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ORLANDO – Dual antiplatelet therapy with clopidogrel and aspirin was more effective and about as safe as aspirin alone for preventing and mitigating migraine headaches in patients who underwent transcatheter atrial-septal defect closure.
The finding both solidified dual-antiplatelet therapy (DAPT) as default treatment following transcatheter atrial-septal defect (ASD) closure, and advanced thrombotic etiology as a plausible explanation for at least some types of migraine headaches, especially those that follow this type of procedure, Dr. Josep Rodés-Cabau said at the American Heart Association scientific sessions.
Prior results indicated a roughly 15% incidence of new-onset migraines following transcatheter ASD closure, and in the current trial patients in the control arm, who received 80 mg/day of aspirin for 3 months, had a 22% rate of new-onset migraines, compared with a 10% rate among patients randomized to postprocedure treatment with 80 mg aspirin plus 75 mg clopidogrel daily, reported Dr. Rodés-Cabau, a cardiologist at the Quebec Heart and Lung Institute of Laval University in Quebec City.
For the study’ primary endpoint, the average number of days with migraine per month during the first 3 months following transcatheter ASD closure, treatment with aspirin alone produced a 1.4-day rate in 87 patients, compared with a 0.4 day per month average rate in patients who received clopidogrel plus aspirin, a 62% relative risk reduction that was statistically significant, Dr Rodés-Cabau said.
He and his associates ran the CANOA (Clopidogrel for the Prevention of New-Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects) trial at six Canadian centers. They enrolled patients who underwent transcatheter ASD repair with the AMPLATZER device and had no history of migraine. The patients’ average age was 49 years, and the average device size was 22 mm. The researchers defined migraines based on 2004 criteria of the International Headache Society (Cephalagia 2004;24 suppl 1:9-160).
Dr. Rodés-Cabau noted that the modest-appearing effect of DAPT on the average number of migraine days per month can be explained by the relatively small percentage of enrolled patients who actually developed migraines. In addition to substantially cutting the number of patients with a migraine, DAPT also produced an important benefit specifically for patients who developed migraines by cutting the number with moderately or severely disabling headaches from eight patients in the aspirin monotherapy arm to zero patients in the DAPT arm.
The adverse event profile in both arms was mild and statistically similar. Five DAPT patients had minor bleeding events, compared with one patient in the aspirin monotherapy arm, a difference that was not statistically significant. No patient in either arm experienced a major bleeding episode during 3 months on study treatment.
Concurrent with Dr. Rodés-Cabau’s report at the meeting the results appeared in an online article (JAMA 2015 Nov 9. doi: 10.1001/jama.2015.13919).
On Twitter @mitchelzoler
Most American centers now routinely treat patients who undergo transcatheter atrial-septal defect closure with dual antiplatelet therapy for 3-6 months, and the results of the CANOA study will only accelerate wider adoption of this approach. The findings of this well-run study support the idea that, in at least a significant percentage of patients with new-onset migraine following closure, the apparent cause is microemboli production, possibly along with serotonin release. Other possible links between closure and migraine could explain other cases. Unfortunately, the study did not try to measure thrombi formation in patients.
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| Mitchel L. Zoler/Frontline Medical News Dr. J. Dawn Abbott |
The CANOA trial fulfilled its primary endpoint, a reduction in average migraine days per month. The overall rate of new-onset migraine in the control arm, 22%, is a bit higher than we might have expected, but when patients are asked to maintain headache diaries, their awareness of headache would be high. The results are not necessarily generalizable to patients who undergo atrial-septal defect closure using devices other than the AMPLATZER device used in this study.
The study did not address the optimal duration of treatment, although 3 months is reasonable, and it would be useful to more closely examine nonresponders to try to gain better insight into the mechanism of effect from dual-antiplatelet therapy in these patients.
Dual antiplatelet therapy poses an increased bleeding risk, compared with aspirin monotherapy. When applying these results to individual patients, it will be important to take into account each patient’s potential risk and benefit from treatment to decide whether treatment seems warranted.
Dr. J. Dawn Abbott is an interventional cardiologist at Brown University in Providence, R.I. She had no disclosures. She made these comments as designated discussant for the report and in an interview.
