Aims:Extensive coronary artery disease (CAD) coexisting with chronic total occlusion (CTO) is associated with adverse outcomes, yet patients with advanced CAD are often underrepresented in randomized trials, and the prognostic impact of CTO percutaneous coronary intervention (CTO-PCI) across different levels of anatomical complexity remains uncertain. We aimed to determine whether the overall CAD burden, quantified by the SYNTAX score (SS), influences the prognostic effect of CTO-PCI. Methods and results:A systematic search of PubMed, Embase, Google Scholar, and Cochrane databases was conducted. Eligible studies compared successful CTO-PCI vs. no CTO-PCI and reported the mean SYNTAX score of the cohort. Two reviewers independently extracted data. The primary endpoint was annualized cardiovascular (CV) mortality. Pooled hazard ratios (HRs) were calculated using fixed- or random-effects models with inverse-variance weighting. Meta-regression explored the relationship between SS and CV mortality, and subgroup analyses were performed according to predefined SS categories. Seventeen studies (3 randomized and 14 prospective observational; n = 11 001) were included. Successful CTO-PCI was associated with significantly lower CV mortality compared with non-revascularization (HR 0.54; 95% CI 0.46-0.64; P < 0.001). The prognostic benefit increased with CAD complexity, with HRs of 0.61, 0.44, and 0.10 across low (SS < 22), intermediate (SS 23-32), and high (SS > 33) strata, respectively (P-trend = 0.04). Meta-regression confirmed a CAD complexity-dependent effect (∼1.5% lower annual CV mortality per 10-point SS increase; P = 0.001). These findings apply to a PCI-selected population, as CABG-treated patients were not included. Conclusion:The survival benefit of CTO-PCI appears to increase with the extent of overall coronary disease, suggesting that patients with higher anatomical burden may derive greater prognostic benefit from successful CTO revascularization.

BACKGROUND:Long-term patency in complex chronic total occlusion percutaneous intervention (CTO-PCI) is often hindered by a high-risk of stent-failure (HR-SF), impacting prognosis. Drug-coated balloon (DCB) angioplasty may offer an alternative after successful crossing. We evaluated an invest-to-treat DCB strategy, determined by plaque modification results. METHODS:Patients with CTO wire-crossing and suboptimal lesion profile for stenting were enrolled at Campus Bio-Medico University Hospital of Rome (April-July 2024). After plaque preparation, results were classified as good, suboptimal, or poor based on residual stenosis and thrombolysis in myocardial infarction (TIMI) flow. Poor results received conventional stenting [drug-eluting stent (DES)]. Good results underwent a nine-month follow-up; suboptimal results underwent a three-month angiography. A "redo-DCB" approach was used for persistent suboptimal results within the invest-to-treat strategy. RESULTS:Of 32 CTO-PCIs performed, 29 completed the nine-month follow-up. 11 patients (38%) had poor outflow and required DES (DES-group). The other 18 patients (62%) were managed with DCB alone: six patients (21%) achieved good immediate results (DCB-group), and 12 (41%) were treated as "DCB-investment" due to suboptimal plaque modification (DCB-investment group). At the three-month follow-up, four patients (14%) showed improved angiographic results, while six (21%) had suboptimal outcomes and received redo-DCB after plaque modification; two (7%) of these required DES. At nine-months, 14 patients (48%) were successfully treated with a DCB-only approach. CONCLUSIONS:This prospective study demonstrates that a DCB strategy for CTO patients with HR-SF is feasible and safe. A DCB-only approach resulted in favorable early outcomes for most patients. In the case of suboptimal initial results, the redo-DCB strategy emerged as a promising alternative to extensive stenting.

