DKCRUSH-VI Compares FFR and Angiography to Guide Provisional Side Branch Stenting

September 14, 2014—Findings from the DKCRUSH-VI trial were reported today at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC. 

According to the press release issued by TCT, the study showed that fractional flow reserve (FFR)-guided provisional side branch stenting of true coronary bifurcation lesions yields similar outcomes to the current standard of care. The DKCRUSH-VI clinical trial is the first study to compare FFR-guided and angiography-guided stenting.

The TCT announcement noted that angiography alone is most commonly used to guide the decision of whether and how to treat the side branch of a coronary bifurcation lesion. Previous studies have demonstrated that this approach is effective for the majority of these lesions. However, there are few data regarding outcomes after FFR-guided provisional bifurcation stenting. FFR integrates both lesion severity and the area of the myocardium supplied by the specific coronary artery and has become the gold standard for assessing the functional significance of a coronary lesion. 

As summarized in the TCT press release, the DKCRUSH-VI trial examined a total of 320 patients at eight centers with true coronary bifurcation lesions (Medina 1,1,1, or 0,1,1) undergoing stenting with a provisional side branch approach. Patients were randomly assigned 1:1 to an angiography-guided or an FFR-guided method. The primary endpoint was the 1-year composite rate of major adverse cardiac events (MACE), including cardiac death, myocardial infarction, and ischemia-driven target vessel revascularization. 

Comparing the angiography and FFR groups, treatment of the side branch (balloon or stenting) was performed in 63.1% vs 56.3% of cases, respectively (P = .07). Stenting of the side branch was attempted in 38.1% vs 25.9%, respectively (P = .01). Among attempted cases, stenting was successful in 83.6% and 77.3% respectively (P = .01). Although fewer side branch stents were used in the FFR group, the 1-year composite MACE rate was 18.1% in both groups (P = 1). 

“Given the nearly identical 1-year MACE rates with both approaches, either the angiography-guided or FFR-guided technique may be recommended for provisional side branch stenting of true bifurcation lesions,” commented Lead Investigator Shao-Liang Chen, MD, in the TCT press release. “The FFR technique may result in somewhat fewer stents being implanted and a slightly lower long-term restenosis rate, but may be technically challenging and require the upfront cost of a pressure wire in all patients.” Dr. Chen is Director of Cardiology and Catheterization Lab at Nanjing First Hospital and Professor of Internal Medicine and Cardiology at Nanjing Medical University in China.