Assessment of the MANTA closure device in real-life transfemoral transcatheter aortic valve replacement: A single-centre observational study.

BACKGROUND: Vascular complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR). Data involving suture-based percutaneous vascular closure devices (VCDs) have been extensive. Although promising, data regarding the efficacy and safety of the MANTA VCD (Teleflex) are scarce. We sought to assess the safety and effectiveness of the MANTA device in a real-life unselected cohort of patients undergoing transfemoral-TAVR (TF-TAVR). METHODS: This single-center retrospective observational study included a cohort of consecutive patients with severe aortic stenosis (AS) treated by our team using TAVR between January 2020 to December 2022. The primary outcome measure was access-related major and minor vascular complications according to the Valve Academic Research Consortium (VARC-3) definition criteria. RESULTS: From January 2020 to December 2022, a total of 347 patients underwent TF-TAVR were treated using the MANTA 18 Fr VCD system for vascular closure. Mean age was 82.4 ± 6.1 years (56-98 years). There were no significant differences in preoperative and procedural characteristics between patients with and without VCD-related major vascular complications. Access site-related major and minor vascular complications occurred in 20 of 347 patients (5.7%). Overall, major vascular complications occurred in 5 patients (1.4%) and device failure was seen in 17 patients (4.9%). CONCLUSION: This French real world evaluation of large-bore arteriotomy closure in TF-TAVR indicated that MANTA VCD is a feasible alternative with an acceptable low rate of access-site-related complications.

Impact of technique on bifurcation stent outcomes in the European Bifurcation Club Left Main Coronary Trial.

BACKGROUND: Techniques for provisional and dual-stent left main bifurcation stenting require optimization. AIM: To identify technical variables influencing procedural outcomes and periprocedural myocardial infarction following left main bifurcation intervention. METHODS: Procedural and outcome data were analyzed in 438 patients from the per-protocol cohort of the European Bifurcation Club Left Main Trial (EBC MAIN). These patients were randomized to the provisional strategy or a compatible dual-stent extension (T, T-and-protrude, or culotte). RESULTS: Mean age was 71 years and 37.4% presented with an acute coronary syndrome. Transient reduction of side vessel thrombolysis in myocardial infarction flow occurred after initial stent placement in 5% of procedures but was not associated with periprocedural myocardial infarction. Failure to rewire a jailed vessel during any strategy was more common when jailed wires were not used (9.5% vs. 2.5%, odds ratio [OR]: 6.4, p = 0.002). In the provisional cohort, the use of the proximal optimization technique was associated with less subsequent side vessel intervention (23.3% vs. 41.9%, OR: 0.4, p = 0.048). Side vessel stenting was predominantly required for dissection, which occurred more often following side vessel preparation (15.3% vs. 4.4%, OR: 3.1, p = 0.040). Exclusive use of noncompliant balloons for kissing balloon inflation was associated with reduced need for side vessel intervention in provisional cases (20.5% vs. 38.5%, OR: 0.4, p = 0.013), and a reduced risk of periprocedural myocardial infarction across all strategies (2.9% vs. 7.7%, OR: 0.2, p = 0.020). CONCLUSION: When performing provisional or compatible dual-stent left main bifurcation intervention, jailed wire use is associated with successful jailed vessel rewiring. Side vessel preparation in provisional patients is linked to increased side vessel dissection requiring stenting. Use of the proximal optimization technique may reduce the need for additional side vessel intervention, and noncompliant balloon use for kissing balloon inflation is associated with a reduction in both side vessel stenting and periprocedural myocardial infarction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02497014.

In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease.

