Sealing Intermediate Nonobstructive Coronary Saphenous Vein Graft Lesions With Drug-Eluting Stents as a New Approach to Reducing Cardiac Events: A Randomized Controlled Trial.
The objective of this study was to assess the efficacy of sealing intermediate nonobstructive coronary saphenous vein graft (SVG) lesions with drug-eluting stents (DES; paclitaxel- or everolimus-eluting stents) for reducing major adverse cardiac events (MACE).



This was a randomized controlled multicenter clinical trial that enrolled patients with a previous coronary artery bypass graft who had developed at least 1 intermediate nonobstructive SVG lesion (30%-60% diameter stenosis by visual estimation). Patients were randomized (1:1) to DES implantation (SVG-DES) or medical treatment (SVG-MT) of the target SVG lesion. The primary efficacy outcome was the first occurrence of MACE defined as the composite of cardiac death, myocardial infarction, or coronary revascularization related to the target SVG during the duration of follow-up (minimum of 2 years). Secondary efficacy outcomes included MACE related to the target SVG lesion and overall MACE. A total of 125 patients (mean age 70±9 years, 87% men) were included, with a mean time from coronary artery bypass graft of 12±5 years. Sixty and 65 patients were allocated to the SVG-DES and SVG-MT groups, respectively. There were no events related to the target SVG at 30 days. After a median follow-up of 3.4 (interquartile range: 2.8-3.9) years, the MACE rate related to the target SVG was not significantly different in the 2 groups (SVG-DES: 15.0%, SVG-MT: 20.0%; hazard ratio, 0.65; 95% confidence interval, 0.23-1.53; P=0.33). There were no significant differences between groups in MACE related to the target SVG lesion (SVG-DES: 10.0%, SVG-MT: 16.9%; hazard ratio, 0.53; 95% confidence interval, 0.20-1.43; P=0.21) or global MACE (SVG-DES: 36.7%, SVG-MT: 44.6%; hazard ratio, 0.73; 95% confidence interval, 0.42-1.27; P=0.26).



Sealing intermediate nonobstructive SVG lesions with DES was safe but was not associated with a significant reduction of cardiac events at 3-year follow-up.



URL: http://www.clinicaltrials.gov. Unique identifier: NCT01223443.
From the Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (J.R.-C., R.D.L.); Population Health Research Institute, Hamilton General Hospital, McMaster University, Ontario, Canada (S.S.J.); Department of Medicine, Vancouver General Hospital, British Columbia, Canada (J.C., D.W.); Cardiology Department, Centre Hospitalier Universitaire de Montreal, Quebec, Canada (S.M.); Department of Medicine, Montreal Heart Institute, Quebec, Canada (P.L.L.); Department of Medicine and University Hospital, London Health Sciences Centre, Ontario, Canada (P.J.T.); Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada (J.J.G.); Department of Cardiology, Ottawa Heart Institute, Ontario, Canada (M.R.L.M.); York PCI Group, Division of Cardiology, Department of Medicine, Southlake Regional Hospital, Newmarket, Ontario, Canada (W.J.C.); Statistics Department, Population Health Research Centre, Hamilton, Ontario, Canada (K.B.); and Department of Medicine, Toronto General Hospital, Ontario, Canada (V.D.). josep.rodes@criucpq.ulaval.ca.
Josep
J
Rodés-Cabau
From the Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (J.R.-C., R.D.L.); Population Health Research Institute, Hamilton General Hospital, McMaster University, Ontario, Canada (S.S.J.); Department of Medicine, Vancouver General Hospital, British Columbia, Canada (J.C., D.W.); Cardiology Department, Centre Hospitalier Universitaire de Montreal, Quebec, Canada (S.M.); Department of Medicine, Montreal Heart Institute, Quebec, Canada (P.L.L.); Department of Medicine and University Hospital, London Health Sciences Centre, Ontario, Canada (P.J.T.); Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada (J.J.G.); Department of Cardiology, Ottawa Heart Institute, Ontario, Canada (M.R.L.M.); York PCI Group, Division of Cardiology, Department of Medicine, Southlake Regional Hospital, Newmarket, Ontario, Canada (W.J.C.); Statistics Department, Population Health Research Centre, Hamilton, Ontario, Canada (K.B.); and Department of Medicine, Toronto General Hospital, Ontario, Canada (V.D.).
