scholarly journals Phase 2 randomized study of oral ibrexafungerp vs fluconazole in vulvovaginal candidiasis

2021 ◽  
Author(s):  
Paul Nyirjesy ◽  
Jane R Schwebke ◽  
David A Angulo ◽  
Itzel A Harriott ◽  
Nkechi E Azie ◽  
...  
Keyword(s):  
Clinical Cure ◽  
Treatment Options ◽  
Randomized Study ◽  
Positive Culture ◽  
Signs And Symptoms ◽  
Primary Objective ◽  
Vulvovaginal Candidiasis ◽  
Dose Finding ◽  
Comparable Efficacy ◽  
Tolerability Profile

Abstract Background Vulvovaginal candidiasis affects approximately 75% of women in their lifetime. Approved treatment options are limited to oral or topical azoles. Ibrexafungerp, a novel, first-in-class oral triterpenoid glucan synthase inhibitor, has demonstrated broad fungicidal Candida activity and a favorable tolerability profile. The primary objective of this dose finding study was to identify the optimal dose of oral ibrexafungerp in patients with acute vulvovaginal candidiasis. Study Design Patients with vulvovaginal signs and symptoms score ≥7 were randomized equally to 6 treatments groups: 5 treatment doses of oral ibrexafungerp or oral fluconazole 150 mg. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms) at the test-of-cure visit (day 10). Results Overall, 186 patients were randomized into the 6 treatment groups. Results, using the modified intent-to-treat population (baseline positive culture), are reported for ibrexafungerp 300 mg BID for 1 day (n=27), which was the dose selected for phase 3 studies, and fluconazole 150 mg for 1 day (n=24). At day 10, the clinical cure rates for ibrexafungerp and fluconazole were, 51.9% and 58.3%, respectively; at day 25, patients with no signs or symptoms were 70.4% and 50.0%, respectively. During the study ibrexafungerp patients required less antifungal rescue medications compared with fluconazole (3.7% vs 29.2%, respectively). Ibrexafungerp was well-tolerated, with the most common treatment-related adverse events being mild gastrointestinal events. Conclusions Ibrexafungerp is a well-tolerated novel antifungal with comparable efficacy to fluconazole in the treatment of acute vulvovaginal candidiasis.

scholarly journals Ibrexafungerp versus placebo for vulvovaginal candidiasis treatment: a phase 3, randomized, controlled superiority trial (VANISH 303)

2021 ◽  
Author(s):  
Jane R Schwebke ◽  
Ryan Sobel ◽  
Janet K Gersten ◽  
Steven A Sussman ◽  
Samuel N Lederman ◽  
...  
Keyword(s):  
Clinical Improvement ◽  
Clinical Cure ◽  
Oral Treatment ◽  
Treatment Options ◽  
Signs And Symptoms ◽  
Current Treatment ◽  
Vulvovaginal Candidiasis ◽  
Symptom Resolution ◽  
Superiority Trial

Abstract Background Current treatment of vulvovaginal candidiasis (VVC) is largely limited to azole therapy. Ibrexafungerp is a first-in-class triterpenoid antifungal with broad-spectrum anti-Candida fungicidal activity. The objective of this study was to evaluate the efficacy and safety of ibrexafungerp compared with placebo in patients with acute VVC. Study Design Patients were randomly assigned 2:1 to receive ibrexafungerp (300 mg twice for 1 day) or placebo. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms [VSS]=0) at test-of-cure (day 11±3). Secondary endpoints included the percentage of patients with mycological eradication, overall success (clinical cure and mycological eradication), clinical improvement (VSS≤1) at test-of-cure, and symptom resolution at follow-up (day 25±4). Results Patients receiving ibrexafungerp had significantly higher rates of clinical cure (50.5% [95/188] vs 28.6% [28/98]; P=0.001), mycological eradication (49.5% [93/188] vs 19.4% [19/98]; P<0.001), and overall success (36.0% [64/178] vs 12.6% [12/95]; P<0.001) compared with placebo. Symptom resolution was sustained and further increased with ibrexafungerp compared with placebo (59.6% [112/188] vs 44.9% [44/98]; P=0.009) at follow-up. Post hoc analysis showed similar rates of clinical cure and clinical improvement at test-of-cure for African American patients (54.8% [40/73] and 63.4% [47/73], respectively) and patients with a body mass index >35 (54.5% [24/44] and 68.2% [30/44], respectively) compared with overall rates. Ibrexafungerp was well tolerated. Adverse events were primarily gastrointestinal and mild in severity. Conclusion Ibrexafungerp provides a promising safe and efficacious oral treatment that mechanistically differs from current azole treatment options for acute VVC.

