The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828).

Aim of FAST-MI 2010To gather data on characteristics, management and outcomes of patients hospitalised for acute myocardial infarction (AMI) at the end of 2010 in France.InterventionsTo provide cardiologists and health authorities national and regional data on AMI management every 5 years.SettingMetropolitan France. 213 academic (n=38), community (n=110), army hospitals (n=2), private clinics (n=63), representing 76% of centres treating AMI patients. Inclusion from 1 October 2010.PopulationConsecutive patients included during 1 month, with a possible extension of recruitment up to one additional month (132 centres); 4169 patients included over the entire recruitment period, 3079 during the first 31 days; 249 additional patients declining participation (5.6%).StartpointsConsecutive adults with ST-elevation and non-ST-elevation AMI with symptom onset ≤48 h. Patients with AMI following cardiovascular procedures excluded.Data captureWeb-based collection of 385 items (demographic, medical, biologic, management data) recorded online from source files by external research technicians; case-record forms with automatic quality checks. Centralised biology in voluntary centres to collect DNA samples and serum. Long-term follow-up organised centrally with interrogation of municipal registry offices, patients' physicians, and direct contact with the patients.Data qualityData management in Toulouse University. Statistical analyses: Université Paris Descartes, Université de Toulouse, Université Pierre et Marie Curie-Paris 06, Paris.Endpoints and linkages to other dataIn-hospital events; cardiovascular events, hospital admissions and mortality during follow-up. Linkage with Institute for National Statistics.Access to dataAvailable for research to any participating clinician upon request to executive committee (fastmi2010@yahoo.fr).

Background-Clopidogrel requires metabolic activation by cytochrome P450 2C19 (CYP2C19). Proton pump inhibitors(PPIs) that inhibit CYP2C19 are commonly coadministered with clopidogrel to reduce the risk of gastrointestinal bleeding. This analysis compares treatment outcomes for patients in the French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) who did or did not receive clopidogrel and/or PPIs. Methods and Results-The FAST-MI registry included 3670 patients (2744 clopidogrel-and PPI-naïve patients) presenting with definite MI. Patients were categorized according to use of clopidogrel and/or PPI within 48 hours after hospital admission. PPI use was not associated with an increased risk for any of the main in-hospital events (in-hospital survival, reinfarction, stroke, bleeding, and transfusion). Likewise, PPI treatment was not an independent predictor of 1-year survival (hazard ratio, 0.97; 95% confidence interval [CI], 0.87 to 1.08; Pϭ0.57) or 1-year MI, stroke, or death (hazard ratio, 0.98; 95% CI, 0.90 to 1.08; Pϭ0.72). No differences were seen when the type of PPI or CYP2C19 genotype was taken into account. In the propensity-matched cohorts, the odds ratios for major in-hospital events in PPI versus no PPI were 0.29 (95% CI, 0.06 to 1.44) and 1.70 (95% CI, 0.10 to 30.3) for patients with 1 and 2 variant alleles, respectively. Similarly, the hazard ratio for 1-year events in hospital survivors was 0.68 (95% CI, 0.26 to 1.79) and 0.55 (95% CI, 0.06 to 5.30), respectively. Conclusion-PPI use was not associated with an increased risk of cardiovascular events or mortality in patients administered clopidogrel for recent MI, whatever the CYP2C19 genotype, although harm could not be formally excluded in patients with 2 loss-of-function alleles. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00673036. Editorial see p 468 Clinical Perspective on p 482Recent pharmacokinetic and pharmacodynamic studies have investigated the effect of concomitant PPI therapy on the antiplatelet response elicited by clopidogrel. 6 -12 Overall, these studies showed that the coadministration of omeprazole, one of the most potent inhibitors of CYP2C19, was associated with reduced platelet inhibition compared with clopidogrel alone 6,7,10 and that PPI use overall was associated with increased platelet aggregation and was an independent predictor of high residual platelet reactivity in patients receiving clopidogrel. 8,9 However, studies also suggest that less potent inhibitors of CYP2C19 such as pantoprazole do not affect the platelet response to clopidogrel. 11,12 Although a reduction in platelet inhibition would be expected to manifest as a reduction in the clinical efficacy of clopidogrel therapy, recent clinical outcome studies have reported conflicting results. Several small studies [13][14][15] and retrospective analyses of 3 larger population-based studies 16 -18 8,19,20 In light of these conflicting results from controlled clinical trials, further lar...