Thibault Lhermusier
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Research Subjects
Thibault Lhermusier has a total of 944 co-authors. Here are the top co-authors by number of shared publications:
- Didier Carrié
Department of Cardiology, Toulouse University Hospital, Toulouse, France
31 shared publications - Ron Waksman
Section of Interventional Cardiology MedStar Washington Hospital Center Washington DC USA
16 shared publications Rebecca Torguson
Division of Cardiology, Medstar Heart and Vascular Institute, Washington, DC
11 shared publicationsMeyer Elbaz
Department of Cardiology, Toulouse University Hospital , 1 av. Du Prof. Jean Poulhès, Toulouse 31400
10 shared publications- Nicolas Boudou
Clinique Saint Augustin Bordeaux France
10 shared publications - Francisco Campelo-Parada
Hôpital Rangueil CHU
9 shared publications
Latest Publications
- 8 November 2026
- Published by Oxford University Press (OUP) in European Journal of Preventive Cardiology
Variability of lipoprotein(a) levels in patients with acute myocardial infarction between admission, discharge, and follow-up
Aims: Lipoprotein(a) [Lp(a)] is an established risk factor for atherosclerotic cardiovascular disease. Using Lp(a) concentrations measured during stable follow-up as the reference, we aimed to assess the temporal variability of Lp(a) after acute myocardial infarction (AMI) and to explore a pragmatic strategy for Lp(a) measurement. Methods and results: The FRENCHIE-Lp(a) cohort enrolled consecutive adults hospitalized for AMI in 21 centres. Lp(a) mass concentration, measured at admission, hospital discharge, and 3–12 months follow-up, was analysed both as a continuous and predefined categorical variable (≤20, >20–≤50, >50–≤70, >70 mg/dL). Assuming follow-up Lp(a) as the reference, we aimed to identify the threshold values that would allow us to accurately identify patients with Lp(a) > 70mg/dL, the threshold mostly used for patient selection in phase III trials of targeted Lp(a) therapies. A cumulative threshold analysis was performed to identify the Lp(a) value below which the misclassification rate (i.e. % of patients with follow-up Lp(a) > 70 mg/dL) remained 70 mg/dL at follow-up compared to 39.9% of those with discharge-Lp(a) >37 mg/dL. Conclusion: Although the median Lp(a) level remained stable between admission and follow-up, one-third of AMI patients shifted within Lp(a) categories over time. Pending external validation, an exploratory two-step strategy based on Lp(a) measurement at discharge, followed by repeat testing in patients with Lp(a) >37 mg/dL, showed a misclassification rate below 1% for identifying patients potentially needing intervention. Registration: Clinical trial Number: NCT04050956
- 8 November 2026
- Published by Oxford University Press (OUP) in European Journal of Preventive Cardiology
Variability of lipoprotein(a) levels in patients with acute myocardial infarction between admission, discharge, and follow-up
Aims: Lipoprotein(a) [Lp(a)] is an established risk factor for atherosclerotic cardiovascular disease. Using Lp(a) concentrations measured during stable follow-up as the reference, we aimed to assess the temporal variability of Lp(a) after acute myocardial infarction (AMI) and to explore a pragmatic strategy for Lp(a) measurement. Methods and results: The FRENCHIE-Lp(a) cohort enrolled consecutive adults hospitalized for AMI in 21 centres. Lp(a) mass concentration, measured at admission, hospital discharge, and 3–12 months follow-up, was analysed both as a continuous and predefined categorical variable (≤20, >20–≤50, >50–≤70, >70 mg/dL). Assuming follow-up Lp(a) as the reference, we aimed to identify the threshold values that would allow us to accurately identify patients with Lp(a) > 70mg/dL, the threshold mostly used for patient selection in phase III trials of targeted Lp(a) therapies. A cumulative threshold analysis was performed to identify the Lp(a) value below which the misclassification rate (i.e. % of patients with follow-up Lp(a) > 70 mg/dL) remained 70 mg/dL at follow-up compared to 39.9% of those with discharge-Lp(a) >37 mg/dL. Conclusion: Although the median Lp(a) level remained stable between admission and follow-up, one-third of AMI patients shifted within Lp(a) categories over time. Pending external validation, an exploratory two-step strategy based on Lp(a) measurement at discharge, followed by repeat testing in patients with Lp(a) >37 mg/dL, showed a misclassification rate below 1% for identifying patients potentially needing intervention. Registration: Clinical trial Number: NCT04050956
