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).
RCT Entities:
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).