Objectives: The aim of this postmarket clinical study was to assess the safety and efficacy of the latest generation polymer-free sirolimus-eluting stents (PF-SES) in an all-comers population comparing outcomes in stable coronary artery disease (CAD) versus acute coronary syndrome (ACS) in France. Background: The efficacy and safety of the first-generation PF-SES have already been demonstrated by randomized controlled trials and "all-comers" observational studies. Methods: For this all-comers observational, prospective, multicenter study, 1456 patients were recruited in 22 French centers. The primary endpoint was target lesion revascularization (TLR) rate at 12 months and secondary endpoints included major adverse cardiac events (MACE) and bleeding. Results: 895 patients had stable CAD and 561 had ACS. At 12 months, 2% of patients had a TLR, with similar rates between stable CAD and ACS (1.9% vs 2.2%, p = 0.7). The overall MACE rate was 5.2% with an expected higher rate in patients with ACS as compared to those with stable CAD (7.3% vs 3.9%, p = 0.007). The overall bleeding event rate was 4.5%, with similar rates in stable CAD as compared to ACS patients (3.8% vs 5.6%, p = 0.3). Dual antiplatelet therapy (DAPT) interruptions prior to the recommended duration occurred in 41.7% of patients with no increase in MACE rates as compared to patients who did not prematurely interrupt DAPT (3.9% vs 6.1%, p = 0.073). Conclusions: The latest generation PF-SES is associated with low clinical event rates in these all-comers patients. There was a high rate of prematurely terminated DAPT, without any effect on MACE at 12 months. This trial is registered with NCT03809715.

Clinical impact of FFR-guided PCI compared to angio-guided PCI from the France PCI registry.

OBJECTIVES: We sought to compare, in a national French registry (FrancePCI), the clinical impact of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared with angio-guided PCI at 1 year. BACKGROUND: FFR has become the invasive gold standard to quantify myocardial ischemia generated by a coronary stenosis in patients with chronic coronary syndrome, but in clinical practice it is still underutilised to guide PCI compared to angiography (angio). METHODS: We extracted from the FrancePCI database all chronic coronary syndrome patients treated with PCI for coronary stenosis <90% between 2014 and 2019. Our composite clinical endpoint was the rate of major adverse clinical events (MACE). RESULTS: Fourteen thousand three hundred eighty-four patients with 1-year clinical follow-up were included. Among them, 13,125 had angio-guided PCI (91%) and 1259 (9%) had FFR-guided PCI. We observed a significantly higher rate of MACE in the angio-guided group versus the FFR-guided group: 1478 (11.3%) versus 100 (7.9%) (p < 0.0001), respectively, with hazard ratio (HR) of 1.440, 95% confidence interval (CI) [1.211-1.713] (p = 0.0004). This result was driven by the higher occurrence of death in the angio-guided group versus the FFR-guided-group: 506 (3.9%) versus 17 (1.4%) (p < 0.0001), respectively, with HR of 2.845, 95% CI [2.099-3.856] (p < 0.0001). After adjustment for potential confounding factors, HRs were 1.287, 95% CI [1.028-1.613] (p = 0.028) for MACE and 2.527, 95% CI [1.452-4.399] (p = 0.001) for death. No significant differences between angio-guided PCI and FFR-guided PCI were observed for other clinical endpoints. CONCLUSIONS: FFR-guided PCI improves outcome at 1 year compared to angio-guided PCI with a reduction of 64% of death.

Outcomes of 10,312 patients treated with everolimus-eluting bioresorbable scaffolds during daily clinical practice - results from the European Absorb Consortium.

OBJECTIVES: To asses mid-term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large-scale all-comers population. BACKGROUND: Several clinical settings are underrepresented in randomized studies investigating BVS against drug-eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation. METHODS: The European ABSORB Consortium comprises the following European registries: GABI-R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient-level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target-vessel myocardial infarction (TVMI) and target-lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics. RESULTS: A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12-month follow-up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST. CONCLUSIONS: The EAC demonstrates reasonable real-world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high.

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the FRANCE-TAVI Registry.

BACKGROUND: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date. METHODS: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality. RESULTS: In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46-1.91]; P<0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63-2.22]; P<0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07-1.66]; P=0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06-1.29]; P=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. CONCLUSION: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. Unique identifier: NCT01777828.

