Abstract Background Treatment of patients with cancer presenting with ST-elevation myocardial infarction (STEMI) is complex given the increased risk of both thrombotic and major bleeding complications. We evaluated the risk of major bleeding and re-infarction in patients with or without cancer following admission with STEMI Methods A nationally-linked cohort of STEMI patients between January 2005 and March 2019 were obtained from the UK Myocardial Infarction National Audit Project (MINAP) registry and the UK national Hospital Episode Statistics Admitted Patient Care (HES APC) registry. Cox proportional hazard models were used, and Kaplan-Meier survival and cumulative survival curves were constructed. Results A total of 322,776 STEMI indexed admissions were identified between Jan 2005 and March 2019. Of those, 7050 (2.2%) patients were diagnosed with active cancer. Cancer patients were older with more cardiovascular comorbidities. Cancer patients received invasive coronary angiography (62.2% vs 72.7%, p<0.001) and PCI (58.4% vs 69.5%) less often compared to patients without cancer and were less likely to be prescribed DAPT (85% vs 95.4%). Major bleeding rate at one year was higher in cancer patients (6.5% vs 3.5%) while re-infarction rates were similar (cancer 5.7%, no cancer 5.1%). Adjustment for differences in baseline covariates, a similar risk of re-infarction (SHR 1.10, 95% CI 0.94-1.27) and a 50% increased risk of major bleeding (SHR 1.49, 95% CI 1.30-1.71) was observed in cancer patients. Conclusion Compared to non-cancer patients, cancer patients have a higher risk of major bleeding but not of re-infarction. Mitigating bleeding risk in STEMI patients with cancer is of paramount importance to improve outcomes.bleeding risk at 1 yearRe-infarction risk at 1 year

Abstract Introduction High bleeding risk (HBR) can represent a challenge, especially in patients with complex coronary lesions undergoing PCI. This study aims at investigating the prevalence of HBR in a wide and comprehensive cohort of patients undergoing left main (LM) PCI, describing their clinical phenotype, and reporting their procedural outcomes. Methods The analysis was performed on data from the DELTA 2 Registry, which prospectively included patients who underwent LM PCI at 19 centers worldwide. The patients were defined to be at HBR if ≥1 Major Criteria or ≥2 Minor Criteria from the Academic Research Consortium (ARC) were met. The primary endpoint was a composite of all–cause death, myocardial infarction (MI) or stroke at median follow–up. Results A total of 1531 patients were included, the rate of HBR was 65.8%. Besides the different clinical characteristics embedded in the ARC definition, HBR had higher prevalence of ACS at presentation (49.2% vs 26.8%, p<0.001), and experienced higher in hospital mortality (1.8% vs 0.2%; p=0.029) and MI (5.0% vs 2.1%, p=0.009) (Figure, Panel A). The median follow–up was 473 days. The rate of the primary endpoint was more than three times higher in HBR patients (20.8% vs 6.1%; HR 3.3; 95% CI: 2.2–4.8) (Figure, Panel B), and significantly driven by all cause death (16.2% vs 4.6%; HR: 3.3; 95% CI:2.2–5.1) and MI (5.8% vs 1.9%; HR 2.9; 95% CI: 1.5–5.7). Conversely no significant difference was reported in terms of target lesion revascularization (TLR) probable or defined stent thrombosis. Conclusions HBR patients undergoing LM PCI experienced higher rates of all cause death and MI at follow–up; similar outcomes were also reported in–hospital.