- 5 August 2026
- Published by Oxford University Press (OUP) in European Heart Journal: Acute Cardiovascular Care
- Vol. 15 (8) , 596-607
Biodegradable polymer sirolimus-eluting or durable polymer zotarolimus-eluting stents in high bleeding-risk patients with acute coronary syndrome: the BIOFLOW-DAPT randomized trial
Aims: Patients at high bleeding risk (HBR) and acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) are at high risk of adverse outcomes. We investigated the clinical outcomes and their consistency after biodegradable polymer sirolimus-eluting (BP-SES) or durable polymer zotarolimus-eluting stent (DP-ZES) implantation in HBR patients with or without ACS. Methods and results: The per-protocol population of the BIOFLOW-DAPT randomized control trial (RCT) consisted of HBR patients with (n = 541) or without ACS (n = 1245) who were randomized to BP-SES or DP-ZES and underwent 1 month dual antiplatelet therapy (DAPT). The primary efficacy and safety endpoints were target lesion failure (TLF), defined as the composite endpoint of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (cd-TLR) as well as major bleeding defined as BARC 3 or 5 (according to Bleeding Academic Research Consortium classification) and definite/probable stent thrombosis (ST). At 1 year, patients with ACS suffered from higher cardiac death rates (3.4 vs. 1.3%, log-rank P = 0.004) but similar TLF (6.8 vs. 6.7%, P = 0.992), TV-MI (2.8 vs. 4.5%, P = 0.100), cd-TLR (1.4 vs. 2.1%, P = 0.300), major bleeding (4.2 vs. 3.1%, P = 0.266), and ST (0.2 vs. 0.9%, P = 0.098) compared with no ACS patients. The rate of TLF and of all secondary endpoints was consistent with BP-SES or DP-ZES across ACS strata. Conclusion: HBR patients with ACS are at higher risk of cardiac death than those without ACS and experience a consistent outcome with BP-SES or DP-ZES followed by 1 month DAPT at 1 year follow-up. Clinical Trial Registration: NCT04137510.
- 5 August 2026
- Published by Oxford University Press (OUP) in European Heart Journal: Acute Cardiovascular Care
- Vol. 15 (8) , 596-607
Biodegradable polymer sirolimus-eluting or durable polymer zotarolimus-eluting stents in high bleeding-risk patients with acute coronary syndrome: the BIOFLOW-DAPT randomized trial
Aims: Patients at high bleeding risk (HBR) and acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) are at high risk of adverse outcomes. We investigated the clinical outcomes and their consistency after biodegradable polymer sirolimus-eluting (BP-SES) or durable polymer zotarolimus-eluting stent (DP-ZES) implantation in HBR patients with or without ACS. Methods and results: The per-protocol population of the BIOFLOW-DAPT randomized control trial (RCT) consisted of HBR patients with (n = 541) or without ACS (n = 1245) who were randomized to BP-SES or DP-ZES and underwent 1 month dual antiplatelet therapy (DAPT). The primary efficacy and safety endpoints were target lesion failure (TLF), defined as the composite endpoint of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (cd-TLR) as well as major bleeding defined as BARC 3 or 5 (according to Bleeding Academic Research Consortium classification) and definite/probable stent thrombosis (ST). At 1 year, patients with ACS suffered from higher cardiac death rates (3.4 vs. 1.3%, log-rank P = 0.004) but similar TLF (6.8 vs. 6.7%, P = 0.992), TV-MI (2.8 vs. 4.5%, P = 0.100), cd-TLR (1.4 vs. 2.1%, P = 0.300), major bleeding (4.2 vs. 3.1%, P = 0.266), and ST (0.2 vs. 0.9%, P = 0.098) compared with no ACS patients. The rate of TLF and of all secondary endpoints was consistent with BP-SES or DP-ZES across ACS strata. Conclusion: HBR patients with ACS are at higher risk of cardiac death than those without ACS and experience a consistent outcome with BP-SES or DP-ZES followed by 1 month DAPT at 1 year follow-up. Clinical Trial Registration: NCT04137510.
