Clinical outcomes with thin versus thick strut polymer-free biolimus-coated stents at 3 years.

BACKGROUND: For high bleeding-risk patients (HBR) undergoing percutaneous coronary intervention (PCI), the LEADERS FREE (LF) and LEADERS FREE II (LF II) trials established the safety and efficacy of a stainless steel polymer-free biolimus-coated stent (SS-BCS) with 30 days of dual antiplatelet treatment (DAPT). The LEADERS FREE III (LF III) trial investigated clinical outcomes after PCI with the next-generation cobalt-chromium thin-strut polymer-free biolimus-coated stent (CoCr-BCS) in HBR patients. AIMS: To report the final 3-year results of the LF III trial and compare them to LF II. METHODS: LF III was a prospective, multicentre, open-label single-arm study to evaluate the safety and efficacy of the CoCr-BCS stent. The primary safety endpoint was the composite of cardiac death (CD), myocardial infarction(MI) or definite/probable stent thrombosis (ST). The primary efficacy endpoint was clinically driven target lesion revascularisation (cd-TLR). We performed a propensity-matched comparison to the 3-year outcomes of LF II. RESULTS: After 3 years, CD/MI/ST had occurred in 57 patients (15%, 95% CI 11.8% to 19%) and cd-TLR in 23 (6.2%, 95% CI 4.1% to 9.2%) patients. In a propensity-matched comparison of patients treated with the CoCr-BCS versus the SS-BCS, there were similar rates of CD (6.6% vs 7.8%, p=0.50), MI (7.1% vs 8.3%, p=0.47) and definite/probable ST (1.1% vs 2%, HR 0.56, 95% CI 0.16 to 1.93, p=0.35). The rates of cd-TLR were 5.3% with CoCr-BCS versus 9.8% with SS-BCS (HR 0.54, 95% CI 0.31 to 0.96, p=0.03). CONCLUSION: LF III confirms the long-term safety and efficacy of the CoCr-BCS in HBR patients treated with 1 month of DAPT. TRIAL REGISTRATION NUMBER: NCT02843633, NCT03118895.

Polymer-free Biolimus-A9 coated thin strut stents for patients at high bleeding risk 1-year results from the LEADERS FREE III study.

BACKGROUND: In patients at high bleeding risk (HBR), the LEADERS FREE (LF) trial established the safety and efficacy of a polymer-free drug coated (Biolimus-A9) stainless steel stent (SS-DCS) with 30 days of dual antiplatelet treatment (DAPT). In LEADERS FREE III, we studied a new cobalt-chromium thin-strut stent (CoCr-DCS) in HBR patients. METHODS: The CoCr-DCS shares all of the design features of the SS-DCS but has a CoCr stent platform with strut thickness of 84-88 µm. The primary safety endpoint was a composite of cardiac death, myocardial infarction (MI), and definite/probable stent thrombosis. The primary efficacy endpoint was clinically indicated target lesion revascularization. Outcomes were compared to those of LF (non-inferiority to SS-DCS for safety and superiority to SS-BMS for efficacy). Additional propensity-matched comparisons were performed to account for baseline differences. RESULTS: We recruited 401 HBR patients using identical criteria to the LF trial. At 1 year, the primary safety endpoint was reached by 31/401 (8.0%) of patients treated with the CoCr-DCS versus 35/401 (8.9%) for the propensity-matched cohort (HR: 0.89, [0.55-1.44], p < 0.001 for non-inferiority, 0.62 for superiority). The efficacy endpoint was reached by 16/401 (4.2%) of CoCr-DCS patients versus 41/401 (10.6%) in the propensity-matched cohort (HR: 0.4 [0.2:0.7]) (p = 0.007 for superiority). There was no statistical difference between CoCr-DCS and SS-DCS in terms of efficacy (HR: 1.46 [0.68-3.15], p = 0.33). CONCLUSIONS: The new thin-strut CoCr-DCS proved non-inferior to the SS-DCS for safety, and superior to the BMS for efficacy in HBR patients treated with 30 days of DAPT.

