scholarly journals Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE Registry

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Gianluca Caiazzo ◽  
Mario De Michele ◽  
Luca Golino ◽  
Vincenzo Manganiello ◽  
Luciano Fattore

Background. Sirolimus-coated balloons (SCBs) represent a novel therapeutic option for both in-stent restenosis (ISR) and de novo coronary lesions treatment, especially in small vessels. Our registry sought to evaluate the procedural and clinical outcomes of such devices in a complex acute coronary syndrome (ACS) clinical setting. Methods and Results. We treated 74 consecutive patients with percutaneous coronary intervention (PCI) with at least 1 SCB used for ISR and/or de novo coronary lesion in small vessels at our institution. Sixty-two patients presented with ACS, and their data were included in our analysis. The mean age was 67 ± 10 years, and patients presenting with ST-elevated myocardial infarction (STEMI) were 14 (23%). De novo lesions were 52%, whereas ISR was 48%. Procedural success occurred in 100% of the cases. At the 11 ± 7 months follow-up, major adverse cardiovascular events (MACEs) were 3 (4.8%). Cardiovascular death (CD) occurred in 1 (1.6%) patient and myocardial infarction (MI) in 2 patients (3.2%) as well as ischemia-driven target lesion revascularization (TLR). One probable subacute thrombosis occurred (1.6%) with no major bleedings. In a subgroup analysis, the incidence of MACE did not show significant differences between patients treated for de novo lesions and ISR (HR: 0.239; CI 95%: 0.003–16.761, p = 0.509 ). Conclusions. In the SELFIE prospective registry, SCB showed a good safety and efficacy profile for the treatment of coronary lesions, both ISR and/or de novo in small vessels, in a complex ACS population of patients at the 11 ± 7 months follow-up.

Critical Care ◽  
2021 ◽  
Vol 25 (1) ◽  
Author(s):  
Raffaele Marfella ◽  
Pasquale Paolisso ◽  
Celestino Sardu ◽  
Luciana Palomba ◽  
Nunzia D’Onofrio ◽  
...  

Abstract Background The viral load of asymptomatic SAR-COV-2 positive (ASAP) persons has been equal to that of symptomatic patients. On the other hand, there are no reports of ST-elevation myocardial infarction (STEMI) outcomes in ASAP patients. Therefore, we evaluated thrombus burden and thrombus viral load and their impact on microvascular bed perfusion in the infarct area (myocardial blush grade, MBG) in ASAP compared to SARS-COV-2 negative (SANE) STEMI patients. Methods This was an observational study of 46 ASAP, and 130 SANE patients admitted with confirmed STEMI treated with primary percutaneous coronary intervention and thrombus aspiration. The primary endpoints were thrombus dimension + thrombus viral load effects on MBG after PPCI. The secondary endpoints during hospitalization were major adverse cardiovascular events (MACEs). MACEs are defined as a composite of cardiovascular death, nonfatal acute AMI, and heart failure during hospitalization. Results In the study population, ASAP vs. SANE showed a significant greater use of GP IIb/IIIa inhibitors and of heparin (p < 0.05), and a higher thrombus grade 5 and thrombus dimensions (p < 0.05). Interestingly, ASAP vs. SANE patients had lower MBG and left ventricular function (p < 0.001), and 39 (84.9%) of ASAP patients had thrombus specimens positive for SARS-COV-2. After PPCI, a MBG 2–3 was present in only 26.1% of ASAP vs. 97.7% of SANE STEMI patients (p < 0.001). Notably, death and nonfatal AMI were higher in ASAP vs. SANE patients (p < 0.05). Finally, in ASAP STEMI patients the thrombus viral load was a significant determinant of thrombus dimension independently of risk factors (p < 0.005). Thus, multiple logistic regression analyses evidenced that thrombus SARS-CoV-2 infection and dimension were significant predictors of poorer MBG in STEMI patients. Intriguingly, in ASAP patients the female vs. male had higher thrombus viral load (15.53 ± 4.5 vs. 30.25 ± 5.51 CT; p < 0.001), and thrombus dimension (4.62 ± 0.44 vs 4.00 ± 1.28 mm2; p < 0.001). ASAP vs. SANE patients had a significantly lower in-hospital survival for MACE following PPCI (p < 0.001). Conclusions In ASAP patients presenting with STEMI, there is strong evidence towards higher thrombus viral load, dimension, and poorer MBG. These data support the need to reconsider ASAP status as a risk factor that may worsen STEMI outcomes.


