Impact of strut thickness and number of crown and connectors on clinical outcomes on patients treated with second-generation drug eluting stent.

INTRODUCTION: In new generation drug eluting stents (DESs) era, the impact of stent geometry on freedom from recurrent events has been poorly explored. Impact of struts thickness and the number of crowns and connectors on clinical outcomes were evaluated in the present study. METHODS: Randomized controlled trials comparing last generation DESs were selected. The primary endpoint was the rate of target lesion revascularization (TLR), while secondary was definite stent thrombosis (ST). RESULTS: Fifty-three studies with 52,006 patients were included. A struts thickness ≤81 nm was associated with a lower incidence of TLR (2.9%: 2.4-3.4 vs. 3.6%: 3.0-4.3) and ST (0.8%: 0.6-1.1 vs. 1.3%: 0.9-1.8). A mean number of connectors >2.5 was also associated with a lower incidence of TLR (3.2%: 2.8-3.6 vs. 3.5%: 2.9-4.2) and ST (1.0%:0.8-1.3 vs. 1.3%: 0.9-1.7 vs. for ST). On the other hand, stents with average number of crowns <7.5 did not perform better than stents with higher average number of crowns. CONCLUSIONS: The findings of the study support that lower struts thickness and higher numbers of connectors have a positive clinical outcome reducing stent thrombosis and target lesion revascularizations, while the average number of stent crowns plays a secondary role.

Comparison between functional and intravascular imaging approaches guiding percutaneous coronary intervention: A network meta-analysis of randomized and propensity matching studies.

BACKGROUND: The optimal approach to guide percutaneous coronary intervention (PCI) has yet to be defined. The aim of this study was to compare functional driven (fractional flow reserve) versus intravascular imaging (intravascular ultrasound, IVUS, and/or optical coherence tomography, OCT) versus standard (coronary angiography only, CA)-guided PCI. METHODS: Randomized controlled trials (RCTs) and propensity score weight-matched studies (PSWMs) comparing FFR versus IVUS versus OCT versus CA-guided PCI were included. Major adverse cardiovascular event (MACE; a composite end point of death or myocardial infarction [MI] or revascularization) was the primary endpoint, whereas definite stent thrombosis (ST) and single components of MACE were the secondary ones. Primary analyses were performed including only RCTs, secondary also with PSWMs. RESULTS: Thirty-three studies were included in the analysis, 16 RCTs and 17 PSWMs. After 2 (1-3) years, IVUS performed better for MACE than CA (odds ratio [OR] 0.75 0.52-0.88), whereas there was just a trend for FFR (OR 0.81, 0.64-1.02). These results were mainly driven by reduced risk of all cause death, MI (FFR OR 0.74:0.57-0.99 and IVUS OR 0.82:0.54-0.94) and revascularization. IVUS reduced ST while FFR did not, and at meta-regression analysis, there was a trend for superiority of IVUS versus FFR to reduce subsequent MI in acute coronary syndrome (ACS) patients. The present results were consistent also after adding studies with PSWMs. CONCLUSIONS: Functional and intravascular imaging approaches seem to perform similarly in term of clinical outcomes, while both performed better compared with the standard approach. Imaging showed a potential benefit for ACS patients. The present results stress the need for a wider use of functional or imaging driven PCI.

Comparison of bioresorbable vs durable polymer drug-eluting stents in unprotected left main (from the RAIN-CARDIOGROUP VII Study).

BACKGROUND: There are limited data regarding the impact of bioresorbable polymer drug eluting stent (BP-DES) compared to durable polymer drug eluting stent (DP-DES) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. METHODS: In the RAIN registry (ClinicalTrials NCT03544294, june 2018 retrospectively registered) patients with a ULM or bifurcation stenosis treated with PCI using ultrathin stents (struts thinner than 81 µm) were enrolled. The primary endpoint was the rate of target lesion revascularization (TLR); major adverse cardiovascular events (MACE, a composite of all-cause death, myocardial infarction, TLR and stent thrombosis) and its components, along with target vessel revascularization (TVR) were the secondary ones. A propensity score with matching analysis to compare patients treated with BP-DES versus DP-DES was also assessed. RESULTS: From 3001 enrolled patients, after propensity score analysis 1400 patients (700 for each group) were selected. Among them, 352 had ULM disease and 1048 had non-LM bifurcations. At 16 months (12-22), rates of TLR (3.7% vs 2.9%, p = 0.22) and MACE were similar (12.3% vs. 11.6%, p = 0.74) as well as for the other endpoints. Sensitivity analysis of outcomes after a two-stents strategy, showed better outcome in term of MACE (20.4% vs 10%, p = 0.03) and TVR (12% vs 4.6%, p = 0.05) and a trend towards lower TLR in patients treated with BP-DES. CONCLUSION: In patients with bifurcations or ULM treated with ultrathin stents BP-DES seems to perform similarly to DP-DES: the trends toward improved clinical outcomes in patients treated with the BP-DES might potentially be of value for speculating the stent choice in selected high-risk subgroups of patients at increased risk of ischemic events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03544294. Retrospectively registered June 1, 2018.

