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Transcatheter aortic valve implantation (TAVI) has become a valid alternative over surgical replacement for the treatment of severe symptomatic aortic stenosis. After the procedure, a regimen of dual antiplatelet therapy with ASA and clopidogrel is a common practice used to reduce the incidence of ischemic events, at the cost of a major bleeding risk. The lack of common guidelines on the use of antiplatelet therapy after TAVI procedures is mainly due to the absence of scientific data coming from adeguate RCTs, comparing dual versus monotherapy. We sought to test the non-inferiority of a single antiplatelet regimen vs a dual antiplatelet therapy in patients undergone to TAVI in our institute.
Materials and Methods
This was a retrospective study comparing 120 patients, selected from the PARMA-TAVI registry from 2009 to 2015, who were divided into two cohorts, one in which patients were discharged with a regimen of three months dual antiplatelet therapy (DAPT) and one with a regimen of single antiplatelet therapy(SAPT). Atrial fibrillation and/or concomitant use of oral anticoagulant was an exclusion criteria. Baseline characteristics of the patients were well balanced in the two cohorts.
According to the protocol used in our institute, patient undergone to transfemoral aortic replacement were discharged with a three months of DAPT of aspirin and clopidogrel followed from a aspirin alone therapy. Conversely, patients undergone to valve replacement trough transapical access were discharged with a protocol of aspirin alone therapy for six months.
Different devices were utilized for the transfemoral TAVI: 33 Edward Sapien; 19 Core valve; 4 Portico, 1 Lotus and 1 direct flow. Edward Sapien was the only kind of valve used for the transapical group. Primary endpoint was a composite of all cause death, cardiovascular death, bleedings, vascular complications and cerebrovascular accidents at 30 days of follow-up, according to VARC-2 definitions.
We calculated the OR (odds ratio) with 95% confidence interval of the primary endpoint, and the cumulative incidences of time to event endpoints were calculated using the Kaplan-Meier method with median follow up analysis.
No significant difference, was found in the OR for the total VARC events as for total bleedings events. The incidence of ischemic events (stroke) didn’t statistically differ over the two groups.
For the time to event endpoints for the VARC composite endpoints, no statistical differences were found between the two cohort.