Introduction No-reflow (NR) phenomenon occurs, when myocardial perfusion is not re-established de... more Introduction No-reflow (NR) phenomenon occurs, when myocardial perfusion is not re-established despite opening the coronary artery during percutaneous coronary intervention (PCI). Purpose Our aim was to identify no-reflow specific characteristics, its independent predictors, and to develop a clinically-adaptable risk score. Methods We have analysed 4085 patient data from two Hungarian cardiovascular centres. We included all STEMI/NSTEMI patients underwent PCI (n=3187). 158 patients treated with papaverine/adenosine formed NR group, while 3029 patients were in control (C) group. Anamnestic parameters, laboratory and operation data were compared. Statistical analysis was carried out with Mann-Whitney-, Fisher test, binary logistic regression and Kaplan Meier survival curve. Based on our results, we designed a risk estimation system, checking its applicability with ROC analysis. Results As for NR-specific characteristics, malignant ventricular arrhythmias (11% vs. 4%, p=0,0031; NR-C consequently) and complications (21% vs. 11%, p=0,064) showed their vulnerability. The increment of glucose (8,1 vs. 7,1 mmol/l, p=0,004), WBC (12,08 vs. 10,5 G/l, p=0,001), CRP (12,46 vs. 7,67 mg/l, p=0,051) and LDL levels (3,34 vs. 3,13 mmol/l, p=0,059) supported the pathomechanism of NR. Higher biomarker levels (troponinT: 2040 vs. 510,5 ng/ml; CK-MB: 100,4 vs. 63,65 U/l, p<0,0001) indicated severe perfusion disturbance. Tendency was seen in higher BMI (28,65 vs. 28,03 kg/m2, p=0,12). STEMI dominated in NR (83 vs. 59%, p<0,0001). Lower platelet level (213,3 vs. 228 G/l, p=0,107) and single vessel disease (46 vs. 25%, p=0,0042) characterized NR. 30-day survival was significantly different (85,1 vs. 93,54%, p<0,0001). The mortality rate of NR in STEMI was 69,7% (69,7% vs. 7,94%, p<0,0001) and in NSTEMI 3,7% (3,7% vs. 4,32%). From the significant differences, CRP was the independent predictor of NR (OR: 1,011, p=0,004; pro 1 mg/l change). Examining STEMI/NSTEMI separately, in STEMI CRP was the independent predictor (OR: 1,0092, p=0,036). In NSTEMI LDL (OR: 4,23, p=0,021) was the independent factor. In the risk score, the following 8 parameters were included: BMI>28 kg/m2, glucose>8 mmol/l, WBC>12 G/l, CK-MB>100 U/l, hs troponin T>2000 ng/ml, CRP>12 mg/l, LDL>3,3 mmol/l, STEMI (yes/no), thus maximum 8 points could be reached. Low (0–1 points, 5–20%), moderate (2–5 points, 55–70%) and high risk groups (6–8 points, 41–11%) were formed. Supervising the model with ROC analysis: AUC=0,69, p=0,0026, which indicates its ability to discriminate effectively between different risk levels of NR. Conclusions The specific characteristics of NR group were identified, from which CRP was the independent predictor - as well as in STEMI, while in NR-NSTEMI LDL was the independent factor. With the elaborated risk estimation system –using anamnestic and routine laboratory parameters– NR could be predicted and unsuccessful PCI could be reduced, resulting in positive therapeutic consequences.
Background: Oral activated factor XI (FXIa) inhibitors may modulate coagulation to prevent thromb... more Background: Oral activated factor XI (FXIa) inhibitors may modulate coagulation to prevent thromboembolic events without substantially increasing bleeding. We explored the pharmacodynamics, safety, and efficacy of the oral FXIa inhibitor asundexian for secondary prevention after acute myocardial infarction (MI). Methods: We randomized 1601 patients with recent acute MI to oral asundexian 10, 20, or 50 mg or placebo once daily for 6 to 12 months in a double-blind, placebo-controlled, phase 2, dose-ranging trial. Patients were randomized within 5 days of their qualifying MI and received dual antiplatelet therapy with aspirin plus a P2Y12 inhibitor. The effect of asundexian on FXIa inhibition was assessed at 4 weeks. The prespecified main safety outcome was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding comparing all pooled asundexian doses with placebo. The prespecified efficacy outcome was a composite of cardiovascular death, MI, stroke, or stent thrombosis comparing ...