Three-year clinical outcomes with the ABSORB bioresorbable vascular scaffold in real life: Insights from the France ABSORB registry.

OBJECTIVES: The aim of this study was to determine the 3-year outcomes of patients treated with Absorb bioresorbable vascular scaffold (BVS) implantation. BACKGROUND: Randomized trials and observational registries performed in patients undergoing percutaneous coronary intervention have demonstrated higher 1-year and midterm rates of device thrombosis and adverse events with BVS compared to contemporary drug eluting stent. Data on long-term follow-up of patients treated with BVS are scarce. METHODS: All patients treated with BVS were included in a large nationwide prospective multicenter registry (FRANCE ABSORB). The primary endpoint was a composite of cardiovascular death, myocardial infarction, and target lesion revascularization at 3 years. Secondary endpoints were 3-year scaffold thrombosis and target vessel revascularization (TVR). RESULTS: Between September 2014 and April 2016, 2070 patients were included (mean age 55 ± 11 years; 80% men). The indication was acute coronary syndrome (ACS) in 49% of patients. At 3 years, the primary endpoint occurred in 184 patients (8.9%) and 3-year mortality in 43 patients (2.1%). Scaffold thrombosis and TVR rates through 3 years were, respectively, 3 and 7.6%. In a multivariable analysis, independent predictors of primary endpoint occurrence were diabetes, oral anticoagulation, active smoking, absence of initial angiographic success and the association of a total BVS length ≥30 mm with the use of 2.5 mm diameter BVS. CONCLUSIONS: Although 3-year mortality was low in this ACS population, device-related events were significant beyond 1 year. Total BVS length and 2.5 mm BVS were associated with higher rates of MACE at long-term follow-up.

Safety and efficacy of the latest generation biodegradable polymer-coated ultrathin sirolimus-eluting stent in the treatment of coronary artery disease in a European all-comer population with or without high bleeding risk: The Cruz HBR Registry.

BACKGROUND: The latest generation ultrathin Supraflex Cruz (Sahajanand Medical Technologies Limited, Surat, India) sirolimus-eluting stent (SES) has shown early healing properties and represents an attractive percutaneous coronary intervention (PCI) device in a high bleeding risk (HBR) population. The aim of this Cruz HBR registry was to assess safety and efficacy of the Supraflex Cruz SES in a large cohort of all-comer patients, of whom about one third were patients at HBR. METHODS: Patients undergoing PCI were enrolled in this prospective, multi-centre, open label registry and stratified into non-HBR and HBR groups. The primary endpoint was a device-oriented composite endpoint (DOCE), a composite of cardiovascular death, myocardial infarction not clearly attributable to a non-target vessel and clinically driven target lesion revascularization within 12 months after PCI. The predefined aims were to show non-inferiority of the non-HBR group to the Supraflex arm of the TALENT Trial, and of the HBR group to polymer-free biolimus-coated stent arm of LEADERS FREE Trial. RESULTS: A total of 1203 patients were enrolled across 26 European centers, including a significant proportion (38.7%; N.=466) of HBR patients. A total of 1745 lesions were treated in 1203 patients and 2235 stents were implanted. The DOCE occurred within the total cohort in 5.8% of patients with a significant difference between HBR patients and non-HBR patients (8.1% vs. 4.4%; P<0.001). All-cause mortality at 12 months was significantly (P<0.0001) different among HBR (9.0%) and non-HBR patients (1.7%), respectively. At 12 months, the overall incidence of definite and probable stent thrombosis was 1.0%. Major bleeding occurred in 5.9% patients of the HBR group. These results met the non-inferiority criteria with respect to the TALENT trial for the non-HBR group (P<0.0001), and the LEADERS FREE trial for the HBR group (P<0.0001). CONCLUSIONS: The Cruz HBR registry confirms that PCI with the Supraflex Cruz SES is associated with a favorable clinical outcome in an all-comer population, including complex patients with HBR.

