Differences In Event Rates Research Articles

Impact of Complete Revascularization in the ISCHEMIA Trial

BackgroundAnatomic complete revascularization (ACR) and functional complete revascularization (FCR) have been associated with reduced death and myocardial infarction (MI) in some prior studies. The impact of complete revascularization (CR) in patients undergoing an invasive (INV) compared with a conservative (CON) management strategy has not been reported. ObjectivesAmong patients with chronic coronary disease without prior coronary artery bypass grafting randomized to INV vs CON management in the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial, we examined the following: 1) the outcomes of ACR and FCR compared with incomplete revascularization; and 2) the potential impact of achieving CR in all INV patients compared with CON management. MethodsACR and FCR in the INV group were assessed at an independent core laboratory. Multivariable-adjusted outcomes of CR were examined in INV patients. Inverse probability weighted modeling was then performed to estimate the treatment effect had CR been achieved in all INV patients compared with CON management. ResultsACR and FCR were achieved in 43.4% and 58.4% of 1,824 INV patients. ACR was associated with reduced 4-year rates of cardiovascular death or MI compared with incomplete revascularization. By inverse probability weighted modeling, ACR in all 2,296 INV patients compared with 2,498 CON patients was associated with a lower 4-year rate of cardiovascular death or MI (difference −3.5; 95% CI: −7.2% to 0.0%). In comparison, the event rate difference of cardiovascular death or MI for INV minus CON in the overall ISCHEMIA trial was −2.4%. Results were similar but less pronounced with FCR. ConclusionsThe outcomes of an INV strategy may be improved if CR (especially ACR) is achieved. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522)

Estimated Population Health Benefits of Intensive Systolic Blood Pressure Treatment Among SPRINT-Eligible US Adults.

The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated an intensive (<120 mm Hg) vs. standard (<140 mm Hg) systolic blood pressure (SBP) goal lowered cardiovascular disease (CVD) risk. Estimating the effect of intensive SBP lowering among SPRINT-eligible adults most likely to benefit can guide implementation efforts. We studied SPRINT participants and SPRINT-eligible participants in the Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study and National Health and Nutrition Examination Surveys (NHANES). A published algorithm of predicted CVD benefit with intensive SBP treatment was used to categorize participants into low, medium, or high predicted benefit. CVD event rates were estimated with intensive and standard treatment. Median age was 67.0, 72.0, and 64.0 years in SPRINT, SPRINT-eligible REGARDS, and SPRINT-eligible NHANES participants, respectively. The proportion with high predicted benefit was 33.0% in SPRINT, 39.0% in SPRINT-eligible REGARDS, and 23.5% in SPRINT-eligible NHANES. The estimated difference in CVD event rate (standard minus intensive) was 7.0 (95% confidence interval [CI] 3.4-10.7), 8.4 (95% CI 8.2-8.5), and 6.1 (95% CI 5.9-6.3) per 1,000 person-years in SPRINT, SPRINT-eligible REGARDS participants, and SPRINT-eligible NHANES participants, respectively (median 3.2-year follow-up). Intensive SBP treatment could prevent 84,300 (95% CI 80,800-87,920) CVD events per year in 14.1 million SPRINT-eligible US adults; 29,400 and 28,600 would be in 7.0 million individuals with medium or high predicted benefit, respectively. Most of the population health benefit from intensive SBP goals could be achieved by treating those characterized by a previously published algorithm as having medium or high predicted benefit.

Risk of new disease activity in patients with multiple sclerosis who continue or discontinue disease-modifying therapies (DISCOMS): a multicentre, randomised, single-blind, phase 4, non-inferiority trial

