Five-year Outcomes Research Articles

Five-year clinical outcomes of STEMI patients treated with a pre-specified bioresorbable vascular scaffold implantation technique: Final results of the BVS STEMI STRATEGY-IT

BackgroundData on Absorb bioresorbable vascular scaffold (BVS) use in patients presenting with ST-segment elevation myocardial infarction (STEMI) are limited. Furthermore, Absorb studies including STEMI patients lacked a prespecified implantation technique to optimize BVS deployment. This study examines the 5-year outcomes of BVS in STEMI patients using an optimized implantation strategy and the impact of prolonged dual antiplatelet therapy (DAPT). MethodsThe BVS STEMI STRATEGY-IT study is a prospective, non-randomized, single-arm multicenter trial (NCT02601781). It involved 505 STEMI patients undergoing primary percutaneous coronary intervention with a predefined BVS implantation protocol. Key endpoints were a 5-year device-oriented composite endpoint (DOCE) of cardiac death, target-vessel myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR). The study also compared outcomes based on DAPT duration (36 months vs. shorter). Results502 (99.4 %) patients completed the 5-year follow-up. DOCE rate was 2.4 %. ID-TLR, TV-MI, and cardiac death rates were 1.6 %, 0.8 %, and 0.6 %, respectively. No DOCE occurred between three and five years. Scaffold thrombosis (ScT) was 1 %, all occurring within 24 months. Longer-term DAPT significantly reduced DOCE (1.3 % vs. 4.3 %; HR: 0.29; 95 % CI: 0.1–0.9; p = 0.03) driven by a lower rate of TV-MI (0 % vs. 2.2 %; p = 0.018) compared to shorter-term DAPT, as well as ScT (0 % vs 2.7 %, p = 0.007). ConclusionsThis study shows favorable 5-year outcomes for BVS in selected STEMI patients with an optimized implantation strategy. Prolonged DAPT further improved outcomes, emphasizing its role in reducing adverse events during scaffold resorption. Further research is needed to assess newer-generation bioresorbable devices.

Five-year outcomes with self-expanding versus balloon-expandable transcatheter aortic valve replacement in patients with left ventricular systolic dysfunction

Abstract Background The importance of transcatheter heart valve (THV) design on clinical outcome in patients with aortic stenosis (AS) and left ventricular (LV) systolic dysfunction remains unknown. Objectives We aimed to compare 5-year outcomes of patients with severe AS and reduced LV ejection fraction (LVEF), undergoing transcatheter aortic valve replacement (TAVR) with balloon-expandable vs. self-expanding THVs. Methods In an institutional TAVR registry, patients with LVEF <50% who underwent TAVR with either balloon-expandable or self-expanding THVs were included. A 1:1 propensity-score matching was performed to account for baseline differences between groups. Results A total of 759 patients were included between August 2007 and December 2022, and propensity-score matching resulted in 134 pairs. Technical success was achieved in over 85% of patients, and was similar in both groups. Self-expanding THVs were associated with a lower mean transvalvular gradient (7.1 ± 3.7 mmHg vs. 9.9 ± 4.3 mmHg; P <0.001) and a higher incidence of ³mild-to-moderate paravalvular regurgitation (36.3% vs. 11.3%; P <0.001) compared to balloon-expandable THVs. At 5 years, patients treated with a self-expanding THV had higher all-cause mortality than those with a balloon-expandable THV (67.8% vs. 55.8%, Adjusted Hazard Ratio: 1.44; 95% CI: 1.02-2.03; P = 0.037). There were no significant differences in other clinical outcomes up to 5 years between groups. Conclusions In the setting of LV systolic dysfunction, patients treated with a self-expanding THV had higher risk of 5-year mortality compared to patients treated with a balloon-expandable THV.

One-Year and Five-Year Outcomes in Medication Overuse Headache: A Real-World Study.

