scholarly journals Value of 68Ga-labeled Bombesin Antagonist (RM2) in the Detection of Primary Prostate Cancer Comparing With [18F]fluoromethylcholine PET/CT and mpMRI – a Phase I/II Study

Author(s):  
Mohsen Beheshti ◽  
Pekka Taimen ◽  
Jukka Kemppainen ◽  
Ivan Jambor ◽  
Andre Müller ◽  
...  

Abstract Purpose: Overexperssion of Gastrin-releasing-peptide receptor (GRPr) in prostate carcinoma (PCa) suggests new means in the detection of prostate cancer foci. The bombesin derivative RM2 (DOTA-4-amino-1-carboxy­methyl­piperidine-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2) is a GRPr antagonist with strong binding affinity. Based on promising results from a first-in-man study on PCa detection in patients with local disease, a Phase I/II study was initiated and the ability of [68Ga]Ga-RM2 PET/CT to detect PCa lesions was compared with [18F]fluoromethylcholine ([18F]FCH) PET/CT and multiparameteric prostate Magnetic Resonance Imaging (mpMRI).Methods: This Phase I/II study was conductedwith a pre-specified interim analysis following the enrollment of 30 biopsy-positive PCa subjects, stratified into low, intermediate and high pretreatment risk of extra-glandular metastases with reference to NCCN criteria. Each subject had PCa detected by transrectal ultrasound guided prostate biopsy and subjects were scheduled to undergo prostatectomy with pelvic lymph node (LN) dissection in intermediate and high risk patients. Following administration of an intravenous dose of 140 MBq of [68Ga]Ga-RM2,imaging was conducted at 60 min. p.i.. Twenty-five (25/30) subjects had concomitant [18F]FCH PET/CT imaging. All patients underwent mpMRI. Intra-prostatic and pelvic nodal PET/CT findings were correlated with histopathologic results.Results: High uptake of [68Ga]Ga-RM2 was seen in pancreas and the urinary system with very low background uptake in the rest of the abdomen or thorax. Despite of high bladder activity, focal intraprostatic uptake was readily well detectable. Of overall 312 analyzed regions, 120 regions (4 to 8 lesions per-patient) showed abnormal finding in the prostate gland. In a region-based analysis overall sensitivity and specificity of [68Ga]Ga-RM2 PET/CT in the detection of primary tumor were 74% and 90%, respectively; while it was 60% and 80% for [18F]FCH PET/CT and 72% and 89% for mpMRI. Although, the overall sensitivity of [68Ga]Ga-RM2 PET/CT was higher comparing to [18F]FCH PET/CT and mpMRI; however, the statistical analysis showed only significant difference between [68Ga]Ga-RM2 PET/CT and [18F]FCH PET/CT in intermediate-risk group (P=0.01) and [68Ga]Ga-RM2 PET/CT and mpMRT in high-risk group (p=0.03). [68Ga]Ga-RM2 PET/CT correctly detected 2 histopathologically verified LN metastases in 2 high risk patients; while 18F-FCH PET/CT only identified the LN lesion in 1 patient.Conclusion: [68Ga]Ga-RM2 is a promising new PET-tracer with a high detection rate for intraprostatic PCa. While index lesion detection rates were similar in both PET/CT studies, the improved specificity of [68Ga]Ga-RM2 for canver versus BPH renders it notably better than [18F]FCH in the detection of intraprostatic lesions. In addition, GRP-R-based imaging seems to play a complementary role to Choline-based imaging for full characterization of PCa extent, biopsy guidance in low and intermediate metastatic risk PCa patients and has the potential to discriminate them from whom of those at higher risks.Trial Registeration number: EudraCT-Nr.: 2014-003027-21, Date: 10 June, 2014

2016 ◽  
Vol 29 (3) ◽  
pp. 182
Author(s):  
Paula Lapa ◽  
Rodolfo Silva ◽  
Tiago Saraiva ◽  
Arnaldo Figueiredo ◽  
Rui Ferreira ◽  
...  

