This multicenter, international randomized controlled trial evaluated 616 patients with non-left main bifurcation lesions. The study compared a systematic side branch intervention (SBI) strategy, involving Resolute Onyx drug-eluting stent use and proximal optimization technique without impairment of side branch flow, against a conservative strategy without systematic side branch intervention.
The primary outcome was periprocedural myocardial infarction (MI) or myocardial injury based on the Academic Research Consortium 2 definition. The study demonstrated noninferiority for this endpoint, with 4.1% (n = 11) in the no-SBI group compared to 5.7% (n = 16) in the SBI group (P < 0.001 for noninferiority; P = 0.38 for superiority). At 12 months, target lesion failure rates showed no significant difference, with 4.9% (n = 15) in the no-SBI group versus 6.4% (n = 20) in the SBI group (P = 0.442).
Regarding safety, side branch dissection was more frequent in the SBI group at 2.9% compared to 0.0% in the no-SBI group (P = 0.004). Additionally, procedure time, radiation dose, and contrast use were significantly lower in the no-SBI group, though specific values were not reported.
Clinicians should note that while the conservative strategy is noninferior regarding primary periprocedural injury, the study demonstrates an association between the systematic SBI strategy and increased side branch dissection. The results support the use of a conservative strategy without systematic side branch intervention as a safe alternative for managing these lesions.
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BACKGROUND: Although provisional stenting is the recommended strategy for most coronary bifurcation lesions, the clinical benefit of additional side branch (SB) intervention remains debated.
OBJECTIVES: The aim of this study was to determine whether a conservative strategy without systematic SB intervention (SBI) is noninferior to systematic SB intervention regarding periprocedural events.
METHODS: The multicenter, international KISS (Keep Bifurcation Single Stenting Simple) trial randomized patients with non-left main bifurcation lesions to 2 groups: no SBI or SBI following main branch stenting with the Resolute Onyx drug-eluting stent and a proximal optimization technique without impairment of SB flow. The primary endpoint was periprocedural myocardial infarction (MI) or myocardial injury, according to the Academic Research Consortium 2 definition. Secondary endpoints included procedural complications and 12-month clinical outcomes, including target lesion failure, defined as the composite of cardiac death, target vessel MI, and target lesion revascularization.
RESULTS: Among the 616 included patients, 81% were treated for chronic coronary disease, and the bifurcation mainly involved was between the left anterior descending coronary artery and the diagonal. In the no-SBI group, an intervention on the SB was required in 2.0% of patients (n = 6). Periprocedural MI or myocardial injury occurred in 4.1% (n = 11) in the no-SBI group vs 5.7% (n = 16) in the SBI group (P < 0.001 for noninferiority; P = 0.38 for superiority). There was no significant interaction with age, sex, Medina classification, or SB residual stenosis. Procedure time, radiation dose, and contrast use were significantly lower in the no-SBI group. Procedural complications were rare, but SB dissection was more frequently observed in the SBI group (2.9% vs 0.0%; P = 0.004). There was no difference in target lesion failure at 1 year (4.9% [n = 15] vs 6.4% [n = 20] in the no-SBI and SBI groups respectively; P = 0.442).
CONCLUSIONS: The KISS trial demonstrates that a conservative strategy without systematic SB intervention is associated with very rare procedural complications and is noninferior to a systematic SB intervention regarding periprocedural MI and myocardial injury.