scholarly journals Linagliptin–-A Novel Dipeptidyl Peptidase Inhibitor for Type 2 Diabetes Therapy

2012 ◽  
Vol 5 ◽  
pp. CMED.S7274 ◽  
Author(s):  
Baptist Gallwitz
Keyword(s):  
Type 2 Diabetes ◽  
Treatment Options ◽  
Comparable Efficacy ◽  
Tolerability Profile ◽  
Pharmacological Profile ◽  
Diabetes Therapy ◽  
Favourable Safety ◽  
Peptidase Inhibitor ◽  
Orally Active

Incretin based therapies have been introduced into the treatment options of type 2 diabetes a few years ago. Among them, the orally active DPP-4 inhibitors have established themselves as insulinotropic agents. Their advantage is the glucose-dependent insulinotropic action without an intrinsic risk for causing hypoglycemia. Additionally DPP-4 inhibitors have a glucose dependent glucagonostatic action contributing to improved glucose control. They are weight neutral and show a good safety and tolerability profile with comparable efficacy to sulfonylureas. Linagliptin is a novel DPP-4 inhibitor with a distinct pharmacological profile. In contrast to the other approved DPP-4 inhibitors it is eliminated by a hepatic/biliary route rather than a renal route. Therefore no dose adjustment is recommended in patients with type 2 diabetes and renal impairment. In clinical studies, it has been shown to be non-inferior to sulfonylurea treatment regarding glycemic parameters, but to possess favourable safety advantages regarding hypoglycemia frequency, body weight development and effects on cardioavascular parameters. This article gives an overview on the pharmacology of linagliptin as well as on the clinical data available.

Phase 1b/2 study of binimetinib (BINI) in combination with nivolumab (NIVO) or NIVO plus ipilimumab (IPI) in patients (pts) with previously treated microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) with RAS mutation.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. TPS870-TPS870 ◽  
Author(s):  
Johanna C. Bendell ◽  
Scott Kopetz ◽  
Mark R. Middleton ◽  
P. Taylor Eves ◽  
Viviana Bozon ◽  
...  
Keyword(s):  
Checkpoint Inhibitors ◽  
Mapk Pathway ◽  
Treatment Options ◽  
Primary Objective ◽  
Dose Finding ◽  
Phase 2 ◽  
Open Label ◽  
Ras Mutation ◽  
Previously Treated ◽  
Phase 1B

TPS870 Background: Approximately 96% of CRCs have an MSS phenotype, which results in more immunologically quiescent tumors for which immunotherapies are largely ineffective (Lee et al. 2015; Overman et al. 2016). Pts with MSS CRC and activating RAS mutation (35%–45% of CRCs) have treatment options limited still further because anti-EGFR monoclonal antibodies (eg, cetuximab) are ineffective owing to dominant activation of RAS in the MAPK pathway (Douillard et al. 2014). However, preclinical and preliminary clinical data suggest that MAPK pathway inhibition enhances antigen presentation and T-cell cytotoxicity to positively modulate the efficacy of checkpoint inhibitors (Brea et al. 2016; Bendell et al. 2014). The main objective of this open-label multicenter phase 1b/2 study is to evaluate whether the potential positive modulation of NIVO or NIVO plus IPI, when combined with BINI, translates into clinically meaningful overall response in pts with MSS mCRC and RAS mutation. Methods: The study will enroll ~90 previously treated pts (1 or 2 prior regimens), ~42 in phase 1b and ~48 in phase 2. The primary objective of phase 1b will be to determine the recommended phase 2 dose (RP2D) of BINI in combination with NIVO ± IPI. Dose finding in the doublet arm will begin with BINI 45 mg BID + NIVO 480 mg Q4W; the triplet arm will begin with the BINI RP2D from the doublet arm + NIVO 480 mg Q4W + IPI 1 mg/kg Q8W. In phase 2, pts will be randomized 1:1 to doublet or triplet arms, incorporating the BINI RP2Ds found in phase 1b; treatment will continue in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, loss to follow-up, or death. The primary objective for phase 2 will be to assess response by RECIST version 1.1. The study will also characterize safety and PK. CT.gov Identifier: Clinical trial information: NCT03271047.