Multiple sclerosis typically has onset in young adults and new disease activity diminishes with age. Most clinical trials of disease-modifying therapies for multiple sclerosis have not enrolled individuals older than 55 years. Observational studies suggest that risk of return of disease activity after discontinuation of a disease-modifying therapies is greatest in younger patients with recent relapses or MRI activity. We aimed to determine whether risk of disease recurrence in older patients with no recent disease activity who discontinue disease-modifying therapy is increased compared to those who remain on disease-modifying therapy. DISCOMS was a multicentre, randomised, controlled, rater-blinded, phase 4, non-inferiority trial. Individuals with multiple sclerosis of any subtype, 55 years or older, with no relapse within the past 5 years or new MRI lesion in the past 3 years while continuously taking an approved disease-modifying therapy were enrolled at 19 multiple sclerosis centres in the USA. Participants were randomly assigned (1:1 by site) with an interactive response technology system to either continue or discontinue disease-modifying therapy. Relapse assessors and MRI readers were masked to patient assignment; patients and treating investigators were not masked. The primary outcome was percentage of individuals with a new disease event, defined as a multiple sclerosis relapse or a new or expanding T2 brain MRI lesion, over 2 years. We assessed whether discontinuation of disease-modifying therapy was non-inferior to continuation using a non-inferiority, intention-to-treat analysis of all randomly assigned patients, with a predefined non-inferiority margin of 8%. This trial is registered at ClinicalTrials.gov, NCT03073603, and is completed. 259 participants were enrolled between May 22, 2017, and Feb 3, 2020; 128 (49%) were assigned to the continue group and 131 (51%) to the discontinue group. Five participants were lost to follow-up (continue n=1, discontinue n=4). Six (4·7%) of 128 participants in the continue group and 16 (12·2%) of 131 in the discontinue group had a relapse or a new or expanding brain MRI lesion within 2 years. The difference in event rates was 7·5 percentage points (95% CI 0·6-15·0). Similar numbers of participants had adverse events (109 [85%] of 128 vs 104 [79%] of 131) and serious adverse events (20 [16%] vs 18 [14%]), but more adverse events (422 vs 347) and serious adverse events (40 vs 30) occurred in the discontinue group. The most common adverse events were upper respiratory infections (20 events in 19 [15%] participants in the continue group and 37 events in 30 [23%] participants in the discontinue group). Three participants in the continue group and four in the discontinue group had treatment-related adverse events, of which one in each group was a serious adverse event (multiple sclerosis relapse requiring admission to hospital). One participant in the continue group and two in the discontinue group died; no deaths were deemed to be related to treatment. We were unable to reject the null hypothesis and could not conclude whether disease-modifying therapy discontinuation is non-inferior to continuation in patients older than 55 years with multiple sclerosis and no recent relapse or new MRI activity. Discontinuation of disease-modifying therapy might be a reasonable option in patients older than 55 years who have stable multiple sclerosis, but might be associated with a small increased risk of new MRI activity. Patient-Centered Outcomes Research Institute and the National Multiple Sclerosis Society.

Comparison of Zenker's per-oral endoscopic myotomy (Z-POEM) with standard flexible endoscopic septotomy for Zenker's diverticulum: a prospective study with 2-year follow-up.

Flexible endoscopic therapy of Zenker's diverticulum using submucosal tunneling (Z-POEM) similar to esophageal Per-Oral Endoscopic Myotomy (POEM) is becoming increasingly common. However, data comparing Z-POEM with traditional flexible endoscopic septotomy (FES) are sparse. The aim of this study was to compare outcomes of Z-POEM with traditional FES over a medium-term follow-up period. This was a prospective study of patients who underwent Z-POEM for treatment of Zenker's diverticulum between 2018 and 2020 at a tertiary academic medical center compared to prior patients who had FES (between 2015 and 2018). Procedural characteristics and clinical outcomes (technical and clinical success, and adverse events) were compared between patients who underwent each treatment. A total of 28 patients underwent ZD therapy during the study period. 13 patients (mean age 70years; 77% male) underwent Z-POEM and 15 patients (mean age 72years; 73% male) underwent traditional FES. The mean Zenker's diverticulum size was 2.4 ± 0.6cm in the ZPOEM group vs 2.5 ± 0.8cm in the FES group. The mean procedure time was similar between groups: 43.9min (range 26-66) in the Z-POEM group and 60.2min (range 25-92) in the traditional FES group (t = 1.74 p = 0.19). Overall technical success was seen in 100% of patients. There was one adverse event in the FES group (dehydration resulting in near-syncope) (1/28, 3.6%). Overall clinical success was seen in 92.8% (26/28) of patients and was not significantly different between groups (Z-POEM; 13/13, 100% vs FES; 13/15, 86.7%, t = -1.36 p = 0.18). This prospective study suggests that ZPOEM is an effective technique for the treatment of Zenker's diverticulum with no significant differences in clinical outcomes or adverse event rates when compared to traditional FES.

