Bioresorbable Stent Safe in Real-World Practice

— Mid-term results on par with a conventional standard in European registries

MedicalToday

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An everolimus-eluting bioresorbable vascular scaffold (BVS) shared similarly low rates of adverse ischemic events at 1 year with the a conventional everolimus-eluting stent (EES) in real-world registry findings.

The composite rate of cardiac death, target-vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR) at 1 year was similar between recipients of the Absorb bioresorbable stent and those who got a conventional Xience stent after adjusting for baseline differences (5.8% vs 7.6%, P=0.12).

Action Points

  • The combined rate of adverse ischemic events was low and not significantly different in matched patients in real-world registries receiving either an everolimus-eluting bioresorbable vascular scaffold stent or a conventional everolimus-eluting stent.
  • The composite endpoint of adverse ischemic events included cardiac death, target-vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR) at 1 year.

"The study showed comparable outcomes between Absorb BVS and Xience EES at 1 year, which partly addresses the important and urgent questions regarding the mid-term safety and efficacy of Absorb BVS in contemporary practice," authors , of Ferrarotto Hospital in Catania, Italy, and colleagues reported online in

Furthermore, "these findings suggest a substantial degree of patient and lesion selection in contemporary daily use of Absorb BVS, translating into mid-term outcomes that resemble those of matched second-generation Xience EES," the authors wrote.

"The benefits of Absorb BVS are expected to be apparent at long term, when bioresorption liberates the vessel from permanent caging and vessel functions are restored," the authors continued. "Therefore, the finding that Absorb BVS show a comparable performance to that of Xience EES at 1 year (the time frame where restenosis may be more likely to occur) is promising."

, of Beth Israel Deaconess Medical Center in Boston, told that the outcomes of Capodanno's study were "similar to the findings of the randomized Absorb III trial published last year," a study in which he was involved.

"Determination of the long-term advantage of BVS will require additional studies," he said, but these mid-term outcomes in commercial practice "should be reassuring to physicians for expanded use" of the device.

Capodanno's investigation included data on 905 matched pairs of patients treated with either the Absorb bioresorbable vascular scaffold or the Xience EES, as part of the GHOST-EU and Xience V USA registries, respectively.

At 1 year, cardiac death was less likely in the Absorb group (0.7% versus 1.9% for Xience EES, P=0.03). Rates of MI also slightly favored the Absorb group but failed to reach statistical significance (2.4% versus 4.0% for Xience EES, P=0.07).

Between the bioresorbable and conventional scaffold stents, there were no differences in ischemia-driven TLR (4.6% versus 3.5%, P=0.22) or device thrombosis (1.8% vs 1.1%, P=0.23).

Somehow there was "less death and a trend towards less MI with BVS, which is hard to explain," , of the Cleveland Clinic in Ohio, told .

However, the investigators "did find a trend toward increased device thrombosis with BVS," which could be due to its larger strut diameter, Ellis suggested, comparing its 157 µm "footprint" with that of the EES at 80 µm. In the future, "2nd gen BVS will have strut diameters more on the order of 95-100 µm," he added.

Ellis emphasized that the investigation was not a randomized controlled trial, even if such studies do not "completely reflect real world experience." He said that "if more complex lesions are treated in the real world experience, then the current paper is correct -- but I would be skeptical and tend to rely mainly on randomized results."

Patients treated with the bioresorbable stent had fewer baseline coronary risk factors and comorbidities, and were more likely to be treated for acute coronary syndromes and long lesions.

Capodanno and colleagues argued that their study "collects more complex patients and lesions than those included in the randomized Absorb II, EVERBIO II, TROFI II, and Absorb-JAPAN trials, where multiple restrictions applied."

In any case, "we can infer from this analysis that the higher scaffold thrombosis seen initially in GHOST was attributed to the treatment of very complex lesion subsets," Popma said. "I am reassured about the use of BVS with this analysis."

Nonetheless, only time will tell if bioresorbable stents might one day eclipse EES.

"The GHOST-EU and much of the ABSORB randomized controlled trial data reflects the learning phase for BVS implantation, so subsequent experiences may show better BVS outcome as more post-dilatation and adjunct imaging is used," according to Ellis.

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    Nicole Lou is a reporter for , where she covers cardiology news and other developments in medicine.

Disclosures

Capodanno reported no relevant conflicts of interest.

Ellis reported consulting for Abbott, Boston Scientific, and Medtronic.

Popma reported receiving institutional grants for the ABSORB III study.

Primary Source

JACC: Cardiovascular Interventions

Tamburino C et al "One-year outcomes of everolimus-eluting bioresorbable scaffolds verus everolimus-eluting stents: a propensity matched comparison of the GHOST-EU and XIENCE V USA registries" JACC Cardiol Interv 2016.