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International Journal of Cardiology

Elsevier BV

All preprints, ranked by how well they match International Journal of Cardiology's content profile, based on 13 papers previously published here. The average preprint has a 0.02% match score for this journal, so anything above that is already an above-average fit. Older preprints may already have been published elsewhere.

1
Left Ventricular Assist Device Outcomes and Strategy 5 Years from Heart Transplant Allocation Score Change

Agronin, J. A.; Brown, M.; Calvelli, H.; Rakita, V.; Toyoda, Y.; Kashem, M.

2023-09-12 transplantation 10.1101/2023.09.11.23295392 medRxiv
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BackgroundThe United Network for Organ Sharing (UNOS) adopted new criteria for the heart allocation score on 10/18/2018 to reflect changing trends of candidates mortality while awaiting transplant. We examined the impact of these policy changes on rates of left ventricular assist device (LVAD) implantation and outcomes posttransplant from a relatively newer UNOS database. MethodsThe UNOS registry was used to identify first-time adult heart recipients with LVAD at listing or transplant who underwent transplantation between 1/1/2016 and 3/10/2020. Survival data was collected through 3/30/2023. Those listed prior to 10/18/2018 but transplanted after were excluded. Patients were divided into before or after change groups. Demographics and clinical parameters were compared. Survival was analyzed with Kaplan-Meier curves and log-rank tests. A p<0.05 was considered significant. ResultsWe identified 4599 heart recipients with LVAD in the before (N=3767) and after (N=832) score change eras. The after group had a lower rate of LVAD implantation while listed compared to the before group (19.4% vs 34.5%, p<0.0001), younger average age (53.1 {+/-} 12.2 vs 54.1 {+/-} 11.9, p=0.0350) and more likely to be female (24.9% vs 19.6%, p=0.0007); in both groups, most recipients (62%) were white. There was significantly farther distance from the donor hospital to transplant center in the after group (259.5 {+/-} 246.8 NM vs 143.2 {+/-} 182.1 NM, p<0.0001) and decreased waitlist days (83.5 {+/-} 103.5 vs 369.0 {+/-} 458.5, p<0.0001). Recipients in the after group were more likely to receive a CDC increased-risk donor organ (37.5% vs 30.2%, p=0.0002). Survival at 5-years was significantly reduced in the after group (60.5% vs 78.9%, p<0.0001). ConclusionsThe allocation score change in 2018 yielded considerable changes in mechanical circulatory support device implantation strategy and survival. The rate of LVAD implantation decreased with profoundly worse 5-year survival, showing further divergence from prior short-term post-transplant data.

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Regional heterogeneity in the use of extracorporeal membrane oxygenation for heart transplant after 2018 allocation policy change

Schumer, E.; Endo, T.; Wada, T.; Schilling, J. D.; Kotkar, K.; Masood, M.; Pawale, A.

2025-02-12 transplantation 10.1101/2025.02.07.25321902 medRxiv
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BackgroundThe 2018 heart transplant allocation policy has changed the profile of patients receiving heart transplant, with an increased use of acute mechanical support and decreased use of durable left ventricular assist devices. We investigated the use of extracorporeal membrane oxygenation (ECMO) use pre- and post-allocation change. MethodsUsing the UNOS database, we identified adult patients who underwent heart transplant from January, 2006 - June, 2022. The study time period was divided into pre- and post-allocation change. We divided ECMO patients by region and analyzed change in the rate of ECMO use by region between eras. Differences between groups and survival comparison were analyzed. ResultsA total of 41,636 recipients were found, of which 891 (2.1%) were on ECMO at the time of transplant. Overall ECMO use increased from 231 (0.8%) to 660 (5.5%) between eras (p<0.001). There was significant regional variation in the rate of ECMO usage (p<0.001) and significant differences in postoperative dialysis (p=0.014) and acute rejection episodes (p<0.001). There was no significant difference in pacemaker rate (p=0.172), stroke (p=0.212), treatment for rejection within 1 year (p=0.358), or post-transplant survival in the current era between regions for patients on ECMO at the time of transplant (p=0.444). ConclusionThere is increased utilization of ECMO following implementation of an allocation system which prioritizes ECMO recipients on the waitlist and there is a differential increase in the use of ECMO in various regions. Further granular studies are needed to see which patients may benefit more from ECMO and what can be done to reduce post-transplant mortality from ECMO to transplant as it remains high before and after allocation change.

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Surgical and percutaneous coronary revascularization in patients with multivessel or left main disease; what happens beyond five years? A systematic review and study level meta-analysis of randomized trials.

Formica, F.; Hernandez-Vaquero, D.; Tuttolomondo, D.; Gallingani, A.; singh, g.; Pattuzzi, C.; Niccoli, G.; Lorusso, R.; Nicolini, F.

2023-03-18 cardiovascular medicine 10.1101/2023.03.17.23287425 medRxiv
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Meta-analysis exploring outcomes beyond 5-years of trials comparing coronary artery bypass graft (CABG) with percutaneous coronary intervention (PCI) utilizing drug-eluting stents in patients with coronary artery disease (CAD), are missing. We conducted a meta-analysis to compare very long-term outcomes, between the two interventions. Using electronic databases, we retrieved 4 trials, between January, 2010 and January, 2023. The primary endpoint was all-cause mortality. Kaplan-Meier curves of endpoint was reconstructed. Comparisons were made by Cox-linear regression frailty model and by landmark analysis. A flexible parametric model for survival analysis was used to obtain the time-dependent hazard-ratio. A random-effect method was applied. 5180 patients were included and randomized to CABG (n=2586) or PCI with DES (n=2594). During 10-year follow-up, PCI showed an overall higher incidence of all-cause mortality [hazard ratio (HR) 1.19; 95% confidence interval (CI), 1.104-1.32; p=0.008)]. At landmark analysis, PCI showed higher risk of the endpoint within 5-years (HR 1.2; 95% CI, 1.06-1.53; p=0.008) while no difference was found at 5-10-year period (HR,1.03; 95%CI, 0.84-1.26; p=0.76). The time-varying HR analysis of PCI versus CABG was consistent with the results of the landmark analysis. There was no long-term difference between the two interventions for myocardial infarction (MI) (OR,1.42; 95%CI, 0.92-2.18; p=0.11), composite of all-cause mortality, stroke or MI (OR,1.07; 95%CI, 0.84-1.36; p=0.57), stroke (OR,0.97; 95%CI, 0.59-1.59; p=0.91) and cardiovascular death (OR,1.02; 95%CI, 0.75-1.40; p=0.90), while PCI was associated with an increased risk for repeat revascularization (OR,2.11; 95%CI, 1.58-2.81; p<0.001) and major adverse cardiac and cerebrovascular events (OR,1.41; 95%CI, 1.13-1.75; p<0.0001). In conclusion, in patients with CAD, there was a significantly overall higher incidence of all-cause mortality after PCI compared to CABG beyond 5-year follow-up. Specifically, CABG is still favorable beyond 5 years and maintains its gold standard role for the CAD treatment; PCI has an evident higher mortality during the first 5 years and a comparable outcome beyond 5 years.

