Uninterrupted Direct-acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures

Summary

Up to 20-30% of patients who are candidates for direct oral anticoagulation (DOAC) present with concomitant ischemic heart disease and often require coronary angiography with or without percutaneous coronary intervention (PCI). The decision whether to continue the DOAC throughout periprocedural period or interrupt DOAC before planned procedure represents a substantial challenge in daily clinical practice. The objective of this study is to evaluate the safety of uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures.

Timeline

Start

2022-01-20

Primary completion

2024-02-20

Completion

2024-04-20

Outcome

Met primary endpoint

paper with the 1-sided upper 95% confidence limit (4.5%) being lower than the OPC of 4.6% (p = 0.045). PMID 40530906 ↗

paper The uninterrupted DOAC strategy was shown to be safe and met the pre-specified OPC PMID 40530906 ↗

Publications

• Background Valgimigli M, Frigoli E, Leonardi S, Rothenbuhler M, Gagnor A, Calabro P, Garducci S, Rubartelli P, Briguori C, Ando G, Repetto A, Limbruno U, Garbo R, Sganzerla P, Russo F, Lupi A, Cortese B, Ausiello A, Ierna S, Esposito G, Presbitero P, Santarelli A, Sardella G, Varbella F, Tresoldi S, de Cesare N, Rigattieri S, Zingarelli A, Tosi P, van 't Hof A, Boccuzzi G, Omerovic E, Sabate M, Heg D, Juni P, Vranckx P; MATRIX Investigators. Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes. N Engl J Med. 2015 Sep 10;373(11):997-1009. doi: 10.1056/NEJMoa1507854. Epub 2015 Sep 1.
• Results Lip GY, Huber K, Andreotti F, Arnesen H, Airaksinen KJ, Cuisset T, Kirchhof P, Marin F; European Society of Cardiology Working Group on Thrombosis. Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary intervention/ stenting. Thromb Haemost. 2010 Jan;103(1):13-28. doi: 10.1160/TH09-08-0580. Epub 2009 Sep 30.
• Results Kogame N, Guimaraes PO, Modolo R, De Martino F, Tinoco J, Ribeiro EE, Kawashima H, Ono M, Hara H, Wang R, Cavalcante R, Moulin B, Falcao BAA, Leite RS, de Almeida Sampaio FB, Morais GR, Meireles GC, Campos CM, Onuma Y, Serruys PW, Lemos PA. Aspirin-Free Prasugrel Monotherapy Following Coronary Artery Stenting in Patients With Stable CAD: The ASET Pilot Study. JACC Cardiovasc Interv. 2020 Oct 12;13(19):2251-2262. doi: 10.1016/j.jcin.2020.06.023. Epub 2020 Sep 16.
• Results Serruys PW, van Hout B, Bonnier H, Legrand V, Garcia E, Macaya C, Sousa E, van der Giessen W, Colombo A, Seabra-Gomes R, Kiemeneij F, Ruygrok P, Ormiston J, Emanuelsson H, Fajadet J, Haude M, Klugmann S, Morel MA. Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II). Lancet. 1998 Aug 29;352(9129):673-81. doi: 10.1016/s0140-6736(97)11128-x.
• Results Lip GYH, Collet JP, Haude M, Byrne R, Chung EH, Fauchier L, Halvorsen S, Lau D, Lopez-Cabanillas N, Lettino M, Marin F, Obel I, Rubboli A, Storey RF, Valgimigli M, Huber K; ESC Scientific Document Group. 2018 Joint European consensus document on the management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous cardiovascular interventions: a joint consensus document of the European Heart Rhythm Association (EHRA), European Society of Cardiology Working Group on Thrombosis, European Association of Percutaneous Cardiovascular Interventions (EAPCI), and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS), Latin America Heart Rhythm Society (LAHRS), and Cardiac Arrhythmia Society of Southern Africa (CASSA). Europace. 2019 Feb 1;21(2):192-193. doi: 10.1093/europace/euy174.
• Sanz-Sanchez J, Chiarito M, Calderon AT, Santos IA, Cao D, Jurado-Roman A, Montilla BV, Tartaglia F, Garrido PP, Nardin M, Romero JS, Vallinas-Hernandez S, Marquez DT, Carrasco-Moraleja M, Reimers B, Dolz LM, Diez-Gil JL, Stefanini G, Garcia-Garcia HM. Uninterrupted Direct-Acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures: The DOAC-NOSTOP. Catheter Cardiovasc Interv. 2025 Aug;106(2):1371-1377. doi: 10.1002/ccd.31691. Epub 2025 Jun 18.
• Teira Calderon A, Chiarito M, Santos IA, Cao D, Vaquerizo Montilla B, Jurado Roman A, Pulido Garrido P, Tartaglia F, Garcia-Garcia HM, Diez-Gil JL, Sanz-Sanchez J. Uninterrupted direct-acting oral anticoagulation in patients undergoing transradial percutaneous coronary procedures: The DOAC-NOSTOP study rationale and design. Cardiovasc Revasc Med. 2024 Jun;63:68-72. doi: 10.1016/j.carrev.2024.01.013. Epub 2024 Jan 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apixaban	Small molecule	—	Oral
Subject	Dabigatran	Unknown	—	Oral
Subject	Edoxaban	Small molecule	—	Oral
Subject	Rivaroxaban	Other / unclassified	—	Oral

Indications