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Clinical question: Does the use of routine thrombectomy for patients presenting with ST-segment elevation myocardial infarction improve outcomes?
Bottom line: For patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the routine use of manual thrombectomy improves some electrocardiographic and angiographic outcomes, but ultimately does not result in improved cardiovascular morbidity or mortality. Moreover, thrombectomy may increase the risk of stroke. (LOE = 1b)
Reference: Jolly SS, Cairns JA, Yusuf S, et al, for the TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015;372(15):1389–1398.
Study design: Randomized controlled trial (nonblinded)
Funding source: Industry + govt
Allocation: Concealed
Setting: Inpatient (any location) with outpatient follow-up
Synopsis
Manual thrombectomy with aspiration of thrombus prior to PCI is thought to prevent distal embolization and improve microvascular perfusion. Whether this results in clinical benefit is unclear. In this study, the investigators randomized patients presenting with STEMI to undergo either routine thrombus aspiration followed by PCI or PCI alone. Those who had a previous history of coronary-artery bypass grafting or those who had received fibrinolytics were excluded. The 2 groups were balanced at baseline, with almost 80% of patients in each group noted to have a high thrombus burden. A modified intention-to-treat analysis was used that included only those patients who actually underwent PCI for the index STEMI.
Although electrocardiographic and angiographic outcomes improved with thrombectomy (eg, increased ST-segment resolution, decreased distal embolization), no clinical benefit was found. Specifically, for the primary outcome of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association class IV heart failure within 180 days of randomization, there were no significant differences detected between the 2 groups. The components of the composite outcome taken individually were also similar in each group. These results persisted across prespecified analyses of the as-treated population, per-protocol population, and the subgroup with high thrombus burden. Additionally, patients in the thrombectomy group were more likely to have a stroke within 30 days and 180 days, although the number of events was relatively small (for 30 days: 0.7% vs 0.3%, P = .02; for 180 days: 1% vs 0.5%, P = .002).
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
Clinical question: Does the use of routine thrombectomy for patients presenting with ST-segment elevation myocardial infarction improve outcomes?
Bottom line: For patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the routine use of manual thrombectomy improves some electrocardiographic and angiographic outcomes, but ultimately does not result in improved cardiovascular morbidity or mortality. Moreover, thrombectomy may increase the risk of stroke. (LOE = 1b)
Reference: Jolly SS, Cairns JA, Yusuf S, et al, for the TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015;372(15):1389–1398.
Study design: Randomized controlled trial (nonblinded)
Funding source: Industry + govt
Allocation: Concealed
Setting: Inpatient (any location) with outpatient follow-up
Synopsis
Manual thrombectomy with aspiration of thrombus prior to PCI is thought to prevent distal embolization and improve microvascular perfusion. Whether this results in clinical benefit is unclear. In this study, the investigators randomized patients presenting with STEMI to undergo either routine thrombus aspiration followed by PCI or PCI alone. Those who had a previous history of coronary-artery bypass grafting or those who had received fibrinolytics were excluded. The 2 groups were balanced at baseline, with almost 80% of patients in each group noted to have a high thrombus burden. A modified intention-to-treat analysis was used that included only those patients who actually underwent PCI for the index STEMI.
Although electrocardiographic and angiographic outcomes improved with thrombectomy (eg, increased ST-segment resolution, decreased distal embolization), no clinical benefit was found. Specifically, for the primary outcome of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association class IV heart failure within 180 days of randomization, there were no significant differences detected between the 2 groups. The components of the composite outcome taken individually were also similar in each group. These results persisted across prespecified analyses of the as-treated population, per-protocol population, and the subgroup with high thrombus burden. Additionally, patients in the thrombectomy group were more likely to have a stroke within 30 days and 180 days, although the number of events was relatively small (for 30 days: 0.7% vs 0.3%, P = .02; for 180 days: 1% vs 0.5%, P = .002).
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
Clinical question: Does the use of routine thrombectomy for patients presenting with ST-segment elevation myocardial infarction improve outcomes?
Bottom line: For patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the routine use of manual thrombectomy improves some electrocardiographic and angiographic outcomes, but ultimately does not result in improved cardiovascular morbidity or mortality. Moreover, thrombectomy may increase the risk of stroke. (LOE = 1b)
Reference: Jolly SS, Cairns JA, Yusuf S, et al, for the TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015;372(15):1389–1398.
Study design: Randomized controlled trial (nonblinded)
Funding source: Industry + govt
Allocation: Concealed
Setting: Inpatient (any location) with outpatient follow-up
Synopsis
Manual thrombectomy with aspiration of thrombus prior to PCI is thought to prevent distal embolization and improve microvascular perfusion. Whether this results in clinical benefit is unclear. In this study, the investigators randomized patients presenting with STEMI to undergo either routine thrombus aspiration followed by PCI or PCI alone. Those who had a previous history of coronary-artery bypass grafting or those who had received fibrinolytics were excluded. The 2 groups were balanced at baseline, with almost 80% of patients in each group noted to have a high thrombus burden. A modified intention-to-treat analysis was used that included only those patients who actually underwent PCI for the index STEMI.
Although electrocardiographic and angiographic outcomes improved with thrombectomy (eg, increased ST-segment resolution, decreased distal embolization), no clinical benefit was found. Specifically, for the primary outcome of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association class IV heart failure within 180 days of randomization, there were no significant differences detected between the 2 groups. The components of the composite outcome taken individually were also similar in each group. These results persisted across prespecified analyses of the as-treated population, per-protocol population, and the subgroup with high thrombus burden. Additionally, patients in the thrombectomy group were more likely to have a stroke within 30 days and 180 days, although the number of events was relatively small (for 30 days: 0.7% vs 0.3%, P = .02; for 180 days: 1% vs 0.5%, P = .002).
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.