Endovenous procedures in varicose veins

Phlebologie ◽  
2008 ◽  
Vol 37 (05) ◽  
pp. 229-236
Author(s):  
N. Cayne ◽  
G. Jacobowitz ◽  
P. Lamparello ◽  
T. Maldonado ◽  
C. Rockman ◽  
...  
Keyword(s):  
Varicose Veins ◽  
Treatment Options ◽  
Postoperative Recovery ◽  
Comparable Efficacy ◽  
Intense Pulse Light ◽  
Efficacy And Safety ◽  
Endovenous Laser Ablation ◽  
The Past ◽  
Early Evidence ◽  
Endovenous Treatment

SummaryOver the past ten years endoveous treatment options for varicose veins have evovled considerably, offering clinicians a multitude of options to meet the needs of their patients. The endothermal ablation procedures have moved to the forefront as the choice modality for treating truncal reflux. Both radiofrequency ablation and endovenous laser ablation are widely accepted and interchangeable, showing comparable efficacy and safety. Although numerous endovenous laser wavelengths exist, the data indicates that the differences do not affect the efficacy or postoperative recovery of the procedure. The endovenous laser innovation that has shown early evidence of improved patient outcome is the jacket-tip fiber. The versatility of sclerotherapy makes it a critical component in the endovenous treatment of varicosities. Although not approved by the Food and Drug Administration (USA), the use of a foamed sclerosing agent is the fastest growing segment of sclerotherapy and an important treatment modality in the future of varicose vein treatment. Cutaneous lasers and intense pulse light devices contribute a crucial element, enabling clinicians to treat minute veins that may be impossible to treat with other therapies.

scholarly journals Early combination therapy with etanercept and methotrexate in JIA patients shortens the time to reach an inactive disease state and remission: results of a double-blind placebo-controlled trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Ekaterina Alexeeva ◽  
Gerd Horneff ◽  
Tatyana Dvoryakovskaya ◽  
Rina Denisova ◽  
Irina Nikishina ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Controlled Trial ◽  
Randomized Study ◽  
Primary Objective ◽  
Disease State ◽  
Inactive Disease ◽  
Open Label ◽  
Standard Regimen ◽  
Double Blind ◽  
Early Combination Therapy

Abstract Background Remission is the primary objective of treating juvenile idiopathic arthritis (JIA). It is still debatable whether early intensive treatment is superior in terms of earlier achievement of remission. The aim of this study was to evaluate the effectiveness of early etanercept+methotrexate (ETA+MTX) combination therapy versus step-up MTX monotherapy with ETA added in refractory disease. Methods A multi-centre, double-blind, randomized study in active polyarticular JIA patients treated with either ETA+MTX (n = 35) or placebo+MTX (n = 33) for up to 24 weeks, followed by a 24-week open-label phase. The efficacy endpoints included pedACR30 criteria improvement at week 12, inactive disease at week 24, and remission at week 48. Patients who failed to achieve the endpoints at week 12 or at week 24 escaped to open-label ETA+MTX. Safety was assessed at each visit. Results By intention-to-treat analysis, more patients in the ETA+MTX group reached the pedACR30 response at week 12 (33 (94.3%)) than in the placebo+MTX group (20 (60.6%); p = 0.001). At week 24, comparable percentages of patients reached inactive disease (11 (31.4%) vs 11 (33.3%)). At week 48, 11 (31.4%) and eight (24.2%) patients achieved remission. The median (+/−IQR) times to achieve an inactive disease state in the ETA+MTX and placebo+MTX groups were 24 (14–32) and 32 (24–40) weeks, respectively. Forty-four (74/100 patient-years) adverse events (AEs) were reported, leading to treatment discontinuation in 6 patients. Conclusions Early combination therapy with ETA+MTX proved to be highly effective compared to the standard step-up regimen. Compared to those treated with the standard regimen, more patients treated with a combination of ETA+MTX reached the pedACR30 response and achieved inactive disease and remission more rapidly.

