Publications by authors named "Fabrizio Ugo"

64 Publications

Renin-angiotensin system inhibitors effect before and during hospitalization in COVID-19 outcomes: Final analysis of the international HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID-19) registry.

Am Heart J 2021 Apr 15;237:104-115. Epub 2021 Apr 15.

Hospital Clínico San Carlos, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.

Background: The use of Renin-Angiotensin system inhibitors (RASi) in patients with coronavirus disease 2019 (COVID-19) has been questioned because both share a target receptor site.

Methods: HOPE-COVID-19 (NCT04334291) is an international investigator-initiated registry. Patients are eligible when discharged after an in-hospital stay with COVID-19, dead or alive. Here, we analyze the impact of previous and continued in-hospital treatment with RASi in all-cause mortality and the development of in-stay complications.

Results: We included 6503 patients, over 18 years, from Spain and Italy with data on their RASi status. Of those, 36.8% were receiving any RASi before admission. RASi patients were older, more frequently male, with more comorbidities and frailer. Their probability of death and ICU admission was higher. However, after adjustment, these differences disappeared. Regarding RASi in-hospital use, those who continued the treatment were younger, with balanced comorbidities but with less severe COVID19. Raw mortality and secondary events were less frequent in RASi. After adjustment, patients receiving RASi still presented significantly better outcomes, with less mortality, ICU admissions, respiratory insufficiency, need for mechanical ventilation or prone, sepsis, SIRS and renal failure (p<0.05 for all). However, we did not find differences regarding the hospital use of RASi and the development of heart failure.

Conclusion: RASi historic use, at admission, is not related to an adjusted worse prognosis in hospitalized COVID-19 patients, although it points out a high-risk population. In this setting, the in-hospital prescription of RASi is associated with improved survival and fewer short-term complications.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ahj.2021.04.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8047303PMC
April 2021

Feasibility and safety of left atrial appendage closure in a patient with previous foramen ovale occlusion: a case report.

Eur Heart J Case Rep 2021 Mar 31;5(3):ytab113. Epub 2021 Mar 31.

Cardiology Division, Sant'Andrea Hospital, Corso Mario Abbiate 21, 13100, Vercelli, Italy.

Background: Left atrial appendage (LAA) closure is an alternative to chronic oral anticoagulation for stroke prevention in patients with atrial fibrillation (AF) at high bleeding risk. Patients with a previous percutaneous closure of a patent foramen ovale (PFO) present an increased risk for developing AF during their life, and the presence of an atrial septal device renders future percutaneous left atrial access more challenging. Very few cases of LAA occlusion in patients with a preexisting PFO closure device have been previously reported.

Case Summary: A 74-years old woman was admitted to our hospital for symptomatic severe anaemia during direct oral anticoagulant treatment. Her past medical history reported an ischaemic stroke at the age of 55, at that time a PFO was diagnosed and a STARFlex™ PFO occluder (NMT Medical, Boston, MA, USA) was implanted. During the current hospitalization, the patient underwent a colonoscopy that showed colonic angiodysplasias unsuitable for endoscopic treatment and LAA closure was indicated for stroke prevention. After a multimodality pre-procedural planning that included a transoesophageal echocardiogram, a cardiac computed tomography scan and a three-dimensional cardiac model printing, the procedure was planned and the LAA successfully occluded.

Discussion: LAA closure can be performed safely and effectively in patients carrying a previously implanted PFO occlusion device. In complex settings, a pre-procedural multimodality imaging is critical for improving the procedural safety and success rate. We describe the first case of percutaneous LAA closure in a patient with a prior PFO occlusion with the implantation of a STARflex™ septal occlusion device.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ehjcr/ytab113DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8010339PMC
March 2021

Impact of COVID-19 pandemic and infection on in hospital survival for patients presenting with acute coronary syndromes: A multicenter registry.

Int J Cardiol 2021 06 29;332:227-234. Epub 2021 Mar 29.

Division of Cardiology, Cardiovascular and Thoracic Department, Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.

Introduction: The impact of Covid-19 on the survival of patients presenting with acute coronary syndrome (ACS) remains to be defined.

Methods: Consecutive patients presenting with ACS at 18 Centers in Northern-Italy during the Covid-19 outbreak were included. In-hospital all-cause death was the primary outcome. In-hospital cardiovascular death along with mechanical and electrical complications were the secondary ones. A case period (February 20, 2020-May 3, 2020) was compared vs. same-year (January 1-February 19, 2020) and previous-year control periods (February 20-May 3, 2019). ACS patients with Covid-19 were further compared with those without.

Results: Among 779 ACS patients admitted during the case period, 67 (8.6%) tested positive for Covid-19. In-hospital all-cause mortality was significantly higher during the case period compared to the control periods (6.4% vs. 3.5% vs. 4.4% respectively; p 0.026), but similar after excluding patients with COVID-19 (4.5% vs. 3.5% vs. 4.4%; p 0.73). Cardiovascular mortality was similar between the study groups. After multivariable adjustment, admission for ACS during the COVID-19 outbreak had no impact on in-hospital mortality. In the case period, patients with concomitant ACS and Covid-19 experienced significantly higher in-hospital mortality (25% vs. 5%, p < 0.001) compared to patients without. Moreover, higher rates of cardiovascular death, cardiogenic shock and sustained ventricular tachycardia were found in Covid-19 patients.

Conclusion: ACS patients presenting during the Covid-19 pandemic experienced increased all-cause mortality, driven by Covid-19 positive status due to higher rates of cardiogenic shock and sustained ventricular tachycardia. No differences in cardiovascular mortality compared to non-pandemic scenarios were reported.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ijcard.2021.03.063DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006512PMC
June 2021

Return towards normality in admissions for myocardial infarction after the lockdown removal for COVID-19 outbreak in Italy.

Int J Cardiol 2021 06 22;332:235-237. Epub 2021 Mar 22.

Coronary Care Unit and Catheterization Laboratory, A.O.U. Maggiore della Carità, Novara, Italy; Dipartimento Medicina Traslazionale, Università del Piemonte Orientale, Novara, Italy. Electronic address:

Background: Investigations demonstrated a decrease of admissions for myocardial infarction (MI) during the CoronaVirus Disease-19 (COVID-19) outbreak. No study has evaluated the time required to reverse this downward curve of MI admissions.

Methods: This is a retrospective analysis on patients (N = 2415) admitted to the Emergency Departments for acute MI in nine Italian centers. Primary endpoint was the incidence rates (IRs) of MI admissions in the post-lockdown COVID-19 period (case-period: from May 4 to July 12, 2020) vs. the following control periods: January 1-February 19, 2020 (pre-lockdown period); February 20-May 3, 2020 (intra-lockdown period); May 4-July 12, 2019 (inter-year non-COVID-19 period).

