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Comparison of Characteristics and Outcomes of Patients Undergoing Saphenous Vein Graft Stenting Who Were or Were Not Enrolled in the Stenting of Saphenous Vein Grafts Randomized Controlled Trial
  1. Tesfaldet T. Michael, MD, MPH,
  2. Neeraj Badhey, MD,
  3. Subhash Banerjee, MD,
  4. Emmanouil S. Brilakis, MD, PhD
  1. From the VA North Texas Healthcare System and University of Texas Southwestern Medical Center at Dallas, Dallas, TX.
  1. Received August 20, 2010, and in revised form November 8, 2010.
  2. Accepted for publication November 12, 2010.
  3. Reprints: Emmanouil S. Brilakis, MD, PhD, VA North Texas Health Care System, The University of Texas Southwestern Medical Center at Dallas, Division of Cardiology (111A), 4500 S Lancaster Rd, Dallas, TX 75216. E-mail: esbrilakis{at}yahoo.com.
  4. Funding: The SOS trial was funded by the Department of Veterans Affairs VISN-17 Startup Award and by the Clark R. Gregg grant of the Harris Methodist Foundation to Dr. Brilakis.
  5. Conflict of interest: Drs. Michael and Badhey have no conflict of interest to disclose. Dr. Banerjee has disclosed receiving speaker honoraria from St Jude Medical, Medtronic, and Johnson & Johnson; research support from Boston Scientific and The Medicines Company. Dr. Brilakis has disclosed receiving speaker honoraria from St Jude Medical and Terumo; research support from Abbott Vascular and InfraReDx; and salary support from Medtronic (spouse).

Abstract

Objective We sought to compare the characteristics and outcomes of patients who were enrolled versus those who were not enrolled in the Stenting of Saphenous Vein Grafts (SOS) randomized controlled trial.

Methods and Results We identified all patients who underwent saphenous vein graft stenting during the SOS Trial enrollment period (May 2005 and October 2007) at our institution. Baseline characteristics and clinical outcomes were compared between patients who were versus those who were not enrolled in SOS. Of the 97 patients who underwent saphenous vein graft stenting during the study period, 62 patients (64%) were enrolled in SOS. In the enrolled group, 62 patients with 91 lesions were randomized to a bare metal stent (BMS) (n = 39) or paclitaxel-eluting stent (n = 41). In the nonenrolled group, 35 patients with 44 lesions received a drug-eluting stent (DES) (n = 27) or BMS (n = 8). During a median follow-up period of 2.66 years, nonenrolled patients had higher mortality (31.4% vs 14.5%, P = 0.039), but lower rates of myocardial infarction (5.7% vs 32.3%, P = 0.005) and target vessel failure (37% vs 61.3%, P = 0.023). Overall, patients who received DES had lower incidence of myocardial infarction, target lesion revascularization, target vessel failure and major adverse cardiac events, and similar mortality compared with the BMS group.

Conclusions Compared with nonenrolled patients, those who were enrolled in SOS had lower mortality. Patients receiving DES had better outcomes than those receiving BMS in both groups.

Key Words
  • saphenous vein graft
  • percutaneous coronary intervention
  • bare-metal stent
  • drug-eluting stent
  • randomized controlled trial
  • external validity

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