Most American centers now routinely treat patients who undergo transcatheter atrial-septal defect closure with dual antiplatelet therapy for 3-6 months, and the results of the CANOA study will only accelerate wider adoption of this approach. The findings of this well-run study support the idea that, in at least a significant percentage of patients with new-onset migraine following closure, the apparent cause is microemboli production, possibly along with serotonin release. Other possible links between closure and migraine could explain other cases. Unfortunately, the study did not try to measure thrombi formation in patients.
|
| Mitchel L. Zoler/Frontline Medical News Dr. J. Dawn Abbott |
The CANOA trial fulfilled its primary endpoint, a reduction in average migraine days per month. The overall rate of new-onset migraine in the control arm, 22%, is a bit higher than we might have expected, but when patients are asked to maintain headache diaries, their awareness of headache would be high. The results are not necessarily generalizable to patients who undergo atrial-septal defect closure using devices other than the AMPLATZER device used in this study.
The study did not address the optimal duration of treatment, although 3 months is reasonable, and it would be useful to more closely examine nonresponders to try to gain better insight into the mechanism of effect from dual-antiplatelet therapy in these patients.
Dual antiplatelet therapy poses an increased bleeding risk, compared with aspirin monotherapy. When applying these results to individual patients, it will be important to take into account each patient’s potential risk and benefit from treatment to decide whether treatment seems warranted.
Dr. J. Dawn Abbott is an interventional cardiologist at Brown University in Providence, R.I. She had no disclosures. She made these comments as designated discussant for the report and in an interview.
Most American centers now routinely treat patients who undergo transcatheter atrial-septal defect closure with dual antiplatelet therapy for 3-6 months, and the results of the CANOA study will only accelerate wider adoption of this approach. The findings of this well-run study support the idea that, in at least a significant percentage of patients with new-onset migraine following closure, the apparent cause is microemboli production, possibly along with serotonin release. Other possible links between closure and migraine could explain other cases. Unfortunately, the study did not try to measure thrombi formation in patients.
|
| Mitchel L. Zoler/Frontline Medical News Dr. J. Dawn Abbott |
The CANOA trial fulfilled its primary endpoint, a reduction in average migraine days per month. The overall rate of new-onset migraine in the control arm, 22%, is a bit higher than we might have expected, but when patients are asked to maintain headache diaries, their awareness of headache would be high. The results are not necessarily generalizable to patients who undergo atrial-septal defect closure using devices other than the AMPLATZER device used in this study.
The study did not address the optimal duration of treatment, although 3 months is reasonable, and it would be useful to more closely examine nonresponders to try to gain better insight into the mechanism of effect from dual-antiplatelet therapy in these patients.
Dual antiplatelet therapy poses an increased bleeding risk, compared with aspirin monotherapy. When applying these results to individual patients, it will be important to take into account each patient’s potential risk and benefit from treatment to decide whether treatment seems warranted.
Dr. J. Dawn Abbott is an interventional cardiologist at Brown University in Providence, R.I. She had no disclosures. She made these comments as designated discussant for the report and in an interview.
ORLANDO – Dual antiplatelet therapy with clopidogrel and aspirin was more effective and about as safe as aspirin alone for preventing and mitigating migraine headaches in patients who underwent transcatheter atrial-septal defect closure.
The finding both solidified dual-antiplatelet therapy (DAPT) as default treatment following transcatheter atrial-septal defect (ASD) closure, and advanced thrombotic etiology as a plausible explanation for at least some types of migraine headaches, especially those that follow this type of procedure, Dr. Josep Rodés-Cabau said at the American Heart Association scientific sessions.
Prior results indicated a roughly 15% incidence of new-onset migraines following transcatheter ASD closure, and in the current trial patients in the control arm, who received 80 mg/day of aspirin for 3 months, had a 22% rate of new-onset migraines, compared with a 10% rate among patients randomized to postprocedure treatment with 80 mg aspirin plus 75 mg clopidogrel daily, reported Dr. Rodés-Cabau, a cardiologist at the Quebec Heart and Lung Institute of Laval University in Quebec City.
For the study’ primary endpoint, the average number of days with migraine per month during the first 3 months following transcatheter ASD closure, treatment with aspirin alone produced a 1.4-day rate in 87 patients, compared with a 0.4 day per month average rate in patients who received clopidogrel plus aspirin, a 62% relative risk reduction that was statistically significant, Dr Rodés-Cabau said.