Results: IR of admissions for MI in the post-lockdown period was higher than the intra-lockdown period (IR ratio, IRR: 1.60, 95% CI 1.42-1.81; p = 0.0001), was lower than the pre-lockdown period (IRR: 0.86, 0.77-0.96; p = 0.009) and similar to the inter-year non-COVID-19 period (IRR: 0.96, 0.87-1.07; p = 0.47). Within the case period, the increase in MI admissions was more pronounced in earlier vs later weeks (IRR 1.19, 95% CI 1.02-1.38, p = 0.024) and, compared to the inter-year control period, was significant for non ST-segment elevation MI (IRR: 1.25, 95% CI 1.08-1.46, p = 0.004), but was not observed for ST-segment elevation MI (STEMI), where hospitalizations were reduced (IRR 0.76, 95% CI 0.65-0.88, p = 0.0001).

Conclusions: Our study first indicates an increase in the number of admissions for MI after the removal of the national lockdown for COVID-19 in Italy. This increase was prevalent in the first weeks following the lockdown removal, but was under-represented in STEMI patients.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ijcard.2021.03.046DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7983363PMC
June 2021

Non-invasive ventilation for SARS-CoV-2 acute respiratory failure: a subanalysis from the HOPE COVID-19 registry.

Emerg Med J 2021 Mar 16. Epub 2021 Mar 16.

Cardiovascular Institute, Hospital Clinico San Carlos, Madrid, Community of Madrid, Spain.

Background: The COVID-19 pandemic has seriously challenged worldwide healthcare systems and limited intensive care facilities, leading to physicians considering the use of non-invasive ventilation (NIV) for managing SARS-CoV-2-related acute respiratory failure (ARF).

Methods: We conducted an interim analysis of the international, multicentre HOPE COVID-19 registry including patients admitted for a confirmed or highly suspected SARS-CoV-2 infection until 18 April 2020. Those treated with NIV were considered. The primary endpoint was a composite of death or need for intubation. The components of the composite endpoint were the secondary outcomes. Unadjusted and adjusted predictors of the primary endpoint within those initially treated with NIV were investigated.

Results: 1933 patients who were included in the registry during the study period had data on oxygen support type. Among them, 390 patients (20%) were treated with NIV. Compared with those receiving other non-invasive oxygen strategy, patients receiving NIV showed significantly worse clinical and laboratory signs of ARF at presentation. Of the 390 patients treated with NIV, 173 patients (44.4%) met the composite endpoint. In-hospital death was the main determinant (147, 37.7%), while 62 patients (15.9%) needed invasive ventilation. Those requiring invasive ventilation had the lowest survival rate (41.9%). After adjustment, age (adjusted OR (adj(OR)) for 5-year increase: 1.37, 95% CI 1.15 to 1.63, p<0.001), hypertension (adj(OR) 2.95, 95% CI 1.14 to 7.61, p=0.03), room air O saturation <92% at presentation (adj(OR) 3.05, 95% CI 1.28 to 7.28, p=0.01), lymphocytopenia (adj(OR) 3.55, 95% CI 1.16 to 10.85, p=0.03) and in-hospital use of antibiotic therapy (adj(OR) 4.91, 95% CI 1.69 to 14.26, p=0.003) were independently associated with the composite endpoint.

Conclusion: NIV was used in a significant proportion of patients within our cohort, and more than half of these patients survived without the need for intubation. NIV may represent a viable strategy particularly in case of overcrowded and limited intensive care resources, but prompt identification of failure is mandatory to avoid harm. Further studies are required to better clarify our hypothesis.

Trial Registration Numbers: NCT04334291/EUPAS34399.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/emermed-2020-210411DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7970657PMC
March 2021

Prevalence and 30-Day Mortality in Hospitalized Patients With Covid-19 and Prior Lung Diseases.

Arch Bronconeumol 2021 04 16;57 Suppl 2:13-20. Epub 2020 Dec 16.

Hospital Clínico San Carlos, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.

Introduction: Patients with pre-existing respiratory diseases in the setting of COVID-19 may have a greater risk of severe complications and even death.

Methods: A retrospective, multicenter, cohort study with 5847 COVID-19 patients admitted to hospitals. Patients were separated in two groups, with/without previous lung disease. Evaluation of factors associated with survival and secondary composite end-point such as ICU admission and respiratory support, were explored.

Results: 1,271 patients (22%) had a previous lung disease, mostly COPD. All-cause mortality occurred in 376 patients with lung disease (29.5%) and in 819 patients without (17.9%) (p<0.001). Kaplan-Meier curves showed that patients with lung diseases had a worse 30-day survival (HR=1.78; 95%C.I. 1.58-2.01; p<0.001) and COPD had almost 40% mortality. Multivariable Cox regression showed that prior lung disease remained a risk factor for mortality (HR, 1.21; 95%C.I. 1.02-1.44; p=0.02). Variables independently associated with all-cause mortality risk in patients with lung diseases were oxygen saturation less than 92% on admission (HR, 4.35; 95% CI 3.08-6.15) and elevated D-dimer (HR, 1.84; 95% CI 1.27-2.67). Age younger than 60 years (HR 0.37; 95% CI 0.21-0.65) was associated with decreased risk of death.

Conclusions: Previous lung disease is a risk factor for mortality in patients with COVID-19. Older age, male gender, home oxygen therapy, and respiratory failure on admission were associated with an increased mortality. Efforts must be done to identify respiratory patients to set measures to improve their clinical outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.arbres.2020.11.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7744014PMC
April 2021

Left atrial appendage occlusion in atrial fibrillation patients with previous intracranial bleeding: A national multicenter study.

Int J Cardiol 2021 Apr 25;328:75-80. Epub 2020 Nov 25.

Department of Cardiology, San Francesco Hospital, ATS Sardegna, Nuoro, Italy. Electronic address:

Background: Intracranial hemorrhage (ICH) represents the most serious complication of oral anticoagulant therapy (OAT) in patients with atrial fibrillation (AF), and AF patients with previous ICH are a challenge for clinicians. Left atrial appendage (LAA) occlusion has emerged as an alternative option for AF patients not suitable for OAT. Currently, few data are available on long term outcomes after LAA occlusion in this population. We evaluated the safety and efficacy of LAA occlusion in a cohort of patients with AF and previous ICH.

Methods: This is a multicenter, observational, retrospective study involving 5 LAA occlusion centers in Italy. It includes all consecutive patients (n = 120) with previous ICH who underwent LAA occlusion for nonvalvular AF and high thromboembolic risk. Procedural outcomes, post-procedural therapies and 12-months follow-up data were analyzed.

