Abstract 16784: Under-Enrollment of Real-World Heart Failure With Preserved Ejection Fraction Patients in Major HFpEF Clinical Trials

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Joban Vaishnav ◽  
Lisa R Yanek ◽  
Virginia S Hahn ◽  
Eunice Yang ◽  
Rishi Trivedi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Outcomes ◽  
Real World ◽  
Loop Diuretic ◽  
Nyha Class ◽  
Clinic Visit ◽  
Inclusion Criteria ◽  
Pulmonary Capillary ◽  
Number Of Patients ◽  
Wedge Pressure

Introduction: Inclusion criteria for enrollment in HFpEF clinical trials vary considerably and often exclude patients with co-morbidities such as obesity. We tested the hypotheses that: 1) a large number of patients with clinical and hemodynamic evidence of HFpEF are excluded from major HFpEF clinical trials; and 2) there is no difference in clinical outcomes between patients excluded versus those who met enrollment criteria by evaluating reasons for exclusion from HFpEF clinical trials and comparing clinical outcomes in a real-world HFpEF cohort. Methods: Patients referred to the Johns Hopkins HFpEF Clinic with clinical and hemodynamic evidence of HFpEF (pulmonary capillary wedge pressure [PCWP] ≥ 12 mmHg on a loop diuretic or PCWP ≥ 15 mmHg) were assessed for inclusion into 4 major HFpEF trials (TOPCAT, I-PRESERVE, PARAGON-HF, and RELAX). Cumulative hazard of HF hospitalization or death at 2 years from index clinic visit was compared between patients included and excluded by each trial. Results: Of 132 HFpEF patients, the median PCWP was 19 mmHg (IQR: 15-22 mmHg). Forty-four (33%) of patients met enrollment criteria for TOPCAT, 39 (29%) for I-PRESERVE, 21 (16%) for PARAGON-HF, and 50 (38%) for RELAX. The top 5 criteria that would have excluded patients included low natriuretic peptide level, obesity, elevated blood pressure, young age, and low hemoglobin (Figure 1A) . There was no difference in HF burden (hospitalizations, diuretic dosing, or NYHA class), or in clinical outcomes including HF hospitalization or death between patients who did or did not meet inclusion criteria for each clinical trial (Figure 1B ). Conclusion: We demonstrate that in a real-world cohort of hemodynamically-proven HFpEF few patients would have met criteria for enrollment in major HFpEF clinical trials, yet HF burden and outcomes were no different. Given the lack of proven therapies in HFpEF, consideration should be given to unifying and broadening enrollment criteria in HFpEF clinical trials.

scholarly journals Trial in Progress: Real-World Safety and Effectiveness of Brentuximab Vedotin in Adults with CD30+ Lymphoma in China

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4552-4552
Author(s):  
Pengpeng Xu ◽  
Mingci Cai ◽  
Wendy Zhang ◽  
Wei Li Zhao
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Survival Rate ◽  
Real World ◽  
Brentuximab Vedotin ◽  
Routine Clinical Practice ◽  
Inclusion Criteria ◽  
Real World Data