Sanjit S
SS
Jolly
From the Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (J.R.-C., R.D.L.); Population Health Research Institute, Hamilton General Hospital, McMaster University, Ontario, Canada (S.S.J.); Department of Medicine, Vancouver General Hospital, British Columbia, Canada (J.C., D.W.); Cardiology Department, Centre Hospitalier Universitaire de Montreal, Quebec, Canada (S.M.); Department of Medicine, Montreal Heart Institute, Quebec, Canada (P.L.L.); Department of Medicine and University Hospital, London Health Sciences Centre, Ontario, Canada (P.J.T.); Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada (J.J.G.); Department of Cardiology, Ottawa Heart Institute, Ontario, Canada (M.R.L.M.); York PCI Group, Division of Cardiology, Department of Medicine, Southlake Regional Hospital, Newmarket, Ontario, Canada (W.J.C.); Statistics Department, Population Health Research Centre, Hamilton, Ontario, Canada (K.B.); and Department of Medicine, Toronto General Hospital, Ontario, Canada (V.D.).
John
J
Cairns
From the Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (J.R.-C., R.D.L.); Population Health Research Institute, Hamilton General Hospital, McMaster University, Ontario, Canada (S.S.J.); Department of Medicine, Vancouver General Hospital, British Columbia, Canada (J.C., D.W.); Cardiology Department, Centre Hospitalier Universitaire de Montreal, Quebec, Canada (S.M.); Department of Medicine, Montreal Heart Institute, Quebec, Canada (P.L.L.); Department of Medicine and University Hospital, London Health Sciences Centre, Ontario, Canada (P.J.T.); Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada (J.J.G.); Department of Cardiology, Ottawa Heart Institute, Ontario, Canada (M.R.L.M.); York PCI Group, Division of Cardiology, Department of Medicine, Southlake Regional Hospital, Newmarket, Ontario, Canada (W.J.C.); Statistics Department, Population Health Research Centre, Hamilton, Ontario, Canada (K.B.); and Department of Medicine, Toronto General Hospital, Ontario, Canada (V.D.).
Samer
S
Mansour
From the Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (J.R.-C., R.D.L.); Population Health Research Institute, Hamilton General Hospital, McMaster University, Ontario, Canada (S.S.J.); Department of Medicine, Vancouver General Hospital, British Columbia, Canada (J.C., D.W.); Cardiology Department, Centre Hospitalier Universitaire de Montreal, Quebec, Canada (S.M.); Department of Medicine, Montreal Heart Institute, Quebec, Canada (P.L.L.); Department of Medicine and University Hospital, London Health Sciences Centre, Ontario, Canada (P.J.T.); Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada (J.J.G.); Department of Cardiology, Ottawa Heart Institute, Ontario, Canada (M.R.L.M.); York PCI Group, Division of Cardiology, Department of Medicine, Southlake Regional Hospital, Newmarket, Ontario, Canada (W.J.C.); Statistics Department, Population Health Research Centre, Hamilton, Ontario, Canada (K.B.); and Department of Medicine, Toronto General Hospital, Ontario, Canada (V.D.).
Philippe L
PL
L'Allier
From the Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (J.R.-C., R.D.L.); Population Health Research Institute, Hamilton General Hospital, McMaster University, Ontario, Canada (S.S.J.); Department of Medicine, Vancouver General Hospital, British Columbia, Canada (J.C., D.W.); Cardiology Department, Centre Hospitalier Universitaire de Montreal, Quebec, Canada (S.M.); Department of Medicine, Montreal Heart Institute, Quebec, Canada (P.L.L.); Department of Medicine and University Hospital, London Health Sciences Centre, Ontario, Canada (P.J.T.); Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada (J.J.G.); Department of Cardiology, Ottawa Heart Institute, Ontario, Canada (M.R.L.M.); York PCI Group, Division of Cardiology, Department of Medicine, Southlake Regional Hospital, Newmarket, Ontario, Canada (W.J.C.); Statistics Department, Population Health Research Centre, Hamilton, Ontario, Canada (K.B.); and Department of Medicine, Toronto General Hospital, Ontario, Canada (V.D.).
