Late-Breaking Clinical Trials II

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Monday, April 4, 8:00–9:30 AM

The late-breaking clinical trials at ACC.11 promise to deliver exciting results from much-anticipated studies.

The PRECOMBAT trial was initiated to establish the safety and effectiveness of coronary stenting with the sirolimus-eluting balloon expandable stent (Cypher, Cordis) compared with bypass surgery for the treatment of an unprotected left main coronary artery stenosis. The alternative hypothesis is that the experimental strategy (coronary stenting with the sirolimus-eluting stents) is not inferior to the standard strategy (bypass surgery).

The primary outcomes are major cardiac and cerebrovascular events (MACCE): the composite of death, MI, stroke and ischemia-driven target vessel revascularization one-year after treatment.

Stenting lesions in the left main coronary artery is a relatively new approach. Some data indicate it is feasible, particularly with bare-metal stents, but its safety and efficacy need to be firmly established, especially with drug-eluting stents, if PCI is to be accepted as an alternative approach to bypass. In-stent restenosis was a problem with bare-metal stents, so drug-eluting stents offer a less restrictive interventional approach in terms of the aggressive debulking atherectomy and other endeavors to decrease in-stent restenosis.

As the field of cardiac intervention attempts to treat more complex disease states via catheter technologies, the focus on treating left main coronary lesions will remain strong. Left main disease is challenging, but preliminary data suggest it is indeed treatable percutaneously. What needs to be worked out, and what PRECOMBAT can offer, are some of the finer points that can help standardize the treatment for optimal outcomes.

Speaker information

  • Seung-Jung Park, MD, Asan Medical Center, Seoul, South Korea -- Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease (PRECOMBAT) trial