All-comers Population Research Articles

Thin- versus thick-strut polymer-free biolimus-eluting stents: the BioFreedom QCA randomised trial.

The BioFreedom drug-coated stent with a stainless steel platform (BF-SS) has been demonstrated to be efficacious in patients at high bleeding risk and receiv-ing only one-month dual antiplatelet therapy. The aim of this study was to evaluate the efficacy of the new BioFreedom Ultra drug-coated stent with a thin-strut cobalt-chromium platform (BF-CoCr) compared to the BF-SS in an all-comers population undergoing percutaneous coronary intervention (PCI). This was a prospective, multicentre, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) as determined by quantitative coronary angiography at nine-month follow-up. Clinical evaluation was performed at one year. A total of 200 patients were randomised (1:1) to either the BF-CoCr or the BF-SS stent at eight centres in Spain and Denmark. Baseline clinical and lesion characteristics were similar between the groups. Mean age was 66 years and 23% were female. The mean number of stents implanted per patient was 1.5. At nine-month follow-up, mean in-stent LLL was 0.34±0.49 mm in the BF-CoCr group versus 0.29±0.37 mm in the BF-SS group, p=0.005 for non-inferiority. At one year, target lesion failure was similar between the groups (7.3% in BF-CoCr vs 9.3% in the BF-SS group; p=0.60). The BF-CoCr was non-inferior to the BF-SS in terms of in-stent LLL at nine months. Larger studies powered for clinical endpoints are warranted to compare the efficacy of this new platform with currently available DES.

Procedural and 1-year outcomes following large vessel coronary artery perforation treated by covered stents implantation: Multicentre CRACK registry.

BackgroundData regarding the clinical outcomes of covered stents (CSs) used to seal coronary artery perforations (CAPs) in the all-comer population are scarce. The aim of the CRACK Registry was to evaluate the procedural, 30-days and 1-year outcomes after CAP treated by CS implantation.MethodsThis multicenter all-comer registry included data of consecutive patients with CAP treated by CS implantation. The primary endpoint was the composite of major adverse cardiac events (MACEs), defined as cardiac death, target lesion revascularization (TLR), and myocardial infarction (MI).ResultsThe registry included 119 patients (mean age: 68.9 ± 9.7 years, 55.5% men). Acute coronary syndrome, including: unstable angina 21 (17.6%), NSTEMI 26 (21.8%), and STEMI 26 (21.8%), was the presenting diagnosis in 61.3%, and chronic coronary syndromes in 38.7% of patients. The most common lesion type, according to ACC/AHA classification, was type C lesion in 47 (39.5%) of cases. A total of 52 patients (43.7%) had type 3 Ellis classification, 28 patients (23.5%) had type 2 followed by 39 patients (32.8%) with type 1 perforation. Complex PCI was performed in 73 (61.3%) of patients. Periprocedural death occurred in eight patients (6.7%), of which two patients had emergency cardiac surgery. Those patients were excluded from the one-year analysis. Successful sealing of the perforation was achieved in 99 (83.2%) patients. During the follow-up, 26 (26.2%) patients experienced MACE [7 (7.1%) cardiac deaths, 13 (13.1%) TLR, 11 (11.0%) MIs]. Stent thrombosis (ST) occurred in 6 (6.1%) patients [4(4.0%) acute ST, 1(1.0%) subacute ST and 1(1.0%) late ST].ConclusionsThe use of covered stents is an effective treatment of CAP. The procedural and 1-year outcomes of CAP treated by CS implantation showed that such patients should remain under follow-up due to relatively high risk of MACE.

Randomized Clinical Comparison of the Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Combo Stent With the Sirolimus-Eluting Orsiro Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT X Trial.

Target lesion failure remains an issue with contemporary drug-eluting stents. Thus, the dual-therapy sirolimus-eluting and CD34+ antibody-coated Combo stent (DTS) was designed to further improve early healing. This study aimed to investigate whether the DTS is noninferior to the sirolimus-eluting Orsiro stent (SES) in an all-comers patient population. The SORT OUT X (Combo Stent Versus Orsiro Stent) trial, was a large-scale, randomized, multicenter, single-blind, 2-arm, noninferiority trial with registry-based follow-up. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction, or target lesion revascularization within 12 months, analyzed using intention-to-treat. The trial was powered for assessing target lesion failure noninferiority of the DTS compared with the SES with a predetermined noninferiority margin of 0.021. A total of 3146 patients were randomized to treatment with the DTS (1578 patients; 2008 lesions) or SES (1568 patients; 1982 lesions). At 12 months, intention-to-treat analysis showed that 100 patients (6.3%) assigned the DTS and 58 patients (3.7%) assigned the SES met the primary end point (absolute risk difference, 2.6% [upper limit of 1-sided 95% CI, 4.1%]; P (noninferiority)=0.76). The SES was superior to the DTS (incidence rate ratios for target lesion failure, 1.74 [95% CI, 1.26-2.41]; P=0.00086). The difference was explained mainly by a higher incidence of target lesion revascularization in the DTS group compared with the SES group (53 [3.4%] vs. 24 [1.5%]; incidence rate ratio, 2.22 [95% CI, 1.37-3.61]; P=0.0012). The DTS did not confirm noninferiority to the SES for target lesion failure at 12 months in an all-comer population. The SES was superior to the DTS mainly because the DTS was associated with an increased risk of target lesion revascularization. However, rates of death, cardiac death, and myocardial infarction at 12 months did not differ significantly between the 2 stent groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03216733.

