scholarly journals TCT-567 Long term Safety and Efficacy of Biodegradable Polymer-Coated Sirolimus-Eluting Stents in “Real-World” Practice: 5 year follow-up of the CREATE (multi-Center Registry of EXCEL Biodegradable Polymer Drug Eluting Stents) Study

2012 ◽  
Vol 60 (17) ◽  
pp. B164-B165
Author(s):  
Ya-Ling Han ◽  
Quan-Yu Zhang
Keyword(s):  
Real World ◽  
Biodegradable Polymer ◽  
Drug Eluting Stents ◽  
Safety And Efficacy ◽  
Drug Eluting

Abstract 2538: Long-Term (up to 6 years) Clinical Outcomes of Patients with Impact of Chronic Kidney Disease in the Treated with Drug-eluting Stents. Insights from the Drug Eluting Stents In the REal World(DESIRE) Registry

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Adriana Moreira ◽  
Amanda Sousa ◽  
José Costa ◽  
Ricardo Costa ◽  
Manuel Cano ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Clinical Outcomes ◽  
Real World ◽  
Negative Impact ◽  
Chronic Renal Disease ◽  
Drug Eluting Stents ◽  
Group I ◽  
Drug Eluting

Background: Chronic renal disease has been consistently shown to be an independent predictor of poorer long-term clinical outcomes after percutaneous treatment of coronary artery disease, even in DES era. We sought to evaluate the very long-term clinical outcome after DES implantation in this high risk subset in a real world cenario. Methods and Results: Between May/2002 and Jan/2007, 2,043 pts treated exclusively with DES were consecutively enrolled in the non-randomized, single-center DESIRE Registry. Recent myocardial infarction (72h), saphenous venous graft and patients with < 6months follow-up were excluded. The remaining pts (n=1500) were divided into 2 groups according to their creatinine clearence: Group I -Clearance ≤ 60 (n= 490) and Group II- clearance >60 (n= 1010). Primary endpoint included combined MACE and stent thrombosis (ST) rate. ST was classified according to ARC definitions. Clinical follow-up was obtained at 1, 3 and 6 months and then annually up to 6 years. Follow-up was achieved in 98% of the eligible cohort (median 3.6 years). Baseline characteristics and late outcomes are displayed in the table . Conclusions: In the DESIRE registry the negative impact of renal dysfunction was considerably minimized by the use of DES, resulting in very low and equivalent rates of myocardial infarction, TLR and ST when compared to patients with preserved renal condition. We especulate that the higher mortality among these very complex pts may reflect the severity of their comorbities.

scholarly journals Real World Experience of a Biodegradable Polymer Sirolimus-Eluting Stent (Yukon Choice PC Elite) in Patients with Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Angioplasty: A Multicentric Observational Study (The Elite India Study)

2019 ◽  
Vol 7 (7) ◽  
pp. 1103-1109
Author(s):  
Bhupendra Verma ◽  
Akhilesh Patel ◽  
Deepak Katyal ◽  
Vivek Raj Singh ◽  
Avinash Kumar Singh ◽  
...  
Keyword(s):  
Observational Study ◽  
Biodegradable Polymer ◽  
Composite Endpoint ◽  
Primary Angioplasty ◽  
Drug Eluting Stents ◽  
Safety And Efficacy ◽  
Drug Eluting ◽  
Sirolimus Eluting Stent ◽  
One Year

BACKGROUND: The durable polymer drug-eluting stents (DPDES) reduce the risk of repeated target vessel revascularisation (TLR) compared with BMS, but are associated with increased risk of late adverse events. In broadly inclusive populations, the biodegradable-polymer drug-eluting stents (BPDES) have favourable results compared with DPDES in the long term. However, its use in primary angioplasty has not been adequately studied, and data of real-world clinical experience is lacking. AIM: Aim of this study was to assess the safety and efficacy of Yukon Choice PC Elite sirolimus-eluting stent (a novel BPDES) in STEMI patients undergoing primary angioplasty. METHODS: We have presented here one-year clinical follow-up data of the Yukon Choice PC Elite sirolimus-eluting stent in patients undergoing primary angioplasty. A total of 636 patients were enrolled in this single arm, prospective observational study from five centres. RESULTS: This multicentric observational study showed excellent safety and efficacy profile of the novel device at one year follow up. The device-oriented composite endpoint (DOCE) of cardiac death, target-vessel reinfarction, and target-lesion revascularisation (TLR) was 2.7%, and the patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, and any revascularisation was 4.2% at one year. Definite or probable stent thrombosis rate was 0.6%, and no events were recorded beyond 6 months of follow up. CONCLUSIONS: In patients with STEMI undergoing primary angioplasty, the use of Yukon Choice PC Elite (biodegradable polymer sirolimus-eluting stent) has excellent results at one year. It, therefore, represents an attractive alternative to second generation DES in this high-risk population.