Conventional transradial access has been established as the gold standard for invasive coronary a... more Conventional transradial access has been established as the gold standard for invasive coronary angiography and percutaneous interventions by the current European and American guidelines. The distal or snuffbox radial artery access represents an alternative transradial access site that allows radial sheath insertion with the patient’s hand pronated. Firstly described 40 years ago, it exploded in popularity only recently. Promising additional benefits, the distal radial access is increasingly being adopted in various types of percutaneous interventions, being preferred by many interventional cardiologists and radiologists for its reduced vascular complications and time to hemostasis, and improvement of patient and operator comfort. Other centers consider it a fad, waiting for solid clear evidence and benefits. The evidence is dynamic and discrepant, depending on the center, the operator, and how it was collected (randomized controlled vs observational studies). Another essential aspe...
Catheterization and Cardiovascular Interventions, 2021
ObjectiveThe multicenter proximal upper limb artery (PULA) Registry was created to study the opti... more ObjectiveThe multicenter proximal upper limb artery (PULA) Registry was created to study the optimal puncture sites for the interventions involving the subclavian, axillary, and innominate arteries.BackgroundLittle is known about the optimal vascular access for PULA interventions, despite the well‐known technical complexity of these procedures.MethodsWe performed the retrospective analysis of consecutive patients treated for symptomatic steno‐occlusive disease of the proximal upper limb arteries between January 2015 and December 2019 in three high‐volume centers. Acute thrombotic occlusions were excluded from the study.ResultsTwo hundred and seventy‐two patients were treated for significant stenosis and 108 for total occlusion. The baseline patient's characteristics were similar, except for the higher median age of the stenotic patients: 68.5 years (31.1; 90.0) versus 64 years (38.0; 86.0) p = 0.0015. Successful revascularization rate was higher in the stenotic group 93.75% (255...
Purpose: To compare the acute success and complication rates of distal radial (DR) vs proximal ra... more Purpose: To compare the acute success and complication rates of distal radial (DR) vs proximal radial (PR) artery access for superficial femoral artery (SFA) interventions. Materials and Methods: Between 2016 and 2019, 195 consecutive patients with symptomatic SFA stenosis were treated via DR (n=38) or PR (n=157) access using a sheathless guide. Secondary access was achieved through the pedal artery when necessary. The main outcomes were technical success, major adverse events (MAEs), and access site complications. Secondary outcomes were treatment success, fluoroscopy time, radiation dose, procedure time, and crossover rate to another puncture site. Results: Overall technical success was achieved in 188 patients (96.4%): 37 of 38 patients (97.3%) in the DR group and 151 of 157 patients (96.2%) in the PR group (p=0.9). Dual (transradial and transpedal) access was used in 14 patients (36.8%) in the DR group and 28 patients (18.9%) in the PR group (p<0.01). Chronic total occlusions...
Introduction The primary purpose of this multicenter prospective register was to evaluate the suc... more Introduction The primary purpose of this multicenter prospective register was to evaluate the success and complication rate of different access sites for subclavian artery intervention. Secondary purpose was to investigate the safety of the distal radial artery access for subclavian artery intervention. Methods The clinical and angiographic data of 223 consecutive patients with symptomatic subclavian and anonym artery stenosis treated via transradial (TR), transbrachial (TB) and transfemoral (TF) access between 2015 and 2019 were evaluated in a multicenter registry. The exclusion criteria of the intervention was the acute proximal subclavian artery thrombosis. Primary endpoint: angiographic outcome of the subclavian and anonym artery intervention, rate of major and minor access site complications. Secondary endpoints: procedural complications, consumption of the angioplasty equipment, cross over rate to another puncture site and hospitalization in days. Results The procedure was suc...
Rotational atherectomy (RA) in peripheral circulation is an advanced revascularization procedure,... more Rotational atherectomy (RA) in peripheral circulation is an advanced revascularization procedure, often used in cases where traditional percutaneous transluminal angioplasty (PTA) is inadequate and bypass grafting is either unavailable or undesired. We report on a case, where RA was successfully performed after failed traditional PTA. The case highlights the importance of RA in peripheral cases where severe calcification occurs and the lesion is not suitable for PTA (cannot be passed with balloon or is undilatable).