Results: The device was successfully implanted in 100% of cases, with a 6% of major peri-procedural complications. 59% had a prior ICH during OAT. The sample had a high risk of stroke (5.18%/year) and bleeding (6.62%/year). 30% were discharged on single and 54.2% on dual antiplatelet therapy. The expected annual risk for thromboembolism was 5.1%. Excluding periprocedural ischemic complications, the stroke annual rate was 1.8%. The expected annual risk of bleeding was 6.7%. The observed annual bleeding rate was 5.45%.

Conclusions: Percutaneous LAA occlusion is an effective option for AF patients and previous intracranial hemorrhage. After LAA occlusion, a single antiplatelet therapy strategy could be considered for patients with the highest risk of recurrent bleeding.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ijcard.2020.11.045DOI Listing
April 2021

Gender differences in acute coronary syndromes patterns during the COVID-19 outbreak.

Am J Cardiovasc Dis 2020 15;10(4):506-513. Epub 2020 Oct 15.

Coronary Care Unit and Catheterization laboratory, A.O.U. Maggiore della Carità Novara, Italy.

Background: Mortality from acute coronary syndromes (ACS) is strictly related to early management. As female patients usually experience longer delays before diagnosis and treatment, we assessed whether women were more affected by the dramatic drop in hospital admissions for ACS during the Covid-19 pandemic.

Methods: We performed a retrospective analysis of clinical and angiographic characteristics of consecutive patients who were admitted for ACS at 15 hospitals in Northern Italy comparing men and women data. The study period was defined as the time between the first confirmed case of Covid-19 in Italy (February 20, 2020) and March 31, 2020. We compared hospitalization rates between the study period and two control periods: the corresponding period during the previous year (February 20 to March 31, 2019) and the earlier period during the same year (January 1 to February 19, 2020). Incidence rate ratios comparing the study period with each of the control periods were calculated with the use of Poisson regression.

Results: Of the 547 patients who were hospitalized for ACS during the study period, only 127 (23%) were females, accounting for a mean of 3.1 admissions per day, while ACS hospitalized males were 420, with a mean of 10.2 admissions per day. There was a significant decrease driven by a similar reduction in ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) diagnosis in both sexes compared to the control periods. A trend toward a greater reduction in admitted females was shown in the intra-year control period (46% admission reduction in females vs 37% in males, with females accounting for 26% of ACS, P=0.10) and a significant reduction when compared to the previous year control period (40% admission reduction in females vs 23% in males, with females accounting for 28% of ACS, P=0.03), mainly related to Unstable Angina diagnosis.

Conclusion: The Covid-19 pandemic period closed the gap between men and women in ACS, with similar rates of reduction of hospitalized STEMI and NSTEMI and a trend toward greater reduction in UA admission among women. Furthermore, many typical differences between males and females regarding ischemic heart disease presentations and vessel distribution were leveled.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7675165PMC
October 2020

Very late stent expansion with intracoronary lithotripsy: a case report.

Eur Heart J Case Rep 2020 Oct 17;4(5):1-4. Epub 2020 Oct 17.

Division of Cardiology, S. Andrea Hospital, Corso Mario Abbiate 21, 13100 Vercelli, Italy.

Background: Underexpanded stent in heavily calcified coronary lesion is common and persists over years. It is related to long-term failure and negative outcomes. Treatment of this situation after many years with intracoronary lithotripsy (ICL-Shockwave) could be an option.

Case Summary: We report a case of a man with underexpanded coronary stent implanted 11 years earlier. Optical coherence tomography highlighted the mechanism of stent underexpansion showing the presence of calcium stones under the old struts. Intracoronary lithotripsy crushed calcium under the stent struts causing its geometric change (from elliptical to round shape) and a consequent better transmission of the true radial force of the old stent.

Discussion: Heavily calcified coronary lesions lead to stent underexpansion which persists over years. Intracoronary lithotripsy could be a very late option to manage this unfavourable common result.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ehjcr/ytaa228DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7649517PMC
October 2020

Clinical profile and predictors of in-hospital mortality among older patients hospitalised for COVID-19.

Age Ageing 2021 02;50(2):326-334

Unidad de Gestión Clínica Área del Corazón, Instituto de Investigación Biomédica de Málaga (IBIMA), Hospital Universitario Virgen de la Victoria, Universidad de Málaga (UMA), Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Málaga, Spain.

Background: the coronavirus disease 2019 (COVID-19) is characterized by poor outcomes and mortality, particularly in older patients.

Methods: post hoc analysis of the international, multicentre, 'real-world' HOPE COVID-19 registry. All patients aged ≥65 years hospitalised for COVID-19 were selected. Epidemiological, clinical, analytical and outcome data were obtained. A comparative study between two age subgroups, 65-74 and ≥75 years, was performed. The primary endpoint was all cause in-hospital mortality.

Results: about, 1,520 patients aged ≥65 years (60.3% male, median age of 76 [IQR 71-83] years) were included. Comorbidities such as hypertension (69.2%), dyslipidaemia (48.6%), cardiovascular diseases (any chronic heart disease in 38.4% and cerebrovascular disease in 12.5%), and chronic lung disease (25.3%) were prevalent, and 49.6% were on ACEI/ARBs. Patients aged 75 years and older suffered more in-hospital complications (respiratory failure, heart failure, renal failure, sepsis) and a significantly higher mortality (18.4 vs. 48.2%, P < 0.001), but fewer admissions to intensive care units (11.2 vs. 4.8%). In the overall cohort, multivariable analysis demonstrated age ≥75 (OR 3.54), chronic kidney disease (OR 3.36), dementia (OR 8.06), peripheral oxygen saturation at admission <92% (OR 5.85), severe lymphopenia (<500/mm3) (OR 3.36) and qSOFA (Quick Sequential Organ Failure Assessment Score) >1 (OR 8.31) to be independent predictors of mortality.

Conclusion: patients aged ≥65 years hospitalised for COVID-19 had high rates of in-hospital complications and mortality, especially among patients 75 years or older. Age ≥75 years, dementia, peripheral oxygen saturation <92%, severe lymphopenia and qSOFA scale >1 were independent predictors of mortality in this population.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ageing/afaa258DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717146PMC
February 2021

Reduction in heart failure hospitalization rate during coronavirus disease 19 pandemic outbreak.

ESC Heart Fail 2020 Oct 23. Epub 2020 Oct 23.

Department of Clinical, Internal, Anesthesiology and Cardiovascular Sciences, Sapienza University of Rome, Viale del Policlinico 155, Rome, 00161, Italy.

Aims: The recent coronavirus disease 19 (COVID-19) pandemic outbreak forced the adoption of restraint measures, which modified the hospital admission patterns for several diseases. The aim of the study is to investigate the rate of hospital admissions for heart failure (HF) during the early days of the COVID-19 outbreak in Italy, compared with a corresponding period during the previous year and an earlier period during the same year.