No difference in outcomes with 15 mm vs. 20 mm lumen-apposing metal stents for endoscopic ultrasound-guided gastroenterostomy for gastric outlet obstruction: a meta-analysis.

We compared outcomes between use of 15 vs. 20 mm lumen-apposing metal stents (LAMSs) in endoscopic ultrasound-guided gastroenterostomy (EUS-GE) for gastric outlet obstruction. Databases were queried for studies that used LAMS for EUS-GE to relieve gastric outlet obstruction, and a proportional meta-analysis was performed. Thirteen studies were included. The 15 mm and 20 mm LAMS had pooled technical success rates of 93.2% (95% confidence interval [CI], 90.5%-95.2%) and 92.1% (95% CI, 68.4%-98.4%), clinical success rates of 88.6% (95% CI, 85.4%-91.1%) and 89.6% (95% CI, 79.0%-95.1%), adverse event rates of 11.4% (95% CI, 8.1%-15.9%) and 14.7% (95% CI, 4.4%-39.1%), and reintervention rates of 10.3% (95% CI, 6.7%-15.4%) and 3.5% (95% CI, 1.6%-7.6%), respectively. Subgroup analysis revealed no significant differences in technical success, clinical success, or adverse event rates. An increased need for reintervention was noted in the 15 mm stent group (pooled odds ratio, 3.59; 95% CI, 1.40-9.18; p=0.008). No differences were observed in the technical, clinical, or adverse event rates between 15 and 20 mm LAMS use in EUS-GE. An increased need for reintervention is possible when using a 15 mm stent compared to when using a 20 mm stent.

Fecal transplantation for treatment of inflammatory bowel disease.

Fecal transplantation for treatment of inflammatory bowel disease.

Efficacy and safety of HAIC alone vs. HAIC combined with lenvatinib for treatment of advanced hepatocellular carcinoma

To investigate efficacy and safety of hepatic arterial infusion chemotherapy combined with lenvatinib (HAIC-Len) and HAIC alone for the treatment of advanced hepatocellular carcinoma (Ad-HCC). Totally 349 patients with Ad-HCC participated in the research from February 2018 to October 2020. On the basis of propensity score matching (PSM), 132 and 110 cases were assigned to the HAIC group and the HAIC-Len group, respectively, with a ratio of 1:1. Progression-free survival (PFS), overall survival (OS), and complications were compared between two groups. The Kaplan-Meier method and log-rank test were utilized to estimate cumulative OS and PFS. Additionally, uni- and multi-variate Cox regression models were employed to identify significant independent factors. The median follow-up period in this study was set to be 20.8months. Following PSM, the one-, two- and three-year cumulative OS rates in the HAIC-Len and HAIC groups were 63.6%, 12.1%, and 3.0%, and 47.2%, 11.8%, and 2.7%, respectively, with a significant difference (P < 0.001). The first-three-year cumulative incidence rates PFS in the HAIC-Len and the HAIC groups were 15.2%, 1.5%, and ND, and 11.8%, 4.5%, and 3.6%, respectively, with no significant difference detected (P = 0.092). BMI (HR 0.709. 95% CI 0.549, 0.915. P = 0.008) and AST (HR 1.005. 95% CI 1.003, 1.007. P < 0.001) represented independent prognostic factors for OS. Additionally, the two groups exhibited no significant difference in the incidence rates of adverse events. HAIC-Len significantly improved survival outcomes of patients with Ad-HCC and demonstrated acceptable toxicity compared to HAIC alone.

Prognostic Impact of the Get-with-the-Guidelines Heart-Failure Risk Score (GWTG-HF) after Transcatheter Aortic Valve Replacement in Patients with Low-Flow–Low-Gradient Aortic Valve Stenosis