Thin Strut CoCr Biodegradable Polymer Biolimus A9-Eluting Stents versus Thicker Strut Stainless Steel Biodegradable Polymer Biolimus A9-Eluting Stents: Two-Year Clinical Outcomes.

BACKGROUND: While thinner struts are associated with improved clinical outcomes in bare-metal stents (BMS), reducing strut thickness may affect drug delivery from drug-eluting stents (DES) and there are limited data comparing otherwise similar thin and thick strut DES. We assessed 2-year outcomes of patients treated with a thin strut (84-88um) cobalt-chromium, biodegradable polymer, Biolimus A9-eluting stent (CoCr-BP-BES) and compared these to patients treated with a stainless steel, biodegradable polymer, Biolimus A9-eluting stent (SS-BP-BES). METHODS: In total, 1257 patients were studied: 400 patients from 12 centres receiving ≥1 CoCr-BP-BES in the prospective Biomatrix Alpha registry underwent prespecified comparison with 857 patients who received ≥1 Biomatrix Flex SS-BP-BES in the LEADERS study (historical control). The primary outcome was major adverse cardiac events (MACE)-cardiac death, myocardial infarction (MI), or clinically driven target vessel revascularization (cd-TVR). Propensity analysis was used to adjust for differences in baseline variables and a landmark analysis at day-3 to account for differences in periprocedural MI definitions. RESULTS: MACE at 2 years occurred in 6.65% CoCr-BP-BES versus 13.23% SS-BP-BES groups (unadjusted HR 0.48 [0.31-0.73]; P=0.0005). Following propensity analysis, 2-year adjusted MACE rates were 7.4% versus 13.3% (HR 0.53 [0.35-0.79]; P=0.004). Definite or probable stent thrombosis, adjudicated using identical criteria in both studies, occurred less frequently with CoCr-BP-BES (1.12% vs. 3.22%; adjusted HR 0.32 [0.11-0.9]; P=0.034). In day-3 landmark analysis, the difference in 2-year MACE was no longer significant but there was a lower patient-orientated composite endpoint (11.7% vs. 18.4%; HR 0.6 [0.43-0.83]; P=0.006) and a trend to lower target vessel failure (5.8% vs. 9.1%; HR 0.63 [0.4-1.00]; P=0.078). CONCLUSION: At 2-year follow-up, propensity-adjusted analysis showed the thin strut (84-88um) Biomatrix Alpha CoCr-BP-BES was associated with improved clinical outcomes compared with the thicker strut (114-120um) Biomatrix Flex SS-BP-BES.

Temporal trends in cardiovascular risk factors' prevalence in patients with myocardial infarction.

INTRODUCTION AND OBJECTIVES: Little is known about changes in cardiovascular risk factors (CVRF) profile over time in patients presenting with acute myocardial infarction (AMI). METHODS: We assessed changes in age and CVRF profile in consecutive AMI patients enrolled in the Swiss nationwide AMIS Plus registry between 1 January 1997 and 31 December 2018. RESULTS: A total of 57 995 AMI patients were included in the analysis. Mean age at presentation was 71.5 ± 11.3 years for women and 63.9 ± 12.8 years for men and did not change over time. Overall, the mean (standard deviation) number of CVRF increased from 1.76 (1.07) in 1997/98 to 2.26 (1.10) in 2017/18 in men (Ptrend  < .001), while the corresponding rates in females were 1.83 (1.11) and 2.24 (1.08) (Ptrend  < .001). In terms of active smoking, no significant trend was detected for males, while there was a significant increase in females (P < .001). As a result, the gap in smoking rates between men and women presenting with AMI decreased from 19.9% (45.3% vs 25.4%) in 1997/98 to 7.9% (41.2% vs 33.3%) in 2017/18. Reassuring was the stability in terms of diabetes prevalence for both genders. Obesity was more prevalent over time in men, while the prevalence of hypertension and dyslipidemia increased in both genders. CONCLUSION: Among patients with AMI in Switzerland over two decades, age at presentation remained stable, while the mean number of CVRF increased in both men and women. Striking was the increase in the prevalence of smoking in women, leading to a reduction of the gender gap over time.

