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Observational Study
. 2025 Sep 22;11(6):524-531.
doi: 10.1093/ehjcvp/pvaf049.

Single vs. dual antiplatelet therapy in patients with severe peripheral arterial disease undergoing transcatheter aortic valve implantation: insights from the Hostile registry

Mattia Galli  1   2 , Roberto Nerla  2 , Fausto Castriota  2 , Francesco Saia  3   4 , Won-Keun Kim  5 , Alessandro Iadanza  6 , Ole De Backer  7 , Francesco Burzotta  8   9 , Nicolas M Van Mieghem  10 , Thomas Pilgrim  11 , Giuseppe Musumeci  12 , Max M Meertens  13 , Michael Joner  14 , Francesco Meucci  15 , Stefan Toggweiler  16 , Luca Testa  17 , Sergio Berti  18 , Matteo Montorfano  19   20 , Daniel Braun  21 , Marco De Carlo  22 , Marco Barbanti  23   24 , Giulio Stefanini  25   26 , Georg Nickenig  27 , Tommaso Piva  28 , Azeem Latib  29 , Italo Porto  30   31 , Ran Kornowski  32 , Antonio L Bartorelli  33 , Mohamed Abdel-Wahab  34 , Tullio Palmerini  3   4
Affiliations
Observational Study

Single vs. dual antiplatelet therapy in patients with severe peripheral arterial disease undergoing transcatheter aortic valve implantation: insights from the Hostile registry

Mattia Galli et al. Eur Heart J Cardiovasc Pharmacother. .

Abstract

Aims: Single antiplatelet therapy (SAPT) has been shown to be a safer alternative to dual antiplatelet therapy (DAPT) in patients without atrial fibrillation (AF) undergoing transcatheter aortic valve implantation (TAVI). However, antithrombotic therapy for TAVI patients with severe peripheral artery disease (PAD) remains an underexplored area. This study aimed to evaluate and compare the outcomes of SAPT and DAPT in this high-risk patient population.

Methods and results: The HOSTILE registry was a multicentre, international, observational study including 1707 consecutive patients with hostile femoral access undergoing TAVI in 28 international centres. Among 573 patients without AF treated through transfemoral or non-thoracic alternative approach, 144 received SAPT and 429 DAPT after TAVI. The primary efficacy endpoint was the propensity-adjusted rate of major adverse cardiovascular events (MACE), a composite of cardiovascular death, myocardial infarction, stroke, or transient ischaemic attack. The primary safety endpoint was the propensity-adjusted rate of major bleeding. Outcomes were reported at 30 days and 12 months. Dual antiplatelet therapy was associated with a non-significant reduction in MACE at 30 days [hazard ratio (HR) 0.74, 95% confidence interval (CI) 0.25-2.18; P = 0.59] and at 12 months (HR 0.89, 95% CI 0.35-2.24; P = 0.80) compared with SAPT, but with a significant interaction between antiplatelet strategy and PAD severity (P = 0.01), suggesting a greater benefit of DAPT in patients with a high PAD severity. Dual antiplatelet therapy was associated with reduced all-cause death at 12 months (HR 0.22, 95% CI 0.10-0.47; P < 0.001) but not at 30 days (HR 0.26, 95% CI 0.05-1.22; P = 0.09) compared with SAPT. There was no difference in major bleeding at 30 days (P = 0.13) or 12 months (P = 0.10) between groups. There were no differences between groups in any bleeding at 30 days (P = 0.16) or 12 months (P = 0.17).

Conclusion: In TAVI patients with severe PAD, DAPT was associated with a trend towards improved outcomes compared with SAPT, particularly in those with higher PAD severity. These findings, including the observed reduction in 1-year mortality with DAPT, warrant further investigation in prospective studies.

Keywords: Dual antiplatelet therapy; Peripheral artery disease; Single antiplatelet therapy; Transcatheter aortic valve implantation.

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Conflict of interest statement

Conflict of interest: M.G. declares that he has received consulting fees from Werfen and Genomadix; He is the PI of the following active grant: Sapienza University of Rome (Grant protocol n. 3 RG1241910F5A1A50). A.L. received consultant and or advisory board for Medtronic, Abbott, Edwards, Boston Scientific, Philipps, and Anteris. I.P. reports consultant or speaker fees (minor) from Medtronic, Siemens, GE, ABIOMED, Philips, Sanofi, Amgen, Daiichi-Sankyo, Astra Zeneca, Bayer, and PIAM, not related to this work. F.B. discloses to have received speaker's fees from Abbott, Abiomed, Edwards, Medtronic, Terumo. R.N. has received honoraria from Medtronic. F.C. has received honoraria from Medtronic, Abbott, Terumo, and Boston Scientific. S.T. has received honoraria from Medtronic, Boston Scientific, Biosensors, Edwards Lifesciences, Hi-D Imaging, Abbott Vascular, Medira, Shockwave, Teleflex, atHeart Medical, Cardiac Dimensions, Polares Medical, Amarin, Sanofi, AstraZeneca, ReCor Medical, Daiichi Sankyo, Bayer, and Armira, has received institutional research grants from Edwards Lifesciences, Abbott Vascular, Boston Scientific, Fumedica, Novartis, Boehringer Ingelheim, and Polares Medical, holds equity in Hi-D Imaging, and serves as a steering committee group member for Boston Scientific. D.B. has received institutional research grants and consulting fees from Abbott, Boston Scientific, and Medtronic. M.D.C. has received speaker fees from Medtronic and Meril and advisory board fees from Sanofi. M.B. has worked as consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. The remaining authors have nothing to declare.

Figures

Figure 1
Figure 1
Study flowchart. TAVI, transcatheter aortic valve implantation; AF, atrial fibrillation; DAPT, dual antiplatelet therapy; IPTW, inverse probability of treatment weighting; nTAA, non-thoracic alternative access (non-femoral, non-thoracic); SAPT, single antiplatelet therapy; TFA, transfemoral access; TTA, transthoracic access.
Figure 2
Figure 2
Antithrombotic therapy regimens used after transcatheter aortic valve implantation. DAPT, dual antiplatelet therapy; DAT, dual antithrombotic therapy; OAC, oral anticoagulant therapy; SAPT, single antiplatelet therapy; TAT, triple antithrombotic therapy.
Figure 3
Figure 3
Weighted Kaplan–Meier curves of major adverse cardiovascular events and major bleeding at 30 days (A) and 12 months (B). DAPT, dual antiplatelet therapy; MACE, major adverse cardiovascular events; HR, hazard ratio; CI, confidence interval; SAPT, single antiplatelet therapy.
Figure 4
Figure 4
Weighted Kaplan–Meier curves of all-cause death at 30 days (A) and 12 months (B). DAPT, dual antiplatelet therapy; MACE, major adverse cardiovascular events; HR, hazard ratio; CI, confidence interval; SAPT, single antiplatelet therapy.
See this image and copyright information in PMC

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