Exercise-based real-time telerehabilitation for older patients recently discharged after transcatheter aortic valve implantation: An extended feasibility study.

OBJECTIVES: To assess the extended feasibility of a telerehabilitation program and its effects on physical performance in older adults who have recently undergone transcatheter aortic valve implantation (TAVI). METHODS: In this single-center feasibility study, patients underwent an eight-week telerehabilitation program, involving web-based home exercise training twice weekly, an activity tracker, access to an informative website, and one online session with a nurse, starting one-week postoperative. Data collection was performed before surgery and three months postoperative. The feasibility of the intervention was based on recruitment and adherence to the program. As a secondary outcome, we evaluated the change in six-minute walk distance from before surgery to three months postoperative. RESULTS: Forty-one patients scheduled for TAVI were assessed for eligibility; 15 patients (37%) were enrolled. Of these, eight were excluded after surgery due to tiredness (n = 2), non-cardiac related hospital readmission (n = 2), fluctuating health (n = 1), death during hospital stay (n = 1), and reduced cognition (n = 2). Seven patients completed the eight-week web-based intervention and were evaluated three months postoperative. Their median (IQR) age was 83 [81, 87] years, and the sample comprised three men and four women. Their walked distance improved from median (IQR) 262 [199, 463] before surgery, to 381 [267, 521] meters three months postoperative. No adverse events were reported. CONCLUSION: Web-based telerehabilitation, including supervised exercise training, in older adults who have recently undergone TAVI was feasible for a small number of patients who completed the eight-week intervention. This was reflected in an improvement in their walked distance three months after the surgery. However, the low recruitment and retention rates do question the overall feasibility of this intervention in a frail, older population of post-TAVI patients.

Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial.

BACKGROUND: Target lesion failure (TLF) remains an issue with contemporary drug-eluting stents. The dual-therapy sirolimus-eluting and CD34 antibody-coated COMBO stent (DTS) was designed to improve early healing. AIMS: We aimed to compare the 3-year outcomes of the DTS and the sirolimus-eluting Orsiro stent (SES) in all-comer patients treated with percutaneous coronary intervention. METHODS: The SORT OUT X trial is a prospective multicentre randomised clinical trial with a registry-based follow-up comparing DTS and SES. The primary endpoint, TLF, is a composite of cardiac death, myocardial infarction or target lesion revascularisation (TLR). RESULTS: A total of 3,146 patients were randomised to treatment with the DTS (1,578 patients) or the SES (1,568 patients). At 3 years, an intention-to-treat analysis showed that 155 patients (9.8%) who were assigned the DTS and 118 patients (7.5%) who were assigned the SES met the primary endpoint (incidence rate ratio for TLF=1.33, 95% confidence interval: 1.04-1.70; p=0.02). This difference was caused by a significantly higher TLF rate in the DTS group compared to the SES group within the first year, which was mainly explained by a higher incidence of TLR in the DTS group compared to the SES group. Of note, the TLF rates were almost identical from 1 year to 3 years in both stent groups. CONCLUSIONS: At 3 years, the SES was superior to the DTS, mainly because the DTS was associated with an increased risk of TLF within the first year but not from 1 to 3 years. CLINICALTRIALS: gov: NCT03216733.

Angiographic outcome in patients treated with deferred stenting after ST-segment elevation myocardial infarction-results from DANAMI-3-DEFER.

