Percutaneous Coronary Intervention Registry Research Articles

No-Reflow Prediction in Acute Coronary Syndrome During Percutaneous Coronary Intervention: The NORPACS Risk Score.

Suboptimal coronary reperfusion (no reflow) is common in acute coronary syndrome percutaneous coronary intervention (PCI) and is associated with poor outcomes. We aimed to develop and externally validate a clinical risk score for angiographic no reflow for use following angiography and before PCI. We developed and externally validated a logistic regression model for prediction of no reflow among adult patients undergoing PCI for acute coronary syndrome using data from the Melbourne Interventional Group PCI registry (2005-2020; development cohort) and the British Cardiovascular Interventional Society PCI registry (2006-2020; external validation cohort). A total of 30 561 patients (mean age, 64.1 years; 24% women) were included in the Melbourne Interventional Group development cohort and 440 256 patients (mean age, 64.9 years; 27% women) in the British Cardiovascular Interventional Society external validation cohort. The primary outcome (no reflow) occurred in 4.1% (1249 patients) and 9.4% (41 222 patients) of the development and validation cohorts, respectively. From 33 candidate predictor variables, 6 final variables were selected by an adaptive least absolute shrinkage and selection operator regression model for inclusion (cardiogenic shock, ST-segment-elevation myocardial infarction with symptom onset >195 minutes pre-PCI, estimated stent length ≥20 mm, vessel diameter <2.5 mm, pre-PCI Thrombolysis in Myocardial Infarction flow <3, and lesion location). Model discrimination was very good (development C statistic, 0.808; validation C statistic, 0.741) with excellent calibration. Patients with a score of ≥8 points had a 22% and 27% risk of no reflow in the development and validation cohorts, respectively. The no-reflow prediction in acute coronary syndrome risk score is a simple count-based scoring system based on 6 parameters available before PCI to predict the risk of no reflow. This score could be useful in guiding preventative treatment and future trials.

Associations Between Metabolic Syndrome and Long-Term Mortality in Patients who underwent Percutaneous Coronary Intervention: An Australian Cohort Analysis

Metabolic syndrome (MetS) provides significant risk for coronary disease, however long-term prognosis after percutaneous coronary intervention (PCI) has been understudied. We assessed the prevalence and outcomes of patients with MetS from an Australian PCI cohort. We retrospectively examined data from the Melbourne Interventional Group multicenter PCI registry using a modified definition for MetS including ≥3 of the following: hypertension, diabetes mellitus, dyslipidemia, and body mass index ≥30 kg/m2. Thirty-day outcomes and long-term mortality were compared with patients without MetS. Cox regression methods were used to assess the multivariable effect of MetS on long-term mortality. Of 41,146 patients, 12,228 (34%) had MetS. Patients with MetS experienced greater 30-day myocardial infarction (2.2% vs 1.8%, p = 0.013), whereas patients without MetS had a trend for greater 30-day mortality (3.0% vs 3.4%, p = 0.051) and greater in-hospital major bleeding (1.7% vs 2.4%, p <0.001). After a median follow-up of 5.62 years (Q1 2.03, Q3 8.89), patients with MetS experienced greater mortality (24% vs 19%, p <0.001). After adjustment, MetS was not an independent predictor of long-term mortality (hazard ratio 0.95 confidence interval 0.86 to 1.05, p = 0.35). In sensitivity analyses, MetS-Diabetic patients had the highest, and MetS-NonDiabetic obese patients had the lowest long-term mortality. One in 3 patients who underwent all-comer PCI presented with MetS and experienced greater long-term mortality compared with others. However, this association was lost after adjustment for baseline confounders, highlighting that MetS is a marker of risk after PCI. Our findings support the obesity paradox and confirm robust associations between diabetes mellitus and long-term mortality.

Annual operator volume and procedural outcomes of chronic total occlusions treated with percutaneous coronary interventions: analysis based on 14,899 patients.

