PARIS – Technical success rates were high and major adverse events impressively low with a two-stent culotte strategy using contemporary drug-eluting stents for coronary bifurcation lesions in the randomized CELTIC Bifurcation Study.
“We initiated this study because of a conviction that the story isn’t finished with bifurcation stenting. We’re very much under the impression that the accepted wisdom of a conservative approach is, we think, not correct, and the issue needs to be kept open,” said Dr. Foley, an interventional cardiologist at Beaumont Hospital in Dublin.
The widely accepted provisional single-stent strategy is based on early-days randomized trial evidence using first-generation drug-eluting stents and older techniques that are no longer relevant in contemporary practice. Moreover, this conservative single-stent approach doesn’t address the important issue of ischemia arising from large side branches, he asserted.
“I’ve always been fond of culotte stenting myself because I think it’s a very elegant, simple, repeatable strategy, and with modern stents it becomes easier for modest-volume operators to carry it out well. We’ve kept on trying to convert new colleagues and older colleagues who are set in their ways,” Dr. Foley said.
Thewas an investigator-initiated trial in which 177 patients at nine centers in Ireland and the United Kingdom were randomized to culotte stenting using either two-connector, third-generation Synergy everolimus-eluting stents or the three-connector, second-generation Xience everolimus-eluting stents. All participants had Medina 1,1,1 coronary bifurcation lesions, which were left anterior descending/diagonal lesions in more than 80% of cases. A radial approach was used in more than 95% of the procedures. The indication for percutaneous coronary intervention was stable angina in more than 60% of cases. The rate of technical procedural success with final kissing balloon inflation exceeded 96%. The primary outcome – a MACCE (major adverse cardiovascular and cerebrovascular events) composite of death, MI, cerebrovascular accident, and target vessel revascularization over the course of 9 months – occurred in 5.9% of patients: 8.6% of the Synergy group and 3.7% with Xience stents, a nonsignificant difference. This MACCE rate was considerably lower than the 10% figure that the investigators had expected on the basis of published studies of PCI in these complex bifurcation lesions.
“The results were better than expected,” the cardiologist said. “We don’t get excited that easily, to be honest, but nonetheless we’re a little bit excited that the overall MACCE rate in this complex lesion presentation was 5.9%.”
Discussant, director of cardiology at Fulda (Germany) Hospital, observed: “It’s always good to reassess what are believed to be answered questions when there are new devices available.” But why not compare culotte stenting to the provisional single-stent strategy? he asked.
“We think provisional versus culotte stenting has been thrashed to death already. And you’d need a bigger trial than we had funding for,” Dr. Foley replied.