Randomized comparison between provisional and routine kissing-balloon technique after main vessel crossover stenting for coronary bifurcation lesions

Abstract

We compared the myocardial ischemic burden of provisional and routine final kissing-balloon inflation (FKI) with the 1-stent strategy using a second-generation drug-eluting stent for coronary bifurcation lesions (CBL). There are no established guidelines for side branch (SB) intervention after main vessel stenting. In total, 113 CBL patients were randomized to receive different SB intervention strategies: provisional-FKI group (n = 57; FKI only when SB flow was TIMI <3) and routine-FKI group (n = 56; mandatory FKI with aggressive treatment until SB-residual stenosis <50%). Dipyridamole-stress myocardial perfusion scintigraphy with Tc was performed after 8 months. The regional summed-difference score (r-SDS) was calculated according to the coronary territory. The primary endpoint included target vessel ischemia (TVI; r-SDS ≥ 2) at 8 months, whereas the clinical primary endpoint was major adverse cardiovascular events (MACE) at 3 years. The percent (%) myocardial ischemia (100 × SDS/68) was also calculated. At 8 months, TVI was identified in 11 and 4% in the provisional-FKI and routine-FKI groups, respectively (p = 0.226). SB-binary restenosis (48 vs. 4%, p< 0.001) and myocardial ischemia at the SB territory (11 vs. 0%, p = 0.030) were more common in the provisional-FKI group; however, in TVI patients, % myocardial ischemia (4.12 ± 1.23% vs. 3.68 ± 1.04%; p = 0.677) did not significantly differ. Moderate/severe ischemia (>10% myocardial ischemia) was not observed in the target vessel in either group. Long-term cumulative MACE were similar between the groups (9 vs. 14%; p = 0.358). Provisional-FKI according to TIMI-SB flow grade led to similar and acceptable myocardial ischemia, in comparison with routine-FKI, which may contribute to the identical long-term follow-up.

Should kissing balloon inflation after main vessel stenting be routine in the one-stent approach? A systematic review and meta-analysis of randomized trials

“…Clinical follow-up periods for the five trials ranged from 6 to 36 months. One trial reported outcomes beyond one year[ 12 ]. Angiographic follow-up and quantitative coronary angiography were performed 6–9 months after the index procedure.…”

“…The rate of angiographic follow-up was 83%. Assessment of the treated vessels with intravascular ultrasound after stenting and at follow-up was performed in 3 of the studies [ 11 – 12 , 14 ]. Bifurcation lesions that included the left main stem were reported in 150 cases in 2 of the studies [ 10 , 14 ].…”

Association of the Extent of Myocardial Ischemia with Outcomes in Patients with Suspected Coronary Artery Disease

“…The sum of the differences between these 2 scores de ned the summed difference score. The percent (%) myocardial ischemia (100 × summed difference score [SDS]/68) was calculated and a SDS ≥7 was considered to be ≥10% myocardial ischemia 5,11 .…”

A Short Term Clinical Outcome of Provisional versus Routine Kissing Balloon Technique after Main Vessel Crossover Stenting for Coronary Bifurcation Lesions

“…One of its benefits is to optimize stent apposition, improve side branch entry and to correct stent deformation [6]. However, in complex anatomy, the procedure-time and contrast media are more increased than without kissing balloon [7,8]. KBI technique is the standard strategy in bifurcation lesions that are treated with the twostent technique, unfortunately, the benefit of this procedure in the one-stent approach remains uncertain due to poor clinical data [9].…”