Background Spontaneous coronary artery dissection (SCAD) is an under-recognized cause of acute coronary syndrome. Data regarding contemporary treatment outcomes remain limited, providing the rationale for the establishment of the SwissSCAD registry. Objectives The primary objective of the SwissSCAD registry, described in this manuscript, is to address contemporary characteristics, management and in-hospital major adverse cardiac events (MACE; defined as a composite of stroke/transient ischemic attack, reinfarction, repeat revascularization and in-hospital death) of patients presenting with SCAD in Switzerland. Methods We performed an investigator initiated, multicentre, retrospective and prospective observational study including patients with non-atherosclerotic SCAD in 8 centres in Switzerland. Institutional ethics approval and patient consents were obtained. We recorded baseline demographics, precipitating/predisposing conditions, angiographic features, as well as in-hospital treatment and MACE. Results From August 2020 to March 2024, 264 patients were enrolled. Mean age was 53.4±10.7 years, 85% were women. Cardiovascular risk factors included hypertension (31%), familial history of myocardial ischaemic disease (31%), hypercholesterolemia (25%), active smoking (23%), and diabetes mellitus (3%). Patients presented with STEMI in 35% and with NST-ACS in 59% of cases. Treatment was conservative in 96% of patients. Percutaneous coronary intervention was performed in 4% of patients, coronary artery bypass grafting was limited to 1 patient. In-hospital MACE occurred in 11% of patients with following distribution: stroke/transient ischemic attack (4%), re-infarction (3%), repeat revascularization (2%), in-hospital death (2%). Dual anti-platelet therapy was prescribed in 55% of patients at discharge. Conclusions Contemporary SCAD patients are treated almost exclusively conservatively. In-hospital MACE rates are sizable, though in-hospital mortality is low. ### Competing Interest Statement Sophie Degrauwe reports grants to the institution from Abbott and Biotronik. Marco Roffi reports research grants to the institution from Biotronik, Medtronic, Terumo, Cordis and Boston Scientific. Matthias Bossard reports speaker and consultant fees from Abbott Vascular, Abiomed, Amarin, Amgen, Astra Zeneca, Bayer, Biosensors S.A., Boehringer Ingelheim, Daichii, MedAlliance S.A., Mundipharma, Novartis, NovoNordisk, OM Pharma S.A., Sanofi S.A., SIS Medical and Vifor. Dik Heg is employed by the Department of Clinical Research (DCR), University of Bern, which has a staff policy of not accepting honoraria or consultancy fees. However, DCR is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. For an up-to-date list of our conflicts of interest see https://www.ctu.unibe.ch/research\_projects/declaration\_of\_interest/index\_eng.html Hans Rickli reports institutional research grants from Biotronik, Medtronic, Cordis and Boston Scientific. Gregor Fahrni, Marion Dupré, Stéphane Cook, Thomas Gillhofer, Christoph Kaiser, Franz Eberli and Daniel Weilenmann report no conflict of interest in connection with the submitted article. ### Clinical Trial The study was registered at ClinicalTrials.gov (NCT 04457544) ### Funding Statement Sophie Degrauwe reports grants to the institution from Abbott and Biotronik. Marco Roffi reports research grants to the institution from Biotronik, Medtronic, Terumo, Cordis and Boston Scientific. Matthias Bossard reports speaker and consultant fees from Abbott Vascular, Abiomed, Amarin, Amgen, Astra Zeneca, Bayer, Biosensors S.A., Boehringer Ingelheim, Daichii, MedAlliance S.A., Mundipharma, Novartis, NovoNordisk, OM Pharma S.A., Sanofi S.A., SIS Medical and Vifor. Dik Heg is employed by the Department of Clinical Research (DCR), University of Bern, which has a staff policy of not accepting honoraria or consultancy fees. However, DCR is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. For an up-to-date list of our conflicts of interest see https://www.ctu.unibe.ch/research\_projects/declaration\_of\_interest/index\_eng.html Hans Rickli reports institutional research grants from Biotronik, Medtronic, Cordis and Boston Scientific. Gregor Fahrni, Marion Dupré, Stéphane Cook, Thomas Gillhofer, Christoph Kaiser, Franz Eberli and Daniel Weilenmann report no conflict of interest in connection with the submitted article. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The central ethic committee was the Geneva Cantonal Commission on Research Ethics (CCER). The study was approved by the local research ethic committee in each participating centre. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data referred to in this manuscript will be made available to the Editor and reviewers if needed.

