‘Top Ten’ Advances of 2012 Highlighted by AHA-ASA, ACC
The American Heart Association (AHA) and American Stroke Association (ASA) have continued their annual tradition of listing the foremost research of the year. This year the American College of Cardiology (ACC) followed suit with its own top 10 list of major stories in cardiology.
Both rankings were announced via press release in mid-December 2012.
Several studies related to interventional cardiology made the cut for the AHA/ASA, spanning research topics as diverse as stem cell therapy, renal denervation, stroke-related devices, and invasive treatment options for CAD patients with diabetes. Another landmark event, the ACC says, was the US Food And Drug Administration’s (FDA) approval of an expanded indication for transcatheter aortic valve replacement (TAVR).
CABG Bests DES for Diabetes Patients
Both top 10 lists cite the FREEDOM trial, which made headlines when it was presented at the AHA Scientific Sessions in Los Angeles, CA, and simultaneously published online ahead of print in the New England Journal of Medicine on November 4, 2012.
Results from FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) showed that CABG surgery is superior to PCI with DES over the long-term. The randomized trial enrolled 1,900 patients with diabetes and multivessel CAD at 140 international centers. At 5-year follow-up, CABG patients had a lower rate of the primary composite endpoint of death, stroke, and MI compared with PCI patients. Both all-cause death and MI were less common with CABG, though surgery resulted in a higher stroke rate.
The population studied in FREEDOM represents “about a quarter of all patients undergoing heart procedures in catheterization labs,” an AHA/ASA press release notes. “The study suggests that bypass surgery should be considered an important treatment option for such patients.”
A Focus on Stroke
The AHA/ASA list also takes note of devices aimed at stroke treatment or prevention.
On October 6, 2012, the Lancet published 2 separate studies—SWIFT and TREVO 2—featuring different ‘stent-on-a-wire’ thrombectomy devices. The novel devices were found superior to an older system for treating acute ischemic stroke patients who had failed or were not candidates for intravenous thrombolytic therapy.
The TREVO 2 trial randomized 170 acute ischemic stroke patients with large artery occlusions ineligible for or refractory to intravenous t-PA to treatment with the newer Trevo Retriever (Stryker Neurovascular, Mountain View, CA) or the older Merci device (Stryker Neurovascular), which has been approved in the United States since 2004.
Trevo was both noninferior and superior to Merci for the study’s primary efficacy endpoint of revascularization success, defined as Thrombolysis in Cerebral Infarction perfusion grade 2 or greater. Procedure-related adverse events at 24 hours were similar for both groups, while Trevo patients saw better clinical outcomes at 90 days in terms of modified Rankin score.
Results for the multicenter SWIFT (Solitaire With the Intention For Thrombectomy) trial, conducted in a similar patient population, were initially presented February 3, 2012, at the American Stroke Association’s annual International Stroke Conference in New Orleans, LA.
After an interim analysis, the trial was halted a year early due to the positive results achieved with the Solitaire device (ev3, Plymouth, MN). The primary endpoint, successful recanalization with no symptomatic intracranial hemorrhage or rescue therapy, was significantly improved with Solitaire vs. Merci. Other endpoints, such as core lab-adjudicated recanalization, use of rescue therapy, symptomatic intracranial hemorrhage, good neurologic outcome, and mortality, were also better with Solitaire.
But as the AHA/ASA report notes, not every story has a happy ending.
Negative findings from the CLOSURE I trial have been known for years, namely that percutaneous closure of patent foramen ovale in patients with cryptogenic stroke or transient ischemic attack offered no better protection against subsequent stroke than medical therapy. Only on March 15 of this year, however, were its final results published in full by NEJM, confirming the disappointment.
Accumulating Evidence for Cell Therapy, Renal Denervation
The AHA/ASA also featured 2 stem cell therapy trials from 2012: SCIPIO and CADUCEUS.
For the open-label, single-center SCIPIO (Stem Cell Infusion in Patients with Ischemic cardiOmyopathy) study, Roberto Bolli, MD, of the University of Louisville (Louisville, KY), and colleagues randomized patients who had undergone CABG and had developed post-infarction LV dysfunction to stem cell therapy or standard treatment. Cell therapy consisted of autologous cardiac stem cells administered via intracoronary infusion at a mean of 113 days after surgery.
The researchers found that the cell infusion safely improved LV systolic function and reduced infarct size through 1 year.
The 2-center CADUCEUS (CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction) trial, meanwhile, demonstrated that MI patients can safely undergo treatment with autologous stem cells derived from endomyocardial biopsy. MRI analysis showed that patients who received stem cells had greater reduction in scar size compared with controls at both 6 and 12 months. While cell therapy patients fared better on 6-minute walk test, functional measures including end-diastolic volume, end-systolic volume, and LVEF did not differ between the 2 groups.
Another major development for the year is the growing evidence base for catheter-based renal denervation. Multiple studies have found the treatment to be “safe and effective at lowering high blood pressure resistant to other treatments,” notes the AHA/ASA press release.
Examples include recent reports from the Symplicity HTN-1 and Symplicity HTN-2 trials.
Broader Approval for TAVR
According to the ACC, an additional noteworthy event is the FDA’s recently expanded indication for TAVR. On the heels of a near-unanimous recommendation by an advisory panel in June, the agency officially extended the use of the Sapien heart valve (Edwards Lifesciences; Irvine, CA) to patients with severe aortic stenosis at high risk for surgery. The device has been FDA approved since November 2011 for inoperable patients.
Sources:
1. American College of Cardiology names top cardiovascular stories of 2012 [press release]. December 19, 2012.
2. 2012 top 10 advances in heart disease and stroke research [press release]. http://newsroom.heart.org/pr/aha/2012-top-10-advances-in-heart-241901.aspx. Published: December 17, 2012. Accessed: December 20, 2012.
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Caitlin E. Cox is News Editor of TCTMD and Associate Director, Editorial Content at the Cardiovascular Research Foundation. She produces the…
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