Treatment of De Novo Chronic Total Occlusions with Drug-Coated Balloon-Only

Author(s):  
Eun-Seok Shin ◽  
Eun Jung jun ◽  
Eu-Vin Teoh ◽  
Youngjune Bhak ◽  
Song Lin Yuan ◽  
...  

Abstract The study aimed to investigate the impact of angiographic and clinical outcomes of the drug-coated balloon (DCB)-only treatment for de novo coronary chronic total occlusion (CTO). One hundred one vessels with de novo CTO lesions dilated by balloon angioplasty with thrombolysis in myocardial infarction (TIMI) flow-grade 3 were assigned. Among them, we analyzed 93-vessel treated using DCB-only treatment. The primary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR), and target vessel thrombosis. The secondary endpoint was late lumen loss (LLL) on follow-up coronary angiography. All 84-patient were followed up clinically, and 67-vessel underwent scheduled coronary angiography after 6-month. There were no procedural complications, and three vessels required bailout-stenting. MACE occurred in 14 patients, including 2 cardiac deaths, 3 non-fatal MIs, and 11 TVRs. There was no target vessel thrombosis. The mean LLL was 0.03 ± 0.53mm. Binary restenosis occurred in 10 and re-occlusion in 2 vessels. The results from a 2-year follow-up with DCB-only treatment are encouraging, with a low rate of hard endpoints and acceptable MACE rates. It may offer an alternative to the implantation of a drug-eluting stent if the CTO lesions have TIMI flow-grade 3 after pre-dilation.

2020 ◽  
Vol 9 (1) ◽  
pp. 178 ◽  
Author(s):  
Martin Geyer ◽  
Johannes Wild ◽  
Marc Hirschmann ◽  
Zisis Dimitriadis ◽  
Thomas Münzel ◽  
...  

(1) Background: Knowledge about predictors for the long-time patency of recanalized chronic total coronary occlusions (CTOs) is limited. Evidence from invasive follow-up in the absence of acute coronary syndrome (routine surveillance coronary angiography) is scarce. (2) Methods: In a monocentric-retrospective analysis, we obtained baseline as well as periprocedural data of patients undergoing routine invasive follow-up. We defined target vessel failure (TVF) as a combined primary endpoint, consisting of re-occlusion, restenosis, and target vessel revascularization (TVR). (3) Results: We included 93 consecutive patients (15.1% female) from October 2013 to May 2018. After a follow-up period of 206 ± 129 days (median 185 (IQR 127–237)), re-occlusion had occurred in 7.5%, restenosis in 11.8%, and TVR in 5.4%; the cumulative incidence of TVF was 15.1%. Reduced TIMI-flow immediately after recanalization (OR for TVR: 11.0 (95% CI: 2.7–45.5), p = 0.001) as well as female gender (OR for TVR: 11.0 (95% CI: 2.1–58.5), p = 0.005) were found to be predictive for pathological angiographic findings at follow-up. Furthermore, higher blood values of high-sensitive troponin after successful revascularization were associated with all endpoints. Interestingly, neither the J-CTO score nor the presence of symptoms at the follow-up visit could be correlated to adverse angiographic results. (4) Conclusions: In this medium-sized cohort of patients with surveillance coronary angiography, we were able to identify reduced TIMI flow and female gender as the strongest predictors for future TVF.


2016 ◽  
Vol 23 (11) ◽  
pp. 1412-1416
Author(s):  
Muhammad Zafar Majeed Babar ◽  
Abdul Majid ◽  
Javed Iqbal

Objectives: To determine Post streptokinase TIMI flow grade (rate) in infarctrelated artery (IRA) in ST elevated myocardial infarction patients. Study Design: A nonrandomizedprospective study. Period: Dec-2014 to Dec-2015. Setting: Sheikh Zayed MedicalCollege and Hospital Rahim Yaar Khan. Methods: 113 patients were selected to see poststreptokinase TIMI flow grade in infarct related artery (IRA). The data was analyzed using SPSSVersion 20. Descriptive statistics was used to see and analyze the data. Results: Mean ageof patients was 50.43±9.81 years. There was more males (87.61%) as compared to females(12.39%). After thrombolyzation with streptokinase 23.01% patients were with TIMI grade 0/1(failed perfusion), 45.13% (51) patients with TIMI grade 2 (partial perfusion) and 31.86% patientswith TIMI grade 3 (full perfusion) in infarct related artery. In our study TIMI flow improved tograde 2/3 (partial to complete perfusion) in 76.99% patients. There were 11.73% patients withTIMI 0/1 with 50% ST segment resolved, 8.85% patients with TIMI 0/1 with persisted 50% STsegment, 32.74% patients with TIMI 2 with 50% ST segment resolved, 11.5% (13) patients withTIMI 2 with 50% ST segment persisted, 32.74% patients with TIMI 3 with 50% ST segmentresolved and 4.42% patients with TIMI 3/1 with 50% ST segment persisted. Post streptokinasethere was no coronary artery thrombus in 91.07 % patients. While 6.25% patients had thrombusin left coronary artery and 2.84% patients had right coronary artery thrombus. Conclusion:Thrombolyzation with streptokinase improves perfusion in infarct related artery and increasesTIMI flow grade in STEMI patients. It reduces the risk of recurrent myocardial infarction byrestoration of blood flow in infarct related artery.