Abstract Aim Pleural effusion (PE) is a common chest radiography (CXR) finding in patients with advanced cardiac disease. The pathophysiology and clinical value of PE in this setting are incompletely defined. We aimed to assess the haemodynamic correlates and prognostic impact of PE in patients with severe aortic stenosis (AS). Methods and results We studied 471 patients (mean age 74 ± 10 years) with severe AS (indexed aortic valve area 0.42 ± 0.12 cm2/m2, left ventricular ejection fraction 58 ± 12%) undergoing right heart catheterization and upright CXR prior to aortic valve replacement (AVR). Two radiologist independently evaluated all CXR for the presence of bilateral PE, unilateral, or no PE, blinded to any other data. There were 49 (10%) patients with bilateral PE, 32 (7%) patients with unilateral PE, and 390 (83%) patients with no PE. Patients with bilateral PE had the highest mean right atrial pressure, mean pulmonary artery wedge pressure (mPAWP), and pulmonary vascular resistance, and had the lowest stroke volume index while those with unilateral PE had intermediate values. In the multivariate analysis, mPAWP was an independent predictor of any PE and bilateral PE. After a median (interquartile range) post‐AVR follow‐up of 1361 (957–1878) days mortality was highest in patients with bilateral PE (2.7 times higher than in patients without PE), whereas patients with unilateral PE had similar mortality as those without PE. Conclusions In severe AS patients, the presence of PE, particularly bilateral PE, is a marker of a poor haemodynamic constellation. Bilateral PE is associated with a substantially increased post‐AVR mortality.

BACKGROUND: There is an association between hyperthyroidism and pulmonary hypertension. However, the prevalence of pulmonary hypertension in hyperthyroidism and the underlying mechanisms are incompletely defined. METHODS: Consecutive patients with severe hyperthyroidism, mostly due to Graves disease, were included in this single-center study. Echocardiographic assessment of pulmonary hemodynamics was performed at the time of hyperthyroidism diagnosis (baseline) and after normalization of thyroid hormones (follow-up; median 11 months). In a subset of patients, right heart catheterization and noninvasive assessment of central hemodynamics was performed. RESULTS: Among all 99 patients, 31% had pulmonary hypertension at baseline. The estimated systolic pulmonary artery pressure correlated significantly with the estimated left ventricular filling pressure (E/e'). The invasively measured systolic pulmonary artery pressure correlated well with the estimated systolic pulmonary artery pressure. Cardiac output, E/e', left and right ventricular dimensions were significantly reduced from baseline to follow-up, whereas the estimated pulmonary vascular resistance did not differ. Diastolic blood pressure was significantly higher at follow-up, with no change in systolic blood pressure. The central systolic blood pressure, however, exhibited a trend for a reduction at follow-up, while the pulse wave velocity was significantly lower at follow-up. CONCLUSIONS: Approximately one-third of patients with hyperthyroidism have evidence of pulmonary hypertension. Our data suggest that an increased cardiac output and left ventricular filling pressure are the main mechanisms underlying the elevated systolic pulmonary artery pressure in hyperthyroidism, whereas there is no evidence of significant pulmonary vascular disease. (c) 2023 Elsevier Inc. All rights reserved. center dot The American Journal of Medicine (2024) 137:350-357