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Reperfusion strategies in patients with ST-segment elevation myocardial infarction during hospitalization in China: Findings from the Improving Care for Cardiovascular disease in China (CCC)-Acute Cronary Synrome project

Wang, J.; zhang, z. q.; Li, J.; Tian, X.; Wang, X.; Han, Y.

2023-12-11 cardiovascular medicine 10.1101/2023.12.10.23299554 medRxiv
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ObjectiveTo analyze the current situation of reperfusion strategies of ST-segment elevation myocardial infarction (STEMI) in China and evaluate the efficacy and safety of different reperfusion strategies, especially pharmaco-invasive percutaneous coronary intervention (PI-PCI). MethodsThe CCC-ACS (Improving Care for Cardiovascular Disease in China-Acute Coronary Syndrome) project is a joint study between the American Heart Association and Chinese Society of Cardiology (CSC). STEMI patients who were recruited to the CCC-ACS project between November 2014 and December 2019 and admitted within 48 hours after symptom onset and treated by thrombolysis or percutaneous coronary intervention (PCI) were included in this cohort study. The primary efficacy outcomes were major adverse cardiac cerebrovascular events (MACCEs) that occurred during hospitalization. The primary safety outcomes were Thrombolysis in Myocardial Infarction (TIMI) major or minor bleedings criteria during hospitalization. Univariate regression logistic analysis, multivariable logistic regression analysis, propensity score-matched analysis, and inverse probability of treatment weighting analysis were performed to evaluate the efficacy and safety of different reperfusion strategies. ResultsOf 37733 STEMI patients, 35019 patients received primary percutaneous coronary intervention (PPCI), 999 patients received thrombolysis and 1715 patients received PI-PCI. Compared with PPCI, the thrombolysis group had higher incidence of all cause death (1.6% vs 2.8%, P =0.003), MACCEs (2.0% vs 3.6%, P < 0.001), and TIMI major bleedings (1.2% vs 2.2%, P=0.007). In the PI-PCI group, the incidence of MACCEs (2.0% vs 0.8%, P =0.001), all cause death (1.6% vs 0.4%, P =0.001), and cardiac death (1.5% vs 0.4%, P =0.001) were significantly lower than PPCI group; and the same conclusion was found in the subgroup of in time from first medical contact(FMC) to reperfusion [&ge;] 3h. However, the risk of TIMI minor bleedings (5.1% vs 6.7%, P=0.008) was higher in the PI-PCI group in the subgroup of in time from FMC to reperfusion [&ge;] 3h. Compared with timely PPCI group, the incidence of all cause death was significantly lower and the incidence of heart failure was higher in the scheduled PCI group. Compared with late PPCI group, the incidence of all cause death, MACCEs were significantly lower in scheduled PCI group. Compared with timely PPCI, the ratio of heart failure was statistically significant higher in the rescue PCI group. There was no significant difference in all outcomes in all models between rescue PCI group and late PPCI group. Moreover, compared with scheduled PCI [&le;] 24h group, the scheduled PCI during 24h to 7d group had lower risk of TIMI major or minor bleedings and the scheduled PCI >7d group had the similar risk of bleedings; the scheduled PCI >7d group had lower risk of heart failure. ConclusionsThis study demonstrates that in STEMI patients who could not perform timely PPCI, PI-PCI is feasible, including rescue PCI,which can reduce the rate of MACCEs and mortality during hospitalization.But the increased risk of bleedings also should be noted.In scheduled PCI after successful thrombolysis, appropriate extension the time window of scheduled PCI can be considered under stable clinical conditions.

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Risk factors of coronary microvascular obstruction

Li, Y.; Lyu, S.

2020-06-01 cardiovascular medicine 10.1101/2020.05.29.20116665 medRxiv
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BackgroundCoronary microvascular obstruction /no-reflow(CMVO/NR) is a predictor of long-term mortality in survivors of ST elevation myocardial infarction (STEMI) underwent primary percutaneous coronary intervention (PPCI). ObjectiveTo identify risk factors of CMVO/NR. MethodsTotally 2384 STEMI patients treated with PPCI were divided into two groups according to thrombolysis in myocardial infarction(TIMI) flow grade:CMVO/NR group(246cases, TIMI 0-2 grade) and control group(2138 cases, TIMI 3 grade). We used univariable and multivariable logistic regression to identify risk factors of CMVO/NR. ResultsA frequency of CMVO/NR was 10.3%(246/2384). Logistic regression analysis showed that the differences between the two groups in age(unadjusted odds ratios [OR] 1.032; 95% CI, 1.02 to 1.045; adjusted OR 1.032; 95% CI, 1.02 to 1.046; P <0.001), periprocedural bradycardia (unadjusted OR 2.357; 95% CI, 1.752 to 3.171; adjusted OR1.818; 95% CI, 1.338 to 2.471; P <0.001),using thrombus aspirationdevices during operation (unadjusted OR 2.489; 95% CI, 1.815 to 3.414; adjusted OR1.835; 95% CI, 1.291 to 2.606; P =0.001), neutrophil percentage (unadjusted OR 1.028; 95% CI, 1.014 to 1.042; adjusted OR1.022; 95% CI, 1.008 to 1.036; P =0.002), and completely block of culprit vessel (unadjusted OR 2.626; 95% CI, 1.85 to 3.728; adjusted-OR 1.656;95% CI, 1.119 to 2.45; P =0.012) were statistically significant (P <0. 05). The area under the receiver operating characteristic curve was 0.6896. ConclusionsAge, periprocedural bradycardia, using thrombus aspirationdevices during operation, neutrophil percentage, and completely block of culprit vessel may be independent risk factors for predicting CMVO/NR. We registered this study with WHO International Clinical Trials Registry Platform (ICTRP) (registration number: ChiCTR1900023213; registered date: 16 May 2019).http://www.chictr.org.cn/edit.aspx?pid=39057&htm=4.