This study examined the prognostic value of the get-with-the-guidelines heart-failure risk score (GWTG-HF) on mortality in patients with low-flow-low-gradient aortic valve stenosis (LFLG-AS) after transcatheter aortic valve implantation (TAVI). Data on feasibility of TAVI and mortality prediction in the LFLG-AS population are scarce. Clinical risk assessment in this particular population is difficult, and a score has not yet been established for this purpose. A total of 212 heart failure (HF) patients with real LFLG-AS were enrolled. Patients were classified into low-risk (n = 108), intermediate-risk (n = 90) and high-risk (n = 14) groups calculated by the GWTG-HF score. Clinical outcomes of cardiovascular events according to Valve Academic Research Consortium (VARC-2) recommendations and composite endpoint of death and hospitalization for heart failure (HHF) were assessed at discharge and 1 year of follow-up. Baseline parameters of the groups showed a median age of 81.0 years [77.0; 84.0] (79.0 vs. 82.0 vs. 86.0, respectively p < 0.001), median EuroSCORE II of 6.6 [4.3; 10.7] (5.5 vs. 7.2 vs. 9.1, p = 0.004) and median indexed stroke volume of 26.7 mL/m2 [22.0; 31.0] (28.2 vs. 25.8 vs. 25.0, p = 0.004). The groups significantly differed at follow-up in terms of all-cause mortality (10.2 vs. 21.1 vs. 28.6%; p < 0.035). There was no difference in intrahospital event rate (VARC). Postprocedural mean gradients were lower in high-risk group (7.0 vs. 7.0 vs. 5.0 mmHg, p = 0.011). No differences in postprocedural aortic valve area (1.9 vs. 1.7 vs. 1.9 cm2, p = 0.518) or rate of device failure (5.6 vs. 6.8 vs. 7.7%, p = 0.731) could be observed. After adjustment for known predictors, the GWTG score (HR 1.07 [1.01-1.14], p = 0.030) as well as pacemaker implantation (HR 3.97 [1.34-11.75], p = 0.013) turned out to be possible predictors for mortality. An increase in stroke volume index (SVI) was, in contrast, protective (HR 0.90 [0.83-0.97]; p = 0.006). The GWTG score may predict mortality after TAVI in LFLG-AS HF patients. Interestingly, all groups showed similar intrahospital event and mortality rates, independent of calculated mortality risk. Low SVI and new conduction disturbances associated with PPI after THV implantation had negative impact on mid-term outcome in post-TAVI HF-patients.

Oral Class I and III antiarrhythmic drugs for maintaining sinus rhythm after catheter ablation of atrial fibrillation.

Oral Class I and III antiarrhythmic drugs for maintaining sinus rhythm after catheter ablation of atrial fibrillation.

Safety and efficacy of direct oral anticoagulants versus vitamin K antagonists in atrial fibrillation electrical cardioversion: An update systematic review and meta-analysis

BackgroundA systematic evaluation focused on efficacy and safety for electrical cardioversion of atrial fibrillation (AF) among different Direct Oral Anticoagulants (DOACs) has not been previously performed. In this setting, we conducted a meta-analysis of studies evaluating DOACs vs vitamin K antagonists (VKA) as common comparator. MethodsWe searched Cochrane Library, Pubmed, Web Of Science and Scopus databases for all English-only articles concerning studies that have estimated the effect of DOACs and VKA on stroke, transient ischemic attack or systemic embolism (SSE) and major bleeding (MB) events in AF patients undergoing electrical cardioversion. We selected 22 articles comprising 66 cohorts and 24,322 procedures (12,612 with VKA). ResultsDuring follow-up (studies' median 42 days), 135 SSE (52 DOACs and 83 VKA) and 165 MB (60 DOACs and 105 VKA) were recorded. The overall pooled effects, DOACs vs VKA, was estimated by an univariate Odds Ratio of 0.92 (0.63–1.33; p = 0.645) for SSE and 0.58 (0.41–0.82; p = 0.002) for MB; at bivariate evaluation, adjusting for study type, were respectively 0.94 (0.55–1.63; p = 0.834) and 0.63 (0.43–0.92, p = 0.016). Each single DOAC showed similar and non statistically different results in outcome occurrence compared to VKA as well as when Apixaban, Dabigatran, Edoxaban and Rivaroxaban were indirectly compared to each other. ConclusionsIn patients undergoing electrical cardioversion, compared to VKA, DOACs have similar thromboembolic protection with lower major bleeding incidence. Single molecule does not show difference in event rate compared to each other. Our findings, provide useful information about safety and efficacy profile of DOACs and VKA.

