AIMS:Timely reperfusion is a key quality-of-care target in ST-segment elevation myocardial infarction (STEMI). When primary percutaneous coronary intervention (PPCI) cannot be delivered within 120 min from first medical contact (FMC), guidelines recommend fibrinolysis as early as possible within 12 h of symptom onset in eligible patients. We quantified missed opportunities for fibrinolysis in a nationwide STEMI network. METHODS AND RESULTS:We analysed consecutive STEMI patients enrolled ≤24 h from symptom onset in the France-PCI registry (2014-22). First medical contact was approximated by the first diagnostic electrocardiogram (ECG). Initial reperfusion was classified as timely PPCI (FMC-to-device ≤120 min), delayed PPCI (>120 min), or fibrinolysis. Among delayed PPCI, eligibility for fibrinolysis required no oral anticoagulant, no prior stroke, and no documented contraindication. We evaluated temporal trends, regional variation, and outcomes. Among 19 472 patients, 12 633 (64.9%) underwent timely PPCI, 5895 (30.3%) delayed PPCI, and 944 (4.8%) fibrinolysis. Timely PPCI increased over time, whereas fibrinolysis declined. Among delayed PPCI, 3279/5895 (55.6%) presented within the prespecified early-presenter window (symptom-to-ECG ≤3 h) and met our strict fibrinolysis-eligibility criteria, yet underwent delayed PPCI; this proportion remained stable across years, with marked regional heterogeneity. Fibrinolysis use was favoured by mobile intensive care units, helicopter transport, and longer distance to PPCI centres, whereas older age was associated with delayed PPCI without fibrinolysis. CONCLUSION:In this national STEMI network, more than half of delayed PPCI in eligible early presenters represented a persistent missed-fibrinolysis gap. Routine audit of delayed PCI and missed fibrinolysis as system-level quality metrics should guide time-based pre-hospital triage and align reperfusion with guideline-recommended targets.

BACKGROUND:Practitioners recommending transcatheter aortic valve implantation (TAVI) currently lack reliable tools to predict periprocedural risk of ischaemic stroke. AIMS:We aimed to develop and internally validate a clinical risk score to accurately stratify this risk. METHODS:Using data from the nationwide, multicentre FRANCE-TAVI registry, we developed a clinical predictive risk score for 30-day ischaemic stroke post-TAVI using multivariable logistic regression analysis. The model was internally validated through cross-validation techniques. RESULTS:Among 62,747 patients, 1712 (2.7%) experienced ischaemic stroke within 30 days. Nine clinical predictors were identified: female sex, age >85 years, weight <60kg, symptomatic status, history of stroke or transient ischaemic attack, multiple (i.e. >1) episodes of acute heart failure, severe mobility reduction, diabetes and creatinine clearance <60mL/min. The resulting scoring model demonstrated good accuracy (Brier score 0.18), moderate discrimination (C-index 0.63) and excellent calibration as assessed by calibration plots, calibration-in-the-large and calibration slope. The score categorized patients into low - (90.2% of the population), intermediate - (8.0%) and high-risk (1.8%) groups. Observed stroke rates increased progressively across these groups, from 2.25% in the low-risk group to 6.51% in the intermediate-risk group and 10.10% in the high-risk group. CONCLUSIONS:This newly developed STRAT score is a clinical, practical and effective tool for predicting early ischaemic stroke in patients undergoing TAVI. It was derived and internally validated in the FRANCE-TAVI registry and may help tailor preventive strategies. Further studies are necessary to externally validate this score and evaluate its impact on clinical decision-making.