Introduction No-reflow (NR) phenomenon occurs, when myocardial perfusion is not re-established de... more Introduction No-reflow (NR) phenomenon occurs, when myocardial perfusion is not re-established despite opening the coronary artery during percutaneous coronary intervention (PCI). Purpose Our aim was to identify no-reflow specific characteristics, its independent predictors, and to develop a clinically-adaptable risk score. Methods We have analysed 4085 patient data from two Hungarian cardiovascular centres. We included all STEMI/NSTEMI patients underwent PCI (n=3187). 158 patients treated with papaverine/adenosine formed NR group, while 3029 patients were in control (C) group. Anamnestic parameters, laboratory and operation data were compared. Statistical analysis was carried out with Mann-Whitney-, Fisher test, binary logistic regression and Kaplan Meier survival curve. Based on our results, we designed a risk estimation system, checking its applicability with ROC analysis. Results As for NR-specific characteristics, malignant ventricular arrhythmias (11% vs. 4%, p=0,0031; NR-C consequently) and complications (21% vs. 11%, p=0,064) showed their vulnerability. The increment of glucose (8,1 vs. 7,1 mmol/l, p=0,004), WBC (12,08 vs. 10,5 G/l, p=0,001), CRP (12,46 vs. 7,67 mg/l, p=0,051) and LDL levels (3,34 vs. 3,13 mmol/l, p=0,059) supported the pathomechanism of NR. Higher biomarker levels (troponinT: 2040 vs. 510,5 ng/ml; CK-MB: 100,4 vs. 63,65 U/l, p&amp;amp;amp;lt;0,0001) indicated severe perfusion disturbance. Tendency was seen in higher BMI (28,65 vs. 28,03 kg/m2, p=0,12). STEMI dominated in NR (83 vs. 59%, p&amp;amp;amp;lt;0,0001). Lower platelet level (213,3 vs. 228 G/l, p=0,107) and single vessel disease (46 vs. 25%, p=0,0042) characterized NR. 30-day survival was significantly different (85,1 vs. 93,54%, p&amp;amp;amp;lt;0,0001). The mortality rate of NR in STEMI was 69,7% (69,7% vs. 7,94%, p&amp;amp;amp;lt;0,0001) and in NSTEMI 3,7% (3,7% vs. 4,32%). From the significant differences, CRP was the independent predictor of NR (OR: 1,011, p=0,004; pro 1 mg/l change). Examining STEMI/NSTEMI separately, in STEMI CRP was the independent predictor (OR: 1,0092, p=0,036). In NSTEMI LDL (OR: 4,23, p=0,021) was the independent factor. In the risk score, the following 8 parameters were included: BMI&amp;amp;amp;gt;28 kg/m2, glucose&amp;amp;amp;gt;8 mmol/l, WBC&amp;amp;amp;gt;12 G/l, CK-MB&amp;amp;amp;gt;100 U/l, hs troponin T&amp;amp;amp;gt;2000 ng/ml, CRP&amp;amp;amp;gt;12 mg/l, LDL&amp;amp;amp;gt;3,3 mmol/l, STEMI (yes/no), thus maximum 8 points could be reached. Low (0–1 points, 5–20%), moderate (2–5 points, 55–70%) and high risk groups (6–8 points, 41–11%) were formed. Supervising the model with ROC analysis: AUC=0,69, p=0,0026, which indicates its ability to discriminate effectively between different risk levels of NR. Conclusions The specific characteristics of NR group were identified, from which CRP was the independent predictor - as well as in STEMI, while in NR-NSTEMI LDL was the independent factor. With the elaborated risk estimation system –using anamnestic and routine laboratory parameters– NR could be predicted and unsuccessful PCI could be reduced, resulting in positive therapeutic consequences.
Background: Oral activated factor XI (FXIa) inhibitors may modulate coagulation to prevent thromb... more Background: Oral activated factor XI (FXIa) inhibitors may modulate coagulation to prevent thromboembolic events without substantially increasing bleeding. We explored the pharmacodynamics, safety, and efficacy of the oral FXIa inhibitor asundexian for secondary prevention after acute myocardial infarction (MI). Methods: We randomized 1601 patients with recent acute MI to oral asundexian 10, 20, or 50 mg or placebo once daily for 6 to 12 months in a double-blind, placebo-controlled, phase 2, dose-ranging trial. Patients were randomized within 5 days of their qualifying MI and received dual antiplatelet therapy with aspirin plus a P2Y12 inhibitor. The effect of asundexian on FXIa inhibition was assessed at 4 weeks. The prespecified main safety outcome was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding comparing all pooled asundexian doses with placebo. The prespecified efficacy outcome was a composite of cardiovascular death, MI, stroke, or stent thrombosis comparing ...
