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Pharmaceutical industry

SYNTAX Clinical Trial Compares Drug-Eluting Stents with Cardiac Surgery in Complex Coronary Artery Disease Patients

Strategic Insights

— 1 min read

The SYNTAX clinical trial, a multicenter, prospective trial, has begun enrolling patients with complex coronary artery disease in Europe and the United States. The trial compares the performance of drug-eluting stents with cardiac surgery in patients with disease in all three coronary arteries, the left main coronary artery, or both. The trial aims to determine the optimal treatment strategy for these high-risk patients, with over 4,200 patients expected to participate across 90 sites.

Key Takeaways:

  • The SYNTAX trial is a randomized, controlled clinical trial comparing 12-month outcomes of percutaneous coronary intervention (PCI) using the TAXUS Express2 paclitaxel-eluting coronary stent system with coronary artery bypass graft (CABG) treatment in patients with complex coronary artery disease.
  • The trial will involve over 4,200 patients at up to 90 sites in Europe and the United States.
  • The primary endpoint of the trial is the 12-month major adverse cardiac and cerebral event (MACCE) rate, which includes death, myocardial infarction, repeat revascularization, and stroke.
  • The trial uses an innovative enrollment methodology that enrolls consecutive patients without significant exclusion criteria.
  • Patients will be jointly decided upon by a treating cardiothoracic surgeon and interventional cardiologist to determine eligibility for both treatment options.
  • Two "nested" registries will track patients eligible for only one treatment option, with approximately 2,750 patients combined.
  • The trial will be led by Principal Investigators Professor Friedrich Mohr, MD, and Professor Patrick Serruys, MD, PhD.
  • The first patient was enrolled in the SYNTAX randomized cohort on April 5 by Marie-Claude Morice, MD, and Arnaud Farge, MD.

Statistics:

  • 4,200 patients will participate across 90 sites in Europe and the United States.
  • 1,500 patients will be enrolled in the randomized arm comparing CABG to PCI.
  • 2,750 patients will be enrolled in the nested registries tracking CABG or PCI.
  • The trial will recruit patients over a period of several weeks.

Sources:

  • Health & Medicine Week via NewsRx.com, April 2005.
  • Health & Medicine Week editors from staff and other reports.
  • NewsRx.com.

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