scholarly journals One-year clinical outcomes of patients implanted with a Resolute Onyx™ zotarolimus-eluting stent

2017 ◽  
Vol 46 (1) ◽  
pp. 457-463 ◽  
Author(s):  
Chor Cheung Tam ◽  
Kelvin Chan ◽  
Simon Lam ◽  
Arthur Yung ◽  
Yui Ming Lam ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Small Vessel Disease ◽  
Clinical Performance ◽  
Cardiovascular Death ◽  
Target Lesion ◽  
World Population ◽  
Vessel Disease ◽  
One Year ◽  
Target Lesion Failure

Objective To evaluate the 1-year clinical outcomes of patients who received the Resolute Onyx™ stent. Methods This was a single-centre, retrospective registry analysis that reviewed the clinical data from all patients who were implanted with a Resolute Onyx™ stent between March 2015 and February 2016. Clinical follow-up was performed at 1 year post-implantation. Results A total of 252 patients received a Resolute Onyx™ stent and two patients were lost to follow-up. The mean age of the cohort was 66.9 years and 113 (45.2%) had diabetes mellitus. Thirty-eight patients (15.2%) had left main disease and 73 (29.2%) had three-vessel disease. A total of 175 patients (70.0%) had small vessel disease (<2.75 mm) and 210 (84.0%) had long lesions (>20 mm). The 1-year target lesion failure was 4.4% (11 of 250), cardiovascular death occurred in eight patients (3.2%), ischaemia-driven target lesion revascularization was undertaken in five patients (2.0%) and stent thrombosis occurred in one patient (0.4%). Conclusion The Resolute Onyx™ stent showed a favourable 1-year clinical performance in a real-world population.

scholarly journals Drug-Coated Balloon-Only Angioplasty Outcomes in Diabetic and Nondiabetic Patients with De Novo Small Coronary Vessels Disease

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Botey Katamu Benjamin ◽  
Wenjie Lu ◽  
Zhanying Han ◽  
Liang Pan ◽  
Xi Wang ◽  
...  
Keyword(s):  
De Novo ◽  
Small Vessel Disease ◽  
Independent Predictor ◽  
Coronary Vessels ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Vessel Disease ◽  
One Year ◽  
Target Lesion Failure ◽  
Drug Coated Balloon

Background. The revascularization of small vessels using drug-eluting stents remains challenging. The use of the drug-coated balloon is an attractive therapeutic strategy in de novo lesions in small coronary vessels, particularly in the diabetic group. This study aimed to assess the outcomes of DCB-only angioplasty in small vessel disease. Methods. A total of 1198 patients with small vessel disease treated with DCB-only strategy were followed. Patients were divided into the diabetic and nondiabetic groups. Clinical and angiographical follow-up were organized at 12 months. The primary endpoints were target lesion failure and secondary major adverse cardiac events. Results. There was a significantly higher rate of target lesion failure among diabetic patients compared to nondiabetic [17 (3.9%) vs. 11 (1.4%), P = 0.006 ], taken separately, the rate of target lesion revascularization significantly differed between groups with a higher rate observed in the diabetic group [9 (2%) vs. 4 (0.5%), P = 0.014 ]. Diabetes mellitus remained an independent predictor for TLF (HR: 2.712, CI: 1.254–5.864, P = 0.011 ) and target lesion revascularization (HR: 3.698, CI: 1.112–12.298, P = 0.033 ) after adjustment. However, no significant differences were observed between groups regarding the target vessel myocardial infarction (0.6% vs. 0.1%, P = 0.110 ) and MACE [19 (4.4%) vs. 21 (2.7%), P = 0.120 ]. Conclusion. Drug-coated balloon-only treatment achieved lower incidence rates of TLF and MACE. Diabetes is an independent predictor for target lesion failure and target lesion revascularization at one year following DCB treatment in small coronary vessels. We observed no significant differences between groups regarding MACE in one year.