scholarly journals Safety and Efficacy of Second-Generation Drug-Eluting Stents in Real-World Practice: Insights from the Multicenter Grand-DES Registry

2020 ◽  
Vol 2020 ◽  
pp. 1-9 ◽  
Author(s):  
You-Jeong Ki ◽  
Kyung Woo Park ◽  
Jeehoon Kang ◽  
Chee-Hoon Kim ◽  
Jung-Kyu Han ◽  
...  
Keyword(s):  
Propensity Score ◽  
Stent Thrombosis ◽  
Real World ◽  
Coronary Intervention ◽  
Drug Eluting Stents ◽  
Drug Eluting Stent ◽  
Safety And Efficacy ◽  
Drug Eluting ◽  
Composite Outcomes

Objective. In this study, we sought to compare the efficacy and safety of the Xience Prime/Xience V/Promus EES and Biomatrix/Biomatrix Flex/Nobori BES with resolute integrity/resolute ZES using the grand drug-eluting stent (Grand-DES) registry. Background. Currently, new-generation drug-eluting stents (DESs) are used as the standard of care in patients undergoing percutaneous coronary intervention. No study has simultaneously compared everolimus-eluting stent (EES), biolimus-eluting stent (BES), and zotarolimus-eluting stent (ZES). Methods. Stent-related composite outcomes (target lesion failure) and patient-related composite outcomes were compared in crude and propensity score-matched analysis. Results. Of the 17,286 patients in the Grand-DES group, 5,137, 2,970, and 4,990 patients in the EES, BES, and ZES groups completed a three-year follow-up. In the propensity score-matched cohort, the stent-related outcome (EES vs. BES vs. ZES; 5.9% vs. 6.7% vs. 7.1%, P=0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P=0.232) were similar among the three groups, at 3 years. The rate of definite or probable stent thrombosis (0.6% vs. 0.8% vs. 0.5%, P=0.549) was similar. In the multivariate analysis, chronic kidney disease was the strongest predictor of stent thrombosis (adjusted hazard ratio 3.178; 95% confidence interval 1.621–6.229; P<0.001). Conclusions. In this robust real-world registry with unrestricted use of EES, BES, and ZES, the three stent groups showed comparable safety and efficacy at the 3-year follow-up.

Long-Term Follow-Up of Drug-Eluting Stents When Inserted for On- and Off-Label Indications

2007 ◽  
Vol 100 (11) ◽  
pp. 1619-1624 ◽  
Author(s):  
Asif Qasim ◽  
John Cosgrave ◽  
Azeem Latib ◽  
Antonio Colombo
Keyword(s):  
Drug Eluting Stents ◽  
Off Label ◽  
Long Term Follow Up ◽  
Drug Eluting

P3385Difference of vascular healing after percutaneous coronary intervention between 4 kinds of new generation drug-eluting stents: an optical coherence tomography analysis

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
Y Matsuhiro ◽  
M Nishino ◽  
H Nakamura ◽  
K Yasumoto ◽  
A Tanaka ◽  
...  
Keyword(s):  
Optical Coherence Tomography ◽  
Biodegradable Polymer ◽  
Neointimal Hyperplasia ◽  
Drug Eluting Stents ◽  
P Value ◽  
Optical Coherence ◽  
Durable Polymer ◽  
Drug Eluting ◽  
New Generation

