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Standardized Technique of Aortic Valve Re-implantation for Valve-sparing Aortic Root Replacement
Published on: December 11, 2017
Usefulness of Clopidogrel Loading in Patients Who Underwent Transcatheter Aortic Valve Implantation (from the BRAVO-3
Vincent Johan Nijenhuis1, Jurrien Maria Ten Berg1, Christian Hengstenberg2
1Department of Cardiology, St. Antonius hospital, Nieuwegein, the Netherlands.
Insights
Initiating clopidogrel with a loading dose (LD) before transcatheter aortic valve implantation (TAVI) did not improve outcomes but increased vascular complications. No significant difference in major adverse cardiovascular events or bleeding was observed between LD and no LD groups.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- P2Y12-inhibitor initiation with clopidogrel loading dose (LD) rapidly inhibits platelet activation and reduces ischemic events post-coronary stenting.
- The efficacy of clopidogrel LD in transcatheter aortic valve implantation (TAVI) patients remains unclear.
Purpose of the Study:
- To evaluate the impact of preprocedural clopidogrel LD versus no LD on 48-hour and 30-day clinical outcomes after TAVI.
- To assess the association between clopidogrel LD and major adverse cardiovascular events, major bleeding, and major vascular complications in TAVI patients.
Main Methods:
- Analysis of 802 patients from the BRAVO-3 trial who underwent transfemoral TAVI.
- Stratification of patients into clopidogrel LD (n=294) and no LD (n=508) groups based on physician discretion.
- Comparison of clinical outcomes, including major adverse cardiovascular events, major bleeding, and major vascular complications, between the two groups.
Main Results:
- Clopidogrel LD was associated with a higher rate of major vascular complications (11.9% vs 7.1%, p=0.02).
- No significant differences were observed in major adverse cardiovascular events (4.1% vs 4.1%, p=0.97) or major bleeding (8.5% vs 7.7%, p=0.68) between LD and no LD groups.
- Multivariable analysis confirmed clopidogrel LD did not significantly affect clinical events, including major vascular complications (OR 0.91, 95% CI 0.60-1.39, p=0.67).
Conclusions:
- In TAVI patients, preprocedural clopidogrel LD is linked to increased vascular complications without improving other clinical outcomes.
- Routine use of clopidogrel LD in TAVI patients is not supported by these findings.
- Further research may be needed to optimize P2Y12 inhibitor strategies in TAVI.
Abstract:
P2Y12-inhibitor initiation with clopidogrel using a loading dose (LD) versus no LD (NLD) provides more rapid inhibition of platelet activation and reduced risk of ischemic events after coronary stenting. Whether a similar beneficial effect is achieved in the setting of transcatheter aortic valve implantation (TAVI) is unknown. We evaluate the effects of preprocedural clopidogrel LD versus no NLD on 48-hour and 30-day clinical outcomes after TAVI. In the BRAVO-3 trial, 802 patients with severe aortic stenosis who underwent transfemoral TAVI were randomized to intraprocedural anticoagulation with bivalirudin or unfractionated heparin. Administration of clopidogrel LD was left to the discretion of the treating physician. For this analysis, patients were stratified according to receiving clopidogrel LD (n = 294, 36.6%) or NLD (n = 508, 63.4%) before TAVI. LD patients more often received a self-expandable prosthesis using larger sheaths. P2Y12-inhibitor maintenance therapy pre-TAVI was similar in patients with LD versus NLD (28.2% vs 33.1%, p = 0.16). LD versus NLD was associated with similar incidences of major adverse cardiovascular events (i e., death, myocardial infarction, or stroke) (4.1% vs 4.1%, p = 0.97) and major bleeding (8.5% vs 7.7%, p = 0.68), but a higher rate of major vascular complications (11.9% vs 7.1%, p = 0.02). Multivariable adjustment showed that clopidogrel LD did not affect any of the studied clinical events, including major vascular complications (odds ratio 0.91, 95% confidence interval 0.60 to 1.39, p = 0.67). Also patients on clopidogrel maintenance therapy and thus considered in steady state were not at reduced risk of major adverse cardiovascular events compared with patients not on clopidogrel (3.7% vs 5.2%, p = 0.36). In conclusion, in patients who underwent TAVI, use of clopidogrel LD was associated with higher vascular complications and otherwise similar clinical events compared to NLD patients.
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