Major Finding: Survey results showed that 36% of responding interventional cardiologists routinely use aspiration thrombectomy when treating patients with an acute ST-segment elevation myocardial infarction.
Data Source: Internet-based survey with responses from 477 interventional cardiologists worldwide.
Disclosures: TOTAL is using the Export catheter, which is marketed by Medtronic. Medtronic is cofunding this trial along with the Canadian Network and Centre for Trials Internationally. Dr. Jolly said that he has received grant support from Medtronic, and has received speakers' honoraria from GlaxoSmithKline, Sanofi-Aventis, and Boehringer Ingelheim.
CHICAGO – Most interventional cardiologists remain wary of using thrombus aspiration as initial treatment for an acute myocardial infarction, despite the striking mortality benefit reported for this approach in a single-center study more than 2 years ago.
“Interventional cardiologists feel that a definitive randomized, controlled trial is needed,” according to results from an Internet-based survey with responses from 477 interventionalists, Dr. Sanjit S. Jolly said at the meeting.
Based in part on the equipoise the survey revealed among interventionalists between aspiration thrombectomy followed by percutaneous coronary intervention (PCI), and PCI alone, for treating an acute myocardial infarction, Dr. Jolly said that he and his associates began TOTAL, a multicenter Trial of Routine Aspiration Thrombectomy With Percutaneous Coronary Intervention versus PCI Alone in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary PCI.
The researchers designed TOTAL to randomize 4,000 patients, said Dr. Jolly, a cardiologist at McMaster University in Hamilton, Ont. He said they hope to have the study completed within the next 2 years.
Aspiration thrombectomy as initial treatment for an acute ST-segment elevation myocardial infarction burst onto the scene in June 2008 with the publication of results from the Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction Study (TAPAS), which involved 1,071 patients treated at the University Medical Center Groningen (the Netherlands).
In that study, at 1 year after treatment, the rate of cardiac death reached 3.6% in the patients randomized to thrombectomy plus PCI and 6.7% in those treated by standard PCI alone. The difference was statistically significant (Lancet 2008;371:1915-20).
This “unexpected” substantial advantage in favor of thrombectomy “created a lot of press,” Dr. Jolly commented.
However, a subsequent meta-analysis of thrombectomy for treating acute myocardial infarctions that included 21 studies (including the results from TAPAS) with a total of nearly 4,300 patients failed to find that adding thrombectomy led to a significant improvement in survival compared with primary PCI alone (Circ. Cardiovasc. Interv. 2010;3:6-16).
To get a better sense of the worldwide use of thrombectomy, Dr. Jolly and his associates distributed their survey to 1,651 interventionalists worldwide and received 477 responses. The results showed that 36% of respondents reported using thrombectomy routinely along with PCI when treating patients with an acute ST-segment elevation MI.
This usage rate appeared similar in all world regions. The respondents most commonly used the Medtronic 6F Export aspiration catheter, the same device used in the TAPAS study. Of respondents, 80% said that they had the suction turned on before crossing the lesion, and 83% left it on as they withdrew the catheter.
In addition, 20% of the respondents said that they had at least one significant complication when using the device, “an important issue,” Dr. Jolly said.
The most common specific complication cited was thrombus pulled back into the left main coronary artery, reported by 5% of respondents.
Finally, 89% of respondents said that they thought a large randomized trial should assess the safety and efficacy of aspiration thrombectomy in this setting, and 85% expressed a willingness to randomize their patients.
Even among cardiologists who said that they already routinely used thrombectomy for treating patients with an acute myocardial infarction, a similar, large majority voiced their preference for running the trial, Dr. Jolly said.
'Interventional cardiologists feel that a definitive randomized, controlled trial is needed.'
Source DR. JOLLY