Two‐year follow‐up of a randomized multicenter study comparing a drug‐coated balloon with a drug‐eluting stent in native small coronary vessels: The RESTORE Small Vessel Disease China trial

2020 ◽  
Vol 95 (S1) ◽  
pp. 587-597 ◽  
Author(s):  
Jian Tian ◽  
Yi‐da Tang ◽  
Shubin Qiao ◽  
Xi Su ◽  
Yundai Chen ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Small Vessel Disease ◽  
Coronary Vessels ◽  
Small Vessel ◽  
Drug Eluting Stent ◽  
Vessel Disease ◽  
Drug Eluting ◽  
Drug Coated Balloon

P2806A novel sirolimus drug eluting stent for Small-Vessel Disease: results from en-ABL e-registry

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L Testa ◽  
S Dani ◽  
D Desai ◽  
R Pandya ◽  
P Parekh ◽  
...  
Keyword(s):  
Stent Thrombosis ◽  
Small Vessel Disease ◽  
Large Vessel ◽  
Small Vessel ◽  
Drug Eluting Stent ◽  
Vessel Disease ◽  
Significant Difference ◽  
Myocardial Infraction ◽  
Drug Eluting

Abstract Objective The aim of the study was to assess the clinical outcome of Abluminus DES in patients with small vessels. Background Percutaneous coronary intervention (PCI) of small coronary vessel (≤2.75 mm) associated with more chances of restenosis and repeat revascularization even when drug eluting stent employed. Methods A total of 2,500 patients enrolled in en-ABL e-registry which is a prospective, multicentre observational post market registry. Out of 2,500 patients, 1,253 patients had small vessel (SV, ≤2.75 mm) while 1,247 had large vessel (LV, >3mm) disease. The primary endpoint was major adverse cardiac events (MACE) which is composite of cardiac death, target vessel myocardial infraction (TV-MI) and target lesion/vessel revascularization (TLR) at 1 year follow up. The secondary endpoint were stent thrombosis and MACE up to 2 years. Results Baseline characteristics were well matched in both groups. In the SV group had higher prevalence of diabetes as compared to large vessel 43.0% vs 25.7%. Total 1,400 lesions treated with 1,612 Abluminus DES and 1,569 lesions treated with 1,675 Abluminus DES in SV and LV groups respectively. The mean diameter of stent was 2.61±0.23 and 3.3±0.3 mm in SV and LV groups respectively. There was a significant difference in MACE in treatment groups (3.7% vs. 1.4%, p=0.004 respectively) at 1 year. No significant differences were observed between SV and LV groups in terms of death/myocardial infarction or stent thrombosis. There were increment of only one TLR and no stent thrombosis reported at 2-year follow-up. Conclusion This result suggests the efficacy and safety of novel Abluminus DES in small vessel disease.

scholarly journals TCTAP A-152 Angioplasty in Small Vessel Disease: Drug Coated Balloon or Drug Eluting Stent?

2015 ◽  
Vol 65 (17) ◽  
pp. S72
Author(s):  
Dasdo Antonius Sinaga ◽  
Hee Hwa Ho ◽  
Fahim Haider Jafary ◽  
Yau Wei Ooi ◽  
Julian K.B. Tan ◽  
...  
Keyword(s):  
Small Vessel Disease ◽  
Small Vessel ◽  
Drug Eluting Stent ◽  
Vessel Disease ◽  
Drug Eluting ◽  
Drug Coated Balloon

scholarly journals Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease

2018 ◽  
Vol 11 (23) ◽  
pp. 2381-2392 ◽  
Author(s):  
Yida Tang ◽  
Shubin Qiao ◽  
Xi Su ◽  
Yundai Chen ◽  
Zening Jin ◽  
...  
Keyword(s):  
Small Vessel Disease ◽  
Small Vessel ◽  
Drug Eluting Stent ◽  
Vessel Disease ◽  
Drug Eluting ◽  
Drug Coated Balloon

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.

Abstract TMP119: High Homocysteine Level is not Associated With White Matter Changes, Dementia nor Mortality After Ischemic Stroke

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Susanna Melkas ◽  
Sami Curtze ◽  
Gerli Sibolt ◽  
Niku K Oksala ◽  
Jukka Putaala ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
White Matter ◽  
Homocysteine Level ◽  
Small Vessel Disease ◽  
Cerebral Small Vessel Disease ◽  
Small Vessel ◽  
Cross Sectional ◽  
White Matter Changes ◽  
Vessel Disease

Background: Association between high homocysteine level and cerebral small-vessel disease has been implicated in cross-sectional studies, but results from longitudinal studies have been less clear. The aim of this study was to investigate whether homocysteine level at 3-months poststroke relates to the occurrence of white matter changes (WMC), the surrogate of cerebral small-vessel disease. We also investigated whether it relates to the prognosis after ischemic stroke regarding the risk of dementia at 3-months and mortality in long-term follow-up. Methods: A total of 321 consecutive acute ischemic stroke patients aged 55 to 85 were included in the study and followed up to 12 years. Plasma homocysteine level and occurrence of WMC in MRI were measured 3 months poststroke and dementia according to DSM-III was evaluated at the same time. Findings: The median homocysteine level was 13.50 μmol/l (interquartile range [IQR] 10.60-18.50 μmol/l). Total of 81 patients (25.2%) had homocysteine level above 18.50 μmol/l. In logistic regression analysis, homocysteine level above 18.50 μmol/l was not associated with severe WMC nor with dementia at 3 months poststroke. In Kaplan-Meier analysis, homocysteine level above 18.50 μmol/l was not associated with survival in 12-year follow-up. For further analysis, the group was divided in quartiles according to homocysteine level. The quartiles did not differ in occurrence of severe WMC at baseline, in the risk of dementia at 3 months, nor in the risk of mortality in 12-year follow-up. Interpretation: In our poststroke cohort homocysteine level is not associated with WMC. Further, it does not relate to impaired prognosis manifested as dementia at 3 months or mortality in 12-year follow-up.

scholarly journals Protocol: The Lacunar Intervention Trial 2 (LACI-2). A trial of two repurposed licenced drugs to prevent progression of cerebral small vessel disease

2020 ◽  
Vol 5 (3) ◽  
pp. 297-308
Author(s):  
Joanna Wardlaw ◽  
Philip M W Bath ◽  
Fergus Doubal ◽  
Anna Heye ◽  
Nikola Sprigg ◽  
...  
Keyword(s):  
Small Vessel Disease ◽  
Cerebral Small Vessel Disease ◽  
Small Vessel ◽  
Large Trial ◽  
Intervention Trial ◽  
Vascular Events ◽  
Phase 3 ◽  
Full Dose ◽  
Vessel Disease

Background Small vessel disease causes a quarter of ischaemic strokes (lacunar subtype), up to 45% of dementia either as vascular or mixed types, cognitive impairment and physical frailty. However, there is no specific treatment to prevent progression of small vessel disease. Aim We designed the LACunar Intervention Trial-2 (LACI-2) to test feasibility of a large trial testing cilostazol and/or isosorbide mononitrate (ISMN) by demonstrating adequate participant recruitment and retention in follow-up, drug tolerability, safety and confirm outcome event rates required to power a phase 3 trial. Methods and design LACI-2 is an investigator-initiated, prospective randomised open label blinded endpoint (PROBE) trial aiming to recruit 400 patients with prior lacunar syndrome due to a small subcortical infarct. We randomise participants to cilostazol v no cilostazol and ISMN or no ISMN, minimising on key prognostic factors. All patients receive guideline-based best medical therapy. Patients commence trial drug at low dose, increment to full dose over 2–4 weeks, continuing on full dose for a year. We follow-up participants to one year for symptoms, tablet compliance, safety, recurrent vascular events, cognition and functional outcomes, Trails B and brain MRI. LACI-2 is registered ISRCTN 14911850, EudraCT 2016–002277-35. Trial outcome: Primary outcome is feasibility of recruitment and compliance; secondary outcomes include safety (cerebral or systemic bleeding, falls, death), efficacy (recurrent cerebral and cardiac vascular events, cognition on TICS, Trails B) and tolerability. Summary LACI-2 will determine feasibility, tolerability and provide outcome rates to power a large phase 3 trial to prevent progression of cerebral small vessel disease.

Provisional Stenting Using the Zilver PTX Drug-Eluting Stent After Drug-Coated Balloon Angioplasty: Initial Experience From the Double Drug Dose “3D” Study

2019 ◽  
Vol 27 (1) ◽  
pp. 34-41
Author(s):  
Fabrizio Fanelli ◽  
Alessandro Cannavale ◽  
Michele Citone ◽  
Mariangela Santoni ◽  
Marianna Gazzetti ◽  
...  
Keyword(s):  
Primary Patency ◽  
Drug Eluting Stent ◽  
Secondary Patency ◽  
Systemic Complications ◽  
Aneurysm Formation ◽  
Drug Eluting ◽  
Provisional Stenting ◽  
Zilver Ptx ◽  
Drug Coated Balloon

Purpose: To explore the provisional use of a drug-eluting stent (DES) after suboptimal drug-coated balloon (DCB) angioplasty in complex, calcified femoropopliteal lesions. Materials and Methods: A prospective, single-center, investigator-initiated pilot study enrolled 15 patients (mean age 71.3 years; 9 men) with symptomatic stenosis (n=6) or occlusion (n=9) of the native superficial femoral and/or proximal popliteal arteries who experienced suboptimal DCB dilation despite postdilation. Lesion characteristics were evaluated with computed tomography angiography and duplex ultrasound confirmed by intravascular ultrasound. Follow-up included clinical and imaging evaluations as well as blood tests to monitor inflammatory markers. Endpoints included systemic inflammation, acute/chronic thrombosis, aneurysm formation, and mortality. Results: Provisional stenting was required for residual stenosis >50% in 4 cases and flow-limiting dissection in 11. Provisional spot stenting was done using the Zilver PTX DES. Clinical improvement was observed in all cases. After 24-month follow-up all patients were alive and in good clinical condition. One- and 2-year primary patency rates were 93.3% and 92.9%, respectively; secondary patency was 100%. Restenosis required reintervention in 2 cases. No local or systemic complications or toxicity were observed due to the use of a double dose of paclitaxel. No significant increase in any inflammation marker was observed in the perioperative period, and no aneurysm formation was seen over 24 months of follow-up. Conclusion: Combined DCB plus DES therapy seems to be safe and correlated with high primary patency following suboptimal angioplasty. Larger studies are required to confirm the safety and efficacy of this approach.

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