scholarly journals Decision Making from the Experience of Orthognathic Surgery Patients: A Grounded Theory Approach

2021 ◽  
pp. 238008442110144
Author(s):  
N.R. Paul ◽  
S.R. Baker ◽  
B.J. Gibson
Keyword(s):  
Decision Making ◽  
Grounded Theory ◽  
Treatment Options ◽  
Study Data ◽  
Primary Objective ◽  
Major Surgery ◽  
Future Research ◽  
Decision Making Process ◽  
Theory Approach

Introduction: Patients’ decisions to undergo major surgery such as orthognathic treatment are not just about how the decision is made but what influences the decision. Objectives: The primary objective of the study was to identify the key processes involved in patients’ experience of decision making for orthognathic treatment. Methods: This study reports some of the findings of a larger grounded theory study. Data were collected through face-to-face interviews of patients who were seen for orthognathic treatment at a teaching hospital in the United Kingdom. Twenty-two participants were recruited (age range 18–66 y), of whom 12 (male = 2, female = 10) were 6 to 8 wk postsurgery, 6 (male = 2, female = 4) were in the decision-making stage, and 4 (male = 0, female = 4) were 1 to 2 y postsurgery. Additional data were also collected from online blogs and forums on jaw surgery. The data analysis stages of grounded theory methodology were undertaken, including open and selective coding. Results: The study identified the central role of dental care professionals (DCPs) in several underlying processes associated with decision making, including legitimating, mediating, scheduling, projecting, and supporting patients’ decisions. Six categories were related to key aspects of decision making. These were awareness about their underlying dentofacial problems and treatment options available, the information available about the treatment, the temporality of when surgery would be undertaken, the motivations and expectation of patients, social support, and fear of the surgery, hospitalization, and potentially disliking their new face. Conclusion: The decision-making process for orthognathic treatment is complex, multifactorial, and heavily influenced by the role of DCPs in patient care. Understanding the magnitude of this role will enable DCPs to more clearly participate in improving patients’ decision-making process. The findings of this study can inform future quantitative studies. Knowledge Transfer Statement: The results of this study can be used both for informing clinical practice around enabling decision making for orthognathic treatment and also for designing future research. The findings can better inform clinicians about the importance of their role in the patients’ decision-making process for orthognathic treatment and the means to improve the patient experience. It is suggested that further research could be conducted to measure some of the key constructs identified within our grounded theory and assess how these change during the treatment process.

scholarly journals Improvement of the heart failure patient process for the prevention of new events through tele-education and continuous tele-optimization of the treatment by nursing staff

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
M Perez Serrano ◽  
CNP Carlos Nicolas Perez Garcia ◽  
DEV Daniel Enriquez Vazquez ◽  
MFE Marcos Ferrandez Escarabajal ◽  
JDD Jesus Diz Diaz ◽  
...  
Keyword(s):  
Heart Failure ◽  
Nyha Class ◽  
Randomized Study ◽  
Primary Objective ◽  
Control Group ◽  
Close Monitoring ◽  
Chronic Patients ◽  
Face To Face ◽  
Funding Sources

