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1.
Eur Heart J Suppl ; 25(Suppl E): E33-E39, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37234234

ABSTRACT

There are several differences between younger and older adults with acute coronary syndrome (ACS). However, few studies have evaluated these differences. We analysed the pre-hospital time interval [symptom onset to first medical contact (FMC)], clinical characteristics, angiographic findings, and in-hospital mortality in patients aged ≤50 (group A) and 51-65 (group B) years hospitalised for ACS. We retrospectively collected data from 2010 consecutive patients hospitalised with ACS between 1 October 2018 and 31 October 2021 from a single-centre ACS registry. Groups A and B included 182 and 498 patients, respectively. ST-segment elevation myocardial infarction (STEMI) was more common in group A than group B (62.6 and 45.6%, respectively; P < 0.001). The median time from symptom onset to FMC in STEMI patients did not significantly differ between groups A and B [74 (40-198) and 96 (40-249) min, respectively; P = 0.369]. There was no difference in the rate of sub-acute STEMI (symptom onset to FMC > 24 h) between groups A and B (10.4% and 9.0%, respectively; P = 0.579). Among patients with non-ST elevation acute coronary syndrome (NSTE-ACS), 41.8 and 50.2% of those in groups A and B, respectively, presented to the hospital within 24 h of symptom onset (P = 0.219). The prevalence of previous myocardial infarction was 19.2% in group A and 19.5% in group B (P = 1.00). Hypertension, diabetes, and peripheral arterial disease were more common in group B than group A. Active smoking was more common in group A than group B (67 and 54.2%, respectively; P = 0.021). Single-vessel disease was present in 52.2 and 37.1% of participants in groups A and B, respectively (P = 0.002). Proximal left anterior descending artery was more commonly the culprit lesion in group A compared with group B, irrespective of the ACS type (STEMI, 37.7 and 24.2%, respectively; P = 0.009; NSTE-ACS, 29.4 and 21%, respectively; P = 0.140). The hospital mortality rate for STEMI patients was 1.8 and 4.4% in groups A and B, respectively (P = 0.210), while for NSTE-ACS patients it was 2.9 and 2.6% in groups A and B, respectively (P = 0.873). No significant differences in pre-hospital delay were found between young (≤50 years) and middle-aged (51-65 years) patients with ACS. Although clinical characteristics and angiographic findings differ between young and middle-aged patients with ACS, the in-hospital mortality rate did not differ between the groups and was low for both of them.

2.
Expert Rev Cardiovasc Ther ; 21(2): 123-132, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36706282

ABSTRACT

INTRODUCTION: Cardiovascular diseases (CVDs) are the leading cause of cardiovascular mortality and a major contributor to disability worldwide. The prevalence of CVDs is continuously increasing, and from 1990 to 2019, it has doubled. Global cardiovascular mortality has increased from 12.1 million in 1990 to 18.6 million cases in 2019. The development of therapeutic options for these diseases is at the forefront of interest concerning the extensive socio-economic consequences. Modern endovascular transcatheter therapeutic options contribute to the reduction of cardiovascular morbidity and mortality. AREAS COVERED: The article concentrates on the triad of the most common causes of acute cardiovascular mortality and morbidity - myocardial infarction, ischemic stroke, and pulmonary embolism. Current evidence-based indications, specific interventional techniques, and remaining unsolved issues are reviewed and compared. A personal perspective on the possible implications for the future is provided. EXPERT OPINION: Primary angioplasty for ST-segment elevation myocardial infarction is a well-established therapeutic option with proven mortality benefits. We suppose that catheter-based interventions for acute stroke will spread quickly from centers of excellence to routine clinical practice. We believe that ongoing research will provide a basis for the expansion of interventional treatment of pulmonary embolism soon.


