Abstract 2985: Impact of PCI in Patients with Recent Onset Severe Angina or Stabilized ACS Treated with Optimal Medical Therapy: a COURAGE Trial High Risk Subset

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
David J Maron ◽  
John A Spertus ◽  
G.B. John Mancini ◽  
Pamela M Hartigan ◽  
Marcin Dada ◽  
...  

Background: The COURAGE trial randomized 2,287 patients with stable coronary artery disease (CAD) to optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI). Eligibility criteria allowed entry of patients with recent onset, severe angina and recently stabilized acute coronary syndromes (ACS). We hypothesized that patients with recent onset, severe angina or recently stabilized ACS had higher risk for death or MI, and that this risk was reduced by PCI. Methods: High risk was defined as Canadian Cardiovascular Society class III angina with first onset of symptoms ≤ 2 months prior to enrollment, recently stabilized class IV angina, or recently stabilized ACS not treated with PCI. Persistent class IV angina patients were excluded. Patients were permitted to undergo revascularization during the trial as clinically indicated for unremitting angina or ACS. The chi square test was used for between group comparisons. Results: At baseline, 12% of COURAGE patients were classified as high risk. Within each treatment arm, high risk patients were more likely to suffer death or MI than non-high risk patients (OMT group, 26% vs. 17%, P=0.006; PCI group 24% vs. 18%, P=0.06). There was no significant difference between treatment arms for major cardiovascular events in patients at high risk (see Table ). As observed in the entire COURAGE cohort, revascularization was more frequent in high risk patients randomized to OMT compared with PCI (42% vs. 30%, P=0.04). Outcomes in High Risk Patients Randomized to OMT Alone or OMT + PCI Conclusions: The addition of PCI to OMT as an initial management strategy did not reduce death, MI or other major cardiovascular events in this high risk subset of COURAGE patients with recent onset severe angina or stabilized ACS.

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 2-OR
Author(s):  
MARCUS V.B. MALACHIAS ◽  
PARDEEP JHUND ◽  
BRIAN CLAGGETT ◽  
MAGNUS O. WIJKMAN ◽  
RHONDA BENTLEY-LEWIS ◽  
...  

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
E Petanovsk. Kostova

Abstract Study question Study aim is to compare implantation,clinical pregnancy and livebirth rates between giving1500IU of hCG4hours after GnRHagonist,on trigger day or GnRHagonist as alone trigger with luteal support withHCG1500IU.35h later on OPUday. Summary answer Adjuvant doze of1500IUhCG4h after bolus of GnRHagonist on trigger day significantly improve quality of blastocyst,implantation,clinical pregnancy and live birth rates without increasing the risk ofOHSS. What is known already The use of GnRHagonist for final oocyte maturation in antagonist cycle significantly decrease the incidence of OHSS,but there have been studies showing lower pregnancy rates in patients triggered with GnRHagonist compared with hCG in autologous cycles,attributed to a defective luteal phase, especially in high–risk patients despite intensive luteal phase support.To improve the results of IVF,an alternative approach is adding a small bolus dose of hCG(1500IU)35h later,on the OPU day after GnRHagonist trigger which provides more sustained support for the corpus luteum.The question is does low doses of hCGgiven on the same day with GnRHagonist trigger is making better quality oocytes. Study design, size, duration Single center prospective longitudinal cohort study fromJanuary2017 to Decembar2019.The initial inclusion criteria were:women age≥18and≤39years,AMH≥3,3ng/ml and ≥12 antral follicles on basal ultrasound.Patients with history of OHSS and PCO are also included in the study.Patients with applied “freeze-all” technique with peak estradiol≥4000pg/ml on trigger day>18oocytes on the OPU day,and recognized significant risk for developing OHSS were also included.The cumulative implantation,clinical pregnancy and live birth rates were analyzed,only in embryos from the same COS protocol in every patient. Participants/materials, setting, methods A total of 231 patients were entered for final analysis,who underwent a flexible antagonist protocol,ICSI and fresh or thawed ET on 3th(38.53%) or 5th( 61.47%)day in women’s autologous cycles.Patients were randomized in one of two groups: GroupA-Dual trigger group 1500IUof hCG 4h after GnRH agonist application on trigger day and GroupB –1500IU of HCG 35h later,on the OPU day.We used nonparametric and parametric statistical tests.Significant differences were considered all values ​​of p < 0.05 Main results and the role of chance Both groups are homogenous regarding several variables:age,BMI,type of sterility,smoking status,AMH,PCO, spermogram.There is no significant difference between the two(AvsB)groups according to average number of retrieved oocytes(13.6 vs 14.6 p > 0,05),M II oocytes(11.03 vs 11.99 p > 0.05).The dual trigger group(A)had a higher fertility rate(69.99% vs 64.11% p < 0,05)compared with GnRHagonist trigger group(B).There are no significant difference between groups(AvsB)according to cumulative average number of:transferred embryos(2.4vs2.5 p > 0.05)TQE transfered on 3th day(1.5.vs 1.3.p>0.05);transferred blastocyst(2.6 vs2.7 >0.05);cryo embryos(2.5vs1.9 p > 0.05),but there are significant difference according to cumulative implantation rate of transferred blastocyst in favor of group A(48.18% vs 33.89%p<0.05).Analyzes of morphological characteristics of transferred blastocyst depicted in the order of degree of blastocyst expansion,inner cellular mass(ICM)and trofoectoderm(TE) and ranking overall blastocysts quality from“excellent”,“good”,“average” and “pore” ,shows that there are significantly more percentage of patient with embryo transfer of “excellent” or even one “excellent” blastocyst in group A (30.56%,31.94% vs 21.54%,23.08% p < 0.05) in opposite of percentage of patients with embryo transfer with “poore “” blastocyst in group B (37.5% vs 46.15.%p<0.05). Clinical pregnanacy rate (71.68% vs 50.84% p < 0.05) , and live birth rate (60,18% vs 42,58% ), were significantly higher in group A. There were no cases of moderate or severe OHSS in both groups. Limitations, reasons for caution Dual trigger in GnRH antagonist protocols should be advocated as a safe approach but undetected high risk patients are reasons for caution for developing clinically significant OHSS. Wider implications of the findings: Adjuvant low dose of hCG on GnRHagonist trigger day improve clinical pregnancy and live birth rates without increasing the risk of clinically significant OHSS.Protocol of dual trigger and freezing all oocytes or embryos in patients with high risk of developing OHSS is promising technique in everyday practice. Trial registration number 8698


