The Cardiac Research program was pioneered at St. Joseph’s Medical Center in 1996. Since then, we have participated in 60 trials with a total enrollment of 380 patients. Device and medication trials studying an array of medical conditions including coronary artery disease, myocardial infarction, acute coronary syndrome, carotid artery stenosis, and coronary artery vein grafting have been conducted.
The trials we participate in are nationally recognized clinical studies, some of which have produced landmark results that have contributed to the treatment of cardiac and vascular diseases. Three of the more prestigious studies are the CREDO, CURE and SIRIUS trials.
The CREDO trial: “Clopidogrel for the Reduction of Events During Observation” in patients undergoing percutaneous coronary intervention (PCI). This study investigated the effectiveness of the revolutionary medication clopidogrel (Plavix.) Over 2,000 patients in 99 North American centers were enrolled, with St. Joseph’s locally enrolling ten patients. Results of this study at one year found: Clopidogrel therapy was associated with a 26.9% relative reduction in combined risk of death, MI, or stroke.
The CURE trial: “Clopidogrel in Unstable Angina to Prevent Recurrent Events” randomized 12,562 Acute Coronary Syndrome (ACS) patients to aspirin alone or aspirin plus clopidogrel. Major cardiovascular events were reduced from 11.5% with aspirin alone to 9.3% with aspirin plus clopidogrel, a 20% reduction. The predominate effect was on nonfatal myocardial infarction being reduced from 6.7% to 5.2%. There was an excess of major bleeding, being increased from 2.7% to 3.6%, however, life threatening bleeding was not significantly increased. According to the findings of the CURE trial, in hospitals that use a conservative treatment strategy for ACS, clopidogrel should be added to the standard medical regimen for the treatment of ACS. The US Food and Drug Administration (FDA) approved clopidogrel for this indication in February 2002. The findings of the CURE study were an important advance in the global treatment of ACS.
The SIRIUS trial was a randomized double blind trial for the treatment of patients with new coronary lesions undergoing PCI. The breakthrough technology of drug eluting stents (DES) was examined. Over 1,000 patients were enrolled in 55 sites across the United States, with ten patients enrolled at St. Joseph’s.
One year results showed:
• A four-fold reduction in the need for subsequent revascularization using the DES compared to a bare metal stent (absolute difference 4.9% for DES vs 20% for bare metal stent).
• A 70 - 80% relative risk reduction in clinical re-stenosis for a high risk subset of patients (vessel size, lesion length, presence of diabetes).
ORCAS - An Original Research Study The ORCAS study: “Oral Rapamune with Bare Metal Coronary Artery Stenting“ was developed by Dr. Gurinder Grewal and the Cardiac Research Department for patients at St. Joseph’s Medical Center. It is for patients who have been diagnosed with coronary artery disease with a narrowing of a coronary artery (stenosis). This is treated with a procedure using a balloon angioplasty and the placement of a coronary stent. The purpose of the ORCAS study is to see if taking the medication, rapamune in pill form for 14 days after bare metal stent implantation improves angioplasty results in reducing the re-occurrence of coronary narrowing (restenosis) as compared to drug-coated stent implantation. Rapamune is one of the drugs used in drug eluting stents (DES).
Carotid Stent Trials
A highlight of the research program at St. Joseph’s Medical Center is our participation in carotid stent trials. We began by developing our own multidisciplinary protocol, approved by the Institutional Review Board, and supported by hospital administration. Subsequently, we have participated in the SAPPHIRE, CREST, EXACT and the CHOICE trials for the treatment of carotid stenosis.
The CREST trial is a study currently in progress co-sponsored by the National Institute of Health, and the Abbott Corporation. St. Joseph’s is one of only five sites in California, and one of only two sites in Northern California to be selected for participation in the prestigious CREST study. Spanning seven years between May of 1999 and 2007, we have performed a total of 150 carotid stent procedures with outstanding results compared to national findings: No myocardial infarctions and no major strokes.
SAPPHIRE -- Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy
CREST -- Carotid Revascularization Endarterectomy Vs Stent Trial
EXACT -- Emboshield and Xact Post Approval Carotid Stent Trial using the Emboshield BareWire Rapid Exchange Embolic Protection System and Xact Rapid Exchange Carotid Stent System
CHOICE -- Carotid Stenting For High Surgical Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence
