Neointimal Healing Evaluated by Optical Coherence Tomography after Drug-Eluting Absorbable Metal Scaffold Implantation in de novo Native Coronary Lesions: Rationale and Design of the Magmaris-OCT Study

Cardiology ◽  
2017 ◽  
Vol 137 (4) ◽  
pp. 225-230 ◽  
Author(s):  
Pasi Karjalainen ◽  
Tuomas Paana ◽  
Jussi Sia ◽  
Wail Nammas
Keyword(s):  
Optical Coherence Tomography ◽  
De Novo ◽  
Quantitative Coronary Angiography ◽  
Vessel Diameter ◽  
Target Lesion ◽  
Lesion Length ◽  
Optical Coherence ◽  
Flow Reserve ◽  
Coronary Lesions

Objectives: We sought to explore neointimal healing assessed by optical coherence tomography (OCT) following implantation of the Magmaris sirolimus-eluting absorbable metal scaffold. Methods: The Magmaris-OCT is a prospective, multicenter, single-arm observational clinical study, intended to enrol 60 consecutive patients with up to 2 de novo native coronary lesions, each located in different major epicardial vessels, with a reference vessel diameter of 2.5-3.5 mm, and a maximum lesion length of 20 mm. Patients will undergo Magmaris scaffold implantation in the target lesion, according to the standard practice. Clinical follow-up will take place at 30 days, and at 3, 6, 9, and 12 months. For invasive-imaging follow-up, patients will be classified into 3 groups: cohort A will be scheduled for follow-up at 3 months, cohort B at 6 months, and cohort C at 12 months. Invasive imaging will include quantitative coronary angiography, OCT evaluation, and coronary flow reserve measurement. The primary end point will be the percentage of uncovered scaffold struts assessed by OCT at the prespecified follow-up. Conclusions: This study will provide insight into the short- and mid-term healing properties following Magmaris scaffold implantation, with special emphasis on the neointimal coverage of scaffold struts.

scholarly journals The Bioengineered Combo Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent in Patients with Chronic Total Occlusion Evaluated by Clinical Outcome and Optical Coherence Tomography Imaging Analysis

2020 ◽  
Vol 10 (1) ◽  
pp. 80
Author(s):  
Recha Blessing ◽  
Majid Ahoopai ◽  
Martin Geyer ◽  
Moritz Brandt ◽  
Andreas M. Zeiher ◽  
...  
Keyword(s):  
Optical Coherence Tomography ◽  
Chronic Total Occlusion ◽  
Quantitative Coronary Angiography ◽  
Dual Therapy ◽  
Coronary Stent ◽  
Neointima Formation ◽  
Optical Coherence ◽  
Total Occlusion ◽  
Angiographic Restenosis

We sought to determine the effects of the use of a Bioengineered Combo Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent (Combo® DTS) in patients with chronic total occlusion (CTO) by evaluating clinical outcomes and by performing an optical coherence tomography (OCT) analysis. We retrospectively analyzed data from 39 patients who had successfully undergone OCT-guided revascularization of a CTO being treated with a Combo® DTS. Clinical assessment, angiography (with quantitative coronary angiography analysis) and OCT examination were performed at baseline and at follow-up. The median follow-up period was 189 days, ranging from 157 to 615 days. At follow-up, revascularization was required due to angiographic restenosis in 40% (14 of 35) of patients. OCT analysis detected neointima proliferation in 23 (76.6%) patients. Neointima formation was often associated with microvessels in 18 patients (60%). Neoatheroslcerosis was observed in 2 (6.6%) patients. Malapposition was found in 4 patients (13.3%), and stent fractures were found in 11 patients (36.6%). Rate of strut coverage was 96.3% at follow-up. In conclusion, the implantation of a Combo® DTS after successful CTO recanalization was associated with a restenosis rate of 40% despite good stent implantation at baseline, proven by OCT. Neointima formation was found as a main contributor to restenosis. Nevertheless, we observed a low rate of major cardiovascular events in our follow-up.

Drug-Coated Balloon Angioplasty in Atherosclerosis Patients With Popliteal Artery Involvement

2018 ◽  
Vol 25 (5) ◽  
pp. 581-587 ◽  
Author(s):  
Tomoharu Dohi ◽  
Andrej Schmidt ◽  
Dierk Scheinert ◽  
Yvonne Bausback ◽  
Daijiro Kabata ◽  
...  
Keyword(s):  
Popliteal Artery ◽  
De Novo ◽  
Vessel Diameter ◽  
Primary Patency ◽  
Lesion Length ◽  
Endovascular Interventions ◽  
Long Term Follow Up ◽  
Drug Coated Balloon

