scholarly journals Efficacy and safety of bioresorbable vascular scaffold Absorb: 6-month outcomes of GABI-R: Russia registry

2019 ◽  
Vol 23 (1S) ◽  
pp. 26
Author(s):  
A. A. Prokhorikhin ◽  
E. I. Fartakov ◽  
D. U. Malaev ◽  
A. A. Boykov ◽  
S. V. Oidup-Ool ◽  
...  

<p><strong>Aim.</strong> The paper demonstrates the interim analysis of efficacy and safety after everolimus-eluting bioresorbable vascular scaffold (BVS) Absorb implantation in “real-world patients” with coronary artery disease.</p><p><strong>Methods.</strong> A cohort of 500 consecutive patients who underwent percutaneous coronary intervention for stable chest pain or acute coronary syndrome with implantation of at least one BVS (Absorb, Abbott Vascular) and followed up by telephone interview and review of medical charts were included in a singlecenter, prospective, all-comers, first in Russia registry. The primary endpoint, target vessel failure, defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization and secondary endpoints, MACCE (composite of cardiovascular death, myocardial infarction, coronary artery bypass surgery, target vessel revascularization, stroke) and stent thrombosis, were assessed during 6-month follow-up.</p><p><strong>Results</strong>. A total of 500 patients with coronary artery disease (CAD) (stable CAD 54.4%, acute coronary syndrome 45.6%) and different amount of affected vessels (1 vessel CAD 40.8%, n = 204; 2-vessel CAD 32.8%, n = 164; 3-vessel CAD 26.4%, n = 132) received 664 scaffolds and 55 stents in 603 stenoses. Procedure success, defined as a residual stenosis less than 30% and TIMI 3 flow in target vessel at the end of procedure, was observed in 98.51% (n = 594). At the moment of 6-month follow-up 4.2% (n = 24) of patients were lost to contact. After 6 months, incidence of target vessel failure and MACCE was 4.2% (n = 21) and 5% (n = 25). The cumulative rate of definite/probable scaffold thrombosis was 1.6% (n = 8).</p><p><strong>Conclusion</strong>. The interim analysis of Gabi-R: Russia registry, the largest trial of BVS Absorb implantation in routine clinical practice, showed high procedural success and low incidence of adverse events during follow-up. However, a tendency to high incidence of scaffold thrombosis compared to drug-eluting stents can be observed. Considering the long-term results of randomized trials retrospective registries, safety in terms of BVS routine use is of big concern. Longterm 24-month data regarding safety endpoints are required to test the afore-mentioned suggestion. </p><p>Received 5 January 2019. Revised 28 March 2019. Accepted 29 March 2019.</p><p>Funding: The study did not have sponsorship.</p><p>Conflict of interest: Authors declare no conflict of interest.</p>

2018 ◽  
Vol 7 (3) ◽  
pp. 56-64 ◽  
Author(s):  
K. M. Vakkosov ◽  
V. I. Ganjukov ◽  
S. V. Ivanov ◽  
O. L. Barbarash ◽  
L. S. Barbarash

Aim. To assess the comparative 30-day effectiveness of percutaneous coronary intervention (PCI) with bioresorbable vascular scaffold (BVS) versus minimally invasive direct coronary artery bypass (MIDCAB) for left anterior descending coronary artery disease.Methods. 130 patients with significant (≥70%) LAD disease were recruited in the study. Patients were randomized either to PCI with BVS (n = 65) or MIDCAB (n = 65). The groups of patients were comparable in baseline demographic, clinical and angiographic parameters. The endpoints included adverse cardiovascular events (all-cause mortality, myocardial infarction, stroke, target vessel revascularization) and scaffold thrombosis and were measured on day 30 after the indexed intervention.Results. At 30-day follow-up, there were no significant differences in the incidence of the adverse cardiovascular events between the study groups (0% MIDCAB vs. 3.1% PCI, р = 0.151), myocardial infarction (0% vs. 3.1%, p = 0.151), target vessel revascularization (0% vs. 1.5%, p = 0.32) and scaffold (graft) thrombosis (0% vs. 1.5%, p = 0.32).Conclusion. PCI with BVS and MIDCAB in patients with stable coronary artery disease and isolated left anterior descending lesions demonstrated comparable outcomes at 30-days follow-up.


