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The American College of Cardiology (ACC) Scientific Session and the Society of Cardiovascular Angiography & Interventions (SCAI)

Study Finds Economic Advantages for 64-Slice CT, SPECT Concludes History of CAD a Factor in Economic Effectiveness of Non-Invasive Methods

A multi-center study has found the cost savings of the two leading non-invasive methods for detecting coronary artery disease (CAD) varies based on the patient’s heart history. The study found that patients who underwent coronary computed tomographic angiography (CCTA), without a prior diagnosis of CAD, incurred costs $603 lower (per patient average) than those who underwent myocardial perfusion imaging (MPI or SPECT). Both groups had equal clinical outcomes. However, patients with known CAD who underwent MPI incurred healthcare costs $2,451 lower (per patient average) than CCTA patients with equal clinical outcomes. These results suggest that CCTA may be a cost-efficient alternative in patients without a prior CAD diagnosis.
New York Presbyterian/Weill Cornell Cardiologist Dr. James K. Min presented the findings April 1st at the 57th Annual Meeting of the American College of Cardiology in Chicago. “These are exciting data,” said Min. “This provides an initial foundation to suggest that CCTA may be used as a cost-efficient alternative to nuclear stress testing for evaluation of patients with suspected coronary artery disease.”
Recently, the Centers for Medicare and Medicaid Services (CMS) assigned transaction codes (T-codes) for CT dedicated to coronary angiography. Looking at multi-center payer claims from five health plans with memberships of at least 10 million people, the study examined cost effectiveness for patients undergoing CCT under “T-codes,” compared to matched patients undergoing MPI testing.
Researchers collected data for 142,535 patients who underwent CCT or MPI for 9 months before and after the test. Pre-test cardiac risk was assessed by cardiac risk factors and medications. MPI patients were matched to CCT patients using 11 categories of demographic and risk states. Cost and clinical effectiveness were measured in both downstream CAD costs and clinical events including myocardial infarction (MI), angina and CAD-related hospitalization.

Study Finds Taxus® Drug-Eluting Stent Beneficial in Treatment of Large Vessels Results from TAXUS IV and V Randomized Clinical Trials Favor DES Compared to Bare-metal Stents
Boston Scientific Corporation welcomed favorable outcomes of one-year data from the company’s TAXUS IV and V randomized clinical trials in patients who received the Taxus® Express Paclitaxel-Eluting Coronary Stent System compared to patients who received bare-metal stents (BMS). These results add to the growing body of evidence that paclitaxel-eluting stents are clinically beneficial over BMS even in the treatment of large vessels (greater than 3.5 mm), which typically have reduced restenosis risk compared to smaller diameter vessels. David A. Cox, MD, FACC, presented the TAXUS IV and V results at the SCAI Annual Scientific Sessions in Partnership with the ACC/i2 Summit in Chicago. In an analysis of TAXUS IV and V one-year clinical events, Dr. Cox reported that patients treated with the Taxus stent had significant reductions in one-year revascularization rates in both large and small diameter vessels compared to BMS. Although the absolute magnitude of the efficacy benefit was reduced in large-diameter vessels, the relative reduction compared to BMS was maintained.
Results include outcomes from 2,458 patients divided into three groups according to maximal device diameter (defined as the diameter of the largest final stent or post-dilatation balloon utilized): <3.5 mm (n=1,528 patients), ≥3.5mm–<4.0mm (n=655), and ≥4.0mm (n=275). Compared to BMS, patients treated with the Taxus stent had lower rates of target lesion revascularization (TLR) at all device diameters: 9.7% vs. 20.4% (p<0.001) for <3.5mm, 4.5% vs. 13.5% (p<0.001) for ≥3.5mm-<4.0mm, and 1.6% vs. 6.5% (p<0.05) for >4.0mm. These rates correspond to reductions of 52.5% for the <3.5mm group, 66.7% for the ≥3.5mm–<4.0mm group, and 75.4% for the ≥4.0mm group, suggesting that although the magnitude of the absolute TLR difference between Taxus and BMS was reduced in larger-diameter vessels, the relative reduction was actually greater. Significant reductions in target vessel revascularization (TVR) and MACE were also reported in both small and larger diameter vessels. There were no statistically significant differences in the incidences of cardiac death, myocardial infarction or stent thrombosis.
“The risk for restenosis with BMS is generally decreased in large vessels, prompting some interventional cardiologists to choose BMS over DES in vessels larger than 3.5mm. However, since larger vessels also surround significant amounts of heart muscle tissue, even small differences in clinical events between BMS and DES may be clinically relevant,” said Dr. Cox. “Our analyses of TAXUS IV and V data clearly add to the growing body of evidence that DES still appear clinically beneficial over BMS in the treatment of large vessels.” The safety and effectiveness of the TAXUS Express Stent has not been established in lesions with reference vessel diameters >3.75mm.