Purpose: To investigate outcomes of drug-coated balloon (DCB) angioplasty in endovascular interventions including or restricted to the popliteal artery. Methods: A retrospective analysis was conducted of 266 patients [median age 72 years, interquartile range (IQR) 62, 78; 166 men] treated with DCB angioplasty in 281 de novo lesions including the popliteal artery between December 2011 and January 2015 at a single center. The median lesion length was 270 mm (IQR 150, 373). The study outcomes were primary patency and predictors of restenosis [reported as the hazard ratio (HR) with 95% confidence interval (CI)]. Results: The primary patency was 77.4% at a median 12.2 months (IQR 5.7, 18.8). Independent variables associated with restenosis included baseline Rutherford category (HR 1.36, 95% CI 1.05 to 1.77, p=0.02), reference vessel diameter (HR 0.77, 95% CI 0.63 to 0.95, p=0.02), dissection (HR 1.69, 95% CI 1.022.79, p=0.04), and standard nitinol stent use (HR 2.08, 95% CI 1.14 to 3.79, p=0.02). Conclusion: Outcomes after DCB angioplasty in lesions including the popliteal artery were acceptable compared with previous studies. Further investigation with long-term follow-up is needed to confirm these results.

scholarly journals Preliminary Evaluation of Clinical and Angiographic Outcomes with Biodegradable Polymer Coated Sirolimus-Eluting Stent inDe NovoCoronary Artery Disease: Results of the MANIPAL-FLEX Study

Scientifica ◽  
2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Ranjan Shetty ◽  
Jayesh Prajapati ◽  
Umesh Pai ◽  
Kiran Shetty
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
De Novo ◽  
Quantitative Coronary Angiography ◽  
Target Lesion ◽  
Preliminary Evaluation ◽  
Safety And Efficacy ◽  
Artery Disease ◽  
Sirolimus Eluting Stent

Objective. The objective of the MANIPAL-FLEX study was to evaluate the feasibility, preliminary safety, and efficacy of the Supraflex sirolimus-eluting stent (SES) implantation, inde novocoronary artery disease, using clinical and quantitative coronary angiography (QCA) follow-ups.Methods. This was a prospective, nonrandomized, multicenter, single-arm study that enrolled 189 patients withde novocoronary artery disease who were treated with the Supraflex SES. Of 189 patients enrolled, the first 61 consecutive patients who consented to a 9-month follow-up evaluation by QCA, irrespective of presence of symptoms, were to be followed up with angiography at 9 months. The primary endpoint of the study was target lesion failure (TLF), including cardiac death, myocardial infarction, and target lesion revascularization during 12-month follow-up after the index procedure.Results. The mean age of the study population was58±11years, with 51.3% (97/189) of hypertensive patients. Total of 66 lesions, analyzed by offline QCA, showed good scaffolding of the target vessel with in-stent late lumen loss at 9 months of0.18±0.23 mm. The observed TLF at 30-day, 6-month, and 12-month follow-up were 2 (1.1%), 6 (3.2%), and 10 (5.3%), respectively.Conclusion. This study provides preliminary evidence for the feasibility, safety, and efficacy of the Supraflex sirolimus-eluting stent.

Predictors of Favorable Angiographic Outcomes After Drug-Coated Balloon Use for de novo Small Vessel Coronary Disease (DCB-ONLY)

Angiology ◽  
2021 ◽  
pp. 000331972110155
Author(s):  
Woong Chol Kang ◽  
Sang Min Park ◽  
Albert Youngwoo Jang ◽  
Pyung Chun Oh ◽  
Eun-Seok Shin ◽  
...  
Keyword(s):  
De Novo ◽  
Small Vessel Disease ◽  
Vessel Diameter ◽  
Target Lesion ◽  
Small Vessel ◽  
Luminal Diameter ◽  
Minimal Luminal Diameter ◽  
Late Luminal Loss ◽  
Drug Coated Balloon

We evaluated the angiographic parameter and clinical outcomes of drug-coated balloon (DCB) to assess the optimal angiographic criteria in de novo small vessel disease (SVD). Patients (n = 424, mean age: 64.4 ± 11.2 years, men: 69.8%) at 20 sites in Korea were prospectively enrolled. The primary end point was late luminal loss (LLL) at 9-month follow-up angiography. Secondary end points included restenosis rates, target lesion failure (TLF), and DCB-related thrombosis during the 12-month follow-up period. We included 403 patients for analysis excluding 21 patients who required bailout stenting. Baseline mean reference vessel .diameter was 2.52 ± 0.39 mm and mean minimal luminal diameter (MLD) was 0.71 ± 0.40 mm. The mean MLD was 1.54 ± 0.37 mm after DCB. Late luminal loss was −0.01 ± 0.43 mm and restenosis was noted in 26 patients (12.2%). Minimal luminal diameter >1.6 mm and % diameter stenosis (DS ) <45% after DCB was associated maintenance of MLD without LLL at 9-months. Multivariate analysis demonstrated that %DS at baseline and post-MLD was associated with the restenosis. During 12-month follow-up, TLF was 2.6% including 1 cardiac death, 1 myocardial infarction, and 10 ischemia-driven target lesion revascularizations. Drug-coated balloon showed a low restenosis and lower LLL despite high in-segment DS. Post-MLD and % DS may be helpful to get optimal results in de novo SVD after DCB.

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