Severe tricuspid regurgitation: prognostic role of right heart remodelling and pulmonary hypertension.

Left heart diseases (LHDs) are the main driving forces for the development of functional tricuspid regurgitation (TR). Therefore, in most cases, the true prognostic value of TR remains concealed by concomitant LHD. This study aimed to analyse right heart remodelling in patients with TR without other valve disease and with normal systolic left ventricular function (sysLVF), and to stratify its prognostic value in the presence (dPH, maximal TR velocity signal (TRVmax) ≥ 3.5 m/s in echocardiography) or absence (nsPH, TRVmax < 3.5m/s) of concomitant pulmonary hypertension (PH). We performed an observational analysis of all patients diagnosed with TR in the absence of other valve disease and reduced sysLVF at our institution between 1 January 2003 and 31 December 2013. Five-year mortality was chosen as endpoint. The final cohort entailed 29979 consecutive patients (median age 60 years, interquartile range 46-70), 49.9% were male, mean follow-up was 95±49 months. Severe TR was present in 790 patients (2.6%). In dPH and in nsPH, severe TR was associated with an excess 5-year mortality that was even more pronounced in the dPH group (58.2% vs. 43.6%, P = 0.001). In nsPH, right ventricular dysfunction predicted mortality. In dPH, mortality was independent of presence or absence of right heart dilatation or dysfunction. Severe TR without concomitant left heart valve disease or LV systolic dysfunction was a rare disease in this large-scale all-comer population and is associated with an unfavourable prognosis. The differentiation of patients with nsPH and dPH is essential as they present with different patterns of right heart remodelling and with different long-time outcomes.

Sharing primary percutaneous coronary intervention care: first experiences with South Limburg ST-elevation myocardial infarction network.

BackgroundIn the region of South Limburg, the Netherlands, a shared ST-elevation myocardial infarction (STEMI) networking system (SLIM network) was implemented. During out-of-office hours, two percutaneous coronary intervention (PCI) centres—Maastricht University Medical Centre and Zuyderland Medical Centre—are supported by the same interventional cardiologist. The aim of this study was to analyse performance indicators within this network and to compare them with contemporary European Society of Cardiology guidelines.MethodsKey time indicators for an all-comer STEMI population were registered by the emergency medical service and the PCI centres. The time measurements showed a non-Gaussian distribution; they are presented as median with 25th and 75th percentiles.ResultsBetween 1 February 2018 and 31 March 2019, a total of 570 STEMI patients were admitted to the participating centres. The total system delay (from emergency call to needle time) was 65 min (53–77), with a prehospital system delay of 40 min (34–47) and a door-to-needle time of 22 min (15–34). Compared with in-office hours, out-of-office hours significantly lengthened system delays (55 (47–66) vs 70 min (62–81), p < 0.001), emergency medical service transport times (29 (24–34) vs 35 min (29–40), p < 0.001) and door-to-needle times (17 (14–26) vs 26 min (18–37), p < 0.001).ConclusionsWith its effective patient pathway management, the SLIM network was able to meet the quality criteria set by contemporary European revascularisation guidelines.

Single versus double use of a suture-based closure device for transfemoral aortic valve implantation

