Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial

Abstract Background Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15 years, and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless, the authors evidenced the moderate/low quality of the included studies and highlighted how 3 out of 4 came from Eastern countries. After 2015, only retrospective studies have been published, all with inconsistent results. Methods ADiGe (Abdominal Drain in Gastrectomy) Trial is a multicenter prospective randomized non-inferiority trial with a parallel design. It aimed to verify whether avoiding routine use of abdominal drain is burdened with complications, particularly an increase in postoperative invasive procedures. Patients with gastric cancer, scheduled for subtotal or total gastrectomy with curative intent, are eligible for inclusion, irrespective of previous oncological treatment. The primary composite endpoint is reoperation or percutaneous drainage procedures within 30 postoperative days. The primary analysis will verify whether the incidence of the primary composite endpoint is higher in the experimental arm, avoiding routine drain placement, than control arm, undergoing prophylactic drain placement, in order to falsify or support the null hypothesis of inferiority. Secondary endpoints assessed for superiority are overall morbidity and mortality, Comprehensive Complications Index, incidence and time for diagnosis of anastomotic and duodenal leaks, length of hospital stay, and readmission rate. Assuming one-sided alpha of 5%, and cumulative incidence of the primary composite endpoint of 6.4% in the control arm and 4.2% in the experimental one, 364 patients allow to achieve 80% power to detect a non-inferiority margin difference between the arm proportions of 3.6%. Considering a 10% drop-out rate, 404 patients are needed. In order to have a balanced percentage between total and subtotal gastrectomy, recruitment will end at 202 patients for each type of gastrectomy. The surgeon and the patient are blinded until the end of the operation, while postoperative course is not blinded to the patient and caregivers. Discussion ADiGe Trial could contribute to critically re-evaluate the role of prophylactic drain in gastrectomy, a still widely used procedure. Trial registration Prospectively registered (last updated on 29 October 2020) at ClinicalTrials.gov with the identifier NCT04227951.

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Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial

10.21203/rs.3.rs-33656/v2 ◽

2021 ◽

Author(s):

Jacopo Weindelmayer ◽

Valentina Mengardo ◽

Alessandro Veltri ◽

Gian Luca Baiocchi ◽

Simone Giacopuzzi ◽

...

Keyword(s):

Subtotal Gastrectomy ◽

Composite Endpoint ◽

Convincing Evidence ◽

Drop Out ◽

Primary Analysis ◽

Curative Intent ◽

Oncological Treatment ◽

Abdominal Drain ◽

Primary Composite Endpoint ◽

Drain Placement

Abstract Background: Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15 years and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless, the Authors evidenced the moderate/low quality of the included studies and highlighted how 3 out of 4 four came from Eastern countries. After 2015 only retrospective studies have been published, all with inconsistent results.Methods: ADiGe (Abdominal Drain in GastrEctomy) Trial is a multicenter prospective randomized non-inferiority trial with a parallel design. It aimed to verify whether avoiding routine use of abdominal drain is burdened with complications, particularly an increase in postoperative invasive procedures. Patients with gastric cancer, scheduled for subtotal or total gastrectomy with curative intent, are eligible for inclusion, irrespective of previous oncological treatment. The primary composite endpoint is reoperation or percutaneous drainage procedures within 30 postoperative days. The primary analysis will verify whether the incidence of the primary composite endpoint is higher in the experimental arm, avoiding routine drain placement, than control arm, undergoing prophylactic drain placement, in order to falsify or support the null hypothesis of inferiority. Secondary endpoints assessed for superiority are overall morbidity and mortality, Comprehensive Complications Index, incidence and time for diagnosis of anastomotic and duodenal leaks, length of hospital stay, readmission rate.Assuming one-sided alpha of 5%, and cumulative incidence of the primary composite endpoint of 6.4% in control arm and 4.2% in the experimental one, 364 patients allow to achieve 80% power to detect a non-inferiority margin difference between the arm proportions of 3.6%. Considering a 10% drop-out rate, 404 patients are needed. In order to have a balanced percentage between total and subtotal gastrectomy, recruitment will end at 202 patients for each type of gastrectomy. The surgeon and the patient are blinded until the end of the operation, while postoperative course is not blinded to patient and caregivers.Discussion: ADiGe Trial could contribute to critically re-evaluate the role of prophylactic drain in gastrectomy, a still widely used procedure.Trial registration: Prospectively registered (last updated on October 29, 2020) at Clinicaltrials.gov with the identifier NCT04227951, https://clinicaltrials.gov/ct2/show/NCT04227951.