Abstract Background: Clinical trials have demonstrated the effectiveness of the CD30-targeted antibody-drug conjugate brentuximab vedotin (BV) for the treatment of classical Hodgkin lymphoma (HL) and non-Hodgkin lymphoma(e.g. ALCL, PTCL-NOS, AITL, CTCL and etc.). While clinical trials are critical for establishing efficacy, collection of real-world data outside of the controlled trial setting is important to evaluate how interventions are applied and assess the effectiveness of new treatments in routine clinical practice. Inclusion criteria are often rather restrictive compared with the patient populations seen by physicians in daily practice. There are limited real-world data related to treatment with BV in China. Our study aims to obtain timely real-world knowledge in terms of safety and effectiveness of BV in CD30+ lymphoma patients in China. Study Design and Methods: The study (NCT04837222) is a real-world, prospective, multicenter study to evaluate the safety and effectiveness of BV in patients with CD30+ lymphoma in China. Consecutive CD30+ lymphoma patients treated with BV as a part of standard clinical practice will be enrolled. Key inclusion criteria includes adult patients undergoing treatment with BV or to be received with BV, patient/legal guardian must be able to read, understand, and sign the Informed Consent Form, CD30+ lymphoma by INV (any CD30 expression). Exclusion criteria includes patient who currently participates in or with plan to participate in any interventional clinical trial, any other reason that, in the investigator's opinion, makes the patient unsuitable to participate in this study. As CD30+ lymphoma is not a common disease and the affordability of novel treatment is limited, 1000 patients with CD30+ lymphoma will be recruited from almost 30 hematology centers. The physician will determine the treatment regimen, as well as the frequency of laboratory and clinical assessment according to her/his routine practice. All patients will be followed up per routine clinical practice and data will be documented at baseline/3/6/9/12/18/24 months unless withdrawal of Informed Consent, death or loss of follow-up, whichever comes first. Loss to follow-up will be minimized through active contact with participating patients thereafter to ensure almost all clinically relevant outcomes will be captured. The primary endpoint is serious adverse events. Secondary endpoints include adverse events, adverse drug reaction, dose adjustment, characteristics of patients receiving BV, use of BV, number of BV cycles administered, disease characteristics, time to next treatment, overall response rate, duration of response, progression free survival rate, overall survival rate, quality of life and cost-effectiveness ratio. Descriptive analysis will be performed for data analysis. Disclosures Zhang: Takeda Pharmaceuticals: Current Employment.

4290Results of transcatheter mitral valve repair for severe mitral regurgitation from a real-world patient cohort according to COAPT and MITRA-FR trial inclusion criteria and echocardiographic parameter

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Orban ◽  
L Stolz ◽  
M Orban ◽  
D Braun ◽  
T Stocker ◽  
...  
Keyword(s):  
Mitral Valve ◽  
Mitral Valve Repair ◽  
Real World ◽  
Nyha Class ◽  
Symptomatic Improvement ◽  
Left Ventricular ◽  
Inclusion Criteria ◽  
Valve Repair ◽  
Transcatheter Mitral Valve Repair ◽  
Intergroup Comparison

Abstract Background Two randomized trials (MITRA-FR and COAPT) of transcatheter mitral valve repair (TMVR) for functional MR have shown symptomatic improvement but discordant results for heart failure hospitalizations compared to optimal medical therapy. Differences between real-world patients similar to the trial population in terms of symptomatic outcome and mortality have not been shown yet. Purpose Our study compared patients similar to both studies in terms of NYHA development and mortality at 1-year follow-up (FU). Methods In our center, 447 patients were treated with TMVR for MR grade 3 and 4 between 2012 and 2018. For the comparative analysis with MITRA-FR and COAPT, we applied filters to our database patients according to the published echocardiographic inclusion criteria and baseline data (COAPT: effective regurgitant orifice area [ERO]) 0.41±0.15cm2; left ventricular ejection fraction [LV-EF] 31.3±9.1%, left ventricular end-diastolic volume [LVEDV] 194.4±69.2ml; MITRA-FR: ERO 0.31±0.1 cm2; LV-EF 33.3±6.5, indexed LVEDV 136.2±37.4 ml). Results Out of our database, 91 patients were categorized as COAPT-like and 92 as MITRA-FR-like. COAPT-like patients had an ERO of 0.40±0.16cm2, LV-EF of 32.7±4.8%, LVEDV of 195±53.7ml and indexed LVEDV of 103.6±26.0ml/cm2 (Figure A). MITRA-FR-like patients had an ERO of 0.31±0.07 cm2, LV-EF of 31.7±5.0%, LVEDV of 221.7±60.8ml and indexed LVEDV of 117.9±29.1 ml/cm2. The difference of ERO and LVEDV between both groups was statistically significant. The majority of patients in both groups were in NYHA class III or IV at baseline (97% COAPT-like group, 98% MITRA-FR-like group, p=0.44). MR reduction was equally effective in both groups, with 85 (93%) COAPT-like patients and 88 (96%) MITRA-FR-like patients having MR grade 1 or 2 at discharge. Clinical FU was available in 62 (68%) and 67 (73%) COAPT-like and MITRA-FR-like patients, respectively. The majority of patients improved symptomatically after TMVR. Before TMVR, 1 (98%) COAPT-like patient and 2 (97%) MITRA-FR-like patients were in NYHA class I or II compared to 36 (58%, p<0.01) COAPT-like patients and 38 (57%, p<0.01) MITRA-FR-like patients at FU (p=1.0 for intergroup comparison). Overall, 40 (65%) COAPT-like patients and 43 (64%) MITRA-FR-like improved at least one NYHA class (p=1.0 for intergroup comparison; Figure B). There were no differences in overall survival between groups with 68.9% of COAPT-like patients and 74.5% of MITRA-FR-like patients alive at 1-year FU (p=0.53, Figure C). Figure 1 Conclusion Our real-world data shows that TMVR leads to symptomatic improvement in both MITRA-FR-like and COAPT-like patients to a similar extent, despite substantial echocardiographic differences. Both patient groups have a similar survival rate.