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Long-Term Outcomes of Successful CTO PCI Using Antegrade and Retrograde Dissection and Re-entry Technique: The LOTUS study

gao, h.; Yu, T.; Wang, H.; Cai, Y.; Wang, M.; Dou, K.; Zhao, L.; Jin, Z.; Hou, Y.-L.; Chen, Y.; Lei, X.; Lian, K.; Chen, G.; Li, C.

2025-09-17 cardiovascular medicine 10.1101/2025.09.10.25335543 medRxiv
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BackgroundThere are always concerns regarding the durability of subintimal stenting after contemporary chronic total occlusion (CTO) recanalization. MethodThis prospective, multicenter clinical trial aimed to compare extraplaque (EP) and intraplaque (IP) tracking for long-term clinical outcomes after CTO recanalization. After IVUS assessment of the wire crossing position, the patients were divided into two groups: (1) the EP group with subintimal length (SL) > 10 mm; and (2) the IP group with intraplaque or minor extraplaque (SL [&le;] 10 mm). The primary endpoint was binary in-segment restenosis (ISR), and the secondary endpoint was the occurrence of major adverse cardiac events. Angiographic follow-up (FU) was scheduled at 13 months, and clinical FU was continued up to 3 years. ResultsA total of 257 successful CTO patients were enrolled. The mean CTO length in the EP group was 46.6 {+/-} 16.1 mm, and the median extraplaque length was approximately 24.5 mm. The J-CTO score was higher (p<0.001). Angiographic FU at 13 months showed that both groups had similar cumulative rates of ISR (p = 0.704). In the 3-year clinical follow-up, the cumulative incidence of target vessel revascularization (TVR) in both groups and across different tracking techniques showed no significant difference (p > 0.05). Independent predictors of ISR were a total stent length >50 mm and a wire crossing time >2 hours, while multivessel lesions showed an independent association with 3-year TVR. ConclusionThe specific long extraplaque tracking had comparable angiographic and long-term clinical outcomes to intraplaque tracking, regardless of the crossing technique used. Graphical Abstract O_FIG O_LINKSMALLFIG WIDTH=200 HEIGHT=131 SRC="FIGDIR/small/25335543v1_ufig1.gif" ALT="Figure 1"> View larger version (57K): org.highwire.dtl.DTLVardef@12c7eb1org.highwire.dtl.DTLVardef@31b5d7org.highwire.dtl.DTLVardef@1995106org.highwire.dtl.DTLVardef@967746_HPS_FORMAT_FIGEXP M_FIG C_FIG

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The Net Clinical Benefit of Fondaparinux vs LMWH in Chinese Non-ST-Segment Elevation Acute Coronary Syndrome Patients

Li, D.; Tuo, X.-d.; Yu, Y.-n.; Ma, G.; Gao, C.; mao, w.; Qu, P.; Liu, l.; Shang, z.; Yin, x.; Wang, g.; Liu, a.; Chen, Y.

2025-02-25 cardiovascular medicine 10.1101/2025.02.24.25322821 medRxiv
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Background and aimsIn Chinese patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS), it is essential to evaluate the net clinical benefit (NCB) of fondaparinux compared to low molecular weight heparin (LMWH) in NSTE-ACS patients with varying bleeding and ischemic risks. MethodsThis multicenter, prospective, open-label, real-world study enrolled 8066 adult patients undergoing non-emergency percutaneous coronary intervention (PCI) at 88 hospitals from July 2019 to July 2021. Patients received fondaparinux (2.5 mg/d) or LMWH (1 mg/kg, twice/day) were followed up within 6 months. The GRACE and CRUSADE scores were used to stratify the included patients. The primary outcome was the incidence of NCB event (all-cause death, reinfarction, nonfatal stroke, or BARC[&ge;] type 2 bleeding) at 30 days. ResultsA total of 5430 patients received fondaparinux and 2636 received LMWH. The NCB outcome occurred in 136 patients (2.5%) receiving fondaparinux and in 110 patients (4.2%) receiving LMWH [HR=0.594 (95% CI: 0.462, 0.764), p<0.001]. The 30-day incidence of BARC[&ge;]2 bleeding was significantly lower in the fondaparinux group compared with the LMWH group [68 (1.3%) vs. 66 (2.5%), HR=0.498 (95% CI: 0.355, 0.699), p<0.001].Among patients with lower risk, defined by GRACE score[&le;]140 and CRUSADE scores[&le;]40, fondaparinux significantly reduced the incidence of MACE and BARC [&ge;] 2 bleeding. Fondaparinux decreased the risk of BARC[&ge;]2 bleeding across different risk groups, with absolute risk reductions (ARD) of -0.9% for CRUSADE score[&le;]40, -3.0% for CRUSADE score>40, -1.2% for GRACE score[&le;]140, and -1.7% for GRACE score>140, indicating a more pronounced protective effect in individuals at high bleeding risk. ConclusionsIn Chinese patients with NSTE-ACS, fondaparinux effectively diminished the incidence of the NCB event of 30 days compared with LMWH. Additionally, fondaparinux exhibited superior safety than LMWH in patients with high bleeding risk, consistently outperformed LMWH in terms of efficacy and safety in the low-risk group as well.

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Development and External Validation of a Diagnostic Model for Coronary Microvascular Obstruction

Li, Y.; Lyu, S.