2021 ◽  
Author(s):  
Youmei Li ◽  
Qi Mao ◽  
Huanyun Liu ◽  
Denglu Zhou ◽  
Jianhua Zhao

Abstract Purpose To compare the effects of paclitaxal-coated balloon (PCB) versus conventional balloon (CB) on side branch (SB) lesion and cardiovascular outcomes in patients with de novo true bifurcation lesions. Methods In total, 219 patients with de novo true bifurcation lesions were enrolled and divided into PCB group (102 cases) and CB group (117 cases) according to angioplasty strategy in SB. Drug-eluting stent (DES) was implanted in main vessel (MV) for each subject. All subjects underwent a 12-month follow-up for late lumen loss (LLL), restenosis and major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI). MACEs included cardiac death, nonfatal myocardial infarction and angina pectoris. Results There were no differences in diameter, minimum lumen diameter (MLD) and stenosis for bifurcation lesions between the two groups before and immediately after PCI (P > 0.05). After 12-month follow-up, no differences occurred in MV-MLD and MV-LLL between the two groups (P > 0.05); SB-MLD in PCB group was higher than that in CB group (1.97 ± 0.36 mm vs. 1.80 ± 0.43 mm, P = 0.007); SB-LLL in PCB group was lower than that in CB group (0.11 ± 0.18 mm vs. 0.19 ± 0.25 mm, P = 0.024). Multivariate COX analyses indicated that PCB group had lower MACE risk than CB group (HR = 0.480, 95%CI 0.244–0.941, P = 0.033). Conclusion PCB could decrease SB-LLL and MACE risk in patients with de novo true coronary bifurcation lesion 12 months after single-DES intervention.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Waqas Ullah ◽  
Salman Zahid ◽  
Smitha Narayana Gowda ◽  
Samavia Munir ◽  
yasar sattar ◽  
...  

Introduction: ST-segment elevation myocardial infarction (STEMI) in patients with concomitant multivessel coronary artery disease (CAD) is associated with poor prognosis. Hypothesis: We sought to determine the merits of percutaneous coronary intervention (PCI) of the culprit-only compared with a complete revascularization approach. Methods: The MEDLINE (PubMed, Ovid), Embase, Clinicaltrials.org and Cochrane databases were queried with various combinations of medical subject headings (MeSH) to identify articles comparing complete and culprit-only revascularization. Data were compared using a random-effect model to calculate unadjusted odds ratio. Results: A total of 26 studies consisting of 26,892 patients, 18,377 in the culprit-only and 8,515 in the complete revascularization group were included. The mean age of patients included in the study was 63 years, comprising 72% of male patients. Baseline characteristics of the two treatment groups were comparable. On a median follow-up of 1-year, culprit-only revascularization was associated with a significantly higher odds of major adverse cardiovascular events (MACE) (OR 1.36, 95% CI 1.10-1.69, p=0.005) (figure), angina (OR 2.28, 95% CI 1.83-2.85, p=<0.00001) and revascularization (OR 1.71, 95% CI 1.18- 2.49, p=0.005) compared to complete revascularization group. The all-cause mortality (OR 1.17, 95% CI 0.89-1.54, p=0.25),, cardiovascular mortality (OR 1.20, 95% CI 0.90-1.61, p=0.22), rate of heart failure (OR 1.17, 95% CI 0.86-1.59, p=0.31), CABG (OR 1.47, 95% CI 0.82-2.64, p=0.19), repeat MI (OR 1.23, 95% CI 0.92-1.63, p=0.17) and stroke (OR 1.27 95% CI 0.68-2.34, p=0.45%) were similar between the two groups. Conclusions: In contrast to the culprit-only approach, complete revascularization in patients with the acute coronary syndrome is associated with a significant reduction in MACE, angina and need for revascularization.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Jakl ◽  
P Cervinka ◽  
P Kala ◽  
J Kanovsky ◽  
A Kupec ◽  
...  

