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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.
The study design is an investigator-initiated, single-arm, open-label, pilot study in patients treated with DOAC undergoing trans-radial percutaneous coronary procedures.
Because of the exploratory nature of this study, no formal sample size calculations are required. On the basis of previous pilot studies with similar designs, a sample of 200 patients is planned; with a safety stopping rule based on the occurrence of BARC type 3 or 5 bleeding. In the present trial, if during the enrollment period more than 3 cases of BARC 3 or 5 bleeding occur up to 30-day follow-up, patient recruitment will be terminated. This number is based on the reported 1.6% BARC type 3 or 5 bleeding in patients undergoing transradial percutaneous coronary procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uninterruped direct-acting oral anticoagulation | Experimental | Uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct-acting oral anticoagulation | Drug | Apixaban Dabigatran Edoxaban Rivaroxaban |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 | 30-day follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of BARC type 3, or 5 | 30-day follow-up | |
| Rate of all-cause death | 30-day follow-up | |
| Rate of cardiac death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorge Sanz Sanchez, MD, PhD | Contact | 440087 | sjorge4@gmx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas Research Hospital | Not yet recruiting | Rozzano | Milan | 20089 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26324049 | 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. | |
| 20062939 |
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The data that support the findings of this study will be available from the corresponding author on reasonable request.
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| 30-day follow-up |
| Rate of stroke | 30-day follow-up |
| Rate of myocardial infarction | 30-day follow-up |
| Rate of definite/probable stent thrombosis | 30-day follow-up |
| Rate of definite stent thrombosis | 30-day follow-up |
| Rate of target-lesion revascularization | 30-day follow-up |
| Rate of target-vessel revascularization | 30-day follow-up |
| Hospital del Mar | Recruiting | Barcelona | Spain |
|
| Hospital La Paz | Recruiting | Madrid | Spain |
|
| Hospital Universitario y Politécnico La Fe | Recruiting | Valencia | 46026 | Spain |
|
| Result |
| 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. |
| 32950419 | Result | 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. |
| 9728982 | Result | 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. |
| 30052888 | Result | 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. |
| 40530906 | Derived | 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. |
| 38307792 | Derived | 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. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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