Low operator and institutional volume is associated with poorer procedural and long-term clinical outcomes in patients treated with percutaneous coronary interventions (PCI). This study was aimed at evaluating the relationship between operator volume and procedural outcomes of patients treated with PCI for chronic total occlusion (CTO). Data were obtained from the national registry of percutaneous coronary interventions (ORPKI) collected from January 2014 to December 2020. The primary endpoint was a procedural success, defined as restoration of thrombolysis in myocardial infarction (TIMI) II/III flow without in-hospital cardiac death and myocardial infarction, whereas secondary endpoints included periprocedural complications. Data of 14,899 CTO-PCIs were analyzed. The global procedural success was 66.1%. There was a direct relationship between the annual volume of CTO-PCIs per operator and the procedural success (OR: 1.006 [95% CI: 1.003-1.009]; P<0.001). The nonlinear relationships of annualized CTO-PCI volume per operator and adjusted outcome rates revealed that operators performing 40 CTO cases per year had the best procedural outcomes in terms of technical success (TIMI flow II/III after PCI), coronary artery perforation rate and any periprocedural complications rate (P<0.0001). Among the other factors associated with procedural success, the following can be noted: multi-vessel, left main coronary artery disease (as compared to single-vessel disease), the usage of rotablation as well as PCI within bifurcation. High-volume CTO operators achieve greater procedural success with a lower frequency of periprocedural complications. Higher annual caseload might increase the overall quality of CTO-PCI.

Prolonged dual antiplatelet therapy in invasively treated acute coronary syndrome patients with different lipoprotein(a) concentrations.

Lipoprotein(a) [Lp(a)] was positively associated with recurrent ischemic events in patients with acute coronary syndrome (ACS). This study was performed to investigate the effect of Lp(a) levels on outcomes of dual antiplatelet therapy (DAPT) > 1 year versus DAPT ≤ 1 year after percutaneous coronary intervention (PCI) in this population. A total of 4,357 ACS patients who were event-free at 1 year after PCI were selected from the Fuwai PCI Registry, and patients were stratified into four groups according to DAPT duration (≤ 1 year vs. > 1 year) and Lp(a) levels (≤ 30 mg/dL vs. > 30 mg/dL). The primary endpoint was major adverse cardiovascular and cerebrovascular event (MACCE), defined as a composite of cardiac death, myocardial infarction or stroke. After 2.4-year follow-up, the incidence of MACCE (HRadjusted 0.284, 95% CI 0.115-0.700; HRIPTW 0.351, 95% CI 0.164-0.751) were significantly reduced in DAPT > 1 year group than that in DAPT ≤ 1 year group in individuals with elevated Lp(a) levels. However, in individuals with normal Lp(a) levels, no statistically difference was found between these two groups in terms of MACCE, although the risks of all-cause death and definite/probable stent thrombosis were lower in DAPT > 1 year group. Notably, the risk of clinically relevant bleeding did not statistically differ between these two groups in individuals with different Lp(a) levels. This study firstly demonstrated that extended DAPT (> 1 year) was statistically associated with lower risk of ischemic events in ACS patients with elevated Lp(a) levels after PCI, whereas this association was not found in individuals with normal Lp(a) levels.

Benchmarking System Monitoring on Quality Improvement in Percutaneous Coronary Intervention: A Nationwide Registry in Japan

BackgroundQuality indicators (QIs) have been developed to improve and standardize care quality in percutaneous coronary intervention (PCI). In Japan, consecutive PCI procedures are registered in a nationwide database (the Japanese Percutaneous Coronary Intervention registry), which introduces a benchmarking system for comparing individual institutional performance against the national average. ObjectivesThe aim of this study was to assess the impact of the benchmarking system implementation on QI improvement at the hospital level. MethodsA total of 734,264 PCIs were conducted at 1,194 institutions between January 2019 and December 2021. In January 2018, a web-based benchmarking system encompassing 7 QIs for PCI at the institutional level, including door-to-balloon time and rate of transradial intervention, was introduced. The process by which institutions tracked their QIs was centrally monitored. ResultsDuring the 3-year study period, the benchmarking system was reviewed at least once at 742 institutions (62.1%) (median 4 times; Q1-Q3: 2-7 times). The institutions that reviewed their records had higher PCI volumes. Among these institutions, although door-to-balloon time was not directly associated, the proportion of transradial intervention increased by 2.3% in the system review group during the initial year compared with 0.7% in their counterparts. However, in the subsequent year, the association between system reviews and QI improvement was attenuated. ConclusionsThe implementation of a benchmarking system, reviewed by participating institutions in Japan, was partially associated with improved QIs during the first year; however, this improvement was attenuated in the subsequent year, highlighting the need for further efforts to develop effective and sustainable interventions to enhance care quality in PCI.