Subject(s)
Myocardial Infarction , Pulmonary Embolism , ST Elevation Myocardial Infarction , Stroke , Humans , Myocardial Infarction/therapy , Myocardial Infarction/drug therapy , ST Elevation Myocardial Infarction/therapy , Stroke/therapy , Stroke/etiology , Pulmonary Embolism/therapy , Treatment Outcome
4.
EuroIntervention ; 18(8): e639-e646, 2022 Oct 07.
Article in English | MEDLINE | ID: mdl-35620984

ABSTRACT

BACKGROUND: Intermediate-high risk acute pulmonary embolism (PE) remains associated with substantial mortality despite anticoagulation therapy. AIMS: The aim of this randomised pilot study was to compare catheter-directed thrombolysis to standard anticoagulation therapy. METHODS: Intermediate-high risk acute PE patients were admitted to a tertiary care centre (November 2019 to April 2021) and randomised in a 1:1 ratio to catheter-directed thrombolysis (CDT) or standard anticoagulation. Two catheters were used for the infusion of alteplase (1 mg/hr/catheter; total dose 20 mg) in the CDT group. The primary efficacy endpoint targeted improvement of right ventricular (RV) function, a decrease in pulmonary pressure, and a reduction of thrombus burden. RESULTS: Twenty-three patients were included (12 in the CDT group and 11 in the standard care group). The primary efficacy endpoint was achieved more frequently in the CDT group than in the standard care group (7 of 12 patients vs 1 of 11 patients, p=0.0004). An RV/left ventricular ratio reduction ≥25% (evident on computed tomography angiography) was achieved in 7 of 12 patients in the CDT group vs 2 of 11 patients in the standard care group (p=0.03). A systolic pulmonary artery pressure decrease of ≥30% or normotension at 24 hrs after randomisation was present in 10 of 12 patients in the CDT group vs 2 of 11 patients in the standard care group (p=0.001). There was no intracranial or life-threatening bleeding (type 5 or 3c bleeding, according to the Bleeding Academic Research Consortium classification). CONCLUSIONS: CDT for intermediate-high risk acute PE appears to be safe and effective. Further research is warranted to assess clinical endpoints.


Subject(s)
Pulmonary Embolism , Tissue Plasminogen Activator , Acute Disease , Anticoagulants/therapeutic use , Catheters , Fibrinolytic Agents/therapeutic use , Hemorrhage/chemically induced , Humans , Pilot Projects , Pulmonary Embolism/therapy , Thrombolytic Therapy/methods , Tissue Plasminogen Activator/therapeutic use , Treatment Outcome
5.
Eur Heart J Suppl ; 24(Suppl B): B36-B41, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35370499

ABSTRACT

Cardiac computed tomography (CT) is vital for safety and efficacy of transcatheter aortic valve implantation (TAVI). We aimed to determine the accuracy of fully automated CT analysis of aortic root anatomy before TAVI by Philips HeartNavigator software. This prospective, academic, single-centre study enrolled 128 consecutive patients with native aortic valve stenosis considered for TAVI. Automated HeartNavigator software was compared to the standard manual CT analysis by experienced operators using FluoroCT software. The sizing of the aortic annulus by perimeter and area significantly differed between both methods: mean perimeter was 76.43 mm vs. 77.52 mm (P < 0.0001) using manual FluoroCT vs. automated HeartNavigator software; mean area was 465 mm2 vs. 476 mm2 (P < 0.0001). Interindividual variability testing revealed mean differences between the two operators were 1.21 mm for the aortic annulus perimeter and 9 mm2 for the aortic annulus area. The hypothetical self-expandable transcatheter prosthesis sizing resulted in 80% agreement in 80% of cases. The time required to perform the automated CT analysis was significantly shorter than the time required for manual analysis (mean 17.8 min vs. 2.1 min, P < 0.0001). Philips HeartNavigator fully automated software for pre-TAVI CT analysis is a promising technology. Differences detected in aortic annulus dimensions are small and similar to the variability of manual CT analysis. Automated prediction of optimal fluoroscopic viewing angles is accurate. Correct transcatheter prosthesis sizing requires clinical oversight.

