10.3390/pharmaceutics15071813.


Nano-Culotte Stenting for Coronary Bifurcation Lesions: Pros and Cons of a Novel Strategy.

Yalta K Anatol J Cardiol. 2023; 27(5):290-291.

PMID: 37119191 PMC: 10160836. DOI: 10.14744/AnatolJCardiol.2023.3149.


References
1.
Medina A, Martin P, Suarez de Lezo J, Amador C, de Lezo J, Pan M . Vulnerable carina anatomy and ostial lesions in the left anterior descending coronary artery after floating-stent treatment. Rev Esp Cardiol. 2009; 62(11):1240-9. DOI: 10.1016/s1885-5857(09)73351-1. View

2.
Kleber F, Rittger H, Ludwig J, Schulz A, Mathey D, Boxberger M . 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):613-21. DOI: 10.1007/s00392-015-0957-6. View

3.
Vranckx P, Cutlip D, Mehran R, Kint P, Silber S, Windecker S . Myocardial infarction adjudication in contemporary all-comer stent trials: balancing sensitivity and specificity. Addendum to the historical MI definitions used in stent studies. EuroIntervention. 2010; 5(7):871-4. DOI: 10.4244/eijv5i7a146. View

4.
Capranzano P, Sanfilippo A, Tagliareni F, Capodanno D, Monaco S, Sardella G . Long-term outcomes after drug-eluting stent for the treatment of ostial left anterior descending coronary artery lesions. Am Heart J. 2010; 160(5):973-8. DOI: 10.1016/j.ahj.2010.07.002. View

5.
Valgimigli M, Bueno H, Byrne R, Collet J, Costa F, Jeppsson A . 2017 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.... Eur Heart J. 2017; 39(3):213-260. DOI: 10.1093/eurheartj/ehx419. View