論文ID: CJ-22-0426
Drug-eluting stents (DES) have been used in the treatment of coronary bifurcation lesions with provisional stenting or systematic 2-stenting in both the main vessel and side branch (SB). Because randomized trials using 1st-generation DES presented either no advantages1 or harmful clinical outcomes with systematic 2-stenting,2 provisional stenting has been regarded as the gold standard.3 However, some trials using current-generation DES have demonstrated the efficacy of systematic 2-stenting due to improvements in the DES platform and a more sophisticated 2-stenting method.4,5 The DKCRUSH-V randomized trial, which was conducted mainly in China, demonstrated the efficacy of double-kissing crush stenting over provisional stenting in an unprotected left main true bifurcation lesion with a mean SB lesion length of 16 mm and a SYNTAX score of 31.4 The DEFINITION II randomized trial, which used the complex lesion criteria (SB lesion length >10 mm, SB stenosis >70%, calcification, thrombus-containing, small main vessel size, shallow or wide bifurcation angle), also demonstrated the superiority of systematic 2-stenting over provisional stenting in lesions with a mean SB lesion length of 20 mm.5 In contrast, the EBC MAIN randomized trial conducted in Europe, which excluded complex lesions with SYNTAX score >32 and serious acute coronary syndrome, revealed no advantage of systematic 2-stenting in the unprotected left main bifurcation lesion with a mean SB lesion length of 7 mm and SYNTAX score of 23.6
Article p ????
Although controversial results have been observed in those studies, the most important factor affecting clinical outcomes is lesion complexity. In particular, longer SB lesions may reverse the advantages of provisional stenting over systematic 2-stenting, possibly because of suboptimal SB treatment with balloon angioplasty alone, such as in cases of residual stenosis and vessel dissection. A scattered bubble chart (Figure A,B) presents the correlation between SB lesion length and clinical event rate at 9–24 months in representative trials that described SB lesion length definitively.4–10 As shown in Figure A, target lesion failure (TLF), including target lesion revascularization (TLR), death, and target vessel-related myocardial infarction (TVMI), showed no significant correlation with SB lesion length in provisional stenting. However, a negative correlation was observed for systematic 2-stenting. A similar trend was observed for TLR (Figure B). In particular, a favorable trend of systematic 2-stenting was apparent in SB lesions >10 mm long. Higher TLF and TLR rates in systematic 2-stenting are observed in shorter SB lesions, which indicates the ineffectiveness of 2-stenting due to thrombogenic events or restenosis derived from metal overlapping and flow retardation. However, due to the selection bias in the randomized trials (EBC MAIN included more simple lesions and DKCRUSH-V/DEFINITION II used more complex lesions), it has been unclear how many complex bifurcation lesions are suitable for systematic 2-stenting in daily practice.
(A) Effect of side branch (SB) lesion length on target lesion failure (TLF) after coronary bifurcation stenting. Each bubble indicates association between SB lesion length and rate of TLF including death, target vessel-related myocardial infarction, and clinically driven target lesion revascularization (TLR) in indicated studies (EBC MAIN,6 DKCRUSH-V,4 COBIS III,7 DEFINITION II,5 Nordic-Baltic Bifurcation Study [NBBS] IV,8 PERFECT,9 and EBC TWO10). The bubble size indicates the scale of enrolled case numbers. (B) Effect of SB lesion length on TLR after coronary bifurcation stenting.
In this issue of the Journal, Jang et al7 investigate the difference in the effect of 1- and 2-stenting on coronary bifurcation lesions in a large multicenter registry, COBIS III, which included 2,648 patients. The comparison was performed after propensity score matching, and lesion complexity in the 1-stent group was elevated to be similar to that in the 2-stent group, in which the mean SB lesion length was 9.5 mm. Although a higher TLR rate was observed in the 2-stent group (hazard ratio [HR] 3.14, 95% confidence interval [CI] [1.42–6.97], P=0.005), a similar TLF rate was observed (HR 1.40, 95% CI [0.83–2.37], P=0.209) due to fewer hard endpoint events of the composite of TVMI and cardiac death (HR 0.44, 95% CI [0.19–1.01], P=0.054).7 Calcification in the main vessel or SB was significantly associated with a lower TLF.7 Because this was a real-world registry study, selection bias of the enrolled patients was excluded, and the actual presence of a complex lesion could be estimated (SB lesion length >10 mm, 50.0%; DEFINITION II criteria, 6.3%; main vessel calcification, 20.2%; SB calcification, 7.4%).7 Complex bifurcation lesions requiring systematic 2-stenting would be 6–20%. Fewer hard endpoint events were observed regardless of more TLR in the 2-stent group. Therefore, to reduce hard endpoint events in lesions, systematic 2-stenting should be considered in cases of diffuse SB lesions or calcified bifurcated lesions.
A Japanese nationwide registry revealed that coronary intervention for SB and adjacent main vessel lesions, including bifurcation lesions, accounted for 9.6% of 257,492 cases.11 In the SB, DES treatment was performed in 45% of patients, which was much higher than the previously reported frequency of 2-stenting in the bifurcation (13–22%).11 Although this subgroup included non-bifurcation lesions, more than half of the SB stenting was spot stenting in the middle or distal part, leaving the proximal bifurcated part. The provisional approach is reasonable to avoid complex bifurcation stenting in simple lesions; however, SB lesion length, complexity, and perfusion territory should be assessed appropriately to determine the lesion’s suitability for systematic 2-stenting.
Conflict-of-Interest Statement: none to declare.
None.
The datasets analyzed in this study are available from the corresponding author on reasonable request.