Medication overuse headache (MOH) is one of the global health-related problems that imposes significant morbidity. Effective management requires the abrupt cessation of the overused medications, transition therapy in the initial days, and initiation of preventive treatment. The objective of this study is to provide one-year and five-year follow-ups of study participants diagnosed with chronic migraine and MOH. The study will examine the efficacy of withdrawal therapy, the use of conventional preventive medication, and the use of anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies. We conducted a single-center, prospective, and descriptive study at a tertiary center in Brazil. The population was included by convenience sampling of consecutive subjects diagnosed with chronic migraine and MOH. Demographics and clinical data at baseline and one-year and five-year follow-ups were collected in the clinical records. Among 142 subjects, 116 were females and 26 were males, with a mean age of 42.1±14.3. They were followed for five years. The diagnosis was performed at the mean age of 24.9±14.7 years after the headache onset, and the time with headache ≥15 days per month was 6.3±7.6 years. On baseline, the average number of headache days per month (HDM) was 25.2±5.9. There was a reduction in HDM. At one-year and five-year follow-ups, a ≥75% reduction in HDM was observed, respectively, in 51.4% and 70.4% of the sample. The five-year follow-up of chronic migraine and MOH treated with the discontinuation of excessive medication, the use of preventative pharmacological agents, and the optional inclusion of anti-CGRP pathway monoclonal antibody led to a significant decrease in the initial occurrence of HDM.

A comparison of the management and five-year outcomes of patients treated for chronic coronary syndrome between 2006-2007 and 2015-2016 - insights from the PRESAGE registry.

Changes in the management of patients with chronic coronary syndromes (CCS) require continuous monitoring of results of treatment in daily clinical practice. The present study contains a comparison of the clinical characteristics, management, and in-hospital and five-year outcomes of patients with CCS enrolled on the Prospective REgistry of Stable AnGina management and trEatment (PRESAGE). A group of 3475 patients with CCS were selected who underwent coronary angiography and were divided into two groups who were treated in the years 2006-2007 (1300 [37.4%]) - group I, and during 2015-2016 (2175 [62.6%] - group II). The composite endpoints involved death, non-fatal myocardial infarction (MI), and acute coronary syndrome-driven revascularization. Comparing patients from group I to those from group II, group I were younger; 61.8 (54.9-68.5) vs. 66.1 (59.7-72.7) years respectively, with a higher incidence of previous MI and percutaneous intervention. Patients from the group II had a higher incidence of hypertension, diabetes, obesity, atrial fibrillation, New York Heart Association class III or more. The incidence of the composite endpoints did not vary significantly between the two groups during the entire period after the index hospitalization, but patients from the group I had a lower mortality rate both within three and five years after discharge (8.5% vs. 10.7, p = 0.03 and 13.2% vs. 17.9%, p < 0.001, respectively). Patients treated during 2006-2007 and 2015-2016 differed in age, clinical characteristics, and comorbidities. The composite endpoint incidence was similar in both groups,butlong-term mortality rates werehigherin the 2015-2016 cohort.

MA01.08 Five-Year Clinical Outcomes of Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer (NADIM Trial)

MA01.08 Five-Year Clinical Outcomes of Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer (NADIM Trial)

Five-year outcomes of a holistic programme for managing early chronic kidney disease in primary care

Five-year outcomes of a holistic programme for managing early chronic kidney disease in primary care

TCT-875 A Multicenter Prospective Clinical Study on TAVI With the J-Valve THV for Native Pure Aortic Regurgitation: Five-Year Follow-Up Outcome

TCT-875 A Multicenter Prospective Clinical Study on TAVI With the J-Valve THV for Native Pure Aortic Regurgitation: Five-Year Follow-Up Outcome

TCT-363 Five-Year Clinical Outcomes of Patients Treated With the Xinsorb Bioresorbable Sirolimus-Eluting Scaffolds

TCT-363 Five-Year Clinical Outcomes of Patients Treated With the Xinsorb Bioresorbable Sirolimus-Eluting Scaffolds

425P Five-year outcomes with delandistrogene moxeparvovec in patients with Duchenne muscular dystrophy (DMD): a phase 1/2a study

425P Five-year outcomes with delandistrogene moxeparvovec in patients with Duchenne muscular dystrophy (DMD): a phase 1/2a study

Five-year outcomes of fractionated stereotactic body radiotherapy for oligometastatic prostate cancer from the TRANSFORM phase II trial.