Patrick J
PJ
Teefy
From the Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (J.R.-C., R.D.L.); Population Health Research Institute, Hamilton General Hospital, McMaster University, Ontario, Canada (S.S.J.); Department of Medicine, Vancouver General Hospital, British Columbia, Canada (J.C., D.W.); Cardiology Department, Centre Hospitalier Universitaire de Montreal, Quebec, Canada (S.M.); Department of Medicine, Montreal Heart Institute, Quebec, Canada (P.L.L.); Department of Medicine and University Hospital, London Health Sciences Centre, Ontario, Canada (P.J.T.); Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada (J.J.G.); Department of Cardiology, Ottawa Heart Institute, Ontario, Canada (M.R.L.M.); York PCI Group, Division of Cardiology, Department of Medicine, Southlake Regional Hospital, Newmarket, Ontario, Canada (W.J.C.); Statistics Department, Population Health Research Centre, Hamilton, Ontario, Canada (K.B.); and Department of Medicine, Toronto General Hospital, Ontario, Canada (V.D.).
John J
JJ
Graham
From the Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (J.R.-C., R.D.L.); Population Health Research Institute, Hamilton General Hospital, McMaster University, Ontario, Canada (S.S.J.); Department of Medicine, Vancouver General Hospital, British Columbia, Canada (J.C., D.W.); Cardiology Department, Centre Hospitalier Universitaire de Montreal, Quebec, Canada (S.M.); Department of Medicine, Montreal Heart Institute, Quebec, Canada (P.L.L.); Department of Medicine and University Hospital, London Health Sciences Centre, Ontario, Canada (P.J.T.); Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada (J.J.G.); Department of Cardiology, Ottawa Heart Institute, Ontario, Canada (M.R.L.M.); York PCI Group, Division of Cardiology, Department of Medicine, Southlake Regional Hospital, Newmarket, Ontario, Canada (W.J.C.); Statistics Department, Population Health Research Centre, Hamilton, Ontario, Canada (K.B.); and Department of Medicine, Toronto General Hospital, Ontario, Canada (V.D.).
Michel R
MR
Le May
From the Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (J.R.-C., R.D.L.); Population Health Research Institute, Hamilton General Hospital, McMaster University, Ontario, Canada (S.S.J.); Department of Medicine, Vancouver General Hospital, British Columbia, Canada (J.C., D.W.); Cardiology Department, Centre Hospitalier Universitaire de Montreal, Quebec, Canada (S.M.); Department of Medicine, Montreal Heart Institute, Quebec, Canada (P.L.L.); Department of Medicine and University Hospital, London Health Sciences Centre, Ontario, Canada (P.J.T.); Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada (J.J.G.); Department of Cardiology, Ottawa Heart Institute, Ontario, Canada (M.R.L.M.); York PCI Group, Division of Cardiology, Department of Medicine, Southlake Regional Hospital, Newmarket, Ontario, Canada (W.J.C.); Statistics Department, Population Health Research Centre, Hamilton, Ontario, Canada (K.B.); and Department of Medicine, Toronto General Hospital, Ontario, Canada (V.D.).
Warren J
WJ
Cantor
From the Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (J.R.-C., R.D.L.); Population Health Research Institute, Hamilton General Hospital, McMaster University, Ontario, Canada (S.S.J.); Department of Medicine, Vancouver General Hospital, British Columbia, Canada (J.C., D.W.); Cardiology Department, Centre Hospitalier Universitaire de Montreal, Quebec, Canada (S.M.); Department of Medicine, Montreal Heart Institute, Quebec, Canada (P.L.L.); Department of Medicine and University Hospital, London Health Sciences Centre, Ontario, Canada (P.J.T.); Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada (J.J.G.); Department of Cardiology, Ottawa Heart Institute, Ontario, Canada (M.R.L.M.); York PCI Group, Division of Cardiology, Department of Medicine, Southlake Regional Hospital, Newmarket, Ontario, Canada (W.J.C.); Statistics Department, Population Health Research Centre, Hamilton, Ontario, Canada (K.B.); and Department of Medicine, Toronto General Hospital, Ontario, Canada (V.D.).