BACKGROUND:Gender-specific data addressing percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) in female patients are scarce and based on small sample size studies.AIMS:We aimed to analyze gender-differences regarding in-hospital clinical outcomes after CTO-PCI.METHODS:Data from 35,449 patients enrolled in the prospective European Registry of CTOs were analyzed. The primary outcome was the comparison of procedural success rate in the two cohorts (women vs. men), defined as a final residual stenosis less than 20%, with Thrombolysis In Myocardial Infarction grade flow = 3. In-hospital major adverse cardiac and cerebrovascular events (MACCEs) and procedural complications were deemed secondary outcomes.RESULTS:Women represented 15.2% of the entire study population. They were older and more likely to have hypertension, diabetes, and renal failure, with an overall lower J-CTO score. Women showed a higher procedural success rate (adjusted OR [aOR] = 1.115, confidence interval [CI]: 1.011-1.230, p = 0.030). Apart from previous myocardial infarction and surgical revascularization, no other significant gender differences were found among predictors of procedural success. Antegrade approach with true-to-true lumen techniques was more commonly used than retrograde approach in females. No gender differences were found regarding in-hospital MACCEs (0.9% vs. 0.9%, p = 0.766), although a higher rate of procedural complications was observed in women, such as coronary perforation (3.7% vs. 2.9%, p < 0.001) and vascular complications (1.0% vs. 0.6%, p < 0.001).CONCLUSIONS:Women are understudied in contemporary CTO-PCI practice. Female sex is associated with higher procedural success after CTO-PCI, yet no sex differences were found in terms of in-hospital MACCEs. Female sex was associated with a higher rate of procedural complications.

Background: The relationship between chest radiograph (CXR) findings of pulmonary congestion and invasive hemodynamics and clinical outcomes in patients with cardiac diseases is unclear. We assessed the correlation between a CXR-based congestion score (RxCS) and the mean pulmonary artery wedge pressure (mPAWP) and the prognostic impact of RxCS and mPAWP in severe aortic stenosis (AS).Methods: In 471 patients with severe AS undergoing right heart catheterization and upright CXR, the RxCS was calculated (6 items, maximum score: 10 points) independently by 2 radiologists (average value taken) blinded to clinical data. Congestion was defined as an RxCS > 1. Four patterns were defined based on the presence or absence of congestion (C+ or C-) and elevated (> 15 mm Hg) or normal mPAWP (P+ or P-).Results: The median (interquartile range) RxCS was 1 (0-2). Patients with an RxCS > 1 (n = 207) had a higher mean right atrial pressure, mean pulmonary artery pressure, mPAWP, and pulmonary vascular resistance than patients with an RxCS <= 1 (n = 264). However, the correlation between the RxCS and the mPAWP was moderate only (r = 0.45). Patients with a C+/P+ pattern had the worst hemodynamics, whereas C-/P- patients had the most favourable constellation. After a median post-valve replacement follow-up of 1361 days, mortality was higher in patients with RxCs > 1 vs <= 1 as well as mPAWP > 15 mm Hg vs <= 15 mm Hg. Mortality was highest in C+/P+ patients and lowest in C-/P- patients, whereas it was intermediate in C-/P+ and C+/P- patients.Conclusions: In AS patients, RxCS and mPAWP have a significant but moderate correlation. Both RxCS and mPAWP provide prognostic information.

Recent data have established non-inferiority of drug-coated balloons (DCB) compared to drug-eluting stents (DES) for treatment of small-vessel coronary artery disease. Since coronary vessels in women might have anatomical and pathophysiological particularities, the safety of the DCB strategy among women compared to men needs to be assessed in more detail. In BASKET-SMALL 2, patients with de novo lesions in coronary vessels < 3 mm and an indication for percutaneous coronary intervention were randomly allocated (1:1) to DCB vs. DES after successful lesion preparation. The primary objective of the randomized trial was to establish non-inferiority of DCB vs. DES regarding major adverse cardiac events (MACE; i.e., cardiac death, non-fatal myocardial infarction, and target vessel revascularization) after 12 months. The aim of the current sub-analysis is to evaluate whether the DCB strategy is equally safe among women and men after 12 and 36 months. Among 758 randomized patients, 382 were assigned to DCB (23 http://www.clinicaltrials.gov . Unique identifier: NCT01574534.

