Randomized comparison of conservative versus aggressive strategy for provisional side branch intervention in coronary bifurcation lesions: results from the SMART-STRATEGY (Smart Angioplasty Research Team-Optimal Strategy for Side Branch Intervention in Coronary Bifurcation Lesions) randomized trial.

OBJECTIVES

The authors sought to compare conservative and aggressive strategies for provisional side branch (SB) intervention in coronary bifurcation lesions.

BACKGROUND

The optimal provisional approach for coronary bifurcation lesions has not been established.

METHODS

In this prospective randomized trial, 258 patients with a coronary bifurcation lesion treated with drug-eluting stents were randomized to a conservative (n = 128) or aggressive (n = 130) SB intervention strategy. The criteria for SB intervention after main vessel stenting differed between the conservative and aggressive groups; Thrombolysis In Myocardial Infarction flow grade <3 versus diameter stenosis >75% for non-left main bifurcations and diameter stenosis >75% versus diameter stenosis >50% for left main bifurcations. The primary endpoint was target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) at 12 months.

RESULTS

Left main bifurcation lesions were noted in 114 patients (44%) and true bifurcation lesions in 171 patients (66%). SB ballooning after main vessel stenting and SB stenting after SB ballooning were performed less frequently in the conservative group than in the aggressive group (25.8% vs. 68.5%, p < 0.001; and 7.0% vs. 30.0%, p < 0.001, respectively). The conservative strategy was associated with a lower incidence of procedure-related myocardial necrosis compared with the aggressive strategy (5.5% vs. 17.7%, p = 0.002). At 12 months, the incidence of target vessel failure was similar in both groups (9.4% in the conservative group vs. 9.2% in the aggressive group, p = 0.97).

CONCLUSIONS

Compared with the aggressive strategy, the conservative strategy for provisional SB intervention was associated with similar long-term clinical outcomes and a lower incidence of procedure-related myocardial necrosis. (Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesions [SMART-STRATEGY]; NCT00794014).