<p><strong>Introduction:</strong> In prostate cancer, after therapy with curative intent, biochemical recurrence frequently occurs. The purpose of this study was to evaluate the impact of PET/CT with 18F-fluorocholine in restaging these patients and in their orientation, and to analyze the effect of the risk stratification, the values of PSA and the hormone suppression therapy, in the technique sensitivity. <br /><strong>Material and Methods:</strong> Retrospective analysis of 107 patients with prostate carcinoma in biochemical recurrence who underwent PET/CT with 18F-fluorocholine in our hospital, between December 2009 and May 2014. <br /><strong>Results:</strong> The overall sensitivity was 63.2% and 80.0% when PSA &gt; 2 ng/mL. It was possible to identify distant disease in 28% of the patients. The sensitivity increased from 40.0%, in patients with low and intermediate risk, to 55.2% in high-risk patients. Without hormonal suppression therapy, the sensitivity was 61.8%, while in the group under this therapy, was 67.7%. <br /><strong>Discussion:</strong> PET/CT with 18F-fluorocholine provided important information even in patients with low levels of PSA, however, with significantly increased sensitivity in patients with PSA &gt; 2 ng/mL. Sensitivity was higher in high-risk patients compared with low and intermediate risk patients, however, without a statistically significant difference. The hormone suppression therapy does not appear to influence uptake of 18F-fluorocholine in patients resistant to castration. <br /><strong>Conclusions:</strong> In this study, PET/CT with 18F-Fluorocholine showed good results in restaging patients with prostate cancer biochemical recurrence, distinguishing between loco regional and systemic disease, information with important consequences in defining the therapeutic strategy.</p>


Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 5169-5169
Author(s):  
John Moppett ◽  
Jerry Hancock ◽  
Christopher J.C. Knechtli ◽  
Anthony Oakhill ◽  
Nicholas J. Goulden

Abstract BMT remains the treatment of choice for early BM relapse of childhood ALL. We reasoned that further intensification of cytoreductive therapy pre-BMT may further improve survival amongst those with the highest risk of treatment failure, early BM relapse (BFM groups S3/4) and high level MRD pre-BMT. A cohort of 32 patients transplanted at a single institution (1996–1999) provided an historical control. 8 high risk patients transplanted 1999–2000 received additional fludarabine cytoreduction therapy at the time of transplant (FLA group). MRD analysis and time to relapse were used in a subsequent cohort of 22 patients (BMT 2000–2002) to allocate those at highest risk of treatment failure to receive a further cytoreductive block, FLX, pre-BMT. Method. All patients were conditioned with cyclophosphamide (60mg/m2 x2) and TBI (14.4 Gy). UD and haplo-BMT were T-cell depleted with Campth-1M in vitro and Campath-1G day -9 to -5 (Control and FLA group), and by Miltenyi CD34+ cell depletion (FLX group). GvHD prophylaxis - CSA + MTX for matched related, CSA for Campath treated grafts and none for Miltenyi grafts. The FLA group received fludarabine 25mg/m2 from d −12 to d −10. Patients with on treatment relapse (S4) or high level MRD pre-BMT (MRD++) in the FLX group received DaunoXome 100mg/m2, fludarabine 30mg/m2 x 5d and cytosine 2g/m2 x 5d 3 weeks prior to BMT. Patients and donors. Control group: 28 precursor-B ALL 4 T-ALL; donors - 7 matched related, 13 matched unrelated (MUD) and 12 mismatched unrelated (MMUD); 14 S2, 18 S3/4. FLA group: 5 presursor-B ALL and 3 T-ALL; donors - 2 SIB, 4 MUD, 1 MMUD and 2 haplo; all S4. FLX group: 21 precursor-B and 1 T-ALL; donors - 6 SIB, 7 MUD, 5 MMUD and 4 haplo;13 S2, 9 S4. 7 patients received FLX intensified conditioning (6 S4, 5 high level MRD ++). 3 high risk patients violated protocol and did not receive FLX (1 age &lt;1yr on treatment relapse, 2 S2 MRD ++). Results. Considering those in the high-risk S3/4 group, there was no significant difference in OS between the 3 groups. Survival by study and risk group Study S2 S3/4 Overall Control 10/14 (71%) 3/18 (17%) 13/32 (41%) FLA 2/8 (25%) 2/8 (25%) FLX 11/13 (85%) 3/9 (33%) 14/22 (64%) No excess cardiac events were seen. The TRM is higher in the FLX group than in the control. Outcome data Study TRM Relapse Alive Total Control 3 16 13 32 S2 2 2 10 14 S3/4 1 14 3 18 FLA 3 3 6 12 S2 - - - - S3/4 3 3 3 9 FLX 6 2 14 22 S2 2 0 11 13 S3/4 4 2 3 9 Total 12 21 33 66 2 of 7 patients treated with FLX are in CCR, 2 relapsed and 3 died of TRM. The 3 high risk patients in the FLX study, but who did not receive FLX, are also in CCR. Survival in those in the S2 group (late BM relapse) has been good throughout the study period. Conclusion. In this study the addition of intensive pre-BMT conditioning has not improved survival amongst high risk (S3/4 or MRD ++ pre-BMT) relapses. The number of post-BMT relapses has fallen but this is not clearly related to the use of FLX. The use of more haploidentical donors, more immunosupressive BMT regimes and additional cytoreductive chemotherapy may have contributed to the increased TRM seen. Time and site of relapse remain the clearest predictor of outcome. Further novel strategies are required to improve survival for the S4 risk group. The good OS for children receiving BMT in the S2 group should be noted.