12-Month Data From ENDEAVOR IV Show Strong Clinical Efficacy Across All Patient Groups

Data showing strong clinical efficacy for Medtronic’s Endeavor® drug-eluting stent were presented at the American College of Cardiology meeting. ENDEAVOR IV is evaluating 1,548 patients at 80 clinical centers in the United States, with a primary endpoint of Target Vessel Failure (TVF) at nine months and a secondary endpoint of major adverse cardiac events (MACE) at 30 days. The principal investigator is Dr. Martin B. Leon of Columbia University Medical Center and the Cardiovascular Research Foundation in New York.
The Endeavor drug-eluting stent is made of a cobalt alloy and is built on the same platform as Medtronic’s Driver bare metal stent, which features a modular architecture designed to enhance deliverability. In addition to the cytostatic drug zotarolimus, Endeavor is coated with phosphorylcholine (PC) technology, a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane. The combination of these components is designed to contribute to rapid, complete and functional healing of the endothelium.
Entitled “One-Year Clinical and Angiographic Results in Diabetics from ENDEAVOR IV: A Randomized Comparison of the Endeavor Drug Eluting Stent System Versus Taxus in de novo Native Coronary Lesions” (2803-8), the presentation featured an analysis of 477 diabetic patients from the ENDEAVOR IV clinical study. ENDEAVOR IV is an ongoing head-to-head comparison of the Endeavor and Taxus stents in 1,548 patients. The two tables shown are a summary of the principal findings for the diabetic subset.
“Performance of drug-eluting stents in diabetic patients is scrutinized by doctors because diabetes complicates so many aspects of the angioplasty procedure. Achieving good efficacy is more difficult, and safety concerns are significantly increased.” said Dr. Jeffrey Popma, Director of Invasive Cardiovascular Services, Caritas Cardiovascular Center for the Caritas Saint Elizabeth’s Medical Center in Boston, and director of the core lab that performed the angiographic analysis for the entire ENDEAVOR clinical program, including ENDEAVOR IV.
Launched in the United States in February and now available in more than 120 countries worldwide, the Endeavor stent is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length ≤ 27 mm in native coronary arteries with reference vessel diameters of ≥ 2.5 mm to ≤ 3.5 mm. Impact of angiography on TLR reinforced. Also presented at the ACC scientific session were the findings of two other substudies from the ENDEAVOR IV clinical trial. One analysis – “The Impact of Mandatory Angiographic Follow-up on the One-Year Clinical and Angiographic Results From Endeavor IV: A Randomized Comparison of the Endeavor Drug Eluting Stent System vs. Taxus in De Novo Native Coronary Lesions” (2900-103) — illustrated the artificial impact of routine angiography on revascularization rates. The first 328 enrolled ENDEAVOR-IV patients were selected to undergo angiography immediately post-procedure and again after eight months. These results were compared to the subsequent 1,200 patients in whom angiography was not performed. In patients receiving angiographic follow-up, the TLR rate at 12 months was 8.5 percent for Endeavor and 3.0 percent for Taxus but with no angiographic follow-up, the TLR rates were 3.6 percent for Endeavor and 3.3 percent for Taxus. These findings support the ARC recommendations that PCI clinical studies assess lesion characteristics with angiography only after the follow up required to assess the primary clinical endpoint. Side-branch occlusion with Endeavor. A second sub-analysis – “The Fate of Side-Branches Among Patients Treated With Zotarolimus-Eluting and Paclitaxel-Eluting Stents: An ENDEAVOR-IV Substudy” (2901-19) – looked at side-branch occlusion post-stenting. The analysis was conducted as doctors seek to explain the significantly increased rate of periprocedural MI with Taxus when compared to Endeavor observed in the ENDEAVOR IV clinical trial. The ENDEAVOR IV clinical trial was not prospectively designed to evaluate side-branch occlusions, so further study is warranted. The safety and effectiveness of the Endeavor stent have not been established in diabetic patients. Data would first require both FDA review and approval.