2020-07-01 cardiovascular medicine 10.1101/2020.06.27.20141416 medRxiv
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BackgroundPrevention of coronary microvascular obstruction /no-reflow phenomenon(CMVO/NR) is a crucial step in improving prognosis of patients with acute ST segment elevation myocardial infarction (STEMI)during primary percutaneous coronary intervention (PPCI). We wanted to develop and externally validate a diagnostic model of CMVO/NR in patients with acute STEMI underwent PPCI. MethodsDesign: Multivariable logistic regression of a cohort of acute STEMI patients. Setting: Emergency department ward of a university hospital. Participants: Diagnostic model development: Totally 1232 acute STEMI patients who were consecutively treated with PPCI from November 2007 to December 2013. External validation: Totally 1301 acute STEMI patients who were treated with PPCI from January 2014 to June 2018. Outcomes: CMVO/NR during PPCI. Results147(11.9%)patients presented CMVO/NR in the development dataset and 120(9.2%) patients presented CMVO/NR in the validation dataset. The strongest predictors of CMVO/NR were age, periprocedural bradycardia, using thrombus aspiration devices during procedure and total occlusion of culprit vessel. We developed a diagnostic model of CMVO/NR.The area under the receiver operating characteristic curve (AUC) was 0.6833 in the development set.We constructed a nomogram using the development database.The AUC was 0.6547 in the validation set. Discrimination, calibration, and decision curve analysis were satisfactory. ConclusionsWe developed and externally validated a diagnostic model of CMVO/NR during PPCI. We registered this study with WHO International Clinical Trials Registry Platform on 16 May 2019. Registration number: ChiCTR1900023213. http://www.chictr.org.cn/edit.aspx?pid=39057&htm=4.

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Effects of Statin Therapy in Patients Treated with Drug-Eluting and Drug-Coated Stents for Femoropopliteal Lesions: STAR-FP Study Outcomes

Takei, T.; Tokuda, T.; Yoshioka, N.; Ogata, K.; Tanaka, A.; Kojima, S.; Yamaguchi, K.; Yanagiuchi, T.; Nakama, T.

2024-09-07 cardiovascular medicine 10.1101/2024.09.06.24313216 medRxiv
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BackgroundThe effects of statins on drug-eluting stents (DESs) and drug-coated stents (DCSs) for femoropopliteal (FP) lesions are not well known. Therefore, this multicenter retrospective evaluated the impact of statins on DES and DCS patency. MethodsBetween January 2018 and December 2021, 449 patients were treated with DES and DCS at eight cardiovascular centers in Japan (LEADers FP registry). These lesions were divided into statin-treated and non-statin-treated arms. After propensity score matching, the effects of statins on DES and DCS were evaluated. The 2-year primary outcome measure was stent patency. The secondary outcomes included secondary patency, clinically driven target lesion revascularization (CD-TLR), limb salvage, major adverse limb events (MALE, CD-TLR+ major amputation), and a composite of overall survival and MALE or all-cause death at 2 years. ResultsAfter propensity score matching, the baseline and procedural characteristics did not differ significantly between the 135 patient pairs in the statin and non-statin groups. The primary patency at two years was significantly better in the statin group than in the non-statin group (86.9% vs. 75.1%, p=0.041). Regarding the secondary endpoints, the statin group demonstrated significantly superior secondary patency and freedom from MALE or all-cause mortality (95.5% vs. 87.0%, p=0.023 and 73.7% vs. 60.0%, p=0.012, respectively). ConclusionsThe results of this retrospective multicenter study demonstrated the superior primary patency in the statin group compared with the non-statin group at two years. These findings suggest that statins improve patency in patients undergoing DES and DCS.

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Assessment and Improvement of Elixhauser Comorbidity Index for Predicting In-hospital Mortality in Heart Transplant Patients

Li, R.

2023-03-29 transplantation 10.1101/2023.03.27.23287837 medRxiv
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BackgroundHeart transplant (HT) has a high in-hospital mortality of around 5%. Risk prediction in-hospital mortality can be informative for transplant candidacy and post-HT prognosis. Elixhauser Comorbidity Index (ECI) is an ICD diagnostic code-based comorbidity measurement tool that can predict in-hospital mortality. While it has been validated in the large in-patient population, the accuracy of the mortality prediction has not been assessed in HT. MethodsThis study assessed the in-hospital mortality risk prediction by ECI as well as demographic variables in HT patients in the National Inpatient Sample (NIS) database. Demographic information was included in the multivariable ECI with demographics (ECID) model to assess in-hospital mortality. Moreover, ECI and age were used to develop a single index adjusted ECI (aECI) for mortality prediction. ResultsAge best predicts (c-statistic = 0.673, 95% CI = 0.638-0.709) in-hospital mortality, followed by ECI (c-statistic = 0.638, 95% CI = 0.598-0.678), race (c-statistic = 0.571, 95% CI = 0.533-0.609). Sex did not have predictive power (c-statistic = 0.501, 95% CI = 0.467-0.535) for in-hospital mortality. The predictive power of ECI was improved (c-statistic = 0.753, 95% CI = 0.720-0.785) in the ECID model. The single measure aECI had comparable discriminative power (c-statistic = 0.763, 95% CI = 0.731-0.794) to ECID in predicting in-hospital mortality. ConclusionThis study showed that ECI was an effective measure to predict post-HT in-hospital mortality. The improved measure aECI can be easily derived from ECI as a quick reference to assess post-HT in-hospital mortality in both the clinic and health administration.

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Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion

Lei, J.; Mei, W.; PU, L.; Dong, L.; Wang, J.-p.; Meng, H.-y.; Kong, X.-Q.; Chen, L.-l.