Metastasis-directed therapy (MDT) for oligometastatic prostate cancer (PCa), including stereotactic body radiotherapy (SBRT), has shown promise but is still considered investigational. This is the 5-year analysis of the TRANSFORM trial, the largest prospective cohort of men with oligometastatic PCa treated with SBRT-based MDT. The primary endpoint was 5-year treatment escalation-free survival (TE-FS), defined as freedom from any new cancer therapy other than further SBRT. In total, 199 men received SBRT; 76.4% were hormone-naïve at baseline. The rate of 5-year TE-FS was 21.7% (95% confidence interval [CI]: 15.7%-28.7%) overall and 25.4% (95% CI: 18.1%-33.9%) in the hormone-naïve subgroup. The subgroups with International Society of Urological Pathology Grade Groups 4-5 disease (hazard ratio [HR] = 1.48, 95% CI: 1.05-2.01, p = .026), a higher baseline prostate-specific antigen (PSA) (HR = 1.06, 95% CI: 1.03-1.09, p < .001) and those who received prior androgen deprivation therapy (ADT) (HR = 2.13, 95% CI: 1.40-3.26, p < .001), were at greater risk of treatment escalation. Outcomes for participants with four or five initial lesions were comparable to those with one to three lesions. At last follow-up, 18.9% (95% CI: 13.2%-25.7%) of participants were free from treatment escalation (median follow-up of 67.9 months) and two participants had an undetectable PSA level. No treatment-related grade three or higher adverse events were reported. The findings of this study demonstrate that SBRT-based MDT is an effective option for delaying systemic treatment escalation in the context of oligometastatic PCa. Future randomised trials comparing SBRT-based MDT to standard-of-care ADT-based approaches are required to evaluate the impact of delaying ADT on survival.

Five-Year Outcomes in Patients Implanted With a HeartMate 3 Left Ventricular Assist Device at a High-Volume Center.

Five-Year Outcomes in Patients Implanted With a HeartMate 3 Left Ventricular Assist Device at a High-Volume Center.

Five-Year Kidney Donation Outcomes After Medical Assistance in Dying.

Five-Year Kidney Donation Outcomes After Medical Assistance in Dying.

Five-year radiological outcomes between decompression alone and decompression with an interlaminar device for lumbar spinal stenosis.

There is limited literature regarding radiological outcomes in the use of interlaminar devices as an adjunct to decompression compared to decompression alone (DA) for symptomatic lumbar spinal stenosis (LSS). This study aims to assess and compare 5-year radiological outcomes following spinal decompression and decompression with ILD (D + ILD). We conducted a retrospective review of prospectively collected data of 94 patients who underwent spinal decompression with or without ILD insertion between 2007-2015. Patients with symptomatic LSS who met the study criteria were offered spinal decompression with or without ILD insertion. Those patients who accepted ILD insertion were placed in the D + ILD group (n=39); while those opting for DA, were placed in the DA group (n=55). Radiological indices were assessed preoperatively, immediate post-operative, 2 years and 5 years postoperatively. There were a total of 94 patients with 55 in the DA group and 39 in the D + ILD group. In both groups, there was no significant change post-operatively in the sagittal balance parameters namely, the mean pelvic incidence, pelvic tilt, sacral slope and pelvic incidence minus lumbar lordosis (PI - LL) during the 5-year follow-up. Comparing between the groups, there was no significant difference in sagittal balance parameters. Comparing between DA versus D + ILD, there was no significant difference in overall lordosis, but the D + ILD had a significant reduction in sagittal angle (at the index level) of 2.3° compared to the DA group (P=0.01). In the control group, there was no significant difference in the anterior disc, posterior disc and foraminal height post-operatively. In the D + ILD group, there was a significant mean increase of 1.3 mm in anterior disc height, 1.8 mm in posterior disc height and 4.7 mm in foraminal height compared to the control group. In both groups, there was significant improvement in all clinical outcomes namely 36-item short form survey physical component summary (SF36 PCS), 36-item short form survey mental component summary (SF36 MCS) and visual analogue scale (VAS). Comparing the groups, there was significant improvement in the D + ILD group in SF36 MCS (P=0.01) but no difference in SF36 PCS or VAS. Reoperation rates were equivalent. Our study found that in the management of lumbar stenosis, the use of an ILD as an adjunct device compared to DA had significant improvement in anterior disc, posterior disc and foraminal height with expected focal kyphosis at the level of intervention without change in the lumbar lordosis and sagittal balance at 5 years.

