Key result
Off-label use of bioabsorbable polymer everolimus-eluting stents was associated with a higher rate of target vessel failure at 2 years compared to on-label use (10.9% vs 2.9%, p=0.01).
Why the study?
Previous reports have showed worse outcomes with bioabsorbable polymer everolimus-eluting stents in real-world settings than in case-controlled clinical trials.
Does off-label use of BP-EES compared to on-label use affect 2-year clinical outcomes in a real-world all-comer population?
Cohort (n=437)
No
Does off-label use of BP-EES compared to on-label use affect 2-year clinical outcomes in a real-world all-comer population?
Absolute Event Rate: 10.9% vs 2.9%
p-value: p=0.01
In a real-world registry of BP-EES implantation, off-label use was associated with higher mortality and target vessel failure driven by patient vulnerability, while stent-related revascularization rates remained similar to on-label use.
Broader revascularization definitions yield 2-3× higher TLR rates in real-world BP-EES use; leaves open whether trial criteria underrepresent clinical events in off-label patients.
Objectives: To clarify the 2 years outcome of Bioabsorbable Polymer Everolimus-Eluting Stent (BP-EES) using several criteria/definitions. Previous reports have showed worse outcomes in Real-World (RW) setting than case-Controlled Clinical trials (CC). Methods and Materials: We studied consecutive patients who received BP-EES implantation from October 2017 through January 2018. We adopted the parameters used in previous BP-EES associated CC (SYNERGY, EVOLVE), compared the CC inclusion criteria (on-label) with others (offlabel) at 2 years follow-up. Results: There were 678 BP-EESs inserted in 437 patients (283 male, mean age 72.3±11.2 years). Data from 4 patients lacked, and therefore the follow-up rate was 99.1%. There were 381 patients (87.2%) satisfying the CC criteria. Male gender, ejection fraction <40%, smoker, multiple stenting, total stent length, target vessel failure and all death was higher in the off-label group (P<0.05). Regarding revascularization- related parameters (all target lesion/non-target lesion revascularization), there was no difference between the 2 groups (TLR 6.1% vs 3.6%, non-TL TVR 5.6% vs 10.9%; CC vs off-label, p=ns, respectively). On the other hand, comparison of TLR using the CC definition (ischemia-oriented TLR) and real-world definition (any TLR) showed approximately 2-3 times higher frequency in the real-world basis (1.6% vs 5.8% per patient basis and 2.1%vs 5.8% per stent basis). Conclusions: Different definitions for repeat angioplasty among the reports may be a key cause of the discrepancy in revascularization frequency in dug-eluting stent studies, and it is the different inclusion criteria among studies that are associated with patient vulnerability.
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Sugie et al. (2023) conducted a cohort in Coronary artery disease (n=437). Off-label indication for BP-EES implantation vs. On-label indication (case-control study criteria) was evaluated on Target Vessel Failure (TVF) (p=0.01). Off-label use of bioabsorbable polymer everolimus-eluting stents was associated with a higher rate of target vessel failure at 2 years compared to on-label use (10.9% vs 2.9%, p=0.01).
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