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September 4, 2014

CvLPRIT Study Supports Complete Revascularization Strategy for MI Treatment

September 1, 2014—Results of the Complete Versus Lesion-Only Primary PCI Trial (CvLPRIT) were presented at the European Society of Cardiology’s ESC Congress 2014 in Barcelona, Spain. The study found that in patients being treated for myocardial infarction (MI), complete revascularization of all significantly blocked arteries leads to better outcomes compared to a strategy of unblocking just the “culprit” artery responsible for the MI.

In the ESC Congress press release, study investigator Anthony Gershlick, MD, from University Hospitals of Leicester NHS Trust, Glenfield Hospital, in Leicester, England, stated that the CvLPRIT findings may be practice-changing when considered with some other recent trials. He commented, “Until now there have been conflicting data regarding the optimal management of patients who, whilst undergoing primary percutaneous coronary intervention (PCI) after MI, are also found to have lesions in their noninfarct-related artery (N-IRA).”

He added, “Current guidelines from ESC and American Heart Association/American College of Cardiology recommend treating the infarct-related artery (IRA) only, but the results of our study demonstrate a highly significant benefit with a strategy of complete revascularization instead. These findings should suggest strongly that all lesions be treated before the patient is discharged.”

According to the ESC, CvLPRIT included 296 heart attack patients who presented at seven interventional cardiology centers in the United Kingdom. Before primary PCI treatment, the patients were randomized to receive IRA-only revascularization (n = 146) or to have complete revascularization of both the IRA and all significantly blocked N-IRAs (n = 150).

For patients in the complete revascularization group, the IRA was treated first, followed by the N-IRAs—preferably in the same sitting but definitely during the same index hospital admission.

The study found that 1 year after the procedure, patients in the complete revascularization group had significantly better outcomes compared to those who had only their IRA revascularized, based on a composite endpoint of major adverse cardiac events (MACE) including all-cause mortality, recurrent MI, heart failure, and ischemic-driven revascularization. MACE occurred in 21.2% of the IRA-only arm versus 10% of the complete revascularization group (hazard ratio [HR] 0.45; P = .009), and the difference between the two groups was seen early (P = .055 at 30 days).

Prof. Gershlick noted in the ESC announcement that procedure time and contrast volume load were significantly higher in the complete revascularization group compared to the IRA-only group (55 vs 41 mins; P < .0001; and 250 vs 190 mL; P < .0001, respectively), but despite this, the complete revascularization patients had no increase in stroke, major bleeding, or contrast-induced nephropathy.

The CvLPRIT results correlate strongly with those of the earlier PRAMI (Preventive Angioplasty in Myocardial Infarction) trial, which was presented last September during ESC Congress 2013.

Prof. Gershlick stated, “The PRAMI trial reported clear clinical benefit in treating both IRA and N-IRAs at the index primary PCI, but there was some criticism of the trial design. As a result, PRAMI has not led to widespread changes in clinical practice, with IRA-only revascularization at primary PCI remaining by far the more common practice. However, he said the results of CvLPRIT reinforce the PRAMI results and strengthen the argument for a strategy of complete revascularization at the time of a patient’s index hospital admission. "The early separation of the curves in CvLPRIT suggests a delayed staged out-patient complete strategy may not be as effective.”

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September 5, 2014

Enrollment Completed in CLEAN-TAVI Trial of Claret Medical's Cerebral Protection System

September 5, 2014

Enrollment Completed in CLEAN-TAVI Trial of Claret Medical's Cerebral Protection System


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