Range of Healthcare Offerings Help Philips Customers Reduce Critical Time to Treatment for Heart Attack Patients
Philips’ Cardiology Solutions Help Providers Reduce Time to Treatment for Phoenix-area Heart Attack Patients by Nearly 45 Minutes
Every minute counts for many heart attack patients. In the case of patients suffering from ST-segment elevation myocardial infarction (STEMI), the current ACC-recommended “door-to-balloon” (D2B) protocol is less than 90 minutes. Philips’ technologies can help hospitals reduce D2B time by clearing a path from discovery to treatment.
The Philips HeartStart MRx monitor/defibrillator enables paramedics to wirelessly transmit vital 12-lead electrocardiogram (ECG) data on the heart’s condition while en route to the hospital. Once this data is received, caregivers move into action, preparing the cath lab before the patient arrives. Philips informatics solutions throughout the D2B care cycle deliver instant access to and seamless sharing of clinical information throughout the hospital. Inside the emergency department and cath lab, Philips cardiovascular imaging equipment helps clinicians pinpoint issues in the heart and allows for confidently planned and executed interventional procedures.
Some of these solutions are helping the community of Glendale, Arizona save valuable time for critical STEMI patients. Outfitted with a HeartStart MRx in every fire engine, the Glendale Fire Department utilizes the innovative pre-hospital triaging technology when a patient displays symptoms consistent with STEMI.
“HeartStart MRx has reduced D2B times, as previously we would have to obtain the 12-lead ECG inside the hospital and wait for a decision on next treatment steps,” said Daniel Wintrow, captain and paramedic with the Glendale Fire Department. “Now, our paramedics are able to send digital quality 12-lead ECG data to the hospital while in transit, which can dramatically cut down on time and help physicians make decisions about appropriate care before arrival.”
“With this new capability, we can mobilize resources quickly, better manage and activate the cath lab, and get interventionalists to the hospital for timely and expedited care,” said Dr. Marc Kates, cardiologist, Banner Thunderbird Medical Center in Glendale, Arizona. “By carefully planning and implementing well-defined processes and taking advantage of new technologies, our hospital has experienced reductions in D2B times. We are currently right around the recommended 90-minute guideline, and have seen as much as 44-minute reductions versus our previous averages.”
Philips has also announced it will acquire TOMCAT Systems Ltd. based in Northern Ireland. TOMCAT offers a software solution that is able to aggregate, from various sources, data relative to the cardiac care of a patient and presents this in a comprehensive patient-centric view for doctors and nurses. This equips caregivers with a strong tool to help monitor progression of treatment, enable better informed decision making and manage patient care.

Heart Attack Patients Benefit from Thrombus Aspiration Prior to Stenting
Using the Export Aspiration Catheter from Medtronic, before stenting, in patients suffering acute myocardial infarction (AMI) can significantly improve blood flow and survival rates compared to conventional treatment with percutaneous coronary intervention (PCI) alone, according to results of a Dutch study presented at the American College of Cardiology meeting.
Presented by Prof. Felix Zijlstra of the University Medical Center Groningen in the Netherlands during a special late-breaking clinical trial session, the study — dubbed TAPAS — found that most AMI patients with ST-segment elevation achieved better reperfusion and clinical outcomes when receiving thrombus aspiration before standard PCI, regardless of their clinical and angiographic characteristics at baseline. It was supported by a grant from Medtronic for angiographic analyses by the core laboratory; all other costs were covered by the Thorax Center of the University Medical Center Groningen.
Dr. Zijlstra’s presentation — “Thrombus Aspiration during Coronary Angioplasty for Acute Myocardial Infarction” (2404-5) — summarized the design and findings of the study. Researchers at his center randomly assigned 1,071 AMI patients with ST-segment elevation to thrombus aspiration using the Export Aspiration Catheter or to conventional PCI prior to coronary angiography. The Export group had 35 percent fewer patients than the conventional PCI group exhibiting angiographic signs of poor blood flow to the heart muscle. In addition, 28 percent more patients in the Export group had resolution of ST-segment elevation compared to the conventional PCI group. Importantly, the study showed a reduction in death and major adverse cardiac events in patients that exhibited angiographic signs of improved blood flow to the heart muscle and resolution of ST-segment elevation. There also was a positive trend in favor of the Export Aspiration Catheter in reducing death.
Results from TAPAS are consistent with those from Medtronic’s EXPORT study, a randomized, controlled trial of 250 patients at 24 sites in Europe and India comparing the use of the Export Aspiration Catheter with conventional PCI. Reported at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in October 2007, the EXPORT study demonstrated that primary aspiration with the Export Aspiration Catheter followed by stenting improved myocardial reperfusion in AMI patients.