BackgroundThe most common method of percutaneous closure in transfemoral transcatheter aortic valve implantation (TAVI) employs two obtusely oriented ProGlide devices. The aim of this study was to assess the feasibility and safety of using a single ProGlide system for primary access site closure in comparison with the double ProGlide approach in an all-comers TAVI population. MethodsBetween March 2016 and December 2018, a total of 1105 patients underwent transfemoral TAVI for severe aortic stenosis at our center. Application of two ProGlide systems was standard until April 2017 (n = 432), whereas thereafter a single ProGlide system was used (n = 663). A 1:1 propensity score matching was performed to adjust for baseline differences between the two groups, resulting in 327 matched cases. Primary outcomes of interest were main access site-related vascular complications. ResultsThe mean number of ProGlide devices used per patient was 1.03 (SD 0.2) in the single-ProGlide group versus 2.01 (SD 0.14) in the double-ProGlide group. An additional vascular closure device was required to obtain full hemostasis in 23.2% versus 9.5% of patients (p < 0.001) in the two groups, respectively. Technical success of ProGlide usage was similar (94.3% versus 92.1%, p = 0.163). In the matched cohorts, the rates of main access site-related major vascular complications were similar (4.0% vs. 6.4%, p = 0.217). ConclusionThe single-ProGlide technique is feasible, with rates of technical success similar to those of the double-ProGlide technique. Use of this method did not lead to more frequent access site-related complications but was more cost effective than the double-ProGlide approach.

Effect of Age on Clinical Outcomes in Elderly Patients (>80 Years) Undergoing Percutaneous Coronary Intervention: Insights From a Multi-Centre Australian PCI Registry

To evaluate the effect of age in an all-comers population undergoing percutaneous coronary intervention (PCI). Age is an important consideration in determining appropriateness for invasive cardiac assessment and perceived clinical outcomes. We analysed data from 29,012 consecutive patients undergoing PCI in the Melbourne Interventional Group (MIG) registry between 2005 and 2017. 25,730 patients <80 year old (78% male, mean age 62±10 years; non-elderly cohort) were compared to 3,282 patients ≥80 year old (61% male, mean age 84±3 years; elderly cohort). The elderly cohort had greater prevalence of hypertension, diabetes and previous myocardial infarction (all p<0.001). Elderly patients were more likely to present with acute coronary syndromes, left ventricular ejection fraction <45% and chronic kidney disease (p<0.0001). In-hospital, 30-day and long-term all-cause mortality (over a median of 3.6 and 5.1 years for elderly and non-elderly cohorts, respectively) were higher in the elderly cohort (5.2% vs. 1.9%; 6.4% vs. 2.2%; and 43% vs. 14% respectively, all p<0.0001). In multivariate Cox regression analysis, estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (HR 3.8, 95% CI: 3.4-4.3), cardiogenic shock (HR 3.0, 95% CI: 2.6-3.4), ejection fraction <30% (HR 2.5, 95% CI: 2.1-2.9); and age ≥80 years (HR 2.8, 95% CI: 2.6-3.1) were independent predictors of long-term all-cause mortality (all p<0.0001). The elderly cohort is a high-risk group of patients with increasing age being associated with poorer long-term mortality. Age, thus, should be an important consideration when individualising treatment in elderly patients.

Clinical value of soluble suppression of tumourigenicity 2 (sST2) in addition to NTproBNP measurements in a general cardiac outpatient population

BACKGROUND AND AIMS: The soluble form of suppression of tumourigenicity 2 (sST2), a recently introduced biomarker, is a strong and NTproBNP-independent predictor of outcome in heart failure patients. This study sought to evaluate the added clinical value of sST2 in addition to NTproBNP in a heterogeneous cardiac outpatient population. METHODS: A total of 297 all-comer patients visiting the outpatient clinic of Heart Clinic Zurich, Switzerland, from January to December 2018 were included. Patients were divided into four groups depending on their sST2 and NTproBNP levels: group 1 (n = 91, 30.6% of all patients) with normal levels of both biomarkers, group 2 (n = 41, 13.8%) with isolated elevation of sST2 but normal NTproBNP, group 3 (n = 97, 32.7%) with elevated NTproBNP but normal sST2 levels, and group 4 (n = 68, 22.9%) with elevation of both biomarkers. Differences between groups, Spearman’s correlations and linear and multiple regression analysis for sST2 were calculated. RESULTS: The median age was 74 ± 19 years and 41.8% were women. NTproBNP levels continuously increased across the groups (medians in pg/ml: group 1 123.0, group 2 152.0, group 3 990.0 and group 4 2610.0), whereas sST2 levels did not (medians in ng/ml: 28.7, 58.9, 28.4 and 63.7 for groups 1 to 4, respectively). In patients with normal NTproBNP (groups 1 and 2), elevation of sST2 (group 2) was associated with significantly higher rates of coronary artery disease, peripheral vascular disease and renal dysfunction. In patients with elevated NTproBNP (groups 3 and 4), the additional elevation of sST2 (group 4) was associated with clinical signs of heart failure, higher EuroScore II and worse left ventricular ejection fraction (LVEF group 3 58.0% vs group 4 53.3%, p = 0.022). Correlation of sST2 was overall weak and weaker than of NTproBNP with most clinical variables. Soluble ST2 significantly correlated with EuroScore II (R = 0.280), kidney function (R = −0.259), C-reactive protein (R = 0.248), right ventricular function (R = 0.213) and left atrial volume (R = 0.199), all p ≤0.001. In multiple regression analysis, left atrial volume was the strongest independent predictor of sST2 elevation (p = 0.002). CONCLUSION: In this all-comer cardiology population, the added clinical value of sST2 measurements in addition to NTproBNP was small. In patients with elevated NTproBNP, the simultaneous elevation of sST2 was associated with clinical signs of heart failure. Soluble ST2 measurements could thus be beneficial in patients with uncertain signs of heart failure and confounding factors for NTproBNP elevation. Surprisingly, this study found elevated sST2 levels in a substantial number of a patients with normal NTproBNP levels, pointing to an additional pathway of sST2 elevation independent of heart failure.