Abstract Background New generation drug eluting stents (DES) have improved target vessel failure as compared with early generation DES and bare metal stent. Contemporary several new generation DES are different each other regarding strut thickness and drug and polymer type. A little is known about which stent induces a more favorable vascular healing at follow up. Purpose In this study, we compared the vascular healing at 8-month follow up by optical coherence tomography (OCT) between 4 different kinds of new generation DES. Methods We enrolled 112 consecutive patients (121 lesions) who underwent PCI using 4 kinds of new generation DES including biodegradable-polymer everolimus-eluting stents (BP-EES), biodegradable-polymer sirolimus-eluting stents (BP-SES), durable-polymer everolimus-eluting stents (DP-EES) and durable-polymer zotarolimus-eluting stents (DP-ZES) and who underwent 8-month follow up angiogram and OCT between July 2016 and April 2018. We compared the OCT parameters including percentage of covered struts, uncovered struts, well-apposed and uncovered struts, malapposed strut and mean neointimal hyperplasia (NIH) thickness between them. Results BP-EES consisted of 29 lesions, BP-SES consisted of 25 lesions, DP-EES consisted of 38 lesions and DP-ZES consisted of 29 lesions. A total of 734 frames with 5163 struts in BP-EES, 481 frames with 4214 struts in BP-SES, 783 frames with 6119 struts in DP-EES and 583 frames with 4708 struts in DP-ZES were analyzed. As shown in a table, mean NIH thickness was significantly higher in BP-EES and BP-SES. Thus, we compared the OCT parameters between durable-polymer (DP) group including DP-ZES and DP-EES and biodegradable-polymer (BP) group including BP-EES and BP-SES. The percentage of uncovered struts was significantly lower and mean NIH thickness was significantly higher in BP group than DP group. Results of OCT parameters BP-EES (n=29) BP-SES (n=25) DP-EES (n=38) DP-ZES (n=29) P value BP group (n=54) DP group (n=67) P value Covered struts (%) 89.5±13.6 92.4±8.6 85.5±17.5 85.0±17.7 0.29 90.9±11.6 85.3±17.4 0.08 Uncovered struts (%) 8.8±10.8 7.1±8.7 14.5±17.5 15.0±17.7 0.14 8.0±9.9 14.7±17.4 0.03 Well-apposed and uncovered struts (%) 7.9±9.9 5.9±7.7 11.7±13.1 12.3±14.0 0.15 7.0±8.9 11.9±13.4 0.04 Malapposed struts (%) 0.8±1.6 1.3±2.2 2.7±5.8 2.7±4.7 0.33 1.0±1.9 2.7±5.3 0.07 Mean NIH thickness (μm) 102±57 121±48 78±28 88±33 <0.01 111±53 82±31 <0.01 Conclusion The present OCT study demonstrated that delayed neointimal healing characterized by the presence of uncovered struts and lower mean NIH thickness was less common in BP group than DP gruop. Biodegradable-polymer may be more favorable than durable-polymer from the point of view of vascular healing.

scholarly journals Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry

2019 ◽  
Vol 40 (42) ◽  
pp. 3474-3482 ◽  
Author(s):  
Felix Mahfoud ◽  
Michael Böhm ◽  
Roland Schmieder ◽  
Krzysztof Narkiewicz ◽  
Sebastian Ewen ◽  
...  
Keyword(s):  
Renal Function ◽  
Real World ◽  
Active Sites ◽  
Renal Denervation ◽  
Uncontrolled Hypertension ◽  
Open Label ◽  
Hypertensive Patients ◽  
Safety And Efficacy

Abstract Aims Several studies and registries have demonstrated sustained reductions in blood pressure (BP) after renal denervation (RDN). The long-term safety and efficacy after RDN in real-world patients with uncontrolled hypertension, however, remains unknown. The objective of this study was to assess the long-term safety and efficacy of RDN, including its effects on renal function. Methods and results The Global SYMPLICITY Registry is a prospective, open-label registry conducted at 196 active sites worldwide in hypertensive patients receiving RDN treatment. Among 2237 patients enrolled and treated with the SYMPLICITY Flex catheter, 1742 were eligible for follow-up at 3 years. Baseline office and 24-h ambulatory systolic BP (SBP) were 166 ± 25 and 154 ± 18 mmHg, respectively. SBP reduction after RDN was sustained over 3 years, including decreases in both office (−16.5 ± 28.6 mmHg, P < 0.001) and 24-h ambulatory SBP (−8.0 ± 20.0 mmHg; P < 0.001). Twenty-one percent of patients had a baseline estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Between baseline and 3 years, renal function declined by 7.1 mL/min/1.73 m2 in patients without chronic kidney disease (CKD; eGFR ≥60 mL/min/1.73 m2; baseline eGFR 87 ± 17 mL/min/1.73 m2) and by 3.7 mL/min/1.73 m2 in patients with CKD (eGFR <60 mL/min/1.73 m2; baseline eGFR 47 ± 11 mL/min/1.73 m2). No long-term safety concerns were observed following the RDN procedure. Conclusion Long-term data from the Global SYMPLICITY Registry representing the largest available cohort of hypertensive patients receiving RDN in a real-world clinical setting demonstrate both the safety and efficacy of the procedure with significant and sustained office and ambulatory BP reductions out to 3 years.

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