6.
Eur Heart J Suppl ; 24(Suppl B): B16-B22, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35370501

ABSTRACT

Long-term follow-up after primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction (STEMI) beyond 5 years is poorly described. There are no risk-stratification systems available for routine use. This retrospective, academic, two-centre analysis included consecutive patients who presented with acute STEMI between March 2008 and December 2019. In total, 5263 patients underwent pPCI; all patients were included in the analysis only once. Baseline characteristics were gathered from prospective local registries and based on initial hospitalization. The study enrolled 5263 patients who had been treated with pPCI; it found that cardiovascular mortality was the most frequent cause of death (65.0%) on long-term follow-up to 12 years. Myocardial infarction associated mortality was 27.2%. Cardiovascular mortality was dominant, including in the landmark analysis beyond 1 year. Multivariate analysis identified significant predictors for long-term cardiovascular mortality: age, history of diabetes mellitus, history of renal insufficiency, history of heart failure, Killip class, and successful pPCI at presentation. A predictive model was built to evaluate the risk of cardiovascular death with a high discrimination value (C-statistic = 0.84). Cardiovascular diseases remain the leading cause of long-term mortality after pPCI in the Central European population. Our novel predictive model provides risk stratification; it could identify patients who would experience the greatest benefit from aggressive secondary prevention measures.

7.
Eur Heart J Suppl ; 24(Suppl B): B3-B9, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35370502

ABSTRACT

Managing patients with acute coronary syndrome (ACS) in an ageing population with comorbidities is clinically and economically challenging. Well-conducted unselected registries are essential for providing information on real-day clinical practice. The aim was to create a long term, very detail-controlled registry of unselected patients admitted with ACS to a high-volume centre in Central Europe. Consecutive patients admitted with confirmed ACS were entered into the prospective registry from 1 October 2018 to 30 September 2021. Data on 214 parameters, including clinical characteristics, angiographic findings, laboratory and therapeutic findings, financial costs, and in-hospital mortality, were obtained for all patients. Analyses were performed on the complete dataset of 1804 patients. Of these patients, 694 (38.5%) were admitted for ST-segment elevation myocardial infarction (STEMI) and 1110 (61.5%) were admitted for non-ST-elevation (NSTE)-ACS [779 with NSTE myocardial infarction (NSTE-MI) and 331 with unstable angina (UA)]. Almost all patients (99%) underwent coronary angiography. Primary percutaneous coronary intervention (PCI) was performed in 93.4% of STEMI patients and 74.5% of NSTE-ACS patients. Patients with NSTE-MI had the longest total hospital stay (8.1 ± 9.1 days) and highest financial costs (8579.5 ± 7173.2 euros). In-hospital mortality was 1.2% in UA, 6.2% in NSTE-MI, and 10.9% in STEMI patients. Age older than 75 years, pre-hospital cardiac arrest and/or mechanical ventilation, subacute STEMI, and ejection fraction below 40% were the most powerful predictors of in-hospital mortality as assessed by multivariate analyses. The in-hospital mortality of unselected NSTE-MI and STEMI patients in daily practice is not low despite very good implementation of guideline-recommended therapy with a high rate of revascularization. The highest financial costs are associated with NSTE-MI.

8.
Eur Heart J Suppl ; 24(Suppl B): B10-B15, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35370503

ABSTRACT

Many scoring systems for predicting the outcomes of patients with acute coronary syndrome (ACS) have been proposed. In some populations, a significant reduction in length of hospital stay may be achieved without compromising patient prognoses. However, the use of such scoring systems in clinical practice is limited. The aim of this study was to propose a universal list of predictors that can identify low-risk ACS patients who may be eligible for an earlier hospital discharge without increased short-term risk for major adverse cardiac events. A cohort of 1420 patients diagnosed with ACS were enrolled into a single-centre registry between October 2018 and December 2020. Clinical, laboratory, echocardiographic, and angiographic measurements were taken for each patient and entered into the study database. Using retrospective univariant analyses of patients treated with percutaneous coronary intervention (PCI) (n = 932), we compared each predictor to 30-day mortality rate using the Czech national registry of dead people. Eleven predictors correlate significantly with 30-day survival: age <80 years, ejection fraction >50%, no cardiopulmonary resuscitation, no mechanical ventilation needed, Killip class I at admission, haemoglobin levels >110 g/L while hospitalized, successful PCI procedure(s), no residual stenosis over 90%, Thrombolysis in Myocardial Infarction 3 flow after PCI, no left main stem disease, and no triple-vessel coronary artery disease. In all, presence of all predictors applies to 328 patients (35.2% of the cohort), who maintained a 100% survival rate at 30 days. A combination of clinical, echocardiographic, and angiographic findings provides valuable information for predicting the outcomes of patients with all types of ACS. We created a simple, useful tool for selecting low-risk patients eligible for early discharge.

