Sealing Intermediate Nonobstructive Coronary Saphenous Vein Graft Lesions With Drug-Eluting Stents as a New Approach to Reducing Cardiac Events: A Randomized Controlled Trial

Circ Cardiovasc Interv. 2016 Nov;9(11):e004336. doi: 10.1161/CIRCINTERVENTIONS.116.004336.

Abstract

Background: 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).

Methods and results: 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).

Conclusions: 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.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01223443.

Keywords: coronary artery bypass; drug-eluting stent; everolimus; myocardial infarction; stents.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Canada
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Constriction, Pathologic
  • Coronary Angiography
  • Coronary Artery Bypass / adverse effects*
  • Coronary Artery Bypass / mortality
  • Drug-Eluting Stents*
  • Female
  • Graft Occlusion, Vascular / etiology
  • Graft Occlusion, Vascular / mortality
  • Graft Occlusion, Vascular / physiopathology
  • Graft Occlusion, Vascular / therapy*
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Myocardial Infarction / etiology
  • Myocardial Infarction / prevention & control
  • Paclitaxel / administration & dosage*
  • Paclitaxel / adverse effects
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Prosthesis Design
  • Risk Factors
  • Saphenous Vein / diagnostic imaging
  • Saphenous Vein / physiopathology
  • Saphenous Vein / transplantation*
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Vascular Patency

Substances

  • Cardiovascular Agents
  • Paclitaxel

Associated data

  • ClinicalTrials.gov/NCT01223443

Grants and funding