Background: We evaluated the outcome of PCI of de novo stenosis with drug-coated balloons (DCB) versus drug-eluting stents (DES) in patients with insulin-treated diabetes mellitus (ITDM) versus non-insulin-treated diabetes mellitus (NITDM). Methods: Patients were randomized in the BASKET-SMALL 2 trial to DCB or DES and followed over 3 years for MACE (cardiac death, non-fatal myocardial infarction [MI], and target vessel revascularization [TVR]). Outcome in the diabetic subgroup (n = 252) was analyzed with respect to ITDM or NITDM. Results: In NITDM patients (n = 157), rates of MACE (16.7% vs. 21.9%, hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.29–1.58, p = 0.37), death, non-fatal MI, and TVR (8.4% vs. 14.5%, HR 0.30, 95% CI 0.09–1.03, p = 0.057) were similar between DCB and DES. In ITDM patients (n = 95), rates of MACE (DCB 23.4% vs. DES 22.7%, HR 1.12, 95% CI 0.46–2.74, p = 0.81), death, non-fatal MI, and TVR (10.1% vs. 15.7%, HR 0.64, 95% CI 0.18–2.27, p = 0.49) were similar between DCB and DES. TVR was significantly lower with DCB versus DES in all diabetic patients (HR 0.41, 95% CI 0.18–0.95, p = 0.038). Conclusions: DCB compared to DES for treatment of de novo coronary lesions in diabetic patients was associated with similar rates of MACE and numerically lower need for TVR both for ITDM and NITDM patients.

Background A decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist‘s toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent restenosis and thrombosis, and shortened anti-platelet therapy. Recently, sirolimus-coated balloon catheters (SCB) have emerged to provide an alternative drug to combat restenosis. Methods The objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months. Discussion Since there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient. Trial registration number ClinicalTrials.gov Identifier: NCT04470934.

In aortic stenosis (AS), estimated glomerular filtration rate (eGFR) is an important prognostic marker but its haemodynamic determinants are unknown. We investigated the correlation between eGFR and invasive haemodynamics and long‐term mortality in AS patients undergoing aortic valve replacement (AVR).

Background Whether ultrathin-strut stents are particularly beneficial for lesions requiring implantation of more than 1 stent is unknown. Methods In a post-hoc lesion-level analysis of 2 randomized trials comparing ultrathin-strut biodegradable polymer Sirolimus-eluting stents (BP-SES) vs thin-strut durable polymer Everolimus-eluting stents (DP-EES), lesions were stratified into multistent lesions (MSL) vs single-stent lesions (SSL). The primary endpoint was target lesion failure (TLF), a composite of lesion-related unclear/cardiac death, myocardial infarction (MI), or revascularization, at 24 months.Results Among 5328 lesions in 3397 patients, 1492 (28%) were MSL (722 with BP-SES, 770 with DP-EES). At 2 years, TLF occurred in 63 lesions (8.9%) treated with BP-SES and 60 lesions (7.9%) treated with DP-EES in the MSL-group (subdistibution hazard ratio [SHR], 1.13; 95% CI, 0.77-1.64; P = .53), and in 121 (6.4%) and 136 (7.4%) lesions treated with BP-SES and DP-EES respectively (SHR, 0.86; 95% CI, 0.62-1.18; P = .35) in the SSL-group ( P for interaction = .241). While the rates of lesion-related MI or revascularization were significantly lower in SSL treated with BP-SES as compared to DP-EES (3.5% vs 5.2%; SHR, 0.67; 95% CI 0.46-0.97; P = .036), no significant difference was observed in MSL (7.1% vs 5.4%; SHR, 1.31; 95% CI 0.85-2.03; P = .216) with significant interaction between groups ( P for interaction = .014).Conclusions Rates of TLF are similar between ultrathin-strut BP-SES and thin-strut DP-EES in MSL and SSL. The use of ultrathin-strut BP-SES vs thin-strut DP-EES did not prove to be particularly beneficial for the treatment of multistent lesions.Trial registration Post-hoc analysis from the BIOSCIENCE (NCT01443104) and BIOSTEMI (NCT02579031) trials. (Am Heart J 2023;263:73-84.)

