Key result
Planned 1-month dual antiplatelet therapy after polymer-free biolimus A9-eluting stent PCI yielded similar patient-oriented composite outcomes as longer DAPT (adj-HR 1.26; 95% CI 0.74-2.13; p=0.747).
Why the study?
Outcomes comparing 1-month versus longer DAPT strategies following PF-BES-PCI had not yet been evaluated.
Does a planned 1-month dual antiplatelet therapy strategy reduce composite adverse events compared to a >1-month strategy in patients undergoing PCI with a polymer-free biolimus A9-eluting stent?
Cohort (n=813)
Yes
Does a planned 1-month dual antiplatelet therapy strategy reduce composite adverse events compared to a >1-month strategy in patients undergoing PCI with a polymer-free biolimus A9-eluting stent?
Effect estimate: adj-HR 1.26 (95% CI 0.74-2.13)
Absolute Event Rate: 11.9% vs 13.2%
p-value: p=0.747
In a real-world registry, a 1-month DAPT strategy following PCI with a polymer-free biolimus A9-eluting stent showed similar 390-day clinical outcomes compared to a longer DAPT strategy.
One-month DAPT yielded comparable outcomes after polymer-free biolimus-eluting stent PCI; leaves open need for randomized confirmation before practice change.
BACKGROUND: A large trial established the favorable profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a 1-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. This is the first study comparing outcomes for a 1-month versus longer DAPT strategies following PF-BES-percutaneous coronary intervention (PCI). METHODS: All patients undergoing PF-BES-PCI (January 2016 to July 2018) were included in the multicenter CHANCE registry. Patients were stratified according to DAPT strategy at discharge (planned 1-month vs. planned >1-month). Primary outcomes were the 390-day estimates of a patient-oriented and of a device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularization; DOCE: cardiac death, target vessel-MI or ischemia-driven target lesion revascularization). Landmark analyses from 1-month post-PCI were carried. RESULTS: Following PF-BES-PCI, 328(40.3%) and 485(59.6%) patients were discharged with 1-month and longer DAPT (12 months [6-12]), respectively. Patients with a previous or index MI were less likely to be discharged on 1-month DAPT. Patients prescribed with 1-month DAPT were more likely to be at HBR than those with longer DAPT (90.2% vs. 69.9%, p = .001). No between-groups differences in the primary outcomes (planned 1-month vs. planned >1-month DAPT: POCE 11.9% vs. 13.2%, p = .747; DOCE: 4.8% vs. 8.1%, p = .500) were observed, also after adjusting for confoundings (POCE: adjusted-hazard ratio [adj-HR] 1.26, 95%CI 0.74-2.13; DOCE: adj-HR 1.00, 95%CI 0.49-1.99). Landmark analyses showed similar results. CONCLUSIONS: In a large all-comers registry of PF-BES PCI, no interaction of planned DAPT strategy (1-month vs. >1-month) with outcomes was found. This observation warrants investigation in adequately powered randomized studies (ClinicalTrials.gov NCT03622203).
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Gallone et al. (2020) conducted a cohort in Patients undergoing percutaneous coronary intervention with a polymer-free biolimus A9-eluting stent (n=813). 1-month dual antiplatelet therapy (DAPT) vs. Longer DAPT (>1-month) was evaluated on Patient-oriented composite endpoint (POCE: death, myocardial infarction, or target vessel revascularization) (adj-HR 1.26, 95% CI 0.74-2.13, p=0.747). Planned 1-month dual antiplatelet therapy after polymer-free biolimus A9-eluting stent PCI yielded similar patient-oriented composite outcomes as longer DAPT (adj-HR 1.26; 95% CI 0.74-2.13; p=0.747).
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