Frequency and Prognostic Value of Acute Periprocedural Myocardial Injury in Elective Percutaneous Coronary Interventions

Background. Periprocedural myocardial injury (PMI) is an acute complication of percutaneous coronary interventions (PCI) in patients with stable coronary artery disease. Its frequency and relationship with the prognosis of the disease are especially important in elective interventions due to the low risk of ischemic events in this cohort of patients. However, according to the literature, there are significant differences in the criteria for PMI and type 4a myocardial infarction (MI), and, accordingly, their frequency and their prognostic value. Aim. To study the frequency and magnitude of PMI during elective PCI in terms of the level of periprocedural increase in cardiospecific biomarkers, as well as to determine the relationship of PMI with long-term adverse events in patients with chronic coronary artery disease. Materials and methods. A single-center open retrospective cohort study was conducted, which included 435 patients (367/84.4 % men, mean age 58.3±8.6 years) from the elective PCI registry. PMI was diagnosed with an increase in the level of creatine phosphokinase MB fraction (CK-MB) or or cardiac troponin I (cTn I) &gt;1×99 percentile URL (Upper Reference Limit), while the level of increase in biomarkers &gt;1, 2, 3, 4 or &gt;5×99 percentile URL was recorded. An increase in biomarkers &gt;5x99 URL percentile was assessed as a large PMI, and in the presence of clinical and imaging evidence of new loss of viable myocardium, as periprocedural MI type 4a. Depending on the level of periprocedural increase in biomarkers, the relative risk (RR) of developing long-term (within 5 years after index PCI) adverse cardiovascular events, death, as well as clinically significant bleeding and newly diagnosed malignant oncological diseases was calculated. In addition, the correlation between PMI and the above endpoints was summarized using Kaplan-Meier analysis. Results. The frequency of periprocedural PMI diagnosed by increased biomarkers &gt;1×99 percentile URL was 40.2 %, &gt;2×99 percentile URL — 9.7 %, &gt;3×99 percentile URL — 6.7 %, &gt;4×99 percentile URL — 4.8 %, &gt;5×99 percentile URL — 3.5 %, type 4a MI — in 2 patients (0.46 %). An association of “major” PMI (&gt;5x99 percentile URL) with cardiovascular complications within 3 years after elective PCI, including fatal ones, was revealed: for acute myocardial infarction (AMI), RR — 6.516, confidence interval (CI) [2.375-17.881]; for death from cardiovascular causes RR — 6.538, CI [1.695-25.227]. An association of “moderate” PMI (&gt;3, but &lt;5 ×99 URL percentile) with acute ischemic events within 3 years after elective PCI was shown: for AMI, RR was 4.073, CI [1.598 — 10.378]. An association of “minor” AKI (&gt;1, but &lt;5 ×99 URL percentile) with acute ischemic events within 3 years after elective PCI was shown: for AMI, RR was 4.073, CI [1.598 — 10.378]. An association of “minor” AKI (&gt;1, but &lt;3 ×99 URL percentile) with newly diagnosed malignant oncological diseases within 5 years after index PCI was revealed: RR 2.319; CI [1.248- 4.310]. An association of late thrombotic events, such as stent thrombosis (index and re-interventions), stent occlusion (index and non-index) as a reason for re-intervention within 5 years after index PCI, was found with most PMI subgroups. Kaplan-Meier analysis of the dependence of clinically significant bleeding within 5 years after index PCI on the development of “moderate” PMI (p=0.003), as well as the association of non-cardiovascular death within 5 years after index PCI with “minor” PMI (p= 0.007). Conclusion. Registration of periprocedural increase in cardiac biomarkers should be carried out during planned PCI not only for the purpose of diagnosing and predicting acute and late ischemic events, but also for assessing the risk of developing stent occlusion, clinically significant bleeding and prognostically important comorbidities in the long-term (5-year) period in order to identification of groups of patients requiring active monitoring, additional examination and selection of an optimal treatment regimen at the outpatient stage of rehabilitation.