Abstract P626: Associations of Supervised and Home-Based Exercise With Serious Adverse Event Rates During Exercise Interventions for Peripheral Artery Disease: A Meta-Analysis of Five Randomized Clinical Trials

Background: Supervised or home-based walking exercise therapy (ET) are guideline recommended to improve walking performance in people with peripheral artery disease (PAD). This study compared serious adverse event (SAE) rates associated with home-based compared to supervised exercise in people randomized into clinical trials of ET for PAD. Methods: Data from five randomized clinical trials of ET for PAD were combined. In three trials (GOALS, HONOR, and LITE), participants were randomized to home-based ET or control. In two trials (PROPEL and TELEX), participants were randomized to supervised ET or control. The primary outcome in all trials was change in six-minute walk. SAEs consisted of hospitalization or death and were identified from participants, family members, and medical records. In post-hoc analyses, a meta-analysis compared associations of supervised ET and home-based ET on odds of a SAE or death. Control groups from the trials of supervised and home-based ET were not combined. Results: 867 unique participants were included (mean age + SD: 69 ±10 years, 47% female, 57 % Black, mean + SD ABI 0.66 ±0.15). Results are shown in the Table. Conclusion: In clinical trials of home-based ET, rates of coronary revascularizations and cardiovascular events were significantly higher in participants randomized to exercise, compared to control. However, there were no significant differences in rates of coronary revascularizations or cardiovascular events between participants randomized to home-based, compared to supervised ET. Improved walking performance from home-based exercise may precipitate symptoms from underlying coronary artery disease in people with PAD.

Endoscopic full-thickness resection (EFTR) compared to submucosal tunnel endoscopic resection (STER) for treatment of gastric gastrointestinal stromal tumors.

Background and study aims Submucosal tunnel endoscopic resection (STER) is being increasingly performed for treatment of gastric gastrointestinal stromal tumor (GIST), while STER has been limited by close dissection within tunnel and risking breach of tumor capsule. Endoscopic full-thickness resection (EFTR) allows resection of GIST with margins to prevent recurrence. This study aimed to compare EFTR against STER for treatment of gastric GIST. Patients and methods We retrospectively reviewed clinical outcomes of patients with gastric GIST who received either STER or EFTR. Patients with gastric GISTs < than 4 cm were included. Clinical outcomes including baseline demographics, perioperative and oncological outcomes were compared between the two groups. Results From 2013 to 2019, 46 patients with gastric GISTs were treated with endoscopic resection, 26 received EFTR and 20 received STER. Most of the GISTs were in the proximal stomach. There was no difference in operative time (94.9 vs 84.9 mins; P = 0.401), while endoscopic suturing was applied more for closure after EFTR ( P < 0.0001). Patients after STER had earlier resumption of diet and shorter hospital stay while there was no difference in adverse event rate between two groups. The en-bloc resection rate for EFTR was significantly higher than for STER (100 % vs 80 %; P = 0.029), while there was no difference in the local recurrence. Conclusions This study demonstrated that although patients who received EFTR had longer hospital stays and slower resumption of diet compared to those who underwent STER, EFTR achieved a significantly higher rate of en-bloc resection compared to STER for treatment of gastric GIST.

Patients with Cognitive Impairment in Parkinson's Disease Benefit from Deep Brain Stimulation: A Case-Control Study.

Deep brain stimulation (DBS) for Parkinson's disease (PD) is generally contraindicated in persons with dementia but it is frequently performed in people with mild cognitive impairment or normal cognition, and current clinical guidelines are primarily based on these cohorts. To determine if moderately cognitive impaired individuals including those with mild dementia could meaningfully benefit from DBS in terms of motor and non-motor outcomes. In this retrospective case-control study, we identified a cohort of 40 patients with PD who exhibited moderate (two or more standard deviations below normative scores) cognitive impairment (CI) during presurgical workup and compared their 1-year clinical outcomes to a cohort of 40 matched patients with normal cognition (NC). The surgery targeted subthalamus, pallidus or motor thalamus, in a unilateral, bilateral or staged approach. At preoperative baseline, the CI cohort had higher Unified Parkinson's Disease Rating Scale (UPDRS) subscores, but similar levodopa responsiveness compared to the NC cohort. The NC and CI cohorts demonstrated comparable degrees of postoperative improvement in the OFF-medication motor scores, motor fluctuations, and medication reduction. There was no difference in adverse event rates between the two cohorts. Outcomes in the CI cohort did not depend on the target, surgical staging, or impaired cognitive domain. Moderately cognitively impaired patients with PD can experience meaningful motor benefit and medication reduction with DBS.