- Open Access
- 8 January 2026
- Published by Oxford University Press (OUP) in ESC Heart Failure
- Vol. 13 (1)
Early initiation of sodium–glucose co-transporter-2 inhibitors in heart failure patients: a nationwide study
Introduction: While sodium–glucose co-transporter-2 inhibitors (SGLT-2i) have shown substantial benefit in heart failure (HF) across clinical trials and are now a cornerstone of HF guideline-directed medical therapy (GDMT), data on their use in Europe remains scarce. This study aimed to assess SGLT-2i initiation after a first HF hospitalization, identify its predictors, and evaluate between-hospital disparities. Methods: Using the French National Healthcare Database (SNDS) between 2021 and 2023, SGLT-2i initiation was assessed in patients discharged from a first HF hospitalization, excluding patients with prior exposure to SGLT-2i. Multilevel logistic regression identified individual- and hospital-level predictors of SGLT-2i initiation and median odds ratio (MOR) estimated between-hospital variance in SGLT-2i initiation. Results: Among 303 118 patients, 16.1% initiated SGLT-2is. Initiation rates were higher in patients ≤75 years (24.3% vs. 12.4%), males (19.7% vs. 12.4%), diabetics (18.9% vs. 14.8%), without chronic kidney disease (CKD) (17.4% vs. 11.4%), and with lower left ventricular ejection fraction (LVEF) (<40%: 36.1%, 40%–49%: 19.7%, ≥50%: 11.7%, P for trend <0.001). Initiation rose from 4.8% in 2021 to 28.5% in 2023 (P for trend <0.001), with similar trends across subgroups. Positive predictors included male sex, critical care unit stay, diabetes, lower LVEF and background GDMT, while older age and CKD were negative predictors. Between-hospital variance in SGLT-2i initiation was high, with 25% of hospitals sharing more than half of SGLT-2i initiators (MOR 1.55, 95% CI 1.50–1.60). Conclusion: In this nationwide study, SGLT-2i initiation increased over the years but remains suboptimal and highly variable across hospitals and patient phenotypes, highlighting opportunities to improve GDMT.
- 8 January 2026
- Published by Oxford University Press (OUP) in ESC Heart Failure
- Vol. 13 (1)
Open AccessEarly initiation of sodium–glucose co-transporter-2 inhibitors in heart failure patients: a nationwide study
Introduction: While sodium–glucose co-transporter-2 inhibitors (SGLT-2i) have shown substantial benefit in heart failure (HF) across clinical trials and are now a cornerstone of HF guideline-directed medical therapy (GDMT), data on their use in Europe remains scarce. This study aimed to assess SGLT-2i initiation after a first HF hospitalization, identify its predictors, and evaluate between-hospital disparities. Methods: Using the French National Healthcare Database (SNDS) between 2021 and 2023, SGLT-2i initiation was assessed in patients discharged from a first HF hospitalization, excluding patients with prior exposure to SGLT-2i. Multilevel logistic regression identified individual- and hospital-level predictors of SGLT-2i initiation and median odds ratio (MOR) estimated between-hospital variance in SGLT-2i initiation. Results: Among 303 118 patients, 16.1% initiated SGLT-2is. Initiation rates were higher in patients ≤75 years (24.3% vs. 12.4%), males (19.7% vs. 12.4%), diabetics (18.9% vs. 14.8%), without chronic kidney disease (CKD) (17.4% vs. 11.4%), and with lower left ventricular ejection fraction (LVEF) (<40%: 36.1%, 40%–49%: 19.7%, ≥50%: 11.7%, P for trend <0.001). Initiation rose from 4.8% in 2021 to 28.5% in 2023 (P for trend <0.001), with similar trends across subgroups. Positive predictors included male sex, critical care unit stay, diabetes, lower LVEF and background GDMT, while older age and CKD were negative predictors. Between-hospital variance in SGLT-2i initiation was high, with 25% of hospitals sharing more than half of SGLT-2i initiators (MOR 1.55, 95% CI 1.50–1.60). Conclusion: In this nationwide study, SGLT-2i initiation increased over the years but remains suboptimal and highly variable across hospitals and patient phenotypes, highlighting opportunities to improve GDMT.