Efficacy and Safety of Abbreviated Eptifibatide Treatment in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.

The glycoprotein IIb/IIIa inhibitor eptifibatide, administered as bolus followed by infusion, is an adjunctive antithrombotic treatment during primary percutaneous coronary intervention (PCI) in selected patients with ST-segment elevation myocardial infarction (STEMI). Whether both bolus and infusion are necessary to improve outcomes is unknown. We hypothesized that primary PCI with eptifibatide bolus only is non-inferior to the conventional treatment (bolus and infusion) with regard to infarct size, while reducing bleeding complications. We analyzed 720 consecutive STEMI patients receiving eptifibatide bolus only or conventional treatment in an observational case-control study utilizing propensity score matching of clinical and intervention-specific confounders. Infarct size was estimated based on myocardial bound creatine kinase, creatine kinase (CK), and CK area under the curve values, with a prespecified non-inferiority margin of 20%. Major bleeding was defined as type 2, 3, or 5 on the Bleeding Academic Research Consortium classification. Eptifibatide bolus only was administered to 147 patients (20%), which were matched 1:1 to patients receiving conventional treatment. Based on peak myocardial bound creatine kinase, CK and CK area under the curve values, infarct size was -8.4% (95% CI [-31.2%, 14.4%]), -11.6% (95% CI [-33.5%, 10.3%]), and -13.9% (95% CI [-34.1%, 6.2%]) after eptifibatide bolus, respectively, reaching prespecified noninferiority compared with conventional treatment. Bolus treatment significantly reduced major bleeding complications (OR 0.48, 95% CI [0.30, 0.79]). In conclusion, eptifibatide given as abbreviated bolus only to selected STEMI patients who underwent primary PCI was noninferior regarding infarct size and resulted in less bleeding complications compared with conventional bolus and infusion treatment.

Prior Stroke in PFO Patients Is Associated With Both PFO-Related and -Unrelated Factors.

Background and Purpose: To identify factors associated with prior stroke at presentation in patients with cryptogenic stroke (CS) and patent foramen ovale (PFO). Methods: We studied cross-sectional data from the International PFO Consortium Study (NCT00859885). Patients with first-ever stroke and those with prior stroke at baseline were analyzed for an association with PFO-related (right-to-left shunt at rest, atrial septal aneurysm, deep venous thrombosis, pulmonary embolism, and Valsalva maneuver) and PFO-unrelated factors (age, gender, BMI, hypertension, diabetes mellitus, hypercholesterolemia, smoking, migraine, coronary artery disease, aortic plaque). A multivariable analysis was used to adjust effect estimation for confounding, e.g., owing to the age-dependent definition of study groups in this cross-sectional study design. Results: We identified 635 patients with first-ever and 53 patients with prior stroke. Age, BMI, hypertension, diabetes mellitus, hypercholesterolemia, coronary artery disease, and right-to-left shunt (RLS) at rest were significantly associated with prior stroke. Using a pre-specified multivariable logistic regression model, age (Odds Ratio 1.06), BMI (OR 1.06), hypercholesterolemia (OR 1.90) and RLS at rest (OR 1.88) were strongly associated with prior stroke.Based on these factors, we developed a nomogram to illustrate the strength of the relation of individual factors to prior stroke. Conclusion: In patients with CS and PFO, the likelihood of prior stroke is associated with both, PFO-related and PFO-unrelated factors.

Temporal trends in in-hospital complications of acute coronary syndromes: Insights from the nationwide AMIS Plus registry.