PRILOZI ◽  
2015 ◽  
Vol 36 (2) ◽  
pp. 147-155
Author(s):  
Jorgo Kostov ◽  
Jelka Davceva-Pavlovska ◽  
Sasko Kedev

Abstract Background: The term acute coronary syndrome (ACS) refers to any group of clinical symptoms compatible with acute myocardial ischemia. These high-risk manifestations of coronary atherosclerosis are important causes of the use of emergency medical care and hospitalization. We evaluated the feasibility and the acute performance of the everolimus-eluting bioresorbable vascular scaffolds (BVS) for the treatment of patients presenting with ACS. Methods and results: The present investigation was a prospective, single-centre study. Clinical outcomes were reported at the 30-day, 6-month, 1 year and 2 years follow-up. The procedural success was 100.0%. After the BVS implantation a TIMI flow 3 was achieved in all 15 patients and the postprocedure percentage diameter stenosis was 16.4 ± 8.6%. No patients had angiographically visible residual thrombus at the end of the procedure. Optical coherence tomography (OCT) analysis was performed in 8 patients (53.3%) and showed that the post-procedure mean lumen area was 7.86 ± 1.81 mm2, minimum lumen area 5.51 ± 1.58 mm2. At the 30-day, 6-month, 1 year (15 patients) and 2 years follow-up (5 patients) target-lesion failure rate was 0%. Non-target vessel revascularization and target vessel myocardial infarction were not reported. No cases of cardiac death or scaffold thrombosis were observed. Conclusion: BVS implantation in patients presenting with ACS appeared feasible, with high rate of final TIMI-flow 3 and good scaffold apposition.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
B Balcer ◽  
I Dykun ◽  
S Hendricks ◽  
F Al-Rashid ◽  
M Totzeck ◽  
...  

Abstract Background Anemia is a frequent comorbidity in patients with coronary artery disease (CAD). Besides a complemental effect on myocardial oxygen undersupply of CAD and anemia, available data suggests that it may independently impact the prognosis in CAD patients. We aimed to determine the association of anemia with long-term survival in a longitudinal registry of patients undergoing conventional coronary angiography. Methods The present analysis is based on the ECAD registry of patients undergoing conventional coronary angiography at the Department of Cardiology and Vascular Medicine at the University Clinic Essen between 2004 and 2019. For this analysis, we excluded all patients with missing hemoglobin levels at baseline admission or missing follow-up information. Anemia was defined as a hemoglobin level of &lt;13.0g/dl for male and &lt;12.0g/dl for female patients according to the world health organization's definition. Cox regression analysis was used to determine the association of anemia with morality, stratifying by clinical presentation of patients. Hazard ratio and 95% confidence interval are depicted for presence vs. absence of anemia. Results Overall, data from 28,917 patient admissions (mean age: 65.3±13.2 years, 69% male) were included in our analysis (22,570 patients without and 6,347 patients with anemia). Prevalence of anemia increased by age group (age &lt;50 years: 16.0%, age ≥80 years: 27.7%). During a mean follow-up of 3.2±3.4 years, 4,792 deaths of any cause occurred (16.6%). In patients with anemia, mortality was relevantly higher as compared to patients without anemia (13.4% vs. 28.0% for patients without and with anemia, respectively, p&lt;0.0001, figure 1). In univariate regression analysis, anemia was associated with 2.4-fold increased mortality risk (2.27–2.55, p&lt;0.0001). Effect sizes remained stable upon adjustment for traditional risk factors (2.38 [2.18–2.61], p&lt;0.0001). Mortality risk accountable to anemia was significantly higher for patients receiving coronary interventions (2.62 [2.35–2.92], p&lt;0.0001) as compared to purely diagnostic coronary angiography examinations (2.31 [2.15–2.47], p&lt;0.0001). Likewise, survival probability was slightly worse for patients with anemia in acute coronary syndrome (2.70 [2.29–3.12], p&lt;0.0001) compared to chronic coronary syndrome (2.60 [2.17–3.12], p&lt;0.0001). Interestingly, within the ACS entity, association of anemia with mortality was relevantly lower in STEMI patients (1.64 [1.10–2.44], p=0.014) as compared to NSTEMI and IAP (NSTEMI: 2.68 [2.09–3.44], p&lt;0.0001; IAP: 2.67 [2.06–3.47], p&lt;0.0001). Conclusion In this large registry of patients undergoing conventional coronary angiography, anemia was a frequent comorbidity. Anemia relevantly influences log-term survival, especially in patients receiving percutaneous coronary interventions. Our results confirm the important role of anemia for prognosis in patients with coronary artery disease, demonstrating the need for specific treatment options. Figure 1. Kaplan Meier analysis Funding Acknowledgement Type of funding source: None