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Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial

10.21203/rs.3.rs-33656/v3 ◽

2021 ◽

Author(s):

Jacopo Weindelmayer ◽

Valentina Mengardo ◽

Alessandro Veltri ◽

Gian Luca Baiocchi ◽

Simone Giacopuzzi ◽

...

Keyword(s):

Subtotal Gastrectomy ◽

Composite Endpoint ◽

Convincing Evidence ◽

Drop Out ◽

Primary Analysis ◽

Curative Intent ◽

Oncological Treatment ◽

Abdominal Drain ◽

Primary Composite Endpoint ◽

Drain Placement

Abstract Background: Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15 years and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless, the Authors evidenced the moderate/low quality of the included studies and highlighted how 3 out of 4 came from Eastern countries. After 2015 only retrospective studies have been published, all with inconsistent results.Methods: ADiGe (Abdominal Drain in GastrEctomy) Trial is a multicenter prospective randomized non-inferiority trial with a parallel design. It aimed to verify whether avoiding routine use of abdominal drain is burdened with complications, particularly an increase in postoperative invasive procedures. Patients with gastric cancer, scheduled for subtotal or total gastrectomy with curative intent, are eligible for inclusion, irrespective of previous oncological treatment. The primary composite endpoint is reoperation or percutaneous drainage procedures within 30 postoperative days. The primary analysis will verify whether the incidence of the primary composite endpoint is higher in the experimental arm, avoiding routine drain placement, than control arm, undergoing prophylactic drain placement, in order to falsify or support the null hypothesis of inferiority. Secondary endpoints assessed for superiority are overall morbidity and mortality, Comprehensive Complications Index, incidence and time for diagnosis of anastomotic and duodenal leaks, length of hospital stay, readmission rate.Assuming one-sided alpha of 5%, and cumulative incidence of the primary composite endpoint of 6.4% in control arm and 4.2% in the experimental one, 364 patients allow to achieve 80% power to detect a non-inferiority margin difference between the arm proportions of 3.6%. Considering a 10% drop-out rate, 404 patients are needed. In order to have a balanced percentage between total and subtotal gastrectomy, recruitment will end at 202 patients for each type of gastrectomy. The surgeon and the patient are blinded until the end of the operation, while postoperative course is not blinded to patient and caregivers.Discussion: ADiGe Trial could contribute to critically re-evaluate the role of prophylactic drain in gastrectomy, a still widely used procedure.Trial registration: Prospectively registered (last updated on October 29, 2020) at Clinicaltrials.gov with the identifier NCT04227951, https://clinicaltrials.gov/ct2/show/NCT04227951.

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Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial

10.21203/rs.3.rs-33656/v1 ◽

2020 ◽

Author(s):

Jacopo Weindelmayer ◽

Valentina Mengardo ◽

Alessandro Veltri ◽

Gian Luca Baiocchi ◽

Simone Giacopuzzi ◽

...