scholarly journals Active surveillance inclusion criteria under scrutiny in magnetic resonance imaging-guided prostate biopsy: a multicenter cohort study

2021 ◽  
Author(s):  
Kira Kornienko ◽  
Fabian Siegel ◽  
Angelika Borkowetz ◽  
Manuela A. Hoffmann ◽  
Martin Drerup ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Active Surveillance ◽  
Real World ◽  
Exclusion Criterion ◽  
Inclusion Criteria ◽  
Resonance Imaging ◽  
Multicenter Cohort Study ◽  
Number Of Patients ◽  
Targeted Mri

Abstract Background Although multiparametric magnetic resonance imaging (mpMRI) is recommended for primary risk stratification and follow-up in Active Surveillance (AS), it is not part of common AS inclusion criteria. The objective was to compare AS eligibility by systematic biopsy (SB) and combined MRI-targeted (MRI-TB) and SB within real-world data using current AS guidelines. Methods A retrospective multicenter study was conducted by a German prostate cancer (PCa) working group representing six tertiary referral centers and one outpatient practice. Men with PCa and at least one MRI-visible lesion according to Prostate Imaging Reporting and Data System (PI-RADS) v2 were included. Twenty different AS inclusion criteria of international guidelines were applied to calculate AS eligibility using either a SB or a combined MRI-TB and SB. Reasons for AS exclusion were assessed. Results Of 1941 patients with PCa, per guideline, 583–1112 patients with PCa in both MRI-TB and SB were available for analysis. Using SB, a median of 22.1% (range 6.4–72.4%) were eligible for AS. Using the combined approach, a median of 15% (range 1.7–68.3%) were eligible for AS. Addition of MRI-TB led to a 32.1% reduction of suitable patients. Besides Gleason Score upgrading, the maximum number of positive cores were the most frequent exclusion criterion. Variability in MRI and biopsy protocols potentially limit the results. Conclusions Only a moderate number of patients with PCa can be monitored by AS to defer active treatment using current guidelines for inclusion in a real-world setting. By an additional MRI-TB, this number is markedly reduced. These results underline the need for a contemporary adjustment of AS inclusion criteria.

