14-day DAPT with nanocoated stent inferior to standard short-term DAPT strategy
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Among patients on oral anticoagulation, those who had dual antiplatelet therapy for 14 days after PCI with a nanocoated stent had worse outcomes compared with those assigned 3-to-6-month DAPT after PCI with a drug-eluting stent.
For the randomized, open-label, active-controlled COBRA-REDUCE trial of 996 patients taking oral anticoagulation for atrial fibrillation or other reasons who underwent PCI, the patients were assigned PCI with the nanocoated stent (Cobra PzF, CeloNova Biosciences) followed by 14 days of DAPT or PCI with any FDA-approved second-generation DES followed by 3 to 6 months of DAPT. For the control group, the choice of DES was left to the operator and the duration of DAPT was made by the principal site investigator based on thrombotic risk, and for both groups, whether to reduce the oral anticoagulation dose during triple therapy was left to the principal site investigator, Robert A. Byrne, MB, BCh, PhD, professor of cardiovascular research at RCSI University of Medicine and Health Sciences and director of cardiology at Mater Private Hospital, both in Dublin, said during a press conference at the virtual TCT Connect.
The Cobra stent is “not drug-eluting, instead it’s coated with the polymer Polyzene-F, which had antithrombotic properties in preclinical studies and also seems to have an antirestenotic efficacy by virtue of very rapid healing that’s somewhere between current-generation drug-eluting stents and regular bare-metal stents,” Byrne said at the press conference. “Because of the rapid healing, it’s been tested with a very short duration of dual antiplatelet therapy of 14 days in high bleeding risk patients.”
The primary endpoint of Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding between 14 days and 6 months occurred in 7.5% of the Cobra group and 8.9% of the DES group (P = .477), Byrne said at the press conference. “It was somewhat surprising that there was a reduction but it was not statistically significant,” he said.
However, he said, for the coprimary endpoint of death, MI, stent thrombosis and ischemic stroke at 6 months, the Cobra strategy did not meet the prespecified noninferiority margin of 5% (Cobra group, 7.7%; DES group, 5.2%; difference, 2.5 percentage points; 95% upper CI, 5.15; P for noninferiority = .061).
The groups were similar in secondary bleeding endpoints except for BARC types 1 to 5 bleeding after randomization, which favored the Cobra group (13% vs. 18.3%; P = .026), Byrne said.
Among secondary thromboembolic endpoints, death/MI/definite or probable stent thrombosis/ischemia-driven target lesion revascularization/ischemic stroke were higher in the Cobra group (9.7% vs. 5.8%; P = .023), driven by ischemia-driven TLR (3.7% vs. 0.9%; P = .004), he said.
“There were low rates in both groups, particularly for stent thrombosis,” he said. “This compares very favorably to other studies of [high bleeding risk] patients.”
Nearly 60% of patients had two major criteria or one major plus two minor criteria for high bleeding risk, Byrne said. “The point estimate [for the primary bleeding endpoint] tends to favor the shorter DAPT in the patients who had multiple criteria, but that has to be interpreted with caution in the context of a negative study.”
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Byrne RA, et al. Late-breaking clinical trial session IV, co-sponsored by European Heart Journal: Stent trials and high bleeding risk patients. Presented at: TCT Connect; Oct. 14-18, 2020 (virtual meeting).
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