Abstract Background Optical coherence tomography (OCT) guidance in primary percutaneous coronary intervention (pPCI) is expected to be safe in short and mid-term follow-up. Long term merits or risks of OCT guidance are unknown. Purpose To assess the possible merits of OCT guidance in pPCI in long-term follow-up. Methods 201 patients with ST-elevation myocardial infarction (STEMI) were enrolled in this study. Patients were randomized either to pPCI alone (angio-guided group, n=96) or to pPCI with OCT guidance (OCT-guided group, n=105) and also either to biolimus A9 or to everolimus-eluting stent implantation. The OCT study was performed after PCI with C7-XRTM intravascular imaging system employing a non-occlusive technique. Incidence of Device-oriented Composite Endpoints (DoCE) was compared in both study groups. DoCE were defined as composite of definite or possible cardiovascular death, myocardial infarction and target vessel revascularization. The search for DoCE was performed by means of medical check-ups, repeated telephone contacts, analysis of medical records and search in national population registry. Results Mean follow-up was 6.5 (6.5–7.1 years). Of these patients, 2 (1.0%) patients died of cardiovascular reason, 4 patients (2%) suffered myocardial infarction and 7 (3.5%) patients underwent target lesion revascularization. In OCT guided group, number of stents per patient was higher (1.4 vs. 1.2, p=0.03). Risk of DoCE was significantly higher in OCT-guided group (7.6% vs. 2.1%, p=0.023). Event-free survival in study groups Conclusion Our data suggest increased risk of adverse events related to OCT guided tailoring of stent implantation performed after pPCI. These findings should be confirmed by further randomised trials with higher statistical power. Acknowledgement/Funding The work was supported by a long-term organization development plan 1011 (FMHS)


Biomolecules ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. 1833
Author(s):  
Michal Kacprzak ◽  
Magdalena Brzeczek ◽  
Marzenna Zielinska

Atrial natriuretic peptide (ANP) is secreted in response to the stretching of the atrial wall. Atrial ischemia most likely impairs the ability of atrial myocytes to produce ANP. Atrial infarction (AI) is rarely diagnosed but not infrequently associated with myocardial infarction (MI). The aim of the study was to assess the association between AI and the prognostic value of N-terminal proANP (NT-proANP) in patients with MI treated with primary percutaneous coronary intervention (PCI). We evaluated data of 100 consecutive patients. Plasma levels of NT-proANP were measured by the ELISA method. ECG recordings were interpreted to diagnose AI according to Liu’s criteria. All patients were followed-up prospectively for 12 months for the manifestation of major adverse cardiovascular events (MACE), defined as unplanned coronary revascularization, stroke, reinfarction or all-cause death. AI was diagnosed in 36 patients. 14% of patients developed MACE. AI did not affect the incidence of MACE or any of its components, nor the patients’ prognosis. NT-proANP revealed to be a strong predictor of death but was not associated with other adverse events. Conclusions: AI in patients with MI treated with primary PCI is not connected with their prognosis nor affects the usefulness of NT-proANP in predicting death during the 12-month follow-up.


2019 ◽  
Vol 27 (7) ◽  
pp. 696-705 ◽  
Author(s):  
Fabrizio D'Ascenzo ◽  
Maurizio Bertaina ◽  
Francesco Fioravanti ◽  
Federica Bongiovanni ◽  
Sergio Raposeiras-Roubin ◽  
...  

Introduction The benefits of short versus long-term dual antiplatelet therapy (DAPT) based on the third generation P2Y12 antagonists prasugrel or ticagrelor, in patients with acute coronary syndromes treated with percutaneous coronary intervention remain to be clearly defined due to current evidences limited to patients treated with clopidogrel. Methods All acute coronary syndrome patients from the REgistry of New Antiplatelets in patients with Myocardial Infarction (RENAMI) undergoing percutaneous coronary intervention and treated with aspirin, prasugrel or ticagrelor were stratified according to DAPT duration, that is, shorter than 12 months (D1 group), 12 months (D2 group) and longer than 12 months (D3 group). The three groups were compared before and after propensity score matching. Net adverse clinical events (NACEs), defined as a combination of major adverse cardiac events (MACEs) and major bleedings (including therefore all cause death, myocardial infarction and Bleeding Academic Research Consortium (BARC) 3–5 bleeding), were the primary end points, MACEs (a composite of all cause death and myocardial infarction) the secondary one. Single components of NACEs were co-secondary end points, along with BARC 2–5 bleeding, cardiovascular death and stent thrombosis. Results A total of 4424 patients from the RENAMI registry with available data on DAPT duration were included in the model. After propensity score matching, 628 patients from each group were selected. After 20 months of follow up, DAPT for 12 months and DAPT for longer than 12 months significantly reduced the risk of NACE (D1 11.6% vs. D2 6.7% vs. D3 7.2%, p = 0.003) and MACE (10% vs. 6.2% vs. 2.4%, p < 0.001) compared with DAPT for less than 12 months. These differences were driven by a reduced risk of all cause death (7.8% vs. 1.3% vs. 1.6%, p < 0.001), cardiovascular death (5.1% vs. 1.0% vs. 1.2%, p < 0.0001) and recurrent myocardial infarction (8.3% vs. 5.2% vs. 3.5%, p = 0.002). NACEs were lower with longer DAPT despite a higher risk of BARC 2–5 bleedings (4.6% vs. 5.7% vs. 6.2%, p = 0.04) and a trend towards a higher risk of BARC 3–5 bleedings (2.4% vs. 3.3% vs. 3.9%, p = 0.06). These results were not consistent for female patients and those older than 75 years old, due to an increased risk of bleedings which exceeded the reduction in myocardial infarction. Conclusion In unselected real world acute coronary syndrome patients treated with percutaneous coronary intervention, DAPT with prasugrel or ticagrelor prolonged beyond 12 months markedly reduces fatal and non-fatal ischaemic events, offsetting the increased risk deriving from the higher bleeding risk. On the contrary, patients >75 years old and female ones showed a less favourable risk–benefit ratio for longer DAPT due to excess of bleedings.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Nogami ◽  
Y Kanaji ◽  
T Sugiyama ◽  
M Hoshino ◽  
M Yamaguchi ◽  
...  