Optimal medical therapy vs. coronary revascularization for patients presenting with chronic total occlusion: A meta-analysis of randomized controlled trials and propensity score adjusted studies.

INTRODUCTION: The optimal management of patients with coronary chronic total occlusions (CTO) remains controversial. This meta-analysis aims to compare percutaneous coronary intervention of CTO (CTO-PCI) versus optimal medical therapy (OMT) in CTO patients. METHODS: A literature search with highly specific terms was conducted using MEDLINE, EMBASE, and Web of Science to identify most relevant randomized controlled trials (RCTs) and observational studies with propensity score matching (PSM) evaluating differences in between CTO-PCI versus OMT. The primary endpoint was the incidence of major adverse cardiac events (MACEs, composite of cardiovascular death, acute coronary syndrome, and repeat PCI, re-PCI) while its single components were defined as secondary endpoints. RESULTS: A total of eight studies was included, four RCTs and four PSMs. 3,971 patients were included in the analysis (2,050 CTO-PCI versus 1,921 OMT) with a mean follow-up of 3 years. No significant differences were found regarding overall MACE, re-PCI and AMI. Regarding CV-death, CTO-PCI was associated with a better outcome compared with OMT driven by PSMs (OR 0.52, 0.0.81, P < 0.01). CONCLUSIONS: As compared to OMT, CTO-PCI was associated with similar MACE rate; however, CTO-PCI may be associated with reduced CV death, mainly due to PSMs effect.

Coronary Artery Calcium and Aging: Physiological Basis, Assessment, and Treatment Options in Percutaneous Coronary Intervention.

Coronary artery calcification is a complex anatomical and histological pathology with different pathways that contribute to calcium deposit and calcification progression. As part of the atherosclerotic process, extensive calcifications are becoming more common and are associated with poorer PCI outcomes if not properly addressed. Since no drug has shown to be effective in changing this process once it is started, proper knowledge of the underlying pathogenesis and how to diagnose and manage it is essential in contemporary coronary intervention. Atherosclerosis is a pandemic disease, quickly spreading across the world and not limited anymore to the industrialized Western world. In this paper, we review the role of intracoronary imaging and the main technologies available and propose a simple and rational algorithm for the choice of a preferential first strategy in the treatment of severely calcified coronary atherosclerosis, followed by three emblematic cases on how we successively applied it.

[Cardiac arrest caused by anomalous origin and course of the right coronary artery]. / Arresto cardiaco causato da coronaria destra ad origine e decorso anomali.

The anomalous origin of the right coronary artery from the left sinus with interarterial course is a rare but life-threatening coronary abnormality. Coronary computed tomography is crucial in identifying this disease whose treatment, based on coronary artery bypass grafting, is recommended in symptomatic patients but is more controversial in asymptomatic patients. The case report presented offers an opportunity to discuss the pathophysiological, diagnostic and therapeutic aspects of this congenital coronary artery disease.

Clinical differences between drug-induced type 1 Brugada pattern and syndrome.

Background: Diagnosis of Brugada syndrome (BrS) may be established by exposing a Type 1 Brugada pattern using a sodium channel blocker. Data on the outcomes of different patient populations with drug-induced Type 1 Brugada pattern are limited. The present study reports on the characteristics and outcome of subjects with ajmaline induced Type 1 Brugada pattern. Methods: A multicenter retrospective study including all consecutive cases of ajmaline-induced Type 1 Brugada pattern from seven centers. Results: A total of 260 patients (69.9% males, mean age 43.4 ± 13.5) were included. Additional characteristics included history of syncope (n = 56, 21.5%), family history of BrS (n = 58, 22.3%) or sudden cardiac death (n = 47, 18.1%) and ventricular fibrillation (n = 3, 1.2%). Patients were divided into those meeting current diagnostic criteria for drug-induced BrS (DIBrS) and compared to the drug-induced Brugada pattern (DIBrECG). Females were significantly overrepresented in the DIBrS group (n = 50, 40% vs. n = 29, 21.5%, p = .001). A significantly higher prevalence of type 2/3 Brugada ECG at baseline was found in the DIBrECG group (n = 108, 80.8% vs. n = 75, 60% in the DIBrS, p = .026). During a median follow up of three (IQR 1.50-5.32) years, a single event of significant arrhythmia occurred in the DIBrS group. Conclusion: Less than half of subjects with ajmaline-induced Brugada pattern met current criteria for BrS. These individuals had very low rate of adverse outcomes during a follow up of 3 years, irrespective of the indication for the test or eligibility for the BrS diagnosis.