BACKGROUND:Biodegradable polymer sirolimus-eluting stents improve early stent-related clinical outcomes compared to durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The long-term advantages of biodegradable polymer sirolimus-eluting stents after complete degradation of its polymer coating in patients with STEMI remains however uncertain. METHODS:BIOSTEMI Extended Survival (BIOSTEMI ES) was an investigator-initiated, follow-up extension study of the BIOSTEMI prospective, multicentre, single-blind, randomised superiority trial that compared biodegradable polymer sirolimus-eluting stents with durable polymer everolimus-eluting stents in patients with STEMI undergoing primary percutaneous coronary intervention at ten hospitals in Switzerland. All individuals who had provided written informed consent for participation in the BIOSTEMI trial were eligible for this follow-up study. The primary endpoint was target lesion failure, defined as a composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target lesion revascularisation, at 5 years. Superiority of biodegradable polymer sirolimus-eluting stents over durable polymer everolimus-eluting stents was declared if the Bayesian posterior probability for a rate ratio (RR) of less than 1 was greater than 0·975. Analyses were performed according to the intention-to-treat principle. The study was registered with ClinicalTrials.gov, NCT05484310. FINDINGS:Between April 26, 2016, and March 9, 2018, 1300 patients with STEMI (1622 lesions) were randomly allocated in a 1:1 ratio to treatment with biodegradable polymer sirolimus-eluting stents (649 patients, 816 lesions) or durable polymer everolimus-eluting stents (651 patients, 806 lesions). At 5 years, the primary composite endpoint of target lesion failure occurred in 50 (8%) patients treated with biodegradable polymer sirolimus-eluting stents and in 72 (11%) patients treated with durable polymer everolimus-eluting stents (difference of -3%; RR 0·70, 95% Bayesian credible interval 0·51-0·95; Bayesian posterior probability for superiority 0·988). INTERPRETATION:In patients undergoing primary percutaneous coronary intervention for STEMI, biodegradable polymer sirolimus-eluting stents were superior to durable polymer everolimus-eluting stents with respect to target lesion failure at 5 years of follow-up. The difference was driven by a numerically lower risk for ischaemia-driven target lesion revascularisation. FUNDING:Biotronik.

Background: Thin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) have been shown to reduce target lesion failure (TLF) at one-year follow-up compared with durable polymer everolimus-eluting stents (DPEES) among patients with acute coronary syndrome (ACS). The long-term clinical benefits of thin-strut BP-SES over DP-EES in ACS patients after complete degradation of the polymer coating remain uncertain. Methods: We performed a post-hoc subgroup analysis of ACS patients included into the BIOSCIENCE randomized trial (NCT01443104). The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction or clinically indicated target lesion revascularization, at 5 years. Results: Among 2119 patients enrolled between March 2012 and May 2013, 1131 (53%) presented with ACS. The 5-year cumulative incidence of TLF was significantly lower in patients with ACS compared to chronic coronary syndrome [16.5% vs. 22.9%; rate ratio (RR), 0.69; 95% confidence interval (CI), 0.57-0.85; p < 0.001]. At 5 years, TLF occurred similarly in ACS patients treated with BP-SES and DP-EES (16.9% vs. 16.0%; RR, 1.04; 95% CI, 0.78-1.41; p = 0.78). The individual components of the primary endpoint did not differ between ACS patients treated with BP-SES or DP-EES at 5 years. Overall, there was no interaction between clinical presentation and treatment effect. Conclusions: In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term outcomes between ACS patients treated with BP-SES or DP-EES at 5 years. (c) 2021 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Although fascinating improvements in surgical, interventional and medical treatment of patients with coronary artery disease have been achieved, a growing number of patients present with refractory angina despite optimal treatment. Currently, different approaches are being investigated to reduce angina and to improve quality of life in these patients with “no options”. Slowing of coronary venous drainage by implantation of a stent device that reduces the diameter of the coronary sinus is a promising approach, as demonstrated by a recent phase II trial. In this report we document the first implantation of this novel device at our institution in Switzerland, give a stepwise description of the implantation procedure and discuss the currently available literature with regard to the physiology and clinical indications for the so-called (coronary sinus) Reducer™ device.