Cangrelor in contemporary patients with ST-segment elevation myocardial infarction pretreated with Ticagrelor: Pharmacodynamic data from the POMPEII study

BackgroundThere are limited data to assess pharmacodynamic (PD) profiles of patients with STEMI undergoing primary percutaneous coronary intervention (PCI) and receiving cangrelor after pretreatment with ticagrelor. MethodsThe PharmacOdynaMic effects of cangrelor in PatiEnts wIth acute or chronIc coronary syndrome undergoing percutaneous coronary intervention (POMPEII) registry (NCT04790032) is a prospective study conducted at Federico II University of Naples enrolling all patients undergoing PCI receiving cangrelor at operator’s discretion. PD assessments were performed with 3 assays: (1) the gold standard light transmittance aggregometry (LTA) (20- and 5-μM adenosine diphosphate [ADP] stimuli); (2) VerifyNow P2Y12-test; (3) Multiplate electrode aggregometry (MEA), ADP-test. ResultsWe analyzed 13 STEMI patients pretreated with ticagrelor within 1 h at the time they underwent primary PCI receiving cangrelor. All patients showed low maximal platelet aggregation at 30-minute during cangrelor infusion, as well as at 3 h and 4–6 h (corresponding to 1 h and 2–4 h after stopping cangrelor infusion) with no cases of high residual platelet reactivity. These results were consistent with all assays. ConclusionsPD data show that in contemporary real-world STEMI patients pretreated within 1 h with ticagrelor undergoing primary PCI, adding cangrelor resulted in fast and potent platelet inhibition, thus suggesting that cangrelor may bridge the gap until ticagrelor reaches its effect.

Safety and efficacy of NOAC vs. VKA in patients treated by PCI: a retrospective study of the FRANCE PCI registry.

Dual antithrombotic therapy (DAT) combining oral anticoagulation (OAC), preferentially Non-vitamin K antagonist OAC (NOAC) and single antiplatelet therapy (SAPT) for a period of 6-12 months is recommended after percutaneous coronary intervention (PCI) in patients with an indication for OAC. To compare outcomes between vitamin K antagonist (VKA) and NOAC-treated patients in the nation-wide France PCI registry. All consecutive patients from the France PCI registry treated by PCI and discharged with OAC between 2014 and 2020 were included and followed one-year. Major bleeding was defined as Bleeding Academic Research Consortium (BARC) classification ≥3 and major adverse cardiac events (MACE) as the composite of all-cause mortality, myocardial infarction (MI), and ischemic stroke. A propensity-score analysis was used. Of the 7,277 eligible participants, 2,432 (33.4%) were discharged on VKA and 4,845 (66.6%) on NOAC. After propensity-score adjustment, one-year major bleeding was less frequent in NOAC vs. VKA-treated participants [3.1% vs. 5.2%, -2.1% (-3.6% to -0.6%), p = 0.005 as well as the rate of MACE [9.2% vs. 11.9%, -2.7% (-5.0% to -0.4%), p = 0.02]. One-year mortality was also significantly decreased in NOAC vs. VKA-treated participants [7.4% vs. 9.9%, -2.6% (-4.7% to -0.5%), p = 0.02]. The area under ROC curves of the anticoagulant treatment propensity score was estimated at 0.93, suggesting potential indication bias. NOAC seems to have a better efficacy and safety profile than VKA. However, potential indication bias were found.

Percutaneous Coronary Intervention Registry from tertiary care hospital : In hospital and One year Follow up outcome

Percutaneous Coronary Intervention Registry from tertiary care hospital : In hospital and One year Follow up outcome

Robotic-assisted percutaneous coronary intervention: experience in Switzerland.