Methods And Results: We performed a retrospective analysis on HF admissions number at eight hospitals in Italy throughout the study period (21 February to 31 March 2020), compared with an inter-year period (21 February to 31 March 2019) and an intra-year period (1 January to 20 February 2020). The primary outcome was the overall rate of hospital admissions for HF. A total of 505 HF patients were included in this survey: 112 during the case period, 201 during intra-year period, and 192 during inter-year period. The mean admission rate during the case period was 2.80 admissions per day, significantly lower compared with intra-year period (3.94 admissions per day; incidence rate ratio, 0.71; 95% confidence interval [CI], 0.56-0.89; P = 0.0037), or with inter-year (4.92 admissions per day; incidence rate ratio, 0.57; 95% confidence interval, 0.45-0.72; P < 0.001). Patients admitted during study period were less frequently admitted in New York Heart Association (NYHA) Class II compared with inter-year period (P = 0.019). At covariance analysis NYHA class was significantly lower in patients admitted during inter-year control period, compared with patients admitted during case period (P = 0.014).

Conclusions: Admissions for HF were significantly reduced during the lockdown due to the COVID-19 pandemic in Italy.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ehf2.13043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7754919PMC
October 2020

Catheterization laboratory activity before and during COVID-19 spread: A comparative analysis in Piedmont, Italy, by the Italian Society of Interventional Cardiology (GISE).

Int J Cardiol 2021 01 25;323:288-291. Epub 2020 Aug 25.

Division of Cardiology, Azienda Ospedaliera Ordine Mauriziano, Turin, Italy.

Background: COronaVIrus Disease 19 (COVID-19) led to the reorganization of Cardiology Units in terms of working spaces and healthcare personnel. In this scenario, both outpatient visits and elective interventional cardiology procedures were suspended and/or postponed. We aimed to report the impact of COVID-19 on interventional coronary and structural procedures in Piedmont, Italy.

Methods: The number of coronary angiographies (CAG), percutaneous coronary interventions (PCI), primary PCI (pPCI), transcatheter aortic valve replacements (TAVR) and Mitraclip performed in Piedmont between March 1st and April 20th, 2020 (CoV-time) were collected from each catheterization laboratory and compared to the number of procedures performed the year before in the same months (NoCoV-time).

Results: Procedural data from 18 catheterization laboratories were collected. Both coronary (5498 versus 2888: difference: -47.5%; mean 305.4 VS 160.4; p = 0.002) and structural (84 versus 17: difference: -79.8%; mean 4.7 Vs 0.9; p < 0.001) procedures decreased during CoV-time compared to NoCoV-time. In particular, coronary angiographies (1782 versus 3460), PCI (1074 versus 1983), p PCI (271 versus 410), TAVR (11 versus 72) and Mitraclip (6 versus 12) showed a reduction of 48.5%, 45.7%, 33.7%, 84.7% and 50.0%, respectively (all p for comparison <0.05).

Conclusions: Compared to the same time-period in 2019, both coronary and structural interventional procedures during COVID-19 epidemic suffered a dramatic decrease in Piedmont, Italy. Organizational change and structured clinical pathways should be created, together with awareness campaigns.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ijcard.2020.08.072DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7446645PMC
January 2021

Cerebral protection in left atrial appendage closure in the presence of appendage thrombosis.

Catheter Cardiovasc Interv 2021 Feb 18;97(3):511-515. Epub 2020 Aug 18.

Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.

Background: Presence of thrombus in the left atrial appendage (LAA) remains a severe contraindication to the percutaneous left atrial appendage closure procedure (LAAC), due to increased embolic risk. Recently, the experience developed in cerebral protection device in transcatheter aortic valve implantation (TAVI) procedure was translated in LAAC to address this issue.

Aim: To evaluate efficacy and safety of Sentinel cerebral protection system (CPS) in supporting LAAC in real-world patient with persistent LAA thrombus.

Methods And Results: The study retrospectively enrolled consecutive patients with non-valvular atrial fibrillation (NVAF) and thrombus in LAA who underwent LAAC supported by Sentinel CPS in seven European high-volume centres. Twenty-seven patients were included with a median age of 69.1 ± 9.7 years old, with median CHA DS -VASc and HAS-BLEED scores 3 [2-5] and 3 [2.75-4], respectively. Technical and procedural success was achieved in all patients. No periprocedural TIA, stroke, or supra-aortic trunks dissection was recorded.

Conclusions: In this multicenter registry, LAAC supported by Sentinel CPS in patients with LAA persistent thrombus seems to be a safe and efficacious treatment.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ccd.29161DOI Listing
February 2021

Real-World Experience With a Tapered Biodegradable Polymer-Coated Sirolimus-Eluting Stent in Patients With Long Coronary Artery Stenoses.

Cardiol Res 2020 Aug 3;11(4):219-225. Epub 2020 Jun 3.

Department of Cardiology, Ospedale Civile, Cirie, Italy.

Background: Treatment of long coronary stenoses (LCS) with long tapered drug-eluting stents (LT-DES) would offer clinical and economic benefits. However, the feasibility of an interventional strategy based upon the systematic LCS treatment with an LT-DES has not been evaluated so far.

Methods: We performed a multicenter prospective study including consecutive patients with: 1) An LCS > 25 mm at coronary angiography; 2) An attempt to fix the LCS with a single BioMime Morph™ stent, a novel LT-DES available from 30 to 60 mm long. The primary efficacy endpoint was procedural success. The secondary safety endpoints were post-procedural TIMI3 flow, stent detachment during delivery, acute stent thrombosis and in-hospital mortality.

Results: From February 2017 to March 2018, we recorded 272 patients with an LCS and an attempt to deploy an LT-DES during percutaneous coronary intervention (PCI) (69.3 ± 11.4 years, 75.7% males, 25.7% diabetic and 43.8% with acute coronary syndromes, mean LCS length 48.8 ± 9.5 mm). LT-DES deployment was successful in 262 patients (96.3%), and failure occurred without stent detachment or other complications. Final TIMI3 flow was present in 270 (99.3%) patients. In-hospital death occurred in five patients (1.8%), with no case of acute stent thrombosis, recurrent myocardial infarction or repeated revascularization.

Conclusion: In this real-world study, a strategy of fixing LCS with a single LT-DES was feasible and safe, with a high rate of procedural success and a low rate of in-hospital complications. More extensive randomized studies are warranted to assess the potential clinical and economic benefits of LT-DES.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.14740/cr1055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7295557PMC
August 2020

IntravaScular Lithotripsy for the Management of UndILatable Coronary StEnt: The SMILE Registry.