AIMS: Stent implantation during primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) occasionally results in flow disturbances and distal embolization, which may cause adverse clinical outcomes. Deferred stent implantation seems to reduce the impairment on myocardial function, although the mechanisms have not been clarified. We sought to evaluate whether deferred stenting could reduce flow disturbance in patients treated with primary PCI. METHODS AND RESULTS: Patients with STEMI included in the DANAMI-3-DEFER trial were randomized to deferred versus immediate stent implantation. The primary and secondary outcomes of this substudy were the incidences of slow/no reflow and distal embolization. A total of 1205 patients were included. Deferred stenting (n = 594) resulted in lower incidences of distal embolization [odds ratio (OR) 0.67, 95% confidence interval (CI) 0.46-0.98, P = 0.040] and slow/no reflow (OR 0.60, 95%CI 0.37-0.97, P = 0.039). In high-risk subgroups, the protective effect was greatest in patients >65 years of age (slow/no reflow: OR 0.36, 95% CI 0.17-0.72, P = 0.004 and distal embolization: OR 0.34, 95% CI 0.18-0.63, P = 0.001), in patients presenting with occluded culprit artery at admission (slow/no reflow: OR 0.33, 95% CI 0.16-0.65, P = 0.001 and distal embolization: OR 0.54, 95% CI 0.31-0.96, P = 0.036) and in patients with thrombus grade >3 (slow/no reflow: OR 0.37, 95% CI 0.20-0.67, P = 0.001 and distal embolization: OR 0.39, 95% CI 0.24-0.64, P < 0.001) with a significant P for interaction for all. CONCLUSION: Deferred stent implantation reduces the incidences of slow/no reflow and distal embolization, especially in older patients and in those with total coronary occlusion or high level of thrombus burden.

Perspectives on Participation in a Feasibility Study on Exercise-Based Cardiac Telerehabilitation After Transcatheter Aortic Valve Implantation: Qualitative Interview Study Among Patients and Health Professionals.

BACKGROUND: Aortic valve stenosis affects approximately half of people aged ≥85 years, and the recommended surgical treatment for older patients is transcatheter aortic valve implantation (TAVI). Despite strong evidence for its advantages, low attendance rate in cardiac rehabilitation is observed among patients after TAVI. Cardiac telerehabilitation (CTR) has proven comparable with center-based rehabilitation; however, no study has investigated CTR targeting patients after TAVI. On the basis of participatory design, an exercise-based CTR program (TeleTAVI) was developed, which included a web-based session with a cardiac nurse, a tablet containing an informative website, an activity tracker, and supervised home-based exercise sessions that follow the national recommendations for cardiac rehabilitation. OBJECTIVE: This study aims to explore patients' and health professionals' experiences with using health technologies and participating in the exercise-based CTR program, TeleTAVI. METHODS: This study is a part of a feasibility study and will only report patients' and health professionals' experiences of being a part of TeleTAVI. A total of 11 qualitative interviews were conducted using a semistructured interview guide (n=7, 64% patients and n=4, 36% health professionals). Patient interviews were conducted after 8 weeks of participation in TeleTAVI, and interviews with health professionals were conducted after the end of the program. The analysis was conducted as inductive content analysis to create a condensed meaning presented as themes. RESULTS: Reticence toward using the website was evident with reduced curiosity to explore it, and reduced benefit from using the activity tracker was observed, as the patients' technical competencies were challenged. This was also found when using the tablet for web-based training sessions, leading to patients feeling worried before the training, as they anticipated technical problems. Disadvantages of the TeleTAVI program were technical problems and inability to use hands-on guidance with the patients. However, both physiotherapists and patients reported a feeling of improvement in patients' physical fitness. The home training created a feeling of safety, supported adherence, and made individualization possible, which the patients valued. A good relationship and continuity in the contact with health professionals seemed very important for the patients and affected their positive attitude toward the program. CONCLUSIONS: The home-based nature of the TeleTAVI program seems to provide the opportunity to support individualization, autonomy, independence, and adherence to physical training in addition to improvement in physical capability in older patients. Despite technological challenges, basing the relationship between the health professionals and patients on continuity may be beneficial for patients. Prehabilitation may also be considered, as it may create familiarity toward technology and adherence to the training.

Exercise-Based Real-time Telerehabilitation for Older Adult Patients Recently Discharged After Transcatheter Aortic Valve Implantation: Mixed Methods Feasibility Study.