Percutaneous coronary intervention (PCI) exposes operators to ionizing radiation. Robotic-assisted PCI (RA-PCI) is a novel technology that enables interventional cardiologists to operate coronary devices remotely from a radiation-shed cockpit. The aim of this study is to describe the experience and challenges during the initiation of a RA-PCI program and to report outcomes of the first 21 patients undergoing RA-PCI in Switzerland. All patients undergoing RA-PCI using the CorPath GRX Vascular Robotic System between 06/2021 and 12/2021 at Inselspital, Bern University Hospital were included in this retrospective registry study. Baseline, procedural and clinical follow-up data were prospectively assessed as part of the Cardiobase Bern PCI registry (NCT02241291). The two endpoints of interest were clinical success [defined as <30% residual diameter stenosis in the absence of in-hospital major adverse cardiovascular events (MACE: composite of death, periprocedural myocardial infarction, target-vessel revascularization, and stroke)] and robotic success (defined as clinical success and completion of RA-PCI without or with partial manual assistance). Additional outcome measures include clinical long-term outcomes at one year. Twenty-five lesions in 21 patients were treated with RA-PCI (age 62.4 ± 9.1 years, 24% female). Clinical success was achieved in 100%, and robotic success in 81% (17/21 procedures, including 4 procedures requiring partial manual assistance). Manual conversion (e.g. manual completion of the procedure) occurred in 19% (4 procedures). Reasons for manual assistance or conversion were poor guiding-catheter back-up or platform limitations (4), adverse events (2x transient slow-flow that was solved manually), safety decision (1x vasovagal reaction not related to robotic approach), and software error (1). No in-hospital MACE occurred. During 12 months of follow-up, one patient suffered a non-target-vessel myocardial infarction requiring repeat PCI. RA-PCI can safely be performed without clinically relevant robot-associated complications in selected patients with approximately 80% of procedures conducted without or with partial manual assistance.

Changing Trends in Mechanical Circulatory Support Use and Outcomes in Patients Undergoing Percutaneous Coronary Interventions for Acute Coronary Syndrome Complicated With Cardiogenic Shock: Insights From a Nationwide Registry inJapan.

Temporal trends in the management of acute coronary syndrome complicated with cardiogenic shock after the revision of guideline recommendations for intra-aortic balloon pump (IABP) use and the approval of the Impella require further investigation, because their impact remains uncertain. Using the Japanese Percutaneous Coronary Intervention (J-PCI) registry database from 2019 to 2021, we identified 12 171 patients undergoing percutaneous coronary intervention for acute coronary syndrome complicated with cardiogenic shock under mechanical circulatory support. The patients were stratified into 3 groups: (1) IABP alone, (2) Impella, and (3) venoarterial extracorporeal membrane oxygenation (VA-ECMO); the VA-ECMO group was further stratified into (3a) VA-ECMO alone, (3b) VA-ECMO in combination with IABP, and (3c) VA-ECMO in combination with Impella. The quarterly prevalence and outcomes were reported. The use of IABP alone decreased significantly from 63.5% in the first quarter of 2019 to 58.3% in the fourth quarter of 2021 (P for trend=0.01). Among 4245 patients requiring VA-ECMO, the use of VA-ECMO in combination with IABP decreased significantly from 78.7% to 67.3%, whereas the use of VA-ECMO in combination with Impella increased significantly from 4.2% to 17.0% (P for trend <0.001 for both). After adjusting for the confounders, the risk difference in the fourth quarter of 2021 relative to the first quarter of 2019 for in-hospital mortality was not significant (adjusted odds ratio, 0.84 [95% CI, 0.69-1.01]). Our study revealed substantial changes in the use of different mechanical circulatory support modalities in acute coronary syndrome complicated with cardiogenic shock, but they did not significantly improve the outcomes.