Background: Patients at high-bleeding risk (HBR) undergoing percutaneous coronary intervention represent a challenging patient population. The use of drug-coated balloon (DCB) allows shorter duration of dual antiplatelet therapy compared with drug-eluting stents (DES) and reduces thrombotic risk due to the absence of a permanent implant. The present analysis aimed to investigate if the effect of DCB versus DES differed between patients with and without HBR treated with percutaneous coronary intervention in small coronary arteries. Methods: This prespecified subgroup analysis of a multicenter, randomized, noninferiority trial included 758 patients with de novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention, randomized to DCB (n=382) or second-generation DES (n=376). Patients were followed over 3 years for major adverse cardiac events. Results: Of the 758 patients randomized, 155 (20%) had HBR; these patients had higher mortality at 3 years (hazard ratio [95% CI], 3.09 [1.78–5.36]; P<0.001). Rates of major bleeding events were overall low but tended to be lower after DCB versus DES (1.6% versus 3.7%; P=0.064), were similar in patients with HBR (4.5% versus 3.4%) but less frequent in DCB-versus DES-treated patients without HBR (0.9% versus 3.8%). There was no difference in major adverse cardiac events between DCB and DES regardless of bleeding risk (HBR, hazard ratio: 1.16 [0.51–2.62]; P=0.719 versus non-HBR, 0.96 [0.62–1.49]; P=0.863). Conclusions: DCBs were similarly safe and effective as current-generation DES in the treatment of coronary arteries <3 mm, regardless of bleeding risk. In patients treated with DCB, there was a trend towards a reduction of severe bleeding events at 3 years. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01574534.

Abstract Aims Blood pressure (BP) targets in patients with aortic stenosis (AS) are controversial. This study sought to describe the haemodynamic profile and the clinical outcome of severe AS patients with low versus high central meaarterial pressure (MAP). Methods and results Patients with severe AS (n = 477) underwent right and left heart catheterization prior to aortic valve replacement (AVR). The population was divided into MAP quartiles. The mean systolic BP, diastolic BP, and MAP in the entire population were 149 ± 25, 68 ± 11, and 98 ± 14 mmHg. Patients in the lowest MAP quartile had the lowest left ventricular ejection fraction (LVEF), systemic vascular resistance, and valvulo‐arterial impedance, whereas there were no significant differences in mean right atrial pressure, mean pulmonary artery wedge pressure, pulmonary vascular resistance, and stroke volume index across MAP quartiles. However, left ventricular stroke work index (LVSWI) was lowest in patients in the lowest and highest in those in the highest MAP quartile. After a median (interquartile range) post‐AVR follow‐up of 3.7 (2.6–5.2) years, mortality was highest in patients in the lowest MAP quartile [hazard ratio 3.08 (95% confidence interval 1.21–7.83); P = 0.02 for lowest versus highest quartile]. In the multivariate analysis, lower MAP [hazard ratio 0.78 (95% confidence interval 0.62–0.99) per 10 mmHg increase; P = 0.04], higher mean right atrial pressure and lower LVEF were independent predictors of death. Conclusions In severe AS patients, lower MAP reflects lower systemic vascular resistance and valvulo‐arterial impedance, which may help to preserve stroke volume and filling pressures despite reduced left ventricular performance, and lower MAP is a predictor of higher long‐term post‐AVR mortality.