BACKGROUND: The use of telehealth technology to improve functional recovery following transcatheter aortic valve implantation (TAVI) has not been investigated. OBJECTIVE: In this study, we aimed to examine the feasibility of exercise-based cardiac telerehabilitation after TAVI. METHODS: This was a single-center, prospective, nonrandomized study using a mixed methods approach. Data collection included testing, researchers' observations, logbooks, and individual patient interviews, which were analyzed using a content analysis approach. The intervention lasted 3 weeks and consisted of home-based web-based exercise training, an activity tracker, a TAVI information website, and 1 web-based session with a nurse. RESULTS: Of the initially included 13 patients, 5 (40%) completed the study and were interviewed; the median age was 82 (range 74-84) years, and the sample comprised 3 men and 2 women. Easy access to supervised exercise training at home with real-time feedback and use of the activity tracker to count daily steps were emphasized by the patients who completed the intervention. Reasons for patients not completing the program included poor data coverage, participants' limited information technology skills, and a lack of functionality in the systems used. No adverse events were reported. CONCLUSIONS: Exercise-based telerehabilitation for older people after TAVI, in the population as included in this study, and delivered as a web-based intervention, does not seem feasible, as 60% (8/13) of patients did not complete the study. Those completing the intervention highly appreciated the real-time feedback during the web-based training sessions. Future studies should address aspects that support retention rates and enhance patients' information technology skills.

Clinical outcomes of no stenting in patients with ST-segment elevation myocardial infarction undergoing deferred primary percutaneous coronary intervention.

BACKGROUND: ST-segment elevation myocardial infarction (STEMI) is treated with stenting, but the underlying stenosis is often not severe, and stenting may potentially be omitted. AIMS: The aim of the study was to investigate outcomes of patients with STEMI treated with percutaneous coronary intervention (PCI) without stenting. METHODS: Patients were identified through the DANAMI-3-DEFER study. Stenting was omitted in the patients with stable flow after initial PCI and no significant residual stenosis on the deferral procedure, who were randomised to deferred stenting. These patients were compared to patients randomised to conventional PCI treated with immediate stenting. The primary endpoint was a composite of all-cause mortality, recurrent myocardial infarction (MI), and target vessel revascularisation (TVR). RESULTS: Of 603 patients randomised to deferred stenting, 84 were treated without stenting, and in patients randomised to conventional PCI (n=612), 590 were treated with immediate stenting. Patients treated with no stenting had a median stenosis of 40%, median vessel diameter of 2.9 mm, and median lesion length of 11.4 mm. During a median follow-up of 3.4 years, the composite endpoint occurred in 14% and 16% in the no and immediate stenting groups, respectively (unadjusted hazard ratio [HR] 0.87, 95% confidence interval [CI]: 0.48-1.60; p=0.66). The association remained non-significant after adjusting for confounders (adjusted HR 0.53, 95% CI: 0.22-1.24; p=0.14). The rates of TVR and recurrent MI were 2% vs 4% (p=0.70) and 4% vs 6% (p=0.43), respectively. CONCLUSIONS: Patients with STEMI, with no significant residual stenosis and stable flow after initial PCI, treated without stenting, had comparable event rates to patients treated with immediate stenting.

Comparison of Effect of Ischemic Postconditioning on Cardiovascular Mortality in Patients With ST-Segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention With Versus Without Thrombectomy.

In patients with ST-segment elevation myocardial infarction (STEMI), ischemic postconditioning (iPOST) have shown ambiguous results in minimizing reperfusion injury. Previous findings show beneficial effects of iPOST in patients with STEMI treated without thrombectomy. However, it remains unknown whether the cardioprotective effect of iPOST in these patients persist on long term. In the current study, all patients were identified through the DANAMI-3-iPOST database. Patients were randomized to conventional primary percutaneous coronary intervention (PCI) or iPOST in addition to PCI. Cumulative incidence rates were calculated, and multivariable analyses stratified according to thrombectomy use were performed. The primary end point was a combination of cardiovascular mortality and hospitalization for heart failure. From 2011 to 2014, 1,234 patients with STEMI were included with a median follow-up of 4.8 years. In patients treated without thrombectomy (n = 520), the primary end point occurred in 15% (48/326) in the iPOST group and in 22% (42/194) in the conventional group (unadjusted hazard ratio [HR] 0.62, 95% confidence interval [CI] 0.41 to 0.94, p = 0.023). In adjusted Cox analysis, iPOST remained associated with reduced long-term risk of cardiovascular mortality (HR 0.53, 95% CI 0.29 to 0.97, p = 0.039). In patients treated with thrombectomy (n = 714), there was no significant difference between iPOST (17%, 49/291) and conventional treatment (17%, 72/423) on the primary end point (unadjusted HR 1.01, 95% CI 0.70 to 1.45, p = 0.95). During a follow-up of nearly 5 years, iPOST reduced long-term occurrence of cardiovascular mortality and hospitalization for heart failure in patients with STEMI treated with PCI but without thrombectomy.