Insights from The National Cardiovascular Disease Database – Percutaneous Coronary Intervention (NCVD-PCI) Registry 2019–2020: PCI to Chronic Total Occlusion (CTO)

Insights from The National Cardiovascular Disease Database – Percutaneous Coronary Intervention (NCVD-PCI) Registry 2019–2020: PCI to Chronic Total Occlusion (CTO)

Percutaneous coronary intervention (PCI) to left main stem (LMS): Insights from The National Cardiovascular Disease Database – Percutaneous Coronary Intervention (NCVD-PCI) Registry 2019–2020

Percutaneous coronary intervention (PCI) to left main stem (LMS): Insights from The National Cardiovascular Disease Database – Percutaneous Coronary Intervention (NCVD-PCI) Registry 2019–2020

Clinical presentations and investigations in Malaysia National Cardiovascular Disease Database: Percutaneous Coronary Intervention (PCI) Registry 2019-2020

Clinical presentations and investigations in Malaysia National Cardiovascular Disease Database: Percutaneous Coronary Intervention (PCI) Registry 2019-2020

Multicenter registry of Impella-assisted high-risk percutaneous coronary interventions and cardiogenic shock in Poland (IMPELLA-PL)

Multicenter registry of Impella-assisted high-risk percutaneous coronary interventions and cardiogenic shock in Poland (IMPELLA-PL)

Prevalence and outcomes of acute coronary syndrome patients with and without standard modifiable risk factors undergoing percutaneous coronary intervention

Abstract Background Prevention strategies in acute coronary syndrome (ACS) have focused on patients with standard modifiable risk factors (SMuRFs; diabetes, hypercholesterolaemia, hypertension, and current smoking). There is increasing awareness that SMuRF-less patients may represent a unique subset of patients experiencing ACS. Purpose To investigate the prevalence, characteristics, and outcomes of SMuRF-less ACS patients compared to those with SMuRFs undergoing percutaneous coronary intervention (PCI) in a major city in Australia. Methods We analysed data from adult (≥18 years) ACS patients receiving PCI between 2005 and 2020 using a PCI Registry which contains data for all patients undergoing coronary intervention at one of six major hospitals. Patients with a known history of coronary artery disease were excluded. Overall clinical characteristics and outcomes for those with and without SMuRFs were examined. The primary outcome was 30-day all-cause mortality. Secondary outcomes included in-hospital outcomes, myocardial infarction (MI), revascularisation, and major adverse cardiovascular and cerebrovascular (MACCE) events at 30 days. Long-term mortality was investigated using Cox-proportional hazards regression. Results From 1 January 2005 to 31 December 2020, 2,727 (14.4%) of 18,988 patients were SMuRF-less. Mean (± standard deviation [SD]) age was similar between patients with and without SMuRFs (63±13 vs 63±12 years) and there were more females with SMuRFs (25% vs 20%, p&amp;lt;0.001). SMuRF-less patients were less likely to have a history of cerebrovascular disease (1.2% vs 4.2%, p&amp;lt;0.001), peripheral vascular disease (0.6% vs 3.0%, p&amp;lt;0.001), and chronic lung disease (8.6% vs 10.1%, p=0.014). They were more likely to present with out-of-hospital cardiac arrest (6.6% vs 3.9%, p&amp;lt;0.001) and ST-elevation MI (59% vs 51%, p&amp;lt;0.001). The left anterior descending artery was the target lesion in 46% of SMuRF-less patients compared to 39% of those with SMuRFs. During hospital stay, SMuRF-less patients were more likely to experience post-procedural cardiogenic shock (4.5% vs 3.6%, p=0.019) and arrhythmia (11.2% vs 9.9%, p=0.029). At 30 days, all-cause mortality did not differ between those with and without SMuRFs (3.2% vs 3.6%, p=0.290). Similarly, there were no differences in 30-day MI, revascularisation, and MACCE. During mean follow-up of approximately 7 years, being SMuRF-less was associated with a 12% decreased rate of mortality (adjusted Hazard Ratio 0.88 [95% confidence interval 0.78, 0.99], p=0.035). Conclusions Despite differences in characteristics (rates of cardiac arrest and ST-elevation MI), no difference in 30-day outcomes was observed among those with and without SMuRFs. However, SMuRF-less patients had lower hazard for long-term mortality. These findings suggest SMuRF-less patients may have novel risk factors and improved long-term outcome warranting further research.