David
D
Wood
From the Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (J.R.-C., R.D.L.); Population Health Research Institute, Hamilton General Hospital, McMaster University, Ontario, Canada (S.S.J.); Department of Medicine, Vancouver General Hospital, British Columbia, Canada (J.C., D.W.); Cardiology Department, Centre Hospitalier Universitaire de Montreal, Quebec, Canada (S.M.); Department of Medicine, Montreal Heart Institute, Quebec, Canada (P.L.L.); Department of Medicine and University Hospital, London Health Sciences Centre, Ontario, Canada (P.J.T.); Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada (J.J.G.); Department of Cardiology, Ottawa Heart Institute, Ontario, Canada (M.R.L.M.); York PCI Group, Division of Cardiology, Department of Medicine, Southlake Regional Hospital, Newmarket, Ontario, Canada (W.J.C.); Statistics Department, Population Health Research Centre, Hamilton, Ontario, Canada (K.B.); and Department of Medicine, Toronto General Hospital, Ontario, Canada (V.D.).
Kumar
K
Balasubramanian
From the Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (J.R.-C., R.D.L.); Population Health Research Institute, Hamilton General Hospital, McMaster University, Ontario, Canada (S.S.J.); Department of Medicine, Vancouver General Hospital, British Columbia, Canada (J.C., D.W.); Cardiology Department, Centre Hospitalier Universitaire de Montreal, Quebec, Canada (S.M.); Department of Medicine, Montreal Heart Institute, Quebec, Canada (P.L.L.); Department of Medicine and University Hospital, London Health Sciences Centre, Ontario, Canada (P.J.T.); Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada (J.J.G.); Department of Cardiology, Ottawa Heart Institute, Ontario, Canada (M.R.L.M.); York PCI Group, Division of Cardiology, Department of Medicine, Southlake Regional Hospital, Newmarket, Ontario, Canada (W.J.C.); Statistics Department, Population Health Research Centre, Hamilton, Ontario, Canada (K.B.); and Department of Medicine, Toronto General Hospital, Ontario, Canada (V.D.).
Robert
R
DeLarochellière
From the Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (J.R.-C., R.D.L.); Population Health Research Institute, Hamilton General Hospital, McMaster University, Ontario, Canada (S.S.J.); Department of Medicine, Vancouver General Hospital, British Columbia, Canada (J.C., D.W.); Cardiology Department, Centre Hospitalier Universitaire de Montreal, Quebec, Canada (S.M.); Department of Medicine, Montreal Heart Institute, Quebec, Canada (P.L.L.); Department of Medicine and University Hospital, London Health Sciences Centre, Ontario, Canada (P.J.T.); Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada (J.J.G.); Department of Cardiology, Ottawa Heart Institute, Ontario, Canada (M.R.L.M.); York PCI Group, Division of Cardiology, Department of Medicine, Southlake Regional Hospital, Newmarket, Ontario, Canada (W.J.C.); Statistics Department, Population Health Research Centre, Hamilton, Ontario, Canada (K.B.); and Department of Medicine, Toronto General Hospital, Ontario, Canada (V.D.).
Vlad
V
Dzavik
D000368:Aged; D002170:Canada; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003251:Constriction, Pathologic; D017023:Coronary Angiography; D001026:Coronary Artery Bypass / Q000009:adverse effects* / Q000401:mortality; D054855:Drug-Eluting Stents; D005260:Female; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011474:Prosthesis Design; D012307:Risk Factors; D012501:Saphenous Vein / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000637:transplantation*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
D002317:Cardiovascular Agents; D017239:Paclitaxel
coronary artery bypass; drug-eluting stent; everolimus; myocardial infarction; stents