LEADERS FREE: Polymer-free drug-coated stent bests BMS in complex PCI

In a substudy of the LEADERS FREE trial, treatment with a polymer-free drug-coated stent was more beneficial in terms of safety and efficacy compared with a bare-metal stent in patients at high risk for bleeding who underwent complex PCI, according to data presented at EuroPCR.

Among the 667 patients who underwent complex PCI in the randomized trial, 346 received the polymer-free biolimus A9-coated stent (BioFreedom, Biosensors Europe) and 321 received a comparable BMS (Gazelle, Biosensors Interventional Technologies).

After 2 years, the primary efficacy endpoint — clinically driven target lesion revascularization — occurred in 10.8% of the drug-coated stent group vs. 18.1% of the BMS group (HR = 0.54; 95% CI, 0.35-0.83). Additionally, the primary safety endpoint — a composite of cardiac death, MI, or definite or probable stent thrombosis — occurred in 16.2% of the drug-coated stent group vs. 21.7% of the BMS group (HR = 0.7; 95% CI, 0.49-0.99).

Among the 1,746 patients who underwent non-complex PCI, the primary efficacy endpoint occurred less frequently with the drug-coated stent vs. the BMS (5.3% vs. 9.9%; HR = 0.52; 95% CI, 0.36-0.75) and the safety endpoint occurred at a similar rate in both groups (11.1% vs. 12.6%; HR = 0.863; 95% CI, 0.653-1.139).

Time-to-event curves for the primary efficacy and safety endpoints showed that patients who underwent complex PCI had higher event rates compared with patients who underwent non-complex PCI. However, the p values for interaction were not significant, indicating that the two patient groups behaved similarly.

The drug-coated stent was also only associated with greater benefit in terms of definite or probable stent thrombosis in the complex PCI group vs. the non-complex PCI group (P for interaction = .0104).

As Cardiology Today’s Intervention previously reported, LEADERS FREE is a randomized, double-blind clinical trial that enrolled 2,432 patients who had a high risk for bleeding at 68 sites in 20 countries. All patients received aspirin and a P2Y12 inhibitor for 30 days, followed by a single antiplatelet agent.

Complex PCI was defined as having at least one of the following characteristics: total stent length of 60 mm or greater, treatment of at least three vessels or lesions, implantation of at least three stents, bifurcation lesion treated with at least two stents and chronically occluded, restenotic or saphenous vein graft lesion. Patients who underwent complex PCI were generally older, had more comorbidities and more often had multivessel CAD.

Currently, the results, which were simultaneously published in EuroIntervention, should only be considered hypothesis-generating, as they are based on a post hoc analysis of a trial subgroup, according to the researchers. However, they noted the data suggest that patients undergoing complex PCI may be among those who benefit most from the drug-coated stent vs. a BMS.

“We believe that these results reinforce the conclusions of the LEADERS FREE trial,” the researchers wrote. “Compared to BMS, the [drug-coated stent] maintained both its efficacy and its safety benefits when used in complex PCI procedures. There is no place today for BMS, except when the choice is driven by economic considerations.” – by Melissa Foster

References:

Urban P, et al. Trial updates – DES trials. Presented at: EuroPCR; May 22-25, 2018; Paris.

Lipiecki J, et al. EuroIntervention. 2018;doi:10.4244/EIJ-D-18-00293.

Disclosures: The LEADERS FREE trial was funded by Biosensors Europe. Two authors report they are employees of Biosensors. Two authors report they are paid consultants of Biosensors. One author reports she is CEO of CERC, the organization that conducted the trial. All other authors report no relevant financial disclosures.