Abstract Funding Acknowledgements Type of funding sources: None. Introduction patients with heart failure (HF) are especially vulnerable to SAR-CoV-2 infection especially due to their worse prognosis for this disease. Purpose to demonstrate that patients with HF will present similar health outcomes if their education and pharmacological treatment is optimised remotely by a nurse rather than through conventional care. Methods  A single-centre, observational, prospective, non-randomized study was carried out in which two groups were compared. The experimental group had most of their care provided virtually by a nurse who could optimise their medication according to the clinical guides whilst the control group received conventional face-to-face care. During a follow-up period of 6 months, patients included in the study have an initial face-to-face consultation with a cardiologist and an evaluation of the patient where the treatment objectives are established. The rest of the follow-ups were done through videoconsultation with the nurse every 15 days for 6 months where the neurohormonal treatment was optimized and an educational program was carried out with different cardiovascular educational topics. Results   Thirty-seven patients have been included. Sex: 30 men (81.0%) and 7 women (19.0%) Mean age: 67.9 years (12.8). Range 42-87 years. Etiology: 61.2% ischemic and 38.8% non-ischemic mean LVEF at inclusion = 30.2%. A total of 17 patients have completed the study: a 13% average improvement of FEVI, a reduction of NT-proBNP of and improvement in functional heart failure class. The primary objective was to compare the proportion of neurohormonal drugs prescribed, as well as the mean of the maximum doses reached in each after 6 months of follow-up, as well as mean ejection fraction, NYHA class and mean NT-proBNP (Table 1) Conclusions Telemedicine offers us valuable tools that allow us to take care of chronic patients, reducing exposure to the virus as much as possible. Efficient use of virtual tools and human resources makes close monitoring possible. Specialized nursing is a key element in the education, pharmacological optimization and monitoring of these patients. Parámetros analíticos Valores iniciales Valores finales NT-proBNP ( pg/mL) 3469,7 (± 4057,3) 1446,4 (± 1305,2) Creatinina (mg/dL) 1,10 (± 0,24) 1,12 (± 0,39) TFG (mL/min/1,73m2 ) 65,4 (± 21,2) 62,7 (± 23, 6) Potasio (meq /L) 4,5 (± 0,5) 4,6 (± 0,4) Fevi 29,4 % (± 7,2) FEVI 42,7 % (± 9,6)

scholarly journals QOLP-37. QUALITATIVE RESEARCH IN LOWER GRADE GLIOMA: UNDERSTANDING SIGNS, SYMPTOMS, AND DISEASE IMPACTS DURING EXPECTANT MANAGEMENT

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi206-vi206
Author(s):  
Audra Boscoe ◽  
Ted Wells ◽  
Christina Graham ◽  
Caitlin Pohl ◽  
Brooke Witherspoon ◽  
...  
Keyword(s):  
Treatment Options ◽  
Expectant Management ◽  
Signs And Symptoms ◽  
Molecular Therapy ◽  
Patient Specific ◽  
Lower Grade ◽  
Concept Elicitation ◽  
Post Surgery ◽  
Lower Grade Glioma ◽  
Isocitrate Dehydrogenase Mutation

Abstract BACKGROUND Patients with lower grade glioma (LGG) (i.e., grade II or III) have limited treatment options. After surgical resection of their tumor, patients will undergo either a period of expectant management (watch and wait) or treatment with adjuvant chemotherapy and/or radiotherapy. Approximately 80% of patients with LGG have an isocitrate dehydrogenase mutation, which is a viable target for molecular therapy. This offers a therapeutic intervention that could potentially delay the need for chemotherapy and/or radiotherapy in select patients. Several prognostic and patient-specific factors contribute to the decision to recommend expectant management, including concerns about the side effects of chemotherapy and radiotherapy. The aim of this project was to understand patients’ signs and symptoms during the expectant management period and how LGG impacts their lives. METHODS Concept elicitation interviews were conducted in the US with patients with LGG as well as key opinion leaders (KOLs) with experience treating patients with LGG. Interview data were analyzed using Atlas.ti, and patient data were reviewed against KOL data. RESULTS Seven patients with ≥ 3 months of expectant management experience and three KOLs were interviewed. During their expectant management periods, patients reported 12 signs/symptoms, mostly related to deficits in cognition. Patients reported 16 impacts across four categories, with a substantial proportion of the impacts identified as negatively affecting emotional function. The signs/symptoms and impacts reported by patients were generally also reported by KOLs. During expectant management, patients typically resume their original quality of life post-surgery, but may also experience anxiety. Patients and KOLs indicated a preference for expectant management and delaying chemotherapy or radiotherapy. CONCLUSIONS Patient and KOL interviews characterized the LGG experience and indicated a preference for expectant management, which may be supported by therapies that delay the initiation of chemotherapy and/or radiotherapy.