Five-Year Prostate-Specific Membrane Antigen Positron Emission Tomography-Based Outcomes of Spot-Scanning Proton Radiation Therapy for Localized Prostate Cancer: A Single Institution Experience

PURPOSE: We report 5-year oncologic outcomes of a prospective series of patients with prostate cancer treated with spot-scanning proton therapy (SSPT).METHODS AND MATERIALS: A prospective registry identified patients with prostate cancer treated with SSPT between January 2016 and December 2018. Five-year overall survival (OS), local control (LC), biochemical failure (BF), regional and distant failures, and adverse events (AEs) were assessed. Biochemical failure was defined as rise in PSA ≥ 2.0 ng/mL above nadir PSA. Baseline-adjusted toxicities were assigned using CTCAE v5.0.RESULTS: With a median follow up of 4.4 years, 284 prostate cancer patients were treated with SSPT. Median total radiation dose was 79.2 Gy over 44 fractions, 70 Gy over 28 fractions, and 38 Gy over 5 fractions for conventional fractionation (CF), hypofractionation (HF), and stereotactic body radiation therapy (SBRT), respectively. Biochemical failure rate for all patients was 6.7%. Five-year LC rates for CF, HF, and SBRT were 100%, 100%, and 97.3%, respectively (p = 0.07). Regional recurrences occurred in 12 (4.2%) patients: 8 treated with CF, 2 with HF, and 2 with SBRT (p = 0.62). Distant failures occurred in 12 patients (4.2%): 5 treated with CF, 7 with HF, and none with SBRT (p = 0.05). Five-year OS for patients treated with CF, HF, and SBRT SSPT were 88.1%, 86.1%, and 97.2%, respectively (p = 0.1). Acute and chronic grade 2+ GI AEs occurred in 8 (2.8%) and 51 (18.0%) patients, respectively. Acute and chronic grade 3+ GI AEs occurred in 3 (1.1%) and 4 (1.4%) patients, respectively. Acute and chronic grade 2+ GU-related AEs were observed in 71 (25%) and 63 (22.2%) patients, respectively. Acute and chronic grade 3+ GU toxicity were observed in 3 (1.1%) and 6 (2.1%) patients, respectively.CONCLUSIONS: SSPT provides high local control rates and excellent oncologic outcomes across different fractionation schedules with low long-term AE rates.

Five-Year Outcomes from a Prospective Study on Safety and Efficacy of Phasix ST Mesh Use at the Hiatus During Paraesophageal Hernia Repair.

Laparoscopic paraesophageal hernia (PEH) repair has a high hernia recurrence rate. The aim of this study was to assess the 5-year hernia recurrence rate after PEH repair using a combination of bioresorbable mesh and advanced surgical techniques to address tension as needed in a prospective group of patients. In 2016, a prospective database was established for 50 patients undergoing primary, elective PEH repair with a new bioresorbable mesh (Phasix ST). Intraoperatively, tension was addressed with Collis gastroplasty and diaphragm relaxing incisions as needed. All 50 patients from the initial study were tracked and asked to return for objective follow-up. Recurrence was considered present for any hernia more than 2 cm in size. Objective follow-up was conducted in 27 of the original 50 (54%) patients at a median of 5.25 years after their PEH repair. Before the 5-year follow-up, 5 patients had a known recurrent hernia. Objective evaluation at 5 years identified an additional 3 recurrences, for a total recurrence rate of 25% (8 of 32 patients). The hernia recurrence rate in patients with a Collis gastroplasty was significantly lower than in those without a Collis (7% vs 54%, p = 0.008). Two patients underwent reoperation for hernia recurrence. No patient had a mesh infection or mesh erosion. The combination of Phasix ST Mesh and tension-reducing techniques during PEH repair led to a 25% hernia recurrence rate at 5 years. The addition of a Collis gastroplasty led to significantly fewer hernia recurrences and is indicative of the potential for esophageal shortening in many patients with a PEH. The long-term safety and efficacy of Phasix ST Mesh in combination with surgical technique for PEH repair is confirmed.

Five-year efficacy outcomes of ocrelizumab in relapsing multiple sclerosis: A propensity-matched comparison of the OPERA studies with other disease-modifying therapies in real-world lines of treatments.