He and his associates ran the CANOA (Clopidogrel for the Prevention of New-Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects) trial at six Canadian centers. They enrolled patients who underwent transcatheter ASD repair with the AMPLATZER device and had no history of migraine. The patients’ average age was 49 years, and the average device size was 22 mm. The researchers defined migraines based on 2004 criteria of the International Headache Society (Cephalagia 2004;24 suppl 1:9-160).
Dr. Rodés-Cabau noted that the modest-appearing effect of DAPT on the average number of migraine days per month can be explained by the relatively small percentage of enrolled patients who actually developed migraines. In addition to substantially cutting the number of patients with a migraine, DAPT also produced an important benefit specifically for patients who developed migraines by cutting the number with moderately or severely disabling headaches from eight patients in the aspirin monotherapy arm to zero patients in the DAPT arm.
The adverse event profile in both arms was mild and statistically similar. Five DAPT patients had minor bleeding events, compared with one patient in the aspirin monotherapy arm, a difference that was not statistically significant. No patient in either arm experienced a major bleeding episode during 3 months on study treatment.
Concurrent with Dr. Rodés-Cabau’s report at the meeting the results appeared in an online article (JAMA 2015 Nov 9. doi: 10.1001/jama.2015.13919).
On Twitter @mitchelzoler
ORLANDO – Dual antiplatelet therapy with clopidogrel and aspirin was more effective and about as safe as aspirin alone for preventing and mitigating migraine headaches in patients who underwent transcatheter atrial-septal defect closure.
The finding both solidified dual-antiplatelet therapy (DAPT) as default treatment following transcatheter atrial-septal defect (ASD) closure, and advanced thrombotic etiology as a plausible explanation for at least some types of migraine headaches, especially those that follow this type of procedure, Dr. Josep Rodés-Cabau said at the American Heart Association scientific sessions.
Prior results indicated a roughly 15% incidence of new-onset migraines following transcatheter ASD closure, and in the current trial patients in the control arm, who received 80 mg/day of aspirin for 3 months, had a 22% rate of new-onset migraines, compared with a 10% rate among patients randomized to postprocedure treatment with 80 mg aspirin plus 75 mg clopidogrel daily, reported Dr. Rodés-Cabau, a cardiologist at the Quebec Heart and Lung Institute of Laval University in Quebec City.
For the study’ primary endpoint, the average number of days with migraine per month during the first 3 months following transcatheter ASD closure, treatment with aspirin alone produced a 1.4-day rate in 87 patients, compared with a 0.4 day per month average rate in patients who received clopidogrel plus aspirin, a 62% relative risk reduction that was statistically significant, Dr Rodés-Cabau said.
He and his associates ran the CANOA (Clopidogrel for the Prevention of New-Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects) trial at six Canadian centers. They enrolled patients who underwent transcatheter ASD repair with the AMPLATZER device and had no history of migraine. The patients’ average age was 49 years, and the average device size was 22 mm. The researchers defined migraines based on 2004 criteria of the International Headache Society (Cephalagia 2004;24 suppl 1:9-160).
Dr. Rodés-Cabau noted that the modest-appearing effect of DAPT on the average number of migraine days per month can be explained by the relatively small percentage of enrolled patients who actually developed migraines. In addition to substantially cutting the number of patients with a migraine, DAPT also produced an important benefit specifically for patients who developed migraines by cutting the number with moderately or severely disabling headaches from eight patients in the aspirin monotherapy arm to zero patients in the DAPT arm.
The adverse event profile in both arms was mild and statistically similar. Five DAPT patients had minor bleeding events, compared with one patient in the aspirin monotherapy arm, a difference that was not statistically significant. No patient in either arm experienced a major bleeding episode during 3 months on study treatment.
Concurrent with Dr. Rodés-Cabau’s report at the meeting the results appeared in an online article (JAMA 2015 Nov 9. doi: 10.1001/jama.2015.13919).
On Twitter @mitchelzoler
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point: Three months of dual antiplatelet therapy surpassed aspirin monotherapy for preventing new-onset migraine headaches following transcatheter atrial-septal defect closure.
Major finding: Patients on DAPT had 0.4 migraine days per month, compared with a 1.4-day per month rate with aspirin monotherapy.
Data source: CANOA, a randomized trial with 171 patients run at six Canadian centers.
Disclosures: CANOA was investigator initiated. It received partial funding with unrestricted grants from Sanofi and St. Jude Medical. St. Jude markets the AMPLATZER device. Dr. Josep Rodés-Cabau had no disclosures. Dr. Abbott had no disclosures.