Cardiovasc Revasc Med 2020 Dec 23;21(12):1555-1559. Epub 2020 May 23.

Clinical and Interventional Cardiology Unit, Istituto Clinico S.Ambrogio, Milan, Italy.

Background: Intravascular lithotripsy (IVL) showed to be effective in dilating heavily calcified de novo coronary lesions but little is known about its performance in under-expanded stents management. Aim of this study was to assess the feasibility, effectiveness and safety of IVL for the treatment of stent underexpansion refractory to balloon dilatation.

Methods: A multicentre, retrospective cohort analysis was performed in patients undergoing IVL to treat under-expanded stents following non-compliant balloon expansion failure. Primary endpoint was successful IVL dilatation defined as IVL balloon delivery and application at the target site followed by an increase of at least 1 mm in minimal stent cross-sectional area (MSA) on intracoronary imaging or an increase of at least 20% in minimal stent diameter (MSD) by quantitative coronary analysis (QCA).

Results: Thirty-nine under-expanded stents (34 patients) were included. Two cases (5.1%) of multiple stent layers and one (2.5%) acutely under-expanded stent were treated. The median IVL balloon diameter was 3.1 mm (IQR: 2.5-3.5 mm) while the number of pulses emitted was 56.7 (IQR: 30-80). IVL was successful in 34 cases (87.1%), with significant improvement in MSD (post: 3.23 mm [IQR: 3-3.5 mm] vs. pre: 0.81 mm [IQR: 0.35-1.2], p < 0.00001) and MSA (post: 7.61mm [IQR: 6.43-7.79mm] vs. pre: 3.35 [IQR: 2.8-4 mm], p < 0.00001). Non-fatal peri-procedural ST-elevation myocardial infarction occurred in one case (2.5%) due to IVL balloon rupture. No cardiac death, target lesion revascularization and stent thrombosis occurred in-hospital and at 30-day follow-up.

Conclusions: Bailout IVL was feasible, efficacious and safe to improve refractory stent under-expansion.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.carrev.2020.05.020DOI Listing
December 2020

Impact of Kissing Balloon in Patients Treated With Ultrathin Stents for Left Main Lesions and Bifurcations: An Analysis From the RAIN-CARDIOGROUP VII Study.

Circ Cardiovasc Interv 2020 03 27;13(3):e008325. Epub 2020 Feb 27.

Division of Cardiology, Department of Medical Science, Città della Salute e della Scienza, Turin (F.D., A.S., F.F., A. Montefusco, G.d.L., F.B., P.O., M.R., F.C., M.D., G.M.D.F.).

Background: There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations.

Methods: All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [<3 mm] versus long overlap), strategy (provisional versus 2-stent), routine versus bail-out FKI, and the use of imaging and proximal optimization technique.

Results: Two thousand seven hundred forty-two patients were included. At 16 months (8-20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; =0.967), this result did not change with use of imaging, proximal optimization technique, or routine versus bail-out FKI. In the 2-stent subgroup, FKI was associated with lower rates of target vessel revascularization (7.8% versus 15.9%; =0.030) and target lesion revascularization (7.3% versus 15.2%; =0.032). Short overlap FKI was associated with a lower rate of target lesion revascularization compared with no FKI (2.6% versus 5.4%; =0.034), while long overlap was not (6.8% versus 5.4%; =0.567).

Conclusions: In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03544294.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008325DOI Listing
March 2020

Real-world reasons and outcomes for 1-month versus longer dual antiplatelet therapy strategies with a polymer-free BIOLIMUS A9-coated stent.

Catheter Cardiovasc Interv 2020 09 3;96(3):E248-E256. Epub 2020 Feb 3.

U.O. Cardiologia Clinica ed Interventistica, Istituto Clinico S. Ambrogio, Milano, Italy.

Background: A large trial established the favorable profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a 1-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. This is the first study comparing outcomes for a 1-month versus longer DAPT strategies following PF-BES-percutaneous coronary intervention (PCI).

Methods: All patients undergoing PF-BES-PCI (January 2016 to July 2018) were included in the multicenter CHANCE registry. Patients were stratified according to DAPT strategy at discharge (planned 1-month vs. planned >1-month). Primary outcomes were the 390-day estimates of a patient-oriented and of a device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularization; DOCE: cardiac death, target vessel-MI or ischemia-driven target lesion revascularization). Landmark analyses from 1-month post-PCI were carried.

Results: Following PF-BES-PCI, 328(40.3%) and 485(59.6%) patients were discharged with 1-month and longer DAPT (12 months [6-12]), respectively. Patients with a previous or index MI were less likely to be discharged on 1-month DAPT. Patients prescribed with 1-month DAPT were more likely to be at HBR than those with longer DAPT (90.2% vs. 69.9%, p = .001). No between-groups differences in the primary outcomes (planned 1-month vs. planned >1-month DAPT: POCE 11.9% vs. 13.2%, p = .747; DOCE: 4.8% vs. 8.1%, p = .500) were observed, also after adjusting for confoundings (POCE: adjusted-hazard ratio [adj-HR] 1.26, 95%CI 0.74-2.13; DOCE: adj-HR 1.00, 95%CI 0.49-1.99). Landmark analyses showed similar results.

Conclusions: In a large all-comers registry of PF-BES PCI, no interaction of planned DAPT strategy (1-month vs. >1-month) with outcomes was found. This observation warrants investigation in adequately powered randomized studies (ClinicalTrials.gov NCT03622203).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ccd.28757DOI Listing
September 2020

Incidence of Adverse Events at 3 Months Versus at 12 Months After Dual Antiplatelet Therapy Cessation in Patients Treated With Thin Stents With Unprotected Left Main or Coronary Bifurcations.

Am J Cardiol 2020 02 23;125(4):491-499. Epub 2019 Nov 23.

Division of Cardiology, Department of Internal Medicine, Città della Salute e della Scienza, Turin, Italy.