Abstract Background Cardiac magnetic resonance (CMR) imaging is a useful instrument for the assessment of pathological and functional conditions without the need for ionizing radiation, radioactive tracers, or intravascular catheterization. Both unrecognized myocardial infarction (UMI) and impaired global myocardial blood flow (g-MBF) have been reported to be strongly associated with worse outcome in patients with cardiovascular disease. However, their combined efficacy remains undetermined. Purpose We sought to assess the prognostic value of the presence of UMI and pre-procedural hyperemic g-MBF evaluated by phase-contrast cine magnetic resonance imaging (PC-CMR) in patients with chronic coronary syndrome who underwent elective percutaneous coronary intervention (PCI). Methods A total of 177 patients with de novo functionally significant stenosis who underwent pre-PCI CMR and PCI between September, 2016 and March, 2019 were retrospectively studied. UMI was defined as a scar detected by late gadolinium enhancement (LGE) without previously diagnosed MI. g-MBF was assessed by quantifying coronary sinus flow using PC-CMR at rest and hyperemic state. The predictors of major adverse cardiac events (MACE; cardiac death, nonfatal myocardial infarction, clinically driven unplanned revascularization, or hospitalization for congestive heart failure) during follow-up were investigated. Results UMI was detected in 40 (27.7%) patients and rest and maximal hyperemic g-MBF evaluated by the coronary sinus flow obtained by PC-CMR were 0.95 ml/min/g and 2.26 ml/min/g, respectively. During the median follow-up of 26 months, cardiovascular death occurred in 1 patient (0.6%), nonfatal myocardial infarction occurred in 4 patients (2.3%), and clinically driven revascularization and hospitalization due to congestive heart failure occurred in 25 patients (14.1%) and 3 patients (1.7%) patients, respectively. In patients with MACE, hyperemic g-MBF was significantly lower and the prevalence of UMI were significantly higher compared with those without MACE (1.94 ml/min/g vs 2.36 ml/min/g P=0.014; 48.3% vs 23.6%, P=0.011). Cox proportional hazards model indicated that impaired hyperemic g-MBF (&lt;2.00 ml/min/g) and the presence of UMI were significant predictors of MACE (HR 2.22, 95% CI 1.060–4.640, P=0.034; HR 2.660, 95% CI 1.290–5.470, P=0.008). During follow-up, cardiac event-free survival was significantly worse in patients with impaired hyperemic g-MBF (&lt;2.00 ml/min/g) and UMI (log-rank χ2=11.0, P=0.010). Conclusion In patients with chronic coronary syndrome undergoing elective PCI, the combined assessment of UMI and hyperemic g-MBF obtained by preprocedural noninvasive CMR may provide significant prognostic information. Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 26 ◽  
pp. 107602962091281
Author(s):  
Minsuk Kim ◽  
Si-Hyuck Kang ◽  
Jeong-Ran Kim ◽  
Jin Joo Park ◽  
Young-seok Cho ◽  
...  