2021 ◽  
Vol 11 ◽  
Author(s):  
Xiao-Xiao Guo ◽  
Hao-Ran Xia ◽  
Hui-Min Hou ◽  
Ming Liu ◽  
Jian-Ye Wang

ObjectiveWe aimed compare the oncologic outcomes of radical prostatectomy (RP) with those of external beam radiotherapy (EBRT), brachytherapy (BT), or EBRT + BT (EBBT) in elderly patients with localised prostate cancer (PCa).MethodsLocalised PCa patients aged ≥70 years who underwent RP, EBRT, BT, or EBBT between 2004 and 2016 were identified from the Surveillance, Epidemiology, and End Results database. Multivariable competing risks survival analyses were used to estimate prostate cancer-specific mortality (CSM) and other-cause mortality (OCM). Subgroup analyses according to risk categories were also conducted.ResultsOverall, 14057, 37712, 8383, and 5244 patients aged ≥70 years and treated with RP, EBRT, BT, and EBBT, respectively, were identified. In low- to intermediate-risk patients, there was no significant difference in CSM risk between RP and the other three radiotherapy modalities (all P &gt; 0.05). The corresponding 10-year CSM rates for these patients were 1.2%, 2.3%, 2.0%, and 1.8%, respectively. In high-risk patients, EBRT was associated with a higher CSM than RP (P = 0.003), whereas there was no significant difference between RP and BT or RP and EBBT (all P &gt; 0.05). The 10-year CSM rates of high-risk patients in the RP, EBRT, BT, and EBBT groups were 7.5%, 10.2%, 8.3%, and 7.6%, respectively. Regarding OCM, the risk was generally lower in RP than in the other three radiotherapy modalities (all P &lt; 0.001).ConclusionsAmong men aged ≥70 years with localised PCa, EBRT, BT, and EBBT offer cancer-specific outcomes similar to those of RP for individuals with low- to intermediate-risk disease. In patients with high-risk disease, EBBT had outcomes equally favourable to those of RP, but RP is more beneficial than EBRT. More high-quality trials are warranted to confirm and expand the present findings.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2095-2095 ◽  
Author(s):  
William G Wierda ◽  
Susan M O’Brien ◽  
Stefan H Faderl ◽  
Alessandra Ferrajoli ◽  
Charles Koller ◽  
...  