An updated review of infliximab biosimilar, CT-P13, in the treatment of immune-mediated inflammatory diseases

Immunotherapy ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 609-623
Author(s):  
Seung Wook Hong ◽  
Yong-Gil Kim ◽  
Byong Duk Ye
Keyword(s):  
Clinical Trials ◽  
Clinical Outcomes ◽  
Real World ◽  
Inflammatory Diseases ◽  
European Medicines Agency ◽  
Immune Mediated ◽  
The Us ◽  
Us Fda ◽  
The Cost

The introduction of anti-TNFs, such as infliximab (IFX), has revolutionized the treatment of immune-mediated inflammatory diseases. Anti-TNF agents have shown outstanding efficacy and long-term improvement of clinical outcomes, but the cost has been relatively high. Out of this concern, several ‘biosimilar’ drugs of anti-TNF agents have been developed. CT-P13, the first biosimilar of reference IFX, was approved by the European Medicines Agency and licensed by the US FDA for use in all indications of IFX. This updated review summarizes all aspects of CT-P13, including pharmacology and pharmacokinetics, and evaluates its efficacy, safety and immunogenicity for all indications based on the results of the latest clinical trials as well as on real-world experiences.

scholarly journals Clinical Outcomes of Pneumonia and Other Comorbidities in Children Aged 2-59 Months in Lilongwe, Malawi: Protocol for the Prospective Observational Study “Innovative Treatments in Pneumonia”

10.2196/13377 ◽  
2019 ◽  
Vol 8 (7) ◽  
pp. e13377 ◽  
Author(s):  
Amy Sarah Ginsburg ◽  
Susanne May ◽  
Evangelyn Nkwopara ◽  
Gwen Ambler ◽  
Eric D McCollum ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Observational Study ◽  
Clinical Outcomes ◽  
Standard Care ◽  
Prospective Observational Study ◽  
World Health ◽  
Severe Illness ◽  
Inclusion Criteria ◽  
Childhood Pneumonia ◽  
District Hospitals

Background Pneumonia is the leading infectious cause of death worldwide among children below 5 years of age. Clinical trials are conducted to determine optimal treatment; however, these trials often exclude children with comorbidities and severe illness. Conclusions Given the paucity of data from Africa, African-based research is necessary to establish optimal management of childhood pneumonia in malaria-endemic settings in the region. An expanded evidence base that includes children with pneumonia and other comorbidities, who are at high risk for mortality or have other complications and are therefore typically excluded from childhood pneumonia clinical trials, can contribute to future iterations of the World Health Organization Integrated Management of Childhood Illness guidelines. Methods The study enrolled 1000 children with pneumonia presenting to the outpatient departments of Kamuzu Central or Bwaila District Hospitals in Lilongwe, Malawi, who were excluded from concurrent randomized controlled clinical trials investigating fast breathing and chest indrawing pneumonia and who met the inclusion criteria for this prospective observational study. Each child received standard care for their illnesses per Malawian guidelines and hospital protocol and was prospectively followed up with scheduled study visits on days 1, 2 (if hospitalized), 6, 14 (in person), and 30 (by phone). Our primary objectives are to describe the clinical outcomes of children who meet the inclusion criteria for this study and to investigate whether the percentages of children cured at day 14 among those with either fast breathing or chest indrawing pneumonia and comorbidities such as severe malaria, anemia, severe acute malnutrition, or HIV are lower than those in children without these comorbidities in the standard care groups in concurrent clinical trials. This study was approved by the Western Institutional Review Board, Malawi College of Medicine Research and Ethics Committee, and the Malawi Pharmacy, Medicines and Poisons Board. Objective This prospective observational study aimed to assess the clinical outcomes of children aged 2-59 months with both pneumonia and other comorbidities in a malaria-endemic region of Malawi. Results The Innovative Treatments in Pneumonia project was funded by the Bill and Melinda Gates Foundation (OPP1105080) in April 2014. Enrollment in this study began in 2016, and the primary results are expected in 2019. International Registered Report Identifier (IRRID) DERR1-10.2196/13377

scholarly journals Real-World Use of Emicizumab in Patients with Hemophilia with and without Inhibitors