Sodium Chloride Physiological Saline Solution Versus Water Preparations Injectable in the Use of Shockwave Intravascular Lithotripsy: A Single-Center Experience.

Background: Shockwave intravascular lithotripsy (IVL) coronary system is a very useful new technology for de novo severely calcified coronary artery plaques before percutaneous coronary intervention (PCI). The device uses a semi-compliant low-pressure balloon, integrated into a sterile catheter, to deliver by vaporizing fluid an expanding bubble that generates high-pressure ultrasonic energy by waves that create multiplane longitudinal micro-macro fractures in calcified plaques, which facilitate optimal stent placement and expansion, and luminal gain. Methods: The use of Shockwave IVL coronary system in our cardiac catheterization laboratory (Cath lab) at the "Clinique Saint-Hilaire" in Rouen, France, started in March 2019, with 42 procedures performed since this date: two patients in 2019, two patients in 2020, seven patients in 2021, 23 patients in 2022, and eight patients since the beginning of 2023. Results: We had experienced problems at the beginning of our activity for the first 11 patients (two patients in 2019, two patients in 2020, and seven patients in 2021): after less than five pulses, the shock therapy stopped. We used initially for Shockwave IVL semi-compliant low-pressure integrated balloons a mixture of 50% contrast and 50% water preparations injectable (PPI). After changing water PPI by sodium chloride physiological saline solution, we never encountered this problem again for the following 31 patients (23 patients in 2022, and eight patients since the beginning of 2023). In fact, the proper functioning of Shockwave IVL system requires ions in balloon mixture in addition to the contrast. It is thanks to the ions contained in sodium chloride physiological saline solution that the spark necessary for shocks delivery after balloon inflation is produced. Conclusions: Water PPI or sodium chloride physiological saline solution is used in angioplasty balloons in a lot of Cath labs worldwide. It is therefore essential to disseminate in the worldwide Cath lab the obligation to put in Shockwave IVL semi-compliant low-pressure integrated balloons sodium chloride physiological saline solution, rather than water PPI for optimal performance, and the importance of Shockwave Medical reporting this to interventional cardiologists.

Safety and efficacy of NOAC vs. VKA in patients treated by PCI: a retrospective study of the FRANCE PCI registry.

Introduction: Dual antithrombotic therapy (DAT) combining oral anticoagulation (OAC), preferentially Non-vitamin K antagonist OAC (NOAC) and single antiplatelet therapy (SAPT) for a period of 6-12 months is recommended after percutaneous coronary intervention (PCI) in patients with an indication for OAC. Objective: To compare outcomes between vitamin K antagonist (VKA) and NOAC-treated patients in the nation-wide France PCI registry. Methods: All consecutive patients from the France PCI registry treated by PCI and discharged with OAC between 2014 and 2020 were included and followed one-year. Major bleeding was defined as Bleeding Academic Research Consortium (BARC) classification ≥3 and major adverse cardiac events (MACE) as the composite of all-cause mortality, myocardial infarction (MI), and ischemic stroke. A propensity-score analysis was used. Results: Of the 7,277 eligible participants, 2,432 (33.4%) were discharged on VKA and 4,845 (66.6%) on NOAC. After propensity-score adjustment, one-year major bleeding was less frequent in NOAC vs. VKA-treated participants [3.1% vs. 5.2%, -2.1% (-3.6% to -0.6%), p = 0.005 as well as the rate of MACE [9.2% vs. 11.9%, -2.7% (-5.0% to -0.4%), p = 0.02]. One-year mortality was also significantly decreased in NOAC vs. VKA-treated participants [7.4% vs. 9.9%, -2.6% (-4.7% to -0.5%), p = 0.02]. The area under ROC curves of the anticoagulant treatment propensity score was estimated at 0.93, suggesting potential indication bias. Conclusions: NOAC seems to have a better efficacy and safety profile than VKA. However, potential indication bias were found.