Observational, multicenter registry of Impella-assisted high-risk percutaneous coronary interventions and cardiogenic shock in Poland (IMPELLA-PL): efficacy and safety outcomes

Abstract Introduction Impella (Abiomed, Danvers, MA, USA) is the smallest and the least invasive mechanical circulatory support device used in the setting of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (HR-PCI). Data regarding the efficacy and safety of Impella in the real-life setting are urgently needed. Purpose The main goal of the IMPELLA-PL registry is to evaluate the efficacy and safety of Impella in patients with CS and undergoing HR-PCI, identify independent predictors of in-hospital and 12-month outcomes and compare it with other registries. Methods IMPELLA-PL is a national, multicentre, retrospective registry including consecutive patients treated with Impella for CS and high-risk PCI in 20 Polish interventional cardiological centres from January 2014 until December 2021, with 12-month follow-up until December 2022. The main efficacy and safety endpoints included (i) in-hospital mortality, (ii) 12-month mortality, (iii) 12-month rate of major adverse cardiovascular events (MACE) following hospital discharge, evaluated according to the prespecified definitions. Results A total of 308 patients were enrolled in the registry: 55 had CS (56.4%) and 253 underwent HR-PCI (43.6%). In the CS group, in-hospital mortality rate was 76.4%, 12-month mortality rate was 80.0% and post-discharge MACE rate was 9.1%. Device-related complications included access site bleeding (30.9%), limb ischaemia (12.7%) and haemolysis (10.9%). In the HR-PCI group, in-hospital mortality rate was 8.3%, 12-month mortality rate was 18.2% and MACE rate post-discharge was 22.5%. Device-related complications included access site bleeding (14.6%), limb ischaemia (2.4%) and haemolysis (1.6%). The independent predictors of 12-month mortality included atrial fibrillation (OR 3.50, 95% CI 1.38-8.95), chronic kidney disease (OR 2.77, 95% CI 1.06-7.26). Conclusions The mortality and complications rate in patients with CS remains high, despite the use of Impella, and higher than reported in other registries. The mortality and complications rate in patients undergoing HR-PCI is acceptable and consistent with other registries.

Iron deficiency and association with mortality in patients with coronary artery disease

Abstract Background Iron is essential for a number of metabolic and physiological processes and the role of iron deficiency (ID) as an adverse prognostic indicator in heart failure is well established. The suitability of the international guideline definition for prognosticating adverse events in heart failure has recently been brought into question due to the inclusion of ferritin, given its reduced specificity during intercurrent inflammation. As inflammation plays an active role in coronary disease, and acute coronary syndromes in particular, we sought to further explore whether ID according to the current guideline definition or alternative definitions without reliance on ferritin is a predictor of clinical outcomes in patients with coronary artery disease. Purpose The aims are to assess whether a)ID is associated with increased all-cause mortality in patients with coronary artery disease requiring percutaneous coronary intervention (PCI) and b) whether different definitions of ID have a stronger association with mortality in these patients. Methods All patients in a UK PCI registry who had full iron studies within thirty days of their index procedure were included. ID was defined according to three different criteria: 1) International guideline criteria (ferritin &amp;lt;100 ng/ml or transferrin saturations (TSATs) &amp;lt;20% if ferritin 100-299 ng/ml), 2) TSATs &amp;lt;20%, or 3) serum iron &amp;lt;13μmol/L. Mortality data was obtained from Hospital Episodes Statistics. Ethical approval was obtained from the Northwest Haydock Research Committee. Results Some 390 patients were included in this analysis. The mean age was 72.5 (62-86) and 33.0% were female. 28.7% of patients presented with a STEMI, 39.7% with an acute coronary syndrome and 31.5% had stable angina. ID according to the serum iron and TSAT definitions were associated with increased all-cause mortality, HR 1.61 (CI 1.07-2.41), p=0.02 and HR 1.64 (CI 1.13-2.37), p=0.009 respectively. However, ID as determined by the international guideline definition was not predictive of increased all-cause mortality, HR 0.99 (CI 0.69-1.42), p=0.97. Conclusions Here we show that ID, defined by serum iron and TSATs but not by the current guideline definition of ID, is associated with increased all-cause mortality in patients with coronary artery disease, undergoing PCI. A randomised controlled trial into treating ID in patients with coronary disease is warranted to determine whether intravenous iron replacement is beneficial in this patient group. The current study supports the growing evidence that alternatives to the current guideline definition of ID may be better suited to identify patients with adverse prognosis and who, in turn, may benefit most from intravenous iron replacement therapy.