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1137-1137 ◽  
Author(s):  
Isabella McCary ◽  
Christine Guelcher ◽  
Jan Kuhn ◽  
Regina Butler ◽  
Gita Massey ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Real World ◽  
National Health System ◽  
Advisory Board ◽  
Inclusion Criteria ◽  
Bleeding Events ◽  
Active Inhibitor ◽  
The Difference

Introduction Emicizumab is a recombinant humanized monoclonal antibody that bridges factor IXa and Factor Xa and is administered via subcutaneous injection. After initial FDA approval for patients with hemophilia A (HA) and inhibitors, it was approved in October 2018 for prophylaxis in patients with HA without inhibitors of all ages. In clinical trials of subjects without inhibitors, emicizumab was studied only in those >12 years of age. The primary objective of this study was to report our "real-world", post-licensure experience with emicizumab across a more heterogenous patient population, comparing annualized bleeding rates prior to and after initiating emicizumab. Secondary objectives included evaluating for serious adverse events including death, thrombosis or drug discontinuation. Methods We conducted a multi-center observational study at 3 federally funded Hemophilia Treatment Centers: Children's Hospital of Philadelphia, Virginia Commonwealth University and Children's National Health System. Inclusion criteria included patients with HA initiated on emicizumab prior to May 15th 2019. Data extraction included: demographics, diagnosis, prior HA history (inhibitor, prophylaxis treatment regimen), emicizumab dosing data, bleeding events (all bleeds, treated bleeds, joint bleeds, traumatic bleeds) and thrombotic events from the 6 months prior to emicizumab until July 15th 2019. Annualized bleeding rates (ABR) were calculated to account for variable follow up. Wilcoxon Sign-Rank Difference Test was used to test the difference in number of bleeds and McNemar's test was used to test the difference in proportions of patients with ABR=0. Results Ninety-two patients met inclusion criteria: 89 male and 89 with severe HA (3 moderate HA) (Table 1). Age at initiation of emicizumab ranged from 5 weeks to 55 years; median 8.6 yrs (IQR 4.8-13.5 yrs). Nineteen patients had an active inhibitor at the time of starting emicizumab; the remaining 73 did not have an inhibitor, and most (86%) were on prophylaxis prior to emicizumab. Sixty-two patients were < 12 years of age (13 with inhibitors). Median duration of emicizumab therapy was 48 weeks (inhibitors) and 22 weeks (non-inhibitors), with a total follow up of 53.3 patient years. In patients with inhibitors, the ABR (treated bleeds) prior to emicizumab was 6.2 events (95% CI, 0.98 to 11.4) compared to 0.3 events (95% CI, 0 to 0.73) on emicizumab, p=0.002. In subjects without inhibitors, the ABR prior to emicizumab was 1.8 events (95% CI, 0.66 to 2.96) compared to 0.22 events (95% CI, 0.05 to 0.39) on emicizumab, p<0.001. Additional data on bleeding events is provided in Table 1. The proportion of patients with ABR=0 increased in both inhibitor (from 46% to 74%, p=0.06) and non-inhibitor subjects (from 60 to 78%, p=0.015). All patients received 1.5 mg/kg weekly x 4 loading doses, followed by either weekly (27%), every other week (70%), or monthly (3%) dosing; patients with inhibitors were more likely to receive weekly dosing. No patients who initiated emicizumab discontinued the drug or developed a neutralizing antibody to FVIII or emicizumab, although patients have not been consistently screened for these antibodies. No thrombotic or thrombotic microangiopathy events or death have occurred. Conclusions Our favorable clinical experience with emicizumab post-licensure in patients with HA is similar to that reported in the clinical trials. Although excluded from the clinical trials, patients with HA without inhibitors < 12 years accounted for the majority (67%) of our cohort. As anticipated, these younger patients appear to experience the same benefit as patients > 12. No serious drug-related adverse events were reported, although the overall study period is relatively short. Ongoing follow up of these patients, and others, will be important to assess the ongoing safety and efficacy profile of this novel therapy. Updated data on this cohort will be presented at the ASH meeting Disclosures Guelcher: NovoNordisk: Other: Advisory Board; Octapharma: Other: Advisory Board; Takeda: Other: Advisory Board; Genetech: Other: Advisory Board. Butler:pfizer: Other: Advisory board; Hema-Biologics: Consultancy; genetech: Other: Advisory board. Guerrera:Genetech: Other: Advisory Board; Kendrion: Other: Advisory Board; Shire: Other: Advisory Board; Bayer: Other: Advisory Board; Bioverativ: Consultancy; Pfizer: Other: Advisory Board; Novo Nordisk: Consultancy. Raffini:Roche: Other: Advisory Board; Bayer: Other: Advisory Board; CSL Behring: Other: Advisory Board.