Prevalence, Management and Outcomes of Percutaneous Coronary Intervention for Coronary In-Stent Restenosis: Insights From the France PCI Registry.

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 management of ISR is lacking. METHODS: The aim was to describe the epidemiology and management of patients with ≥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.

The France PCI registry: Design, methodology and key findings.

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) procedures 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.

Impact of the Lubrizol factory fire in Rouen on coronary events: A retrospective study from the France PCI registry.

BACKGROUND: On 26 September 2019, an industrial fire occurred in the Lubrizol factory in Rouen (France), exposing the population to the inhalation of many volatile toxic agents secondary to combustion. AIM: To assess the impact of the Lubrizol factory fire on the incidence of coronary artery events. METHODS: All coronary angiograms performed in Rouen (exposed) and Le Havre (unexposed) from May 2019 to December 2019 were extracted from the prospective France Percutaneous Coronary Intervention (France PCI) registry. To study the impact of the fire on coronary events, an interrupted time series analysis was performed in Rouen, with adjustment on Le Havre in an autoregressive moving average (ARMA)(1,1) model with the precision of 1 week. The primary outcome was the incidence of acute coronary syndrome, and the secondary outcome was the incidence of ST-segment elevation myocardial infarction. RESULTS: The mean number of acute coronary syndromes per week in the exposed zone (Rouen) increased non-significantly from 37.5±9.4 before the fire to 43.2±6.2 after the fire, for an estimated effect of +5.5 (95% confidence interval -0.7 to 11.8; P=0.09) events per week. In municipalities exposed to the plume of smoke (subgroup of Rouen), the mean number of acute coronary syndromes increased non-significantly from 7.3±2.8 before the fire to 8.7±3.6 after the fire, for an estimated effect of +1.0 (95% confidence interval -2.0 to 4.0; P=0.51) events per week. The results were similar when taking into account only ST-segment elevation myocardial infarctions or all coronary events. CONCLUSIONS: Our study did not find a significant effect of the Lubrizol factory fire on the incidence of acute coronary syndrome. Further studies are needed to investigate the impact of industrial accidents on air pollution and coronary events.

Indirect Transfer to Catheterization Laboratory for ST Elevation Myocardial Infarction Is Associated With Mortality Independent of System Delays: Insights From the France-PCI Registry.

Background: First medical contact (FMC)-to-balloon time is associated with outcome of ST-elevation myocardial infarction (STEMI). We assessed the impact on mortality and the determinants of indirect vs. direct transfer to the cardiac catheterization laboratory (CCL). Methods: We analyzed data from 2,206 STEMI patients consecutively included in a prospective multiregional percutaneous coronary intervention (PCI) registry. The primary endpoint was 1-year mortality. The impact of indirect admission to CCL on mortality was assessed using Cox models adjusted on FMC-to-balloon time and covariables unequally distributed between groups. A multivariable logistic regression model assessed determinants of indirect transfer. Results: A total of 359 (16.3%) and 1847 (83.7%) were indirectly and directly admitted for PCI. Indirect admission was associated with higher risk features, different FMCs and suboptimal pre-PCI antithrombotic therapy.At 1-year follow-up, 51 (14.6%) and 137 (7.7%) were dead in the indirect and direct admission groups, respectively (adjusted-HR 1.73; 95% CI 1.22-2.45). The association of indirect admission with mortality was independent of pre-FMC and FMC characteristics. Older age, paramedics- and private physician-FMCs were independent determinants of indirect admission (adjusted-HRs 1.02 per year, 95% CI 1.003-1.03; 5.94, 95% CI 5.94 3.89-9.01; 3.41; 95% CI 1.86-6.2, respectively). Conclusions: Our study showed that, indirect admission to PCI for STEMI is associated with 1-year mortality independent of FMC to balloon time and should be considered as an indicator of quality of care. Indirect admission is associated with higher-risk features and suboptimal antithrombotic therapy. Older age, paramedics-FMC and self-presentation to a private physician were independently associated with indirect admission. Our study, supports population education especially targeting elderly, more adequately dispatched FMC and improved pre-CCL management.

