Catheterization and Cardiovascular Interventions 82:1054–1055 (2013)
Editorial Comment To Aspirate or Not? The Question is Still Unanswered Sa’ar Minha, MD and Lowell F. Satler,* MD Division of Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
In this issue of Catheterization and Cardiovascular Interventions, Waldo et al. had a comprehensive and exhaustive extraction of patients from the University of California Stent Thrombosis Registry who were evaluated to determine the impact of adjunctive aspiration thrombectomy during percutaneous coronary intervention (PCI) for stent thrombosis [1]. Although aspiration thrombectomy was associated with improved procedural outcomes including Thrombolysis In Myocardial Infarction III flow, and higher angiographic and procedural success, the use of aspiration thrombectomy was not associated with any difference in long-term mortality or major cardiovascular events. This confusing conclusion is a common one in catheter-based thrombectomy (CBT). As this study was not a randomized trial, the authors admit that there is a significant limitation of the analysis. The interventionalist chooses a CBT strategy based on the patient’s duration of symptoms, angiographic appearance, hemodynamics, and presence of visible thrombus; as a result, the unpredictable confounding variability between patients undergoing thrombus aspiration and those who did not, creates operator biases that potentially could affect outcome. In addition, the total ischemic time of ischemia between the onset of symptoms and CBT is unknown, again potentially masking any important differences between the groups. In primary PCI for ST-segment elevation myocardial infarction (STEMI), the demonstration of CBT in the setting of acute MI is confusing. The thrombus aspiration during percutaneous coronary intervention in acute myocardial infarction (TAPAS) trial [2] showed a significant reduction in all-cause mortality at 1 year. This trial was one of the main reasons for considering CBT as a class IIb indication for PCI in STEMI patients, both by the ESC and the ACC guidelines. Other trials, such as INFUSE-AMI [3] and TASTE [4] failed to demonstrate significant reductions in all-cause mortality between the aspiration group and the conventional PCI group at 30 days. Why is there confusing clinical data regarding CBT? This may be due to one of several reasons. C 2013 Wiley Periodicals, Inc. V
1. There actually is no long-term effect with aspiration. 2. The confounding clinical variables overwhelm the minor benefit of improvement in reducing microvascular obstruction. 3. The long-term outcome is mainly driven by the safe and effective results of the current generation stents. 4. The aspiration devices are inadequate in effective aspiration. More efficient systems still need to be pursued. Neurointerventionalists have shifted to stent retrievers to enhance clot removal. Early reports in the coronary arteries suggest enhanced benefit [5]. May be a simpler approach for the need for CBT needs to be considered since not every intraprocedural device used necessarily has to have an improvement in hard outcome metrics (i.e., mortality at 1 year). We should acknowledge the following potential parameters that may assist when considering the use of CBT: 1. Prompt assessment of distal vessel size and characteristics. 2. Improved assessment of stent’s landing zone caliber and length. 3. Potential reductions in procedure time, radiation, and contrast load. Most of these metrics were not explored in the mentioned trial. In summary, why will interventionalists still use CBT in the setting of STEMI? Intraprocedural simplicity will trump confusing but important data. REFERENCES 1. Waldo SW, Armstrong EJ, Yeo K-K, Patel M, Reeves R, MacGregor JS, Low RI, Mahmud E, Rogers JH, Shunk K. Procedural success and long-term outcomes of aspiration thrombectomy for the treatment of stent thrombosis. Catheter Cardiovasc Interv 2013;82:1048–1053.
Conflict of interest: Nothing to report. *Correspondence to: Lowell F. Satler, MD; Division of Cardiology, MedStar Washington Hospital Center, Washington, DC 20010. E-mail: [email protected] Received 10 October 2013; Revision accepted 12 October 2013 DOI: 10.1002/ccd.25260 Published online 19 November 2013 in Wiley Online Library (wileyonlinelibrary.com)
To Aspirate or Not? The Question is Still Unanswered 2. Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the thrombus aspiration during percutaneous coronary intervention in acute myocardial infarction study (TAPAS): a 1-year follow-up study. Lancet 2008;371:1915–1920. 3. Stone GW, Maehara A, Witzenbichler B, Godlewski J, Parise H, Dambrink JH, Ochala A, Carlton TW, Cristea E, Wolff SD, Brener SJ, Chowdhary S, El-Omar M, Neunteufl T, Metzger DC, Karwoski T, Dizon JM, Mehran R, Gibson CM, INFUSE-AMI Investigators. Intracoronary abciximab and aspiration thrombec-
1055
tomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial. JAMA 2012;307:1817–1826. 4. Fr€obert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angera˚s O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Ka˚regren A, Nilsson J, Robertson L, Sandhall L, Sj€ogren I, Ostlund O, Harnek J, James SK. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med 2013. [Epub ahead of print] 5. Widimsky P, Coram R, Abou-Chebl A. Reperfusion therapy of acute ischaemic stroke and acute myocardial infarction: similarities and differences. Eur Heart J 2013. [Epub ahead of print]