Incidence and predictors of adverse events after dual antiplatelet therapy (DAPT) cessation in patients treated with thin stents (<100 microns) in unprotected left main (ULM) or coronary bifurcation remain undefined. All consecutive patients presenting with a critical lesion of an ULM or involving a main coronary bifurcation who were treated with very thin strut stents were included. MACE (a composite end point of cardiovascular death, myocardial infarction [MI], target lesion revascularization [TLR], and stent thrombosis [ST]) was the primary endpoint, whereas target vessel revascularization (TVR) was the secondary endpoint, with particular attention to type and occurrence of ST and occurrence of ST, CV death, and MI during DAPT or after DAPT discontinuation. All analyses were performed according to length of DAPT dividing the patients in 3 groups: Short DAPT (3-months), intermediate DAPT (3 to 12 months), and long DAPT (12-months). A total of 117 patients were discharged with an indication for DAPT ≤3 months (median 1: 1 to 2.5), 200 for DAPT between 3 and 12 months (median 8: 7 to 10), and 1,958 with 12 months DAPT. After 12.8 months (8 to 20), MACE was significantly higher in the 3-month group compared with 3 to 12 and 12-month groups (9.4% vs 4.0% vs 7.2%, p ≤0.001), mainly driven by MI (4.4% vs 1.5% vs 3%, p ≤0.001) and overall ST (4.3% vs 1.5% vs 1.8%, p ≤0.001). Independent predictors of MACE were low GFR and a 2 stent strategy. Independent predictors of ST were DAPT duration <3 months and the use of a 2-stent strategy. In conclusion, even stents with very thin strut when implanted in real-life ULM or coronary bifurcation patients discharged with short DAPT have a relevant risk of ST, which remains high although not significant after DAPT cessation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.amjcard.2019.10.058DOI Listing
February 2020

Average daily ischemic versus bleeding risk in patients with ACS undergoing PCI: Insights from the BleeMACS and RENAMI registries.

Am Heart J 2020 02 11;220:108-115. Epub 2019 Nov 11.

Department of Cardiology, University of Torino, Italy.

Background: The risk of recurrent ischemia and bleeding after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) may vary during the first year of follow-up according to clinical presentation, and medical and interventional strategies.

Methods: BleeMACS and RENAMI are 2 multicenter registries enrolling patients with ACS treated with PCI and clopidogrel, prasugrel, or ticagrelor. The average daily ischemic and bleeding risks (ADIR and ADBR) in the first year after PCI were the primary end points. The difference between ADBR and ADIR was calculated to estimate the potential excess of bleeding/ischemic events in a given period or specific subgroup.

Results: A total of 19,826 patients were included. Overall, in the first year after PCI, the ADBR was 0.008085%, whereas ADIR was 0.008017% (P = .886). In the first 2 weeks ADIR was higher than ADBR (P = .013), especially in patients with ST-segment elevation myocardial infarction or incomplete revascularization. ADIR continued to be, albeit non-significantly, greater than ADBR up to the third month, whereas ADBR became higher, although not significantly, afterward. Patients with incomplete revascularization had an excess in ischemic risk (P = .003), whereas non-ST-segment elevation ACS patients and those on ticagrelor had an excess of bleeding (P = .012 and P = .022, respectively).

Conclusions: In unselected ACS patients, ADIR and ADBR occurred at similar rates within 1 year after PCI. ADIR was greater than ADBR in the first 2 weeks, especially in ST-segment elevation myocardial infarction patients and those with incomplete revascularization. In the first year, ADIR was higher than ADBR in patients with incomplete revascularization, whereas ADBR was higher in non-ST-segment elevation ACS patients and in those discharged on ticagrelor.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ahj.2019.10.001DOI Listing
February 2020

Efficacy and Safety of Clopidogrel, Prasugrel and Ticagrelor in ACS Patients Treated with PCI: A Propensity Score Analysis of the RENAMI and BleeMACS Registries.

Am J Cardiovasc Drugs 2020 Jun;20(3):259-269

Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano and Infermi Hospital, Rivoli (Turin), Turin, Italy.

Introduction: Real-life data comparing clopidogrel, prasugrel, and ticagrelor for unselected patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) are lacking, as are data for the temporal distribution of ischemic and bleeding risks.

Methods: A total of 19,825 patients were enrolled from the RENAMI and BleeMACS registries. Both were multicenter, retrospective, observational registries including the data and outcomes of consecutive patients with ACS who underwent primary PCI and were discharged with dual antiplatelet therapy (DAPT). We evaluated the long-term outcome stratified by the different antiplatelet agents.

Results: A total of 14,105 patients (71.2%) were treated with clopidogrel, 2364 patients (11.9%) with prasugrel and 3356 patients (16.9%) with ticagrelor. After propensity score matching, at 1 year, prasugrel reduced the incidence of net adverse clinical events (NACE; a composite endpoint of all-cause death, myocardial infarction [MI] and Bleeding Academic Research Consortium [BARC] 3-5 bleeding) (4.2% vs.7.6%, p = 0.002) and of major adverse cardiovascular events (MACE; a composite endpoint of death and MI) compared with clopidogrel (2.6% vs. 5.2%, p = 0.007). Ticagrelor decreased rates of MACE compared with clopidogrel (2.7% vs. 6.2%, p < 0.001), but not of NACE (6.6% vs. 8.7%, p = 0.07). Ticagrelor presented similar performance in terms of MACE compared with prasugrel (2.8% vs. 2.4%, p = 0.56), with a trend towards a reduction in MI (0.2% vs. 0.4%, p = 0.56), but with higher risk of BARC 3-5 bleedings (3.8% vs. 1.7%, p = 0.04). In the daily risk analysis, clopidogrel presented a binomial distribution with a peak of ischemic risk at 3 months, which decreased towards bleedings; prasugrel had a constant equivalence between opposite risks; and ticagrelor constantly reduced recurrent MIs despite higher risk of BARC 3-5 events.

Conclusion: In real life, ticagrelor is more effective in reducing ischemic events during the first year after ACS, despite an increased risk of major bleedings, while prasugrel assures a better balance between ischemic and bleeding recurrent events.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s40256-019-00373-1DOI Listing
June 2020

P2Y12 inhibitors in acute coronary syndrome patients with renal dysfunction: an analysis from the RENAMI and BleeMACS projects.

Eur Heart J Cardiovasc Pharmacother 2020 01;6(1):31-42

Department of Cardiology, University Heart Center, University Hospital Zurich, Raemistrasse 100, Zurich, Switzerland.

Aims: The aim of the present study was to establish the safety and efficacy profile of prasugrel and ticagrelor in real-life acute coronary syndrome (ACS) patients with renal dysfunction.

Methods And Results: All consecutive patients from RENAMI (REgistry of New Antiplatelets in patients with Myocardial Infarction) and BLEEMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registries were stratified according to estimated glomerular filtration rate (eGFR) lower or greater than 60 mL/min/1.73 m2. Death and myocardial infarction (MI) were the primary efficacy endpoints. Major bleedings (MBs), defined as Bleeding Academic Research Consortium bleeding types 3 to 5, constituted the safety endpoint. A total of 19 255 patients were enrolled. Mean age was 63 ± 12; 14 892 (77.3%) were males. A total of 2490 (12.9%) patients had chronic kidney disease (CKD), defined as eGFR <60 mL/min/1.73 m2. Mean follow-up was 13 ± 5 months. Mortality was significantly higher in CKD patients (9.4% vs. 2.6%, P < 0.0001), as well as the incidence of reinfarction (5.8% vs. 2.9%, P < 0.0001) and MB (5.7% vs. 3%, P < 0.0001). At Cox multivariable analysis, potent P2Y12 inhibitors significantly reduced the mortality rate [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.54-0.96; P = 0.006] and the risk of reinfarction (HR 0.53, 95% CI 0.30-0.95; P = 0.033) in CKD patients as compared to clopidogrel. The reduction of risk of reinfarction was confirmed in patients with preserved renal function. Potent P2Y12 inhibitors did not increase the risk of MB in CKD patients (HR 1.00, 95% CI 0.59-1.68; P = 0.985).