Recently, an increase in the number of patients with severe aortic stenosis eligible for transcatheter aortic valve implantation (TAVI) has been observed worldwide. In order to reduce waiting lists, provide to all patients referred to us equal access to care and to further improve the collaboration with spoke centers, we developed a specific Hub & Spoke specific protocol for TAVI. According to our protocol, a clinical selection (with echo and computed tomography scan) is done by Spoke centers, the case is discussed with a multidisciplinary team online and the procedure is planned (access, valve type size). At day 0, the patient is admitted in Spoke centers where blood samples are taken; at day 1, the patient is transferred to a Hub center for the TAVI procedure and after 2 h of observation, if no adverse events are registered, the patient is transferred back to the Spoke center. Since 2019, an agreement among our center and two hospitals has been signed. According to this Hub & Spoke model, a total of 72 patients with aortic stenosis were treated with TAVI (mean age 83 years, 48.6% female, median Society of Thoracic Surgeons risk 2.4 ± 1.1%, left ventricular ejection fraction 58.0 ± 7.75%). More frequently CoreValve Evolut R (47.2%) was used. Only 2 patients had a prolonged admission at Hub and were not transferred at day 1 (1 vascular complication and 1 intra-procedural resuscitated cardiac arrest). This Hub & Spoke model guaranteed shortening of waiting lists, more effective turnover of bed, equal access to care to patients referred to our center. In addition, it helped also to increase Awareness and education as well as appropriate training of the teams from spoke facilities.

Abstract Background Acute pulmonary embolism (PE) is a common disease associated with a high mortality rate. Catheter–Directed Treatments (CDTs) could address some unsolved issues in high and intermediate–high risk PE patients evolving towards hemodynamic deterioration when systemic thrombolysis (ST) is contraindicated or fails. Few data in literature suggest that female patients hospitalized for PE experience adverse clinical outcomes as compared with their male counterparts. However, whether there is a specific impact of sex on CDTs outcomes in PE within real–world clinical settings remains unexplored. Methods This is a multicenter retrospective study including patients admitted in five Italian Centers, who underwent CDTs for high and intermediate–high risk PE, as defined by ESC Guidelines. In–hospital and one–year clinical outcomes were evaluated using medical records and follow–up assessments. Bleeding events were defined according to the Bleeding Academic Research Consortium (BARC) criteria. Results A total of 191 patients were included, 101 women (52.9%) and 90 men (47.1%). High risk PE was diagnosed in 56 (29%) patients, while intermediate–high risk PE was diagnosed in 135 (71%). Of these, 132 (69%) were treated by ultrasound–assisted thrombolysis (USAT), with negligible sex disparity between treatment modalities. Notably, female patients presented more frequently with cardiac arrest (11% vs. 2.6%, p = 0.03), had lower prevalence of absolute contraindications to ST (23% vs. 42%, p = 0.004) and history of recent major surgery (8.9% vs. 22%, p = 0.01). Female patients had a trend towards higher procedural–related complications (17% versus 9%, OR 2.07 95%CI 0.87–5.33, p=0.11), higher in–hospital mortality rate (20% versus 8.9%, OR 2.53 95%C.I. 1.09–6.41, p=0.038) and higher likelihood of bleeding events (22% versus 10%, OR 2.54 95%CI 1.13–6.14, p=0.029). At 1 year follow–up, female sex was associated with higher all–cause mortality (29.1% versus 12.7%, HR 2.50 95%CI 1.15–5.43, p=0.022). Multivariate regression analysis identified female sex, diagnosis of high–risk PE and a history of neoplasia as independent predictors of 1–year all–cause mortality. Conclusions In our experience, female patients undergoing CDTs for acute PE showed worse clinical presentation, higher procedural–related complications, and poorer outcomes than males. In our opinion this sex disparity underscores the need for sex–specific considerations in acute PE management strategies.