Early survival after acute myocardial infarction with ST-segment elevation: What could be improved? Insights from France PCI French registry.

Early mortality post-ST-segment elevation myocardial infarction (STEMI) in France remains high. The multicentre France Percutaneous Coronary Intervention Registry includes every patient undergoing coronary angiography in France. We analyzed the prevalence and impact of unmodifiable and modifiable risk factors on 30-day survival in patients experiencing STEMI. Patients admitted for STEMI between 01/2014 and 12/2016 were included in the analysis. Patients with nonobstructive coronary artery disease, with cardiogenic shock or cardiac arrest without STEMI, were excluded. Prehospital, clinical and procedural data were collected prospectively by the cardiologist in the cath lab using medical reporting software. Information on outcomes, including mortality, was obtained by a dedicated research technician by phone calls or from medical records. Marginal Cox proportional hazards regression was used to test the predictive value for survival at 30 days in a multivariable analysis. Included were 2590 patients (74% men) aged 63 ± 14 years. During the first month, 174 patients (6.7%) died. After adjustment, unmodifiable variables significantly associated with reduced 30-day survival were: age > 80 years (prevalence 15%; hazard ratio [HR] 2.7; 95% confidence interval [CI] 1.5-4.7), chronic kidney disease (2%; HR 5.3; 95% CI 2.6-11.1), diabetes mellitus (14%; HR 1.6; 95% CI 1.0-2.5), anterior or circumferential electrical localization (39%; HR 2.0; 95% CI 1.4-2.9), and Killip class 2, 3, or 4 (7%; HR 3.4; 95% CI 1.9-5.9; 2%; HR 10.1; 95% CI 5.3-19.4; 4%; HR 18; 95% CI 10.8-29.8, respectively). Among modifiable variables, total ischemic time > 3 hours (68%; HR 1.8; 95% CI 1.1-3.0), lack of appropriate premedication (18%; HR 2.2; 95% CI 1.5-3.3), and post-PCI TIMI < 3 (6%; HR 4.9; 95% CI 3.2-7.6) were significantly associated with reduced 30-day survival. Most predictors of 30-day survival post-STEMI are unmodifiable, but outcomes might be improved by optimizing modifiable factors, most importantly ischemic time and appropriate premedication.

Five-year clinical outcomes using the bioresorbable vascular scaffold: Insights from the FRANCE ABSORB registry.

BACKGROUND: Randomized trials comparing the first-generation absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA, USA) with a drug-eluting stent showed a moderate but significant increase in the rate of 3-year major adverse cardiac events and scaffold thrombosis, followed by a decrease in adverse events after 3 years. AIM: The objective of this study was to assess the 5-year outcomes of patients treated with at least one absorb BVS and included in the FRANCE ABSORB registry. METHODS: All patients treated in France with an absorb BVS were prospectively included in a large nationwide multicentre registry. The primary efficacy outcome was the occurrence of 5-year major adverse cardiac events. Secondary efficacy outcomes were the rates of 5-year target vessel revascularization and definite/probable scaffold thrombosis. RESULTS: Between September 2014 and April 2016, 2,070 patients were included in 86 centres (mean age 55±11 years; 80% men; 49% with acute coronary syndrome). The rates of 1-, 3- and 5-year major adverse cardiac events were 3.9%, 9.4% and 12.1%, respectively (including cardiac death in 2.5% and target vessel revascularization in 10.4%). By multivariable analysis, diabetes, oral anticoagulation, the use of multiple Absorb BVSs and the use of a 2.5mm diameter absorb BVS were associated with 5-year major adverse cardiac events. The rates of 1-, 3- and 5-year definite/probable scaffold thrombosis were 1.5%, 3.1% and 3.6%, respectively. By multivariable analysis, older age, diabetes, anticoagulation at discharge and the use of a 2.5mm diameter absorb BVS were associated with 5-year scaffold thrombosis. CONCLUSIONS: Absorb BVS implantation was associated with low rates of 1-year major adverse cardiac events, which increased significantly at 3-year follow-up. There was a clear decrease in the rates of scaffold thrombosis and major adverse cardiac events after 3 years.