9.
Eur Heart J Suppl ; 24(Suppl B): B23-B27, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35370506

ABSTRACT

Transcatheter aortic valve implantation (TAVI) has become a high-volume procedure with increasing demands on hospital resources. Local anaesthesia with sedation supervised by an anaesthesiology team is the current standard of care. We aimed to describe our experience with a simplified, nurse-led sedation (NLS) protocol. This study enrolled 128 consecutive patients who underwent transfemoral TAVI with self-expandable Evolut R prosthesis between November 2019 and April 2021. Operators selected 50% of patients for NLS based on the clinical expectation of lower risk of procedural difficulties. Nurse-led sedation protocol demanded only mild to moderate levels of sedation. The clinical outcomes were determined from the local TAVI registry and the national mortality database. Baseline patient characteristics were similar in the NLS (n = 64) and anaesthesiologist-led sedation (ALS) (n = 64) groups except higher prevalence of diabetes mellitus (48.4% vs. 31.3%, P = 0.035) and peripheral vascular disease (20.3% vs. 7.8%, P = 0.036) in the ALS group. There was a trend for the larger prostheses used in the ALS group (P = 0.058). The procedural results did not differ, and coronary care team backup was rarely needed in the NLS group (6% of patients). The in-hospital outcomes were identical from both clinical and echocardiography perspectives, and 30-day mortality was low in both groups (1.5%). For the NLS group, preparation in the catheterization laboratory was quicker by 6.4 min (P = 0.01), and intensive care unit stay was shorter (2.03 vs. 3.48 days, P = 0.001). In conclusion, the NLS for the selected transfemoral TAVI population seems safe.

10.
Cardiovasc Drugs Ther ; 36(6): 1129-1136, 2022 12.
Article in English | MEDLINE | ID: mdl-34505954

ABSTRACT

BACKGROUND: Magnesium-based bioresorbable Magmaris stents are rapidly resorbed. Few randomized studies have evaluated the efficacy of such stents in patients with acute coronary syndrome. AIM: To investigate late lumen loss as assessed via quantitative coronary angiography (QCA) and optical coherence tomography (OCT) in patients with acute coronary syndrome treated with Magmaris stents or permanent, everolimus-eluting metallic Xience stents. METHODS AND RESULTS: This PRAGUE-22 study was a two-centre, investigator-initiated, randomized study. Fifty patients were randomized based on the inclusion criteria for acute coronary syndrome and the anatomical suitability to receive Magmaris or Xience stents. The patient characteristics did not differ between the Magmaris group (n = 25) and Xience group (n = 25). The mean ages were 57.0 ± 10.5 vs. 55.5 ± 9.2 years (p = 0.541) and the total implanted stent length was 24.6 ± 10.7 mm vs. 27.6 ± 11.1 mm (p = 0.368), respectively. Four clinical events occurred in the Magmaris group and one in the Xience group during 12 months of follow-up. The extent of late lumen loss (assessed via QCA) at 12 months was greater in the Magmaris group than in the Xience group (0.54 ± 0.70 vs. 0.11 ± 0.37 mm; p = 0.029). The late lumen loss diameter (measured via OCT) in the Magmaris group was also significantly larger than that in the Xience group (0.59 ± 0.37 vs. 0.22 ± 0.20 mm; p = 0.01). CONCLUSION: Implantation of a magnesium-based bioresorbable stent in patients with acute coronary syndrome is associated with a greater extent of late lumen loss at the 12-month follow-up compared with implantation of a permanent, everolimus-eluting metallic stent. TRIAL REGISTRATION: ISRCTN89434356.