High bleeding risk mainly predicts non-access site bleeding events in the first month after percutaneous coronary intervention

Abstract Background/Introduction The majority of bleeding events after percutaneous coronary intervention (PCI) occur in the first month after PCI. To predict and anticipate on events during hospitalisation and in the first month, the CRUSADE- and ACUITY scores have been developed. In order to enhance the use of bleeding risk stratification, a consortium of PCI centres in the South East of the Netherlands has created and implemented a simple binary variant of the existing models. High bleeding risk (HBR) is defined by one of the following: eGFR&amp;lt; 30; anaemia (Hb &amp;lt; 7mmol/L); a spontaneous bleeding within one year before PCI; a history of intracranial haemorrhage. Purpose We evaluated the predictive value of our risk model and other risk factors for bleeding events in the first month after PCI and discriminated between access site- non-access site bleedings. Methods In an ongoing multicentre prospective PCI registry in the South East of the Netherlands collects baseline and follow-up data of all patients undergoing PCI. We compared access site- and non- access site bleedings between HBR and non HBR using the Kaplan Meier method and Cox regression. Also, we performed multivariate analysis of the separate factors of the model and other probable risk factors. Results We collected baseline and 30 day follow-up data in 3996 patients of which 357 with HBR (9%). Access site bleedings occurred in 3% of patients with HBR vs 2% without (sens. 0.13; spec. 0.98). Patients with HBR showed 5% non-access site bleedings versus 1% in non HBR (sens. 0.21; spec. 0.99). Survival curves and hazard ratios presented in figure 1 show that these differences are significant only for non-access site bleedings (HR: 4.2, 95% CI: 2.47-7.30). The multivariate analysis is presented in table 1. All bleeding events were predicted by age ≥ 60 and peripheral arterial disease. Furthermore, non-access site bleedings were predicted by anaemia and bleeding events in the previous year. Additional risk factors for access site bleedings were female sex and double access site punction. Conclusion The simplified risk model showed to be conservative in the determination of HBR as depicted by the sensitivity and specificity. However, it showed good discriminative value for non-access site bleedings which was driven by anemia and a history of bleedings. Furthermore, these results suggest that age ≥60 and peripheral arterial disease should be taken into consideration. Extra precaution for access site bleedings should also be taken in female patients and in the case of double access site punction.Figure 1Table 1

New criteria to identify patients at higher risk for cardiovascular complications after percutaneous coronary intervention

Abstract A universal definition to identify patients at higher risk of complications after percutaneous coronary intervention (PCI) is lacking. We aimed to validate a recently developed score to identify patients at increased risk of all-cause death after PCI. All consecutive patients from a large PCI registry not presenting with ST-elevation myocardial infarction or cardiogenic shock were included. Each patient was assigned a score obtained by summing the points associated with the following variables: age &amp;gt;80 years (3 points), dialysis (6 points), left ventricular ejection fraction &amp;lt;30% (2 points), and multivessel PCI (2 points). Patients were stratified in 3 groups: low risk (score 0), intermediate risk (score 2 to 3), or high risk (score ≥4). The primary outcome was all-cause death, and the secondary outcomes were major adverse cardiovascular events and major bleeding. Events were assessed at 1 year after PCI. Between January 2014 and December 2019, 12,689 patients underwent PCI. Compared with the 9,884 patients at low risk, those at intermediate and high risk had a fourfold (hazard ratio 3.99, 95% confidence interval 2.95 to 5.38) and ninefold (hazard ratio 9.55, 95% confidence interval 6.89 to 13.2) higher hazard for all-cause death at 1 year, respectively. The score had a good predictive value for all-cause death at 1 year (area under the curve 0.70). The risk of major adverse cardiovascular events and major bleeding increased consistently from the low- to the high-risk group. In conclusion, in patients who underwent PCI for stable ischemic heart disease or non−ST-elevation acute coronary syndrome, a score based on 4 variables well predicted the risk of all-cause death at 1 year.Derivation of risk scoreAll-cause death rate at 1 year