Abstract Introduction Acute pulmonary embolism (PE) is associated with high morbidity and mortality rate. Catheter–directed treatments (CDTs) seem a therapeutical option in case of sistemic thrombolysis (ST) contraindication or failure. Ultrasound–assisted thrombolysis (USAT) allows low–dose thrombolytic loco–regional infusion facilitated by ultrasounds. Methods and Results A multicentre retrospective observational cohort study was conducted among 4 Cardiovascular Interventional Centres in Lombardy Region to evaluate safety and efficacy of USAT in high risk and intermediate–high risk PE patients presenting with contraindications to ST. Patients at high risk were included in case of USAT because of ST contraindications. Patients at intermediate–high risk were included in case of rescue USAT. Loco–regional thrombolysis was performed using rTPA. Procedural success was defined as successful catheters‘ deployment in pulmonary arteries and patient survival during the procedure. Bleeding were defined according to BARC criteria. Echocardiographic evaluation to determine the prevalence of right ventricular (RV) dysfunction and pulmonary hypertension was performed at presentation, discharge and follow–up. Between 2011 and 2021, 109 patients were included. 21.1% presented with high risk PE, the remaining 78.9% with intermediate–high risk. Procedural success was obtained in 99.1% of the cases; major bleedings occurred in 9.2%, minor bleedings in 11.9% and vascular complications in 7.3% of the patients. 91.7% of patients were alive at discharge. In–hospital all–cause mortality was higher in high risk patients (26.1% vs 3.5%; p = 0.003) that showed a steep decline in survival as compared to intermediate–high risk patients that constantly maintained a high survival rate throughout the observation period. At six–months follow–up 3 patients in intermediate–high risk group died so that the overall mortality remains higher in high risk patients (26.1% vs 7%; p = 0.018). No re–hospitalization for recurrent PE at six–months occurred. Prevalence of RV dysfunction and pulmonary hypertension significantly decreased from hospital admission to discharge and to six–months follow–up (p–value <0.0001 for all comparisons). Conclusions Our experience shows good short and mid–term outcomes in USAT in high risk and intermediate–high risk PE patients with contraindications to ST, suggesting that it might be considered in a neglected subset of patients with no alternative therapeutical options.

Abstract Background There is limited literature available on the impact of myocardial ischemia but no obstructive coronary arteries (INOCA) on patients' lives. Purpose We sought to determine how INOCA impacts the physical, social, and mental health of persons with this diagnosis. Methods A survey was made available to all members of the patient support group from INOCA International over a 3-month time period. Fitness was estimated using the Duke Activity Status Index (DASI), assessing levels of activities performed prior to the onset of INOCA symptoms, and after the diagnosis of INOCA. The formula to estimate fitness in metabolic equivalents (METs) = 0.43 × DASI + 9.6 / 3.5 Results A total of 297 patients with INOCA responded to the survey; 91.2% were women. The most common diagnosis was coronary microvascular dysfunction (64.3%) and coronary artery spasm (50.5%) (Table 1). 34.4% reported living with symptoms for ≥3 years before their diagnosis of INOCA was made. 77.8% who had been told their symptoms were not cardiac. The symptoms the respondents experienced were numerous, but 92.9% reported symptoms of chest pain, pressure, or discomfort. Fitness levels prior to the onset of INOCA symptoms were significantly higher compared to after diagnosed with INOCA (8.6±1.8 METs vs 5.6±1.8 METs; P<0.0001). Most respondents reported an adverse impact on their home life (80.5%), social life (80.1%), mental health (70.4%), outlook on life (69.7%), sex life (55.9%), and their partner/spouse relationship (53.9%). Work life was also affected once living with INOCA: approximately three-quarters had reduced their work hours or stopping work completely, 47.5% retired early, and 38.4% applied for disability. While living with INOCA, for each 1-MET decrease in fitness, there was a loss of 3.0±0.6 days/months of physical health, 1.8±0.6 days/month of mental health, and 2.9±0.7 days/months of inability to perform recreational activities (p<0.0001) (Figure 1). Conclusions Living with INOCA has significant impact on physical, mental and social health. Significant physical fitness declines are seen in those living with INOCA and are lower in those experiencing any adverse impact of living with INOCA. Additionally, the impact of INOCA on the ability to work has important economic consequences to both the patient and society. Increased recognition of the impact of INOCA on these aspects of health need to be recognized and further work is needed to better diagnosis and treat the symptoms of INOCA to improve the quality of life, cardiovascular outcomes, and overall health of this frequently encountered cardiovascular disorder. Funding Acknowledgement Type of funding sources: None.