Subject(s)
Acute Coronary Syndrome , Coronary Artery Disease , Drug-Eluting Stents , Percutaneous Coronary Intervention , Humans , Everolimus/adverse effects , Sirolimus , Magnesium , Absorbable Implants , Acute Coronary Syndrome/diagnostic imaging , Acute Coronary Syndrome/therapy , Coronary Angiography , Treatment Outcome , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Coronary Artery Disease/therapy
11.
J Clin Med ; 10(1)2020 Dec 24.
Article in English | MEDLINE | ID: mdl-33374167

ABSTRACT

The COVID-19 pandemic presents several challenges for managing patients with acute coronary syndrome (ACS). Modified treatment algorithms have been proposed for the pandemic. We assessed new algorithms proposed by The European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the Acute Cardiovascular Care Association (ACCA) on patients with ACS admitted to the hospital during the COVID-19 pandemic. The COVID-19 period group (CPG) consisted of patients admitted into a high-volume centre in Prague between 1 February 2020 and 30 May 2020 (n = 181). The reference group (RG) included patients who had been admitted between 1 October 2018 and 31 January 2020 (n = 834). The proportions of patients with different types of ACS admitted before and during the pandemic did not differ significantly: in all ACS patients, KILLIP III-IV class was present in 13.9% in RG and in 9.4% of patients in CPG (p = 0.082). In NSTE-ACS patients, the ejection fraction was lower in the CPG than in the RG (44.7% vs. 50.7%, respectively; p < 0.001). The time from symptom onset to first medical contact did not differ between CPG and RG patients in the respective NSTE-ACS and STEMI groups. The time to early invasive treatment in NSTE-ACS patients and the time to reperfusion in STEMI patients were not significantly different between the RG and the CPG. In-hospital mortality did not differ between the groups in NSTE-ACS patients (odds ratio in the CPG 0.853, 95% confidence interval (CI) 0.247 to 2.951; p = 0.960) nor in STEMI patients (odds ratio in CPG 1.248, 95% CI 0.566 to 2.749; p = 0.735). Modified treatment strategies for ACS during the COVID-19 pandemic did not cause treatment delays. Hospital mortality did not differ.

12.
JACC Cardiovasc Interv ; 13(21): 2560-2570, 2020 11 09.
Article in English | MEDLINE | ID: mdl-33153569

ABSTRACT

OBJECTIVES: The aim of this study was to define the optimal fluoroscopic viewing angles of both coronary ostia and important coronary bifurcations by using 3-dimensional multislice computed tomographic data. BACKGROUND: Optimal fluoroscopic projections are crucial for coronary imaging and interventions. Historically, coronary fluoroscopic viewing angles were derived empirically from experienced operators. METHODS: In this analysis, 100 consecutive patients who underwent computed tomographic coronary angiography (CTCA) for suspected coronary artery disease were studied. A CTCA-based method is described to define optimal viewing angles of both coronary ostia and important coronary bifurcations to guide percutaneous coronary interventions. RESULTS: The average optimal viewing angle for ostial left main stenting was left anterior oblique (LAO) 37°, cranial (CRA) 22° (95% confidence interval [CI]: LAO 33° to 40°, CRA 19° to 25°) and for ostial right coronary stenting was LAO 79°, CRA 41° (95% CI: LAO 74° to 84°, CRA 37° to 45°). Estimated mean optimal viewing angles for bifurcation stenting were as follows: left main: LAO 0°, caudal (CAU) 49° (95% CI: right anterior oblique [RAO] 8° to LAO 8°, CAU 43° to 54°); left anterior descending with first diagonal branch: LAO 11°, CRA 71° (95% CI: RAO 6° to LAO 27°, CRA 66° to 77°); left circumflex bifurcation with first marginal branch: LAO 24°, CAU 33° (95% CI: LAO 15° to 33°, CAU 25° to 41°); and posterior descending artery and posterolateral branch: LAO 44°, CRA 34° (95% CI: LAO 35° to 52°, CRA 27° to 41°). CONCLUSIONS: CTCA can suggest optimal fluoroscopic viewing angles of coronary artery ostia and bifurcations. As the frequency of use of diagnostic CTCA increases in the future, it has the potential to provide additional information for planning and guiding percutaneous coronary intervention procedures.