Clinical trials comparing the efficacy of ocrelizumab (OCR) with other disease-modifying therapies (DMTs) other than interferon (IFN) β-1a in relapsing multiple sclerosis (RMS) are lacking. To compare the treatment effect of OCR vs six DMTs' (IFN β-1a, glatiramer acetate, fingolimod, dimethyl fumarate, teriflunomide, natalizumab) treatment pathways used in clinical practice by combining clinical trial and real-world data. Patient-level data from OPERA trials and open-label extension phase, and from the German NeuroTransData (NTD) MS registry, were used to build 1:1 propensity score-matched (PSM) cohorts controlling for seven baseline covariates, including brain imaging activity. Efficacy outcomes were time to first relapse and time to 24-week confirmed disability progression over 5.5years of follow-up. Intention-to-treat analysis using all outcome data irrespective of treatment switch was applied. The analyses included 611 OPERA patients and 7141 NTD patients. We built 12 paired-matched cohorts (six for each outcome, two for each DMT) to compare efficacy of OCR in OPERA with each DMT treatment pathway in NTD. Post-matching, baseline covariates and PS were well balanced (standardized mean difference <.2 for all cohorts). Over 5.5years, patients treated with OCR showed a statistically significant reduction in the risk of relapse (hazard ratios [HRs] .30 to .54) and disability progression (HRs .51 to .67) compared with all index therapies and their treatment switching pathways in NTD. Treatment switch and/or discontinuation occurred frequently in NTD cohorts. OCR demonstrates superiority in controlling relapses and disability progression in RMS compared with real-world treatment pathways over a 5.5-year period. These analyses suggest that high-efficacy DMTs and high treatment persistence are critical to achieve greatest clinical benefit in RMS. OPERA I (NCT01247324), OPERA II (NCT01412333).

Outcomes of lymphoma patients admitted to the ICU are not influenced by HIV status: a retrospective, observational cohort study.

Lymphoma patients may require intensive care (ICU) due to disease- or treatment-related complications. The lymphoma-HIV interaction complicates management, but whether outcomes are worse in these patients, when critically ill, is unclear. A retrospective observational cohort study reviewed outcomes of patients admitted to ICU, subsequent 5-year survival, and prognostic factors. General ICU at the UK National Centre for HIV Malignancy. Records between 2007-2020, identified the following cohorts: HIV lymphoma, lymphoma-alone, HIV-alone and patients without HIV/lymphoma. Patient demographics, lymphoma characteristics, ICU admission data, and survival outcomes were collected. Five-year survival outcomes were analyzed for the lymphoma cohorts. ICU outcomes were analyzed for all cohorts. Descriptive statistics summarized baseline characteristics and outcomes. Multivariate regression identified factors associated with ICU mortality. Of 5929 patients admitted to the ICU, 63 had HIV lymphoma and 43 had lymphoma-alone. Survival to ICU discharge was 71% and 72%, respectively. Adjusted log-odds ratio for ICU survival was significantly better in the comparator cohort. ICU survival between the HIV lymphoma and lymphoma-alone cohorts was not significantly different. Adjusted 5-year survival was not significantly different between lymphoma cohorts. Factors independently associated with a worse ICU survival prognosis were emergency admissions, APACHE II score, initial lactate, and day requiring level 3 support. Mechanical ventilation and higher APACHE II scores were independent risk factors for worse 5-year survival in the lymphoma cohorts. ICU outcomes and 5-year survival rates of lymphoma patients were unaffected by HIV status, revealing favorable outcomes in patients with HIV-related lymphoma admitted to the ICU.

Durvalumab With or Without Tremelimumab in Combination With Chemotherapy in First-Line Metastatic NSCLC: Five-Year Overall Survival Outcomes From the Phase 3 POSEIDON Trial