Abstract Background TAVI (Transcatheter aortic valve implantation) is now established as the preferred treatment option for patients with symptomatic severe aortic stenosis at prohibitive or high surgical risk and its application is increasingly supported by an accumulating evidence base in patients at intermediate and low risk, but the issue of valve durability are still unsettled. Purpose To evaluate long-term clinical outcomes and bioprosthesis valve dysfunction after TAVI. Methods All patients treated with transfemoral TAVI, from November 2007 to December 2014 were analyzed. Baseline clinical, procedural and in-hospital outcomes were collected and revised. Clinical and echocardiographic follow-up was conducted either by clinic visits or telephone consultations. All definitions of the clinical endpoints and bioprosthesis valve failure used were in concordance with the Valve Academic Research Consortium 2 and the European Society of Cardiology consensus, respectively. Results Four hundred and eight patients were included in the analysis. Median follow-up was 2.733 days (7.5 years), with the longest follow-up at 4.096 days (11.2 years). At 7.5 years (IQR 5.4–9.3 years), all-cause mortality was 64.5% (n=263), of these cardiovascular death was adjudicated in 33.6% (n=137), non-cardiovascular death in 30.9% (n=126) and valve-related death was 1.9% (n=8). Structural valve deterioration occurred in 2.9% (n=12), non-structural valve deterioration in 0.2% (n=1), thrombosis in 2.2% (n=9) and endocarditis in 3.2% of patients (n=13). Fourteen patients (3.4%) required surgical (1.2%) or percutaneous (2.2%) aortic valve re-intervention. Conclusions Percutaneous aortic bioprosthesis demonstrated a low bioprosthesis valve failure at a median of 7.5 years of clinical follow-up after implantation, with low rate of degeneration or need of re-intervention. Overall mortality was high with acceptable rates of cardiovascular mortality and low rates of valve-related deaths. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): EAPCI Education and Training Grants

Abstract Background Women have worse outcomes than men after PCI, with some studies suggesting a lower mortality of CABG vs PCI in females. Purpose To assess the outcomes of CABG and PCI according to sex in a large registry population of patients with unprotected left main coronary artery (ULMCA) disease. Methods The DELTA and DELTA 2 registries are two multicentric, prospective registries evaluating the outcomes of subjects undergoing coronary revascularization for ULMCA disease. Results Total population was 6253 patients, 27% women. Table 1 shows baseline clinical characteristics. Median follow up was of 880 days. Women undergoing CABG had lower incidence of death, myocardial infarction (MI) or cerebrovascular accidentc (CVA) (HR 0.53, 95% CI 0.35–0.79) and a lower risk of death (HR 0.40, 95% CI 0.24–0.67). No significant differences were observed in men (Figure 1A). SIgnificant interaction was observed between sex and revascularization strategy for both outcomes (p<0.01-Figure 1B). CABG was associated with lower risk of target-vessel and target-lesion revascularization consistently inwomen and men (pint=0.49 and pint=0.89, respectively–Figure 1B). Conclusions In women undergoing coronary revascularization for ULMCA disease, CABG is associated to lower risk of death, MI or CVA. Further dedicated studies are needed to determine the optimal revascularization strategy in women with ULMCA disease. Figure 1 Funding Acknowledgement Type of funding source: None

Abstract Background Most patients undergoing transcatheter aortic valve implantation (TAVI) develop silent cerebral ischemic lesions (SCIL) detectable at magnetic resonance imaging (MRI). The natural history and clinical relevance of SCIL are not well established. We aimed to assess the characteristics, predictors, evolution, and neurocognitive effects of SCIL. Methods Cerebral MRI was performed within 7 days before TAVI to assess baseline status and age-related white matter changes (ARWMC) score. MRI was repeated postoperatively to assess the occurrence, location, number and dimensions of SCIL. Patients developing SCIL underwent a third MRI at 3–5 months follow-up. A neurocognitive evaluation was performed before TAVI, at discharge and at 3-month follow-up. Results Of the 117 patients enrolled, 96 underwent a postprocedural MRI; SCIL were observed in 76% of patients, distributed in all vascular territories, with a median number of 2 lesions, median diameter 4.5 mm, and median total volume 140 mm3. Independent predictors of SCIL occurrence were a higher baseline ARWMC score and the use of self-expanding or mechanically-expanded bioprostheses. Among 47 patients who underwent follow-up MRI, only 26.7% of postprocedural SCIL evolved into a gliotic scar. SCIL occurrence was associated with a more pronounced transient neurocognitive decline early after TAVI and with a lower recovery at follow-up. Conclusions SCIL occur in the vast majority of patients undergoing TAVR and are predicted by a more diffuse white matter damage at baseline and by the use of non-balloon-expandable prostheses. Although most SCIL disappear within months, their occurrence has a limited but significant impact on neurocognitive function. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): unrestricted grants from Edwards Lifesciences SA, Nyon, Switzerland, and from Medtronic Italia SpA, Milan, Italy

