Triple drug-coated stent may reduce risk for stent thrombosis, target lesion failure
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Key takeaways:
- A stent coated with site-specific antithrombotic therapy safely managed thrombotic and bleeding risk after PCI.
- There were no target lesion failure or MI events in the triple drug-eluting stent group.
SAN FRANCISCO — The first-time application of a triple-drug, site-specific antithrombotic therapy on a stent platform was safe and effective for managing thrombotic and bleeding risk after PCI, data presented at TCT 2023 show.
Stent thrombosis after PCI is associated with large-territory MI events and poor outcomes, with death rates as high as 50% for early thrombosis cases, Stefan Verheye, MD, PhD, a senior interventional cardiologist at Antwerp Cardiovascular Center, ZNA Middelheim in Antwerp, Belgium, told Healio. Balancing ischemic and bleeding risk with oral antithrombotic drugs remains a significant clinical challenge, especially for adults at high thrombotic risk and high bleeding risk, Verheye said.
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“To prevent stent thrombosis, patients are required to take oral dual antiplatelet therapy, which increases the risk for system bleeding,” Verheye told Healio. “Management of ischemic and thrombotic risk requires a tradeoff between the two and is complex for clinicians and patients, requiring medication adherence and delay of surgical procedures. Having a device that may prevent stent thrombosis from occurring immediately post-implant and does so without systemic medication is a welcome option for our high thrombotic risk and high bleeding risk patient populations. It also can act as ‘safety belt’ if the patient discontinues DAPT or a treating physician is not able to adjust medication in time for an urgent surgery.”
For the DESyne trial, researchers tested for the first time the application of triple-drug, site-specific antithrombotic therapy — two anticoagulants, rivaroxaban and argatroban, plus sirolimus — on a stent platform. The small doses and elution profiles are designed to be therapeutic at the implant site and tissue level, but not detectable systemically, Verheye said.
For the DESyne BDS trial, Verheye and colleagues analyzed data from 202 adults who underwent PCI across 14 sites in Brazil, Europe and New Zealand who received the DESyne BDS Plus triple drug-eluting coronary implant (Elixir Medical; n = 100) or the DESyne X2 drug-eluting coronary stent system (Elixir Medical; n = 102). The mean age of patients was 63 years; the DESyne group was 22% women and the DES group was 26% women. Diabetes was more common in the DESyne group than in the DES group (28% vs. 15%) and about one-third of patients in both groups had ACS, Verheye said. Within the cohort, 29 patients in each group underwent angiographic and OCT assessment within the first 6 months.
At day 3 or at hospital discharge, rates of target lesion failure were 0% for the DESyne BDS Plus and 5% for the durable polymer DES (95% CI, –11.8 to 1.8; P for noninferiority < .001), meeting the study’s primary endpoint. At 6 months, TLF rates were 1% in the DESyne group and 8.2% in the DES group (95% CI, –14.8 to –1.3; P = .035).
Researchers did not observe stent thrombosis, target vessel MI or CV death events with the DESyne stent. At 6 months, target vessel MI rates were 0% in the DESyne group and 6.3% in the DES group.
The secondary endpoint, in-device late lumen loss at 6 months, was similar for both devices, Verheye said (difference, 0.05; 95% CI, –0.07 to 0.17; P for noninferiority < .001).
Additionally, pharmacokinetic data confirmed systemic subtherapeutic levels while maintaining site-specific therapeutic levels, Verheye said.
“This was a large first in-human study based on significant preclinical evidence developed for this therapy,” Verheye told Healio. “In a randomized fashion, the trial established that triple drug site-specific therapy is safe and effective, as demonstrated in significantly lower clinical event rates and imaging data compared with a DES. The combination of three drugs works as intended.”
Verheye said researchers plan to conduct larger studies looking specifically at patients at high bleeding risk, possibly including those currently contraindicated for PCI, as well as larger studies investigating a change to or even eliminating an oral systemic antithrombotic DAPT regimen.
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Verheye S, et al. Coronary spotlight 5: Disruptive stent technologies. Presented at: TCT Scientific Symposium; Oct. 23-26, 2023; San Francisco (hybrid meeting).
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