BACKGROUND: Acute coronary syndrome (ACS)-related morbidity and mortality remain substantial. Data on temporal trends in in-hospital complications of ACS patients are scarce. This study sought to investigate whether the incidence of in-hospital complications of ACS patients changed over time. METHODS: Acute coronary syndrome patients prospectively enrolled in the National Registry of Acute Myocardial Infarction in Switzerland (AMIS Plus) between 2003 and 2018 and with available data on in-hospital complications were included in the analysis. Rates of in-hospital complications, including recurrent angina, recurrent myocardial infarction, cerebrovascular events, cardiogenic shock, bleeding, acute renal failure, sepsis/systemic inflammatory response syndrome (SIRS)/multiorgan dysfunction syndrome (MODS), AV block needing pacing and new-onset atrial fibrillation, were assessed for each 2-year period. RESULTS: Among 47,845 ACS patients, in-hospital complications significantly decreased from 22.0% in 2003/2004 to 18.9% in 2017/2018 (p for trend <0.001). An initial decline in rates of in-hospital complications to 15.7% in 2009/2010 (p for trend <0.001) was followed by a constant increase thereafter (p for trend = 0.002). While rates of recurrent angina, recurrent myocardial infarction, and cardiogenic shock decreased over time, rates of bleeding events, acute renal failure, sepsis/SIRS/MODS, and new-onset atrial fibrillation increased. Rates of in-hospital complications were higher in women, mainly due to a constantly increased risk of bleeding and AV block needing pacing. CONCLUSIONS: The decrease in ischemic complications was paralleled by a concomitant increase in non-ischemic events. These findings emphasize that advanced strategies targeting non-ischemic complications are warranted to further improve quality of care of ACS patients.

First clinical evidence characterizing safety and efficacy of the new CoCr Biolimus-A9 eluting stent: The Biomatrix Alpha™ registry.

BACKGROUND: The biolimus-eluting stent (BES) was the first to elute anti-proliferative drug from a biodegradable polymer. In the randomized LEADERS trial, a stainless steel BES showed non-inferior efficacy compared to a sirolimus-eluting stent and a long-term safety advantage. We report the first clinical efficacy and safety outcomes of a new thin-strut cobalt chromium biolimus-eluting stent (CoCr-BES) from an international multi-centre registry. METHODS: We studied 400 all-comer patients with coronary disease receiving CoCr-BES at 12 centres, with follow-up at 9 months and 2 years. The primary endpoint was incidence of major adverse cardiac events (MACE) at 9 months comprising cardiac death, myocardial infarction (MI), and clinically indicated target vessel revascularization (ci-TVR). Key protocol elements were the same as the randomized LEADERS trial to enable a historical control for propensity-matched comparison. RESULTS: Mean patient age was 65 ± 11 years, 19% had diabetes, and 55% presented with unstable angina or MI. On discharge, 96% of patients were on dual antiplatelet therapy (DAPT) and 69% were on DAPT at 9 months. MACE at 9 months occurred in 3.9% of patients, cardiac death in 0.8%, MI in 1.1% and ci-TVR in 2.7%. One patient (0.25%) experienced definite or probable stent thrombosis (ST). A propensity-adjusted comparison showed similar clinical outcomes to the BES arm in the LEADERS trial for the primary endpoint MACE. CONCLUSIONS: The new CoCr-BES showed low rates of MACE, MI, ci-TVR and ST at 9 months, similar to the BES arm in LEADERS.

Differences in presentation and clinical outcomes between left or right bundle branch block and ST segment elevation in patients with acute myocardial infarction.