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.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Characterisation of patients with and without cardiac magnetic resonance imaging abnormalities presenting with myocardial infarction with non-obstructive coronary arteries (MINOCA).

OBJECTIVE: The objective of the current study is to determine the characteristics of myocardial infarction with non-obstructive coronary arteries (MINOCA) patients with and without cardiac magnetic resonance (CMR) abnormalities. METHODS: We evaluated patients admitted with a presentation of acute myocardial infarction (MI) with no coronary obstruction on invasive angiography in our institution between 2012 and 2017. Patients with prior cardiac disease, myocarditis, Takotsubo cardiomyopathy and type 2 myocardial infarction were excluded. Myocardial fibrosis was determined by late gadolinium enhancement (LGE). Patients were divided into two groups based on the presence or absence of CMR abnormalities (LGE or oedema). Major adverse cardiovascular events (MACE) were defined as non-fatal MI, all-cause mortality, ventricular arrythmias or heart failure hospitalisation at follow-up. RESULTS: Thirty-four patients fulfilling the inclusion criteria were identified. Myocardial changes with CMR were observed in 20 (59%) patients with signs of subendocardial infarct by LGE in 13 (38%) patients, transmural infarct by LGE in 6 (18%) patients and one patient had myocardial oedema. ECG and echocardiographic features were similar between patients with and without CMR abnormalities. Troponin T was significantly higher among patients with CMR abnormalities. The median duration of follow-up was 702 (IQR 456-1394) days. Two patients had MACE (both heart failure). One of them had LGE changes. CONCLUSIONS: A significant number of patients with MINOCA have ischaemic LGE changes or myocardial wall oedema. The patients with CMR abnormalities have similar ECG and echocardiographic features except higher biomarker, highlighting the role of CMR in patients with MINOCA.

Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial.

BACKGROUND: In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared with a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is noninferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention. METHODS: The SORT OUT IX trial (Scandinavian Organization for Randomized Trials With Clinical Outcome IX), was a large-scale, registry-based, randomized, multicenter, single-blind, 2-arm, noninferiority trial. The primary end point, major adverse cardiovascular events, was defined as the composite of cardiac death, myocardial infarction not related to any segment other than the target lesion, or target lesion revascularization within 1 year, analyzed by intention-to-treat. The trial was powered to assess noninferiority for major adverse cardiovascular events of the BioFreedom stent compared with the Orsiro stent with a predetermined noninferiority margin of 0.021. RESULTS: Between December 14, 2015 and April 21, 2017, 3151 patients were assigned to treatment with the BioFreedom stent (1572 patients, 1966 lesions) or to the Orsiro stent (1579 patients, 1985 lesions). Five patients were lost to follow-up because of emigration (99.9% follow-up rate). Mean age was 66.3±10.9, diabetes mellitus was seen in 19.3% of patients, and 53% of the patients had acute coronary syndromes. At 1 year, intention-to-treat analysis showed that 79 (5.0%) patients, who were assigned the BioFreedom stent, and 59 (3.7%), who were assigned the Orsiro stent, met the primary end point (absolute risk difference 1.29% [upper limit of one-sided 95% CI 2.50%]; Pnoninferiority=0.14). Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77 [95% CI, 1.66-4.62]; P<0.0001). CONCLUSIONS: The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02623140.

Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV.

Background: It is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation. Methods: The study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates. Results: A total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI -0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment. Conclusion: In the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years. Trial registration number: NCT01496638.

Interaction of ischaemic postconditioning and thrombectomy in patients with ST-elevation myocardial infarction.

