Long-term outcomes with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in ST-segment elevation myocardial infarction: 5-year follow-up of the BIOSTEMI randomised superiority trial.

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.

Proximal optimization technique and percutaneous coronary intervention for left main disease: POTENTIAL-LM.

BACKGROUND: Optimal stent deployment in left main (LM) bifurcation is paramount, and incomplete stent apposition may cause major adverse cardiac events (MACE). Bench studies show that the proximal optimization technique (POT) provides the best stent apposition. AIMS: We aimed to investigate the impact of POT on clinical outcomes in patients treated for unprotected LM (ULM) disease at our institution. METHODS: We identified 162 patients who underwent percutaneous coronary intervention (PCI) for ULM coronary disease in the Cardio-FR database. Out of these, 99 (61%) had undergone POT, while 63 patients were treated without POT. The primary outcome was the bifurcation-oriented composite endpoint (BOCE) of cardiac death, target-bifurcation myocardial infarction and target-bifurcation revascularization at maximal follow-up. RESULTS: Mean age was 76 years, and 69% presented with acute coronary syndrome. Mean follow-up was 2.25 years (822 days). The BOCE occurred in 43 (27%) of which 20 (20%) in the POT group and 23 (37%) in the no-POT group (p = 0.009). Cardiac death occurred in 15 (15%) patients in the POT- and 17 (27%) in no-POT group (p = 0.26). Target bifurcation revascularization occurred in 4 (4%) patients in the POT- and 6 (10%) patients in the no-POT group (p = 0.19). POT In the multivariate analysis, POT was the strongest parameter and was associated with BOCE, cardiac death, occurrence of any revascularization and all-cause mortality. CONCLUSION: The POT improves clinical outcomes. These findings strongly support the systematic use of POT in patients undergoing ULM-PCI.

Clinical outcomes after unprotected left main coronary artery occlusion: A retrospective multicentre cohort analysis.

AIMS: Unprotected left main coronary artery (ULMCA) occlusion is a rare and disastrous condition with scarce data on presentation and outcomes. Herein, we report data on patients presenting with acute coronary syndrome due to ULMCA occlusion at four different institutions. METHODS: This is an international multicentre observational study. Baseline characteristics were retro- and prospectively collected. Clinical follow-up was prospective. The primary outcome was in-hospital death. Patients surviving the index hospitalization were compared with nonsurvivors to find predictors of survival. RESULTS: The study population consisted of 55 patients. Eight patients (15%) died in the cath lab, and 23 (42%) died in hospital. Three (6%) deaths were noncardiac and due to major bleeding. Thirty-two (58%) patients survived the index hospitalization and were discharged. These patients were followed for a median of 17.5 months during which three cardiac deaths occurred. Repeat revascularization was performed in 25% (n = 8). Overall mortality at maximum follow-up was 47% (n = 26). The only significant predictor for hospital survival was left ventricular ejection fraction (odds ratio [OR]: 1.10 (per 1 point increase); 95% confidence interval [CI]: 1.02-1.19; p = 0.02). CONCLUSION: ULMCA occlusion carries a high short-term mortality. Patients who survive index hospitalization have similar mortality rates as compared with other st elevation myocardial infarction patients.

[Cardiac tumors in clinical practice]. / Les tumeurs cardiaques.

Cardiac tumors are rare in clinical practice but remain an essential part of the fast-growing field of cardio-oncology. They can be detected incidentally and consist of primary tumors (benign or malignant) and of the more prevalent secondary tumors (metastasis). They form a heterogeneous group of pathologies presenting with a wide panel of clinical symptoms according to their location and size. Multimodality cardiac imaging (echocardiography, CT, MRI and PET), in association with clinical and epidemiological factors, plays a key role in the diagnosis of cardiac tumors and a biopsy is therefore not systematically required. Treatment strategies for cardiac tumors vary depending on the malignancy and class of the tumor, but also consider associated symptoms, hemodynamic impact and embolic risk.