Conventional transradial access has been established as the gold standard for invasive coronary a... more Conventional transradial access has been established as the gold standard for invasive coronary angiography and percutaneous interventions by the current European and American guidelines. The distal or snuffbox radial artery access represents an alternative transradial access site that allows radial sheath insertion with the patient’s hand pronated. Firstly described 40 years ago, it exploded in popularity only recently. Promising additional benefits, the distal radial access is increasingly being adopted in various types of percutaneous interventions, being preferred by many interventional cardiologists and radiologists for its reduced vascular complications and time to hemostasis, and improvement of patient and operator comfort. Other centers consider it a fad, waiting for solid clear evidence and benefits. The evidence is dynamic and discrepant, depending on the center, the operator, and how it was collected (randomized controlled vs observational studies). Another essential aspe...
Catheterization and Cardiovascular Interventions, 2021
ObjectiveThe multicenter proximal upper limb artery (PULA) Registry was created to study the opti... more ObjectiveThe multicenter proximal upper limb artery (PULA) Registry was created to study the optimal puncture sites for the interventions involving the subclavian, axillary, and innominate arteries.BackgroundLittle is known about the optimal vascular access for PULA interventions, despite the well‐known technical complexity of these procedures.MethodsWe performed the retrospective analysis of consecutive patients treated for symptomatic steno‐occlusive disease of the proximal upper limb arteries between January 2015 and December 2019 in three high‐volume centers. Acute thrombotic occlusions were excluded from the study.ResultsTwo hundred and seventy‐two patients were treated for significant stenosis and 108 for total occlusion. The baseline patient's characteristics were similar, except for the higher median age of the stenotic patients: 68.5 years (31.1; 90.0) versus 64 years (38.0; 86.0) p = 0.0015. Successful revascularization rate was higher in the stenotic group 93.75% (255...
Purpose: To compare the acute success and complication rates of distal radial (DR) vs proximal ra... more Purpose: To compare the acute success and complication rates of distal radial (DR) vs proximal radial (PR) artery access for superficial femoral artery (SFA) interventions. Materials and Methods: Between 2016 and 2019, 195 consecutive patients with symptomatic SFA stenosis were treated via DR (n=38) or PR (n=157) access using a sheathless guide. Secondary access was achieved through the pedal artery when necessary. The main outcomes were technical success, major adverse events (MAEs), and access site complications. Secondary outcomes were treatment success, fluoroscopy time, radiation dose, procedure time, and crossover rate to another puncture site. Results: Overall technical success was achieved in 188 patients (96.4%): 37 of 38 patients (97.3%) in the DR group and 151 of 157 patients (96.2%) in the PR group (p=0.9). Dual (transradial and transpedal) access was used in 14 patients (36.8%) in the DR group and 28 patients (18.9%) in the PR group (p<0.01). Chronic total occlusions...
Introduction The primary purpose of this multicenter prospective register was to evaluate the suc... more Introduction The primary purpose of this multicenter prospective register was to evaluate the success and complication rate of different access sites for subclavian artery intervention. Secondary purpose was to investigate the safety of the distal radial artery access for subclavian artery intervention. Methods The clinical and angiographic data of 223 consecutive patients with symptomatic subclavian and anonym artery stenosis treated via transradial (TR), transbrachial (TB) and transfemoral (TF) access between 2015 and 2019 were evaluated in a multicenter registry. The exclusion criteria of the intervention was the acute proximal subclavian artery thrombosis. Primary endpoint: angiographic outcome of the subclavian and anonym artery intervention, rate of major and minor access site complications. Secondary endpoints: procedural complications, consumption of the angioplasty equipment, cross over rate to another puncture site and hospitalization in days. Results The procedure was suc...
Rotational atherectomy (RA) in peripheral circulation is an advanced revascularization procedure,... more Rotational atherectomy (RA) in peripheral circulation is an advanced revascularization procedure, often used in cases where traditional percutaneous transluminal angioplasty (PTA) is inadequate and bypass grafting is either unavailable or undesired. We report on a case, where RA was successfully performed after failed traditional PTA. The case highlights the importance of RA in peripheral cases where severe calcification occurs and the lesion is not suitable for PTA (cannot be passed with balloon or is undilatable).
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