Key result
The polymer-free biolimus A9 drug-coated stent with shortened dual anti-platelet therapy resulted in similar rates of major adverse cardiac events compared to standard drug-eluting stents in patients at high bleeding risk.
Why the study?
Does a polymer-free biolimus A9 drug-coated stent with shortened DAPT prevent stent-related events compared to standard drug-eluting stents with prolonged DAPT in patients at high risk of bleeding?
Cohort (n=1,879)
Yes
Does a polymer-free biolimus A9 drug-coated stent with shortened DAPT prevent stent-related events compared to standard drug-eluting stents with prolonged DAPT in patients at high risk of bleeding?
Effect estimate: HR 0.84 (95% CI 0.59-1.21)
Absolute Event Rate: 6.2% vs 7.3%
p-value: p=0.353
In patients at high bleeding risk, polymer-free biolimus A9 drug-coated stents with abbreviated DAPT demonstrated similar rates of stent thrombosis and restenosis compared to standard DES with prolonged DAPT.
May support abbreviated DAPT with polymer-free stents in high-bleeding-risk patients; hypothesis-generating pending randomized confirmation.
INTRODUCTION: Prolonged dual anti-platelet therapy (DAPT) may cause excess bleeding in certain patients. The biolimus-A9 drug-coated stent (BA9-DCS) has a rapid drug-elution profile allowing shortened DAPT. Data were gathered on the early experience implanting this stent in drug-eluting stent eligible patients deemed to be at high risk of bleeding. BACKGROUND AND METHODS: The demographics, procedural data and clinical outcomes were gathered prospectively for 249 patients treated with a BA9-DCS stent at 2 UK centres, and compared to a cohort of patients treated in the same period with drug-eluting stents (PCI-DES). RESULTS: Operator-defined BA9-DCS indications included warfarin therapy, age, and anaemia. Patients receiving a BA9-DCS were older (71.6±11.8 vs. 64.8±11.6yrs, p<0.001), more often female (38.2 vs. 26.8%, P<0.001), and more likely to have comorbidity including chronic kidney disease or poor LV function than PCI-DES patients. The baseline Mehran bleed risk score was also significantly higher in the BA9-DCS group (19.4±8.7 vs. 13.1±5.8, p<0.001). Of the BA9-DCS cohort, 95.5% of patients demonstrated disease fitting NICE criteria for DES placement. The number of lesions treated (1.81±1.1 vs. 1.58±0.92, p = 0.003), total lesion length (32.1±21.7 vs. 26.1±17.6mm, p<0.001), number of stents used (1.93±1.11 vs. 1.65±1.4, p = 0.007) and total stent length (37.5±20.8 vs. 32.4±20.3, p<0.01) were greater for BA9-DCS patients. DAPT was prescribed for 3.3±3.9 months for BA9-DCS patients and 11.3±2.4 months for PCI-DES patients (p<0.001). At follow up of 392±124 days despite the abbreviated DAPT course stent related event were infrequent with ischemia-driven restenosis PCI (2.8 vs. 3.4%, p = 0.838), and stent thrombosis (1.6 vs. 2.1%, p = 0.265) rates similar between the BA9-DCS ad PCI-DES groups. After propensity scoring all clinical end-points were similar between both cohorts. CONCLUSIONS: This early experience using polymer-free BA9 drug-coated stents in drug-eluting stent type patients at risk of bleeding are encouraging. Further studies are warranted.
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Kinnaird et al. (2016) conducted a cohort in Coronary artery disease requiring percutaneous coronary intervention (n=1,879). Polymer-free Biolimus A9 drug-coated stent (BA9-DCS) vs. Drug-eluting stents (PCI-DES) was evaluated on All MACE (death, stent thrombosis, and ischemia-driven target lesion revascularization) (HR 0.84, 95% CI 0.59-1.21, p=0.353). The polymer-free biolimus A9 drug-coated stent with shortened dual anti-platelet therapy resulted in similar rates of major adverse cardiac events compared to standard drug-eluting stents in patients at high bleeding risk.
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