Key result
Absorb bioresorbable scaffold linked to ~334% higher risk of definite stent thrombosis vs modern DES.
Why the study?
Randomised trials indicated higher rates of stent thrombosis and target lesion failure after PCI with the Absorb bioresorbable scaffold compared with modern drug-eluting stents, but real-world outcome data were needed.
Does the Absorb bioresorbable scaffold increase the risk of definite stent thrombosis compared to modern drug-eluting stents in patients undergoing PCI?
Observational (n=68,719)
Yes
Does the Absorb bioresorbable scaffold increase the risk of definite stent thrombosis compared to modern drug-eluting stents in patients undergoing PCI?
Hazard Ratio: 4.34 (95% CI 2.37–7.94)
Absolute Event Rate: 1.5% vs 0.6%
p-value: p=<0.001
In a real-world Swedish registry, the Absorb bioresorbable scaffold was associated with a more than 4-fold increased adjusted risk of definite stent thrombosis compared to modern drug-eluting stents.
Supports avoiding Absorb BRS outside trials; confirms higher thrombosis risk in observational data but leaves open newer scaffold performance.
AIMS: Randomised trials indicate higher rates of stent thrombosis (ST) and target lesion failure (TLF) after percutaneous coronary intervention (PCI) with the Absorb bioresorbable scaffold (BRS) compared with modern drug-eluting stents (DES). We aimed to investigate the outcome of all Swedish patients treated with the Absorb BRS. METHODS AND RESULTS: The Absorb BRS (n=810) was compared with commonly used modern DES (n=67,909). The main outcome measure was definite ST; mean follow-up was two years. Despite being implanted in a younger, lower-risk population compared with modern DES, the Absorb BRS was associated with a higher crude incidence of definite ST at stent level: 1.5 vs. 0.6%, hazard ratio (HR) 2.38 (95% confidence interval [CI]: 1.34-4.23), adjusted HR 4.34 (95% CI: 2.37-7.94); p<0.001. The patient level adjusted HR was 4.44 (95% CI: 2.25-8.77). Rates of in-stent restenosis were similar for BRS and DES. Non-compliance with dual antiplatelet therapy (DAPT) guidelines was noted in six out of 12 BRS ST events. Three very late ST events occurred with the Absorb BRS. CONCLUSIONS: In this real-world observational study, the Absorb BRS was associated with a significantly higher risk of definite ST compared with modern DES. Non-compliance with DAPT guideline recommendations was common among Absorb definite ST events.
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Grimfjärd et al. (2017) conducted an observational in Coronary artery disease requiring percutaneous coronary intervention (n=68,719). Absorb bioresorbable scaffold (BRS) vs. Modern drug-eluting stents (DES) was evaluated on Definite stent thrombosis (ST) at stent level (adjusted HR 4.34, 95% CI 2.37-7.94, p=<0.001). The Absorb bioresorbable scaffold was associated with a significantly higher risk of definite stent thrombosis compared with modern drug-eluting stents (adjusted HR 4.34).
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