Incidence, Predictors, and Outcome of In-Hospital Bleeding in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction

Bleeding after acute myocardial infarction (AMI) is associated with an increased morbidity and mortality. The frequency and consequences of bleeding events in patients with AMICS are not well described. The objective was to investigate incidence and outcome of bleeding complications among unselected patients with AMI complicated by cardiogenic shock (AMICS) and referred for immediate revascularization. Bleeding events were assessed by review of medical records in consecutive AMICS patients admitted between 2010 and 2017. Bleedings during admission were classified according to Bleeding Academic Research Consortium classification. Patients who did not survive to admission in the intensive care unit were excluded. Of the 1,716 patients admitted with AMICS, 1,532 patients (89%) survived to ICU admission. At 30 days, mortality was 48%. Severe bleedings classified as BARC 3/5 were seen in 87 non-coronary bypass grafting patients (6.1%). Co-morbidity did not differ among patients; however, patients who had a BARC 3/5 bleeding had significantly higher lactate and lower systolic blood pressure at admission, indicating a more severe state of shock. The use of mechanical assist devices was significantly associated with severe bleeding events. Univariable analysis showed that patients with a BARC 3/5 bleeding had a significantly higher 30-day mortality hazard compared with patients without severe bleedings. The association did not sustain after multivariable adjustment (hazard ratio 0.90, 95% confidence interval 0.64; 1.26, p = 0.52). In conclusion, severe bleeding events according to BARC classification in an all-comer population of patients with AMICS were not associated with higher mortality when adjusting for immediate management, hemodynamic, and metabolic state. This indicates that mortality in these patients is primarily related to other factors.

Comparación de seguridad y efectividad entre los accesos radiales derecho e izquierdo en la intervención coronaria percutánea

Introduction and objectivesThere is a paucity of data comparing the left radial approach (LRA) and right radial approach (RRA) for percutaneous coronary intervention (PCI) in all-comers populations and performed by operators with different experience levels. Thus, we sought to compare the safety and clinical outcomes of the RRA and LRA during PCI in “real-world” patients with either stable angina or acute coronary syndrome (ACS). MethodsTo overcome the possible impact of the nonrandomized design, a propensity score was calculated to compare the 2 radial approaches. The study group comprised 18 716 matched pairs with stable angina and 46 241 with ACS treated with PCI and stent implantation between 2014 and 2017 in 151 tertiary invasive cardiology centers in Poland (the ORPKI Polish National Registry). ResultsThe rates of death and periprocedural complications were similar for the RRA and LRA in stable angina patients. A higher radiation dose was observed with PCI via the LRA in both clinical presentations (stable angina: 1067.0±947.1 mGy vs 1007.4±983.5 mGy, P=.001; ACS: 1212.7±1005.5 mGy vs 1053.5±1029.7 mGy, P=.001). More contrast was used in LRA procedures but only in ACS patients (174.2±75.4mL vs 167.2±72.1mL, P=.001). Furthermore, periprocedural complications such as coronary artery dissection (0.16% vs 0.09%, P=.008), no-reflow phenomenon (0.65% vs 0.49%, P=.005), and puncture site bleeding (0.09% vs 0.05%, P=.04) were more frequently observed with the LRA in ACS patients. There was no difference in mortality between the 2 groups (P=.90). ConclusionsOur finding of poorer outcomes with the LRA may be related to lower operator experience with this approach. While both the LRA and RRA are safe in the setting of stable angina, the LRA was associated with a higher rate of periprocedural complications during PCI in ACS patients.Full English text available from:www.revespcardiol.org/en

One-Year Clinical Outcome of Inspiron Stent in All-Comers Population (Analysis from 790 Consecutive Patients)

