This article is more than 5 years old. Information may no longer be current.
Two bioresorbable scaffolds yield comparable clinical outcomes
Click Here to Manage Email Alerts
For two types of bioresorbable scaffolds, clinical outcomes, including rates of MACE, target lesion failure and definite scaffold thrombosis, were similar after 1 year, according to recently published data.
To compare outcomes of an everolimus-eluting bioresorbable vascular scaffold (BVS; Absorb, Abbott Vascular) and a novolimus-eluting bioresorbable coronary scaffold (BCS; DESolve, Elixir Medical) in patients undergoing PCI, Holger M. Nef, MD, from the department of cardiology at the University of Giessen in Germany, and colleagues evaluated consecutive patients who underwent implantation with one of the two scaffolds using 2:1 propensity matching.
Of 506 patients who were eligible for matching, 212 (mean age, 62.9 years) who received a BVS and 106 (mean age, 63.1 years) who received a BCS were included in the analysis.
No relevant differences
After matching, there were no relevant differences between the BVS and the BCS groups in baseline characteristics, including the proportion of patients with ACS (53.3% vs. 48.1%; P = .383), STEMI (19.3% vs. 17%), non-STEMI (18.9% vs. 18.9%) and stable angina (43.4% vs. 48.1%). Lesion characteristics were also comparable between groups, and a similar proportion of matched BVS and BCS patients underwent predilatation (99.5% vs. 98.1%; P = .218) and postdilatation (84.4% vs. 86.8%; P = .576).
After 1 year, there were no relevant differences in clinical outcomes between the BVS and BCS study arms. The rates of MACE, which included target lesion revascularization, MI or cardiac death, did not differ significantly in patients implanted with a BVS vs. a BCS (5.8% vs. 4.5%; P = .602), nor did the rates of TLF (4.7% vs. 4.5%; P = .851) and definite scaffold thrombosis (2% vs. 1%; P = .529). Cardiac death also was not significantly different between the BVS and BCS groups (1.5% vs. 2%; P = .752).
Not yet definitive
In an accompanying editorial, Davide Capodanno, MD, PhD, associate professor and interventional cardiologist at Ferrarotto Hospital, University of Catania in Italy, noted that the study design may prevent clinicians and researchers from drawing firm conclusions.
“Indeed, since the study was retrospective and nonrandomized, its results can be considered only as good as the methods used to gather the data,” Capodanno wrote. “In particular, considerations on how the propensity score was built and used for matching are crucial to drive a correct interpretation.”
Moreover, although the BVS and BCS are similar, they have differences that may affect later outcomes, according to Capodanno. For instance, resorption time is 1 to 2 years for the BCS and 3 to 4 years for the BVS.
“Clearly, if differences between the two devices exist, these will be more likely to emerge after 1 year, when the BCS rapidly loses its mass while the BVS stays longer,” Capodanno wrote. “Whether a more rapid mass loss such as that of BCS or other upcoming [bioresorbable scaffolds] in the pipeline may be associated with superior clinical outcomes is a question for randomized studies vs. BVS and ideally vs. drug-eluting stents, with a follow-up plan of at least 5 years.” – by Melissa Foster
Disclosure: Nef reports receiving research grants and speaker honoraria from Abbott Vascular and Elixir Medical. Please see the full study for a list of the other researchers’ relevant financial disclosures. Capodanno reports receiving consultant fees from Abbott Vascular.
Click Here to Manage Email Alerts