Endoscopy ◽  
2017 ◽  
Vol 50 (04) ◽  
pp. 378-385 ◽  
Author(s):  
Chang-Hwan Park ◽  
Woo Paik ◽  
Eun Park ◽  
Chan Shim ◽  
Tae Lee ◽  
...  

Abstract Background and study aims The present study aimed to determine the type of intravenous hydration that is best suited to reducing the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. Patients and methods In a prospective randomized multicenter trial, average-to-high risk patients who underwent first-time ERCP were randomly assigned to three groups (1:1:1) who received: aggressive intravenous hydration (3 mL/kg/h during ERCP, a 20-mL/kg bolus and 3 mL/kg/h for 8 hours after ERCP) with either lactated Ringer’s solution (LRS) or normal saline solution (NSS), or standard intravenous hydration with LRS (1.5 mL/kg/h during and for 8 hours after ERCP). The primary end point was post-ERCP pancreatitis (PEP). Results 395 patients were enrolled, and 385 completed the protocols. The three groups showed no significant differences in demographic characteristics. There was a significant difference in the intention-to-treat (ITT) PEP rate between the aggressive LRS group (3.0 %, 95 % confidence interval [CI] 0.1 % – 5.9 %; 4 /132), the aggressive NSS group (6.7 %, 95 %CI 2.5 % – 10.9 %; 9 /134) and the standard LRS group (11.6 %, 95 %CI 6.1 % – 17.2 %; 15 /129; P = 0.03). In the two-group comparisons, the ITT PEP rate was significantly lower for the aggressive LRS group than for the standard LRS group (relative risk [RR] 0.26, 95 %CI 0.08 – 0.76; P = 0.008). There was no significant difference in the ITT PEP rate between the aggressive NSS group and the standard LRS group (RR 0.57, 95 %CI 0.26 – 1.27; P = 0.17). Conclusion Aggressive hydration with LRS is the best approach to intravenous hydration for the prevention of PEP in average-to-high risk patients.


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Michael F Waters ◽  
Brian L Hoh ◽  
Michael J Lynn ◽  
Tanya N Turan ◽  
Colin P Derdeyn ◽  
...  

Background: The SAMMPRIS trial showed that aggressive medical therapy was more effective than stenting for preventing stroke in high-risk patients with symptomatic intracranial stenosis. However, 15% of patients in the medical group still had a primary endpoint (any stroke or death within 30 days of enrollment or stroke in the territory beyond 30 days) during a median follow-up of 32.7 months. We sought to determine baseline risk factors that were associated with a primary endpoint in the medical arm of SAMMPRIS. Methods: Data on 227 patients randomized to the medical group in SAMMPRIS were analyzed. Baseline demographic features, vascular risk factors, qualifying event, brain imaging and angiographic features were analyzed. The hazard ratio and p-value from a Cox proportional hazard regression model relating time until a primary endpoint to each factor were calculated. Results: Female gender, diabetes, stroke as the qualifying event (especially non-penetrator stroke), old infarct in the territory of the stenotic artery, and > 80% stenosis were associated (p < 0.10) with a higher risk of the primary endpoint on univariate analysis (see accompanying table) (multivariate analysis will be available by the time of ISC). Variables not associated with a higher risk of a primary endpoint in the medical arm included: age, race, antithrombotic therapy at the time of a qualifying event, time from qualifying event to enrollment (< 7 days vs. > 7 days), and location of stenosis. Conclusions: Several features were associated with an increased risk of the primary endpoint in the medical group in SAMMPRIS. On univariate analysis, the most important risk factors were an old infarct in the territory of the stenotic artery and stroke (especially non-penetrator stroke) as the qualifying event. These features will be useful for identifying particularly high-risk patients who should be targeted for future clinical trials testing alternative therapies to aggressive medical management.


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