Les tumeurs cardiaques sont des pathologies rares mais elles ­appartiennent à un domaine en plein essor de la cardio-oncologie. Souvent découvertes fortuitement, elles comprennent les ­tumeurs cardiaques primaires (bénignes ou malignes) et, plus fréquemment, secondaires (métastases). Elles constituent un ­ensemble très hétérogène de pathologies, dont les manifestations cliniques varient en fonction de la taille et de la localisation. Le diagnostic repose sur une approche clinique, épidémiologique et plusieurs modalités d'imagerie (échocardiographie, CT, IRM et PET-CT), sans nécessité systématique de biopsie. La stratégie de traitement d'une tumeur cardiaque dépend de la symptomatologie du patient, du risque embolique ou hémodynamique lié à la masse, ainsi que de sa malignité.

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.

Five-year angiographic, OCT and clinical outcomes of a randomized comparison of everolimus and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds.

AIMS: To compare 5-year angiographic, optical coherence tomography (OCT), and clinical outcomes between patients treated with bioresorbable vascular scaffolds (BVS) and drug-eluting stents (DES). METHODS: The EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) was a single-center, assessor-blinded, randomized controlled trial in which 240 patients were randomly allocated (1:1:1) to BVS, everolimus-eluting (EES) or biolimus-eluting (BES) DES. Clinical follow-up was scheduled up to 5 years. All patients, alive and who did not have repeat revascularization of the target lesion during follow-up were asked to return for angiographic follow-up at 5 years. RESULTS: Five-year angiographic follow-up was completed in 122 patients (51%) and OCT analysis was performed in 86 (36%) patients. In-stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20. Clinical follow-up was complete in 232 patients (97%) at 5 years. The rate of the device-oriented endpoint was 22% in the BVS and 18% in the EES/BES group (p = 0.49). The patient-oriented composite endpoint occurred in 40% of BVS- and 43% of EES/BES-treated patients (p = 0.72) at 5 years. No acute coronary syndrome due to stent thrombosis was detected after 2 years. Complete BVS strut resorption was observed at 5 years in the OCT subgroup. CONCLUSION: Five-year clinical outcomes were similar between BVS and DES patients as well as angiographic outcomes in a selected subgroup. However, a definitive conclusion cannot be drawn because the EverBio-2 trial was not powered for clinical and angiographic endpoints at 5 years of follow-up.

Left atrial appendage closure with the II generation Ultraseal device: An international registry. The LIGATE study.

OBJECTIVES: To assess feasibility and safety of second-generation left atrial appendage closure (LAAC) Ultraseal device in patients with nonvalvular atrial fibrillation (NVAF). BACKGROUND: LAAC with first-generation Ultraseal device (Cardia, Eagan, Minnesota) has been shown to be a feasible therapeutic option in patients with NVAF. However, there is a paucity of data regarding the novel second-generation Ultraseal device. METHODS: All patients with NVAF undergoing second-generation Ultraseal device implantation between February 2018 and September 2020 were included in a multicenter international registry. Periprocedural and post-discharge events were collected through 6-month follow-up. Co-primary efficacy endpoints were device success and technical success while primary safety endpoint was in-hospital major adverse event (MAE) occurrence. RESULTS: A total of 52 patients were included: mean age 75 ± 8, 30.8% women, mean HAS-BLED 3 ± 1. The device was successfully implanted in all patients. Technical success was achieved in 50 patients (96.1%). In-hospital MAEs occurred in three patients (5.8%). The incidence of 6-month all-cause death and major bleeding was 11.6% and 2.1%, respectively. No strokes, transient ischemic attacks, systemic embolisms, or device embolization were reported after discharge. CONCLUSIONS: Second-generation Ultraseal device implantation was associated with high success rates and a low incidence of peri-procedural complications. Larger studies with longer follow-up are warranted to further evaluate the safety and the efficacy of this device, especially at long-term follow-up.

Treating Femoral Artery Pseudoaneurysm by Tumescence Anesthesia and Echo-Guided Compression Technique (TACT): Clinical Outcome in 82 Consecutive Patients.