Subject(s)
Computed Tomography Angiography , Multidetector Computed Tomography , Coronary Angiography , Fluoroscopy , Humans , Treatment Outcome
13.
J Cardiol Cases ; 22(4): 149-151, 2020 Oct.
Article in English | MEDLINE | ID: mdl-33014192

ABSTRACT

Radiotherapy-induced coronary artery disease (RT-CAD) is a well-known late complication of anti-neoplastic treatment. Although definitive diagnosis requires standard coronary angiography, modern intracoronary imaging techniques, such as optical coherence tomography (OCT), are able to provide detailed morphological characteristics of RT-CAD lesions. We report the case of a 42-year-old male with a previous history of treated Hodgkin's lymphoma who complained of typical chest pain on minimal exertion. Coronary angiography showed significant 2-vessel disease. Use of OCT documented the fibro-fatty nature of coronary lesions, showing a constrictive pattern, compatible with RT-CAD. The patient underwent successful revascularization of both lesions. .

14.
Vnitr Lek ; 66(5): 282-286, 2020.
Article in English | MEDLINE | ID: mdl-32942865

ABSTRACT

stenosis is the most common acquired valve disease in adults and the prevalence of this disease is increasing with the aging population. Transcatheter aortic valve implantation (TAVI) became fully established method for treating this disease. The aim of this review is to present the current view of the performance technique, to summarize the data on the outcome of patients from recently published randomized studies and registries and to simply describe patient care after the procedure.


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Adult , Aged , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Humans , Registries , Treatment Outcome
15.
Eur Heart J Suppl ; 22(Suppl F): F44-F50, 2020 Jul.
Article in English | MEDLINE | ID: mdl-32694953

ABSTRACT

We aimed to determine the incidence, severity, and long-term impact of intravascular haemolysis after self-expanding transcatheter aortic valve implantation (TAVI). We believe this should be evaluated before extending the indications of TAVI to younger low-risk patients. Prospective, academic, single centre study of 94 consecutive patients treated with supra-annular self-expandable TAVI prosthesis between April 2009 and January 2014. Haemolysis at 1-year post-TAVI was defined per the published criteria based on levels of haemoglobin, reticulocyte and schistocyte count, lactate dehydrogenase (LDH), and haptoglobin. All patients had long-term clinical follow-up (6 years). The incidence of haemolysis at 1-year follow-up varied between 9% and 28%, based on different haemolysis definitions. Haemolysis was mild in all cases, no patient had markedly increased LDH levels. The presence of moderate/severe paravalvular aortic regurgitation was associated with haemolysis (7.7% vs. 23.1%, P = 0.044) and aortic valve area post-TAVI did not differ between groups with or without haemolysis (1.01 vs. 0.92 cm2/m2, P = 0.23) (definition including schistocyte count). The presence of haemolysis did not have any impact on patient prognosis after 6 years with log-rank test P = 0.80. Intravascular haemolysis after TAVI with self-expandable prosthesis is present in 9-28% of patients depending on the definition of haemolysis. The presence of haemolysis is associated with moderate/severe paravalvular aortic regurgitation but not with post-TAVI aortic valve area. Haemolysis is mild with no impact on prognosis.

16.
EuroIntervention ; 16(8): 645-653, 2020 Oct 23.
Article in English | MEDLINE | ID: mdl-32451321

ABSTRACT

AIMS: The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of a bioresorbable vascular scaffold (BVS). METHODS AND RESULTS: The COMPARE-ABSORB trial was an investigator-initiated, prospective randomised study. Patients at high risk of restenosis were randomly assigned to receive either a BVS or an everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically indicated target lesion revascularisation at one year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS arm. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1%) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval [CI]: -1.2%-3.0%, p non-inferiority <0.001). Definite or probable device thrombosis (2.0% vs 0.6%, hazard ratio [HR] 3.32, 95% CI: 1.22-8.99, p=0.012) and TVMI (4.0% vs 2.1%, HR 1.96, 95% CI: 1.10-3.51, p=0.02) were significantly higher in the BVS group than in the EES group. CONCLUSIONS: In patients at high risk of restenosis, non-inferiority of BVS compared with EES in terms of TLF was met at one year. BVS carried a higher risk of device thrombosis and TVMI than EES.


