Methods

We prospectively compared 2 strategies of antiplatelet regimen using mono versus dual antiplatelet therapy in 362 consecutive patients enrolled in the FRANCE 2 TAVI registry from January 2010 and December 2011 in 3 French tertiary centers (Clinique Saint Gatien, Tours; European Georges Pompidou Hospital, Paris; and University Hospital of Rouen, Rouen).

On the basis of criteria specified by the French Ministry of Health, patients included in the registry were symptomatic adults with severe aortic stenosis who were not candidate for surgical aortic valve replacement because of coexisting illnesses. Severe aortic stenosis was defined as an aortic valve area of <0.8 cm ² , a mean aortic gradient of ≥40 mm Hg, or a peak aortic jet velocity of ≥4.0 m/s. All patients had New York Heart Association class II, III, or IV symptoms. All patients who had undergone implantation on the basis of these criteria were included in the registry without the use of exclusion criteria. At each center, a multidisciplinary team determined eligibility for TAVI on the basis of systematic clinical evaluation, angiographic assessment, computed tomography, and echocardiography. Criteria for the use of nontransfemoral approaches were based on the diameter, degree of tortuosity, and atheroma of the aortoiliofemoral arterial tree, as assessed by computed tomography. SAPIEN devices (Edwards Lifesciences, Irvine, California) were implanted by either the transfemoral or the transapical route in 3 centers, whereas transfemoral or subclavian route was used for CoreValve devices (Medtronic, Minneapolis, Minnesota) in only 2 centers, as previously described.

All patients provided written informed consent before undergoing the procedure.

Of 362 patients included in the 3 centers, 70 were pretreated by the combination of aspirin and clopidogrel before TAVI and were thus excluded from this study. In the remaining 292 patients, 2 antiplatelet strategies, as summarized in Table 1 , were compared. A strategy using monoantiplatelet therapy (aspirin or clopidogrel antiplatelet therapy alone, group A) was prospectively and consecutively adopted in 2 centers for all the TAVI procedures since January 2010 (Clinique Saint Gatien, Tours and European Georges Pompidou Hospital, Paris). In naive antiplatelet therapy patients, aspirin alone (75 mg) was introduced the day before TAVI and followed lifelong. In patients previously treated by aspirin, aspirin alone was continued during and after TAVI. In patients previously treated by clopidogrel, clopidogrel was continued during TAVI without either additional loading dose the day before TAVI or association with aspirin.

The second strategy using common dual antiplatelet therapy (group B) was systematically adopted in the University Hospital of Rouen. A 300-mg loading dose of clopidogrel was systematically administered on the day before TAVI in all the transfemoral procedures followed by a 1-month maintenance dose of 75 mg/day plus aspirin 75 mg/day lifelong. In transapical cases, no loading dose of clopidogrel was administered before TAVI, and 1-month maintenance dose of 75 mg/day was introduced the day after TAVI in association with 75 mg/day of aspirin lifelong. Patients previously treated by clopidogrel were not reloaded for transfemoral procedures.

In patients previously treated by vitamin K antagonist (VKA), VKA was stopped 3 to 5 days before TAVI to obtain an international normalized ratio of <1.5 and was reintroduced 1 or 2 days after TAVI in both groups. In group B, patients received a 300 mg loading dose of clopidogrel the day before TAVI without additional maintenance dose after TAVI and 75 mg/day of aspirin during 1 month in association with VKA.

Finally, procedural parenteral anticoagulation consisted of a 70-IU/kg bolus of unfractionated heparin in both groups.

The procedural characteristics for the 2 prostheses have been described previously. Transarterial access was obtained percutaneously or after surgical cutdown. The femoral access was closed percutaneously (Prostar XL; Abbott Vascular, Chicago, Illinois) or surgically. The choice between general and local anesthesia for transfemoral implantation was left up to the individual teams.

The primary end point was a combination of mortality, major stroke, life-threatening bleeding (LTB), myocardial infarction, and major vascular complications at 30 days.

Secondary 30-day end points were transfusion, any vascular complication, any stroke, any bleeding, acute kidney injury, and success rate. All adverse events were adjudicated according to the Valve Academic Research Consortium. Data were recorded on a standardized electronic case report form and sent to a central database (Axonal) over the Internet. Data from 3 of the 34 centers participating in the FRANCE 2 TAVI registry were obtained for this study. Database quality control was performed by checking data against source documents for 10% of patients in randomly selected centers, as previously described.

Statistical analysis was performed using SPSS software (version 17.0; SPSS Inc., Chicago, Illinois). Discrete variables are expressed as percentages, and quantitative variables are expressed as mean ± SD. Comparisons were made with chi-square or Fisher’s exact test for discrete variables and by unpaired Student t and Wilcoxon signed-rank tests for continuous variables, when appropriate. A backward logistic regression multivariate analysis was used to assess independent correlates of the primary combined end point. The model was built on the basis of the univariate association between the variable and the primary combined end point with a p = 0.05 and an elimination p = 0.10. All the variables listed in Tables 2 to 4 and the strategies of antiplatelet therapy were tested. In addition, a propensity score for getting mono rather than dual antiplatelet therapy strategy was calculated using multiple logistic regressions. The propensity score was used as a covariate, together with the strategy used, in a further backward logistic regression multivariate analysis of the primary end point. The propensity score was also used to match 2 cohorts of patients, one receiving mono and the other dual antiplatelet therapy. Comparison between propensity score–matched cohorts used paired Student t tests for continuous variables and McNemar tests for discrete variables. For all analyses, a p value <0.05 was considered significant.

Table 4

End points in the overall cohort

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