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

Percutaneous coronary intervention (PCI) for coronary bifurcation lesions (CBL) represents one of the most challenging procedures in interventional cardiology because of lower angiographic success rate and increased risk of procedural complications (1).Currently, the single stent strategy has been considered as the default approach for the treatment of CBL (2); however, the optimal therapy for Medina type 0,1,0 or 0,0,1 left main stem (LMS) bifurcation lesions remains unclear. For these lesions, precise ostial stent placement and crossover stenting technique have been proposed. Nevertheless, precise stent placement is known to be challenging, and there is no established technique for perfect ostial stent deployment despite the fact that different strategies and/or devices have been tested (3). Several studies have shown that the cross-over stenting approach is superior to the ostial stenting with a lower rate of major adverse cardiovascular event (MACE) rate during longterm clinical follow-up (4, 5). However, data indicates that this procedure may be complicated by a significant stenosis of the other major branch of the LMS even if ABSTRACT Objective: To investigate the safety and efficacy of a percutaneous revascularization strategy that is based on the use of drug-coated balloon (DCB) for the treatment of patients with acute coronary syndrome (ACS) and de novo Medina type 0,1,0 or 0,0,1 left main stem (LMS) bifurcation lesions. Methods:In this multicenter, prospective, proof-of-concept study, patients fulfilling the above criteria were enrolled and received treatment with DCB combined with provisional drug-eluting stent (DES) implantation in the proximal major branches of the LMS. Patients who declined this revascularization approach were treated with DES implantation 1-2 mm distally to the LAD or LCx ostium followed by DCB therapy for the ostial disease. The primary endpoint of the study was percent diameter stenosis (%DS) on quantitative coronary angiography post procedure as well as event rate at 8 months follow-up.Results: Thirty patients were enrolled in the study with mean age of 60.3±7.8 years, of whom 22 (73.3%) were male. Twenty-two patients were treated only with DCB and provisional DES implantation, and 8 had DES implantation followed by DCB therapy of the ostium of the LMS major branch. All the procedures were successful with no immediate complications. Lesion %DS decreased significantly post-procedure from 62.9±14.6 to 13.3±7.5, p<0.001. During the follow-up period, no major adverse cardiac events were reported. Conclusion:This proof-of-concept study indicates that ostial DCB therapy of the LMS major branches is safe and effective. Larger clinical data and longer follow-up is needed before advocating its regular use in clinical practice.

Harnessing drug-coated balloons for the management of left main coronary disease: A promising strategy?

“…In clinical practice, management of unprotected left main stem (LMS) stenoses with percutaneous coronary intervention (PCI) has been quite challenging, particularly in the presence of bifurcation or aorto-ostial stenoses [1][2][3]. In this context, certain stentbased PCI techniques have been described as having variable safety and efficacy [1].…”

“…In particular, these stent-related complications appear to be substantially higher in aorto-ostial and bifurcation points largely due to a variety of adverse rheological, anatomical, and histopathological factors that might potentially be associated with geographic miss along with stent malapposition and/or delayed endothelization [3,4]. Moreover, "carina shift" might arise as a significant procedural complication frequently encountered in management of bifurcation stenoses (including distal LMS), particularly with the use of certain techniques including cross-over stenting and ostial stenting [1][2][3].…”

“…Consequently, the use of alternative tools and techniques potentially with better safety outcomes might arise as a viable option in management of LMS stenoses, particularly involving aorto-ostial or distal bifurcation points [2,3]. In this context, harnessing DCBs has been suggested as a safe and effective option for management of de-novo atherosclerosis involving small and large coronary arteries, even in the setting of stenoses with precarious anatomical features (including stenoses at bifurcation points) [2]. In a recent study, management with DCBs alone (with the guidance of optic coherence tomography [OCT]) was demonstrated to work well in most patients with stenosis involving the distal LMS (Medina types 0,1,0 or 0,0,1) [2].…”

“…In this context, harnessing DCBs has been suggested as a safe and effective option for management of de-novo atherosclerosis involving small and large coronary arteries, even in the setting of stenoses with precarious anatomical features (including stenoses at bifurcation points) [2]. In a recent study, management with DCBs alone (with the guidance of optic coherence tomography [OCT]) was demonstrated to work well in most patients with stenosis involving the distal LMS (Medina types 0,1,0 or 0,0,1) [2]. Importantly, none of the patients in the study population had any adverse clinical events at 7.7 ± 6.0 months following PCI with DCBs [2].…”

“…In a recent study, management with DCBs alone (with the guidance of optic coherence tomography [OCT]) was demonstrated to work well in most patients with stenosis involving the distal LMS (Medina types 0,1,0 or 0,0,1) [2]. Importantly, none of the patients in the study population had any adverse clinical events at 7.7 ± 6.0 months following PCI with DCBs [2]. However, the clinical value of DCBs remains to be established in more complex types of LMS disease (including Medina 1,1,1, etc.)…”