Impact of core laboratory assessment on treatment decisions and clinical outcomes using combined fractional flow reserve and coronary flow reserve measurements – DEFINE-FLOW core laboratory sub-study

ObjectiveThe role of combined FFR/CFR measurements in decision-making on coronary revascularization remains unclear. DEFINE-FLOW prospectively assessed the relationship of FFR/CFR agreement with 2-year major adverse cardiac event (MACE) and target vessel failure (TVF) rates, and uniquely included core-laboratory analysis of all pressure and flow tracings. We aimed to document the impact of core-laboratory analysis on lesion classification, and the relationship between core-laboratory fractional flow reserve (FFR) and coronary flow reserve (CFR) values with clinical outcomes and angina burden during follow-up. MethodsIn 398 vessels (348 patients) considered for intervention, ≥1 coronary pressure/flow tracing was approved by the core-laboratory. Revascularization was performed only when both FFR(≤0.80) and CFR(<2.0) were abnormal, all others were treated medically. ResultsMACE was lowest for concordant normal FFR/CFR, but was not significantly different compared with either discordant group (low FFR/normal CFR: HR:1.63; 95%CI:0.61–4.40; P = 0.33; normal FFR/low CFR: HR:1.81; 95%CI:0.66–4.98; P = 0.25). Moreover, MACE did not differ between discordant groups treated medically and the concordant abnormal group undergoing revascularization (normal FFR/low CFR: HR:0.63; 95%CI:0.23–1.73;P = 0.37; normal FFR/low CFR: HR:0.70; 95%CI:0.22–2.21;P = 0.54). Similar findings applied to TVF. ConclusionsPatients with concordantly normal FFR/CFR have very low 2-year MACE and TVF rates. Throughout follow-up, there were no differences in event rates between patients in whom revascularization was deferred due to preserved CFR despite reduced FFR, and those in whom PCI was performed due to concordantly low FFR and CFR. These findings question the need for routine revascularization in vessels showing low FFR but preserved CFR.Clinical trial registration: http://ClinicalTrials.govNCT02328820

DB-2-4: NO, WE SHOULD NOT STOP ANTIHYPERTENSIVE MEDICATIONS FOR END-OF-LIFE PATIENTS WITH HYPERTENSION

End-of-life patients, the Debate theme, are sometimes described as patients with limited life expectancy. Even if one is under the impression that death shortly is inevitable for the patient in front of them due to a specific disease, the duration of life expectancy varies and is difficult to estimate. Factors affecting the period of life expectancy are complicated, including the causative disease, comorbidities, the environment of care, and the individual's physical and mental capacity. Although high blood pressure does not directly affect life expectancy, hypertension affects life expectancy, quality of life, and ADL through the development or exacerbation of stroke, cardiovascular disease, and renal failure. This situation is the same even for end-of-life individuals, who are at high risk of hypertensive complications if their hypertension is poorly controlled. Worsened blood pressure control increases the risk of stroke and heart failure, even within a few months. The VALUE trial found a significant difference in the incidence of events within the first six months after randomization to the two treatment groups. This difference in event rate was attributed to differences in blood pressure levels between the two groups during that period. The VALUE trial did not include end-of-life patients. Still, it can be assumed that even in end-of-life patients, an increase in blood pressure due to withdrawal of antihypertensive medication may increase the incidence of events within a few months. Of course, deprescribing may be acceptable if blood pressure is still controlled within a level less than 140/90. However, there are currently no randomized controlled trials on the effects of such reduction of antihypertensive drugs. There have been several studies and systematic reviews on whether overall withdrawal of therapeutic drugs should be undertaken for end-of-life patients, not specific to antihypertensive medications. None of these studies has reached a clear conclusion in favor of drug treatment withdrawal. In the most plausible conclusion, “We should not stop antihypertensive medications for end-of-life patients with hypertension.”

