scholarly journals Efficacy and Safety of Dual-Drug-Eluting Stents for de Novo Coronary Lesions in South Korea—The Effect Trial

2020 ◽  
Vol 10 (1) ◽  
pp. 69
Author(s):  
Jung-Joon Cha ◽  
Gi Chang Kim ◽  
Seung Ho Hur ◽  
Jang Ho Bae ◽  
Jae Woong Choi ◽  
...  

Background: Drug-eluting stents (DESs) are commonly used in percutaneous coronary intervention (PCI) procedures; however, complications including in-stent restenosis and stent thrombosis are significant challenges. The dual-DES is a stent that elutes two drugs to target various stages of the restenosis reaction. This study investigated the safety and efficacy of dual-DES in clinical practice. Methods: This study included 375 patients who underwent PCI with Cilotax™ or DXR™ dual-DESs at one of 13 centers in South Korea. The primary endpoint was target lesion failure (TLF) within 1 year. The secondary endpoints were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and stent thrombosis. Results: The rates of TLF in dual-DESs (3.7%) were comparable to those reported in conventional DES. In addition, the DXR™ group had a significantly lower rate of TLF than the Cilotax™ group. In multivariate analysis, the DXR™ group had a lower risk of TLF (adjusted hazard ratio (HR) 0.30, 95% CI 0.09–0.92, p = 0.036) and MI (adjusted HR 0.16, 95% CI 0.03–0.82, p = 0.027) than the Cilotax™ group. Conclusion: Dual-DESs had similar clinical outcomes regarding efficacy and safety as conventional DES. Among the dual-DES, the DXR™ stent as a new generation dual-DES had more favorable clinical outcomes than the Cilotax™ stent.

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Naoki Mori ◽  
Masami Nishino ◽  
Naotaka Okamoto ◽  
Akihiro Tanaka ◽  
Takahiro Yoshimura ◽  
...  

Background: Although overlapping coronary stents in long lesions by percutaneous coronary intervention are common, some clinical studies revealed adverse clinical and angiographic outcomes of early generation overlapping drug-eluting stents (DES) due to increased drug and polymer toxicity, as compared to non-overlapping or single DES. However, recent clinical reports have shown safety and efficacy outcomes of overlapping newer generation DES, as compared with early generation overlapping DES and newer generation non-overlapping DES. Thus, the purpose of this study was to compare angiographic and 1-year clinical outcomes between long single stent and overlapping double stent in patients treated with newer generation DES for similar long lesions. Methods: We analyzed 8-10 months angiographic and 1-year clinical outcomes of 106 patients treated with everolimus-eluting stent (EES, newer generation DES) in a de novo similar long lesions (≥ 32mm, ≤38mm) by a long single stent or overlapping double stents. We divided our patients into single long stent group and overlapping double stent group. We compared the incidence of in-stent restenosis (ISR), which was defined as more than 50% angiographical stenosis, and analyzed freedom from major adverse cardiovascular events (MACE: defined as the composite of death, myocardial infarction, or target vessel revascularization) and freedom from target lesion revascularization (TLR) at 1 year using Kaplan-Meier method. Results: The incidence of ISR at 8-10 months after stent implantation was similar between long single stent group (n=41) and overlapping double stent group (n= 65). The rate of freedom from MACE and TLR during 1-year were also similar between two groups (figures). Conclusions: According to our study, newer generation DES, EES, provided similar angiographic and 1-year clinical outcomes irrespective of overlap status in long lesions.


2020 ◽  
Vol 10 (6) ◽  
pp. 382-391
Author(s):  
Yusuke Watanabe ◽  
Satoru Mitomo ◽  
Toru Naganuma ◽  
Kensuke Takagi ◽  
Satoshi Matsuoka ◽  
...  

<b><i>Background:</i></b> The impact of diabetes mellitus (DM) on clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main (ULM) distal bifurcation lesions in patients with chronic kidney disease (CKD) is poorly understood in the era of drug-eluting stents (DESs). <b><i>Objective:</i></b> We assessed the impact of DM on clinical outcomes after PCI for ULM distal bifurcation lesions in CKD patients compared to patients without DM. <b><i>Methods:</i></b> We identified 1,832 consecutive patients who underwent PCI for ULM lesions at New Tokyo Hospital, Matsudo, Japan, San Raffaele Scientific Institute, Milan, Italy, and EMO-GVM, Centro Cuore Columbus, Milan, Italy between January 2005 and August 2015. Of the 1,832 patients, 1,391 were treated with DESs. We excluded 750 patients without CKD and 89 hemodialysis patients. Finally, 552 patients with CKD were included: 219 with DM (DM group) and 333 without DM (no DM group). The primary endpoint was target lesion failure (TLF) at 5 years. TLF was defined as a composite of cardiac death, target lesion revascularization (TLR), and myocardial infarction. <b><i>Results:</i></b> Patients in the DM group were more likely to have hypertension, dyslipidemia, peripheral artery disease, and lower ejection fraction and were more frequently using insulin for DM. The TLF rate during the follow-up period was significantly higher in the DM than in the no DM group (adjusted hazard ratio [HR] 1.50; 95% confidence interval [CI] 1.06–2.13; <i>p</i> = 0.023). Cardiac mortality was comparable between both groups (adjusted HR 1.11; 95% CI 0.63–1.95; <i>p</i> = 0.71). The TLR rate was significantly higher in the DM group than in the no DM group (adjusted HR 1.69; 95% CI 1.12–2.54; <i>p</i> = 0.012). <b><i>Conclusion:</i></b> DM is strongly associated with adverse event after PCI for ULM distal bifurcation lesions in CKD patients compared to those without DM.


Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Probal Roy ◽  
Ashesh N Buch ◽  
Aamir Javaid ◽  
Teruo Okabe ◽  
Vikram Raya ◽  
...  

Background: The utilization of drug-eluting stents (DES) in “real world” practice has deviated substantially from Food and Drug Administration (FDA) approved indications. The outcomes of patients undergoing intracoronary DES implantation (versus BMS) for non-FDA approved indications has not been determined. Methods : The clinical outcomes of 546 patients undergoing DES implantation for ≥1 non-FDA approved (“Off label”) indication after device approval were assessed. This group was then compared to 546 propensity-matched patients receiving BMS prior to DES approval for the same indications. The primary endpoint was major adverse cardiac events [MACE; death-all cause, non-fatal Q-wave MI and target vessel revascularization (TVR)] at 12 months. Results: Baseline clinical and procedural characteristics were well matched. Patients in the BMS group were more likely to be treated with larger diameter and shorter stents. Though both in-hospital and 30-day all-cause mortality was greater in the DES group, there was no significant difference in cardiac death at both time points. At 30 days all other clinical outcomes were comparable. At 12 months MACE was significantly reduced in the DES group (27.8% vs. 21.4% p=0.014) driven by reductions in repeat revascularization [target lesion revascularization (TLR): 16.4% vs. 7.8% p<0.001, TVR: 20.2% vs.13.1% p<0.003]. There was no significant increase in death and non-fatal Q-wave MI with DES. Conclusions: The utilization of DES for non-FDA approved indications proved to be efficacious and safe when compared to a propensity-matched BMS cohort. These findings support broadening the current FDA indications for DES use.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Basavarajaiah ◽  
S Handi ◽  
L Foley ◽  
R Watkin ◽  
B Freestone ◽  
...  

Abstract Background The incidence of bailout stenting post-drug coated balloon use (DCB) in the literature has been more than 10%; ranging up-to 21% in Bello trial and this variation could be due to the different criteria used to consider bailout stenting and may also reflect aggressive pre-dilatation. Our eyes are trained to expect stent like result and anything less is considered sub-optimal and this could be one of the reasons for high incidence of bailout stenting. The current recommendation is to use drug eluting stent (DES) for bailout stenting and hence raising in the possibility of drug toxicity or maybe even synergistic effect from combination of Paclitaxel (DCB) and limus (DES). Aim We have evaluated the incidence and outcomes of patients needing bailout stenting in our centre. Methods and results We evaluated all patients who were treated with DCB between January 2016-August 2017. Bailout stenting per lesion were identified and studied for endpoints which included cardiac death, target vessel MI, stent thrombosis, target lesion revascularization and target vessel revascularisation. Between the study period; 468 lesions (in 364 patients) were treated with paclitaxel DCB (Sequent Please, B Braun, Germany). Bailout stenting was required in 23 lesions (4.9%) and of which 12 (52%) was for flow limiting dissections (type C or more) and the remaining 11 was for recoil of more than 50%. Majority of the lesions were de novo (18; 78%). All bailout stenting was performed with third generation limus eluting stents. During a median follow-up of 18.14 months; range; 7–33 months, there was no cardiac death and target vessel MI occurred in 1 patient (4.3%), TLR and TVR were in 3 lesions (13%). MACE rate (combination of cardiac death, target vessel MI and TVR) was 13%. There were no cases of stent thrombosis as per the ARC definition. Conclusion One of the highlighting features of our study is very low-rates of bailout stenting. This may be due to our criteria of not stenting mild dissections (unless they are flow limiting) and also to accepting recoil of up-to 50% post-DCB use. The outcome in bailout stenting group is acceptable especially with hard endpoints (cardiac death, target vessel MI and stent thrombosis) although TLR and TVR rates were higher indicating synergistic effect of paclitaxel and limus may not offer additional benefits.


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