2021 ◽  
Vol 52 (4) ◽  
pp. 249-257
Author(s):  
Tanja Šobot ◽  
Nikola Šobot ◽  
Zorislava Bajić ◽  
Nenad Ponorac ◽  
Rade Babić

Background/Aim: Bioresorbable vascular scaffold (BVS) represents a novel generation of intracoronary devices designed to be fully resorbed after healing of the stented lesion, delivering antiproliferative drug to suppress restenosis, providing adequate diameter of the coronary vessel and preserving the vascular endothelial function. It was supposed that BVS will reduce neointimal proliferation and that their late bioresorption will reduce the negative effects of traditional drug-eluting stents, including the late stent thrombosis, local vessel wall inflammation, loss of coronary vasoreactivity and the need for the long-term dual antiplatelet therapy. The purpose of this research was to investigate efficacy and safety of Absorb everolimus-eluting BVS implantation and the prevalence of major adverse cardiovascular events (MACE) at the mid-term follow-up. Methods: The study encompassed 42 patients selected for BVS implantation and fulfilling inclusion criteria - 37 male and 5 female - admitted to the Dedinje Cardiovascular Institute, Belgrade, Serbia over the one-year period (from January 2015 to January 2016) for percutaneous coronary intervention (PCI). Coronary vessel patency before and after stenting was assessed by the Thrombolysis in Myocardial Infarction flow (TIMI) grades. After the index PCI procedure with BVS all patients were clinically followed by regular (prescheduled or event-driven) visits during the next 12-month period. Results: In the intention-to-treat analysis, all Absorb BVS procedures were successful, without the need for conversion to other treatment modalities. The complete reperfusion (TIMI flow grade 3) after the intervention was established in 97.6 % of patients and 100 % of them achieved the TIMI flow grade ≥ 2. The presence of angina pectoris was reduced significantly by the BVS procedure: stable angina 57.1 % to 11.9 %, (p < 0.001) and unstable angina 31 % to 0 %, respectively (p < 0.001). After the one-year follow-up, the MACE rate was 11.9 %. Myocardial infarction occurred in 4.8 % and the need for PCI reintervention in 2.4 % of cases (not influenced by the gender or the age of patients). There were 4 cases of death (all patients were older and had lower values of left ventricular ejection fraction). Conclusion: The results of the current research demonstrated a high interventional success rate of the Absorb BVS implantation, followed by the early improvement of the anginal status. However, that was not translated into the favourable mid-term clinical outcomes, opening debate about the current status of Absorb BVS and the need for future refinements of stent design and implantation techniques.


2010 ◽  
Vol 33 (5) ◽  
pp. 304 ◽  
Author(s):  
Jun Jin ◽  
Hong Wang ◽  
Yao-Ming Song ◽  
Ai-Ming Li ◽  
Jun Qin ◽  
...  