Aims The goal of this study was to evaluate the performance of the InspironTM coronary stent (Scitech Medical™, Goiás, Brazil). The InspironTM sirolimus-eluting stent uses an ultrathin L-605 cobalt-chromium alloy with a 75 μm strut thickness platform coated with an abluminal biodegradable polymer. The polymer is eliminated from the body through the tricarboxylic acid cycle in 6–9 months, releasing 80% of the drug within 30 days after its deployment. Methods It was a prospective, single-center registry. To represent clinical practice, all patients undergoing percutaneous coronary intervention were included in this registry. There were no exclusion criteria. Clinical follow-ups were performed at twelve months. The endpoints were the occurrence of all-cause death, definite stent thrombosis, and new revascularization. Results Between November 2017 and May 2019, 790 patients were included (1067 lesions). The mean age was 60.42 ± 14.94 years, and 74.7% presented with acute coronary syndrome. Diabetes mellitus was present in 43.9% of patients, and previous myocardial infarction and previous percutaneous coronary intervention were present in 17.9% and 11.3%, respectively. Angiographic success was achieved in 99.1%. The incidence of all-cause death was 11.5% (6.2% in-hospital and 5.3% in the follow-up) and definitive stent thrombosis was 0.2%. New revascularization was performed in only 5.8% (target lesion revascularization: 2.2%; progression of disease in another lesion: 3.6%). Based on the multivariate regression analysis, only chronic renal failure was an independent predictor of adverse events (OR: 3.3; 95% CI: 1.22–8.92). Conclusion The result of this single-center registry demonstrates the safety and excellent performance of the InspironTM stent in daily clinical practice with a low rate of adverse cardiac events.

Real-world evidence for a prescription digital therapeutic to treat opioid use disorder

Objectives To evaluate patient engagement and usage of a prescription digital therapeutic (PDT) and associated outcomes of opioid use and treatment retention in a large real-world dataset of patients with opioid use disorder (OUD) treated with buprenorphine medication for opioid use disorder (MOUD). PDTs are software-based disease treatments evaluated for safety and effectiveness in randomized clinical trials (RCTs), and authorized by the U.S. Food and Drug Administration (FDA) to treat disease with approved directions for use (label). Methods A real-world observational evaluation of an all-comer population of patients who redeemed a 12-week prescription for the reSET-O PDT. Engagement and therapeutic use data were collected and analysed on a population level. Substance use was evaluated as a composite of self-reports recorded with reSET-O and urine drug screens (UDS). Results Data from 3144 individuals with OUD were evaluated. 45.5% were between ages 30 and 39 years. 80% completed at least 8 of the 67 possible therapeutic modules, 66% completed half of all modules, and 49% completed all modules. Abstinence during the last 4 weeks of treatment was calculated with two imputation methodologies: 66% abstinent using “missing data excluded (patients with no data as positive)”, and 91% abstinent with “missing data removed (patients with no data excluded)”. 91% of patients met the responder definition of ≥80% of self-report or UDS negative. 74.2% of patients were retained through the last 4 weeks of treatment. Subgroup analysis of patients using reSET-O appropriately (4 or more modules per week for the first 4 weeks) showed 88.1% abstinence using “missing data excluded (patients with no data as positive)”, and retention at weeks 9–12 of 85.8%. Conclusions Results demonstrate that reSET-O is readily and broadly used by patients with OUD and that high real-world engagement with the therapeutic is positively associated with abstinence and retention in treatment. ReSET-O is a potentially valuable adjunct to buprenorphine MOUD therapy for patients with OUD.

Impact of Coronary Stent Architecture on Clinical Outcomes: Do Minor Changes in Stent Architecture Really Matter?

IntroductionThe objective of this study was to compare the accumulated clinical outcomes of two Malaysian all-comers populations, each treated with different polymer-free sirolimus-eluting stents (PF-SES) of similar stent design.MethodsThe Malaysian subpopulation of two all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined and compared to a Malaysian-only cohort which was treated with a later-generation PF-SES. The PF-SES’s used differed only in their bare-metal backbone architecture, with otherwise identical sirolimus coating. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 12 months. The rates of major adverse cardiac events (MACE), stent thrombosis (ST) and myocardial infarction (MI) were part of the secondary endpoints.ResultsA total of 643 patients were treated with either the first-generation PF-SES (413 patients) or second-generation PF-SES (230 patients). Patient demographics were similar in terms of age (p = 0.744), male gender (0.987), diabetes mellitus (p = 0.293), hypertension (p = 0.905) and acute coronary syndrome (ACS, 44.8% vs. 46.1%, p = 0.752) between groups. There were no differences between treatment groups in terms of lesion length (20.8 ± 7.3 mm vs. 22.9 ± 7.9, p = 0.111) or vessel diameter (2.87 ± 0.39 vs. 2.93 ± 0.40, p = 0.052) despite numerically smaller diameters in the first-generation PF-SES group. The second-generation PF-SES tended to have more complex lesions as characterized by calcification (10.3% vs. 16.2%, p = 0.022), severe tortuosity (3.5% vs. 6.9%, p = 0.041) and B2/C lesions (49.2% vs. 62.8%, p < 0.001). The accumulated TLR rates did not differ significantly between the first- and second-generation PF-SES (0.8% vs. 0.9%, p = 0.891). The accumulated MACE rates were not significantly different (p = 0.561), at 1.5% (6/413) and 2.2% (5/230), respectively.ConclusionsModifications in coronary stent architecture which enhance the radial strength and radiopacity without gross changes in strut thickness and design do not seem to impact clinical outcomes.Clinical Trial RegistrationClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214.