Conclusion: In ACS patients with CKD, prasugrel and ticagrelor are associated with lower risk of death and recurrent MI without increasing the risk of MB.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ehjcvp/pvz048DOI Listing
January 2020

Prediction of long-term patient outcome after contemporary left main stenting using the SYNTAX and SYNTAX II scores: A comparative analysis from the FAIL-II multicenter registry (failure in left main study with 2nd generation stents-Cardiogroup III study).

Catheter Cardiovasc Interv 2020 07 2;96(1):E17-E26. Epub 2019 Sep 2.

Department of Cardiology, Hopital Clínico San Carlos, Madrid, Spain.

Aims: To establish the value of the SYNTAX Score-II (SS-II) in predicting long-term mortality of patients treated with left main PCI (LM-PCI) using second-generation drug-eluting stents (DES).

Methods And Results: The SYNTAX score (SS) and the SS-II were calculated in 804 patients included in the FAILS-2 registry (failure in left main study with 2nd generation stents). Patients were classified in low (SS-II ≤33; n = 278, 34.6%), intermediate (SS-II 34-43; n = 260, 32.3%) and high (SS-II ≥44; n = 266, 33.1%) SS-II tertiles. Primary endpoint was all-cause mortality. A significant difference in long-term mortality was noted (5.2 ± 3.6 years): 4.1, 7.5, and 16.7% in low, mid and high SS-II tertiles respectively (p < .001). SS-II score was more accurate in predicting mortality than SS (AUC = 0.73; 95%CI: 0.67-0.79 vs. AUC = 0.55; 95%CI: 0.48-0.63, respectively; p < .001). SS-II led to a reclassification in the risk of all-cause mortality re-allocating 73% of patients from the CABG-only indication to PCI or equipoise PCI-or-CABG indication. Using multiple Cox regression analysis, SS-II (HR: 1.07; 95%CI: 1.05-1.09; p < .001), along with Acute coronary syndrome (ACS) (HR: 1.66; 95%CI: 1.03-2.66; p = .07) and Cardiogenic shock (CS) (HR: 2.82 (95%CI: 1.41-5.64; p = .003) were independent predictors of long-term mortality. SS-II (HR: 1.05; 95%CI: 1.04-1.06; p < .001) along with Insulin dependent Type 2 DM (HR: 1.58, 95%CI: 1.09-2.30.; p < .05), ACS (HR: 1.58, 95%CI: 1.16-2.14; p < .001) and CS (HR: 2.02 95%CI 1.16-3.53; p < .05), were independent predictors of long-term MACE.

Conclusion: The SS-II was superior to the SS in predicting outcomes associated with contemporary LM-PCI. In this real-world population, two clinical variables not included in the SS-II, ACS and T2DM, were identified as additional markers of poor outcome.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ccd.28468DOI Listing
July 2020

Safety and efficacy of polymer-free biolimus-eluting stents versus ultrathin stents in unprotected left main or coronary bifurcation: A propensity score analysis from the RAIN and CHANCE registries.

Catheter Cardiovasc Interv 2020 02 5;95(3):522-529. Epub 2019 Aug 5.

Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain.

Objectives: Evaluate safety and efficacy of polymer-free biolimus-eluting stents (PF-BESs) versus ultrathin stents in unprotected left main (ULM) or bifurcation.

Background: PF-BESs due to reduced length of dual antiplatelet therapy (DAPT) are increasingly used. However, there are limited data about safety and efficacy for ULM or bifurcation.

Methods: We selected all-patients treated for ULM or bifurcation from two multicenter real life registries (RAIN [NCT03544294] evaluating ultrathin stents, CHANCE [NCT03622203] appraising PF-BES). After propensity score with matching, the primary endpoint was major adverse cardiac events (MACE; a composite of all-cause death, myocardial infarction, target lesion revascularization [TLR], and stent thrombosis [ST]), while its components along with target vessel revascularization (TVR) secondary endpoints.

Results: Three thousand and three patients treated with ultrathin stents and 446 with PF-BESs, resulting respectively in 562 and 281 after propensity score with matching (33 and 22%, respectively, with ULM disease). After 12 (8-20) months, rates of MACE were similar (9 vs. 8%, p = 0.56) without difference in TLR and ST (3.0 vs. 1.7%, p = .19 and 1.8 vs. 1.1%, p = .42). These results were consistent for ULM group (3 vs. 1.7% and 1.8 vs. 1.1%, p = .49 and .76), for non-ULM group (2.1 vs. 3.4%, p = .56 and 1.2 vs. 1.7%, p = .78) and for two-stent strategy (8.7 vs. 4.5% and 4.3 vs. 3.2%, p = .75 and .91). Among patients treated with 1 month of DAPT in both groups, those with ultrathin stents experienced higher rates of MACE related to all-cause death (22 vs. 12%, p = .04) with higher although not significant rates of ST (3 vs. 0%, p = .45).

Conclusions: PF-BES implanted on ULM or BiF offered freedom from TLR and ST comparable to ultrathin stents. PF-BESs patients assuming DAPT for 1 month experienced a lower despite not significant incidence of ST.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ccd.28413DOI Listing
February 2020

Coronary artery aneurysms, insights from the international coronary artery aneurysm registry (CAAR).

Int J Cardiol 2020 01 19;299:49-55. Epub 2019 Jul 19.

Cardiology, Città della Salute e della Scienza, Molinnette I, Torino, Italy.

Background: Coronary Aneurysms are a focal dilatation of an artery segment >1.5-fold the normal size of adjacent segments. Although some series have suggested a prevalence of 0.3-12%, data are lacking. In addition, they are not mentioned in practice guidelines. Our aim was investigate its prevalence, management and long-term outcomes.