PURPOSE: Pseudoaneurysm (PA) of the access artery is a common and potentially severe complication after percutaneous endovascular interventions. Most PA require interventional therapy, including thrombin injection, covered stent implantation, or surgical repair, which are costly and associated with other complications. Treating PA by external compression is uncomfortable and time consuming, with a low success rate. By injecting local tumescence anesthesia around the PA and close to its neck, the tumescence anesthesia and echo-guided compression technique (TACT) aims to improve efficacy and patient's comfort. MATERIALS AND METHODS: We retrospectively reviewed all consecutive patients treated for femoral PA in our center from May 2009 to July 2019 and estimated efficacy and safety. Vascular specialists performed TACT according to a standardized protocol including ultrasound-guided injection of tumescence solution (45 ml of 0.9% saline, 15 ml of lidocaine 1%/epinephrine 5 µg/ml) in the soft tissue around the PA and its neck, local compression with the sonography probe until PA closure, and external compression by elastic belt for 3 hours. RESULTS: Among a total of 125 patients with femoral artery PA, 82 (65.6%) were treated by TACT (including 3 patients with haemorrhagic shock), 14 (11.2%) by thrombin injection; 12 (9.6%) by endovascular interventions; 8 (6.4%) by open surgery; and 9 (7.2%) conservatively. In patients treated by TACT, PA neck was short (<1 cm) in 51.8% and mean cavity diameter 30 ± 23 mm. After injection of 58 ± 8 ml of tumescence solution, mean time of echo-guided compression was 12 ± 8 minutes. Pseudoaneurysm was successfully closed in 92.7% after the first attempt and in 96.3% after the second attempt. The intervention was well tolerated, without any adverse event. CONCLUSION: Tumescence anesthesia and echo-guided compression technique (TACT) is an effective and safe treatment for PA. Compared to other therapies, TACT is minimally invasive and widely available for minimal costs, even for large PA and in unstable patients. CLINICAL IMPACT: Tumescence anesthesia and echo-guided compression technique seems to be an efficient, safe, and a fair economical choice in comparison with alternative techniques. The implementation of this procedure is simple with low risk of complications. Based on the results of this study, we believe that TACT should be considered as the first-line treatment of most iatrogenic PA.

[Wellens Syndrome: A rare entity not to be neglected]. / Syndrome de Wellens : une entité rare à ne pas méconnaître.

Wellens syndrome is a particular presentation of acute coronary syndrome which manifests, in a patient most often asymptomatic at the time of the examination, by specific electrocardiographic signs, in particular T waves in the precordial leads V2 and V3. The absence of chest pain at the time of the examination and the normality of cardiac enzymes can be falsely reassuring and constitute diagnostic pitfalls. This syndrome is associated with an often critical stenosis of the IVA (anterior descending artery). A good reading of the ECG is mandatory for the diagnosis. The management is done in interventional cardiology in order to avoid a massive anterior infarction.

Le syndrome de Wellens est une présentation particulière de syndrome coronarien aigu qui se manifeste chez un patient le plus souvent asymptomatique au moment de l'examen, par des signes électrocardiographiques spécifiques, notamment des ondes T dans les dérivations précordiales V2 et V3. L'absence de douleur thoracique et la normalité des enzymes cardiaques peuvent être faussement rassurantes et constituer des pièges diagnostiques. Ce syndrome est associé à une sténose souvent critique de l'IVA (artère interventriculaire antérieure). Une bonne lecture de l'ECG permet d'en faire le diagnostic. La prise en charge se fait en cardiologie interventionnelle afin d'éviter un infarctus antérieur massif.

Future culprit detection based on angiography-derived FFR.

