March 27, 2012 (Updated March 29, 2012) (Chicago, Illinois)— The coronary computed-tomography angiography (CCTA)-based strategy for screening chest-pain patients in the emergency department is safe and reduces overall patient time in the hospital but costs about the same overall as the current standard approach, the Rule Out Myocardial Infarction Using Computer Assisted Tomography II (ROMICAT II) results show.
Dr Udo Hoffman (Massachusetts General Hospital, Boston) presented results of the randomized ROMICAT II trial today at the American College of Cardiology (ACC) 2012 Scientific Sessions.
The study randomized 1000 chest-pain patients with suspected acute coronary syndrome on a 1:1 ratio to either a CCTA screening approach or standard care left to the discretion of the physician. ROMICAT II was designed following the completion of the observational ROMICAT study, which showed that about 8% of patients screened for ACS in emergency departments are actually suffering ACS.
The primary end point of ROMICAT II was length of stay, because "it represents a summary measure of the effectiveness of the management and the decisions that were made during the index hospitalization of the local care team," Hoffman said. The average time to diagnosis was 10.4 hours in the CCTA group and 18.7 hours in the control group (p=0.001). By reducing the time to diagnosis in the patients who were not suffering ACS, the CCTA-first approach reduced chest-pain patients' average hospital stay from about 31 hours to 23 hours (p=0.0002) compared with the standard approach. About half the chest-pain patients scanned with CCTA to rule out possible noncardiac causes of their chest pain were safely discharged from the hospital within nine hours of arriving at the emergency department. Only 15% of patients receiving standard care were in and out that fast. The hospital stay for patients with ACS was about 3.5 days in both groups.
Patients in the CCTA group were much more likely to be discharged directly from the emergency department (46.7% vs 12.4%), but only slightly less likely to be admitted to the hospital (25.4% vs 31.7%). About half the patients in the control group were moved to an observation unit, compared with about a quarter of the CCTA patients.
The safety of the CCTA-based approach was comparable to that of the standard approach. There were no missed ACS cases in either group, and major adverse events within 30 days were statistically similar in both the CCTA and standard-care groups (0.4 and 1.0, p=0.37). Results of the ACRIN-PA study, presented earlier at the ACC meeting, also affirmed the safety and low-miss rate of the CCTA-first approach.
Commenting on the study at the ACC meeting, Dr Matthew Budoff (Los Angeles Biomedical Research Institute, CA) pointed out that this is the third multicenter randomized trial examining the effectiveness of CCTA vs the standard of care following CT STAT and ACRIN-PA. "We're now garnering significant clinical evidence with three randomized trials that are all very consistent."
If It Doesn't Reduce Cost, How Is It Better?
ROMICAT II also shows that the CCTA-first strategy cost about the same overall as the standard approach. Hospital billing data show that the CCTA-first approach cost about 19% less per patient than the standard approach, but hospital costs were about 50% more with the CCTA approach, apparently because CCTA patients underwent more angiography (12% vs 8%, p=0.04) and a statistically insignificant greater number of coronary interventions--either percutaneous intervention or bypass surgery (6.4% vs. 4.2%, p=0.16).
However, Dr Ray Gibbons (Mayo Clinic, Rochester, MN) argues that, viewed in the context of the current healthcare-cost crisis in the US, a screening strategy that yields similar results without saving money should not be considered superior.
"The difference in total hospital admissions--about 25% vs 32%--is probably not significant. The ROMICAT-II investigators "chose to analyze it in terms of direct discharge, but I think that's more of a matter of semantics," Gibbons told heartwire in an interview. "Will a patient really see it as different having a CCTA and being discharged vs going down the hall [to the chest-pain unit] for a few hours? Is that a big difference? I don't think so. . . . As for time in the emergency department? I'd view that as secondary.
"If the patients went home directly from the emergency department more often, which is what they should do, why aren't the costs different?" he asked. In the ROMICAT II data, the answer appears to be that the minor differences in percutaneous-intervention and bypass-surgery rates between the two groups drive more costs, he said. And, he added, the revascularization rates shown in ROMICAT-II are relatively low. Gibbons believes that if the CCTA-first strategy were tried across the country, it would be associated with much greater costs than the standard-screening approach in many areas where hospitals revascularize a much higher portion of the chest-pain patients that present to the emergency department than the centers in ROMICAT-II.