Aim: Myocardial contrast echocardiography (MCE) is effective in predicting myocardial viability and functional recovery on a segmental level in patients with acute myocardial infarction (AMI). In this study, we investigated whether insufficient myocardial reperfusion plays an important role in left ventricular (LV) remodeling and functional recovery in patients with thrombolysis in myocardial infarction (TIMI) flow grade 3 and corrected TIMI frame count (CTFC) < 40 after recanalization of the infarct-related artery. Method: Patients underwent intracoronary injection of microbubbles for echocardiographic assessment of myocardial microvascular perfusion, wall motion score, LV volume and ejection function (EF) at baseline, 30 minutes, one month and six months after recanalization. The patients with MCESI < 1 were considered to have insufficient myocardial reperfusion (group A, n=11), while the patients with MCESI≥1 were considered to have sufficient myocardial reperfusion (group B, n=47) after AMI recanalization. Results: The wall motion score index (WMSI) and the left ventricular ejection fraction (LVEF) showed significant improvement at 1 month and 6 months in group B, but only at six months in group A. Left ventricular end-systolic and end-diastolic volumes (LVESV and LVEDV) were also significantly decreased at one and six months in group B. WMSI, LVESV, LVEDV and LVEF were significantly improved in group B in comparison with group A at one month and six months (P < 0.01). By six months, significant correlations were seen in all patients between MCESI and changes in LVESV, LVEDV and LVEF at 6 months. Similar correlations were observed between the myocardial regional blood flow (Q) and changes in LVESV , LVEDV and LVEF.. Conclusion: Insufficient myocardial reperfusion was a strong independent predictor of LV remodeling and functional recovery in AMI patients with TIMI flow grade 3 and CTFC < 40 after recanalization. MCE has important additional value for prognosis and risk assessment in patients with acute myocardial infarction following recanalization.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
A M Fawzy ◽  
B H Loku Waduge ◽  
H Kalkat ◽  
A M Saif ◽  
S Athulorala ◽  
...  

Abstract Aims The use of scoring balloon prior to drug coated balloon has been proven to be effective in restenotic lesions. However, their effect in de novo lesions has not been tested. Logic tells that the use of scoring balloons should enhance the drug uptake into the vessel wall. In this study, we evaluated this concept of scoring balloon prior to DCB in de novo lesions and compared to those who were treated with a conventional approach (semi-compliant and/or non-compliant balloons). Methods and results We evaluated all de novo lesions treated with DCB between March 2018 and October 2020 at our centre. The results are reported as cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularisation (TLR) and MACE (combination of cardiac death, target vessel MI and TLR). During the study period 348 patients with de novo lesions were treated with DCB. Of those, 49 were predilated with scoring balloon prior to use of DCB and the remaining 299 were predilated with non-scoring balloons (semi-compliant and/or non-compliant). The majority of the baseline characteristics had no statistically significant differences (table 1), with the exception of the mean diameter of the lesions were larger in the scoring balloon group than non-scoring balloon group: 2.7±0.5 vs. 2.49±0.4; p=0.003 and mean length of lesions were longer in the non-scoring balloon group: 26±8.8 vs. 23±7.7; p=0.02. During the median follow-up of 660 days, clinical outcomes between the scoring and non-scoring balloons were; cardiac death: 0 vs. 8 (3%); p=0.5, TVMI: 2 (4%) vs. 8 (3%); p=0.9, TLR: 3 (6%) vs. 25 (8.4%); p=0.8, MACE: 4 (8%) vs. 34 (11%) p=0.7 Conclusion There were no differences in the clinical outcomes between the two groups indicating that use of scoring balloon prior to DCB may not offer additional benefit, although this needs to be confirmed in a larger patient group. FUNDunding Acknowledgement Type of funding sources: None.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.M.Z Mohd Saad Jalaluddin

