Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk

Abstract

BACKGROUND: Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. METHODS: In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization. RESULTS: We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval [CI], -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the baremetal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001). CONCLUSIONS: Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180.).

Diagnosis and Management of Cardiovascular Disease in Advanced and End‐Stage Renal Disease

“…Nevertheless, it is important to note that a BMS may be preferred in patients in whom renal transplantation is planned within 6 to 12 months, such as those planned to receive living donor transplants, to limit the duration of dual antiplatelet therapy (DAPT). More novel stents that are polymer‐ and carrier‐free but are drug‐coated have been shown to be superior to BMSs with respect to requiring target vessel revascularization on only 1 month of DAPT 61. This type of stent confers the benefit of a DES with an improved safety profile over a BMS, with the additional advantage of a short course of DAPT, which may be ideal for patients with ESRD 61.…”

“…More novel stents that are polymer‐ and carrier‐free but are drug‐coated have been shown to be superior to BMSs with respect to requiring target vessel revascularization on only 1 month of DAPT 61. This type of stent confers the benefit of a DES with an improved safety profile over a BMS, with the additional advantage of a short course of DAPT, which may be ideal for patients with ESRD 61. Aggressive medical therapy is also an option, given the high restenosis rates in patients with CKD and ESRD 62, 63, 64.…”

“…Important factors to consider in perioperative DAPT management are the type, number, and size of stents versus the risk of delaying renal transplantation in favor of prolonging DAPT to prevent stent thrombosis. A newer generation of DESs with enhanced biocompatibility and reduced thrombogenicity may require only 1 to 6 months of DAPT depending on the type of stent, but more evidence is needed 61, 66, 67. These considerations highlight the fact that DAPT should be tailored to the individual patient.…”

“…The choice to place a BMS or a DES should be individualized to each patient. BMSs or polymer‐ and carrier‐free DESs may be used in patients who require more urgent renal transplantation and a shorter course of DAPT 61. Stent placement with intravascular imaging guidance is recommended to optimize the intervention as imaging guidance has been shown to result in a larger final minimal stent area, minimizing the risk of restenosis and stent thrombosis 69…”

Percutaneous coronary intervention in the elderly: current updates and trends

“…Recent data still suggesting under-utilization of DES in elderly patients undergoing PCI with stenting [70] . The characteristics and clinical outcomes of 1564 high bleeding risk old patients aged 75 years or older who participated in the LEADERS FREE trial and underwent PCI with the deployment of either polymer-free DES or similar BMS and only 1 month of DAPT were analyzed [73,74] . They showed a high yet similar bleeding rate in the 2 groups.…”