Keyword(s):

Length Of Hospital Stay ◽

Composite Endpoint ◽

Convincing Evidence ◽

Drop Out ◽

Primary Analysis ◽

Curative Intent ◽

Oncological Treatment ◽

Abdominal Drain ◽

Primary Composite Endpoint ◽

Drain Placement

Abstract Background: Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15 years and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless the Authors evidenced the moderate/low quality of the included studies and highlighted how 3 out of four came from Eastern countries. After 2015 only retrospective studies have been published, all with inconsistent results.Methods: ADiGe (Abdominal Drain in GastrEctomy) Trial is a multicenter prospective randomized non-inferiority trial with a parallel design. It aimed to verify whether avoiding routine use of abdominal drain is burdened with complications, particularly an increase in postoperative invasive procedures. Patients with gastric cancer, scheduled for subtotal or total gastrectomy with curative intent, are eligible for inclusion, irrespective of previous oncological treatment. The primary composite endpoint is reoperation or percutaneous drainage procedures within 30 postoperative days. The primary analysis will verify whether the incidence of the primary composite endpoint is higher in the experimental arm, avoiding routine drain placement, than control arm, undergoing prophylactic drain placement, in order to falsify or support the null hypothesis of inferiority. Secondary endpoints assessed for superiority are overall morbidity and mortality, Comprehensive Complications Index, incidence and time for diagnosis of anastomotic and duodenal leaks, length of hospital stay, readmission rate.Assuming one-sided alpha of 5%, and cumulative incidence of the primary composite endpoint of 14.5% in control arm and 9% in the experimental one, 256 patients allow to achieve 80% power to detect a non-inferiority margin difference between the arm proportions of 4.5%. Considering a 15.5% drop-out rate, 304 patients are needed. In order to have a balanced percentage between total and subtotal gastrectomies, recruitment will end at 152 patients for each type of gastrectomy. The surgeon and the patient are blinded until the end of the operation, while postoperative course is not blinded to patient and caregivers.Discussion: ADiGe Trial could contribute to critically re-evaluate the role of prophylactic drain in gastrectomy, a still widely used procedure.Trial registration: Retrospectively registered on 01/10/2020 at Clinicaltrials.gov with the identifier NCT04227951, https://clinicaltrials.gov/ct2/show/NCT04227951.

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Comparison of prasugrel and ticagrelor for patient with acute coronary syndrome: a systematic review and meta-analysis

European Heart Journal ◽

10.1093/ehjci/ehaa946.1434 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

L.C.W Fong ◽

N Lee ◽

A.T Yan ◽

M.Y Ng

Keyword(s):

Acute Coronary Syndrome ◽

Stent Thrombosis ◽

Meta Analysis ◽

Composite Endpoint ◽

Cardiovascular Death ◽

Coronary Syndrome ◽

Primary Composite Endpoint ◽

Significant Difference ◽

St Elevation

Abstract Background Prasugrel and ticagrelor are both effective anti-platelet drugs for patients with acute coronary syndrome. However, there has been limited data on the direct comparison of prasugrel and ticagrelor until the recent ISAR-REACT 5 trial. Purpose To compare the efficacy of prasugrel and ticagrelor in patients with acute coronary syndrome with respect to the primary composite endpoint of myocardial infarction (MI), stroke or cardiac cardiovascular death, and secondary endpoints including MI, stroke, cardiovascular death, major bleeding (Bleeding Academic Research Consortium (BARC) type 2 or above), and stent thrombosis within 1 year. Methods Meta-analysis was performed on randomised controlled trials (RCT) up to December 2019 that randomised patients with acute coronary syndrome to either prasugrel or ticagrelor. RCTs were identified from Medline, Embase and ClinicalTrials.gov using Cochrane library CENTRAL by 2 independent reviewers with “prasugrel” and “ticagrelor” as search terms. Effect estimates with confidence intervals were generated using the random effects model by extracting outcome data from the RCTs to compare the primary and secondary clinical outcomes. Cochrane risk-of-bias tool for randomised trials (Ver 2.0) was used for assessment of all eligible RCTs. Results 411 reports were screened, and we identified 11 eligible RCTs with 6098 patients randomised to prasugrel (n=3050) or ticagrelor (n=3048). The included trials had a follow up period ranging from 1 day to 1 year. 330 events on the prasugrel arm and 408 events on the ticagrelor arm were recorded. There were some concerns over the integrity of allocation concealment over 7 trials otherwise risk of other bias was minimal. Patients had a mean age of 61±4 (76% male; 50% with ST elevation MI; 35% with non-ST elevation MI; 15% with unstable angina; 25% with diabetes mellitus; 64% with hypertension; 51% with hyperlipidaemia; 42% smokers). There was no significant difference in risk between the prasugrel group and the ticagrelor group on the primary composite endpoint (Figure 1) (Risk Ratio (RR)=1.17; 95% CI=0.97–1.41; p=0.10, I2=0%). There was no significant difference between the use of prasugrel and ticagrelor with respect to MI (RR=1.24; 95% CI=0.81–1.90; p=0.31); stroke (RR=1.05; 95% CI=0.66–1.67; p=0.84); cardiovascular death (RR=1.01; 95% CI=0.75–1.36; p=0.95); BARC type 2 or above bleeding (RR=1.17; 95% CI =0.90–1.54; p=0.24); stent thrombosis (RR=1.58; 95% CI =0.90–2.76; p=0.11). Conclusion Compared with ticagrelor, prasugrel did not reduce the primary composite endpoint of MI, stroke and cardiovascular death within 1 year. There was also no significant difference in the risk of MI, stroke, cardiovascular death, major bleeding and stent thrombosis respectively. Figure 1. Primary Objective Funding Acknowledgement Type of funding source: None