scholarly journals One-year clinical outcomes in patients with renal insufficiency after contemporary PCI: data from a multicenter registry

2019 ◽  
Vol 109 (7) ◽  
pp. 845-856 ◽  
Author(s):  
Sean S. Scholz ◽  
Lucas Lauder ◽  
Sebastian Ewen ◽  
Saarraaken Kulenthiran ◽  
Nikolaus Marx ◽  
...  
Keyword(s):  
Small Vessel Disease ◽  
Reference Population ◽  
Target Lesion ◽  
Bleeding Complications ◽  
Major Adverse Cardiovascular Events ◽  
Artery Disease ◽  
One Year ◽  
Target Lesion Failure ◽  
New Generation

Abstract Background Chronic kidney disease (CKD) is highly prevalent in patients with coronary artery disease (CAD). Objective The outcome following revascularization using contemporary technologies (new-generation abluminal sirolimus-eluting stents with thin struts) in patients with CKD (i.e., glomerular filtration rate of < 60 mL/min/1.73m2) and in patients with hemodialysis (HD) is unknown. Methods e-Ultimaster is a prospective, single-arm, multi-center registry with clinical follow-up at 3 months and 1 year. Results A total of 19,475 patients were enrolled, including 1466 patients with CKD, with 167 undergoing HD. Patients with CKD had a higher prevalence of overall comorbidities, multiple/small vessel disease (≤ 2.75 mm), bifurcation lesions, and more often left main artery treatments (all p < 0.0001) when compared with patients with normal renal function (reference). CKD patients had a higher risk of target lesion failure (unadjusted OR, 2.51 [95% CI 2.04–3.08]), target vessel failure (OR, 2.44 [95% CI 2.01–2.96]), patient-oriented composite end point (OR, 2.19 [95% CI 1.87–2.56]), and major adverse cardiovascular events (OR, 2.34 [95% CI 1.93–2.83, p for all < 0.0001]) as reference. The rates of target lesion revascularization (OR, 1.17 [95% CI 0.79–1.73], p = 0.44) were not different. Bleeding complications were more frequently observed in CKD than in the reference (all p < 0.0001). Conclusion In this worldwide registry, CKD patients presented with more comorbidities and more complex lesions when compared with the reference population. They experienced higher rate of adverse events at 1-year follow-up. Graphic abstract

scholarly journals Clinical Outcomes Following Large Vessel Coronary Artery Perforation Treated with Covered Stent Implantation: Comparison between Polytetrafluoroethylene- and Polyurethane-Covered Stents (CRACK-II Registry)

2021 ◽  
Vol 10 (22) ◽  
pp. 5441
Author(s):  
Jerzy Bartuś ◽  
Rafał Januszek ◽  
Damian Hudziak ◽  
Michalina Kołodziejczak ◽  
Łukasz Kuźma ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Clinical Outcomes ◽  
Cardiac Death ◽  
Real Life ◽  
Target Lesion ◽  
Covered Stents ◽  
Cardiac Events ◽  
Coronary Artery Perforation ◽  
One Year

Data on the clinical outcomes comparing synthetic fluorocarbon polymer polytetrafluoroethylene- (PTFE, GraftMaster) and polyurethane- (Papyrus) covered stents (CSs) to seal coronary artery perforations (CAPs) are limited. We aimed to evaluate 30-day and 1-year clinical outcomes after PCI complicated by CAP and treated with CS. We assessed 106 consecutive patients with successful CAP sealing (122 CSs): GraftMaster (51 patients, 57 CSs) or Papyrus CS (55 patients, 65 CSs). The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined as the composite of cardiac death, target lesion revascularisation (TLR), and myocardial infarction (MI). The mean age of subjects was 69 ± 9.6 years (53.8% males). No significant differences were identified between the GraftMaster and Papyrus groups at the 30-day follow-up for MACE, cardiac death, MI and stent thrombosis (ST), while significantly lower rate of TLR and TVR (p = 0.02) were confirmed in the Papyrus group. At one year, differences remained similar between stents for MACE, a trend towards a lower rate of TLR (p = 0.07), MI (p = 0.08), and ST (p = 0.08), and higher for cardiac death (p = 0.07) was observed in the Papyrus group. This real-life registry of CAP illustrated that the use of Papyrus CS is associated with lower rates of TLR and TVR at 30-day follow-up in comparison to the GraftMaster CSs and no significant differences between both assessed CS at one year of follow-up.