OBJECTIVES: We sought to characterize the hemodynamic impact of mild coronary artery disease (CAD) using quantitative flow ratio (QFR, an angiography-derived fractional flow reserve [FFR]) in a population of patients with only non-significant CAD at baseline that subsequently experienced a myocardial infarction (MI). BACKGROUND: The discriminatory value of FFR in patients with mild CAD remains imperfect. METHODS: We retrospectively included patients who underwent invasive coronary angiography for an MI, in whom another angiogram had been performed within the previous 5 years. Three-dimensional quantitative coronary angiography, QFR, and lesion length analysis were conducted on lesions responsible for the MI (future culprit lesions, [FCL]) as well as on control lesions (non-culprit lesions, [NCL]). RESULTS: Eighty-three FCL and 117 NCL were analyzed in 83 patients: FCL were more severe (median % diameter of stenosis [DS] 39.1% [29.8; 45.7] vs. 29.8% [25.0; 37.2], p < .001), had lower QFR values (0.94 [0.86; 0.98] vs. 0.98 [0.96; 1.00], p < .001) and tended to be longer (15.2 mm [10.0; 27.3] vs. 12.7 mm [9.3; 22.4], p = .070) than NCL. In lesions with an interval < 2 years between baseline angiography and MI, the difference in QFR was more pronounced compared to the lesions with a longer interval (FCL: 0.92 [0.85; 0.97] vs. NCL: 0.98 [0.94; 1.00], p < .001 and FCL: 0.96 [0.88; 1.00] vs. NCL: 0.98 [0.96;1.00], p = .006 respectively) CONCLUSION: Mild coronary stenoses that are subsequently responsible for an MI (FCL) exhibit a higher DS and lower QFR years before the event. Furthermore, FCL with a lower QFR at baseline appear to lead earlier to MI.

Two-year outcomes after percutaneous coronary intervention with drug-eluting stents or bare-metal stents in elderly patients with coronary artery disease.

OBJECTIVES: Report the results at 2 years of the patients included in the SENIOR trial. BACKGROUND: Patients above 75 years of age represent a fast-growing population in the cathlab. In the SENIOR trial, patients treated by percutaneous coronary intervention (PCI) with drug eluting stent (DES) and a short duration of P2Y12 inhibitor (1 and 6 months for stable and unstable coronary syndromes, respectively) compared with bare metal stents (BMS) was associated with a 29% reduction in the rate of all-cause mortality, myocardial infarction (MI), stroke, and ischaemia-driven target lesion revascularization (ID-TLR) at 1 year. The results at 2 years are reported here. METHODS AND RESULTS: We randomly assigned 1,200 patients (596[50%] to the DES group and 604[50%] to the BMS group). At 2 years, the composite endpoint of all-cause mortality, MI, stroke and ID-TLR had occurred in 116 (20%) patients in the DES group and 131 (22%) patients in the BMS group (RR 0.90 [95%CI 0.72-1.13], p = .37). IDTLR occurred in 14 (2%) patients in the DES group and 41 (7%) patients in the BMS group (RR 0.35 [95%CI 0.16-0.60], p = .0002). Major bleedings (BARC 3-5) occurred in 27(5%) patients in both groups (RR 1.00, [95%CI 0.58-1.75], p = .99). Stent thrombosis rates were low and similar between DES and BMS (0.8 vs 1.3%, (RR 0.52 [95%CI 0.01-1.95], p = .27). CONCLUSION: Among elderly PCI patients, a strategy combining a DES together with a short duration of DAPT is associated with a reduction in revascularization up to 2 years compared with BMS with very few late events and without any increased in bleeding complications or stent thrombosis.

Mapping interventional cardiology in Europe: the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Atlas Project.

AIMS: The European Association of Percutaneous Cardiovascular Interventions (EAPCI) Atlas of Interventional Cardiology has been developed to map interventional practice across European Society of Cardiology (ESC) member countries. Here we present the main findings of a 16-country survey in which we examine the national availability of interventional infrastructure, human resource, and procedure volumes. METHODS AND RESULTS: Sixteen ESC member countries participated in the EAPCI Atlas survey. Interventional data were collected by the National Cardiac Society of each participating country. An annual median of 5131 [interquartile range (IQR) 4013-5801] diagnostic heart procedures per million people were reported, ranging from <2500 in Egypt and Romania to >7000 in Turkey and Germany. Procedure rates showed significant correlation (r = 0.67, P = 0.013) with gross national income (GNI) per capita. An annual median of 2478 (IQR 1690-2633) percutaneous coronary interventions (PCIs) per million people were reported, ranging from <1000 in Egypt and Romania to >3000 in Switzerland, Poland, and Germany. Procedure rates showed significant correlation with GNI per capita (r = 0.62, P = 0.014). An annual median of 48.2 (IQR 29.1-105.2) transcatheter aortic valve implantation procedures per million people were performed, varying from <25 per million people in Egypt, Romania, Turkey, and Poland to >100 per million people in Denmark, France, Switzerland, and Germany. Procedure rates showed significant correlation with national GNI per capita (r = 0.92, P < 0.001). CONCLUSION: The first report from the EAPCI Atlas has shown considerable international heterogeneity in interventional cardiology procedure volumes. The heterogeneity showed association with national economic resource, a reflection no doubt of the technological costs of developing an interventional cardiology service.