PS-C19-7: HYPERTENSION INDUCED BY BEVACIZUMAB

Objectives: To determine the incidence of the novo hypertension in patients under bevacizumab treatment. To determine the blood pressure (BP) effect of Bevacizumab in previously diagnosed hypertensive patients. To evaluate the clinical significance of Bevacizumab induced hypertension. Design and Methods: Retrospective, Cohort study. Time period from 1/2015 to 06/2020 at Hospital Privado Universitario de Córdoba, Argentina. Inclusion criteria: All patients over 18 years of age. Under Bevacizumab as antineoplastic treatment, either as a single or as a combined agent. No history of previous anti-VEGF treatment. Uncontrolled BP if mean office BP &gt; 140/90mmHg. Results: n = 93. Mean age 63.7 years (40 - 81). Female 52.8%. Smokers 39.8%. BMI 26.3 ± 4.8. Previous HTN 56.6%, 90% under antihypertensive treatment. Hypertensive patients were older and with greater history of familiar with HTN than those normotensives. Before Bevacizumab administration, the prevalence of uncontrolled BP was 10.9% in previous normotensive and 19.5% in previous hypertensive patients. After 12 months of treatment with Bevacizumab, 75% of those previous normotensives and 87.5% of those previous hypertensives had uncontrolled BP. There were no differences in rates of cardiovascular events (5.4%), cardiovascular deaths (2.7%) and survival between those with controlled and uncontrolled BP after the administration of Bevacizumab (Figure 1). Conclusions: High prevalence of uncontrolled BP after initiation of Bevacizumab. While it is widely accepted that the long-term risks of hypertension are serious, the short-term risk seems to be less relevant. BP target could be higher than in the general population, adjusted to performance status and comorbidities.

Efficacy of lumen-apposing metal stents for the management of benign gastrointestinal stricture: a systematic review and meta-analysis.

Lumen-apposing metal stents (LAMS) are an evolving option for the management of benign gastrointestinal (GI) strictures. Multiple studies have reported on the efficacy and safety of LAMS for benign GI strictures, but were limited by their small sample size. Hence, we conducted this meta-analysis to assess the critical role of LAMS for the management of benign GI strictures. A literature search of various databases from inception until October 2022 was conducted for studies evaluating the outcome of LAMS in patients with benign GI strictures. The outcomes assessed included technical and clinical success, adverse events including stent migration, and reintervention. Pooled event rates across studies were expressed with summative statistics. A total of 18 studies (527 patients) were included in the present analysis. The pooled event rates for technical, short-term and long-term clinical success were 99.9% (95% confidence interval [CI] 99.1-100.0), 93.9% (95%CI 90.7-100.0), and 72.8% (95%CI 55.7-90.0), respectively. The pooled incidence of adverse events and stent migration with LAMS for benign GI strictures was 13.5% (95%CI 8.6-18.5) and 10.6% (95%CI 6.0-15.2), respectively. The pooled event rate for reintervention with LAMS for GI strictures was 23.0% (95%CI 15.7-30.3). In a subgroup analysis focusing only on anastomotic strictures there was no significant difference in the pooled event rates for various outcomes. LAMS have a high technical and short-term clinical success rate, with an acceptable safety profile for the management of benign GI strictures. Further studies are needed to determine the appropriate duration of stent therapy and long-term outcomes.

Comparison of Large-Bore Thrombectomy With Catheter-Directed Thrombolysis for the Treatment of Pulmonary Embolism.

There is significant debate on whether large-bore thrombectomy (LBT) or catheter-directed thrombolysis (CDT) is superior for the treatment of intermediate- and high-risk pulmonary embolism (PE) while employing an early invasive strategy through endovascular therapies. Between 2018 and 2021, 147 patients who presented to our institution with acute intermediate- or high-risk PE and had undergone PE Response Team-guided endovascular intervention with either LBT (Inari FlowTriever) or CDT (EKOSonic) were retrospectively reviewed. Data on the patients' clinical characteristics, comorbidities, serum biomarkers, hemodynamics, and imaging characteristics were obtained. The primary outcome was all-cause mortality; the secondary outcomes were all-cause readmission, readmission for PE, and length of stay in the intensive care unit and hospital. The safety outcome of procedure-related bleeding was evaluated. Kaplan-Meier curves were used to estimate the cumulative event rate. Multivariate Cox-proportional hazard regression and inverse propensity weighting were used to adjust for confounders. The median age of the patients was 63 (IQR, 53-73) years, and 48.3% of the patients were women. Patients in the LBT group had a higher PE Severity Index score (LBT vs CDT: median, 132 vs 108; P = .015) and greater prevalence of malignancy (LBT vs CDT: median, 22.7% vs 6%; P = .011). After propensity matching for baseline characteristics, there was no significant difference in all-cause mortality (LBT vs CDT: median, 15.8% vs 9.1%; hazard ratio, 0.64; 95% CI, 0.21-1.98; P = .442) for up to 1 year. The secondary outcomes or safety end points were also similar between the 2 interventions. An exploratory analysis showed elevated PE Severity Index scores, lower systolic blood pressures, and higher lactic acid levels to be associated with an increased risk of early death at 30 days. In this retrospective cohort study, there was no significant difference in the cumulative event rate of all-cause mortality between LBT and CDT. Further studies are needed to evaluate the use of LBT versus CDT versus noninvasive therapy to understand outcomes and appropriate patient selection among those with intermediate- and high-risk PE.