Subject(s)
Drug-Eluting Stents , Percutaneous Coronary Intervention , Absorbable Implants , Drug-Eluting Stents/adverse effects , Humans , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , Prosthesis Design , Tissue Scaffolds , Treatment Outcome
17.
Cardiovasc Drugs Ther ; 34(3): 335-344, 2020 06.
Article in English | MEDLINE | ID: mdl-32212061

ABSTRACT

OBJECTIVES: The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population. METHODS: Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel. RESULTS: For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis. CONCLUSION: Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.


Subject(s)
Cardiovascular Agents/administration & dosage , Coronary Artery Disease/therapy , Drug-Eluting Stents , Dual Anti-Platelet Therapy , Percutaneous Coronary Intervention/instrumentation , Platelet Aggregation Inhibitors/administration & dosage , Sirolimus/administration & dosage , Aged , Aged, 80 and over , Cardiovascular Agents/adverse effects , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Thrombosis/etiology , Coronary Thrombosis/prevention & control , Dual Anti-Platelet Therapy/adverse effects , Dual Anti-Platelet Therapy/mortality , Female , Guideline Adherence , Hemorrhage/chemically induced , Humans , Male , Middle Aged , Multicenter Studies as Topic , Observational Studies as Topic , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Platelet Aggregation Inhibitors/adverse effects , Practice Guidelines as Topic , Practice Patterns, Physicians' , Prosthesis Design , Risk Assessment , Risk Factors , Sirolimus/adverse effects , Time Factors , Treatment Outcome
18.
J Transl Med ; 18(1): 33, 2020 01 30.
Article in English | MEDLINE | ID: mdl-32000796

ABSTRACT

BACKGROUND: Bioresorbable scaffold (BRS) Absorb™ clinical use has been stopped due to higher rate of device thrombosis. Scaffold struts persist longer than 2 years in the vessel wall. Second generation devices are being developed. This study evaluates long-term invasive imaging in STEMI patients. METHODS: PRAGUE-19 study is an academic study enrolling consecutive STEMI patients with intention to implant Absorb™ BRS. A total of 83 STEMI patients between December 2012 and March 2014 fulfilled entry criteria. Coronary angiography and optical coherence tomography at 5 year follow-up was performed in 25 patients. RESULTS: Primary combined clinical endpoint (death, myocardial infarction or target vessel revascularization) occurred in 12.6% during the five-year follow-up with overall mortality 6.3%. Definite scaffold thrombosis occurred in 2 patients in the early phase after BRS implantation. Quantitative coronary angiography after 5 years demonstrated low late lumen loss of 0.11 ± 0.35 mm with binary restenosis rate of 0%. Optical coherence tomography demonstrated complete resorption of scaffold struts and mean lumen diameter of 3.25 ± 0.30 and 3.22 ± 0.49 (P = 0.73) at baseline and after 5 years, respectively. Three patients developed small coronary artery aneurysm in the treated segment. CONCLUSION: Invasive imaging results 5 years after BRS implantation in STEMI showed complete resorption of scaffold struts and stable lumen vessel diameter. Trial registration ISRCTN43696201 (retrospectivelly registred, June 7th, 2019). https://www.isrctn.com/ISRCTN43696201.


Subject(s)
Drug-Eluting Stents , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Absorbable Implants , Coronary Angiography , Humans , Prosthesis Design , ST Elevation Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/surgery , Treatment Outcome
19.
Medicine (Baltimore) ; 99(8): e19119, 2020 Feb.
Article in English | MEDLINE | ID: mdl-32080086