Abstract Background The Impella () percutaneous mechanical circulatory support device is a catheter-based, impeller-driven, axial-flow pump. It reduces left ventricular (LV) stroke work and myocardial oxygen demand while increasing systemic and coronary perfusion in the setting of cardiogenic shock (CS). Purpose The aim of the study was to evaluate clinical characteristics and outcomes of patients with CS treated with Impella at our center. Methods Our single-center, real-world, observational registry included all consecutive patients with CS treated with Impella 2.5, CP, 5.0, or RP at our center from February 2013 to June 2018. Indication for Impella implantation was CS, defined as hypotension (systolic blood pressure <90 mmHg) despite adequate filling status with signs of hypoperfusion. Results A total of 130 patients were included in the registry, mean age was 61±12 years, and 79.2% were males. A history of prior MI, chronic heart failure, and chronic kidney disease was present in 28.9%, 26.1%, and 18.3%, respectively. The etiologies of CS were the following: fulminant myocarditis in 6.1% of the patients, acute coronary syndromes in 59.2%, peri-procedural CS during ventricular tachycardia ablation in 7.7% and acute heart failure in 27%. Out-of-hospital cardiac arrest was present in 30.4% of the patients; 60.2% were in INTERMACS I class at presentation. At admission, mean arterial pressure (MAP) was 65±18 mmHg, serum lactate was 6.7±5.5 mmol/L, mean left ventricular ejection fraction 21.4±11.7%, right ventricular dysfunction was indeed present in 48.6% of the patients. Inotropic drugs support was used in 66.4% of the patients. Impella 2.5, CP, and 5.0 were implanted in 76.1%, 15.4%, and 1.5% of the patients, respectively. Impella RP was also used in 11.5% of patients.The mean duration of support was 135±167 hours. Of note, extra-corporeal membrane oxygenation (ECMO) and intra-aortic balloon pump (IABP) were implanted before Impella insertion in 42.8% and 46.7% of the patients, respectively. Escalation to ECMO, ventricular assist device, or heart transplantation was needed in 35.8% of the patients. During hospital stay, acute kidney injury occurred in 56.7% of the patients; need of renal replacement therapy (RRT) 31.7%; access site-related bleeding 14.3%; life-threatening bleeding 31.5%; acute limb ischemia 14.5%; hemolysis 33.3%. The rate of all-cause mortality at 30 day was 39.7%. Need of RRT was the only independent predictor of 30-day mortality (OR 6.56; CI 1.71–25.15; p=0.006). Conclusion Our single-center, real-world, observational experience reports acceptable clinical outcomes after Impella implantation in a particularly complex population of patients with CS (INTERMACS class I in 60.2% of patients, prior use of ECMO in 42.8% of patients). All-cause mortality at 30 days was 39.7%, and need of RRT was the only independent predictor for 30-day mortality.