2024-06-07 cardiovascular medicine 10.1101/2024.06.05.24308526 medRxiv
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BackgroundCoronary chronic total occlusions (CTOs) are considered to increase the risk of adverse clinical outcomes. The purpose of this study was to evaluate whether long-term clinical outcomes could be improved by successful percutaneous coronary intervention (PCI) over optimal medical therapy (OMT) in CTO patients. Methods258 consecutive patients with CTO lesions undergoing PCI at the First Affiliated Hospital of Nanjing Medical University from January 2011 to December 2017 were enrolled. After 25 were excluded due to CABG surgery, a total of 233 patients who met the enrollment criteria were divided into successful CTO-PCI group (n=187) and CTO-OMT group (n=46) based on the treatment received. The study primary endpoint was major adverse cardiac cerebrovascular events (MACCE), including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke. The secondary endpoint was all-cause death. ResultsDuring a median follow-up of 78 months, PCI treatment significantly improved MACCE incidence survival probability compared with OMT (29.55% vs 21.95% p=0.028). There was no difference between these two groups in secondary endpoint (p=0.93). There was also no significant difference in MACCE between single vessel CTO lesions and single vessel CTO combined with multiple vessel lesions(p=0.54). The cumulative survival of LAD is the highest among different branch lesion groups(p=0.044). Elderly patients ([&ge;]65 years) in PCI group showed a significant decrease of MACCE incidence compared with OMT (35.00% vs 21.33% p=0.001). ConclusionsSuccessful PCI in CTO patients is associated with a significant decrease of MACCE compared with OMT.

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Comparative Clinical Outcomes of Everolimus versus Biolimus-Eluting Stents: A Meta-Analysis of 27,071 Patients from Randomized Trials

Reza, I. M. K.; Biswas, S.; Krishnan, E.; KC, A.; Bezawada, V.; Namala, S. S.; Chaudhari, M.; Peniel, J. J.; Shah, Z. A.; Bodar, Y. P.; Wazir, H.; Ahmed, S.; Tahir, O.; Castellanos, J. M.; Khan, M. S.

2025-10-07 cardiovascular medicine 10.1101/2025.09.29.25336296 medRxiv
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BackgroundThe comparative clinical outcomes of everolimus-eluting stents (EES) versus biolimus-eluting stents (BES) remains uncertain despite widespread use. This study conducted a systematic review and meta-analysis of randomized controlled trials comparing contemporary drug-eluting stent platforms. MethodsWe searched MEDLINE, Embase, CENTRAL, and Scopus through May 2025 for randomized trials comparing EES with BES in patients undergoing percutaneous coronary intervention. The primary outcomes were major adverse cardiac events (MACE) and device-oriented composite endpoint (DOCE) at the longest follow-up. Secondary outcomes included all-cause mortality, target lesion revascularization (TLR), and stent thrombosis. Random-effects meta-analysis was performed using risk ratios (RR) and 95% confidence intervals (CI). Heterogeneity was assessed using I{superscript 2} statistics. The GRADE approach evaluated the certainty of evidence. ResultsThirteen trials randomizing 27,071 patients (12,226 EES; 14,845 BES), with follow-up 9-120 months, were included. EES demonstrated a trend toward reduced MACE compared with BES (9.7% vs 10.3%; RR 0.93, 95% CI: 0.87-1.00; p=0.053; I{superscript 2}=0%) with an absolute risk reduction of 0.7% (number needed to treat=142). DOCE showed similar results (RR 0.94, 95% CI: 0.88-1.01; p=0.10; I{superscript 2}=0%). No significant differences were observed for all-cause mortality (RR 0.96, 95% CI: 0.88-1.05; p=0.37), TLR (RR 0.95, 95% CI: 0.86-1.05; p=0.36), or stent thrombosis (RR 0.93, 95% CI: 0.69-1.23; p=0.60), all with I{superscript 2}=0%. Subgroup analysis by follow-up duration showed consistent results (p-interaction=0.88). No publication bias was detected. GRADE assessment indicated moderate certainty evidence for most outcomes. ConclusionsIn this meta-analysis, EES showed a trend toward reduced MACE compared with BES, though not reaching statistical significance. The remarkable homogeneity and small absolute differences suggest both platforms provide excellent outcomes. Both stent platforms remain appropriate first-line options for percutaneous coronary intervention. RegistrationPROSPERO CRD42025108092

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Mortality Risk and Treatment Disparities in the Chinese SMuRF-less STEMI Patients: A Nationwide Cohort Study

Sun, B.; Liang, C.; Sun, P.; A, G.; Li, L.; Zhao, L.; Li, P.; Li, Y.; Foo, R. S.; Chan, M. Y.-Y.; Yang, Q.; Zhou, X.

2025-04-10 cardiovascular medicine 10.1101/2025.04.08.25325498 medRxiv
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AimsIn ST-segment elevation myocardial infarction (STEMI) patients, standard modifiable cardiovascular risk factors (SMuRFs) are strongly associated with increased risk of morbidity and mortality. However, clinical studies have shown that SMuRF-less patients have worse clinical outcomes. Limited research exists in China, and the clinical characteristics and prognosis of SMuRF-less patients remain unclear. This study aims to provide insight into the clinical features, treatments, and outcomes of SMuRF-less patients in China. MethodsWe retrospectively analysed adult patients with STEMI using data from the China Chest Pain Center database. We examined the impact of SMuRF-less on short-term (0 to 30 days) and long-term (31 to 365 days) mortality. Cox-proportional hazard models and Kaplan-Meier analysis for short-term and long-term mortality. ResultsOf the 379,811 patients, 87,830 (23.1%) were SMuRF-less. Patients in the SMuRF-less group were older (65 years vs. 63 years), a higher proportion of female (29.4% vs. 23.3%) and less like to receiving reperfusion therapy (81.1% vs. 85.6%). On short-term SMuRFs patients had significantly lower all-cause mortality (5.1% vs 8.7%, hazard ratios (HR) 0.82 [95% Confidence interval (CI) 0.80-0.84], P < 0.001). However, on long-term there was no significant difference in mortality between the groups (3.4% vs 3.8%, HR: 1.00, 95% CI: 0.96-1.05; P = 0.841). ConclusionsSMuRF-less patients exhibited higher mortality, particularly within the first 30 days after STEMI onset, with a more pronounced effect observed in male patients. Treatment disparities and delayed care were key contributors to this difference. Graphical abstract O_FIG O_LINKSMALLFIG WIDTH=200 HEIGHT=139 SRC="FIGDIR/small/25325498v1_ufig1.gif" ALT="Figure 1"> View larger version (53K): org.highwire.dtl.DTLVardef@778aaborg.highwire.dtl.DTLVardef@30ee20org.highwire.dtl.DTLVardef@61865corg.highwire.dtl.DTLVardef@bc1199_HPS_FORMAT_FIGEXP M_FIG C_FIG Comparison of clinical characteristics and outcomes between STEMI patients with SMuRF-less and SMuRFs. SMuRF-less was defined as having no traditional risk factors (hypertension, hyperlipidemia, diabetes, or smoking history), while SMuRFs had [&ge;]1 risk factor. Among STEMI patients, SMuRF-less patients, who accounted for 23% of the cohort, had a higher proportion of females, longer delays to first medical contact (FMC), lower rates of guideline-directed medical therapy (GDMT) and reperfusion, and higher short-term mortality compared to SMuRFs (77%). Kaplan-Meier analysis shows lower 30-day mortality in SMuRF-less patients (HR:0.82, 95% CI: 0.80-0.84, P < 0.001), with no significant difference in long-term mortality (HR: 1.00, 95% CI: 0.96-1.05, P = 0.841). Abbreviations: STEMI, ST elevation myocardial infarction; SMuRFs, standard modifiable cardiovascular risk factors; FMC, first medical contact; GDMT, guideline-directed medical therapy; HR, hazard ratio; CI, confidence interval.

