Ultrathin Drug-eluting Stent Research Articles

Short versus conventional DAPT in patients undergoing PCI with ultra-thin DES by renal function: an analysis from the HOST-IDEA trial

Abstract Background Patients with impaired renal function are known to have an elevated risk of both ischemic and bleeding events following percutaneous coronary intervention (PCI). However, there is insufficient data available on the optimal duration of dual antiplatelet therapy (DAPT), especially with the latest generation of drug-eluting stent (DES)s. Objective We investigated to assess the efficacy and safety of abbreviated duration of DAPT in patients undergoing PCI with 3rd generation DESs based on their renal function. Methods In this prespecified subgroup analysis of the HOST-IDEA trial, a total of randomized 1997 patients with available baseline estimated glomerular filtration rate (eGFR) were categorized into three groups: high eGFR (>90 mL/min), intermediate eGFR (60 to 90 mL/min), and low eGFR (<60 mL/min). The primary outcome assessed during the 1-year follow-up period was net adverse clinical events (NACE). Ischemic and bleeding endpoints were also evaluated. Results Compared to intermediate or high eGFR groups, the low eGFR group resulted in significantly worse outcomes (P < 0.001). 3-6 month DAPT was associated with similar risk of NACE across all eGFR groups (High eGFR: HR: 0.91; 95% CI: 0.38-2.20; Intermediate eGFR: HR: 0.76; CI: 0.33-1.73; Low eGFR: HR: 0.99; CI: 0.51-1.92). There was also no significant difference in target lesion failure (HR: 0.95; CI: 0.32-2.83, HR: 0.77; CI: 0.29-2.06, and HR: 1.14; CI: 0.47-2.75) and major bleeding (HR: 0.84; CI: 0.19-3.74, HR: 0.59 CI: 0.14-2.48; and HR 0.83 CI: 0.34-2.05) among all stratified eGFR groups. This effect was also consistent in patients of end stage of renal disease (eGFR <15 mL/min). Conclusions In patients undergoing PCI with third generation DESs, short DAPT was comparable to conventional DAPT regardless of their baseline renal function.

Comparison Among Ultra-Thin Coronary Stents: A Network Meta-Analysis

Ultrathin-strut drug-eluting stents (DES) have been related to potential improvement in stent-related outcomes compared with thicker-struts DES. However, comparisons among different ultrathin devices are lacking. All randomized controlled trials comparing ultrathin (struts thickness <70 µm) and thicker-struts DESs in an all-comers population were included. Target lesion failure (TLF), as defined by included trials, at 1-year follow-up was the primary end point. Overall mortality, myocardial infarction, target lesion revascularization (TLR), and stent thrombosis were the secondary end points. Arms of included trials were compared using network meta-analysis. Nine studies encompassing 20,081 patients were included, of which 9,509 patients had an ultrathin DES: Orsiro (evaluated in 7 arms with 8,086 patients), MiStent (1 arm with 703 patients), or Supraflex (1 arm with 720 patients). At 1-year follow-up, no significant differences were noted for TLF among these ultrathin DES. In particular, Orsiro was associated with a similar risk of TLF compared with Supraflex (risk rate 1.07, 95% confidence interval 0.59 to 1.78) and showed the highest probability of performing best in terms of TLF, myocardial infarction, and TLR. Ultrathin DES are all associated with a comparable risk of TLF compared with thicker-strut DES. In terms of TLR and TLF risk, Orsiro was the one with the highest probability of best performances, either compared with other ultrathin DES or to devices with thicker struts.

