What is the clinical evidence from this study?

Study design: Cohort. Population: Severe mitral regurgitation (n=609). Intervention: Oral anticoagulant (OAC) monotherapy vs. OAC plus single or dual antiplatelet therapy. Primary outcome: All-cause mortality (HR 0.6, 95% CI 0.5-0.9, p=0.04).

What does this research mean for the field?

In patients undergoing transcatheter edge-to-edge mitral valve repair (TEER) who have an indication for oral anticoagulation, OAC monotherapy is associated with a significantly decreased risk of long-term all-cause mortality compared to regimens that include additional antiplatelet therapy. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

October 25, 2022Open Access

Antithrombotic Treatment and Its Association with Outcome in a Multicenter Cohort of Transcatheter Edge-to-Edge Mitral Valve Repair Patients

CWChristian WaechterElectrophysiology FAFelix AusbuettelPhilipps University of Marburg GCGeorgios ChatzisPhilipps University of Marburg

Key Result

In patients undergoing transcatheter edge-to-edge mitral valve repair, OAC monotherapy was associated with a decreased risk of all-cause mortality (HR 0.6; 95% CI 0.5-0.9; p=0.04).

Study Design

Type

Cohort (n=609)

Multicenter

Yes

Structured PICO

Does OAC monotherapy improve long-term outcomes compared to other antithrombotic regimens in patients undergoing TEER with an indication for OAC?

Population

609 patients successfully treated with transcatheter edge-to-edge mitral valve repair for severe mitral regurgitation, followed for a median of 419 days.

Exposure

Postprocedural antithrombotic therapy (ATT) regimens, including OAC monotherapy, OAC + single antiplatelet therapy (SAPT), OAC + dual antiplatelet therapy (DAPT), DAPT alone, SAPT alone, or no APT.

Comparator

Different antithrombotic therapy regimens compared against each other (e.g., OAC monotherapy vs. OAC + antiplatelet therapy).

Outcome

In-hospital mortality, rate of major adverse cardiac and cerebrovascular events (MACCE), and all-cause mortality at median 419 days follow-up.hard clinical

In patients undergoing TEER who have an indication for oral anticoagulation, OAC monotherapy is associated with a lower risk of long-term all-cause mortality compared to regimens adding antiplatelet therapy.

Main Result

Hazard Ratio: 0.6 (95% CI 0.5–0.9)

p-value: p=0.04

Abstract

Transcatheter edge-to-edge mitral valve repair (TEER) has become established as a safe and efficacious therapy for severe mitral regurgitation (MR) in high-risk patients. Despite its widespread use, postprocedural antithrombotic therapy (ATT) still to date is based on local expertise rather than evidence. In a multicenter, observational cohort study, 646 consecutive patients undergoing TEER were enrolled; 609 patients were successfully treated and antithrombotic therapy analyzed; 449 patients (73.7%) were previously treated with oral anticoagulants (OAC) due to the high prevalence of atrial fibrillation (459/609, 75.4%). Postprocedural ATT in patients previously treated with OAC consisted of no additional, additional single (SAPT) or dual antiplatelet therapy (DAPT) in 146/449 (33.6%), 248/449 (55.2%) and 55/449 (12.2%), respectively. There were 234/449 (52.1%) patients treated with vitamin-k antagonists (VKA) and 215/449 (47.9%) with nonvitamin-k antagonist oral anticoagulants (NOAC). One hundred sixty patients (26.3%) had no prior indication for OAC and were predominantly treated with DAPT (132/160, 82.5%). Use of SAPT (17/160, 10.6%) and no APT (11/160, 6.9%) was marginal. No statistically significant differences in terms of in-hospital mortality or the rate of major adverse cardiac and cerebrovascular events (MACCE) between the different antithrombotic therapy regimens were observed. Multiple Cox regression analysis showed a statistically significant decreased risk for all-cause mortality after a median follow-up of 419 days for OAC monotherapy (HR 0.6, 95%-CI 0.5–0.9, p = 0.04). This study provides evidence for a more favorable long-term outcome of OAC monotherapy in patients with an indication for OAC and reiterates the urgent need for randomized controlled trials on the optimal antithrombotic treatment of TEER patients.

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