[COVID-19 and myocardial injury]. / Covid-19 et atteintes myocardiques.

SARS-CoV-2 affects the cardiovascular system triggering a proinflammatory response which results in direct and indirect myocardial injury. The objective of this article is to describe the underlying mechanisms and clinical implications.

Le système cardiovasculaire est largement affecté par le coronavirus SARS-CoV-2. La maladie à coronavirus 2019 (Covid-19) peut déclencher une réaction inflammatoire intense, responsable de lésions myocardiques directes et indirectes chez environ un quart des patients hospitalisés. L'objectif de cet article est de décrire les mécanismes sous-jacents aux atteintes cardiovasculaires et de discuter les potentielles implications cliniques.

Resolute zotarolimus-eluting stent in ST-elevation myocardial infarction (resolute-STEMI): A prespecified prospective register from the DAPT-STEMI trial.

OBJECTIVES: To evaluate the safety and efficacy outcomes after primary percutaneous coronary intervention (pPCI) with second-generation Resolute™ zotarolimus-eluting stent (R-ZES) in patients enrolled in the DAPT-STEMI Trial (NCT01459627). BACKGROUND: R-ZES is one of the most used drug eluting stents worldwide. To date, the safety and efficacy data of this stent in setting of STEMI is limited. METHODS: The Resolute-STEMI is a prespecified prospective register that reports the safety and efficacy of R-ZES in setting of ST-Elevation Myocardial Infarction (STEMI) at 6 months for the following endpoints: a composite endpoint of all-cause mortality, any myocardial infarction (MI), any (unscheduled) revascularization, stroke and TIMI major bleeding, as well as target lesion failure and stent thrombosis (ST). RESULTS: From a total of 1,100 STEMI patients enrolled in the trial, 998 received a R-ZES. At 6 months the PE occurred in 42 (4.2%) patients. All-cause death, MI, revascularization, stroke and TIMI major bleeding was respectively 8 (0.8%), 9 (0.8%), 34 (3.4%), 2 (0.2%), and 4 (0.4%). The rate of target lesion revascularizations involving the culprit lesion was 1.1%. Target lesion failure was 1.5%. The rate of definite ST was 0.5%. The rate of both definite or probable ST was 0.7%. CONCLUSIONS: The present analysis is the largest to date reporting short-term and mid-term clinical outcomes with the R-ZES stent in setting of STEMI. At 30 days and 6-months R-ZES has an outstanding safety and efficacy even in this high-risk category of patients.

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.

Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial.