Symptoms-to-emergency-call timing delay in acute coronary syndrome before and during COVID-19: independent predictors and their impact on mortality.

BACKGROUND: The COVID-19 pandemic severely impacted global health. The aim of this study was to compare predictors of symptoms-to-emergency-call timing delay in acute coronary syndrome (ACS) and their impact on mortality before and during the COVID-19 outbreak. METHODS: We collected sociodemographic, clinical data, procedural features, preadmission and intra-hospital outcomes of consecutive patients admitted for ACS in seventeen Italian centers from March to April 2018, 2019, and 2020. RESULTS: In 2020, a 32.92% reduction in ACS admissions was observed compared to 2018 and 2019. Unstable angina, typical and atypical symptoms, and intermittent angina were identified as significant predictors of symptoms-to-emergency-call timing delay before and during the COVID-19 pandemic (P<0.005 for all the items). Differently from 2018-2019, during the pandemic, hypertension and dyspnea (P=0.002 versus P=0.490 and P=0.001 vs. P=0.761 for 2018-2019 and 2020, respectively) did not result as predictors of delay in symptoms-to-emergency-call timing. Among these predictors, only the atypical symptoms (HR 3.36; 95% CI: 1.172-9.667, P=0.024) in 2020 and the dyspnea (HR 2.64; 95% CI: 1.345-5.190, P=0.005) in 2018-2019 resulted significantly associated with higher mortality. Finally, the family attendance at the onset of the symptoms resulted in a reduction in symptoms-to-emergency-call timing (in 2020 P<0.001; CI: -1710.73; -493.19) and in a trend of reduced mortality (HR 0.31; 95% CI: 0.089-1.079, P=0.066) in 2020. CONCLUSIONS: During the COVID-19 outbreak, atypical symptoms and family attendance at ACS onset were identified, respectively, as adverse and favorable predictors of symptoms-to-emergency-call timing delay and mortality.

The Incidence and Impact of In-Hospital Bleeding in Patients with Acute Coronary Syndrome during the COVID-19 Pandemic.

BACKGROUND: The COVID-19 pandemic increased the complexity of the clinical management and pharmacological treatment of patients presenting with an Acute Coronary Syndrome (ACS). AIM: to explore the incidence and prognostic impact of in-hospital bleeding in patients presenting with ACS before and during the COVID-19 pandemic. METHODS: We evaluated in-hospital Thrombolysis In Myocardial Infarction (TIMI) major and minor bleeding among 2851 patients with ACS from 17 Italian centers during the first wave of the COVID-19 pandemic (i.e., March-April 2020) and in the same period in the previous two years. RESULTS: The incidence of in-hospital TIMI major and minor bleeding was similar before and during the COVID-19 pandemic. TIMI major or minor bleeding was associated with a significant threefold increase in all-cause mortality, with a similar prognostic impact before and during the COVID-19 pandemic. CONCLUSIONS: the incidence and clinical impact of in-hospital bleeding in ACS patients was similar before and during the COVID-19 pandemic. We confirmed a significant and sizable negative prognostic impact of in-hospital bleeding in ACS patients.

"Never Trust to General Impressions, My Boy, but Concentrate Yourself upon Details": An Unusual and Challenging Presentation of Pheochromocytoma.

We present the case of a 45-year-old woman admitted to our unit with acute heart failure and cardiogenic shock, requiring an intra-aortic balloon pump insertion and inotropes and vasopressors infusion. Despite such treatment, the patient developed multi organ failure and intravascular disseminated coagulation with haemolysis. The initial diagnosis of acute myocarditis was subsequently denied by the finding of bilateral adrenal masses by MRI scan, and urine and plasma metanephrines measurements confirmed a pheochromocytoma (PCC). Genetic analysis revealed a mutation in the neurofibromatosis type 1 (NF1) gene, and an accurate physical examination drew attention to small cafè-au-lait spots, usually associated with this syndrome. PCC diagnosis should be promptly considered in patients presenting with unexplained acute heart failure and cardiogenic shock of unknown origin, considering its life-threatening complications and the good prognosis after radical surgery.

