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Pharmaceutical industry

SYNTAX Clinical Trial: A Comparative Study of PCI and CABG Treatments

Strategic Insights

— 1 min read

The SYNTAX clinical trial, initiated by Boston Scientific Corporation in partnership with Angiotech Pharmaceuticals, Inc., aims to investigate the effectiveness of drug-eluting stents versus cardiac surgery in treating patients with complex coronary artery disease. The trial, which began enrolling patients in April, will involve over 4,200 patients across 90 sites in Europe and the United States. The study seeks to compare 12-month outcomes of percutaneous coronary intervention (PCI) using the Taxus Express2 paclitaxel-eluting coronary stent system with coronary artery bypass graft (CABG) treatment.

Key Takeaways:

  • The SYNTAX trial is a randomized, controlled clinical trial designed to compare 12-month outcomes of PCI using the Taxus Express2 paclitaxel-eluting coronary stent system with 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, making it one of the largest clinical trials in the field of cardiology.
  • The study will use an enrollment methodology that enrolls consecutive patients without significant exclusion criteria, allowing for a more representative sample of patient populations.
  • The trial will compare outcomes of PCI and CABG treatments in patients with complex coronary artery disease, including those with coronary artery disease in all 3 coronary arteries, in the left main coronary artery, or both.
  • The primary endpoint of the study is the 12-month major adverse cardiac and cerebral event (MACCE) rate, which includes death, myocardial infarction, repeat revascularization, and stroke.
  • The trial will also involve "nested" registries to track patients who are eligible for only one treatment option.
  • The principal investigators for the trial are professors Friedrich Mohr, Patrick Serruys, and Marie-Claude Morice.

Statistics:

  • The SYNTAX trial will involve over 4,200 patients.
  • The trial will be conducted at up to 90 sites in Europe and the United States.
  • Approximately 1,500 patients will be enrolled in the randomized arm comparing CABG to PCI.
  • Approximately 2,750 patients will be enrolled in the "nested" registries tracking either CABG or PCI.
  • The trial will follow patients for a period of 12 months.
  • The primary endpoint of the study is the 12-month MACCE rate.

Sources:

  • Health & Medicine Week editors (2005, April 5). SYNTAX Clinical Trial Begins Enrolling Patients. NewsRx.com
  • NewsRx.com (Copyright 2005, Health & Medicine Week)

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