BACKGROUND:The link to mortality and respective weight of ischemic events, hemorrhagic events or both after percutaneous coronary interventions (PCI) remain unclear, especially in regards of the time of occurrence. OBJECTIVES:To compare the association between ischemic and bleeding complications and mortality according to the timing of their occurrence after PCI. METHODS:All patients included in the FRANCE PCI registry between 2014 and 2020 were categorized, according to the occurrence of an ischemic complication (stent thrombosis, myocardial infarction, stroke or unplanned revascularization), a major bleeding (BARC type≥3), both or none of these complications. The analysis was also performed according to the timing of the complication (in-hospital or within one year of PCI). The primary outcome was all-cause mortality, analyzed 1/ during the index hospitalization for PCI by multivariable logistic regression, and 2/ over different periods of time after discharge from the index hospitalization, with a piecewise Cox multivariable model using ischemic and hemorrhagic complications as time-dependent variables. RESULTS:A total of 54,599 patients were included (75% male, median age 69 years), with an acute PCI in 52.9% of the cases. During hospitalization, ischemic complications (aOR 8.4, 95% CI 6.4-10.9), bleeding complications (aOR 10.3, 95% CI 8.1-13.2), and their combination (aOR 13.2, 95% CI 7.0-24.7) were all associated with increased mortality. After discharge, both ischemic and bleeding complications remained significantly associated with all-cause mortality although the strength of these associations decreased over time. Late (beyond 24 weeks) bleeding complications were more strongly associated with mortality (aHR 6.0 95%CI:5.0-7.3) than late ischemic complications (aHR 2.5 95%CI:2.0-3.1). CONCLUSIONS:After PCI there is an incremental risk of death with ischemic, bleeding and the combination of ischemic and bleeding complications occurring during hospitalization. Bleeding complications late after discharge seem to bear a higher risk of death than ischemic complications.

BACKGROUND:Dual antiplatelet therapy reduces ischaemic complications after percutaneous coronary intervention, but increases bleeding risk, especially in patients who are already at high bleeding risk. Current guidelines therefore recommend abbreviated dual antiplatelet therapy in this population. AIM:To evaluate the real-world use of abbreviated dual antiplatelet therapy (≤3 months) after percutaneous coronary intervention according to bleeding risk, using data from the nationwide FRANCE-PCI registry. METHODS:All consecutive patients undergoing percutaneous coronary intervention for either acute or chronic coronary syndrome between 2014 and 2023 across 56 hospitals, who were alive at 1 year, and in whom dual antiplatelet therapy duration was known, were included. High bleeding risk was defined as the presence of at least one of the following: age≥75 years; chronic oral anticoagulant therapy; previous stroke; or chronic kidney disease. RESULTS:Among 115,992 patients included, 41.4% met the criteria for high bleeding risk. Abbreviated dual antiplatelet therapy was prescribed in 23.1% of patients with a high bleeding risk versus 3.6% of patients without a high bleeding risk. Among patients with a high bleeding risk, factors independently associated with prolonged (>3 months) dual antiplatelet therapy use were: increasing age (odds ratio [OR] 1.02, 95% confidence interval [CI] 1.02-1.03); female sex (OR 1.18, 95% CI 1.11-1.25); diabetes mellitus (OR 1.15, 95% CI 1.08-1.22); previous stroke (OR 1.54, 95% CI 1.39-1.69); chronic kidney disease (OR 1.24, 95% CI 1.15-1.34); acute coronary syndrome (OR 1.52, 95% CI 1.44-1.61); and stent length≥60mm (OR 1.18, 95% CI 1.09-1.28). CONCLUSIONS:In real-word practice, less than one third of patients with a high bleeding risk received abbreviated dual antiplatelet therapy after percutaneous coronary intervention. The use of prolonged dual antiplatelet therapy remained driven by ischaemic risk markers, highlighting persistent uncertainty in bleeding risk/ischaemic risk trade-offs.

Background In a context of extending transcatheter aortic valve replacement (TAVR) to patients with a longer life expectancy, it is important to better document the incidence and outcomes of reintervention. Objectives The authors sought to evaluate the incidence, predictive factors, and long-term outcomes of surgical (explant TAVR) or transcatheter (redo TAVR) reintervention after TAVR. Methods Patients who had a TAVR between 2010 and 2022 recorded in the FRANCE 2 and FRANCE TAVI registries were included in the analysis. Cumulative incidence of early (≤1 year) and late (>1 year) reintervention was assessed using the Kalbfleisch and Prentice method to account for all-cause death as a competing risk. Patients who had reintervention for infective endocarditis were excluded. Long-term mortality was evaluated using Kaplan-Meier analysis. Results Among 72,850 patients included, the cumulative incidence of overall reintervention at 8 years was 1.7% including 591 patients who had redo TAVR and 111 patients who required explant TAVR with a low incidence of Bentall intervention. Reintervention occurred mostly early in 62.1% of cases and was more frequent in patients who had a mean aortic gradient >20 mm Hg immediately after index TAVR. Age and mean aortic gradient before TAVR and mean aortic gradient >20 mm Hg, aortic regurgitation ≥ grade 2, and percutaneous coronary intervention after TAVR were predictive of reintervention. Six-year mortality was high but was similar in patients who had early and late reintervention (76.2% vs 64.0%; P = 0.77). Conclusions Reintervention after TAVR remains rare and was mostly performed early after the procedure and by redo TAVR. Further studies are warranted, particularly in younger patients with longer life expectancy.

