Early Clinical Experience with a Polymer-Free Biolimus A9 Drug-Coated Stent in DES-Type Patients Who Are Poor Candidates for Prolonged Dual Anti-Platelet Therapy

Abstract

IntroductionProlonged 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 MethodsThe 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).ResultsOperator-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.ConclusionsThis 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.

Baseline anemia in patients undergoing percutaneous coronary intervention after an acute coronary syndrome—A paradox of high bleeding risk, high ischemic risk, and complex coronary disease

“…In the LEADERS‐FREE trial (in which baseline anemia was a major inclusion criteria), use of a biolimus‐A9 coated stent without a polymer with only a 1‐month DAPT course demonstrated superior efficacy and safety over a BMS strategy . Subsequent clinical reports of the same technology along with several other trials of other emerging stent technologies are adding to the knowledge base of abbreviated DAPT in high‐risk groups . In future, abbreviated DAPT therapy in certain high‐risk groups combined with newer stent technologies might enable interventional cardiologists to undertake more effective revascularization in high risk groups such as the anemic, which may in turn improve outcomes.…”

Safety and efficacy of the polymer‐free and polymer‐coated drug‐eluting stents in patients undergoing percutaneous coronary intervention

“…Following the removal of articles that did not meet our selection criteria (857) and duplicate items (613), 129 articles were deemed relevant for full‐text review. We further excluded 101 articles due to insufficient data, and 27 studies (24 RCTs, 3 OCS) qualified for the final analysis 8,10–36 . The PRISMA flow diagram is shown in Figure 1.…”

Benefit and risk of prolonged dual antiplatelet therapy after drug-eluting stent implantation in patients with chronic kidney disease: A nationwide cohort study

“…Furthermore, many studies have suggested that CKD has an independent influence on the incidence and prognosis of ischemic cardiac events [1,[20][21][22]. CKD is also posited to increase bleeding risk in patients requiring antiplatelet therapy because CKD is associated concurrently with increased bleeding tendency with platelet dysfunction and abnormal coagulation cascades [23,24]. Although previous study reported that patients with CKD tended to discontinue DAPT earlier than those without CKD [25], presence of renal insufficiency did not impact on the duration of DAPT in our study cohort.…”