Abstract Background Drug-coated balloon has been widely used to treat In-Stent Restenosis as recommended by ESC/EACT coronary intervention guideline. However, trials of effectiveness of DCB in treating de novo lesions in diabetic patients are limited. This study will highlight the impact of DCB in diabetic patients with only de novo lesions against non-diabetic patients. Aim To compare the outcomes of Paclitaxel Drug Coated Balloon (DCB) in Diabetic and non-diabetic patients with only de novo coronary artery disease. Methods A retrospective, single center study was conducted from January 2016 till December 2018. All diabetic and non-diabetic patients underwent angioplasty to only de novo coronary artery lesions were included in the study. Patients' baseline characteristic, angiographic data, post procedural and 12 months follow-up outcomes including major adverse coronary artery event (MACE), target lesion revascularization (TLR) and myocardial infarction (MI) are compared. Results A total of 1257 patients (726 diabetic and 531 non-diabetic patients) with total 1385 de novo coronary artery lesions (791 lesions in diabetic group and 594 lesions in non-diabetic group) were included in this study. Mean age for non-diabetic group was 57.6±10.6 years and diabetic group was 59.6±9.6 years with male predominance (91.1% in non-diabetic group, n=484 and 79.2% in diabetic group, n=575). Majority of diabetic group has hypertension (83.7%, n=608 vs 58.6%, n+311), chronic renal failure (10.3%, n=75 vs 1.9%, n=10), documented coronary artery disease (55.6%, n=404 vs 47.5%, n=252) and previous coronary angioplasty 39.5%, n=287 vs 28.8%, n=153). Adequate pre-dilatation was done in both groups (98.5%, n=585 in non-diabetic group and 99.4%, n=786 in diabetic group; p=0.000). Mean DCB diameter and length were almost similar in both groups. Mean residual stenosis after DCB was 11.15±16.9% in non-diabetic group and 13.13±13.4% in the diabetic group (p=0.008). 74.6% of non-diabetic group (n=396) and 77.1% of diabetic group (n=560) were on double antiplatelet therapy for 12 months. 86.8% (n=461) of non-diabetic and 88.4% (n=642) of diabetic patients were available for follow up. MACE events were significantly higher (p=0.000) in diabetic group (4.3%, n=31) as compare to non-diabetic group (0.6%, n=3). Target lesion revascularization (TLR) and myocardial infarction (MI) was also significantly higher in diabetic group (TLR 1.4%, N=10 vs 0.6%, n=3, p=0.049; MI 2.6%, n=19 vs 0.4%, n=2, p=0.002). Conclusion Treating de novo coronary lesions in diabetic patients with DCB associated with significantly higher MACE events, target lesion revascularization and myocardial infarction. Diabetic patients appear to have a greater volume of atherosclerotic plaque and increased propensity for atherosclerotic plaque rupture. Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 22 (Supplement_3) ◽  
pp. iii387-iii387
Author(s):  
Andrey Levashov ◽  
Dmitry Khochenkov ◽  
Anna Stroganova ◽  
Marina Ryzhova ◽  
Sergey Gorelyshev ◽  
...  

Abstract The aim of this study was to estimate treatment toxicity and event-free survival (EFS) according to therapeutic program, MYC/MYC-N gene amplification and MGMT/DNMT (1, 3a, 3b) proteins expression in tumor cells. From 2016 to 2018 twenty four patients were included in trial. Children underwent adjuvant therapy: craniospinal radiation (CSI) or local radiation therapy (RT) to the relapsed site up to 23.4Gy with 5-azacytidine, 2 cycles methotrexate/5-azacytidine/cisplatin/etoposide, 3 cycles 5-azacytidine/temozolomide - for relapsed group (arm A, n = 5); for patients with de novo medulloblastoma: arm B, n = 11 – vincristine/cyclophosphamide/cisplatin/etoposide (OPEC) - based induction, CSI 36Gy + local RT to the tumor bed up to 54Gy with 5-azacytidine, 1 cycle OPEC and 2 cycles thiophosphamide/carboplatin with auto stem cell transplantation (auto-SCT); arm C, n = 8 – cyclophosphamide/cisplatin - based induction, CSI 23.4 Gy followed by 2 cycles 5-azacytidine/thiophosphamide/carboplatin with auto-SCT, local RT with 5-azacytidine. The combination of 5-azacytidine with local RT or temozolomide was safety and tolerability. Arm C was discontinued due to severe gastrointestinal grade 3/4 toxicity, hemorrhagic syndrome after combination of 5-azacytidine with thiophosphamide/carboplatin. EFS was 0% in arm A, 53.0 ± 15.5%, 50.0 ± 17.7% in arms B and C, a median follow-up 8.8 ± 1.1 months (arm A), 18.8 ± 2.5 months (arm B), 25.0 ± 4.4 months (arm C). Addition of 5-azacytidine to RT or chemotherapy did not improve EFS of patients with MYC/MYC-N gene amplification positive tumor. There was not determined any prognostic significance of MGMT/DNMT (1, 3a, 3b) proteins expression in this cohort.


2018 ◽  
Vol 10 (9) ◽  
pp. e24-e24 ◽  
Author(s):  
Jun Zhang ◽  
Xiao Zhang ◽  
Jin-Ping Zhang ◽  
Ju Han

The optimal treatment for patients with chronic symptomatic middle cerebral artery (MCA) total occlusion is not well established. In addition to medical therapy, vessel recanalisation with stenting has shown much promise, especially for patients with recurrent ischemic symptoms. Nevertheless, the incidence of symptomatic in-stent restenosis (ISR) is high, and is associated with an unfavorable prognosis. Drug coated balloons (DCBs) have been proven to be effective in treating and preventing ISR. However, the feasibility of DCBs for de novo intracranial atherothrombotic stenosis has not been previously described, especially for total occlusion lesions. Here we reported a patient with chronic left MCA total occlusion successfully treated with DCBs, with a good outcome at the 1 year follow-up. More studies are warranted to further compare the efficacy of DCBs and stentings for intracranial revascularisation.