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Management of Patients with Pancreatic Ductal Adenocarcinoma in the Real-Life Setting: Lessons from the French National Hospital Database

Cancers ◽

10.3390/cancers13143515 ◽

2021 ◽

Vol 13 (14) ◽

pp. 3515

Author(s):

Christelle de la Fouchardière ◽

Mustapha Adham ◽

Anne-Marie Marion-Audibert ◽

Antoine Duclos ◽

Claude Darcha ◽

...

Keyword(s):

Pancreatic Ductal Adenocarcinoma ◽

Real Life ◽

Ductal Adenocarcinoma ◽

University Hospitals ◽

National Hospital ◽

Curative Intent ◽

The Real ◽

Oncological Treatment ◽

Real Life Setting ◽

Number Of Patients

Pancreatic ductal adenocarcinoma (PDAC) remains a major public health challenge, and faces disparities and delays in the diagnosis and access to care. Our purposes were to describe the medical path of PDAC patients in the real-life setting and evaluate the overall survival at 1 year. We used the national hospital discharge summaries database system to analyze the management of patients with newly diagnosed PDAC over the year 2016 in Auvergne-Rhône-Alpes region (AuRA) (France). A total of 1872 patients met inclusion criteria corresponding to an incidence of 22.6 per 100,000 person-year. Within the follow-up period, 353 (18.9%) were operated with a curative intent, 743 (39.7%) underwent chemo- and/or radiotherapy, and 776 (41.4%) did not receive any of these treatments. Less than half of patients were operated in a high-volume center, defined by more than 20 PDAC resections performed annually, mainly university hospitals. The 1-year survival rate was 47% in the overall population. This study highlights that a significant number of patients with PDAC are still operated in low-volume centers or do not receive any specific oncological treatment. A detailed analysis of the medical pathways is necessary in order to identify the medical and territorial determinants and their impact on the patient’s outcome.

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Abstract P023: Relationship Between Vitamin D Status and Incidence of Macro-vascular Events in the Veterans Affairs Diabetes Trial (VADT)

Circulation ◽

10.1161/circ.125.suppl_10.ap023 ◽

2012 ◽

Vol 125 (suppl_10) ◽

Author(s):

Jimmy D Alele ◽

Kelly J Hunt ◽

Bruce W Hollis ◽

Deirdre K Luttrell ◽

Louis M Luttrell ◽

...