Analysis of length of stay after transfemoral transcatheter aortic valve replacement: results from the FRANCE TAVI registry.

BACKGROUND: Currently, there are no recommendations regarding the minimum duration of in-hospital monitoring after transfemoral (TF) transcatheter aortic valve replacement (TAVR) and practices are extremely heterogeneous. We, therefore, aimed to evaluate length of stay (LOS) and predictive factors for late discharge after TF TAVR using data from the FRANCE TAVI registry. METHODS: TAVR was performed in 12,804 patients in 48 French centers between 2013 and 2015. LOS was evaluated in 5857 TF patients discharged home. LOS was calculated from TAVR procedure (day 0) to discharge. The study population was divided into three groups based on LOS values. Patients discharged within 3 days constituted the "very early" discharge group, patients with a LOS between 3 and 6 days constituted the "early" discharge group, and patients with a length of stay > 6 days constituted the "late" discharge group. RESULTS: The median LOS was 7 (5-9) days and was extremely variable among centers. The proportion of patients discharged very early, early, and late was 4.4% (n = 256), 33.7% (n = 1997), and 61.9% (n = 3624) respectively. Variables associated with late discharge were female sex, co-morbidities, major complications, self-expandable valve, general anesthesia, and a significant center effect. In contrast, history of previous pacemaker was a protective factor. The composite of death and re-admission in the very early and early versus late discharge groups was similar at 30 days (3.3% vs. 3.5%, p = 0.66). CONCLUSIONS: LOS is extremely variable after TF TAVR in France. Co-morbidities and complications were predictive factors of late discharge after TAVI. Interestingly, the use of self-expandable prosthesis and general anesthesia may also contribute to late discharge. Our results confirm that early discharge is safe.

Is coronary multivessel disease in acute myocardial infarction patients still associated with worse clinical outcomes at 1-year?

BACKGROUND: ST-elevation myocardial infarction (STEMI) patients with multivessel disease (MVD) are associated with a worse prognosis. However, few comparisons are available according to coronary status in the era of modern reperfusion and optimized secondary prevention. HYPOTHESIS: We hypothesized that the difference in prognosis according to number of vessel disease in STEMI patients has reduced. METHODS: All consecutive STEMI patients undergoing primary percutaneous coronary intervention (PCI) within 24 h of symptoms onset between January 1, 2014 and June 30, 2016 enrolled in the CRAC (Club Régional des Angioplasticiens de la région Centre) France PCI registry were analyzed. Baseline characteristics, management, and outcomes at 1-year were analyzed according to coronary status (one-, two-, and three-VD). RESULTS: A total of 1886 patients (mean age 62.2 ± 14.0 year; 74% of male) were included. Patients with MVD (two or three-VD) represented 53.7%. They were older with higher cardiovascular risk factor profile. At 1 year, the rate of major adverse cardiovascular events (MACE, defined as all-cause death, stroke or re-MI) was 10%, 12%, and 12% in one-, two, and three-VD respectively (p = .28). In multivariable adjusted Cox proportional hazard regression model, two- and three-VD were not associated with higher rate of MACE compared to patients with single VD (HR, 1.09; 95%CI 0.76-1.56 for two-VD; HR, 0.74; 95%CI 0.48-1.14 for three-VD). CONCLUSIONS: MVD still represents an important proportion of STEMI patients but their prognoses were not associated with worse clinical outcomes at 1-year compared with one-VD patients in a modern reperfusion area and secondary medication prevention.