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Frequent gastrointestinal cancer complications in Japanese patients with coronary syndromes undergoing percutaneous coronary intervention

Chiba, Y.; Imagawa, S.; Takahashi, Y.; Kubo, K.; Otsuka, K.; Shimazu, K.; Anzai, T.; Yonezawa, K.; Kato, M.; Anzai, T.

2024-12-18 cardiovascular medicine 10.1101/2024.12.17.24319200 medRxiv
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BackgroundGastrointestinal bleeding is a major complication of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI). Malignancy may be detected due to gastrointestinal bleeding, necessitating critical decisions regarding treatment selection and influencing patient prognosis. This study investigated the frequency of gastrointestinal malignancies, associated factors, and prognoses in patients undergoing perioperative PCI through upper and lower gastrointestinal endoscopy. MethodsThis single-center, retrospective, observational study included 501 Japanese patients who underwent initial PCI between January 2019 and January 2023. Of these patients, 393 who underwent perioperative upper and lower gastrointestinal endoscopy were evaluated for the presence of gastrointestinal malignancy. ResultsOf the total patients, 36% presented with acute coronary syndrome (ACS). Gastrointestinal malignancies were identified in 30 patients (8%), including 18 cases of colorectal cancer and eight cases of gastric cancer. No difference in the frequency of malignancies was observed between patients with ACS and chronic coronary syndrome (CCS) (p = 0.7398). Malignancies were significantly more common in patients with positive faecal immunochemical testing (FIT) (p < 0.0001); however, FIT did not detect all malignancies. The 1500-day survival rate for patients with gastrointestinal malignancies was 64%, with no difference in overall survival between treatment modalities. ConclusionsA considerable proportion of Japanese patients undergoing PCI had gastrointestinal malignancies, regardless of whether they had ACS or CCS, and their prognosis was poor. Upper and lower gastrointestinal endoscopic evaluations should be conducted, including for ACS cases, to prevent DAPT-induced gastrointestinal bleeding and improve prognosis.

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Complex and High Risk PCI assisted by VA-ECMO

Ullah, K.; Liu, B.

2023-06-04 cardiovascular medicine 10.1101/2023.05.26.23290621 medRxiv
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BackgroundDespite improvements in PCI techniques and equipment, there are still cases where traditional PCI is insufficient to manage complex and high-risk lesions. Patients with these lesions have increased rates of major adverse cardiac events, including myocardial infarction, cardiogenic shock, and death. In recent years, the use of extracorporeal membrane oxygenation (ECMO) during PCI has emerged as a potential solution to managing complex and high-risk lesions. MethodsThis retrospective study included patients who underwent elective complex and high-risk percutaneous coronary interventions with hemodynamic support provided by Veno-Arterial external membrane oxygenation (VA-ECMO) from 2018 to 2022. Complications related to VA-ECMO rates, Complications related to PCI, death, and major cardiovascular, cerebral events (MACCE) during hospitalization and after one-year follow-up were analyzed. ResultsThis retrospective study overall included 81 patients in which Males (N=60, 74.1%) and females (N=21, 25.9%) having (Average age: 62.74 {+/-}10.807 years) underwent complex and high-risk percutaneous coronary intervention assisted ECMO. The VA-ECMO support was provided for an average of 21.0 hours (With a range of 1-312). Intra-aortic Balloon Pump IABP support was done in 32.1% of patients. The pre-and post-PCI SYNTAX scores of the patients were 39.92 {+/-} (6.4) and 6.04 {+/-} (9.25) respectively. (P <0.001). Most of the patients had triple vessel coronary disease which was the common coronary lesion (47%). Interoperated complications include Cardiac Tamponade (N=1,1.2%), Acute Myocardial Infarction (N=6,7.2%), Cardiogenic Shock (N=2,2.4%), Cardiac Arrest (N=2,2.4%), Arrhythmias malignant in nature which required electro cardioversion (2,2.4%), Ventricular tachycardia (N=1,1.2%), Non-infectious multiple organ failure MODS(N=1,1.2%), Aortic Dissection Type-A (N=1,1.2%). Blood hemoglobin Pre-CHIP assisted VA-ECMO PCI and Post-procedure were 136.17 {+/-} 21.479 g/L and 106.67 {+/-} 19.103 g/L respectively P<0.001). eGFR pre and post-PCI were 67.22 {+/-} 26.85 and 60.09 {+/-} 27.78 respectively (<0.002), Pre and Post PCI EF were 38.69 {+/-} 13.65 and 43.55 {+/-} 13.72 respectively (<0.001), During hospitalization the outcomes for the CHIP assisted by ECMO procedure include Death(N=16,19.8%), Inguinal Hematoma (N=2,2.5%), Bleeding from the punctured site (N=2,2.5%), Peudoaneurysm (N=1,1.2%), Cerebral Infarction(N=1,1.2%), Subarachnoid hemorrhage (N=1,1.2%), No lower limb ischemia, No acute renal injury, Bacteremia, were noted in any of the hospitalization. Patient Hb decline requiring blood transfusion therapy was (N=59, 72.8%). Survival at discharge (Healthy) was (N=65, 80.2%). After one year of post-operation death (N=6, 7.2%) ConclusionIn conclusion, ECMO-assisted high-risk PCI proves to be a safe and effective strategy for complex procedures in patients who are not candidates for Coronary artery bypass grafting (CABG). The use of VA-ECMO resulted in minimal complications and low rates of MACCE during hospitalization and one-year follow-up. Further research is needed to determine the optimal timing for VA-ECMO initiation.