Impact of early hospital discharge on clinical outcomes after transcatheter aortic valve implantation.

Early discharge after transcatheter aortic valve implantation (TAVI) may potentially impact post-procedural safety of the patient. The study aim was to compare safety of TAVI in patients planned for fast track hospital stay with patients planned for standard hospital stay. All-comers patients undergoing transfemoral TAVI between 2011 and 2017 were allocated to two matched groups depending whether the procedure was performed before or after transition from standard to fast track course. Data on vital status and hospitalizations were obtained through national registries. Three hundred and nineteen matched pairs were eligible for analysis. The median length of post-procedural stay was 3 days (IQR: 2-4) for patients in the fast track group compared to 6 days (IQR: 4-8) in the standard approach group (p < .0001). There was no difference in all-cause mortality between groups at 30-day (1.3% vs. 1.9%, p=.52) or 90-day follow-up (2.9% vs. 4.1%, p=.42). There was no difference in the risk of new permanent pacemaker implantation (PPI) in pacemaker naïve patients between groups at 30-day (15.8% vs. 21.2%, p=.16) or 90-day follow-up (15.8% vs. 21.9%, p=.12). There was no difference in the rate of rehospitalization between groups between discharge and 90-day follow-up (2.09 per patient-year vs. 2.09 per patient-year, p=.99). Early discharge in an all-comers population undergoing transfemoral TAVI is safe with regards to all-cause mortality, need for PPI, and rehospitalization.

Comparison of safety and effectiveness between the right and left radial artery approach in percutaneous coronary intervention

Introduction and objectivesThere is a paucity of data comparing the left radial approach (LRA) and right radial approach (RRA) for percutaneous coronary intervention (PCI) in all-comers populations and performed by operators with different experience levels. Thus, we sought to compare the safety and clinical outcomes of the RRA and LRA during PCI in “real-world” patients with either stable angina or acute coronary syndrome (ACS). MethodsTo overcome the possible impact of the nonrandomized design, a propensity score was calculated to compare the 2 radial approaches. The study group comprised 18 716 matched pairs with stable angina and 46 241 with ACS treated with PCI and stent implantation between 2014 and 2017 in 151 tertiary invasive cardiology centers in Poland (the ORPKI Polish National Registry). ResultsThe rates of death and periprocedural complications were similar for the RRA and LRA in stable angina patients. A higher radiation dose was observed with PCI via the LRA in both clinical presentations (stable angina: 1067.0±947.1 mGy vs 1007.4±983.5 mGy, P=.001; ACS: 1212.7±1005.5 mGy vs 1053.5±1029.7 mGy, P=.001). More contrast was used in LRA procedures but only in ACS patients (174.2±75.4mL vs 167.2±72.1mL, P=.001). Furthermore, periprocedural complications such as coronary artery dissection (0.16% vs 0.09%, P=.008), no-reflow phenomenon (0.65% vs 0.49%, P=.005), and puncture site bleeding (0.09% vs 0.05%, P=.04) were more frequently observed with the LRA in ACS patients. There was no difference in mortality between the 2 groups (P=.90). ConclusionsOur finding of poorer outcomes with the LRA may be related to lower operator experience with this approach. While both the LRA and RRA are safe in the setting of stable angina, the LRA was associated with a higher rate of periprocedural complications during PCI in ACS patients.

Bendamustine Followed By Obinutuzumab and Idelalisib in Patients with Chronic Lymphocytic Leukemia (CLL): CLL2-BCG Trial of the German CLL Study Group (GCLLSG)

Bendamustine Followed By Obinutuzumab and Idelalisib in Patients with Chronic Lymphocytic Leukemia (CLL): CLL2-BCG Trial of the German CLL Study Group (GCLLSG)

A prospective multicentre randomized all-comers trial to assess the safety and effectiveness of the ultra-thin-strut sirolimus-eluting coronary stent Supraflex: 2-year results of the TALENT trial