Keyword(s):

Myocardial Infarction ◽

Heart Failure ◽

Type 2 Diabetes ◽

Vitamin D ◽

Composite Endpoint ◽

Cardiovascular Death ◽

Veterans Affairs ◽

Vitamin D Status ◽

Primary Composite Endpoint

BACKGROUND: Few studies have examined the relationship between vitamin D levels and incident cardiovascular events in large well-characterized type 2 diabetes cohorts. METHODS: We performed prospective analyses to determine associations between vitamin D status and vascular endpoints among 936 Veterans Affairs Diabetes Trial (VADT) participants (mean age 59.7 years; 96.7% male; 40.4% minority). 25 (OH)-vitamin D was measured a median of two years after entry into the VADT study and participants were subsequently followed an average of 3.7 years for outcomes. Cox proportional hazard models were used to calculate hazard ratios (HRs) for macrovascular endpoints in relation to vitamin D quartile. The primary composite endpoint included documented myocardial infarction; stroke; death from cardiovascular causes; new or worsening congestive heart failure; surgical intervention for cardiac, cerebrovascular, or peripheral vascular disease; inoperable coronary artery disease; and amputation for ischemic gangrene. RESULTS: On average VADT participants had high cardiovascular risk at entry into the study: 65.3% of the patients recruited were obese, 38.5% had previously had a vascular event, 78.7% had hypertension and 59.5% were using statins. During follow-up, 17.2%, 5.0%, 5.9%, 2.4% and 6.6% of participants had a primary composite endpoint, myocardial infarction, chronic heart failure, cardiovascular death or all-cause death, respectively. After adjusting for age, minority status, treatment arm and history of prior event, individuals in the lowest quartile of vitamin D (i.e., 1 to 15.9 ng/ml) were at similar risk of the primary composite endpoint [HR=1.26 (95% CI: 0.81, 1.96)], myocardial infarction [HR=1.13 (95% CI: 0.53, 2.42)], congestive heart failure [HR=1.44 (95% CI: 0.67, 3.06)], cardiovascular death [HR=0.86 (95% CI: 0.28, 2.63)], and death from any cause [HR=1.04 (95% CI: 0.53, 2.04)] as individuals in the highest quartile of vitamin D (i.e., 29.9 to 77.2 ng/ml). CONCLUSIONS: These data indicate that vitamin D status had no significant impact on the incidence of macrovascular events in a cohort of high-risk veterans with type 2 diabetes mellitus in which traditional risk factors were managed according to current treatment guidelines. SUPPORT: This work was supported by American Heart Association Grant-in-Aid AHA0755466U and the Research Service of the Charleston SC VA Medical Center.

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Anti-amphiphysin positive stiff-person syndrome due to invasive ductal carcinoma in a male patient

BMJ Case Reports ◽

10.1136/bcr-2020-237738 ◽

2021 ◽

Vol 14 (5) ◽

pp. e237738

Author(s):

Christopher Connolly ◽

Erin Cobain ◽

Tasha Hughes

Keyword(s):

Invasive Ductal Carcinoma ◽

Ductal Carcinoma ◽

Diagnostic Testing ◽

Muscle Rigidity ◽

Stiff Person Syndrome ◽

Curative Intent ◽

Lung Cancers ◽

Oncological Treatment ◽

Positron Emission ◽

Magnetic Resonance Imaging Mri

Stiff-person syndrome (SPS) is a rare progressive neurological disorder characterised by painful muscle spasms and progressive muscle rigidity, leading in some cases to impaired ambulation. Anti-amphiphysin positive SPS is a paraneoplastic variant, frequently associated with breast carcinomas and small cell lung cancers. We report the case of a 53-year-old patient who developed symptoms of anti-amphiphysin positive SPS 3 years before being diagnosed with invasive ductal carcinoma. Specifically, computed tomography (CT) of the chest, abdomen and pelvis, positron emission tomography-CT (PET-CT), mammogram, colonoscopy and magnetic resonance imaging (MRI) did not identify malignancy during the 3 years following the onset of symptoms. Following diagnosis of invasive ductal carcinoma and completion of curative-intent oncological treatment, the patient experienced improvement, though not complete resolution, in his SPS symptoms. This case highlights the importance of thorough oncological workup when clinical presentation and diagnostic testing are suggestive of anti-amphiphysin positive SPS.