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.


Vascular ◽  
2020 ◽  
pp. 170853812095494
Author(s):  
AbdulRahman Dia ◽  
Joseph M Venturini ◽  
Rohan J Kalathiya ◽  
Stephanie Besser ◽  
Jeremy Raider Estrada ◽  
...  

Objectives To assess the safety, efficacy, and durability of the Absorb bioresorbable vascular scaffold in predominantly complex, infra-popliteal lesions for the management of chronic limb ischemia at two-year clinical follow-up. Bioresorbable vascular scaffold are biodegradable scaffolds that provide short-term vascular support before undergoing intravascular degradation. A recent trial reported excellent 36-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb bioresorbable vascular scaffold. Methods This single-center, retrospective study evaluated the use of the Absorb bioresorbable vascular scaffold (everolimus impregnated poly-L-lactic scaffold) in patients with infra-popliteal peripheral arterial disease (PAD) with respect to safety (thrombosis and TIMI bleeding), technical success, and freedom from clinically driven target vessel failure at 24 months. Results 31 patients (51.6% male) with a median age of 67 years with predominantly advanced infra-popliteal disease were treated with 49 bioresorbable vascular scaffold in 41 vessels. The mean stenosis was 94% (80–100), with 49% of lesions being chronic thrombotic occlusions. No scaffold thrombosis or peri-procedural bleeding was observed. Procedural success was achieved in all patients; 93.5% of patients experienced freedom from clinically driven target vessel failure at 24 months, driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months and 87.1% at 24 months. All patients were alive at 12 and 24 months. Conclusions At 24 months, our study found that patients with predominantly advanced infra-popliteal PAD who were treated with Absorb bioresorbable vascular scaffold reported improved clinical status and a low and durable rate of clinically driven target vessel failure extending out to 24 months.


Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001314
Author(s):  
Shouaib Qayyum ◽  
Jennifer Ann Rossington ◽  
Raj Chelliah ◽  
Joseph John ◽  
Benjamin J Davidson ◽  
...  

BackgroundElderly, frail patients are often excluded from clinical trials so there is lack of data regarding optimal management when they present with symptomatic coronary artery disease (CAD).ObjectiveThe aim of this observational study was to evaluate an unselected elderly population with CAD for the occurrence of frailty, and its association with quality of life (QoL) and clinical outcomes.MethodsConsecutive patients aged ≥80 years presenting with CAD were prospectively assessed for frailty (Fried frailty phenotype (FFP), Edmonton frailty scale (EFS)), QoL (Short form survey (SF-12)) and comorbidity (Charlson Comorbidity Index (CCI)). Patients were re-assessed at 4 months to determine any change in frailty and QoL status as well as the clinical outcome.ResultsOne hundred fifty consecutive patients with symptomatic CAD were recruited in the study. The mean age was 83.7±3.2 years, 99 (66.0%) were men. The clinical presentation was stable angina in 68 (45.3%), the remainder admitted with an acute coronary syndrome including 21 (14.0%) with ST-elevation myocardial infarction. Frailty was present in 28% and 26% by FFP and EFS, respectively, and was associated with a significantly higher CCI (7.5±2.4 in frail, 6.2±2.2 in prefrail, 5.9±1.6 in those without frailty, p=0.005). FFP was significantly related to the physical composite score for QoL, while EFS was significantly related to the mental composite score for QoL (p=0.003). Treatment was determined by the cardiologist: percutaneous coronary intervention in 51 (34%), coronary artery bypass graft surgery in 15 (10%) and medical therapy in 84 (56%). At 4 months, 14 (9.3%) had died. Frail participants had the lowest survival. Cardiovascular symptom status and the mental composite score of QoL significantly improved (52.7±11.5 at baseline vs 55.1±10.6 at follow-up, p=0.04). However, overall frailty status did not significantly change, nor the physical health composite score of QoL (37.2±11.0 at baseline vs 38.5±11.3 at follow-up, p=0.27).ConclusionsIn patients referred to hospital with CAD, frailty is associated with impaired QoL and a high coexistence of comorbidities. Following cardiac treatment, patients had improvement in cardiovascular symptoms and mental component of QoL.