Abstract Background and purpose Supraflex is a sirolimus-eluting stent with a biodegradable polymeric coating and 60um ultra-thin struts. In the TALENT study, we found the Supraflex stent was non-inferior to the Xience stent for a device-oriented composite endpoint (DOCE, defined as cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation) at 12 months in an all-comer population. Additionally, per-protocol analysis showed a significantly lower clinically indicated target lesion revascularisation (CI-TLR) in the Supraflex group than in the Xience group. We now present the 2-year follow-up results. Methods The TALENT study was a prospective, randomised, single-blind, multicentre study across 23 centres in Europe. Eligible participants underwent percutaneous coronary intervention in an all-comers fashion in vessels of 2.25–4.5 mm. Patients were randomized (1:1) to implantation of either Supraflex or Xience (NCT02870140). Results Between October 21, 2016 and July 3, 2017, 720 patients with 1046 lesions were randomly assigned to Supraflex, and 715 patients with 1030 lesions to Xience. At 24 months, DOCE had occurred in 49 patients (6.9%) in the Supraflex group and in 56 patients (7.9%) in the Xience group (absolute difference −1.0% [95% CI: −3.7 to 1.7], Plog-rank=0.491). Per-protocol analysis at 24 months showed CI-TLR occurred in 21 and 30 patients in the Supraflex and Xience, respectively (3.3% versus 4.5%, absolute difference −1.2%, [95% CI: −3.3 to 0.9], Plog-rank=0.267). Conclusion In an all-comer population, at 2-year follow-up, the use of Supraflex stent was at least as safe and efficacious as Xience stent. However, the significantly lower rate of CI-TLR shown in patients treated with Supraflex at 1-year was no longer retained in the 2-year results. Whether theoretical advantage of ultra-thin strut drug eluting stents Supraflex can translate into clinical benefit or not will be further elucidated through a total of 3 years of follow-up. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): SMT

Bioresorbable scaffold versus drug coated balloon for treatment of in-stent-restenosis – long-term outcomes of the randomized ABSORB-ISR trial

Abstract Background Observational studies showed promising results after treatment of coronary instent-restenosis (ISR) using the everolimus-eluting bioresorbable vascular scaffold (BVS) Absorb®. Purpose We compared long-term outcomes after treatment of ISR with BVS versus the paclitaxel-eluting drug coated balloon (PE-DCB) SeQuent® Please, which is commonly used for treatment of ISR. Methods This was randomized-controlled trial of Absorb® BVS versus SeQuent® Please PE-DCB in an all-comers population with clinically relevant ISR. The patients were randomized in a 1:1 fashion. The angiographic primary endpoint was late lumen loss (LLL) at 9 months. Clinical follow-ups (FU) up to 48 months were conducted. Results Totally, 53 patients and lesions were enrolled. The mean age was 66.7±9.8 years, 23 (43.4%) had an acute coronary syndrome (ACS) and 16 (30.2%) were diabetic. PCI was successful in all patients. After 9 months, the mean LLL did not significantly differ between patients treated with BVS versus PE-DCB (median 0.41 (interquartile range (IQR) 0.15; 1.23)mm versus 0.27 (IQR 0.13; 0.66)mm, p=0.86). Moreover, mean lumen area on optical coherence tomography (OCT) did not significantly differ (median 5.47 (IQR 4.44; 7.69)mm2 versus 6.70 (IQR 5.00; 7.82)mm2, p=0.24). Rates of significant ISR (angiographic stenosis &amp;gt;70%) were similar with BVS versus PE-DCB (7 (30.4%) versus 6 (27.3%), p=0.81). The target vessel revascularization rates were 9 (33.3%) versus 9 (34.6%) using the BVS versus PE-DCB (p=0.72), also highlighted in the Figure below). No stent/ scaffold thrombosis occurred during FU. The study was prematurely stopped due to withdrawal of the Absorb® BVS in September 2017. Conclusions In this randomized pilot study, we found no significant difference in angiographic, OCT and clinical endpoints after treatment of ISR lesions using the Absorb BVS versus SeQuent® Please PE-DCB during long-term follow-up (≥48months). However, rates of target vessel revascularization were very high in both groups (&amp;gt;30%). TVR and TLF with BVS or PE-DCB for ISR Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott Vascular

Patients undergoing urgent trans-aortic valve implantation suffer from an increased mortality rate