BACKGROUND: Elderly patients regularly receive bare-metal stents (BMS) instead of drug-eluting stents (DES) to shorten the duration of double antiplatelet therapy (DAPT). The aim of this study was to compare outcomes between these two types of stents with a short duration of DAPT in such patients. METHODS: In this randomised single-blind trial, we recruited patients from 44 centres in nine countries. Patients were eligible if they were aged 75 years or older; had stable angina, silent ischaemia, or an acute coronary syndrome; and had at least one coronary artery with a stenosis of at least 70% (≥50% for the left main stem) deemed eligible for percutaneous coronary intervention (PCI). Exclusion criteria were indication for myocardial revascularisation by coronary artery bypass grafting; inability to tolerate, obtain, or comply with DAPT; requirement for additional surgery; non-cardiac comorbidities with a life expectancy of less than 1 year; previous haemorrhagic stroke; allergy to aspirin or P2Y12 inhibitors; contraindication to P2Y12 inhibitors; and silent ischaemia of less than 10% of the left myocardium with a fractional flow reserve of 0·80 or higher. After the intended duration of DAPT was recorded (1 month for patients with stable presentation and 6 months for those with unstable presentation), patients were randomly allocated (1:1) by a central computer system (blocking used with randomly selected block sizes [two, four, eight, or 16]; stratified by site and antiplatelet agent) to either a DES or similar BMS in a single-blind fashion (ie, patients were masked), but those assessing outcomes were masked. The primary outcome was to compare major adverse cardiac and cerebrovascular events (ie, a composite of all-cause mortality, myocardial infarction, stroke, or ischaemia-driven target lesion revascularisation) between groups at 1 year in the intention-to-treat population, assessed at 30 days, 180 days, and 1 year. This trial is registered with ClinicalTrials.gov, number NCT02099617. FINDINGS: Between May 21, 2014, and April 16, 2016, we randomly assigned 1200 patients (596 [50%] to the DES group and 604 [50%] to the BMS group). The primary endpoint occurred in 68 (12%) patients in the DES group and 98 (16%) in the BMS group (relative risk [RR] 0·71 [95% CI 0·52-0·94]; p=0·02). Bleeding complications (26 [5%] in the DES group vs 29 [5%] in the BMS group; RR 0·90 [0·51-1·54]; p=0·68) and stent thrombosis (three [1%] vs eight [1%]; RR 0·38 [0·00-1·48]; p=0·13) at 1 year were infrequent in both groups. INTERPRETATION: Among elderly patients who have PCI, a DES and a short duration of DAPT are better than BMS and a similar duration of DAPT with respect to the occurrence of all-cause mortality, myocardial infarction, stroke, and ischaemia-driven target lesion revascularisation. A strategy of combination of a DES to reduce the risk of subsequent repeat revascularisations with a short BMS-like DAPT regimen to reduce the risk of bleeding event is an attractive option for elderly patients who have PCI. FUNDING: Boston Scientific.

Efficacy of the SEPARPROCATH® radiation drape to reduce radiation exposure during cardiac catheterization: A pilot comparative study.

BACKGROUND: Interventional cardiologists are exposed to radiation-induced diseases, partly due to patient's scatter radiation. OBJECTIVES: We sought to compare the radiation exposure (RE) of the cardiac catheterization room staff using SEPARPROCATH®, a novel radio-protective drape versus standard shielding equipment. METHODS: This was a two-step prospective, randomized pilot trial: first, in experimental conditions using a phantom model, and second, during cardiac catheterization. Primary end-point was operator RE corresponding to the ratio between operator cumulative dose (CD) and dose area product (DAP). Secondary end-points were nurse RE, operator and nurse CD, DAP, and fluoroscopy time. RESULTS: A total of 51 patients were included. SEPARPROCATH® was associated with a lower operator RE (0.07 [0-0.19] vs. 0.37 [0.23-0.81] µSv/Gy.cm2 without SEPARPROCATH®, p value <0.0001) and lower nurse RE (0 [0-0.05] vs. 0.13 [0.03-0.28] µSv/Gy.cm2 , p value <0.0001) corresponding to an RE relative risk reduction of 81% and 99%, respectively. Similar reductions were observed for operator and nurse CDs. No difference was found in DAP (19 [11-29] vs. 14 [10-32] Gy.cm2 without SEPARPROCATH®, p value 0.81). CONCLUSION: SEPARPROCATH® offers significant additional radioprotection to the operator and nurse during cardiac catheterization without affecting patient safety.

Cost-Effectiveness of Drug-Eluting Stents in Elderly Patients With Coronary Artery Disease: The SENIOR Trial.