Abstract Background Females are continuously growing in interventional communities, but some unmet needs exist on the issue of gender's differences. Purposes To investigate gender's differences on job-habits and private-life in Italian Cath-Labs. Further, the topic of temporary abstention from the interventional activity for any cause (pregnancy, illness, injury) and radioprotection issues were also assessed. Methods A national survey supported by Italian Interventional Cardiology Society (GISE) was submitted by mail to overall 1,230 GISE-members. Questions were formulated in multiple-choice and some required an open answer or a scale definition. Categorical data are presented as numbers and percentages and compared using chi-square test. P-values <0.05 were considered significant. Results Responders were 326 (26.5%). Sixty-six (20.2%) were young (<35-years), and 29.6% were aged between 41–50 years. Among these, 211 (65.9%) were expert operators with more than 10-years of Cath-Lab experience. Notably 86 (26.4%) of responders were females. There were more females aged <40-years as compared with males (50 vs. 34%, p=0.010). No differences were observed according to the job-position (consultants-females 72.1% vs males 78.3%, p=0.15), as well as workload (females performing “on call” 69.8% vs. males 68.3%, p=0.12). However, as compared with males, females were more frequently single (22.1% vs. 8.7%, p=0.02), childless (58.1% vs 26.7%, p<0.001). In addition, males had more frequently a partner working in the hospital-staff as compared to females (56% vs 44.8%, p<0.001). In case of abstention from Cath-Lab, 39.7% and 70.9% of the population believe that, it is useful to perform PCI-robotics simulations, and to participate in “Refresh-skill”-sessions, respectively. Indeed, 53.3% of responders argue that pregnancy/breastfeeding negatively affect professional skill and job-career. Even it allowed, 71.9% suggest abstention from Cath-Lab during pregnancy. Notably, only 50% declare to be aware of the laws that regulate access to the Cath-Lab during pregnancy and only 23% of females report to have received detailed information regarding the radio-exposition during the first trimester of pregnancy and breastfeeding. The 80% of responders retains the current radioprotection counseling programs not enough specific for age and gender and more than 80% agree there are not campaigns designed and promoted to prevent infertility. Finally, more than 60% of responders reported to have had any type of job-discriminations. Conclusions The number of Young-females' Italian interventional cardiologists is increasing. According to this National survey there are not gender disparities in the working. Conversely several important differences exist in the private-life. There is the need of developing strategies for education, professional advancement in cases of Cath-Lab abstention as well as of sex-specific radio-exposure programs in the field of interventional cardiology. Acknowledgement/Funding None

Background: Balancing ischemic and bleeding risk is an evolving framework. Methods and Results: Our objectives were to simulate changes in risks for adverse events and event-driven costs with use of ticagrelor or prasugrel versus clopidogrel according to varying levels of ischemic and bleeding risk. Using the validated PARIS risk functions, we estimated 1-year ischemic (myocardial infarction or stent thrombosis) and bleeding (Bleeding Academic Research Consortium types 3 or 5) event rates among PARIS study participants who underwent percutaneous coronary intervention with drug-eluting stent implantation for an acute coronary syndrome and were discharged with aspirin and clopidogrel (n=1497). Simulated changes in adverse events with ticagrelor or prasugrel were calculated by applying treatment effects from randomized trials for a 1-year time horizon. Event costs were estimated using National Inpatient Sample data. Net costs were calculated between antiplatelet therapy groups according to level of ischemic and bleeding risk. After weighting events for quality-of-life impact, we calculated event rates and costs for risk-tailored treatment versus clopidogrel under multiple drug pricing assumptions. One-year rates (per 1000 person-years) for ischemic events were 12.6, 24.1, and 66.1, respectively, among those at low (n=630), intermediate (n=536), and high (n=331) ischemic risk. Analogous bleeding rates were 11.0, 23.9, and 66.2, respectively, among low (n=728), intermediate (n=634), and high (n=135) bleeding risk patients. Mean per event costs were $22 174 (ischemic) and $12 203 (bleeding). When risks for ischemia matched or exceeded bleeding, simulated utility-weighted event rates favored ticagrelor/prasugrel, whereas clopidogrel reduced utility-weighted events when bleeding exceeded ischemic risk. One-year costs were sensitive to drug pricing assumptions, and risk-tailored treatment with either agent progressed from cost incurring to cost saving with increasing generic market share. Conclusions: Tailoring antiplatelet therapy intensity to patient risk may improve health utility and could produce cost savings in the first year after percutaneous coronary intervention. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00998127.