Abstract 11320: Long-Term Stent-Related and Patient-Related Outcomes of Second-Generation Everolimus-Eluting Xience V Stents versus Zotarolimus-Eluting Resolute Stents in Real-World Practice: Three Year Results From the Multicenter Prospective EXCELLENT and RESOLUTE-Korea Registries

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Jonghanne Park ◽  
Joo Myung Lee ◽  
Kyung Woo Park ◽  
Jung-Kyu Han ◽  
Han-Mo Yang ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Stent Thrombosis ◽  
Second Generation ◽  
Target Lesion ◽  
Off Label ◽  
Drug Eluting ◽  
Target Lesion Failure ◽  
Label Indication

Background: Long term outcomes are imperative to confirm safety of drug-eluting stents. There have been two randomized controlled trials comparing everolimus-eluting stents (EES) and Resolute zotarolimus-eluting stents (ZES-R). To date, long-term clinical outcomes of these stents were limited to only one report which has recently reported 4-year comparisons of these stents. Therefore, more evidences are needed regarding long-term clinical outcomes of the second generation stents. This study compared the long-term clinical outcomes of EES with ZES-R in “all-comer” cohorts up to 3-year follow-up. Methods: The EXCELLENT and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with EES and 1,998 with ZES-R. Target lesion failure and patient-related composite events were compared in crude and propensity score matched analyses. Results: Of 5054 patients, 3830 patients (75.8%) had off label indication (2217 with EES and 1613 with ZES-R). The stent-related outcome (189 [6.2%] vs. 127 [6.4%], p=0.812) and the patient-related outcome (420 [13.7%] vs. 250 [12.5%], p=0.581) did not differ between EES and ZES-R respectively at 3 year, which was corroborated by similar results from the propensity score-matched cohort (HR 0.92, 95% CI 0.70-1.20, p=0.523 and 0.85, 95% CI 0.70-1.02, p=0.081, for stent and patient related outcomes, respectively). The rate of definite or probable stent thrombosis up to 3 years (22 [0.7%] vs. 10 [0.5%], p=0.370) was also similar. The rate of stent thrombosis was very low and comparable between the two stents (3 [0.1%] vs. 1 [0.1%], p=0.657). In multivariate analysis, chronic renal failure (adjusted HR 3.615, 95% CI 2.440-5.354, p<0.001) and off label indication (adjusted HR 1.782, 95% CI 1.169-2.718, p=0.007) were the strongest predictors of target lesion failure. Conclusion: In this robust real world registry with unrestricted use of EES and ZES-R, both stents showed comparable safety and efficacy at 3-year follow-up. Overall incidences of target lesion failure and definite stent thrombosis, including very late stent thrombosis, were low, even in the patients with off label indications, suggesting excellent long term safety and sustained efficacy of both types of second generation drug-eluting stents.

Abstract 11993: Three Year Clinical and Imaging Data of the Paclitaxel-Eluting Absorbable Magnesium Scaffold (Dreams) From the Biosolve-I Study

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Michael Haude ◽  
Raimund Erbel ◽  
Paul Erne ◽  
Stefan Verheye ◽  
Paul Vermeersch ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Target Lesion ◽  
Imaging Data ◽  
Absorption Process ◽  
Efficacy Data ◽  
Scaffold Thrombosis ◽  
Ultrasound Signal ◽  
Target Lesion Failure