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Prolonged Dual Antiplatelet Therapy in Acute Myocardial Infarction Patients without Revascularization: Results from a China Acute Myocardial Infarction (CAMI) registry study

Huang, C.; CAMI (China Acute Myocardial Infarction) Registry Study Group, ; Yang, J.; Li, L.; He, S.; Zhang, X.; Xu, H.; Wu, Y.; Zhang, J.; Qiao, S.; Wu, Y.; Zhao, Y.; Wang, Y.; Li, W.; Jin, C.; Gao, X.; Yang, Y.

2023-08-24 cardiovascular medicine 10.1101/2023.08.22.23294450 medRxiv
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BackgroundAt least 12-month dual antiplatelet therapy (DAPT) is one of the standards of care following Percutaneous Coronary Intervention (PCI) in patients with acute coronary syndrome. However, study on prolonged DAPT for acute myocardial infarction (AMI) patients without revascularization is limited. MethodsWe studied 1744 AMI patients without revascularization from the China Acute Myocardial Infarction registry between January 2013 and September 2014. These patients were on DAPT and did not experience AMI, stroke, or bleeding events at 12-month follow-up. We divided them into two groups: 12-month DAPT group (DAPT for at least 12 months but less than 18 months) and 18-month DAPT group (DAPT for at least 18 months). The primary outcome is 24-month all-cause death. ResultsOverall, 1221 (70.0%) patients took DAPT for [&ge;]12 months but <18 months, while 523 (30.0%) patients took DAPT for [&ge;]18 months. The two groups had comparable proportions with high ischemic risk (27.0% vs. 25.6%, P = 0.5418), as well as high bleeding risk (29.0% vs. 28.5%, P = 0.8316). At 24 months, the all-cause mortality rate of 18-month DAPT group was significantly lower than that for 12-month DAPT group (3.7% vs 5.9%, P = 0.0471). Adjusted hazard ratio for all-cause death also showed statistical significance (0.59, 95% CI: 0.35-0.99, P = 0.0444). ConclusionsDAPT for at least 18 months was associated with lower 24-month mortality for non-revascularization AMI patients without events within 12 months after onset.

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Percutaneous coronary intervention of patients with chronic total occlusion is associated with higher mortality and complications despite propensity score matching

Garcia, D.; Langland, D.; Hashemzadeh, M.; Movahed, M. R.

2025-10-07 cardiovascular medicine 10.1101/2025.10.05.25337387 medRxiv
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BackgroundThe rate of percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) is increasing, yet its clinical value remains controversial. CTO-PCI is associated with high procedural risk, such as perforation and tamponade. The goal of this study was to compare complications and mortality of patients undergoing CTO-PCI with patients without CTO undergoing PCI (non-CTO-PCI) by using propensity score matching. MethodsThe national Inpatient Sample database (NIS), years 2016-2020, was studied using International Classification of Diseases, Tenth Revision Codes. Propensity Score Matching was used to compare patients with CTO-PCI with patients non-CTO-PCI. ResultsAmong 519,620 PCI hospitalizations, 259,810 had CTO-PCI. After matching, CTO-PCI had higher mortality (OR 1.13; 95% CI 1.05-1.22; p=0.001) and higher odds of myocardial infarction (OR 1.97; 1.64-2.38), perforation (OR 3.36; 2.63-4.28), tamponade (OR 2.07; 1.63- 2.65), bleeding (OR 1.88; 1.64-2.15), and respiratory failure (OR 1.80; 1.45-2.24); all p<0.001. Overall risk doubled for any complication (OR 2.04; 1.85-2.25) and rose to 42% for MACE (OR 1.42; 1.34-1.51). When perforation or tamponade occurred, mortality was striking much higher in CTO-PCI compared to non-CTO-PCI (2.43% vs 0.55% and 22.86% vs 1.17%; both p<0.001). ConclusionsPropensity-matched national cohort confirmed that CTO-PCI was associated with higher in-hospital complications and mortality compared to non-CTO-PCI, mostly driven by perforation and tamponade. These findings support the previous report that CTO-PCI is associated with worse outcomes.

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Drug-Coated Balloon Versus Drug-Eluting Stent for Treating De Novo Large Vessel Coronary Artery Disease: A Systematic Review and Meta-Analysis of 13 Studies Involving 2,888 Patients

Caminiti, R.; Vizzari, G.; Ielasi, A.; Vetta, G.; Parlavecchio, A.; Della Rocca, D.; Pellicano, M.; Pellegrini, D.; Montonati, C.; Tespili, M.; Micari, A.

2023-12-11 cardiovascular medicine 10.1101/2023.12.10.23299794 medRxiv
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IntroductionDrug-coated balloon (DCB) is an established treatment option for in-stent restenosis and small vessel, de novo, coronary artery disease (CAD). Although the use of this tool is increasing in everyday practice, little is known about its performance in the treatment of de novo, large vessel CAD (LV-CAD). A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB versus drug-eluting stent (DES) in this setting. MethodsA comprehensive literature search was performed including Medline, Embase and Cochrane electronic databases up to October 24th 2023, for studies which compared efficacy and safety of DCB versus DES in the treatment of de novo lesions in large vessels ([&ge;] 2.5 mm), reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The outcomes analysed were cardiovascular death (CVD), myocardial infarction (MI), target lesion revascularization (TLR), all cause death (ACD) and late lumen loss (LLL) at follow-up. The effect size was estimated using a random-effect model as risk ratio (RR) and mean difference (MD) and relative 95% confidence interval (CI). ResultsA total of 13 studies (6 randomized controlled trials and 7 observational studies) involving 2,888 patients (DCB n=1,334; DES n=1,533) with de novo LV-CAD were included in this meta-analysis following our inclusion criteria. A DCB-only strategy was non inferior to percutaneous coronary intervention (PCI) with DES in terms of CVD (RR 0.49; 95% CI [0.23 - 1.03]; p=0.06), MI (RR 0.48; 95% CI [0.16 - 1.45]; p=0.89), TLR (RR 0.73; 95% CI [0.40 - 1.34]; p=0.32), ACD (RR 0.78; 95% CI [0.57 - 1.07]; p=0.12) and LLL (MD -0.14; 95% CI [-0.30 - 0.02]; p=0.18) at follow-up. ConclusionOur meta-analysis showed that DCB PCI might provide a promising option for the management of selected, de novo LV-CAD compared to DES. However, more focused RCTs are needed to further prove the benefits of a "metal free" strategy in this subset of CAD.