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Abstract WP113: Impact of Apixaban on Clinical Outcome of the Patients With Large Vessel Occlusion or Stenosis (alvo) Study

Stroke ◽

10.1161/str.51.suppl_1.wp113 ◽

2020 ◽

Vol 51 (Suppl_1) ◽

Author(s):

Shinichi Yoshimura ◽

Nobuyuki Sakai ◽

Hiroshi Yamagami ◽

Masunari Shibata ◽

Yukiko Enomoto ◽

...

Keyword(s):

Cumulative Incidence ◽

Composite Endpoint ◽

Recombinant Tissue Plasminogen Activator ◽

Large Vessel ◽

Large Vessel Occlusion ◽

Nonvalvular Atrial Fibrillation ◽

Vessel Occlusion ◽

Coronary Syndrome ◽

Primary Composite Endpoint ◽

Ischemic Events

Background: Efficacy and safety of direct oral factor Xa inhibitor in patients with acute large vessel occlusion (LVO) and nonvalvular atrial fibrillation (NVAF) were questionable because recombinant tissue plasminogen activator (rt-PA) and endovascular therapy (EVT) became the standard therapy. Methods: We conducted historical and prospective multicenter registry from July 2016 to Feb 2018 at 38 centers in Japan. The eligible criteria were 20-year old or elder and patients with NVAF and acute LVO who received apixaban within 14 days from the onset. The primary endpoint was a composite of all-cause death, International Society of Thrombosis and Hemostasismajor bleedings, and ischemic events. Ischemic events included ischemic stroke, acute coronary syndrome, acute myocardial infarction and systemic embolism. The secondary endpoints were each component of primary composite endpoint. Results: We registered 713 patients but 27 patients were excluded due to logical error or ineligibility. The mean age was 78 (SD 10) years and 52% were male among 686 enrolled patients. The median NIHSS and ASPECTS on admission were 14 (range 0-38) and 8 (range 0-10), respectively. The use of rt-PA and EVT were 39.1% and 52.3% of patients, respectively. The median time from onset to the start of apixaban was 2.5 days (range 0-14). The cumulative incidence of primary composite endpoint at 90 days and 365 days were 9.6% (95%CI 7.4-11.9) and 17.5% (95%CI 14.4-20.5), respectively. The cumulative incidence of primary composite endpoint were 15.6% and 12.2% in those with and without EVT at 365 days (p=0.20) The cumulative incidences of ISTH major bleedings and ischemic events at 365 days were 9.0% (95%CI 6.7-11.2) and 4.4% (95%CI 2.8-6.0), respectively. Conclusions: We estimated the cumulative incidences of bleeding and ischemic events as well as all-cause mortality in patients on apixaban for NVAF and acute LVO. (Funded by Bristol-Myers Squibb; ClinicalTrials.gov number, NCT02818868.)

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Effects of dapagliflozin in DAPA-HF according to background heart failure therapy

European Heart Journal ◽

10.1093/eurheartj/ehaa183 ◽

2020 ◽

Vol 41 (25) ◽

pp. 2379-2392 ◽

Cited By ~ 25

Author(s):

Kieran F Docherty ◽

Pardeep S Jhund ◽

Silvio E Inzucchi ◽

Lars Køber ◽

Mikhail N Kosiborod ◽

...