Shear stress (SS)-induced platelet activation is suggested as an essential mechanism of the acute coronary syndrome (ACS). We aimed to compare SS-induced thrombotic and thrombolytic activities among 3 treatment regimens in patients with ACS who underwent percutaneous coronary intervention (PCI). Patients were nonrandomly enrolled and treated with one of 3 regimens (TICA: ticagrelor 180 mg/d; RIVA: clopidogrel 75 mg/d and rivaroxaban 5 mg/d; CLP: clopidogrel 75 mg/d), administered in addition to aspirin (100 mg/d) for 30 days. The global thrombosis test was applied to measure SS-induced thrombotic (occlusion time [OT]) and thrombolytic activity (lysis time [LT]) at day 2 and 30. Aspirin reaction unit (ARU) and P2Y12 reaction unit (PRU) were simultaneously measured using VerifyNow. Group differences in the OT, LT, ARU, and PRU were evaluated. Seventy-five patients (25 patients in each group) finished 30 days of follow-up. Clinical and angiographic characteristics did not differ among the 3 groups, except ACS subtype and pre-PCI coronary flow. No major adverse cardiovascular events occurred in any group during follow-up. The OT and LT did not differ among the 3 groups at day 30 (OT: TICA, 447.2 ± 87.1 vs RIVA, 458.5 ± 70.3, vs CLP, 471.9 ± 90.7, LT: 1522.3 ± 426.5 vs 1734.6 ± 454.3 vs 1510.2 ± 593.9) despite significant differences in the PRU among the 3 groups. Shear stress–induced thrombotic and thrombolytic activities did not differ among the 3 investigated antithrombotic treatments.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Paolisso ◽  
F Donati ◽  
L Bergamaschi ◽  
S Toniolo ◽  
E.C D'Angelo ◽  
...  

Abstract Background Myocardial infarction with non-obstructive coronary arteries (MINOCA) is a heterogeneous clinically entity and represents 5% to 10% of all patients with myocardial infarction (MI). Besides type 2 diabetes mellitus (DM), which is a common comorbidity in patients hospitalized for an acute coronary syndrome, high glucose levels (HGL) at admission are frequently observed in this context. The risk of major adverse cardiovascular events following acute coronary syndrome is increased in people with DM and HGL. However, evidence regarding diabetes and high glucose level among MINOCA patients is lacking. Purpose To examine the incidence of major adverse cardiovascular events (MACEs) in diabetic and non-diabetic MINOCA patients as well as according to HGL at presentation. Methods Among 1995 patients with acute MI admitted to our coronary care unit from 2016 to 2018, we enrolled 186 consecutive MINOCA patients according to the current ESC diagnostic criteria. HGL at admission was defined as serum glucose level above 180 mg/dl. All-cause mortality and a composite end-point of all-cause mortality and myocardial re-infarction were compared. The median follow-up time was 19.6±12.9 months. Results Diabetic MINOCA patients were older (mean age 75.5±9.6 vs 66.5±14.7; p=0.002) and with higher prevalence of hypertension (p=0.016). Conversely, there were no significant differences in gender, BMI, dyslipidemia and atrial fibrillation. Similarly, no significant differences were observed regarding clinical and ECG presentation, echocardiographic features and laboratory tests. The rates of death (30.8% vs 8.3%; p=0.013) and MACEs (22.2% vs 6.8%; p=0.025) were significantly higher in MINOCA-DM patients; conversely, no significant differences were observed for re-MI (p=0.58). At multivariate regression model adjusted for age and sex, type 2 DM was not an independent predictor of all cause deaths (p=0.36) and MACE (p=0.24). Patients with admission HGL had similar baseline characteristics, cardiovascular risk factors, clinical presentations, echocardiographic features and troponin values as compared to patients with no-HGL. HGL at admission was associated with higher incidence of all-cause-death (p&lt;0.001) and MACE (p=0.003) during follow-up compared to patients with no HGL; conversely, no significant differences were observed in the incidence of re-MI (p=0.7). Multivariate analysis adjusted for age and sex demonstrated that HGL was an independent predictor of death (HR 6.25; CI 1.64–23.85; p=0.007) and MACEs (HR 6.17; CI 1.79–21.23, p=0.004). Conclusion In MINOCA patients, HGL was an independent risk factor for both MACEs and death while type 2 DM was not correlated with these hard endpoints. As a consequence, HGL could have a still unexplored pathophysiological role in MINOCA. Properly powered randomized trials are warranted. Funding Acknowledgement Type of funding source: None


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