Data on the safety and efficacy of drug-coated balloon (DCB) compared to drug-eluting stent (DES) in patients with chronic kidney disease (CKD) are scarce, particularly at long term. This pre-specified analysis aimed to investigate the 3-year efficacy and safety of DCB versus DES for small coronary artery disease (< 3 mm) according to renal function at baseline. BASKET-SMALL-2 was a large multi-center, randomized, controlled trial that tested the efficacy and safety of DCBs (n = 382) against DESs (n = 376) in small vessel disease. CKD was defined as eGFR < 60 ml/min/1.73m2. The primary endpoint was the composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization (MACE) during 3 years. A total of 174/758 (23%) patients had CKD, out of which 91 were randomized to DCB and 83 to DES implantation. The primary efficacy outcome during 3 years was similar in both, DCB and DES patients (HR 0.98; 95%-CI 0.67–1.44; p = 0.937) and patients with and without CKD (HR 1.18; 95%-CI 0.76–1.83; p = 0.462), respectively. Rates of cardiac death and all-cause death were significantly higher among patients with CKD but not affected by treatment with DCB or DES. Major bleeding events were lower in the DCB when compared to the DES group (12 vs. 3, HR 0.26; 95%-CI 0.07–0.92; p = 0.037) and not influenced by presence of CKD. The long-term efficacy and safety of DCB was similar in patients with and without CKD. The use of DCB was associated with significantly fewer major bleeding events (NCT 01574534).

BACKGROUND: Drug-coated balloons (DCBs) are an established treatment strategy for coronary artery disease. Randomized data on the application of DCBs in patients with an acute coronary syndrome (ACS) are limited. We evaluated the impact of clinical presentation (ACS versus chronic coronary syndrome) on clinical outcomes in patients undergoing DCB or drug-eluting stent (DES) treatment in a prespecified analysis of the BASKET-SMALL 2 trial (Basel Kosten Effektivitats Trial-Drug-Coated Balloons Versus Drug-Eluting Stents in Small Vessel Interventions). METHODS: BASKET-SMALL 2 randomized 758 patients with small vessel coronary artery disease to DCB or DES treatment and followed them for 3 years regarding major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target vessel revascularization). RESULTS: Among 758 patients, 214 patients (28.2%) presented with an ACS (15 patients [7%], ST-segment-elevation myocardial infarction; 109 patients [50.9%], non-ST-segment-elevation myocardial infarction; 90 patients [42.1%], unstable angina pectoris). At 1-year follow-up, there was no significant difference in the incidence of the primary end point by randomized treatment in patients with ACS (hazard ratio, 0.50 [ 95% CI, 0.19-1.26] for DCB versus DES) or chronic coronary syndrome (hazard ratio, 1.29 [95% CI, 0.67-2.47] for DCB versus DES). There was no significant interaction between clinical presentation and treatment effect (P for interaction, 0.088). For cardiac death (P for interaction, 0.049) and nonfatal myocardial infarction (P for interaction, 0.010), a significant interaction between clinical presentation and treatment was seen at 1 year with lower rates of these secondary end points in patients with ACS treated by DCB. At 3 years, there were similar major adverse cardiac event rates throughout groups without significant interaction between clinical presentation and treatment (P for interaction, 0.301). All-cause mortality was higher in ACS compared with chronic coronary syndrome; however, there was no difference between DCB and DES irrespective of clinical presentation. CONCLUSIONS: In this subgroup analysis of the BASKET-SMALL 2 trial, there was no interaction between indication for percutaneous coronary intervention (acute versus chronic coronary syndrome) and treatment effect of DCB versus DES in patients with small vessel coronary artery disease.