BACKGROUND:The optimal timing for initiating P2Y12 inhibitor therapy in patients undergoing percutaneous coronary intervention (PCI) remains controversial. In this study we analyzed the impact of dual antiplatelet therapy (DAPT) pretreatment on premature stent thrombosis in patients with chronic coronary syndrome and non-ST-elevation myocardial infarction treated by PCI. METHODS:We analyzed data from 53,898 PCI procedures (44,412 patients) in the "France PCI" registry between 2014 and 2020. Patients were divided into P2Y12 inhibitor pretreatment (83.2%) and no-pretreatment (16.8%) groups. The primary endpoint was incidence of in-hospital definite stent thrombosis. RESULTS:Pretreatment was associated with a significantly lower incidence of in-hospital stent thrombosis (0.1% vs 0.4%; odds ratio [OR] 0.35, 95% confidence interval [CI] 0.22-0.57). At 1 year, the pretreatment group showed lower rates of major adverse cardiovascular events (6.6% vs 7.8%; OR 0.83, 95% CI 0.74-0.92) and all-cause mortality (4.6% vs 6.0%; OR 0.71, 95% CI 0.63-0.80). Notably, there was no significant increase in major bleeding events in the pretreatment group. CONCLUSIONS:In this large, real-world cohort, P2Y12 inhibitor pretreatment was associated with a significant reduction in in-hospital stent thrombosis and improved 1-year clinical outcomes without increased major bleeding risk. Our findings suggest that selective use of antiplatelet pretreatment may still play a crucial role in improving ischemic outcomes for patients undergoing PCI.

Background: Despite improved patency with newer-generation nitinol stents, one-half of patients will require secondary interventions for in-stent restenosis (ISR). The best treatment strategy remains unclear. This study aimed to compare drug-coated balloons (DCBs) used alone or in association with excimer laser atherectomy (ELA) to simple percutaneous transluminal angioplasty (PTA) in the treatment of femoropopliteal-ISR. Methods: The INTACT trial is a multicenter, prospective, triple-arm randomized trial conducted across 14 centers from December 2015 to November 2019. Patients Rutherford Class 2-5 with ISR≥70% were followed-up for 18 months. The primary efficacy endpoint was recurrent ISR>70% by duplex ultrasound analysis. The primary safety endpoint was major adverse events (MAEs) defined as death, major amputation, or target lesion revascularization (TLR). Results: Around 134 subjects were randomized to PTA alone (n=41), PTA+DCB (n=43) or PTA+ELA+DCB (n=50). Procedural success was similar (p=.74), as was clinical success (p=.17). The number of recurrent ISR>70% decreased after PTA+ELA+DCB (30.0%; p=.04) and PTA+DCB (30.2%; p=.05) compared to PTA alone (51.2%). Primary patency was higher after PTA+ELA+DCB (log-rank p=.04) and PTA+DCB (log-rank p=.02) compared to PTA alone at 12 months (78.7% and 70.4% vs 61.5%) and 18 months (61.6% and 67.7% vs 37.3%). Freedom from MAEs was lower after PTA+DCB (27.9%) compared to PTA alone (53.7%; p=.02) but did not differ with PTA+ELA+DCB (40.0%). It was primarily driven by TLR; 2 major amputations occurred after PTA+ELA+DCB (4.0%; p=.18). Conclusion: This independent study demonstrated a decrease in recurrent ISR>70% and increase in primary patency up to 18 months after PTA+ELA+DCB and PTA+DCB compared to PTA alone in the treatment of FP-ISR. It did not show an increase in MAEs but could have lacked power. Clinical Impact This multicenter, prospective, triple-arm randomized, controlled trial focuses on the results of adjunctive therapies, such as excimer laser atherectomy (ELA) and/or drug-coated balloons (DCBs) in the treatment of in-stent restenosis (ISR) in femoropopliteal lesions in 134 patients. It has the originality of being an independent study funded by a grant from the French Ministry of Health. This study confirms a significant decrease in recurrent ISR >70% and increase in primary patency up to 18 months after the use of ELA+DCB and DCBs compared to simple percutaneous transluminal angioplasty in the treatment of femoropopliteal ISR without an increase in major adverse events.

