DKCRUSH-VI: FFR-guided stenting outcomes similar to angiography

WASHINGTON — Patients who received provisional side branch stenting after main vessel stenting had no difference in outcomes if the procedure was guided by fractional flow reserve or angiography, researchers for the DKCRUSH-VI study reported at TCT 2014.

Although FFR is the gold standard to assess functional ischemia of a coronary lesion, whether it is superior to angiography in guiding a provisional side branch stenting procedure was not known, Shao-Ling Chen, MD, director of cardiology and the cath lab at Nanjing First Hospital in China, said during a press conference.

Chen and colleagues randomly assigned 320 patients with Medina 1, 1, 1 or 0, 1, 1 bifurcation lesions with a side branch ≥2.5 mm to an FFR-guided (n=160) or angiography-guided (n=160) procedure to determine whether side branch stenting was required. All patients underwent clinical follow-up at 1 year and angiographic follow-up at 13 months.

The primary endpoint was major adverse cardiac events, including cardiac death, MI and target vessel revascularization. Secondary endpoints included cardiac death; MI; a composite of target lesion revascularization, CABG and TVR; restenosis and stent thrombosis.

Side branch PCI occurred in 56.3% of the FFR group and 63.1% of the angiography group (P=.07). Side branch stenting was attempted in 25.9% of the FFR group and 38.1% of the angiography group (P=.01). Of those patients, side branch stenting was successful in 77.3% of the FFR group and 83.6% of the angiography group (P=.01), Chen said.

There was no difference between the groups at 1 year in the following outcomes:

Major adverse cardiac events: angiography group, 18.1%; FFR group, 18.1%; HR=1; 95% CI, 0.566-1.766;
Cardiac death: angiography group, 0.6%; FFR group, 1.3%; P=.56
MI: angiography group, 13.8%; FFR group, 11.9%; HR=0.845; 95% CI, 0.438-1.631;
TLR: angiography group, 5%; FFR group, 3.1%; P=.57.
TVR: angiography group, 6.9%; FFR group, 5.6%; HR=0.807; 95% CI, 0.325-2.005;
Definite or probable stent thrombosis: angiography group, 1.3%; FFR group, 0.6%; P=.56.

There were no instances of CABG in either group.

In a post-hoc analysis, the angiography group was more likely to have in-stent restenosis in the distal main vessel (9.2% vs. 1.7%; P=.01), and the FFR group was more likely to have in-stent restenosis in the side branch (11.8% vs. 21.2%; P=.037). There was no difference in the proximal main vessel (3.4% vs. 1.7%; P=.68), Chen said.

“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,” Chen said in a press release.

For more information:

Chen S-L. Plenary Session XII: Late-Breaking Clinical Trials #2. Presented at: TCT 2014; Sept. 13-17, 2014; Washington, D.C.

Disclosure: The study was funded by the Jiangsu Provincial Special Program of Medical Science. Chen reports no relevant financial disclosures.