scholarly journals Oral vinorelbine and cisplatin as first-line therapy for advanced squamous NSCLC patients: a prospective randomized international phase II study (NAVoTrial 03)

2021 ◽  
Vol 13 ◽  
pp. 175883592110229
Author(s):  
Francesco Grossi ◽  
Piotr Jaśkiewicz ◽  
Marion Ferreira ◽  
Grzegorz Czyżewicz ◽  
Dariusz Kowalski ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Current Knowledge ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Comparable Efficacy ◽  
Open Label ◽  
Oral Vinorelbine ◽  
First Line Therapy ◽  
Nsclc Patients

Objective: The study investigated the efficacy and safety of oral vinorelbine-cisplatin (OV-CDDP) and gemcitabine-cisplatin (GEM-CDDP) in patients with squamous non-small cell lung cancer (sq-NSCLC). Patients and methods: This was an open-label, prospective, multicenter, international phase II study that enrolled untreated patients with advanced sq-NSCLC. Patients were randomized to receive 3-week cycles of either 60–80 mg/m2 OV days 1 and 8 in combination with 80 mg/m2 CDDP day 1 (arm A) or 1250 mg/m2 GEM days 1 and 8 in combination with 75 mg/m2 CDDP day 1 (arm B). After four cycles, patients without disease progression continued maintenance dose of OV or GEM until progression or unacceptable toxicity. The primary objective was disease control rate (DCR). Secondary objectives included progression-free survival (PFS), time to treatment failure (TTF), overall survival (OS), safety, and quality of life (QoL). Results: A total of 114 patients with sq-NSCLC were randomized, and 113 were treated (57 in arm A and 56 in arm B). DCR was high in both arms: 73.7% (95%CI: 62.4–100.0) in arm A and 75.0% (95%CI: 63.7–100.0) in arm B. Median PFS and TTF were similar in arm A and B 4.2 and 2.8 months, and 4.3 and 3.1 months, respectively. Even though the difference was not significant, the OS was 10.2 for arm A and 8.4 months for arm B. The safety profiles were consistent with the current knowledge of adverse events. QoL results revealed an improvement in patients under OV treatment. Conclusion: The OV-CDDP combination showed comparable efficacy to GEM-CDDP with acceptable safety profile and enhanced patients’ QoL. Trial registration: The study was registered under EudraCT number 2012-003531-40.

Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The Randomized PERSIST-AVR Study Design

2018 ◽  
Vol 68 (02) ◽  
pp. 114-123 ◽  
Author(s):  
Roberto Lorusso ◽  
Thierry Folliguet ◽  
Malakh Shrestha ◽  
Bart Meuris ◽  
Arie Pieter Kappetein ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Severe Aortic Stenosis ◽  
Artery Bypass ◽  
Randomized Study ◽  
Primary Objective ◽  
Surgical Aortic Valve Replacement ◽  
Open Label ◽  
Number Of Patients

Abstract Introduction Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches. The stentless configuration of the sutureless valve was designed to achieve optimal hemodynamic performance. Materials and Methods PERSIST-AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement) is a prospective, randomized, adaptive, open-label, international, postmarket trial (NCT02673697). The primary objective of the trial is to assess the safety and efficacy of the Perceval (LivaNova, London, UK) sutureless bioprosthesis among patients undergoing SAVR in the presence of severe aortic stenosis to demonstrate the noninferiority of Perceval as compared with standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting. Sample size will be determined adaptively through interim analyses performed by an Independent Statistical Unit till a maximum of 1,234 patients, enrolled at ∼60 sites in countries where the device is commercially available. Patients will be followed up for 5 years after implant. The primary end point is the number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year. Additional secondary outcomes will be assessed up to 5 years. Discussion PERSIST-AVR is the first prospective, randomized study comparing in-hospital and postdischarge outcomes in a robust population of patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years.

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