Coronary calcifications are associated with major procedural complications and worst patient outcomes. Intravascular lithotripsy (IVL) is a safe solution for calcified coronary lesions. However, patients included in the IVL development program are highly selected and do not encounter interventional cardiologist community daily practice. We conducted France LILI registry to assess the efficacy and safety of IVL in real-life patients, on behalf of the National French Group of Interventional Cardiology (GACI). France LILI is a prospective multicenter registry including all patients undergoing coronary intervention with IVL. We planned to include prospectively 500 patients in 40 French centers. The primary endpoint is 12-month Target Vessel Failure, including cardiac death, TV-MI according to ARC II definition, and target vessel revascularization. Secondary endpoints are stent thrombosis, device-oriented, patient-oriented, and patient-oriented endpoints according to ARC definition at 30 days, six months and 12 months FU. From November 2021 to February 2023, 500 patients were prospectively included. Mean age was 73.4 (±9.5), with 81.4% male and 39.8% diabetic. 454 (82.1%) patients were treated for de novo lesions and 99 (17.9%) patients for in-stent restenosis. Adjudicated periprocedural complications post-IVL and post-final angiography were extremely low (dissection in 0.2%, Abrupt vessel closure 0.2%, distal embolization in 0.2%, perforation in 0.6%) No in-hospital cardiac death was reported. The one-month death rate is 4 (0.8%), all considered as cardiovascular death with a 30 days TVF of 2.6% (13 events).Independent factors of TVF were: more than one lesion treated by IVL (9.3% vs 1.8%; p = 0.008), stent length implantation of more than 30 mm (4.1% vs 1.2%; p = 0.043), and patient receiving less than 80 pulses delivered to the target lesion (6.6% vs 0.9%; p = 0.001). In multivariate analysis, multiple lesion treated by IVL and patients receiving less than 80 pulses delivered to the target lesion were powerful independent factors of TVF occurrence (respectively OR = 7.01; IC95(2.04–24.03) and OR = 7.38; IC95(1.93–28.19). France LILI is the largest registry of all comers’ patients. This trial confirms the high safety and efficacy of IVL in an unselected population and highlights, for the first time, powerful independent predictors of 30 days TVF.

Background: The influence of permanent pacemaker implantation upon outcomes after transcatheter aortic valve implantation (TAVI) remains controversial. Aims: To evaluate the impact of permanent pacemaker implantation after TAVI on short- and long-term mortality, and on the risk of hospitalization for heart failure. Methods: Data from the large FRANCE-TAVI registry, linked to the French national health single -payer claims database, were analysed to compare 30 -day and long-term mortality rates and hospitalization for heart failure rates among patients with versus without permanent pacemaker implantation after TAVI. Multivariable regressions were performed to adjust for confounders. Results: A total of 36,549 patients (mean age 82.6 years; 51.6% female) who underwent TAVI from 2013 to 2019 were included in the present analysis. Among them, 6999 (19.1%) received permanent pacemaker implantation during the index hospitalization, whereas 232 (0.6%) underwent permanent pacemaker implantation between hospital discharge and 30 days after TAVI, at a median of 11 (interquartile range: 7-18) days. In -hospital permanent pacemaker implantation was not associated with an increased risk of death between discharge and 30 days (adjusted odds ratio: 0.91, 95% confidence interval: 0.64-1.29). At 5 years, the incidence of all -cause death was higher among patients with versus without permanent pacemaker implantation within 30 days of the procedure (adjusted hazard ratio: 1.13, 95% confidence interval: 1.07-1.19). Permanent pacemaker implantation within 30 days of TAVI was also associated with a higher 5 -year rate of hospitalization for heart failure (adjusted subhazard ratio: 1.17, 95% confidence interval: 1.11-1.23). Conclusions: Permanent pacemaker implantation after TAVI is associated with an increased risk of longterm hospitalization for heart failure and all -cause mortality. Further research to mitigate the risk of postprocedural permanent pacemaker implantation is needed as TAVI indications expand to lower -risk patients. (c) 2024 Elsevier Masson SAS. All rights reserved.

