In patients with a large coronary bifurcation lesion undergoing provisional bifurcation stenting, a conservative strategy appears to yield better 3-year clinical outcomes compared with an aggressive strategy, according to recent findings.
In the prospective, randomized, nonblinded, single-center trial, researchers evaluated 258 patients with stable CAD or non-ST-segment elevation ACS and a de novo coronary bifurcation lesion who underwent PCI with a drug-eluting stent between July 2007 and December 2010. Participants had a main vessel diameter of at least 2.5 mm, and the side branch diameter of at least 2.3 mm based on visual estimation.
Patients were stratified by presence or absence of a left main bifurcation lesion and randomly allocated 1:1 to a conservative (n = 128) or aggressive (n = 130) intervention strategy for provisional side branch intervention after stenting of the main vessel.
For non-left main bifurcations, the criteria for starting side branch intervention in the conservative group was TIMI-flow grade lower than 3 vs. a stenosis diameter of more than 75% in the aggressive group. For left main bifurcations, the criteria for side branch intervention initiation was stenosis diameter of more than 75% in the conservative group vs. stenosis diameter of more than 50% in the aggressive group.
The primary endpoint was incidence of target vessel failure, defined as a composite of cardiac death, spontaneous MI or target vessel revascularization at 3-year follow-up. Secondary endpoints included the individual constituents of the primary endpoint, as well as all-cause death, stent thrombosis, target lesion revascularization and target bifurcation revascularization at 3 years.
Conservative approach favored
The researchers found that between randomization and 3-year follow-up, the conservative approach correlated with a lower incidence of TVF (11.7% vs. 20.8%; P = .049). Although there were no significant between-group differences in TVF at 1 year (9.4% conservative vs. 9.2% aggressive; P = .97), a landmark analysis between 1 year and 3 years revealed fewer TVF events in patients on the conservative regimen (2.6% vs. 12.7%; P = .004).
During the 3-year follow-up, there was a lower incidence of the composite of cardiac death or MI in the conservative group vs. the aggressive group (0.8% vs. 6.2%; P = .036), with lower rates of TVR.
At 3 years, TLR was similar between the two groups. However, a landmark analysis of TLR at 1 year after randomization found lower rates of 3-year TLR.
There were two cases (0.8%) of stent thrombosis, both of which occurred among patients in the aggressive group, despite the use of dual antiplatelet therapy.
Crossover to the two-stent technique was found to be independently predictive of TVF (P < .001) and TLR (P = .049).
According to the researchers, a large-scale confirmatory study is needed to determine the best strategies for provisional side branch intervention in patients with coronary bifurcation lesions.
“The conservative strategy for provisional [side branch] intervention had better long-term clinical outcomes compared with the aggressive strategy, mainly due to lower crossover rate to the two-stent technique,” the researchers wrote. “The clinical benefits of a conservative strategy for provisional [side branch] intervention appeared remarkably in the landmark analysis between 1 and 3 years, mainly driven by the difference of TLR for [main vessel].” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.