Optimal Strategy for Provisional Side Branch Intervention in Coronary Bifurcation Lesions: 3-Year Outcomes of the SMART-STRATEGY Randomized Trial

Objectives: This study compared the long-term follow-up results of conservative versus aggressive strategies for provisional side branch (SB) intervention in coronary bifurcation lesions.

Background: The appropriate criteria for provisional SB ballooning or stenting have not been established.

Methods: A total of 258 patients with a large bifurcation lesion were randomized to a conservative or aggressive SB intervention strategy. Different criteria applied for the initiation of SB intervention after main vessel stenting in the conservative and aggressive groups were Thrombolysis In Myocardial Infarction flow grade lower than 3 versus a stenosis diameter >75% for non-left main bifurcations, and a stenosis diameter >75% versus a stenosis diameter >50% for left main bifurcations. The primary endpoint was target vessel failure (TVF), defined as a composite of cardiac death, spontaneous myocardial infarction, or target vessel revascularization at 3 years.

Results: At 3 years, TVF occurred in 11.7% of the conservative group versus 20.8% of the aggressive group (p = 0.049). Although no significant differences were observed in the incidence of TVF between groups at 1 year (9.4% vs. 9.2%; p = 0.97), landmark analysis between 1 and 3 years showed significantly less TVF in patients assigned to the conservative strategy (2.6% vs. 12.7%; p = 0.004). The crossover to the 2-stent technique was an independent predictor of TVF (hazard ratio: 5.42, 95% confidence interval: 2.03 to 14.5; p < 0.001). There was no interaction between left main bifurcation and treatment effects for TVF (p for interaction = 0.8).

Conclusions: A conservative strategy compared with an aggressive strategy for provisional SB intervention is associated with long-term benefits for patients with a large bifurcation lesion. (Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion; NCT00794014).