- Open Access
- 19 March 2025
- Published by Oxford University Press (OUP) in EP Europace
- Vol. 27 (4)
Late arrhythmic burden in patients with left bundle branch block after TAVR with the Evolut valve
Aims: Arrhythmic burden after discharge in patients with new-onset persistent left bundle branch block (NOP-LBBB) following transcatheter aortic valve replacement (TAVR) with Evolut devices remains largely unknown. The aim of this study is to assess the incidence and type of arrhythmias at 2-year follow-up in patients with NOP-LBBB post-TAVR. Methods and results: This is a prospective multicentre study including 88 patients with LBBB persisting for ≥3 days post-implantation. Before discharge, an implantable loop recorder (REVEAL XT/LINQ) was implanted; patients had continuous monitoring for 2 years. Arrhythmic events were adjudicated in a central core lab. Of the arrhythmic events, 411 were detected in 58 patients [65.9%; 2 (1–4) events per patient]. Symptoms were reported in 12/58 (20.7%), and therapy was changed in 25/58 (43.1%). There were 101 bradyarrhythmic events in 33 patients [35 high-grade atrioventricular block (HAVB) and 66 severe bradycardia]. The HAVB incidence was higher in the early (4-week) phase and remained stable over time, whereas severe bradycardia increased after 1 year. Permanent pacemaker was required in 11 (12.5%) patients (6.8% and 5.7% in the first and second year, respectively). There were 310 tachyarrhythmic events in 29 patients (120 AF/AFL, 111 AT, 72 SVT, 6 NSVT, and 1 VT); its incidence decreased throughout the 2 years. New AF/AFL episodes occurred in 20/69 patients [29%; symptomatic in 2/20 (10%)]. Conclusion: Patients with NOP-LBBB post-TAVR with Evolut devices exhibited a high burden of late arrhythmias, with events occurring in two-thirds of patients and leading to treatment changes in about half of them. These data should inform future studies on cardiac monitoring devices for follow-up and treatment optimization in this challenging population.
- 19 March 2025
- Published by Oxford University Press (OUP) in EP Europace
- Vol. 27 (4)
Open AccessLate arrhythmic burden in patients with left bundle branch block after TAVR with the Evolut valve
Aims: Arrhythmic burden after discharge in patients with new-onset persistent left bundle branch block (NOP-LBBB) following transcatheter aortic valve replacement (TAVR) with Evolut devices remains largely unknown. The aim of this study is to assess the incidence and type of arrhythmias at 2-year follow-up in patients with NOP-LBBB post-TAVR. Methods and results: This is a prospective multicentre study including 88 patients with LBBB persisting for ≥3 days post-implantation. Before discharge, an implantable loop recorder (REVEAL XT/LINQ) was implanted; patients had continuous monitoring for 2 years. Arrhythmic events were adjudicated in a central core lab. Of the arrhythmic events, 411 were detected in 58 patients [65.9%; 2 (1–4) events per patient]. Symptoms were reported in 12/58 (20.7%), and therapy was changed in 25/58 (43.1%). There were 101 bradyarrhythmic events in 33 patients [35 high-grade atrioventricular block (HAVB) and 66 severe bradycardia]. The HAVB incidence was higher in the early (4-week) phase and remained stable over time, whereas severe bradycardia increased after 1 year. Permanent pacemaker was required in 11 (12.5%) patients (6.8% and 5.7% in the first and second year, respectively). There were 310 tachyarrhythmic events in 29 patients (120 AF/AFL, 111 AT, 72 SVT, 6 NSVT, and 1 VT); its incidence decreased throughout the 2 years. New AF/AFL episodes occurred in 20/69 patients [29%; symptomatic in 2/20 (10%)]. Conclusion: Patients with NOP-LBBB post-TAVR with Evolut devices exhibited a high burden of late arrhythmias, with events occurring in two-thirds of patients and leading to treatment changes in about half of them. These data should inform future studies on cardiac monitoring devices for follow-up and treatment optimization in this challenging population.