[Takotsubo syndrome complicated by ventricular thrombosis and pericarditis]. / Sindrome takotsubo complicata da trombosi ventricolare e pericardite.

Takotsubo syndrome is a heart disease characterized by transient ventricular dysfunction; although it is considered a benign pathology, it is not free from serious complications. Intraventricular thrombosis is a rare occurrence as well as pericarditis, and the simultaneous presence of both complications is very exceptional. Here we describe a case. Diagnosis and therapeutic management was successfully guided by multimodality imaging.

Incidence, Management, Immediate and Long-Term Outcome of Guidewire and Device Related Grade III Coronary Perforations (from G3CAP - Cardiogroup VI Registry).

Ellis grade III coronary artery perforations (G3-CAP) remain a life-threatening complication of percutaneous coronary intervention (PCI), with high morbidity and mortality and lack of consensus regarding optimal treatment strategies. We reviewed all PCIs performed in 10 European centers from 1993 to 2019 recording all G3-CAP along with management strategies, in-hospital and long-term outcome according to Device-related perforations (DP) and Guidewire-related perforations (WP). Among 106,592 PCI (including 7,773 chronic total occlusions), G3-CAP occurred in 311 patients (0.29%). DP occurred in 194 cases (62.4%), more commonly in proximal segments (73.2%) and frequently secondary to balloon dilatation (66.0%). WP arose in 117 patients (37.6%) with chronic total occlusions guidewires involved in 61.3% of cases. Overall sealing success rate was 90.7% and usually required multiple maneuvers (80.4%). The most commonly adopted strategies to obtain hemostasis were prolonged balloon inflation (73.2%) with covered stent implantation (64.4%) in the DP group, and prolonged balloon inflation (53.8%) with coil embolization (41%) in the WP group.  Procedural or in-hospital events arose in 38.2% of cases: mortality was higher after DP (7.2% vs 2.6%, p = 0.05) and acute stent thrombosis 3-fold higher (3.1% vs 0.9%, p = 0.19). At clinical follow-up, median 2 years, a major cardiovascular event occurred in one-third of cases (all-cause mortality 8.2% and 7.1% respectively, without differences between groups). In conclusion, although rare and despite improved rates of adequate perforation sealing G3-CAP cause significant adverse events. DP and WP result in different patterns of G3-CAP and management strategies should be based on this classification.

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

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.

Case report: intravascular ultrasound sonography-guided re-entry technique in crushed stent.

BACKGROUND: Stent thrombosis (ST) is a rare, but potentially fatal complication. Procedural problems, such as stent under-dimension/under-expansion or dual antiplatelet drug resistance may result into ST. These conditions are more frequent during primary percutaneous coronary intervention for ST-elevation myocardial infarction (STEMI). CASE SUMMARY: A 60-year-old male patient presented to our hospital with an inferior STEMI. In the emergency department, a dual antiplatelet therapy was administered with ticagrelor 180 mg and aspirin 250 mg IV. During the observation, the patient experienced a ventricular fibrillation. Urgent coronary angiography showed an occlusion of the proximal right coronary artery. Thrombus aspiration was performed followed by implantation of one drug-eluting stent. After 45 min early ST occurred and was treated by immediate thrombus aspiration and post-dilatation. Intravascular ultrasound sonography (IVUS) showed severe strut malapposition due to a partial crush after post-dilatation. Since it was not possible to directly insert the first guidewire in the stent lumen, the IVUS probe was placed between the vessel wall and the crushed stent to guide the manoeuvre. DISCUSSION: Crushed stent is a rare complication, being caused by an incorrect passage of the guidewire between the stent's struts and the vessel wall in case of severe underexpansion. In this case, an IVUS-guided re-entry could be an option to gain the stent true lumen and avoid a second stent implantation.

PK Papyrus coronary stent system: the ultrathin struts polyurethane-covered stent.

In the emergency setting of a coronary vessel perforation, the knowledge of materials needed to fix it and the intrinsic quality of the device used is mandatory for the interventional cardiologist. The PK Papyrus covered stent (Biotronik AG) is an ultrathin strut (60 µm) balloon-expandable stent covered on the abluminal surface with an electrospun polyurethane matrix. It is intended to facilitate device delivery and effectively treat coronary artery perforations. In published studies, rates of successful device delivery and perforation sealing were above 90%, respectively, and most events were usually resolved with a single stent. In this review we focused on the main technical characteristics as well on the published evidence that compare its performance with other coronary covered stent.

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

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.

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

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.