Quality of Life (QoL) and Clinical Outcomes of Dasatinib Treatment in TKI-Naive and Early Switched from Imatinib Patients with Chronic Myeloid Leukemia in Chronic Phase (CP CML) in a Real World Setting

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5456-5456
Author(s):  
Tatyana Ionova ◽  
Natalia Bulieva ◽  
Olga Vinogradova ◽  
Kira Kurbatova ◽  
Elza Lomaia ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Outcomes ◽  
Real World ◽  
Research Funding ◽  
Imatinib Treatment ◽  
Healthy Controls ◽  
Front Line ◽  
Real World Setting ◽  
Dasatinib Treatment

Abstract Dasatinib as a front-line is a promising treatment option for CP-CML pts. Assessment of benefits and risks of this treatment regimen both from physician's and patient's perspective sounds worthy. We aimed to study QoL and clinical outcomes of dasatinib as a front-line treatment in CP CML pts in a real world setting. The total of 30 pts with CP CML (16 pts - TKI-naive, 14 pts - early switched to dasatinib after failure of imatinib treatment, median duration of imatinib treatment - 6 mths; switched pts) were involved in the multicenter observational prospective study. Median age - 47.6 y.o. (20-74), female - 33.3%; median disease duration - 5 mths; distribution of pts according to the Sokal score - 27.6% pts at low risk, 41.4% - at intermediate risk, 31% - at high risk. 27% pts had comorbidities: median Charlson Comorbidity Index was 3.0. All the pts filled out the QoL questionnaire SF-36 before dasatinib treatment, 3 and 12 mths after treatment start. Hematological, cytogenetic and molecular response rates (HR, CyR, MR) were registered after 3 and 12 mths of dasatinib treatment. Healthy controls (n=30) from QoL population normative database adjusted by age and gender to pts group were used for QoL comparison at baseline. Group comparisons were made using Mann-Whitney test, ANOVA and Wilcoxon matched pair test. QoL in CP CML pts at baseline was lower than in healthy controls: Integral QoL Index - 0.358 in pts vs 0.497 in healthy controls (p<0.05). Physical functioning in CP CML pts was significantly lower than in healthy controls: 78.8 vs 90.8 (p<0.05). No QoL differences were found between TKI-naive and switched pts before dasatinib treatment (p>0.05). During 12 months of dasatinib treatment positive changes in QoL were observed: Integral Quality of Life Index increased from 0.358 at baseline to 0.493 after 12 mths (p=0.05) and became comparable to healthy controls (p>0.05). Significant QoL improvement was registered in 12 mths of dasatinib treatment for role emotional (48.1 vs 81.5), role physical (44.4 vs 56.5) and social functioning(62.5 vs 80.6); p<0.05. Clinical outcomes were similar to the data of randomized clinical trials. After 3 mths of dasatinib treatment the majority of pts (92%) achieved complete HR, others had partial HR. After 12 mths of treatment 81.6% pts maintained or achieved complete HR; 69.2% pts exhibited complete CyR; 53.8% pts - major/complete MR. Four pts were dropped out of the study due to resistance to dasatinib (n=2) or due to severe AE (n=2). No cases of death were observed during the study. AE were similar to the ones registered within the clinical trials: in the most cases they were non-severe/moderate; severe AE (lung edema, bleeding from stomach ulcer) were observed in 2 pts; no cases of pleural effusion were revealed. In conclusion, patient-reported and clinical outcomes of dasatinib treatment in TKI-naïve pts and in pts early switched to dasatinib after failure of imatinib were obtained in a real world study. Significant QoL improvement in terms of role physical, role emotional and social functioning was observed. Clinical outcomes support the data obtained in clinical trials. Benefits and risks of front-line treatment with dasatinib in CML-CP both from physician's and patient's perspective were demonstrated in a real world setting. Disclosures Ionova: BMS: Research Funding; MSD: Speakers Bureau. Bulieva:BMS: Research Funding. Vinogradova:BMS: Research Funding. Kurbatova:BMS: Research Funding. Nikitina:BMS: Research Funding. Novitskaya:BMS: Research Funding. Rodionova:BMS: Research Funding. Usacheva:BMS: Research Funding. Chukavina:BMS: Research Funding. Shumkova:BMS: Research Funding.