Three-Year Follow-up Data Suggest Better Outcomes Were Maintained with the Cypher® Sirolimus-Eluting Coronary Stent Compared to Brachytherapy in Patients with In-Stent Restenosis
Long-term, follow-up data presented suggest that patients who received the Cypher® sirolimus-eluting coronary stent for blockage of a bare metal stent were significantly less likely to need another procedure (target lesion revascularization or TLR) at three years compared to patients who received brachytherapy. In addition, there were no significant differences in safety endpoints, such as the rates of death, myocardial infarction (MI), or stent thrombosis between the two treatment arms of this study.
These data were presented at the Society for Cardiovascular Angiography and Interventions (SCAI) Annual Scientific Sessions in Partnership with American College of Cardiology (ACC) i2 Summit during the 57th Annual Scientific Sessions.
The SISR Trial (A Randomized Trial Comparing Sirolimus-Eluting Stent with Vascular Brachytherapy for the Treatment of In-Stent Restenosis Within Bare Metal Stents) is a multi-center, randomized study of 384 patients from 26 academic and community health centers in the United States. The original trial was designed for follow-up at nine months. This longer-term, follow-up analysis focused on pre-specified safety endpoints, namely death, MI and stent thrombosis, as well as target lesion revascularization (TLR), an efficacy endpoint, to determine whether any new safety issues emerged and whether the major benefit of the Cypher stent, namely reduction in TLR, was maintained. Cordis Corporation sponsored the trial.
“These data continue to favor the Cypher stent compared to radiation therapy in these patients with complex coronary artery disease,” said David R. Holmes Jr., MD, Principal Investigator and Professor of Medicine, The Mayo Clinic College of Medicine, Rochester, Minnesota. “Neither treatment modality in this study was associated with any new safety issues or concerns.” Dr. Holmes also serves as an advisory board member to the company’s e-SELECT registry, which is being conducted outside the United States.
At three years, 81 percent of patients who received the Cypher stent were free from a TLR compared to 71.6 percent of patients receiving brachytherapy (p=0.018). For target vessel revascularization, the survival free rates were 78.2 percent for the Cypher stent and 68.8 percent for the brachytherapy arm (p=0.022).
The stent thrombosis rates, as defined as definite and probable per the Academic Research Consortium (ARC) definitions, were not significantly different (3.7 percent for the Cypher stent vs. 2.6 percent for brachytherapy; p=0.606).
Although three year rates of target vessel failure (the Cypher stent, 75.1 percent; brachytherapy, 67.9 percent; p=0.067) and major adverse cardiac events, also known as MACE, were both improved with the Cypher stent, this did not reach statistical significance, likely reflecting progression of coronary artery disease at sites other than the original location of bare metal stent restenosis. Rates of MACE were 75.5 percent for the Cypher stent and 70.5 percent for brachytherapy (p=0.186). The Cypher stent does not have an approved indication for the treatment of in-stent restenosis in the United States.

ExoSeal Vascular Plug Gets Good Reviews in ECLIPSE Study
A new bioabsorbable plug that seals the arterial puncture site after diagnostic angiography and interventional procedures significantly shortens bleeding time and enables patients to get up and walk around far sooner than when manual compression is applied to the groin. In addition, there were no access site complications at 30 days in the ECLIPSE Trial, a multicenter randomized study that is testing the safety and effectiveness of the investigational ExoSeal vascular closure device.
The study was reported in a Late-Breaking Clinical Trials session at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit (SCAI-ACCi2) in Chicago.
“We demonstrated that the ExoSeal device is a great alternative to manual compression following diagnostic and interventional procedures,” said Shing-Chiu Wong, MD, a professor of medicine at Weill Medical College of Cornell University and director of the cardiac catheterization laboratories at New York Presbyterian Hospital/Weill Cornell Medical Center, New York City. “It enables early ambulation and, potentially, early discharge from the hospital following the procedure.”
The ExoSeal Vascular Closure Device consists of a felt-like plug made of polyglycolic acid. It is anchored in place on top of the puncture in the femoral artery, after the catheter is removed. Because none of the plug is inserted into the artery itself, it does not interfere with blood flow. Over about three months, it completely dissolves. For the study, Dr. Wong and his colleagues recruited 488 patients from 17 medical centers, half of whom were undergoing diagnostic angiography and half, an interventional procedure. Some 90 percent were being examined or treated for coronary disease, the remaining 10 percent for peripheral disease. Patients were randomly assigned to treatment with the ExoSeal or to manual compression.
The ExoSeal device was put into place in an average of just one minute and was used successfully in 89.1 percent of patients. There was no difference in procedural success between the ExoSeal and manual compression groups (91.8 percent and 91.0 percent, respectively). However, the average time to cessation of bleeding was significantly shorter in patients treated with the ExoSeal (4.38 minutes vs. 20.05 minutes, p<0.0001). Similarly, patients treated with the vascular closure device were able to get out of bed and walk around far sooner, within 2.54 hours, on average, with the ExoSeal, as compared with 6.24 hours with manual compression (p=0.028).
“Further investigation is needed to delineate the device’s applicability in patients with access puncture sites at or below the branchpoint of the femoral and iliac arteries and in patients with mild or moderate peripheral vascular disease,” he said. “Comparative studies of efficacy and patient comfort with the ExoSeal and other vascular closure devices will also be intriguing.”

 

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