- Open Access
- 27 February 2025
- Published by Oxford University Press (OUP) in European Journal of Preventive Cardiology
- Vol. 32 (8) , 708-711
Modalities and safety of cardiac rehabilitation in a population managed for spontaneous haematoma or coronary disruption: insights from the READAPT-DISCO study
- 27 February 2025
- Published by Oxford University Press (OUP) in European Journal of Preventive Cardiology
- Vol. 32 (8) , 708-711
Open AccessModalities and safety of cardiac rehabilitation in a population managed for spontaneous haematoma or coronary disruption: insights from the READAPT-DISCO study
- 1 June 2024
- Published by Wolters Kluwer Health in Circulation: Cardiovascular Interventions
- Vol. 17 (6) , e013913
Three-Year Outcomes With Fractional Flow Reserve–Guided or Angiography-Guided Multivessel Percutaneous Coronary Intervention for Myocardial Infarction
BACKGROUND: In patients with multivessel disease with successful primary percutaneous coronary intervention for ST-segment–elevation myocardial infarction, the FLOWER-MI trial (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) showed that a fractional flow reserve (FFR)–guided strategy was not superior to an angiography-guided strategy for treatment of noninfarct-related artery lesions regarding the 1-year risk of death from any cause, myocardial infarction, or unplanned hospitalization leading to urgent revascularization. The extension phase of the trial was planned using the same primary outcome to determine whether a difference in outcomes would be observed with a longer follow-up. METHODS: In this multicenter trial, we randomly assigned patients with ST-segment–elevation myocardial infarction and multivessel disease with successful percutaneous coronary intervention of the infarct-related artery to receive complete revascularization guided by either FFR (n=586) or angiography (n=577). RESULTS: After 3 years, a primary outcome event occurred in 52 of 498 patients (9.40%) in the FFR-guided group and in 44 of 502 patients (8.17%) in the angiography-guided group (hazard ratio, 1.19 [95% CI, 0.79–1.77]; P =0.4). Death occurred in 22 patients (4.00%) in the FFR-guided group and in 23 (4.32%) in the angiography-guided group (hazard ratio, 0.96 [95% CI, 0.53–1.71]); nonfatal myocardial infarction in 23 (4.13%) and 14 (2.56%), respectively (hazard ratio, 1.63 [95% CI, 0.84–3.16]); and unplanned hospitalization leading to urgent revascularization in 21 (3.83%) and 18 (3.36%; hazard ratio, 1.15 [95% CI, 0.61–2.16]), respectively. CONCLUSIONS: Although event rates in the trial were lower than expected, in patients with ST-segment–elevation myocardial infarction undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization up to 3 years. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02943954.