2021 ◽  
Vol 15 (15) ◽  
pp. 1357-1366
Author(s):  
Ömer Şen ◽  
Sıdıka B Şen ◽  
Ayşe N Topuz ◽  
Mustafa Topuz

Aim: No-reflow phenomenon (NRP) is an undesirable result of coronary interventions, and usually occurred during the primary percutaneous coronary intervention (PPCI). On the other hand, there is growing evidence of epidemiological studies suggest that serum 25 hydroxy-vitamin D (25(OH)D3) level is significantly associated with cardiovascular mortality and morbidity. Objective: To investigate whether there is a relationship between admission serum 25(OH)D3 levels and NRP in patients with ST elevation myocardial infarction (STEMI). Methods: This study consisted of 496 consecutive acute STEMI patients who underwent PPCI. After the restoration of antegrade flow, the patients were divided into the normal flow and no-reflow groups. No-reflow defined as; thrombosis in myocardial infarction (TIMI) flow grade ≤2, or a TIMI flow grade = 3 with a myocardial perfusion grade ≤1. Results: Angiographic no-reflow occurred 18.2% of all study patients. Serum 25(OH)D3 levels were significantly lower when compared with the normal flow group (14.6 ± 7.3 vs 22.6 ± 9.6 ng/ml; p < 0.001). 25(OH)D3 level was significantly negatively correlated with Neutrophil/lymphocyte (N/L) ratio. In multivariate analysis, 25(OH)D3 level on admission (OR: 0.738; 95% CI: 0.584–0.878; p = 0.001) was found an independent predictor of NRP together with N/L ratio, N-Terminal-proBNP, balloon pre dilatation and syntax score I. On receiver operating curve analysis (ROC), the cut-off value of admission 25(OH)D3 level was 10.5 ng/ml for the prediction of NRP with a sensitivity of 93% and specificity of 68%. The area under the ROC curve (AUC) was 0.772 (95% CI: 0.697–0.846; p < 0.001). Conclusion: We have shown that lower 25(OH)D3 level on admission is associated with higher NRP frequency and may be used as a predictor for NRP in STEMI patients undergoing PPCI.


2020 ◽  
Author(s):  
Yong Hoon Kim ◽  
Ae-Young Her ◽  
Myung Ho Jeong ◽  
Byeong-Keuk Kim ◽  
Sung-Jin Hong ◽  
...  

Abstract Background: Studies comparing long-term clinical outcomes between prediabetes and diabetes based on pre-percutaneous coronary intervention (PCI) Thrombolysis in Myocardial Infarction (TIMI) flow grade in patients with ST-segment elevation myocardial infarction (STEMI) after successful PCI with newer-generation drug-eluting stents are limited. We compared 2-year clinical outcomes of these two groups. Methods: Overall, 6448 STEMI patients were divided into two groups: pre-PCI TIMI 0/1 group (n = 4854) and pre-PCI TIMI 2/3 group (n = 1594). Subsequently, these two groups were further divided into patients with normoglycemia, prediabetes, and type 2 diabetes mellitus (T2DM). The major endpoint was the occurrence of major adverse cardiac events (MACEs), defined as all-cause death, recurrent myocardial infarction, or any repeat revascularization. Results: After adjustment, in the pre-PCI TIMI 0/1 group, the cumulative incidence of all-cause death was higher in both prediabetes (adjusted hazard ratio [aHR]: 1.633, p = 0.045) and T2DM (aHR: 2.064, p = 0.002) groups than in the normoglycemia group. In the pre-PCI TIMI 2/3 group, the cumulative incidence of any repeat revascularization was higher in both prediabetes (aHR: 2.511, p = 0.039) and T2DM (aHR: 3.156, p = 0.009) groups than in the normoglycemia group. However, in each group (pre-PCI TIMI 0/1 or 2/3), the cumulative incidences of MACEs and all other clinical outcomes were not significantly different between the prediabetes and T2DM groups. Conclusions: In this retrospective registry study, prediabetes showed worse clinical outcomes similar to those of T2DM regardless of the pre-PCI TIMI flow grade. However, further studies are warranted to confirm these results.


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