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Randomized comparison between provisional and routine kissing-balloon technique after main vessel crossover stenting
Masahiro Yamawaki1, Masaki Fujita2, Shinya Sasaki3
1Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi Tsurumi, Yokohama, 230-8765, Japan. m_yamawaki@tobu.saiseikai.or.jp.
Insights
Routine final kissing-balloon inflation (FKI) for coronary bifurcation lesions (CBL) showed similar myocardial ischemic burden and long-term outcomes compared to provisional-FKI. Both strategies resulted in acceptable ischemia levels in patients undergoing stenting.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Imaging
Background:
- Coronary bifurcation lesions (CBL) management requires optimal side branch (SB) intervention after main vessel stenting.
- Established guidelines for SB intervention post-stenting are lacking.
- Second-generation drug-eluting stents are used for CBL treatment.
Purpose of the Study:
- To compare the myocardial ischemic burden between provisional and routine final kissing-balloon inflation (FKI) strategies in patients with CBL.
- To evaluate the long-term clinical outcomes, specifically major adverse cardiovascular events (MACE), associated with each strategy.
Main Methods:
- A randomized trial involving 113 CBL patients comparing provisional-FKI (n=57) and routine-FKI (n=56).
- Dipyridamole-stress myocardial perfusion scintigraphy with 99mTc was performed at 8 months to assess target vessel ischemia (TVI) using the regional summed-difference score (r-SDS).
- Primary endpoints were TVI at 8 months and MACE at 3 years; secondary analysis included % myocardial ischemia.
Main Results:
- Target vessel ischemia (TVI) rates at 8 months were similar (11% vs. 4%, p=0.226).
- SB-binary restenosis and SB territory ischemia were higher in the provisional-FKI group (48% vs. 4%, p<0.001 and 11% vs. 0%, p=0.030, respectively).
- No significant difference in % myocardial ischemia was observed in TVI patients (4.12% vs. 3.68%, p=0.677), and moderate/severe ischemia was absent in both groups. Long-term MACE rates were comparable (9% vs. 14%, p=0.358).
Conclusions:
- Provisional-FKI, guided by TIMI-SB flow, results in acceptable myocardial ischemia and comparable long-term outcomes to routine-FKI in CBL treatment.
- Routine FKI may reduce SB restenosis and ischemia, but overall clinical outcomes remain similar.
- The study supports the use of provisional-FKI as a viable strategy for managing 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 99mTc 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.