"If the outcomes are equivalent, you should try to reduce total costs, and that should be the primary goal," Gibbons said. "I know that in some areas of the country that emergency-department overcrowding is an issue, but that pales in comparison to what is happening to Medicare and the total healthcare costs in this country."
Gibbons said that Medicare data show that increased utilization of CCTA screening leads to higher revascularization rates, and "I'm very worried about the impact of CCTA on revascularization rates, because these are [often] revascularizations of low value."
Getting patients out of the emergency room faster will not save nearly as much money as keeping the very low-risk patients from ever coming to the emergency department, Gibbons said. So a next step in the effort to cut costs in ACS treatment should be to develop tools to better screen the calls of worried patients who believe they might be suffering an ACS and encourage the very low-risk patients to see their cardiologist or general practitioner rather than come to the emergency department.
Hoffman has a more optimistic perspective on the cost data from ROMICAT II. "Previous reports [from Medicare data] showed a doubling of the cost with CT, really attributed to subsequent catheterizations, bypass surgeries, and stent placements, so we were very happy to see no increase in costs. That's a major step forward.
"But there's always room for improvement . . . in people getting used to using CT instead of nuclear stress testing in these patients," Hoffman said. He speculated that CCTA screening may become more cost-effective as emergency-department personnel gain more experience with the technology. In order to ensure that the ROMICAT II results could be generalizable to a broad range of medical centers, the centers chosen for the study were "not CT aficionados," and the trial investigators conducted education sessions to teach the trial sites how to use the CCTA to screen chest-pain patients. "We tried to provide a level ground. It will be interesting to see if there is a learning curve. I expect in the future, with this strong evidence that we have, that physicians can be more confident in making decisions [based on CCTA], so I expect that the effectiveness of CT will increase, because it's still a relatively new method," Hoffman said. He also expects to see continued improvement in the image quality of CCTA scans.
Dr Michael Crawford (University of California, San Francisco) pointed out that ROMICAT-II was confined to patients coming to the emergency department during the day, "so if you expand this to 24/7 coverage, the cost has to go up. So the question is, will you save downstream by ordering fewer tests, etc? That remains to be shown in the future."
Radiation Risk
At the conference, Dr Elliott Antman (Brigham and Women's Hospital, Boston, MA) pointed out that the patients' average total radiation exposure from imaging in the CCTA arm was about three times that of the patients in the control group (14.3 mSv vs 5.3 mSv, p<0.0001). "So this is the cost of saving about eight hours on the length of stay. If we adopt this strategy, I think it's important to recognize that patients with chest pain often re-present to emergency departments, and it might not be the same hospital where they [first] present," he said. "There is the potential for patients to have repeated exposures."
Hoffman acknowledged the risks of radiation exposure but pointed out that although the CCTA-screened patients absorbed more radiation than the control group because they underwent more imaging tests, the per-test dose of CCTA is much lower than the dose delivered to many of the control patients in the nuclear stress tests (average 11 mSv vs 40 mSv). Also, Budoff pointed out that in all three of the studies of the CCTA-screening strategy, the CCTA-screened patients had fewer repeat visits to the emergency department than the control group, "so if we look at cumulative radiation over the subsequent year, perhaps, rather than just 28 days, it might actually start to balance out a bit better."
Hoffmann added, "The trials so far have not been able to grasp the full association of implementing CT to the benefit of being able to bring in other patients more quickly and treatment more quickly." So a full account of the benefits of the CCTA-first approach would also have to measure the advantages of a less crowded emergency department. "That's a collateral effect that many emergency-department physicians consider as important as improving the triage of patients with ACS," he said.
Hoffman reported research grants from the National Institutes of Health and Siemens Medical Systems. Gibbons reports consulting for Lantheus Medical Imaging. Antman has research funding from Daiichi- Sankyo, Eli Lilly, Sanofi, AstraZeneca, Pfizer, Inotek, Roche, Schering-Plough, Merck, Millennium, GlaxoSmithKline, Novartis, and Amgen. Budoff has no disclosures.
Disclosure: Reed Miller has disclosed no relevant financial relationships.