AIMS: In order to assess the long term safety, clinical performance and the bioabsorption process of the paclitaxel-pluting absorbable magnesium scaffold (DREAMS) 3-year clinical data and multi-modality imaging outcomes are reported. METHODS AND RESULTS: Forty-six subjects were enrolled in the first-in-man BIOSOLVE-I study in two different cohorts with clinical follow-up at 1, 6, 12, 24 and 36 months; angiographic and IVUS follow-up for cohort 1 at 6-month and for cohort 2 at 12-month. A subgroup of patients underwent OCT and vasomotion testing. The primary endpoint is Target Lesion Failure (TLF) at 6-month for cohort 1 and at 12-month for cohort 2. For some patients also 18-month and 24-month imaging data are available.TLF rate at 36-month was 6.8% including 2 TLRs and 1 peri-procedural MI occurring at the 12-month follow-up angiography; no events emerged from 12- to 36-month. No cardiac death or scaffold thrombosis was observed. Vasoconstriction after acetylcholine at 6-month (delta=-10.04%; p=0.0008 versus baseline) followed by vasodilatation after nitroglycerine (delta=8.69%; p<0.0001 versus baseline) demonstrates the uncaging aspect of the absorption process with no further change at the 12-month follow-up. Six-month virtual histology (VH) data showed a significant decrease in the dense calcium by 39.5% (p=0.0015) remaining stable from 6- to 12-month follow-up.This decrease is interpreted as a surrogate assessment for the bioabsorption process of the scaffold material. Echogenicity data using the decrease in intensity of the ultrasound signal to quantify the change in strut structure demonstrate a continuous decrease in % hyperechogenicity over the follow-up period, with the most pronounced changes within the first 6 months (22 to 16% p<0.001). CONCLUSIONS: DREAMS shows excellent safety and efficacy data with no death and no scaffold thrombosis up to 3 years in the BIOSOLVE-I trial. Multi-modality imaging documented the absorption process and the uncaging aspect of this device already at 6 months.

The current treatment and predictors of outcome in elderly patients with non-ST-elevation myocardial infarction in an all comers population: the POPular Age registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M.E Gimbel ◽  
D.R.P.P Chan Pin Yin ◽  
R.S Hermanides ◽  
F Kauer ◽  
A.H Tavenier ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Dual Antiplatelet Therapy ◽  
Bleeding Risk ◽  
Cardiovascular Death ◽  
St Elevation ◽  
One Year

Abstract Background Elderly patients form a large and growing part of the patients presenting with non-ST-elevation myocardial infarction (NSTEMI). Choosing the optimal antithrombotic treatment in these elderly patients is more complicated because they frequently have characteristics indicating both a high ischaemic and high bleeding risk. Purpose We describe the treatment of elderly patients (&gt;75 years) admitted with NSTEMI, present the outcomes (major adverse cardiovascular events (MACE) and bleeding) and aim to find predictors for adverse events. Methods The POPular AGE registry is an investigator initiated, prospective, observational, multicentre study of patients aged 75 years or older presenting with NSTEMI. Patients were recruited between August 1st, 2016 and May 7th, 2018 at 21 sites in the Netherlands. The primary composite endpoint of MACE included cardiovascular death, non-fatal myocardial infarction and non-fatal stroke at one-year follow-up. Results A total of 757 patients were enrolled. During hospital stay 76% underwent coronary angiography, 34% percutaneous coronary intervention and 12% coronary artery bypass grafting (CABG). At discharge 78.6% received aspirin (non-users mostly because of the combination of oral anticoagulant and clopidogrel), 49.7% were treated with clopidogrel, 34.2% with ticagrelor and 29.6% were prescribed oral anticoagulation. Eighty-three percent of patients received dual antiplatelet therapy (DAPT) or dual therapy consisting of oral anticoagulation and at least one antiplatelet agent for a duration of 12 months. At one year, the primary outcome of cardiovascular death, myocardial infarction or stroke occurred in 12.3% of patients and major bleeding (BARC 3 or 5) occurred in 4.8% of the patients. The risk of MACE and major bleeding was highest during the first month and stayed high over time for MACE while the risk for major bleeding levelled off. Independent predictors for MACE were age, renal function, medical history of CABG, stroke and diabetes. The only independent predictor for major bleeding was haemoglobin level on admission. Conclusion In this all-comers registry, most elderly patients (≥75 years) with NSTEMI are treated with DAPT and undergoing coronary angiography the same way as younger NSTEMI patients from the SWEDEHEART registry. Aspirin use was lower as was the use of the more potent P2Y12 inhibitors compared to the SWEDEHEART which is very likely due to the concomitant use of oral anticoagulation in 30% of patients. The fact that ischemic risk stays constant over 1 year of follow-up, while the bleeding risk levels off after one month may suggest the need of dual antiplatelet therapy until at least one year after NSTEMI. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): AstraZeneca