BACKGROUND: In patients with acute myocardial infarction, the presence of a left bundle branch block or right bundle branch block may be associated with worse prognosis compared to isolated ST segment elevation. However, specificities in clinical presentation and outcomes of acute myocardial infarction patients with left bundle branch block or right bundle branch block are poorly characterized. METHODS: We analysed acute myocardial infarction patients with left bundle branch block (n=880), right bundle branch block (n=732) or ST segment elevation without bundle branch block (n=15,852) included in the Acute Myocardial Infarction in Switzerland-Plus registry between 2008-2019. RESULTS: Acute myocardial infarction patients with bundle branch block were older and had more pre-existing cardiovascular conditions compared to ST segment elevation. Pulmonary oedema and cardiogenic shock were most frequent in patients with left bundle branch block (18.8% vs 12.0% for right bundle branch block and 7.9% for ST segment elevation, p<0.001). Acute myocardial infarction patients with bundle branch block had more three-vessel (40.6% vs 25.3%, p<0.001 vs ST segment elevation) and left main disease (5.6% vs 2.0%, p<0.001 vs ST segment elevation). Major adverse cardiac and cerebrovascular events, a composite of reinfarction, stroke/transient ischaemic attack, and death during hospitalization, were highest in acute myocardial infarction patients with left bundle branch block (13.9% vs 9.9% for right bundle branch block and 6.7% for ST segment elevation, p<0.05), which was driven by hospital mortality. After multivariate adjustment, however, mortality was similar in patients with left bundle branch block and lower in patients with right bundle branch block, respectively, when compared to ST segment elevation. Mortality was only increased when a right bundle branch block with concomitant STE was present (odds ratio 1.77, 95% confidence interval 1.19-2.64, p<0.01 vs ST segment elevation). CONCLUSIONS: Compared to ST segment elevation, an isolated bundle branch block reflects high-risk clinical characteristics but does not independently determine increased hospital mortality in acute myocardial infarction.

Multisite vascular disease in acute coronary syndromes: increased in-hospital mortality and no improvement over time.

INTRODUCTION: Limited data are available on the impact of multisite artery disease in patients with acute coronary syndromes. In particular, it is unknown whether the outcomes of those high-risk patients have improved over time. Therefore, we addressed the multisite artery disease patient population enrolled in the Swiss nationwide prospective acute coronary syndromes cohort study AMIS Plus over two decades. METHODS: All patients enrolled from January 1999 to October 2016 were stratified according to the presence of isolated coronary artery disease or multisite artery disease, defined as coronary artery disease with known concomitant vascular disease (i.e. cerebrovascular disease and/or peripheral artery disease). Multisite artery disease 1 (MSAD1) and multisite artery disease 2 (MSAD2) defined patients with one and two additional vascular conditions, respectively. Primary outcome measures were in-hospital mortality and major adverse cardiovascular events (defined as re-infarction, stroke or death). RESULTS: Among a total of 44,157 patients, 39,613 (89.7%) had coronary artery disease only while 4544 (10.3%) had multisite artery disease (4097 (9.3%) had MSAD1 and 447 (1.0%) had MSAD2). Compared with patients with coronary artery disease only, multisite artery disease patients were older, had a longer delay from symptom onset to hospital admission, had more frequently atypical presentation, presented more frequently with non-ST-segment elevation acute coronary syndromes, were more frequently in Killip class III/IV, had higher Charlson comorbidity index, more frequently had three-vessel coronary artery disease and were treated less frequently with evidence-based treatments such as aspirin, P2Y12 inhibitors, or beta-blockers. Similarly, multisite artery disease benefitted less frequently from coronary angiography as well as percutaneous coronary revascularisation. In-hospital mortality was 10.9% in multisite artery disease patients and 4.4% in coronary artery disease-only patients (P<0.001). Corresponding major adverse cardiovascular events rates were 13.4% and 5.4% (P<0.001). Cardiogenic shock, re-infarction and cerebrovascular events were significantly more frequent in multisite artery disease patients compared with coronary artery disease-only patients. In multivariable logistic regression analysis, multisite artery disease was identified as an independent predictor of in-hospital mortality (odds ratio 1.69, 95% confidence interval 1.47-1.94, P<0.001). Among multisite artery disease patients, mortality was the highest in MSAD2 individuals (15.4% vs. 10.4% among MSAD1 patients, P=0.001), the same was true for the major adverse cardiovascular events rates (19.1% in MSAD2 patients vs. 12.7% in MSAD1 patients, P<0.001). When stratified for the decade of enrollment, no improvement in mortality or major adverse cardiovascular events rates was observed in multisite artery disease patients. CONCLUSION: Patients presenting with multisite artery disease were less likely to receive evidence-based therapies than coronary artery disease-only patients and had increased in-hospital morbidity and mortality, with no improvement over time. The worse outcomes were observed among MSAD2 patients. These results should prompt awareness for multisite artery disease as a high-risk condition in the setting of multisite artery disease.