Keyword(s):

Heart Failure ◽

Enzyme Inhibitor ◽

Sglt2 Inhibitor ◽

Renin Angiotensin System ◽

Study Drug ◽

Composite Endpoint ◽

Cardiac Resynchronization ◽

Mineralocorticoid Receptor Antagonist ◽

Reduced Ejection Fraction ◽

Primary Composite Endpoint

Abstract Aims In the DAPA-HF trial, the SGLT2 inhibitor dapagliflozin reduced the risk of worsening heart failure (HF) and death in patients with HF and reduced ejection fraction. We examined whether this benefit was consistent in relation to background HF therapy. Methods and results In this post hoc analysis, we examined the effect of study treatment in the following yes/no subgroups: diuretic, digoxin, mineralocorticoid receptor antagonist (MRA), sacubitril/valsartan, ivabradine, implanted cardioverter-defibrillating (ICD) device, and cardiac resynchronization therapy. We also examined the effect of study drug according to angiotensin-converting enzyme inhibitor/angiotensin receptor blocker dose, beta-blocker (BB) dose, and MRA (≥50% and <50% of target dose). We analysed the primary composite endpoint of cardiovascular death or a worsening HF event. Most randomized patients (n = 4744) were treated with a diuretic (84%), renin–angiotensin system (RAS) blocker (94%), and BB (96%); 52% of those taking a BB and 38% taking a RAS blocker were treated with ≥50% of the recommended dose. Overall, the dapagliflozin vs. placebo hazard ratio (HR) was 0.74 [95% confidence interval (CI) 0.65–0.85] for the primary composite endpoint (P < 0.0001). The effect of dapagliflozin was consistent across all subgroups examined: the HR ranged from 0.57 to 0.86 for primary endpoint, with no significant randomized treatment-by-subgroup interaction. For example, the HR in patients taking a RAS blocker, BB, and MRA at baseline was 0.72 (95% CI 0.61–0.86) compared with 0.77 (95% CI 0.63–0.94) in those not on all three of these treatments (P-interaction 0.64). Conclusion The benefit of dapagliflozin was consistent regardless of background therapy for HF.

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Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial

Thorax ◽

10.1136/thoraxjnl-2019-214246 ◽

2020 ◽

Vol 75 (5) ◽

pp. 413-421 ◽

Cited By ~ 5

Author(s):

Henrik Hansen ◽

Theresa Bieler ◽

Nina Beyer ◽

Thomas Kallemose ◽

Jon Torgny Wilcke ◽

...

Keyword(s):

Pulmonary Rehabilitation ◽

Controlled Trial ◽

Drop Out ◽

Group Differences ◽

Primary Analysis ◽

Intention To Treat ◽

Registration Number ◽

Randomised Controlled

RationalePulmonary rehabilitation (PR) is an effective, key standard treatment for people with COPD. Nevertheless, low participant uptake, insufficient attendance and high drop-out rates are reported. Investigation is warranted of the benefits achieved through alternative approaches, such as pulmonary tele-rehabilitation (PTR).ObjectiveTo investigate whether PTR is superior to conventional PR on 6 min walk distance (6MWD) and secondarily on respiratory symptoms, quality of life, physical activity and lower limb muscle function in patients with COPD and FEV1 <50% eligible for routine hospital-based, outpatient PR.MethodsIn this single-blinded, multicentre, superiority randomised controlled trial, patients were assigned 1:1 to 10 weeks of groups-based PTR (60 min, three times weekly) or conventional PR (90 min, two times weekly). Assessments were performed by blinded assessors at baseline, end of intervention and at 22 weeks’ follow-up from baseline. The primary analysis was based on the intention-to-treat principle.Measurements and main resultsThe primary outcome was change in 6MWD from baseline to 10 weeks; 134 participants (74 females, mean±SD age 68±9 years, FEV1 33%±9% predicted, 6MWD 327±103 metres) were included and randomised. The analysis showed no between-group differences for changes in 6MWD after intervention (9.2 metres (95% CI: −6.6 to 24.9)) or at 22 weeks’ follow-up (−5.3 metres (95% CI: −28.9 to 18.3)). More participants completed the PTR intervention (n=57) than conventional PR (n=43) (χ2 test p<0.01).ConclusionPTR was not superior to conventional PR on the 6MWD and we found no differences between groups. As more participants completed PTR, supervised PTR would be relevant to compare with conventional PR in a non-inferiority design.Trial registration numberClinicalTrials.gov (NCT02667171), 28 January 2016.

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