Faisal Latif1,2, Lauren Uyeda3, Robert Edson3, Deepak L Bhatt4,5,6, Steven Goldman7, David R Holmes8, Sunil V Rao9, Kendrick Shunk10, Kul Aggarwal11,12, Barry Uretsky13,14, Islam Bolad15,16, Khaled Ziada17, Edward McFalls18,19, Anand Irimpen20,21, Huu Tam Truong22, Scott Kinlay3, Vasilios Papademetriou23,24, Raghava S Velagaleti4, Bavana V Rangan25, Kreton Mavromatis26,27, Mei-Chiung Shih3, Subhash Banerjee28,29, Emmanouil S Brilakis25,30,31. 1. VA Medical Center, Oklahoma City (F.L.). 2. University of Oklahoma, Oklahoma City (F.L.). 3. VA Cooperative Studies Program Coordinating Center, Mountain View, CA (L.U., R.E., M.-C.S.). 4. VA Boston Healthcare System, MA (D.L., S.K., R.S.V). 5. Brigham and Women's Hospital Heart & Vascular Center, Boston, MA (D.L.B.). 6. Harvard Medical School, Boston, MA (D.L.B.). 7. University of Arizona Sarver Heart Center, Tucson (S.G.). 8. Mayo Clinic, Rochester, MN (D.R.H.). 9. Durham VA Medical Center, NC (S.V.R.). 10. San Francisco VA Medical Center, CA (K.S.). 11. Harry S Truman VA Hospital, Columbia, MO (K.A.). 12. University of Missouri Healthcare, Columbia (K.A.). 13. Central Arkansas Veterans Health System, Little Rock (B.U.). 14. University of Arkansas for Medical Sciences, Little Rock (B.U.). 15. Indiana University School of Medicine, Indianapolis (I.B.). 16. Roudebush VA Medical Center, Indianapolis, Indiana (I.B.). 17. University of Kentucky, Lexington (K.Z.). 18. VA Medical Center, Minneapolis, MN (E.M.). 19. University of Minnesota, Minneapolis (E.M.). 20. Southeast Louisiana Veterans Health Care System, New Orleans (A.I.). 21. Tulane University Heart and Vascular Institute, New Orleans, LA (A.I.). 22. VA Loma Linda Medical Center, CA (H.T.T.). 23. VA Medical center Washington DC (V.P.). 24. Georgetown University, Washington DC (V.P.). 25. Minneapolis Heart Institute Foundation, MN (B.V.R., E.S.B.). 26. Atlanta VA Healthcare System, GA (K.M.). 27. Emory University, Atlanta, GA (K.M.). 28. Dallas VA Medical Center, TX (S.B.). 29. University of Texas Southwestern Medical Center, Dallas (S.B.). 30. Minneapolis Heart Institute, MN (E.S.B.). 31. Abbott Northwestern Hospital, Minneapolis, MN (E.S.B.).
Abstract
BACKGROUND:Direct stenting without pre-dilation or post-dilation has been advocated for saphenous vein graft percutaneous coronary intervention to decrease the incidence of distal embolization, periprocedural myocardial infarction, and target lesion revascularization. METHODS: We performed a post hoc analysis of patients enrolled in theDIVA (Drug-Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Angioplasty; NCT01121224) prospective, double-blind, randomized controlled trial. Patients were stratified into stent-only and balloon-stent groups. Primary end point was 12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization). Secondary end points included all-cause death, stent thrombosis, myocardial infarction, and target lesion revascularization during follow-up. RESULTS: Of the 575 patients included in this substudy, 185 (32%) patients underwent stent-only percutaneous coronary intervention. Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86-2.08]; P=0.19). During long-term follow-up (median of 2.7 years), the incidence of definite stent thrombosis (1% versus 5%; hazard ratio, 9.20 [95% CI, 1.23-68.92]; P=0.0085), the composite of definite or probable stent thrombosis (5% versus 11%; hazard ratio, 2.52 [95% CI, 1.23-5.18]; P=0.009), and target vessel myocardial infarction (8% versus 14%; hazard ratio, 1.92 [95% CI, 1.08-3.40]; P=0.023) was lower in the stent-only group. Multivariable analysis showed that a higher number of years since coronary artery bypass grafting and >1 target saphenous vein graft lesions were associated with increased target vessel failure during entire follow-up, while preintervention Thrombolysis in Myocardial Infarction-3 flow was protective. CONCLUSIONS: In patients undergoing percutaneous coronary intervention of de novo saphenous vein graft lesions, there was no difference in target vessel failure at 12 months and long-term follow-up in the stent-only versus the balloon-stent group; however, the incidence of stent thrombosis was lower in the stent-only group, as was target vessel myocardial infarction. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01121224.
RCT Entities:
BACKGROUND: Direct stenting without pre-dilation or post-dilation has been advocated for saphenous vein graft percutaneous coronary intervention to decrease the incidence of distal embolization, periprocedural myocardial infarction, and target lesion revascularization. METHODS: We performed a post hoc analysis of patients enrolled in the DIVA (Drug-Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Angioplasty; NCT01121224) prospective, double-blind, randomized controlled trial. Patients were stratified into stent-only and balloon-stent groups. Primary end point was 12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization). Secondary end points included all-cause death, stent thrombosis, myocardial infarction, and target lesion revascularization during follow-up. RESULTS: Of the 575 patients included in this substudy, 185 (32%) patients underwent stent-only percutaneous coronary intervention. Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86-2.08]; P=0.19). During long-term follow-up (median of 2.7 years), the incidence of definite stent thrombosis (1% versus 5%; hazard ratio, 9.20 [95% CI, 1.23-68.92]; P=0.0085), the composite of definite or probable stent thrombosis (5% versus 11%; hazard ratio, 2.52 [95% CI, 1.23-5.18]; P=0.009), and target vessel myocardial infarction (8% versus 14%; hazard ratio, 1.92 [95% CI, 1.08-3.40]; P=0.023) was lower in the stent-only group. Multivariable analysis showed that a higher number of years since coronary artery bypass grafting and >1 target saphenous vein graft lesions were associated with increased target vessel failure during entire follow-up, while preintervention Thrombolysis in Myocardial Infarction-3 flow was protective. CONCLUSIONS: In patients undergoing percutaneous coronary intervention of de novo saphenous vein graft lesions, there was no difference in target vessel failure at 12 months and long-term follow-up in the stent-only versus the balloon-stent group; however, the incidence of stent thrombosis was lower in the stent-only group, as was target vessel myocardial infarction. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01121224.
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