Gender differences in patient and system delay for primary percutaneous coronary intervention: current trends in a Swiss ST-segment elevation myocardial infarction population.

BACKGROUND: Women with ST-segment elevation myocardial infarction (STEMI) experience greater delays for percutaneous coronary intervention-facilitated reperfusion than men. Whether women and men benefit equally from current strategies to reduce ischaemic time and whether there are gender differences in factors determining delays is unclear. METHODS: Patient delay (symptom onset to first medical contact) and system delay (first medical contact to percutaneous coronary intervention-facilitated reperfusion) were compared between women ( n=967) and men ( n=3393) in a Swiss STEMI treatment network. Trends from 2000 to 2016 were analysed, with additional comparisons between three time periods (2000-2005, 2006-2011 and 2012-2016). Factors predicting delays and hospital mortality were determined by multivariate regression modelling. RESULTS: Female gender was independently associated with greater patient delay ( P=0.02 vs. men), accounting for a 12% greater total ischaemic time among women in 2012-2016 (median 215 vs. 192 minutes, P<0.001 vs. men). From 2000-2005 to 2012-2016, median system delay was reduced by 18 and 25 minutes in women and men, respectively ( P<0.0001 for trend, P=n.s. for gender difference). Total occlusion of the culprit artery, stent thrombosis, a Killip class of 3 or greater, and presentation during off-hours predicted delays in men, but not in women. A Killip class of 3 or greater and age, but not gender or delays, were independently associated with hospital mortality. CONCLUSIONS: STEMI-related ischaemic time in women remains greater than in men due to persistently greater patient delays. In contrast to men, clinical signs of ongoing chest discomfort do not predict delays in women, suggesting that female STEMI patients are less likely to attribute symptoms to a condition requiring urgent treatment.

Ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents versus thin-strut, durable-polymer, everolimus-eluting stents for percutaneous coronary revascularisation: 5-year outcomes of the BIOSCIENCE randomised trial.

BACKGROUND: Drug-eluting stents combining an ultrathin cobalt-chromium stent platform with a biodegradable polymer eluting sirolimus have been shown to be non-inferior or superior to thin-strut, durable-polymer, everolimus-eluting stents in terms of 1 year safety and efficacy outcomes. METHODS: In the randomised, single-blind, multicentre, non-inferiority BIOSCIENCE trial, we compared biodegradable-polymer sirolimus-eluting stents with durable-polymer everolimus-eluting stents in patients with chronic stable coronary artery disease or acute coronary syndromes. Here, we assess the final 5-year clinical outcomes of BIOSCIENCE with regards to the primary clinical outcome of target lesion failure, which was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. The primary analysis was done by intention to treat. The BIOSCIENCE trial is registered with ClinicalTrials.gov, number NCT01443104. FINDINGS: 2008 (95%) of 2119 patients recruited between March 1, 2012, and May 31, 2013, completed 5 years of follow-up. Target lesion failure occurred in 198 patients (cumulative incidence 20·2%) treated with biodegradable-polymer sirolimus-eluting stents and in 189 patients (18·8%) treated with durable-polymer everolimus-eluting stents (rate ratio [RR] 1·07, 95% CI 0·88-1·31; p=0·487). All-cause mortality was significantly higher in patients treated with biodegradable-polymer sirolimus-eluting stents than in those treated with durable-polymer everolimus-eluting stents (14·1% vs 10·3%; RR 1·36, 95% CI 1·06-1·75; p=0·017), driven by a difference in non-cardiovascular deaths. We observed no difference between groups in cumulative incidence of definite stent thrombosis at 5 years (1·6% in both groups; 1·02, 0·51-2·05; p=0·950). INTERPRETATION: 5-year risk of target lesion failure among all-comer patients undergoing percutaneous coronary intervention is similar after implantation of ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents or thin-strut, durable-polymer, everolimus-eluting stents. Higher incidences of all-cause and non-cardiovascular mortality in patients treated with biodegradable-polymer stents eluting sirolimus than in those treated with durable-polymer stents eluting everolimus warrant careful observation in ongoing clinical trials. FUNDING: Clinical Trials Unit of the University of Bern and Biotronik.