Ultrathin Polymeric Platform for Drug-Eluting Stent: A proof of concept

Recent innovations in Drug-Eluting Stents (DES) technology have led to the development of new stents with further reduction in strut width, the ultrathin DES, with struts thinner than 70 µm. Ultrathin DES may further improve the efficacy and safety profile of Percutaneous Coronary Intervention (PCI) by reducing the risk of target-lesion and target-vessel failures compared to the current-generation DES. However, the ultrathin DES metallic platform still presents some associated problems, such as biofilm formation, infection, and migration, all related to the cellular response.The present work aims to produce an ultrathin permanent polymeric platform for a new generation of polymeric drug-eluting stents (PDES). In this work, the cellular response was compared with the traditional stainless steel (SS316L) and polycaprolactone (PCL) to determine whether these polymers could address this challenge. An innovative method of tubular 3D micro stereolithography tubular (ST3DT) was used. Different PDES platforms were fabricated with different polymeric materials (based on polyurethane and urethane dimethacrylate). Subsequently, HFL1 fibroblasts were seeded on the PDES, PCL and SS316L for 3 days. The findings from the assays of cell biocompatibility and proliferation (75%PCL), coupled with the successful fabrication of stent struts below 70 µm using the Surgical Guide resin and the ST3DT method, suggest that resin is a promising candidate for a PDES.

Comparison among ultra-thin coronary stents: a network metanalysis

Abstract Background Ultrathin-struts drug eluting stents (DESs) have been related to potential improvement in stent-related outcomes compared to thicker-struts DES. However, comparison among different ultrathin devices are lacking. Methods All Randomized Controlled Trials (RCTs) comparing ultrathin (strut thickness &amp;lt; 70 µm) vs thicker struts DES in an all-comers population were included. Target lesion failure (TLF), as defined by included trials, at one year follow up was the primary endpoint. Cardiovascular (CV) death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis (ST) were the secondary ones. Arms of included trials were compared by means of Network Meta Analysis (NMA). Results Nine studies encompassing 20081 patients were included: Orsiro DESs were evaluated in 7 arms with 8086 patients, MiStent in one arm (703 patients) and Supraflex in one arm with 720 patients. At one year follow up, no significant differences were noted for TLF. In particular, Orsiro was associated with similar risk of TLF compared with Supraflex (RR 1.7; CI 0.59 - 1.78) and with Xience (RR 0.98; CI 0.71 - 1.35), being the one with the highest probability of performing best. Orsiro stent was the one with the highest probability of performing best also for MI and TLR. Conclusions Ultrathin DES are all associated with a comparable risk of TLF as compared with second generation, thicker struts DES. As for the risk of repeat revascularization and of TLF, Orsiro was the one with the highest probability of performing best, either compared with other ultrathin DES or with thicker-struts devices.TLR: RRs among different devices

Long term outcomes of ultrathin versus standard thickness second-generation drug eluting stents: Meta-analysis of randomized trials.

Identify the effect of ultrathin drug eluting stents on long term outcomes in coronary artery disease. Although second-generation drug eluting stents (DES) are superior to first-generation DES, persistence of adverse outcomes has led to continued refinement in design. Ultrathin second-generation DES have been shown to improve outcomes at 1-year follow-up. Beyond 1-year their effect remains unknown. PubMed, Embase and Cochrane Database were searched for randomized controlled trials that compared ultrathin (defined as <70 um) to standard thickness second-generation DES. Studies were chosen according to the PROSPERO protocol (CRD42020185374). Data from randomized controlled trials were pooled using random-effects model (Mantel-Haenszel). The primary outcome was target lesion failure (TLF) at 2 years, a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. Secondary outcomes included TLF at 3 and 5 years, the components of TLF and definite or probable stent thrombosis. Differences in outcomes between groups were presented in Forest plots as risk ratios (RR) with corresponding 95% confidence intervals (CIs) for each trial. We identified 18 publications from 10 trials with14,649 patients. At 2-years there was a significant 12% reduction in TLF (RR, 0.88; 95% CI 0.78-0.99; p < 0.05) associated with the use of ultrathin DES. At 3-years, there was a significant 19% reduction in TLF with ultrathin DES (RR, 0.79; 95% CI 0.64-0.98; p < 0.05). In patients undergoing percutaneous coronary intervention, ultrathin DES improve long term clinical outcomes.