Abstract Background The Impella (Abiomed, Danvers, MA) mechanical circulatory support is a catheter-based axial-flow pump. It reduces left ventricular (LV) stroke work and myocardial oxygen demand while increasing systemic and coronary perfusion in the setting of cardiogenic shock (CS), and it provides hemodynamic support during high-risk percutaneous coronary intervention (PCI). Purpose To evaluate the outcomes of Impella-supported patients in the context of CS and protected-PCI. Methods This single-center registry includes all patients implanted with Impella device at our institution between February 2013 and June 2018. Indications for Impella support were CS (hypotension despite adequate filling status with signs of hypoperfusion) and protected-PCI (prophylactic hemodynamic support during non-emergent high-risk PCI). Results A total of 145 patients were implanted with Impella: 130 (89.7%) for CS and 15 (10.3%) for protected-PCI. Among CS patients, mean age was 61.6±12.9, 79.2% males. The prevalence of chronic heart failure (HF) was 26.1%, prior myocardial infarction (MI) 29% and myocardial revascularization 36.6%, chronic kidney disease (CKD) 18.3%. Among protected PCI patients, mean age was 73.4±8.7 years, 86.7% males. The prevalence of HF was 85.7%, prior MI 42.9%, myocardial revascularization 35.7%, CKD 57.1%. In CS group, the indications for Impella implantation were myocarditis in 8 (6.2%) patients, acute coronary syndromes in 77 (59.2%), periprocedural ventricular tachycardia ablation CS in 10 (7.7%), decompensated heart failure in 26.9%. Out of hospital cardiac arrest occurred in 35 (30.4%) patients, INTERMACS I class in 70 (59.3%), mean arterial pressure was 65.4±18.4 mmHg, serum lactate 6.7±5.5 mmol/l, at least 1 inotropic agent use in 73 (66.4%), mean LV EF 21.4±11,7%, right ventricular dysfunction in 53 (48.6%). The rate of device-related complications was not negligible in CS group: 18 (14.5%) patients had limb ischemia and vascular surgery was required in 14, 17 (14.3%) had access-site bleeding. A total of 42 (33.3%) had haemolysis, and 67 (56.8%) acute kidney injury (AKI), half of whom requiring renal replacement therapy. Escalation to other therapies was necessary in 43 cases. Conversely, in the protected-PCI group a low rate of AKI (n=4, 28.6%) and acute limb ischemia (n=1, 7.1%) was observed, whereas no cases of haemolysis nor need of escalation therapy were recorded. Mean Impella support was 135.5±167.21 days for CS group, 60.6±80 for protected-PCI group. Survival at 30 days was 60.33% for CS group and 92.9% for protected-PCI group. One-year all-cause death was 50% for CS group and 13.3% for protected-PCI group. Conclusion Mechanical circulatory support with Impella is associated with good outcomes and reasonable rates of complications in the protected-PCI group, whereas less favorable results were observed in CS population probably due to the greater severity of clinical presentation.

Abstract Background Duration of Dual Antiplatelet Therapy (DAPT) following Acute Coronary Syndromes (ACS) or Stable Coronary Artery Disease (SCAD) treated with coronary stenting is still debated. Although current guidelines consider several “clinical” criteria to decide for short DAPT (<6 months), standard DAPT (12 months) and prolonged DAPT (>12 months), the relationship between DAPT duration, treatment of bifurcations and its impact on clinical outcome has been poorly investigated in real world registries. Purpose We evaluated the impact of DAPT duration on clinical outcomes in consecutive all-comers patients treated with stenting of coronary artery bifurcation lesions included in the Euro Bifurcation Club -P2BiTO - registry. Methods Data on 5036 consecutive patients who underwent PCI on coronary bifurcation at 17 major coronary intervention centres between January 2012 and December 2014 were collected. The primary endpoint of the study was the cumulative occurrence of Major Adverse Cardiac Events (MACCE), defined as a composite of overall-death death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR) and stroke during the follow-up; the secondary endpoints were the single occurrence of any of the above mentioned events. Results Data on DAPT duration was available for 3992 patients (79%). Patients were divided into 3 groups: Group 1) DAPT <6-months (n=720); Group 2) DAPT >6-months but <12-month (n=1602); Group 3) DAPT >12-months (n=1670). Follow up was completed in 3935 (98%) patients with a median of 20 months (C.I.=12–28). At 24 months after the index procedure, MACCE occurred more frequently in the DAPT <6-month group (Group 1) as compared with both Group 2 and 3 (respectively, 102 (14%) versus 154 (10%) and 164 (10%), HR: 0.72 (0.64–0.82), p<0.001). This difference remains after adjustment for clinical and angiographic characteristics (HR: 0.66 (0.58–0.77), p<0.001). On the contrary, no significant difference was found between Group 2 and Group 3 patients. At the Kaplan-Meier analysis (Figure 1), freedom from MACCE survival was significantly lower in patients receiving DAPT for less than 6 months (Log-Rank: 29.5, p<0.001). Figure 1. Kaplan-Meier curves Conclusions In the P2BiTO registry, short DAPT duration of less than 6 months was associated with a significantly higher risk of MACCE compared to longer DAPT in a real-world registry of patients treated for coronary artery bifurcation stenosis.

