Key result
Final kissing balloon during PCI with ultrathin stents did not significantly alter major adverse cardiac events compared to no kissing balloon (15.1% vs 15.5%; P=0.967).
Why the study?
Data were limited regarding the impact of final kissing balloon inflation in patients undergoing percutaneous coronary intervention with ultrathin stents for left main or bifurcation lesions.
Does final kissing balloon reduce major adverse cardiac events in patients undergoing left main or bifurcations percutaneous coronary intervention using ultrathin stents?
Cohort (n=2,742)
Yes
Does final kissing balloon reduce major adverse cardiac events in patients undergoing left main or bifurcations percutaneous coronary intervention using ultrathin stents?
Absolute Event Rate: 15.1% vs 15.5%
p-value: p=0.967
Final kissing balloon did not reduce overall MACE in patients treated with ultrathin stents for left main or bifurcation lesions, but short overlap FKI and FKI in a 2-stent strategy were associated with reduced revascularization.
Does not support routine kissing balloon use; leaves open targeted benefit in 2-stent strategies.
Background: There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. Methods: All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [<3 mm] versus long overlap), strategy (provisional versus 2-stent), routine versus bail-out FKI, and the use of imaging and proximal optimization technique. Results: Two thousand seven hundred forty-two patients were included. At 16 months (8–20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; P =0.967), this result did not change with use of imaging, proximal optimization technique, or routine versus bail-out FKI. In the 2-stent subgroup, FKI was associated with lower rates of target vessel revascularization (7.8% versus 15.9%; P =0.030) and target lesion revascularization (7.3% versus 15.2%; P =0.032). Short overlap FKI was associated with a lower rate of target lesion revascularization compared with no FKI (2.6% versus 5.4%; P =0.034), while long overlap was not (6.8% versus 5.4%; P =0.567). Conclusions: In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03544294.
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Gaido et al. (2020) conducted a cohort in Left main lesions and bifurcations (n=2,742). Final kissing balloon (FKI) vs. No final kissing balloon (no-FKI) was evaluated on Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) (p=0.967). Final kissing balloon during PCI with ultrathin stents did not significantly alter major adverse cardiac events compared to no kissing balloon (15.1% vs 15.5%; P=0.967).
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