Abstract High-risk patients (pts) with CLL can be identified by prognostic factors. Traditional prognostic factors that identify high-risk pts include Rai stage, absolute lymphocyte count (ALC), rapid lymphocyte doubling time, and serum beta-2 microglobulin (β2M). Del 17p is associated with loss of the tumor suppressor gene TP53. Patients with del 17p also tend to have mutations in TP53, thereby providing a second mechanism for complete TP53 knockout. Pts with del 17p have poor response to purine analogue-based treatments. β2M greater than twice the upper limit of normal (2XULN) was an independent high-risk feature for pts treated with the frontline fludarabine (F), cyclophosphamide (C), rituximab (R) regimen (FCR). Pts younger than 70 years with β2M &gt;2XULN treated with FCR had a complete remission (CR) rate of 60% and median time to progression (TTP) of 70 months, compared to 84% and 86 months for pts &lt;70 yrs old with β2M &lt;2XULN. We evaluated the CFAR regimen (F 20mg/m2 d3–5; C 200mg/m2 d3–5; R 375–500mg/ m2 d2; and Alemtuzumab 30mg d1,3,5 of each 4-wk course) as frontline treatment in a high-risk group of pts with CLL. The trial completed planned enrollment of 60 pts; 48 are currently evaluable for response and follow-up. In this high-risk group, 28% of the 48 evaluable high-risk pts had del 17p prior to treatment by FISH analysis. Overall, the CR rate for the 48 pts was 69%, 54% CR for the 13 pts with del 17p. The overall response rates were 94% and 77% for the 48 pts and 13 pts with del 17p, respectively. CFAR was associated with more myelosuppression and fewer pts could receive all 6 intended courses compared with the historic high-risk group treated with FCR. However, a higher proportion of CFAR pts had no evidence of residual disease in the bone marrow by 2-color flow cytometry evaluation at response assessment. There is currently no difference in TTP or OS, comparing CFAR and FCR in this retrospective historical analysis with a short median follow-up time of 16 months for the CFAR group. There was no significant difference in incidence of infection during treatment with CFAR compared to FCR, with the exception of CMV reactivation. The CFAR regimen is active and tolerated in the highrisk group of pts with CLL, including those with del 17p. Follow-up continues for the pts treated on this trial in order to evaluate responses in all 60 enrolled pts and to evaluate time-to-event endpoints and compare with the historic FCR experience.


2017 ◽  
Vol 9 (11) ◽  
pp. 241-250 ◽  
Author(s):  
Gabriele Cozzi ◽  
Gennaro Musi ◽  
Roberto Bianchi ◽  
Danilo Bottero ◽  
Antonio Brescia ◽  
...  

Background: The aim of this study was to compare oncologic outcomes of radical prostatectomy (RP) with brachytherapy (BT). Methods: A literature review was conducted according to the ‘Preferred reporting items for systematic reviews and meta-analyses’ (PRISMA) statement. We included studies reporting comparative oncologic outcomes of RP versus BT for localized prostate cancer (PCa). From each comparative study, we extracted the study design, the number and features of the included patients, and the oncologic outcomes expressed as all-cause mortality (ACM), PCa-specific mortality (PCSM) or, when the former were unavailable, as biochemical recurrence (BCR). All of the data retrieved from the selected studies were recorded in an electronic database. Cumulative analysis was conducted using the Review Manager version 5.3 software, designed for composing Cochrane Reviews (Cochrane Collaboration, Oxford, UK). Statistical heterogeneity was tested using the Chi-square test. Results: Our cumulative analysis did not show any significant difference in terms of BCR, ACM or PCSM rates between the RP and BT cohorts. Only three studies reported risk-stratified outcomes of intermediate- and high-risk patients, which are the most prone to treatment failure. Conclusions: our analysis suggested that RP and BT may have similar oncologic outcomes. However, the analysis included a limited number of studies, and most of them were retrospective, making it impossible to derive any definitive conclusion, especially for intermediate- and high-risk patients. In this scenario, appropriate urologic counseling remains of utmost importance.


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&gt;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 &lt; 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 &gt; 0,05),M II oocytes(11.03 vs 11.99 p &gt; 0.05).The dual trigger group(A)had a higher fertility rate(69.99% vs 64.11% p &lt; 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 &gt; 0.05)TQE transfered on 3th day(1.5.vs 1.3.p&gt;0.05);transferred blastocyst(2.6 vs2.7 &gt;0.05);cryo embryos(2.5vs1.9 p &gt; 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&lt;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 &lt; 0.05) in opposite of percentage of patients with embryo transfer with “poore “” blastocyst in group B (37.5% vs 46.15.%p&lt;0.05). Clinical pregnanacy rate (71.68% vs 50.84% p &lt; 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


2021 ◽  
Author(s):  
Ádám Jóna ◽  
Anna Kenyeres ◽  
Sándor Barna ◽  
Árpád Illés ◽  
Zsófia Simon