Impact of previous lumbar spine surgery on the outcome of lumbar total disc replacement: analysis of prospective 5-year follow-up study data.

It is sometimes anticipated that patients with prior spine surgery will have a compromised outcome from future procedures. The purpose of this study was to compare TDR outcomes in patients with prior lumbar spine surgery to those with no previous surgery. Post hoc analysis was performed on 5-year follow-up data collected prospectively in the multi-centre FDA-regulated trial for the activL® Artificial Disc which involved 376 patients treated for single-level symptomatic disc degeneration. Clinical outcome measures included the Oswestry Disability Index (ODI), visual analog scales (VAS) assessing back and leg pain, SF-36, adverse events, and re-operations. Radiographic outcomes included flexion/extension range of motion (ROM) and translation of the operated segment. Patients were divided into two groups: Prior Lumbar Surgery (PLS, n = 92) and No Prior Lumbar Surgery (NPLS, n = 284). Baseline demographics were similar in the two groups. ODI, VAS, and SF-36 Physical Component Scale scores improved significantly (p < 0.05) from baseline in both groups with improvements maintained through 5-year post-TDR with no significant differences between groups. There were no statistically significant differences in rates of serious device-related events, procedure-related events, or re-operations. While ROM was significantly less prior to TDR surgery in the PLS group, there was no significant difference in ROM at post-operative points. Prior lumbar spine surgery was not associated with compromised outcomes following TDR. These results are in line with reports from earlier studies with shorter follow-up, finding that non-destabilizing prior surgery is not a contra-indication for TDR provided that selection criteria are met. Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.

Efficacy and Tolerability of 14-Day Tegoprazan- versus Rabeprazole-Based Triple Therapy for Eradication of Helicobacter pylori: A Real-World Evidence Study.

Tegoprazan, a new, fast, and strong potassium-competitive acid blocker, has been approved for the treatment of gastric acid-related diseases in Korea. However, real-world clinical data regarding this drug are scarce. We aimed to compare the Helicobacter pylori eradication rates of tegoprazan- and rabeprazole-based triple therapy. We retrospectively reviewed data from patients who received first-line treatment for H. pylori infection using tegoprazan- or rabeprazole-based triple therapy for 2 weeks (50 mg tegoprazan or 20 mg rabeprazole+1,000 mg amoxicillin+500 mg clarithromycin twice daily). The primary endpoint was the eradication rate as determined by intention-to-treat analysis. Of the 677 patients included in our study, 344 and 333 received tegoprazan-based and rabeprazole-based triple therapy, respectively. The eradication rate from intention-to-treat analysis was 76.7% (95% confidence interval [CI], 72.1% to 81.0%) for tegoprazan-based triple therapy and 75.4% (95% CI, 70.5% to 79.8%) for rabeprazole-based triple therapy. There was no significant difference in the eradication rates between the two groups (p>0.999). Per-protocol analysis also revealed no significant difference between the eradication rates of the two groups (tegoprazan 83.4% [95% CI, 79.0% to 87.2%] vs rabeprazole 83.5% [79.0% to 87.4%], p>0.999). Furthermore, there was no significant difference in adverse event rates between the two groups (tegoprazan, 27.6%; rabeprazole, 25.8%; p=0.604). The eradication rate of tegoprazan-based triple therapy was similar to that of rabeprazole-based triple therapy. Further studies on the dose-escalation effect of tegoprazan for H. pylori eradication and the efficacy of tegoprazan in regimens other than conventional triple therapy are needed.