Dr Udo Hoffman (Massachusetts General Hospital, Boston) presented results of the randomized ROMICAT II trial today at the American College of Cardiology (ACC) 2012 Scientific Sessions.
The study randomized 1000 chest-pain patients with suspected acute coronary syndrome on a 1:1 ratio to either a CCTA screening approach or standard care left to the discretion of the physician. ROMICAT II was designed following the completion of the observational ROMICAT study, which showed that about 8% of patients screened for ACS in emergency departments are actually suffering ACS.
The primary end point of ROMICAT II was length of stay, because "it represents a summary measure of the effectiveness of the management and the decisions that were made during the index hospitalization of the local care team," Hoffman said. The average time to diagnosis was 10.4 hours in the CCTA group and 18.7 hours in the control group (p=0.001). By reducing the time to diagnosis in the patients who were not suffering ACS, the CCTA-first approach reduced chest-pain patients' average hospital stay from about 31 hours to 23 hours (p=0.0002) compared with the standard approach. About half the chest-pain patients scanned with CCTA to rule out possible noncardiac causes of their chest pain were safely discharged from the hospital within nine hours of arriving at the emergency department. Only 15% of patients receiving standard care were in and out that fast. The hospital stay for patients with ACS was about 3.5 days in both groups.
Patients in the CCTA group were much more likely to be discharged directly from the emergency department (46.7% vs 12.4%), but only slightly less likely to be admitted to the hospital (25.4% vs 31.7%). About half the patients in the control group were moved to an observation unit, compared with about a quarter of the CCTA patients.
The safety of the CCTA-based approach was comparable to that of the standard approach. There were no missed ACS cases in either group, and major adverse events within 30 days were statistically similar in both the CCTA and standard-care groups (0.4 and 1.0, p=0.37). Results of the ACRIN-PA study, presented earlier at the ACC meeting, also affirmed the safety and low-miss rate of the CCTA-first approach.
Commenting on the study at the ACC meeting, Dr Matthew Budoff (Los Angeles Biomedical Research Institute, CA) pointed out that this is the third multicenter randomized trial examining the effectiveness of CCTA vs the standard of care following CT STAT and ACRIN-PA. "We're now garnering significant clinical evidence with three randomized trials that are all very consistent."
If It Doesn't Reduce Cost, How Is It Better?
ROMICAT II also shows that the CCTA-first strategy cost about the same overall as the standard approach. Hospital billing data show that the CCTA-first approach cost about 19% less per patient than the standard approach, but hospital costs were about 50% more with the CCTA approach, apparently because CCTA patients underwent more angiography (12% vs 8%, p=0.04) and a statistically insignificant greater number of coronary interventions--either percutaneous intervention or bypass surgery (6.4% vs. 4.2%, p=0.16).
However, Dr Ray Gibbons (Mayo Clinic, Rochester, MN) argues that, viewed in the context of the current healthcare-cost crisis in the US, a screening strategy that yields similar results without saving money should not be considered superior.
"The difference in total hospital admissions--about 25% vs 32%--is probably not significant. The ROMICAT-II investigators "chose to analyze it in terms of direct discharge, but I think that's more of a matter of semantics," Gibbons told heartwire in an interview. "Will a patient really see it as different having a CCTA and being discharged vs going down the hall [to the chest-pain unit] for a few hours? Is that a big difference? I don't think so. . . . As for time in the emergency department? I'd view that as secondary.
"If the patients went home directly from the emergency department more often, which is what they should do, why aren't the costs different?" he asked. In the ROMICAT II data, the answer appears to be that the minor differences in percutaneous-intervention and bypass-surgery rates between the two groups drive more costs, he said. And, he added, the revascularization rates shown in ROMICAT-II are relatively low. Gibbons believes that if the CCTA-first strategy were tried across the country, it would be associated with much greater costs than the standard-screening approach in many areas where hospitals revascularize a much higher portion of the chest-pain patients that present to the emergency department than the centers in ROMICAT-II.
"If the outcomes are equivalent, you should try to reduce total costs, and that should be the primary goal," Gibbons said. "I know that in some areas of the country that emergency-department overcrowding is an issue, but that pales in comparison to what is happening to Medicare and the total healthcare costs in this country."