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Editorial Comment To Aspirate or Not? The Question is Still Unanswered Sa’ar Minha, MD and Lowell F. Satler,* MD Division of Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
In this issue of Catheterization and Cardiovascular Interventions, Waldo et al. had a comprehensive and exhaustive extraction of patients from the University of California Stent Thrombosis Registry who were evaluated to determine the impact of adjunctive aspiration thrombectomy during percutaneous coronary intervention (PCI) for stent thrombosis [1]. Although aspiration thrombectomy was associated with improved procedural outcomes including Thrombolysis In Myocardial Infarction III flow, and higher angiographic and procedural success, the use of aspiration thrombectomy was not associated with any difference in long-term mortality or major cardiovascular events. This confusing conclusion is a common one in catheter-based thrombectomy (CBT). As this study was not a randomized trial, the authors admit that there is a significant limitation of the analysis. The interventionalist chooses a CBT strategy based on the patient’s duration of symptoms, angiographic appearance, hemodynamics, and presence of visible thrombus; as a result, the unpredictable confounding variability between patients undergoing thrombus aspiration and those who did not, creates operator biases that potentially could affect outcome. In addition, the total ischemic time of ischemia between the onset of symptoms and CBT is unknown, again potentially masking any important differences between the groups. In primary PCI for ST-segment elevation myocardial infarction (STEMI), the demonstration of CBT in the setting of acute MI is confusing. The thrombus aspiration during percutaneous coronary intervention in acute myocardial infarction (TAPAS) trial [2] showed a significant reduction in all-cause mortality at 1 year. This trial was one of the main reasons for considering CBT as a class IIb indication for PCI in STEMI patients, both by the ESC and the ACC guidelines. Other trials, such as INFUSE-AMI [3] and TASTE [4] failed to demonstrate significant reductions in all-cause mortality between the aspiration group and the conventional PCI group at 30 days. Why is there confusing clinical data regarding CBT? This may be due to one of several reasons. C 2013 Wiley Periodicals, Inc. V
1. There actually is no long-term effect with aspiration. 2. The confounding clinical variables overwhelm the minor benefit of improvement in reducing microvascular obstruction. 3. The long-term outcome is mainly driven by the safe and effective results of the current generation stents. 4. The aspiration devices are inadequate in effective aspiration. More efficient systems still need to be pursued. Neurointerventionalists have shifted to stent retrievers to enhance clot removal. Early reports in the coronary arteries suggest enhanced benefit [5]. May be a simpler approach for the need for CBT needs to be considered since not every intraprocedural device used necessarily has to have an improvement in hard outcome metrics (i.e., mortality at 1 year). We should acknowledge the following potential parameters that may assist when considering the use of CBT: 1. Prompt assessment of distal vessel size and characteristics. 2. Improved assessment of stent’s landing zone caliber and length. 3. Potential reductions in procedure time, radiation, and contrast load. Most of these metrics were not explored in the mentioned trial. In summary, why will interventionalists still use CBT in the setting of STEMI? Intraprocedural simplicity will trump confusing but important data. REFERENCES 1. Waldo SW, Armstrong EJ, Yeo K-K, Patel M, Reeves R, MacGregor JS, Low RI, Mahmud E, Rogers JH, Shunk K. Procedural success and long-term outcomes of aspiration thrombectomy for the treatment of stent thrombosis. Catheter Cardiovasc Interv 2013;82:1048–1053.
Conflict of interest: Nothing to report. *Correspondence to: Lowell F. Satler, MD; Division of Cardiology, MedStar Washington Hospital Center, Washington, DC 20010. E-mail: [email protected] Received 10 October 2013; Revision accepted 12 October 2013 DOI: 10.1002/ccd.25260 Published online 19 November 2013 in Wiley Online Library (wileyonlinelibrary.com)
To Aspirate or Not? The Question is Still Unanswered 2. Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the thrombus aspiration during percutaneous coronary intervention in acute myocardial infarction study (TAPAS): a 1-year follow-up study. Lancet 2008;371:1915–1920. 3. Stone GW, Maehara A, Witzenbichler B, Godlewski J, Parise H, Dambrink JH, Ochala A, Carlton TW, Cristea E, Wolff SD, Brener SJ, Chowdhary S, El-Omar M, Neunteufl T, Metzger DC, Karwoski T, Dizon JM, Mehran R, Gibson CM, INFUSE-AMI Investigators. Intracoronary abciximab and aspiration thrombec-
1055
tomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial. JAMA 2012;307:1817–1826. 4. Fr€obert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angera˚s O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Ka˚regren A, Nilsson J, Robertson L, Sandhall L, Sj€ogren I, Ostlund O, Harnek J, James SK. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med 2013. [Epub ahead of print] 5. Widimsky P, Coram R, Abou-Chebl A. Reperfusion therapy of acute ischaemic stroke and acute myocardial infarction: similarities and differences. Eur Heart J 2013. [Epub ahead of print]
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