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Potential risk polarization for acute myocardial infarction during the COVID-19 pandemic: Single-center experiences in Osaka, Japan

Furui, M.; Kawajiri, K.; Yoshida, T.; Kakii, B.; Oshiro, N.; Asanuma, M.; Nishioka, H.; Wada, H.

2022-10-30 cardiovascular medicine 10.1101/2022.10.28.22281657 medRxiv
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This study compared the time course and outcomes of acute myocardial infarction, including mechanical complications and hospital mortality, before and after the coronavirus disease 2019 (COVID-19) pandemic at a regional core hospital in South Osaka, Japan. Moreover, it identified predictors for hospital mortality and mechanical complications. In total, 503 patients who underwent emergency percutaneous coronary intervention between January 2011 and December 2021 at our institution were examined retrospectively. The time course of acute myocardial infarction, mechanical complications, and mortality rate before and after the COVID-19 emergency declaration were compared. Overall, 426 patients with ST-segment elevation myocardial infarction and 77 patients with non-ST-segment elevation myocardial infarction were identified. For patients with ST-segment elevation myocardial infarction, the onset-to-door time was longer (181 vs. 156 min, P = 0.001) and mechanical complications were worse (7.8% vs. 2.6%, P = 0.025) after the emergency declaration of COVID-19 than before the pandemic. Age, low ejection fraction, out-of-hospital cardiac arrest, and mechanical complications were identified as independent risk factors for hospital mortality among patients with ST-segment elevation myocardial infarction, using multivariable analysis. Post-declaration, age, walk-ins, referrals, and intra-aortic balloon pump use were independent predictors of mechanical complications among patients with ST-segment elevation myocardial infarction. Onset-to-door time and mechanical complication rate increased after the COVID-19 declaration among patients with ST-segment elevation myocardial infarction. Arrival by walk-in and a referral that caused treatment delay were identified as independent risk factors for mechanical complication, in addition to age, use of intra-aortic balloon pump, and post-declaration of COVID-19. Therefore, the risks posed by the COVID-19 pandemic might have a polarization tendency resulting from the relief or worsening of cardiac symptoms.

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The neutrophil-to-lymphocyte ratio, as an emerging marker, is an important indicator predicting spontaneous reperfusion and clinical prognosis in patients with ST-segment elevation myocardial infarction

Li, B.; Zhang, M.; Zhang, Y.; Zheng, Y.; Cai, H.

2023-03-08 cardiovascular medicine 10.1101/2023.03.07.23286964 medRxiv
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BackgroundNeutrophil to lymphocyte ratio (NLR) has emerged as a new inflammation marker, which plays a major role in plaque instability, rupture, and erosion, and facilitates its progression, leading to acute myocardial infarction. The study aims to explore the role of NLR in predicting spontaneous reperfusion (SR) and prognosis in patients with ST-segment elevation myocardial infarction (STEMI). MethodsThis was a retrospective analysis including 506 STEMI patients undergoing primary percutaneous coronary intervention treatment, who were divided into two groups according to the thrombolysis in myocardial infarction (TIMI) flow: SR group (69 patients, initial TIMI flow 3) and No-SR group (437 patients, initial TIMI flow 0-2). ResultsThe incidence of SR was 13.6%. SR group was associated with a remarkably lower level of NLR [5.14 (2.97, 7.02) vs. 8.03 (4.54, 10.92), P<0.001], more proportions of final TIMI 3 flow (98.6% vs. 91.5%, P < 0.05), lower incidence of congestive heart failure (8.7% vs. 18.5%, P < 0.05), and significantly better outcomes. Using multivariate logistic regression analysis, NLR (OR: 0.799, 95% CI: 0.730-0.874, P < 0.001) and fasting blood glucose were the independent predictors of SR. On multivariate Cox regression analysis, NLR (HR: 1.035, 95% CI: 1.001-1.071, P < 0.05) was the independent predictor of MACEs during follow-up. ConclusionsNLR had the ability in predicting SR in STEMI patients and SR flow was associated with a favorable outcome. We also revealed an association between NLR and increased risk of MACEs during follow-up. Clinical PerspectiveO_ST_ABSWhat Is New?C_ST_ABSO_LIThe incidence of spontaneous reperfusion was 13.6%. Patients with spontaneous reperfusion had a remarkably low level of NLR [5.14 (2.97, 7.02) versus 8.03 (4.54, 10.92), P<0.001], more proportions of final TIMI 3 flow (98.6% versus 91.5%, P < 0.05), lower incidence of congestive heart failure (8.7% versus 18.5%, P < 0.05), and favorable outcomes. C_LIO_LINLR was not only an independent predictor of spontaneous reperfusion, but also was the independent predictor of major adverse cardiac events during follow-up (HR: 1.035, 95% CI: 1.001-1.071, P < 0.05) in patients with ST-segment elevation myocardial infarction. C_LI What Are the Clinical Implications?O_LIThe level of neutrophil to lymphocyte ratio in patients with ST-segment elevation myocardial infarction is associated with low occurrence of spontaneous reperfusion and adverse outcomes, although, the patients received primary percutaneous coronary intervention. C_LIO_LINeutrophil to lymphocyte ratio the plays a major role in the risk classification of patients with ST-segment elevation myocardial infarction. C_LI