Methods And Results: The coronary artery aneurysm registry (CAAR) involved 32 hospitals across 9 countries in America and Europe. We reviewed 436,467 consecutive angiograms performed over the period 2004-2016. Finally, 1565 patients were recruited. Aneurysm global prevalence was 0.35%. Most patients were male (78.5%) with a mean age of 65 years and frequent cardiovascular risk factors. The main indication for angiogram was an acute coronary syndrome, 966 cases. The number of aneurisms was ≤2 per patient in 95.8% of the cases, mostly saccular, most frequently found in the left anterior descending and with numbers proportional with coronary stenosis. Aortopathies were related with more aneurysms too. Most patients received any revascularization procedure (69%), commonly percutaneous (53%). After a median follow-up of 37.2 months, 485 suffered a combined event (MACE) and 240 died. Without major differences comparing CABG vs PCI, MACE and death were more frequent in patients who received bare metal stents.

Conclusions: Coronary artery aneurysms are not uncommon. Usually, they are associated with coronary stenosis and high cardiovascular risk. Antiplatelet therapy seems reasonable and a percutaneous approach is safe and effective.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ijcard.2019.05.067DOI Listing
January 2020

Self-expandable sirolimus-eluting stents compared to second-generation drug-eluting stents for the treatment of the left main: A propensity score analysis from the SPARTA and the FAILS-2 registries.

Catheter Cardiovasc Interv 2019 02 8;93(2):208-215. Epub 2018 Oct 8.

Interventional Cardiology, ASST Fatebenefratelli-Sacco, Milan, Italy.

Objectives: To compare the effectiveness and safety of self-expandable, sirolimus-eluting Stentys stents (SES) and second-generation drug-eluting stents (DES-II) for the treatment of the unprotected left main (ULM).

Background: SES may provide a valuable option to treat distal ULM, particularly when significant caliber gaps with side branches are observed.

Methods: Patients from the multicenter SPARTA (clinicaltrials.gov: NCT02784405) and FAILS2 registries were included. Propensity-score with matching was performed to account for the lack of randomization. Primary end-point was the rate of major adverse cardiovascular events (MACE, a composite of all cause death, myocardial infarction, target lesion revascularization [TLR], unstable angina and definite stent thrombosis [ST]). Single components of MACE were the secondary end-points.

Results: Overall, 151 patients treated with SES and 1270 with DES-II were included; no differences in MACE rate at 250 days were observed (9.8% vs. 11.5%, P = 0.54). After propensity score with matching, 129 patients treated with SES and 258 with DES-II, of which about a third of female gender, were compared. After a follow-up of 250 days, MACE rate did not differ between the two groups (9.9% vs. 8.5%, P = 0.66), as well as the rate of ULM TLR (1.6% vs. 3.1%, P = 0.36) and definite ST (0.8% vs. 1.2%, P = 0.78). These results were consistent also when controlling for the treatment with provisional vs. 2-stents strategies for the ULM bifurcation.

Conclusion: SES use for ULM treatment was associated with a similar MACE rate compared to DES-II at an intermediate-term follow-up. SES might represent a potential option in this setting.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ccd.27809DOI Listing
February 2019

Acute and long-term outcomes after polytetrafluoroethylene or pericardium covered stenting for grade 3 coronary artery perforations: Insights from G3-CAP registry.

Catheter Cardiovasc Interv 2018 12 23;92(7):1247-1255. Epub 2018 Sep 23.

Division of Cardiology, Interventional Unit, Infermi Hospital, Rivoli and AOU San Luigi Gonzaga, Orbassano, Turin, Italy.

Background: Covered stent (CS) implantation is considered a useful device in the setting of Grade III Coronary Perforation (G3CP), one of the most harmful PCI complication. However, data regarding efficacy of this device and clinical outcomes are still limited.

Methods And Results: From 1993 to 2015, among 97,779 patients from 9 European centres undergoing PCI, 224 patients had G3CP (0.23%), and 102 patients were managed with CS implantation (96 with PTFE, 6 with pericardium). Device oriented composite endpoint (DOCE), a composite of cardiac death, target lesion revascularization, and stent thrombosis (ST) in-hospital and at long term follow-up were evaluated. G3-CP perforations were successfully sealed with CS in 88 patients (86.3%) with need of intraprocedural pericardiocentesis in one-third of cases. Protamine as heparin reversal agent was administered in 36 (35%) of cases. The cumulative incidence of in-hospital DOCE were 16.6% (17/102): death 14.7%, TLR 2.9%, ST 3.9%. At long-term follow-up (mean 42 ± 38 months), DOCE rates occurred in 19.7%: death 7.4%, TLR 11%, and ST 6.2%. Indication to Dual Antiplatelet Therapy (DAPT) was lifelong in 20% of cases, 1 to 6 months in 22.5% and 12-months in 57.5% without differences in long-term DOCE before and after DAPT interruption (8.0 vs. 6.6%, respectively, P = 0.20).

Conclusions: Use of CS was successful in sealing grade 3 coronary artery perforations in the majority of cases. Beside the high rate of clinical events at short and long-term, ST remains the leading cause of device failure.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ccd.27789DOI Listing
December 2018

Unprotected Left Main Coronary Artery Disease: Outcomes of Treatment With Second-Generation Drug-Eluting Stents - Insight From the FAILS-2 Study.

J Invasive Cardiol 2018 08 15;30(8):283-288. Epub 2018 May 15.

Invasive Cardiology Unit, "SS. Maria Annunziata" Hospital, Via Ospedali 14, Savigliano, Italy.

Objective: To evaluate the outcome of patients undergoing PCI for unprotected left main coronary artery (ULMCA) disease with different drug-eluting stent (DES) types.

Background: Published literature suggests that second-generation DES options have differing vascular responses and outcomes, but there is a paucity of data in real-life patients in the LM setting.

Methods: This is a retrospective, multicenter study, including patients treated with a second-generation DES for ULMCA disease between 2007 and 2015. The primary endpoint was target-lesion revascularization (TLR). Secondary endpoints were major adverse cardiac events, myocardial infarction (MI), and stent thrombosis (ST).

Results: A total of 1209 patients were enrolled; 840 patients (69.5%) received an everolimus-eluting stent (EES), 133 patients (11.0%) received a zotarolimus-eluting stent (ZES), and 236 patients (19.5%) received a biodegradable polymer, biolimus-eluting stent (BP-BES). During a mean follow-up of 722 ± 640 days, TLR occurred in 47 patients (3.8%). At univariate analysis, EES patients had a lower TLR rate (3.6% vs 4.5% in ZES vs 4.2% in BP-BES), which was statistically significant at multivariate analysis (hazard ratio, 0.50; 95% confidence interval, 0.27-0.93; P=.03). No differences in major adverse cardiac events, death, MI, or ST were observed between groups.

Conclusion: The safety profile of the stents used was comparable over the follow-up period. However, EES patients had lower restenosis rates, with a reduced need for repeat PCI.
View Article and Find Full Text PDF

Download full-text PDF

Source
August 2018