Impact of total ischemic time on manual thrombus aspiration benefit during primary percutaneous coronary intervention.

BACKGROUND: The benefits of manual thrombus aspiration (TA) during primary percutaneous coronary intervention (pPCI) for ST-elevation myocardial infarction (STEMI) remain uncertain. We assessed the influence of total ischemic time (TIT) on clinical outcomes among STEMI patients undergoing manual TA during pPCI. METHODS AND RESULTS: We conducted a retrospective study of patients enrolled in the Acute Myocardial Infarction in Switzerland Plus registry. STEMI patients undergoing pPCI with (TA group) or without (PCI-alone group) manual TA were stratified based on short (<3 hours), intermediate (3-6 hours), and long (>6 hours) TIT. The primary endpoint was in-hospital all-cause mortality. The secondary endpoint was in-hospital major adverse cardiac events (MACE), a composite of all-cause death, myocardial reinfarction and stroke. Between 2008 and 2014, 4'154 patients (TA 48%) were included. Risk-adjusted in-hospital all-cause mortality was not different between TA and PCI-alone groups (OR 1.29; 95%CI 0.83-1.98; p=0.26), whereas there was significantly increased risk of MACE (OR 1.52; 95%CI 1.05-2.19; p=0.03) in patients treated with manual TA compared with PCI-alone. There was no significant difference between manual TA and PCI-alone with respect to risk-adjusted all-cause mortality according to TIT groups, but risk-adjusted MACE rates were significantly higher in the group of patients with long TIT treated with manual TA compared with PCI-alone (OR 2.42; 95%CI 1.16-5.04; p=0.02). CONCLUSION: In a large registry of STEMI patients, manual TA was not associated with lower risk-adjusted in-hospital all-cause mortality compared with PCI-alone regardless of TIT but was associated with significantly greater risk of MACE. In patients with prolonged TIT, manual TA was associated with higher risk-adjusted MACE rates compared with PCI-alone.

Screening For Pulmonary Hypertension With Multidetector Computed Tomography Among Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

Aim: To assess the accuracy of multi-detector computed tomography (MDCT) derived pulmonary vessel measurements in predicting pulmonary hypertension (PH) among patients with severe symptomatic aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). Background: PH is common among patients with severe AS undergoing TAVI and is associated with adverse outcomes. MDCT is the imaging modality of choice to assess anatomical dimensions among patients selected for TAVI. Methods: One hundred and thirty-nine patients with severe AS undergoing TAVI with both CT scans and right heart catheterizations (RHC) were included. CT diameters of the main pulmonary artery (MPA), right (RPA) and left (LPA), and ascending aorta (AA) were measured. The relationship between CT measurements and PA pressures assessing using RHC was tested with linear regression. Results: The CT derived ratio of the diameter of the MPA to the diameter of the AA (PA/AAratio) correlated best with mean PA pressure (R2 = 0.48) and PA systolic pressure (R2 = 0.50). Receiver operating characteristic curve analysis showed that the PA/AAratio is a moderate predictor of PH (AUC 0.74, 95% CI 0.65-0.83, p < 0.0001) and that the optimal cut off point is 0.80 (sensitivity 56%, specificity 88%, positive predictive value 95.5%, negative predictive value 30.6% for PH). Conclusions: Elderly patients with severe AS and PA/AAratio values ≥ 0.80 on MDCT are more likely to have PH but PH cannot be reliably excluded among such patients with lower PA/AAratio values.

