Intravascular Ultrasound Evaluated Efficacy of"L-Sandwich"Technique in the Percutaneous Coronary Intervention of True Bifurcation Lesions in Coronary Artery Disease:a Proof-of-concept Study
Objectives:To investigate the intravascular ultrasound(IVUS)evaluated efficacy of the"L-sandwich"technique in the percutaneous coronary intervention treatment of true bifurcation lesions of coronary artery.Methods:Ninety-nine patients with true bifurcation lesions(medina type 1.1.1)of the coronary arteries were divided into the L-sandwich group(n=38),the double-stent group(n=32),and the main vessel(MV)single-stent with side branch(SB)drug-coated balloon(DCB)only group(n=29).The primary study endpoint was the loss of late lumen area(LLAL)in the MV,SB ostium and SB shaft at 12 months,and the secondary endpoints were minimum lumen area(MLA)at each site and major adverse cardiac events(MACE)at 12 months.As this is a proof-of-concept study,statistical analyses were performed in the as-treated(AT)analysis set.Results:At 12-month follow-up,there was no statistically significant difference in the MV LLAL among patients in the"L-sandwich"technique group,the double stent technique group,and the MV DES with SB DCB technique group([0.12±0.42]mm2 vs.[0.07±0.38]mm2 vs.[-0.01±0.31]mm2,P=0.419).Similarly,there was no statistically significant difference in the LLAL at the SB shaft([-0.11±0.45]mm2 vs.[-0.10±0.28]mm2 vs.[0.24±1.04]mm2,P=0.078],with the maximum LLAL observed in the double stent technique group and the minimum in the"L-sandwich"technique group([-0.48±0.78]mm2 vs.[0.45±0.64]mm2 vs.[0.14±1.37]mm2,P<0.001).The MV MLA was similar among the three groups([8.39±1.65]mm2 vs.[8.28±0.98]mm2 vs.[8.02±1.37]mm2,P=0.565),while the maximum MLA at the SB ostium was observed in the double stent technique group and the minimum in the MV DES with SB DCB group([5.08±0.74]mm2 vs.[5.63±0.80]mm2 vs.[3.57±1.35]mm2,P<0.001).In terms of MLA at the SB shaft,the"L-sandwich"technique group was similar to the double stent technique group,while the MV DES with SB DCB group exhibited the minimum MLA([5.94±0.72]mm2 vs.[5.86±0.59]mm2 vs.[3.74±1.07]mm2,P<0.001).Two patients in the double stent technique group underwent target vessel revascularization,there was no MACE in the other two groups(P=0.118).Conclusions:The"L-sandwich"technique is safe and feasible for the treatment of coronary bifurcation lesions.Compared with double-stent group,the SB ostium has a smaller LLAL at the time of review,and there is no significant difference in the MLA of each site,and the operation steps are significantly simplified.Use of the"L-sandwich"technique is associated with a better branching benefit compared with MV single-stent group.The"L-sandwich"technique could be used as a remedial procedure for severe entrapment in the setting of branching with DCB alone.
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