OBJECTIVE: The Third Danish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction - Ischaemic Postconditioning (DANAMI-3-iPOST) did not show improved clinical outcome in patients with ST-segment elevation myocardial infarction (STEMI) treated with ischaemic postconditioning. However, the use of thrombectomy was frequent and thrombectomy may in itself diminish the effect of ischaemic postconditioning. We evaluated the effect of ischaemic postconditioning in patients included in DANAMI-3-iPOST stratified by the use of thrombectomy. METHODS: Patients with STEMI were randomised to conventional primary percutaneous coronary intervention (PCI) or ischaemic postconditioning plus primary PCI. The primary endpoint was a combination of all-cause mortality and hospitalisation for heart failure. RESULTS: From March 2011 until February 2014, 1234 patients were included with a median follow-up period of 35 (interquartile range 28 to 42) months. There was a significant interaction between ischaemic postconditioning and thrombectomy on the primary endpoint (p=0.004). In patients not treated with thrombectomy (n=520), the primary endpoint occurred in 33 patients (10%) who underwent ischaemic postconditioning (n=326) and in 35 patients (18%) who underwent conventional treatment (n=194) (adjusted hazard ratio (HR) 0.55 (95%confidence interval (CI) 0.34 to 0.89), p=0.016). In patients treated with thrombectomy (n=714), there was no significant difference between patients treated with ischaemic postconditioning (n=291) and conventional PCI (n=423) on the primary endpoint (adjusted HR 1.18 (95% CI 0.62 to 2.28), p=0.62). CONCLUSIONS: In this post-hoc study of DANAMI-3-iPOST, ischaemic postconditioning, in addition to primary PCI, was associated with reduced risk of all-cause mortality and hospitalisation for heart failure in patients with STEMI not treated with thrombectomy. TRIAL REGISTRATION NUMBER: NCT01435408.

Relapsing Classical Takotsubo Syndrome in a Postmenopausal Woman Successfully Managed with Psychology Consultations.

Takotsubo syndrome (TTS) is an acute and often fully reversible heart failure condition. TTS was initially regarded as a benign syndrome, but it is known that TTS is associated with a mortality comparable to that of ST-elevation myocardial infarction. Interestingly, 2/3 of TTS occurrences are triggered by emotional or physical stressors. Meanwhile, the pathophysiology behind TTS is poorly understood. As no randomized trials exist to define the optimal treatment, current guidelines are based on expert opinion and the management of TTS-patients is often supportive. We present the case of a postmenopausal woman with relapsing TTS from two different emotional stressors where the treatment was carried out in cooperation between psychiatric and cardiology specialists. This case bears significance as severe relapsing TTS was managed successfully in collaboration between cardiologists and psychiatrists.

Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial.

BACKGROUND: Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months. METHODS: We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed. FINDINGS: Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91-1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed. INTERPRETATION: Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI. FUNDING: British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden.

Everolimus-Eluting Versus Biolimus-Eluting Coronary Stent Implantation in Patients With and Without Diabetes Mellitus.

Diabetes mellitus is associated with a higher risk of target lesion revascularization after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus, treated with everolimus-eluting stents (EES; Synergy; Boston Scientific, Marlborough, Massachusetts) or biolimus-eluting stents (BES; BioMatrix NeoFlex; Biosensors Interventional Technologies Pte Ltd., Singapore). In total, 2,764 patients were randomized to stent implantation with EES (n = 1,385, diabetes: n = 250) or the BES (n = 1,379, diabetes: n = 262), stratified by gender and diabetes. The primary end point, target lesion failure (TLF), was a composite of cardiac death, target-lesion myocardial infarction, or target lesion revascularization at 12 months. Secondary end points included individual components of TLF, all-cause death, and stent thrombosis. TLF was 2.1% lower in the EES versus the BES groups in patients with diabetes (3.6% vs 5.7%; rate ratios 0.61, 95% confidence interval [CI] 0.27 to 1.41) and similar in patients without diabetes (4.1% vs 4.0%; rate ratios 0.99, 95% CI 0.66 to 1.51). In patients with diabetes, the point estimates of the individual components of TLF also favored the EES but CIs were wide. No interaction between stent type and presence of diabetes was found. The current subgroup analysis found that a thin-strut EES as compared with a thicker strut BES had a numerically lower TLF rate in patients with diabetes, but the subgroup analysis was underpowered for definite conclusions.

Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial).

OBJECTIVES: The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES). BACKGROUND: Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation. METHODS: This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%. RESULTS: A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001). CONCLUSIONS: At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent-SORT-OUT VIII; NCT02093845).

Impact of diabetes on clinical outcomes after revascularization with sirolimus-eluting and biolimus-eluting stents with biodegradable polymer from the SORT OUT VII trial.

OBJECTIVES: In this substudy of the SORT OUT VII trial, the clinical outcomes among patient with diabetes mellitus treated with Orsiro sirolimus-eluting stent (O-SES; Biotronik, Bülach, Switzerland) or Nobori biolimus-eluting stent (N-BES; Terumo, Tokyo, Japan) were compared. BACKGROUND: Diabetes is associated with increased risk of target lesion failure (TLF) after percutaneous coronary intervention. METHODS: In total, 2525 patients were randomized to stent implantation with O-SES (n = 1261, diabetes: n = 236) or N-BES (n = 1264, diabetes: n = 235). The primary endpoint, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 2 years. RESULTS: At 2 year, TLF did not differ between O-SES vs N-BES in diabetic (9.3% vs 9.4%; RR 0.98, 95% CI 0.54-1.78) patients. The individual components of the primary endpoint did not differ among stent type. In diabetics, cardiac death occurred in 3% of O-SES-treated and in 3.8% of N-BES-treated patients (RR 0.77, 95% CI 0.29-2.08), MI occurred in 3.0% of O-SES-treated and in 3.8% of N-BES-treated patients (RR 0.76, 95% CI 0.28-2.06) and TLR occurred in 5,5% of O-SES-treated and in 6.0% of N-BES-treated patients (RR 0.91, 95% CI 0.43-1.95). CONCLUSION: TLF did not differ between O-SES- and N-BES-treated diabetic patients.

[Transcatheter aortic valve implantation in Denmark].

During the latest decade, transcatheter aortic valve implantation (TAVI) has evolved from being indicated only in patients with severe aortic stenosis and prohibitive or high surgical risk, to be an alternative to surgical aortic valve replacement in patients with intermediate surgical risk. Improvements of the peri-procedural management have resulted in marked reduction of complications and an increasing number of patients treated with TAVI every year in Denmark. By a minimalist approach, TAVI can be performed in local anesthaesia, with same day mobilisation and discharge within few days, without affecting the safety.

Short- and Long-Term Mortality and Stroke Risk After Transcatheter Aortic Valve Implantation.

No published studies have compared the outcome after transcatheter aortic valve implantation (TAVI) with the outcome in the general population. Thus, it is unknown whether TAVI restores normal life expectancy and stroke risk. Furthermore, despite the increasing use of TAVI, only little is known about the temporal trends for TAVI regarding patient characteristics and outcomes. We identified all Danish patients treated with TAVI from 2006 to 2014 (n = 1,631) and 9,737 general population controls matched by gender, age, and co-morbidity. The primary end point was a composite end point of all-cause mortality and stroke. During the first 90 days, the risk of the combined end point, the stroke risk, and mortality were significantly higher among TAVI patients compared with controls (9.4%, 7.5%, and 2.5%, respectively, in TAVI patients compared with 2.0%, 1.6%, and 0.5% in controls). After 90 days, there were no differences (adjusted mortality rate ratio, stroke rate ratio, and mortality or stroke rate ratio 0.92 [0.79 to 1.06], 1.32 [0.98 to 1.78], and 1.00 [0.90 to 1.10], respectively). During the study period, there were small changes in the characteristics of patients treated with TAVI; however, more patients were treated by transfemoral access; fewer needed blood transfusions, hospital stays were shorter, and the overall mortality rate decreased. In conclusion, 90 days after TAVI, the stroke risk and mortality of the TAVI patients were comparable with the stroke risk and mortality of the general population. Over time, the patient risk profiles have remained largely unchanged; however, outcomes have improved substantially, including lower short- and long-term mortality.

[Extracorporeal cardiopulmonary resuscitation for patients with out-of-hospital refractory cardiac arrest].

Out-of-hospital cardiac arrest is associated with high mortality and morbidity. Treatment options remain few in refractory cases, but extracorporeal cardiopulmonary resuscitation (eCPR) is increasingly applied to improve the outcome. This article summarizes the use, experience and outcome of eCPR focussing on current knowledge of criteria for selection of relevant patients for treatment.