Percutaneous coronary intervention in octogenarians – a real-world experience from a large non-surgical centre in the UK

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Abramik ◽  
A Dastidar ◽  
N Kontogiannis ◽  
G Patri ◽  
V North ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Percutaneous Coronary Intervention ◽  
Clinical Practice ◽  
Clinical Outcomes ◽  
Real World ◽  
Coronary Intervention ◽  
Left Ventricular ◽  
Randomised Clinical Trials ◽  
Predictors Of Mortality ◽  
Percutaneous Coronary

Abstract Background With an ageing population, the demand for percutaneous coronary intervention (PCI) in the elderly is on the rise. Technical advances, better peri-procedural pharmacology and greater operator experience have led to improved outcomes after PCI. Octogenarians as a group, however, have been underrepresented in randomised clinical trials of coronary revascularisation. Observational studies therefore provide useful insights into the safety and efficacy of PCI in this patient population in a real-world clinical practice. Aim The aim of this study was to examine the trends in patient characteristics and clinical outcomes after PCI in octogenarians over a 10-year period in a large non-surgical PCI centre and to determine the predictors of mortality in this high risk patient cohort. Methods A total of 782 consecutive octogenarians were identified from a prospectively collected database of all patients undergoing PCI at our centre between 2007 and 2016. We analysed the characteristics of the cohort with respect to all-cause in-hospital and 1-year mortality, in-hospital Major Adverse Cardiovascular Events (MACE) rates, complexity of coronary artery disease and major comorbidities. The patients were stratified into three chronological tertiles to assess differences over time. A multivariate analysis was performed to determine predictors of mortality. Results The number of octogenarians undergoing PCI was found to have increased nearly ten-fold, from 19 in 2007 to 178 in 2016. Despite this, there were no significant differences in adverse clinical outcomes. A greater use of radial access was noted (p&lt;0.0001). Increasing age, the presence of cardiogenic shock, severe left ventricular impairment, peripheral vascular disease, diabetes mellitus and low creatinine clearance were identified as independent predictors of mortality after PCI (Table 1). Conclusion PCI in octogenarians is a safe and effective revascularisation option, the use of which is increasing in the real-world clinical practice. Future PCI randomised clinical trials should include this challenging cohort to enhance the evidence base. Funding Acknowledgement Type of funding source: None

P16.06 Comparison of Clinical Outcomes of Patients With Advanced NSCLC In Clinical Trials and in the Real World Received PD-1/PD-L1 Inhibitor

2021 ◽  
Vol 16 (10) ◽  
pp. S1017
Author(s):  
H. Wang ◽  
C. Wei ◽  
G.W. Zhang ◽  
M. Zhang ◽  
X. Yan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Outcomes ◽  
Real World ◽  
Advanced Nsclc ◽  
The Real
Sign in / Sign up

Export Citation Format

Share Document