IntroductionThe primary analysis (median follow-up 34.9 mo across all arms) of the phase 3 POSEIDON study revealed a statistically significant overall survival (OS) improvement with first-line tremelimumab plus durvalumab and chemotherapy (T+D+CT) versus CT in patients with EGFR and ALK wild-type metastatic NSCLC (mNSCLC). D+CT had a trend for OS improvement versus CT that did not reach statistical significance. This article reports prespecified OS analyses after long-term follow-up (median >5 y). MethodsA total of 1013 patients were randomized (1:1:1) to T+D+CT, D+CT, or CT, stratified by tumor cell programmed cell death ligand-1 (PD-L1) expression (≥50% versus <50%), disease stage (IVA versus IVB), and tumor histologic type (squamous versus nonsquamous). Serious adverse events were collected during follow-up. ResultsAfter a median follow-up of 63.4 months across all arms, T+D+CT had sustained OS benefit versus CT (hazard ratio [HR] = 0.76, 95% confidence interval [CI]: 0.64–0.89; 5-y OS: 15.7% versus 6.8%). OS improvement with D+CT versus CT (HR = 0.84, 95% CI: 0.72–1.00; 5-y OS: 13.0%) was consistent with the primary analysis. OS benefit with T+D+CT versus CT remained more pronounced in nonsquamous (HR = 0.69, 95% CI: 0.56–0.85) versus squamous (HR = 0.85, 95% CI: 0.65–1.10) mNSCLC. OS benefit with T+D+CT versus CT was still evident regardless of PD-L1 expression, including patients with PD-L1 tumor cell less than 1%, and remained evident in STK11-mutant (nonsquamous), KEAP1-mutant, and KRAS-mutant (nonsquamous) mNSCLC. No new safety signals were identified. ConclusionsAfter a median follow-up of more than 5 years, T+D+CT had durable long-term OS benefit versus CT, supporting its use as first-line treatment in mNSCLC, including in patient subgroups with harder-to-treat disease.

Five-year outcomes of patients with diabetes mellitus treated with a sirolimus-eluting or a biolimus-eluting stents with biodegradable polymer. From the SORT OUT VII trial.

Diabetes mellitus is associated with higher risk of target lesion failure (TLF) after percutaneous coronary intervention. We studied the 5-year outcome in patients with diabetes mellitus treated with biodegradable polymer stents. The SORT OUT VII was a randomised trial comparing the ultrathin sirolimus-eluting Orsiro stent (O-SES) and the biolimus-eluting Nobori stent (N-BES) in an all-comer setting. Patients (n = 2525) were randomised to receive O-SES (n = 1261, diabetes: n = 236) or N-BES (n = 1264, diabetes: n = 235). Endpoints were TLF (a composite of cardiac death, target-lesion myocardial infarction (MI), target lesion revascularization (TLR)), definite stent thrombosis and a patient related outcome (all-cause mortality, MI and revascularization) within 5years. Patients with diabetes mellitus had higher TLF (20.6% vs 11.0%, (Rate ratio (RR) 1.85 95% confidence interval (CI): (1.42-2.40) and patient related outcome (42.0% vs 31.0%, RR 1.43 95% CI: (1.19-1.71)) compared to patients without diabetes. Among patients with diabetes mellitus, TLF after 5 years did not differ between O-SES and N-BES (21.2% vs 20.0%), RR 1.05 95% CI: (0.70-1.58), p = 0.81). Cardiac death, MI, TLR, and definite stent thrombosis did not differ between the groups. In patients with diabetes mellitus, 5-year outcomes were similar among patients treated with biodegradable polymer O-SES or N-BES. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01879358.

Five-Year Outcomes of Measured and Predicted Prosthesis-Patient Mismatch following Transcatheter Aortic Valve Implantation

BackgroundData on the long-term outcomes of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) remain controversial. ObjectivesThe aim of this study was to investigate the incidence and clinical outcomes of measured PPM (PPMM) and predicted PPM (PPMP) in patients undergoing TAVI. MethodsThis is a retrospective analysis of 3,016 patients who underwent TAVI at a large Healthcare System between 2012 and 2021. Effective orifice area indexed to body surface area (EOAi) was measured at discharge using the continuity equation. EOAi was predicted according to the published predictive tables for each model and size of the valve. Primary endpoint was 5-year survival rate. ResultsMean age was 80 years and 55.6% were male. The mean STS risk score was 4.66%. 74.9% of patients received a BEV and 25.1% received a SEV. The incidence of severe PPM was markedly lower when defined by predicted vs. measured EOAi (0.8% vs. 6.3%, P < 0.001) and when assessed in SEV vs. BEV (5.3% vs. 6.6%, p= 0.02). Neither severe PPMp nor severe PPMM was associated with 5-year mortality (HR=1.26, 95% CI= 0.96-1.66, p=0.095; HR=1.03, 95% CI= 0.42-2.49, p=0.954, respectively), irrespective of the presence of high residual pressure gradient. Neither BEV nor SEV was associated with an increased 5-year mortality, irrespective of PPM definition or severity. ConclusionsIn this large healthcare system analysis, neither severe PPMP nor severe PPMM was associated with five-year all-cause mortality. There was no difference between BEV and SEV in terms of mortality, irrespective of the definition or severity of PPM.