Background: Despite the evolution of stent technology, there is a non-negligible risk of in-stent restenosis (ISR) after Percutaneous coronary intervention (PCI). Large-scale registry data on the prevalence and clinical manage-ment of ISR is lacking.Methods: The aim was to describe the epidemiology and management of patients with & GE;1 ISR lesions treated with PCI (ISR PCI). Data on characteristics, management and clinical outcomes were analyzed for patients undergoing ISR PCI in the France-PCI all-comers registry.Results: Between January 2014 and December 2018, 31,892 lesions were treated in 22,592 patients, 7.3 % of whom underwent ISR PCI. Patients undergoing ISR PCI were older (68.5 vs 67.8; p < 0.001), and more likely to have diabetes (32.7 % vs 25.4 %, p < 0.001), chronic coronary syndrome or multivessel disease. ISR PCI concerned drug eluting stents (DES) ISR in 48.8 % of cases. Patients with ISR lesions were more frequently treated with DES than drug eluting balloon or balloon angioplasty (74.2 %, 11.6 % and 12.9 %, respectively). Intravascular imaging was rarely used. At 1 year, patients with ISR had higher target lesion revascularization rates (4.3 % vs. 1.6 %; HR 2.24 [1.64-3.06]; p < 0.001).Conclusions: In a large all-comers registry, ISR PCI was not infrequent and associated with worse prognosis than non-ISR PCI. Further studies and technical improvements are warranted to improve the outcomes of ISR PCI.& COPY; 2023 Elsevier Inc. All rights reserved.

AIMS:Unprotected left main coronary artery (ULMCA) occlusion is a rare and disastrous condition with scarce data on presentation and outcomes. Herein, we report data on patients presenting with acute coronary syndrome due to ULMCA occlusion at four different institutions.METHODS:This is an international multicentre observational study. Baseline characteristics were retro- and prospectively collected. Clinical follow-up was prospective. The primary outcome was in-hospital death. Patients surviving the index hospitalization were compared with nonsurvivors to find predictors of survival.RESULTS:The study population consisted of 55 patients. Eight patients (15%) died in the cath lab, and 23 (42%) died in hospital. Three (6%) deaths were noncardiac and due to major bleeding. Thirty-two (58%) patients survived the index hospitalization and were discharged. These patients were followed for a median of 17.5 months during which three cardiac deaths occurred. Repeat revascularization was performed in 25% (n = 8). Overall mortality at maximum follow-up was 47% (n = 26). The only significant predictor for hospital survival was left ventricular ejection fraction (odds ratio [OR]: 1.10 (per 1 point increase); 95% confidence interval [CI]: 1.02-1.19; p = 0.02).CONCLUSION:ULMCA occlusion carries a high short-term mortality. Patients who survive index hospitalization have similar mortality rates as compared with other st elevation myocardial infarction patients.

Background: Obstructive coronary artery disease is the main cause of death worldwide. By tracking events and gaining feedback on patient management, the most relevant information is provided to public health services to further improve prognosis.Aims: To create an inclusive and accurate registry of all percutaneous coronary intervention (PCI) proce-dures performed in France, to assess and improve the quality of care and create research incentives. Also, to describe the methodology of this French national registry of interventional cardiology, and present early key findings. Methods: The France PCI registry is a multicentre observational registry that includes consecutive patients undergoing coronary angiography and/or PCI. The registry was set up to provide online data analysis and structured reports of PCI activity, including process of care measures and assessment of risk-adjusted outcomes in all French PCI centres that are willing to participate. More than 150 baseline data items, describing demographic status, PCI indications and techniques, and in-hospital and 1-year outcomes, are captured into local reporting software by medical doctors and local research technicians, with subsequent encryption and internet transfer to central data servers. Annual activity reports and scoring tools available on the France PCI website enable users to benchmark and improve clinical practices. External validation and consistency assessments are performed, with feedback of data completeness to centres.Results: Between 01 January 2014 and 31 December 2022, participating centres increased from six to 47, and collected 364,770 invasive coronary angiograms and 176,030 PCIs, including 54,049 non-ST -segment elevation myocardial infarction cases and 31,631 ST-segment elevation myocardial infarction cases. Fifteen studies stemming from the France PCI registry have already been published. Conclusions: This fully electronic, daily updated, high-quality, low-cost, national registry is sustainable, and is now expanding. Merging with medicoeconomic databases and nested randomized scientific studies are ongoing steps to expand its scientific potential. (c) 2023 Elsevier Masson SAS. All rights reserved.