Background: Data examining the impact of diabetes mellitus (DM) on ischemic risk after percutaneous coronary intervention in women are limited as most clinical trial participants are male. We evaluated (1) the impact of DM on ischemic outcomes in women undergoing drug-eluting stent (DES) implantation and (2) whether the outcomes of new- versus early-generation DES vary by DM status. Methods and Results: We pooled patient-level data of 10 448 women undergoing percutaneous coronary intervention with DES from 26 randomized trials. Baseline characteristics and 3-year clinical outcomes were stratified according to DM status (noninsulin-dependent and insulin-dependent) and DES generation. The primary end point was the composite of all-cause death or myocardial infarction. Secondary end points were definite or probable stent thrombosis and target lesion revascularization. Compared with women without DM (n=7154, 68.5%), adjusted risks (adjusted hazard ratios [95% CI]) for death or myocardial infarction among women with noninsulin-dependent DM (n=2241, 21.4%) and insulin-dependent DM (n=1053, 10.1%) were 1.30 (1.11-1.53) and 1.71 (1.41-2.07), respectively (P-trend<0.001). Similar trends were observed for def/prob stent thrombosis and target lesion revascularization. Compared with early-generation DES, use of newer-generation DES was associated with significant reductions in death or myocardial infarction in the absence of DM whereas differences were nonsignificant in the presence of DM, with similar findings for def/prob stent thrombosis and target lesion revascularization. Conclusions: The presence of DM is associated with substantial, graded, and durable risks for ischemic events among women undergoing percutaneous coronary intervention with DES. The safety and efficacy profile of newer-generation DES is preserved among women without DM, while benefits are nonsignificant among women with DM.

Incidence and predictors of adverse events after dual antiplatelet therapy (DAPT) cessation in patients treated with ultrathin stents in unprotected left main (ULM) or coronary bifurcation remain undefined. All consecutive patients presenting with a critical lesion of an ULM or a lesion involving a main coronary bifurcation and 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, while target vessel revascularization (TVR) was the secondary endpoint. Moreover, type and occurrence of ST and occurrence of ST, CV death and MI during DAPT or after DAPT discontinuation were also evaluated. All analyses were performed according to length of DAPT dividing the patients in 3 groups: short DAPT (3-months), intermediate DAPT (3–12 months) and long DAPT (12-months). 117 patients were discharged with an indication for DAPT≤3 months (median 1:1–2.5), 200 for DAPT between 3 and 12 months (median 8:7–10) and 1958 with 12 months DAPT. After 12.8 months (8–20), MACE was significantly higher in the 3-month group compared to 3–12 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). ST post DAPT cessation were comparable (1.7% vs. 0% vs. 0.7%, p=0.42) with a median time to ST post DAPT discontinuation of 1.67 months (0.48–4.7). At multivariate analysis, DAPT of 12-months compared to 3-months reduces the risk of overall ST (OR 0.103: 0.019–0.0563, 95% CI) while only a trend was noted for DAPT between 3 and 12 months (OR 0.61: 0.186–2.005, 95% CI). When analysed by stent strategy a 2-stent strategy predicted ST post DAPT cessation (OR 3.241: 1.048–10.026, 95% CI), which was reduced by use of FKB (OR 0.101:0.01–0.872, 95% CI). 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. The correct identification before PCI of the more fragile patients who may receive a shorter DAPT regimen could help identify the safest PCI technique: provisional stenting and use of final kissing balloon (FKB) are the safest options.