scholarly journals Two-year clinical performance of Absorb BVS compared to Xience EES in ST-segment elevation myocardial infarction: a pooled analysis of AIDA and COMPARE-ABSORB trials

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L.S.M Kerkmeijer ◽  
G Chao ◽  
R Tijssen ◽  
T Gori ◽  
R.P Kraak ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Target Lesion ◽  
Pooled Analysis ◽  
St Segment Elevation ◽  
Patient Level ◽  
Segment Elevation Myocardial Infarction ◽  
St Segment ◽  
Absorb Bvs ◽  
Target Lesion Failure

Abstract Introduction Bioresorbable vascular scaffolds (BVS) use appears theoretically attractive in patients presenting with ST-segment elevation myocardial infarction (STEMI) as acute lesions are generally composed of soft plaques, in which optimal BVS deployment and expansion is easier to achieve. Furthermore, those patients are generally younger and would benefit longer from the promise of vascular restoration therapy. Purpose In this patient level pooled analysis of two clinical trials, we evaluated the clinical outcomes of Absorb BVS versus Xience everolimus-eluting stent (EES) in STEMI patients at 2-year follow-up. Methods We performed an individual patient-level pooled analysis of the AIDA and COMPARE-ABSORB trials in which 3515 patient were randomly assigned to Absorb BVS (n=1772) or Xience EES (n=1743). Clinical outcomes in STEMI patients were analyzed by randomized treatment assignment cumulative through 2 years. The primary efficacy outcomes measure was target lesion failure (cardiac death, target-vessel myocardial infarction or target lesion revascularization), and the primary safety outcome measure was device thrombosis at 2-year follow-up. Results 350 (19.8%) STEMI patients were allocated to Absorb BVS versus 328 (18.8%) to Xience EES. The mean age of patient presenting with STEMI was 60 years old, 76.0% were males and 15.3% had diabetes mellitus. At 2-years target lesion failure occurred in 8.4% of BVS STEMI patients and 6.2% of EES STEMI patients (p=0.253). The 2-year rates of cardiac death (2.6% vs 1.6%, p=0.332), TV-MI (4.7% vs 2.5%) and TLR (6.8% vs 4.1%) were not significantly different. The 2-year incidence of definite device thrombosis was 4.7% in Absorb BVS versus 1.8% in Xience EES (p=0.045). Conclusion In the present patient-level pooled analysis of the AIDA and COMPARE-Absorb trials, BVS was associated with increased rates of device thrombosis in STEMI patients compared to Xience EES. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

scholarly journals One-Year Outcome of Small-Vessel Disease Treated with Sirolimus-Eluting Stents: A Subgroup Analysis of the e-SELECT Registry

2012 ◽  
Vol 26 (2) ◽  
pp. 163-172 ◽  
Author(s):  
RUNLIN GAO ◽  
ALEXANDRE ABIZAID ◽  
ADRIAN BANNING ◽  
ANTONIO L. BARTORELLI ◽  
VLADIMÍR DŽAVÍK ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Small Vessel Disease ◽  
Small Vessel ◽  
Vessel Disease ◽  
One Year
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