Paul W A Janssen1, Joyce Peper1,2, Laura M Willemsen1, Mohamed A Soliman-Hamad3, Albert H M van Straten3, Patrick Klein4, Chris M Hackeng5, Uday Sonker4, Margreet W A Bekker6, Clemens von Birgelen7,8, Marc A Brouwer9, Pim van der Harst10,11, Eline A Vlot12, Vera H M Deneer13,14, Dean R P P Chan Pin Yin1, Marieke E Gimbel1, Kasper F Beukema1, Edgar J Daeter4, Johannes C Kelder1, Jan G P Tijssen15,16, Benno J W M Rensing1, Hendrik W van Es17, Martin J Swaans1, Jurrien M Ten Berg1,18. 1. Department of Cardiology (L.M.W., P.W.A.J., J.P., D.R.P.P.C.P.Y., M.E.G., K.F.B., J.C.K., B.J.W.M.R., M.J.S., J.M.t.B.), St Antonius Hospital, Nieuwegein, The Netherlands. 2. Department of Radiology (J.P.), University Medical Center Utrecht, Utrecht, The Netherlands. 3. Department of Cardiothoracic Surgery, Catharina Hospital, Eindhoven, The Netherlands (M.A.S.-H., A.H.M.v.S.). 4. Department of Cardiothoracic Surgery (P.K., U.S., E.J.D.), St Antonius Hospital, Nieuwegein, The Netherlands. 5. Department of Clinical Chemistry (C.M.H.), St Antonius Hospital, Nieuwegein, The Netherlands. 6. Department of Cardiothoracic Surgery, Erasmus MC, Rotterdam, The Netherlands (M.W.A.B.). 7. Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands (C.v.B.). 8. Health Technology and Services Research, University of Twente, Enschede, The Netherlands (C.v.B.). 9. Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands (M.A.B.). 10. Department of Cardiology (P.v.d.H.), University Medical Center Utrecht, Utrecht, The Netherlands. 11. Department of Cardiology, University Medical Center Groningen, The Netherlands (P.v.d.H.). 12. Department of Anesthesiology, Intensive Care, and Pain Medicine (E.A.V.), St Antonius Hospital, Nieuwegein, The Netherlands. 13. Department of Clinical Pharmacy, Division of Laboratories, Pharmacy, and Biomedical Genetics (V.H.M.D.), University Medical Center Utrecht, Utrecht, The Netherlands. 14. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands (V.H.M.D.). 15. Department of Cardiology, Amsterdam University Medical Centers, The Netherlands (J.G.P.T.). 16. Cardialysis B.V. Rotterdam, The Netherlands (J.G.P.T.). 17. Department of Radiology (H.W.v.E.), St Antonius Hospital, Nieuwegein, The Netherlands. 18. Cardiovascular Research Institute Maastricht, Maastricht, The Netherlands (J.M.t.B.).
Abstract
BACKGROUND: Approximately 15% of saphenous vein grafts (SVGs) occlude during the first year after coronary artery bypass graft surgery (CABG) despite aspirin use. The POPular CABG trial (The Effect of Ticagrelor on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting Surgery) investigated whether ticagrelor added to standard aspirin improves SVG patency at 1 year after CABG. METHODS: In this investigator-initiated, randomized, double-blind, placebo-controlled, multicenter trial, patients with ≥1 SVGs were randomly assigned (1:1) after CABG to ticagrelor or placebo added to standard aspirin (80 mg or 100 mg). The primary outcome was SVG occlusion at 1 year, assessed with coronary computed tomography angiography, in all patients that had primary outcome imaging available. A generalized estimating equation model was used to perform the primary analysis per SVG. The secondary outcome was 1-year SVG failure, which was a composite of SVG occlusion, SVG revascularization, myocardial infarction in myocardial territory supplied by a SVG, or sudden death. RESULTS: Among 499 randomly assigned patients, the mean age was 67.9±8.3 years, 87.1% were male, the indication for CABG was acute coronary syndrome in 31.3%, and 95.2% of procedures used cardiopulmonary bypass. Primary outcome imaging was available in 220 patients in the ticagrelor group and 223 patients in the placebo group. The SVG occlusion rate in the ticagrelor group was 10.5% (51 of 484 SVGs) versus 9.1% in the placebo group (43 of 470 SVGs), odds ratio, 1.29 [95% CI, 0.73-2.30]; P=0.38. SVG failure occurred in 35 (14.2%) patients in the ticagrelor group versus 29 (11.6%) patients in the placebo group (odds ratio, 1.22 [95% CI, 0.72-2.05]). CONCLUSIONS: In this randomized, placebo-controlled trial, the addition of ticagrelor to standard aspirin did not reduce SVG occlusion at 1 year after CABG. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02352402.
BACKGROUND: Approximately 15% of saphenous vein grafts (SVGs) occlude during the first year after coronary artery bypass graft surgery (CABG) despite aspirin use. The POPular CABG trial (The Effect of Ticagrelor on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting Surgery) investigated whether ticagrelor added to standard aspirin improves SVG patency at 1 year after CABG. METHODS: In this investigator-initiated, randomized, double-blind, placebo-controlled, multicenter trial, patients with ≥1 SVGs were randomly assigned (1:1) after CABG to ticagrelor or placebo added to standard aspirin (80 mg or 100 mg). The primary outcome was SVG occlusion at 1 year, assessed with coronary computed tomography angiography, in all patients that had primary outcome imaging available. A generalized estimating equation model was used to perform the primary analysis per SVG. The secondary outcome was 1-year SVG failure, which was a composite of SVG occlusion, SVG revascularization, myocardial infarction in myocardial territory supplied by a SVG, or sudden death. RESULTS: Among 499 randomly assigned patients, the mean age was 67.9±8.3 years, 87.1% were male, the indication for CABG was acute coronary syndrome in 31.3%, and 95.2% of procedures used cardiopulmonary bypass. Primary outcome imaging was available in 220 patients in the ticagrelor group and 223 patients in the placebo group. The SVG occlusion rate in the ticagrelor group was 10.5% (51 of 484 SVGs) versus 9.1% in the placebo group (43 of 470 SVGs), odds ratio, 1.29 [95% CI, 0.73-2.30]; P=0.38. SVG failure occurred in 35 (14.2%) patients in the ticagrelor group versus 29 (11.6%) patients in the placebo group (odds ratio, 1.22 [95% CI, 0.72-2.05]). CONCLUSIONS: In this randomized, placebo-controlled trial, the addition of ticagrelor to standard aspirin did not reduce SVG occlusion at 1 year after CABG. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02352402.
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