Gibbons said that Medicare data show that increased utilization of CCTA screening leads to higher revascularization rates, and "I'm very worried about the impact of CCTA on revascularization rates, because these are [often] revascularizations of low value."
Getting patients out of the emergency room faster will not save nearly as much money as keeping the very low-risk patients from ever coming to the emergency department, Gibbons said. So a next step in the effort to cut costs in ACS treatment should be to develop tools to better screen the calls of worried patients who believe they might be suffering an ACS and encourage the very low-risk patients to see their cardiologist or general practitioner rather than come to the emergency department.
Hoffman has a more optimistic perspective on the cost data from ROMICAT II. "Previous reports [from Medicare data] showed a doubling of the cost with CT, really attributed to subsequent catheterizations, bypass surgeries, and stent placements, so we were very happy to see no increase in costs. That's a major step forward.
"But there's always room for improvement . . . in people getting used to using CT instead of nuclear stress testing in these patients," Hoffman said. He speculated that CCTA screening may become more cost-effective as emergency-department personnel gain more experience with the technology. In order to ensure that the ROMICAT II results could be generalizable to a broad range of medical centers, the centers chosen for the study were "not CT aficionados," and the trial investigators conducted education sessions to teach the trial sites how to use the CCTA to screen chest-pain patients. "We tried to provide a level ground. It will be interesting to see if there is a learning curve. I expect in the future, with this strong evidence that we have, that physicians can be more confident in making decisions [based on CCTA], so I expect that the effectiveness of CT will increase, because it's still a relatively new method," Hoffman said. He also expects to see continued improvement in the image quality of CCTA scans.
Dr Michael Crawford (University of California, San Francisco) pointed out that ROMICAT-II was confined to patients coming to the emergency department during the day, "so if you expand this to 24/7 coverage, the cost has to go up. So the question is, will you save downstream by ordering fewer tests, etc? That remains to be shown in the future."
Radiation Risk
At the conference, Dr Elliott Antman (Brigham and Women's Hospital, Boston, MA) pointed out that the patients' average total radiation exposure from imaging in the CCTA arm was about three times that of the patients in the control group (14.3 mSv vs 5.3 mSv, p<0.0001). "So this is the cost of saving about eight hours on the length of stay. If we adopt this strategy, I think it's important to recognize that patients with chest pain often re-present to emergency departments, and it might not be the same hospital where they [first] present," he said. "There is the potential for patients to have repeated exposures."
Hoffman acknowledged the risks of radiation exposure but pointed out that although the CCTA-screened patients absorbed more radiation than the control group because they underwent more imaging tests, the per-test dose of CCTA is much lower than the dose delivered to many of the control patients in the nuclear stress tests (average 11 mSv vs 40 mSv). Also, Budoff pointed out that in all three of the studies of the CCTA-screening strategy, the CCTA-screened patients had fewer repeat visits to the emergency department than the control group, "so if we look at cumulative radiation over the subsequent year, perhaps, rather than just 28 days, it might actually start to balance out a bit better."
Hoffmann added, "The trials so far have not been able to grasp the full association of implementing CT to the benefit of being able to bring in other patients more quickly and treatment more quickly." So a full account of the benefits of the CCTA-first approach would also have to measure the advantages of a less crowded emergency department. "That's a collateral effect that many emergency-department physicians consider as important as improving the triage of patients with ACS," he said.
Hoffman reported research grants from the National Institutes of Health and Siemens Medical Systems. Gibbons reports consulting for Lantheus Medical Imaging. Antman has research funding from Daiichi- Sankyo, Eli Lilly, Sanofi, AstraZeneca, Pfizer, Inotek, Roche, Schering-Plough, Merck, Millennium, GlaxoSmithKline, Novartis, and Amgen. Budoff has no disclosures.
Authors and Disclosures
Journalist
Reed Miller
Reed Miller joined theheart.org in 2009 after nearly a decade covering the medical technology industry, most recently as a senior editor for Elsevier's The Gray Sheet. He has been to more FDA advisory panel meetings than he cares to count. At Elsevier, he has also contributed to In Vivo and The Pink Sheet and spent a year as a managing editor for HCPro in Marblehead, MA writing about drug and device industry regulation and compliance.Disclosure: Reed Miller has disclosed no relevant financial relationships.
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