Kardiologiia ◽  
2018 ◽  
Vol 58 (12) ◽  
pp. 30-35 ◽  
Author(s):  
K. M. Vakkosov ◽  
N. A. Kochergin ◽  
K. A. Kozyrin ◽  
V. I. Ganjukov

The aim. Evaluates long­term clinical outcomes of percutaneous coronary intervention (PCI) with bioresorbable vascular scaffold (BVS) versus minimally invasive direct coronary artery bypass (MIDCAB) surgery for the treatment of left anterior descending (LAD) lesions.Methods and Results. In this single­center study were included 130 patients with stable angina and significant (≥ 70 %) LAD disease. Patients were randomly assigned in a 1:1 ratio to PCI with everolimus­eluting BVS (n=65) or MIDCAB (n=65). The primary end­point was major adverse cerebro­cardiovascular events (MACCE) and secondary was scaffold (graft) thrombosis at 1 year. The groups of patients were comparable for all baseline demographic, clinical and angiographic parameters. MACCE at 12 month occurred in 9.2 % of patients in the BVS group and in 4.6 % of patients in the MIDCAB group (p=0.3). There was no significant difference between the groups in rates of all cause death (1.5 % vs 1.5 %, p=1.0), myocardial infarction (3.1 % vs. 6.1 %, p=0.4), any revascularization (1.5 % vs. 6.1 %, p=0.1) and scaffold (graft) thrombosis (1.5 % vs. 1.5 %, p=1.00).Conclusion. At 12­month follow up, there was no significant difference in the rate of MACCE between PCI by BVS and MIDCAB in patients with isolated LAD lesions.


2012 ◽  
Vol 7 (9) ◽  
pp. 1060-1061 ◽  
Author(s):  
Dariusz Dudek ◽  
Yoshinobu Onuma ◽  
John Ormiston ◽  
Leif Thuesen ◽  
Karine Miquel-Hebert ◽  
...  

Vessel Plus ◽  
2022 ◽  
Author(s):  
George Jose Valooran ◽  
Meenakshi Subbiah ◽  
Mohammed Idhrees ◽  
Mukesh Karuppannan ◽  
Mohamad Bashir ◽  
...  

Repeat revascularization after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) is one of the most common long-term complications which warrants continuous clinical follow up. Re-interventions negatively impact long-term survival in patients with coronary artery disease. The repeat revascularization after PCI can be either a target lesion revascularization (stent thrombosis/in-stent restenosis) or a revascularization of native coronary artery after PCI (target vessel revascularization/non-target vessel revascularization). The EVENT registry reports that repeat revascularization rates in patients undergoing PCI is 12% in the first year of follow up. Repeat revascularization with additional stent deployment increases the rate of stent thrombosis and restenosis, thereby leading to recurrent ischemic events. Repeat revascularization after CABG can be either in the early postoperative period or later due to native disease progression or late graft stenosis. The need for re-intervention after surgical or percutaneous revascularization is inevitable and is dependent on modifiable and non-modifiable risk factors.


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