Abstract Introduction Information on the outcome of urgent Transcatheter valve implantations (TAVI) is scarce, but available data suggest that it could be a reasonable option for the treatment of decompensated severe aortic valve stenosis. The prospects of an all-comer urgent population, however, are unknown. Here we report our experience with clinically indicated urgent TAVI implantation in an unselected patient population with severe aortic valve stenosis (AS). Purpose To compare the outcome of patients undergoing urgent or elective TAVI and to identify potential predictors of outcome. Methods A retrospective, single centre study of AS patients undergoing femoral or apical TAVI between 01. 01.2013 and 30.09.2018 was performed. Demographic information, medical history, clinical and procedural data were collected from the local electronic database. Urgent implantation was defined as accelerated, in-hospital patient preparation and urgent device placement following an acute admission. Survival was investigated with Kaplan-Meier survival analysis and log-rank test. Regression analysis was performed to identify possible predictors of mortality. Results During the study period TAVI was performed in 631 patients, of whom 53 (8.4%) underwent urgent TAVI. In the case of urgent procedures, the median admission-to-procedure time was 18 [10–29] days. Age, gender and the prevalence of diabetes mellitus, chronic obstructive lung disease (COPD) and a glomerular filtration rate of ≤30ml/min was comparable among the groups. Patients in the urgent group had a lower BMI (26 [23–28] vs. 27 [24–30]; p&amp;lt;0.05), had more frequently an ejection fraction &amp;lt;30% (30% vs 4%p&amp;lt;0.001) and a higher Euroscore II (5.3 [3.4–10.9]% vs 2.9 [1.7–4.5]%; p&amp;lt;0.001). The rate of apical implantation and post-operative stroke, pacemaker implantation and renal failure did not differ between the groups. Urgent patients, however, needed longer post-procedural hospitalization (6 [4–9] vs 4 [3–6] days; p&amp;lt;0.001) and had higher in-hospital (11.3% vs 3,1%; &amp;lt;0.001) and one-year mortality rates (28.3% vs 8.5%; p&amp;lt;0.001). Urgency was an independent predictor of overall one-year mortality (HR 3.0, p=0.001) and worsened the survival of the individuals who were discharged from the hospital (out-of-hospital mortality at one-year; HR 2.8, p=0.011), but had no effect on in-hospital mortality. In-hospital mortality was mainly determined by apical access (OR 3.1; p=0.016) and major post-operative stroke (OR 8.8.; p=0.006), with both worsening overall 1-year survival too (HR 1.8 for apical access and 4.8 for stroke; p&amp;lt;0.05). Mortality after a successful hospital discharge was increased not only by urgency (HR 2.8, p=0.011), but by COPD (HR 2.1; p=0.04) and prolonged post-operative hospitalization (HR 1.05/day; p=0.001) as well. Conclusion Stabilizing AS patients can mitigate the effect of urgency on peri-procedural survival. Urgency remains, however, an important determinant of one-year TAVI outcome. Funding Acknowledgement Type of funding source: None

Twenty-year trends in clinical outcome of randomized controlled trial for coronary intervention: systematic review and meta-regression analysis of 46 randomized controlled trials

Abstract Aim The technology of percutaneous coronary intervention (PCI) has been developed after the advent of coronary stent. However, the impact of the technological development on clinical outcomes is still unclear, whereas a remarkable improvement of clinical outcomes after PCI has not been observed in the trials comparing to medical therapy or coronary bypass graft. The current analysis aims to investigate trends in clinical outcomes after PCI after the emargence of coronary stent, using the randomized controlled trials (RCTs) comparing coronary stents. Methods and results We performed a systematic review of RCTs investigating coronary stents in non-specific population (excluding the trials particularly enrolling diabetic or myocardial infarction etc.) conducted between 1996 and 2015 (publication between 1997 and 2019) with independent clinical event adjudication. The random-effect meta-regression analysis including 90 arms with 94,831 patients in 46 RCTs was performed investigating the 20-year trends in clinical outcomes such as death, cardiac death, myocardial infarction, target lesion revascularization (TLR) and stent thrombosis at one and five years after the index procedure. The sensitivity analysis was performed by limiting to 20 all comer trials. In the meta-regression analysis, we did not observe significant change in the incidences of cardiac death and myocardial infarction after PCI over 20 years (P values for cardiac death: 0.666 at one year, 0.256 at five years and P values for myocardial infarction: 0.121 at one year, 0.376 at five years; R2 for cardiac death: &amp;lt;0.01 at one year and five years and R2 for myocardial infarction: &amp;lt;0.01 at one year and five years), whereas the incidences of clinically indicated TLR (P value &amp;lt;0.001, R2 = 0.40 at one year, P value = 0.002, R2 = 0.22 at five years) and stent thrombosis were decreased steeply in the first decade and slightly in the second decade (P value = 0.040, R2 = 0.09 at one year; P value = 0.017, R2 = 0.17 at five year). The sencitivity analysis limiting all-comer population revealed the consistent results. Conclusion The development of PCI had an impact on the 20-year trends in TLR and ST, despite there were no trends in the cardiac death and myocardial infarction. Trends in the incidence of the outcomes Funding Acknowledgement Type of funding source: None