ObjectivesThe aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics.BackgroundDES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating.MethodsWithin a multicenter, first-in-man, single-arm study, 100 patients with symptomatic femoropopliteal disease (Rutherford category 2-4, mean lesion length 5.8 ± 3.9 cm, 35.0% total occlusions) were treated with the NiTiDES stent (Alvimedica). Two-year follow-up included assessment of primary patency (defined as absence of clinically driven target lesion revascularization or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, functional, and clinical outcomes.ResultsAt 24 months, Kaplan-Meier estimates of primary patency and freedom from clinically driven target lesion revascularization were 83.4% (95% CI: 73.9%-89.6%) and 93.1% (95% CI: 85.3%-96.9%), respectively. Over the study period, 3 deaths were reported with no major limb amputation. Functional and clinical benefits were sustained, as 82.1% of patients fell into Rutherford category 0 or 1 at 24 months, which was associated with preserved improvements in all walking disability questionnaire scores.ConclusionsThe 2-year results of the ILLUMINA (Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy) study demonstrate a sustained treatment benefit with a novel sirolimus-eluting stent that also compares favorably to other femoropopliteal intervention trials. Head-to-head comparisons of NiTiDES with a paclitaxel-based DES are warranted. (The ILLUMINA Study [ILLUMINA]; NCT03510676)

Background: Transcatheter aortic valve implantation (TAVI) is the preferred treatment for symptomatic severe aortic stenosis (AS) in a majority of patients across all surgical risks. Patients and methods: Paravalvular leak (PVL) and patient–prosthesis mismatch (PPM) are two frequent complications of TAVI. Therefore, based on the large France-TAVI registry, we planned to report the incidence of both complications following TAVI, evaluate their respective risk factors, and study their respective impacts on long-term clinical outcomes, including mortality. Results: We identified 47,494 patients in the database who underwent a TAVI in France between 1 January 2010 and 31 December 2019. Within this population, 17,742 patients had information regarding PPM status (5138 with moderate-to-severe PPM, 29.0%) and 20,878 had information regarding PVL (4056 with PVL ≥ 2, 19.4%). After adjustment, the risk factors for PVL ≥ 2 were a lower body mass index (BMI), a high baseline mean aortic gradient, a higher body surface area, a lower ejection fraction, a smaller diameter of TAVI, and a self-expandable TAVI device, while for moderate-to-severe PPM we identified a younger age, a lower BMI, a larger body surface area, a low aortic annulus area, a low ejection fraction, and a smaller diameter TAVI device (OR 0.85; 95% CI, 0.83–0.86) as predictors. At 6.5 years, PVL ≥ 2 was an independent predictor of mortality and was associated with higher mortality risk. PPM was not associated with increased risk of mortality. Conclusions: Our analysis from the France-TAVI registry showed that both moderate-to-severe PPM and PVL ≥ 2 continue to be frequently observed after the TAVI procedure. Different risk factors, mostly related to the patient’s anatomy and TAVI device selection, for both complications have been identified. Only PVL ≥ 2 was associated with higher mortality during follow-up.

Background: Intravascular lithotripsy (IVL) is a promising new technology for disrupting de-novo calcified cor-onary lesions (DNL) before percutaneous coronary intervention (PCI). We assessed 12-month outcomes of IVL in patients undergoing PCI for DNL or intra stent restenosis (ISR) lesions related to device underexpansion. Methods: Prospective analysis of patients in the multicentre all-comers French Shock Initiative IVL registry. The primary safety endpoints in this analysis were in-hospital and 12-month major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). The primary effectiveness endpoint was procedural success, defined as <30% residual stenosis without severe angiographic complications. Event rates were analysed for the cohort and for DNL and ISR procedures separately. Results: A total of 220 lesions were treated (76.7% DNL and 23.3% ISR) in 202 patients. Procedural success was achieved in 95.5% of patients (DNL group: 96.5%; ISR group: 92.0%). In-hospital MACE occurred in 6.4% of cases, mainly driven by periprocedural infarctions. The rate of MACE-free survival at 1 year was 86.6% in the overall cohort. Rates of target vessel (TVR) and lesion (TLR) revascularisation were 6.4% and 2.5%, respectively. The 1-year MACE rate was 91.5% in DNL group and 83.8% in ISR group. Conclusions: In this large all-comers IVL cohort, rates of in-hospital and 1-year MACE were moderate. The safety and efficiency of IVL was comparable in DNL and ISR lesions. A comparative study of the impact of IVL on outcomes appears warranted.