BACKGROUND: Elderly patients receive bare metal stents instead of drug-eluting stents (DES) to shorten the duration of dual antiplatelet therapy (DAPT). The SENIOR trial compared outcomes between these 2 types of stents combined with a short duration of DAPT. A significant decrease in the number of patients with at least 1 major adverse cardiac and cerebrovascular event (MACCE) was noted in the DES group. OBJECTIVES: The objective of this article was to perform an economic evaluation of the SENIOR trial. METHODS: This evaluation was performed separately in 5 participating countries using pooled patient-level data from all study patients and country-specific unit costs and utility values. Costs, MACCEs, and quality-adjusted life-years (QALYs) were calculated in both arms at 1 year, and an incremental cost-effectiveness ratio was estimated. Uncertainty was explored by probabilistic bootstrapping. RESULTS: A total of 1200 patients underwent randomization. The average total cost per patient was higher in the DES group. The number of MACCEs and average QALYs were not statistically different between the 2 groups. The 1-year incremental cost-effectiveness ratio for each country of reference ranged from €13 752 to €20 511/MACCE avoided and from €42 835 to €68 231/QALY gained. The scatter plots found a wide dispersion, reflecting a large uncertainty surrounding the results. But in each country studied, 90% of the bootstrap replications indicated a higher cost for greater effectiveness for the DES group. Assuming a willingness to pay of €50 000/QALY, there was between a 40% and 50% chance that the use of DES was cost-effective in 4 countries. CONCLUSION: The use of DES instead of bare metal stents combined with a short duration of DAPT in elderly patients induced higher cost for greater effectiveness in each of the 5 countries studied.

Leadless pacing using the transcatheter pacing system (Micra TPS) in the real world: initial Swiss experience from the Romandie region.

AIMS: Leadless pacemakers are implanted in Switzerland since June 2015. Large worldwide registries have shown high implant success, low complication rates, and good electrical parameters up to 12 months' follow-up. However, data are scarce outside the investigational setting. The purpose of this study is to assess the real-world experience regarding clinical safety and efficacy of Micra TPS (transcatheter pacing system) leadless pacemakers. METHODS AND RESULTS: Retrospective observational, multi-centre study designed to assess initial safety and efficacy of the Micra TPS in the Swiss Romande region. A total of 92 patients were included from four different centres with an implantation success rate of 97.8% (90 of 92). Thresholds were overall low at implantation (median 0.38 V/0.24 ms, ranging from 0.13 to 2.88 V/0.24 ms) and remained stable over 1-year follow-up. The perioperative serious adverse event rate was 6.5% in six patients which lead to prolonged hospitalization in five patients and death in one patient. In addition, three further major events (3.3%) occurred during an average follow-up of 1 year, requiring implantation of a standard transvenous pacemaker in two patients, and surgical explantation of the Micra TPS in one patient due to intractable ventricular tachycardia. CONCLUSION: Leadless pacemakers are a valuable adjunct for treating selected patients requiring single-chamber pacing. However, in this initial experience, major complication rates were high (9.8%). The implant procedure requires proper training and should be performed in an adequate setting.

Myocardial infarction stabilization by cell-based expression of controlled Vascular Endothelial Growth Factor levels.

Vascular Endothelial Growth Factor (VEGF) can induce normal or aberrant angiogenesis depending on the amount secreted in the microenvironment around each cell. Towards a possible clinical translation, we developed a Fluorescence Activated Cell Sorting (FACS)-based technique to rapidly purify transduced progenitors that homogeneously express a desired specific VEGF level from heterogeneous primary populations. Here, we sought to induce safe and functional angiogenesis in ischaemic myocardium by cell-based expression of controlled VEGF levels. Human adipose stromal cells (ASC) were transduced with retroviral vectors and FACS purified to generate two populations producing similar total VEGF doses, but with different distributions: one with cells homogeneously producing a specific VEGF level (SPEC), and one with cells heterogeneously producing widespread VEGF levels (ALL), but with an average similar to that of the SPEC population. A total of 70 nude rats underwent myocardial infarction by coronary artery ligation and 2 weeks later VEGF-expressing or control cells, or saline were injected at the infarction border. Four weeks later, ventricular ejection fraction was significantly worsened with all treatments except for SPEC cells. Further, only SPEC cells significantly increased the density of homogeneously normal and mature microvascular networks. This was accompanied by a positive remodelling effect, with significantly reduced fibrosis in the infarcted area. We conclude that controlled homogeneous VEGF delivery by FACS-purified transduced ASC is a promising strategy to achieve safe and functional angiogenesis in myocardial ischaemia.