- 1 June 2024
- Published by Wolters Kluwer Health in Circulation: Cardiovascular Interventions
- Vol. 17 (6) , e013913
Three-Year Outcomes With Fractional Flow Reserve–Guided or Angiography-Guided Multivessel Percutaneous Coronary Intervention for Myocardial Infarction
BACKGROUND: In patients with multivessel disease with successful primary percutaneous coronary intervention for ST-segment–elevation myocardial infarction, the FLOWER-MI trial (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) showed that a fractional flow reserve (FFR)–guided strategy was not superior to an angiography-guided strategy for treatment of noninfarct-related artery lesions regarding the 1-year risk of death from any cause, myocardial infarction, or unplanned hospitalization leading to urgent revascularization. The extension phase of the trial was planned using the same primary outcome to determine whether a difference in outcomes would be observed with a longer follow-up. METHODS: In this multicenter trial, we randomly assigned patients with ST-segment–elevation myocardial infarction and multivessel disease with successful percutaneous coronary intervention of the infarct-related artery to receive complete revascularization guided by either FFR (n=586) or angiography (n=577). RESULTS: After 3 years, a primary outcome event occurred in 52 of 498 patients (9.40%) in the FFR-guided group and in 44 of 502 patients (8.17%) in the angiography-guided group (hazard ratio, 1.19 [95% CI, 0.79–1.77]; P =0.4). Death occurred in 22 patients (4.00%) in the FFR-guided group and in 23 (4.32%) in the angiography-guided group (hazard ratio, 0.96 [95% CI, 0.53–1.71]); nonfatal myocardial infarction in 23 (4.13%) and 14 (2.56%), respectively (hazard ratio, 1.63 [95% CI, 0.84–3.16]); and unplanned hospitalization leading to urgent revascularization in 21 (3.83%) and 18 (3.36%; hazard ratio, 1.15 [95% CI, 0.61–2.16]), respectively. CONCLUSIONS: Although event rates in the trial were lower than expected, in patients with ST-segment–elevation myocardial infarction undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization up to 3 years. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02943954.
- 4 March 2024
- Published by HMP Communications, LLC in Journal of Invasive Cardiology
- Vol. 36 (3)
Snare Technique Failure in Extracting an Embolized Coronary Sinus Reducer to the Pulmonary Artery
The authors report the case of a 79-year-old male patient who benefited from the implantation of a coronary sinus reducer (CSR) (Reducer; Neovasc, Inc.) in the management of typical angina with mild exertion with optimal medical treatment. Clinical Images from Journal of Invasive Cardiology. coronary sinus reducer chronic coronary syndrome ischemic heart disease percutaneous coronary intervention
- 4 March 2024
- Published by HMP Communications, LLC in Journal of Invasive Cardiology
- Vol. 36 (3)
Snare Technique Failure in Extracting an Embolized Coronary Sinus Reducer to the Pulmonary Artery
The authors report the case of a 79-year-old male patient who benefited from the implantation of a coronary sinus reducer (CSR) (Reducer; Neovasc, Inc.) in the management of typical angina with mild exertion with optimal medical treatment. Clinical Images from Journal of Invasive Cardiology. coronary sinus reducer chronic coronary syndrome ischemic heart disease percutaneous coronary intervention
- Open Access
- 2 November 2023
- Published by Oxford University Press (OUP) in European Heart Journal - Case Reports
- Vol. 7 (11) , ytad543
Complication of a Swan–Ganz catheter: an intravascular knot
We describe the case of a 59-year-old woman admitted for an arterial pulmonary hypertension exploration. A transthoracic echocardiography revealed a preserved left ventricular ejection fraction and an arterial pulmonary hypertension with a systolic pulmonary arterial pressure estimated at 70 mmHg.
- 2 November 2023
- Published by Oxford University Press (OUP) in European Heart Journal - Case Reports
- Vol. 7 (11) , ytad543
Open AccessComplication of a Swan–Ganz catheter: an intravascular knot
We describe the case of a 59-year-old woman admitted for an arterial pulmonary hypertension exploration. A transthoracic echocardiography revealed a preserved left ventricular ejection fraction and an arterial pulmonary hypertension with a systolic pulmonary arterial pressure estimated at 70 mmHg.
- Open Access
- 26 September 2023
- Published by Wolters Kluwer Health in Circulation
- Vol. 148 (13) , 989-999
Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial
BACKGROUND: Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI. METHODS: The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha. RESULTS: A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1; P <0.0001 for noninferiority for both tests). CONCLUSIONS: Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04137510.
- 26 September 2023
- Published by Wolters Kluwer Health in Circulation
- Vol. 148 (13) , 989-999
Open AccessBiodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial
BACKGROUND: Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI. METHODS: The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha. RESULTS: A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1; P <0.0001 for noninferiority for both tests). CONCLUSIONS: Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04137510.