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Bioresorbable scaffold increases risk for stent thrombosis, MI vs. DES
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Compared with a drug-eluting stent, patients who underwent PCI with a bioresorbable vascular scaffold had increased risk for definite or probable stent thrombosis and MI, according to a new meta-analysis.
Researchers analyzed studies with outcomes data that included 10,510 patients (mean age, 60 years; 78% men). Of those, 8,351 were assigned a bioresorbable vascular scaffold (BVS; Absorb, Abbott Vascular) and 2,159 were assigned a DES. Mean follow-up was 6.4 months.
Among those who received a BVS, CV death occurred in 0.6%, MI in 2.1%, target lesion revascularization in 2% and definite/probable stent thrombosis in 1.2% (0.27% acute stent thrombosis, 0.57% subacute stent thrombosis) during the study period, Michael J. Lipinski, MD, PhD, from MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, D.C., and colleagues found.
Compared with DES, patients assigned BVS had increased risk for MI (OR = 2.06; 95% CI, 1.31-3.22) and increased risk for definite/probable stent thrombosis (OR = 2.06; 95% CI, 1.07-3.98), according to the results.
However, assignment to BVS was associated with a trend toward decreased all-cause mortality (OR = 0.4; 95% CI, 0.15-1.06), according to the researchers.
The groups had similar rates of CV death, MACE, TLR and target vessel revascularization.
The stent thrombosis finding “should be viewed as hypothesis generating, as much of the data were generated from propensity-matched and retrospective studies,” Lipinski and colleagues wrote. “Further prospective, randomized controlled trials, especially in patients with ACS, will be very helpful in assessing whether patients undergoing PCI are at increased risk [for stent thrombosis] after BVS placement compared with DES.”
Antonio Colombo
Postdilation may be the key to reducing stent thrombosis and MI in patients receiving a BVS, Antonio Colombo, MD, from the department of interventional cardiology, San Raffaele Scientific Institute, and EMO-GVM, Centro Cuore Columbus, Milan, and Neil Ruparelia, MBBS, DPhil, from the department of cardiology, Imperial College London, wrote in a related editorial. Colombo and Ruparelia noted that postdilation was performed in only 52% of patients analyzed.
“Aware of the high compliance of the balloon on which the Absorb BVS is mounted, we are surprised that postdilation was not performed in a greater number of lesions,” they wrote. “The potential sequelae of this procedural omission is further multiplied in the absence of intravascular imaging guidance, with low reported usage rates in the larger published registries that were included in this meta-analysis.”
Colombo and Ruparelia concluded that “the important final message we should take away from this study is: ‘Absorb BVS may have a higher risk [for stent thrombosis], but this can be overcome by the operator who is in charge to ensure optimal implantation.’” – by Erik Swain
Disclosure: The researchers, Colombo and Ruparelia report no relevant financial disclosures.
Perspective
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Ajay J. Kirtane , MD, SM, FACC, FSCAI
With any new technology, we have to be vigilant regarding safety signals, particularly if the technology is used more widely and broadly than outside of the carefully controlled trials used for regulatory approval. Longer term follow-up is definitely needed to see if there is a realized advantage of this technology, given that BVS take time to resorb.
BVS do appear to be more difficult to implant at present, and specific techniques are required to optimize the results with these stents. Whether further refinements in technique can definitively be associated with improved outcomes is not proven at present, but does make intuitive sense.
As always, observational comparisons between BVS and conventional DES are fraught with potential unmeasured confounders. The truest comparison of BVS vs. conventional DES comes from within randomized studies.
I do think that the more labor-intensive nature of BVS implantation will limit uptake, relative to if this were just like a newer, very deliverable current DES. That having been said, if the late benefits of BVS are ultimately proven, this will provide an impetus to make the effort to implant BVS. It’s not clear to me what effect this will have on regulatory approvals other than potentially some training requirements, or possible warnings regarding BVS use in specific lesion subsets such as small vessels. However, we need to reserve judgment on which patients might benefit more from BVS as opposed to DES until late data are available.
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