Circadian dependence of manual thrombus aspiration benefit in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

BACKGROUND: The clinical benefit of manual thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) in patients with ST-segment elevation myocardial infarction (STEMI) remains uncertain. This study assessed the impact of circadian rhythms on the effectiveness of manual TA. METHODS AND RESULTS: We conducted an observational study of patients enrolled in the Acute Myocardial Infarction in Switzerland Plus registry. STEMI patients undergoing PPCI with (TA group) or without (PCI-alone group) manual TA were divided based on time-of-day symptom onset: group 1 (00:00-05:59), group 2 (06:00-11:59), group 3 (12:00-17:59) and group 4 (18:00-23:59). The primary endpoint was circadian variation of myocardial infarction (MI) size. The secondary endpoint was in-hospital all-cause mortality. Between 2009 and 2014, 3648 patients underwent PPCI (TA, 49%). After propensity-score matching, 2860 patients were included. Minimal myocardial Injury was observed in groups 2 and 3 (peak creatine kinase level group 1, 2723 ± 148 U/l; group 2, 2493 ± 105 U/l; group 3, 2550 ± 106 U/l; group 4, 2952 ± 144 U/l; p = 0.044) in the TA group, whereas no time-of-day dependence was found in PCI-alone group. After periodic sinusoidal regression analysis, a circadian relationship between time-of-day symptom onset and MI size was demonstrated in the TA group (p < 0.001). In-hospital all-cause mortality was 3.4% in the TA group and 4.3% in the PCI-alone group (p = 0.20). CONCLUSIONS: In this large registry of STEMI patients, manual TA did not reduce in-hospital all-cause mortality. Nonetheless, there was a circadian dependence of TA effectiveness with greatest myocardial salvage for patients with symptom onset between 06:00 and 17:59.

Left ventricular pseudoaneurysm formation in a patient presenting with a subacute myocardial infarction.

Left ventricular pseudoaneurysm is a rare mechanical complication of acute myocardial infarction. In the present case, an 80-year-old man presenting with a subacute non-ST segment elevation myocardial infarction was found to have an occluded second obtuse marginal branch of the left circumflex coronary artery. Following the implantation of two drug-eluting stents, the patient developed no-reflow phenomenon. Coronary angiography 6 weeks later revealed persistence of the no-reflow phenomenon. During the left ventriculogram, a massive pseudoaneurysm was diagnosed and the patient successfully underwent emergency surgery. The persistence of no-reflow was likely due to the fact that the myocardial territory supplied by the infarct-related artery was completely necrosed resulting in persistent flow impairment through the vessel.

Heart failure in patients admitted for acute coronary syndromes: A report from a large national registry.

BACKGROUND: Data on temporal trends of heart failure (HF) in acute coronary syndrome (ACS) are scarce. HYPOTHESIS: Improved treatment options may have led to lower case-fatality rates (CFRs) during the last years in ACS complicated by HF. METHODS: Patients of the nationwide Acute Myocardial Infarction in Switzerland (AMIS)-Plus ACS registry were analyzed from 2000 to 2014. RESULTS: Of 36 366 ACS patients, 3376 (9.3%) had acute or chronic HF, 2111 (5.8%) de novo acute HF (AHF), 964 (2.7%) chronic HF (CHF), and 301 (0.8%) acute decompensated CHF (ADCHF). In-hospital CFRs were highest in patients with ADCHF (32.6%) and de novo AHF (29.7%), followed by patients with CHF (12.9%) and without HF (3.2%, P < 0.001). Although in-hospital CFRs gradually decreased in CHF patients (14.3% to 4.5%, P = 0.003) and patients without HF (3.5% to 2.2%, P < 0.001), they remained high in patients with ADCHF (36.4% to 40.0%, P = 0.45) and de novo AHF (50.0% to 29.4%, P = 0.37). Although there was an increase in specific ACS therapies in the cohort over time, ACS patients with HF received significantly less pharmacological and interventional ACS therapies than patients without HF. There was no significant change in HF medication rates except less frequent use of ß-blockers and diuretics in de novo AHF patients in recent years. CONCLUSIONS: HF is present in 1 out of 10 patients presenting with ACS and is associated with high in-hospital CFRs, particularly in acute HF. Although advances in ACS therapy improved in-hospital CFRs in patients with no HF or CHF, CFRs remained unchanged and high in patients with acute HF and ACS over the last decade.