Fractional Flow Reserve to Guide Treatment of Patients With Multivessel Coronary Artery Disease.

BACKGROUND: There is limited evidence that fractional flow reserve (FFR) is effective in guiding therapeutic strategy in multivessel coronary artery disease (CAD) beyond prespecified percutaneous coronary intervention or coronary graft surgery candidates. OBJECTIVES: The FUTURE (FUnctional Testing Underlying coronary REvascularization) trial aimed to evaluate whether a treatment strategy based on FFR was superior to a traditional strategy without FFR in the treatment of multivessel CAD. METHODS: The FUTURE trial is a prospective, randomized, open-label superiority trial. Multivessel CAD candidates were randomly assigned (1:1) to treatment strategy based on FFR in all stenotic (≥50%) coronary arteries or to a traditional strategy without FFR. In the FFR group, revascularization (percutaneous coronary intervention or surgery) was indicated for FFR ≤0.80 lesions. The primary endpoint was a composite of major adverse cardiac or cerebrovascular events at 1 year. RESULTS: The trial was stopped prematurely by the data safety and monitoring board after a safety analysis and 927 patients were enrolled. At 1-year follow-up, by intention to treat, there were no significant differences in major adverse cardiac or cerebrovascular events rates between groups (14.6% in the FFR group vs 14.4% in the control group; hazard ratio: 0.97; 95% confidence interval: 0.69-1.36; P = 0.85). The difference in all-cause mortality was nonsignificant, 3.7% in the FFR group versus 1.5% in the control group (hazard ratio: 2.34; 95% confidence interval: 0.97-5.18; P = 0.06), and this was confirmed with a 24 months' extended follow-up. FFR significantly reduced the proportion of revascularized patients, with more patients referred to exclusively medical treatment (P = 0.02). CONCLUSIONS: In patients with multivessel CAD, we did not find evidence that an FFR-guided treatment strategy reduced the risk of ischemic cardiovascular events or death at 1-year follow-up. (Functional Testing Underlying Coronary Revascularisation; NCT01881555).

Does helicopter transport delay prehospital transfer for STEMI patients in rural areas? Findings from the CRAC France PCI registry.

AIMS: The aim of this study was to analyse delays in emergency medical system transfer of ST-segment elevation myocardial infarction (STEMI) patients to percutaneous coronary intervention (PCI) centres according to transport modality in a rural French region. METHODS AND RESULTS: Data from the prospective multicentre CRAC / France PCI registry were analysed for 1911 STEMI patients: 410 transferred by helicopter and 1501 by ground transport. The primary endpoint was the percentage of transfers with first medical contact to primary percutaneous coronary intervention within the 90 minutes recommended in guidelines. The secondary endpoint was time of first medical contact to primary percutaneous coronary intervention. With helicopter transport, time of first medical contact to primary percutaneous coronary intervention in under 90 minutes was less frequently achieved than with ground transport (9.8% vs. 37.2%; odds ratio 5.49; 95% confidence interval 3.90; 7.73; P<0.0001). Differences were greatest for transfers under 50 km (13.7% vs. 44.7%; P<0.0001) and for primary transfers (22.4% vs. 49.6%; P<0.0001). The median time from first medical contact to primary percutaneous coronary intervention and from symptom onset to primary percutaneous coronary intervention (total ischaemic time) were significantly higher in the helicopter transport group than in the ground transport group (respectively, 137 vs. 103 minutes; P<0.0001 and 261 vs. 195 minutes; P<0.0001). There was no significant difference in inhospital mortality between the helicopter and ground transport groups (6.9% vs. 6.6%; P=0.88). CONCLUSIONS: Helicopter transport of STEMI patients was five times less effective than ground transport in maintaining the 90-minute first medical contact to primary percutaneous coronary intervention time recommended in guidelines, particularly for transfer distances less than 50 km.