Abstract Introduction: Follicular lymphoma (FL) is an indolent yet heterogeneous B-cell lymphoproliferative disorder. Most people respond to treatment well. However, a particular group of patients has a poor prognosis, and these patients are difficult to define.Patients and methods: We retrospectively analyzed FL patients treated at the University of Debrecen in the past 20 years. We investigated prognostic factors that may influence the survival of FL patients.Results: We found a standardized uptake value (SUV)max cut-off value of 9.85 at the staging PET/CT to significantly separate FL patients’ progression-free survival (PFS) (p=0.0003, HR: 0.2560, 95%CI: 0.1232-0.5318). Lymphocyte/ monocyte (Ly/Mo) ratio of 3.45 drawn at diagnosis also significantly predicted PFS (p=0.0324, HR: 1.806, 95% CI: 1.051-3.104). Combining patients’ with staging SUVmax >9.85 and Ly/Mo < 3.45 a high-risk group of FL patients can be identified (p<0.0001, HR: 0.1033, 95%CI: 0.03719-0.2868). Similarly, a significant difference was shown with a SUVmax cut-off of 3.15 at the interim PET/CT (p<0.0001, HR: 0.1535, 95%CI: 0.06329-0.3720). Combining patients with staging SUVmax >9.85 and interim SUVmax >3.15, a high-risk group of FL patients can be identified (p<0.0001, HR: 0.1037, 95%CI: 0.03811-0.2824). The PFS difference is translated into overall survival advantage (p=0.0506, HR: 0.1187, 95%CI: 0.01401-1.005).Discussion: Biological prognostic factors, such as the Ly/ Mo ratio, may improve the prognostic assessment of staging PET/CT. Nevertheless, PFS difference is translated into OS when using a combination of staging and interim SUVmax. We consider investigating additional biological prognostic factors while currently highlighting PET/CT's role in FL.


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.


2008 ◽  
Vol 01 (03) ◽  
Author(s):  
Bernd J Schmitz-Dräger ◽  
Arndt Hartmann ◽  
Gert Hüsgens ◽  
Jack Groskopf ◽  
Jochen Gleissner ◽  
...  

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Grinberg ◽  
T Bental ◽  
Y Hammer ◽  
A R Assali ◽  
H Vaknin-Assa ◽  
...  

Abstract Background Following Myocardial Infarction (MI), patients are at increased risk for recurrent cardiovascular events, particularly during the immediate period. Yet some patients are at higher risk than others, owing to their clinical characteristics and comorbidities, these high-risk patients are less often treated with guideline-recommended therapies. Aim To examine temporal trends in treatment and outcomes of patients with MI according to the TIMI risk score for secondary prevention (TRS2°P), a recently validated risk stratification tool. Methods A retrospective cohort study of patients with an acute MI, who underwent percutaneous coronary intervention and were discharged alive between 2004–2016. Temporal trends were examined in the early (2004–2010) and late (2011–2016) time-periods. Patients were stratified by the TRS2°P to a low (≤1), intermediate (2) or high-risk group (≥3). Clinical outcomes included 30-day MACE (death, MI, target vessel revascularization, coronary artery bypass grafting, unstable angina or stroke) and 1-year mortality. Results Among 4921 patients, 31% were low-risk, 27% intermediate-risk and 42% high-risk. Compared to low and intermediate-risk patients, high-risk patients were older, more commonly female, and had more comorbidities such as hypertension, diabetes, peripheral vascular disease, and chronic kidney disease. They presented more often with non ST elevation MI and 3-vessel disease. High-risk patients were less likely to receive drug eluting stents and potent anti-platelet drugs, among other guideline-recommended therapies. Evidently, they experienced higher 30-day MACE (8.1% vs. 3.9% and 2.1% in intermediate and low-risk, respectively, P<0.001) and 1-year mortality (10.4% vs. 3.9% and 1.1% in intermediate and low-risk, respectively, P<0.001). During time, comparing the early to the late-period, the use of potent antiplatelets and statins increased among the entire cohort (P<0.001). However, only the high-risk group demonstrated a significantly lower 30-day MACE (P=0.001). During time, there were no differences in 1-year mortality rate among all risk categories. Temporal trends in 30-day MACE by TRS2°P Conclusion Despite a better application of guideline-recommended therapies, high-risk patients after MI are still relatively undertreated. Nevertheless, they demonstrated the most notable improvement in outcomes over time.


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