ABSTRACT

Stent designs with ultrathin struts may further increase the procedural success of challenging lesion subsets. The objective of this study was to assess the safety and efficacy of ultrathin strut, polymer-free sirolimus eluting stent (PF-SES) implantations in a large scale, unselected patient population.Adult patients underwent percutaneous coronary interventions (PCI) with a thin-strut PF-SES. Data from two all-comers observational studies having the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled. The accumulated target lesion revascularization (TLR) rate at 9-12 months was the primary endpoint. All dual antiplatelet therapy strategies according to the applicable guidelines were permissible.In total, 7243 patients were prospectively enrolled for PCI with PF-SES in stable coronary artery disease or acute coronary syndrome (ACS). Major risk factors in the overall cohort were diabetes (37.3%), ST elevation myocardial infarction (18.1%) and non-ST myocardial infarction (24.6%). The follow-up rate was 88.6% in the overall population. The TLR rate in the overall cohort was 2.2% whereas definite/probable stent thrombosis (ST) occurred in 0.7%. In patients with in-stent restenosis lesions, the major adverse cardiac events rate was 6.4% whereas the corresponding rate for isolated left main coronary artery (LMCA) disease was highest with 6.7% followed by patients with culprit lesions in vein bypasses (VB, 7.1%). The mortality rate in patients treated in VB lesions was highest with 5.4%, followed by the isolated LMCA subgroup (3.4%) and ACS (2.6%).PCI with PF-SES in an unselected patient population, is associated with low clinical event and ST rates. Furthermore, PF-SES angioplasty in niche indications demonstrated favorable safety and efficacy outcomes with high procedural success rates.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Drug-Eluting Stents/adverse effects , Percutaneous Coronary Intervention/instrumentation , Sirolimus/therapeutic use , Absorbable Implants/adverse effects , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/mortality , Acute Coronary Syndrome/surgery , Aged , Blood Vessel Prosthesis Implantation/methods , Coronary Artery Disease/diagnosis , Coronary Artery Disease/mortality , Coronary Artery Disease/surgery , Diabetes Mellitus/epidemiology , Drug-Eluting Stents/trends , Graft Occlusion, Vascular/epidemiology , Humans , Middle Aged , Non-ST Elevated Myocardial Infarction/complications , Non-ST Elevated Myocardial Infarction/epidemiology , Polymers , Practice Patterns, Physicians'/standards , Prospective Studies , Prosthesis Design , Risk Factors , ST Elevation Myocardial Infarction/complications , ST Elevation Myocardial Infarction/epidemiology , Treatment Outcome
20.
PLoS One ; 15(1): e0226606, 2020.
Article in English | MEDLINE | ID: mdl-31929543

ABSTRACT

BACKGROUND: The objective of this study was to assess regional and ethnic differences in an unselected patient population treated with polymer-free sirolimus-eluting stents (PF-SES) in Asia and Europe. METHODS: Two all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined for data analysis to assure sufficient statistical power. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 9-12 months. RESULTS: Of the total population of 7243 patients, 44.0% (3186) were recruited in the Mediterranean region and 32.0% (2317) in central Europe. The most prominent Asian region was South Korea (17.6%, 1274) followed by Malaysia (5.7%, 413). Major cardiovascular risk factors varied significantly across regions. The overall rates for accumulated TLR and MACE were low with 2.2% (140/6374) and 4.4% (279/6374), respectively. In ACS patients, there were no differences in terms of MACE, TLR, MI and accumulated mortality between the investigated regions. Moreover, dual antiplatelet therapy (DAPT) regimens were substantially longer in Asian countries even in patients with stable coronary artery disease as compared to those in Europe. CONCLUSIONS: PF-SES angioplasty is associated with low clinical event rates in all regions. Further reductions in clinical event rates seem to be associated with longer DAPT regimens.


Subject(s)
Coronary Artery Disease/therapy , Drug-Eluting Stents , Ethnicity/statistics & numerical data , Immunosuppressive Agents/therapeutic use , Myocardial Infarction/prevention & control , Percutaneous Coronary Intervention/methods , Sirolimus/therapeutic use , Aged , Europe/epidemiology , Female , Follow-Up Studies , Humans , Incidence , Malaysia/epidemiology , Male , Mediterranean Region/epidemiology , Middle Aged , Myocardial Infarction/epidemiology , Polymers , Prognosis , Prospective Studies , Republic of Korea/epidemiology
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