TCT: Routine thrombectomy with PCI raises stroke risk 66% in STEMI patients

Routine manual thrombectomy during percutaneous coronary intervention offers no significant long-term benefit over PCI alone for patients with acute ST-segment–elevation myocardial infarction.

In fact, thrombectomy was associated with a 66% increase in stroke risk in the year following a heart attack, Dr. Sanjit Jolly reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

A 1-year analysis of the TOTAL trial confirmed the study’s recently published 1-month findings: Routine thrombectomy isn’t any better than PCI alone in the clinical outcomes of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure.

As it was at 1 month, however, stroke at 1 year was significantly more common; it occurred in 60 patients (1.2%) in the thrombectomy group and 36 (0.7%) in the PCI-alone group, for an increase in risk of 66% (P = .015).

The findings were simultaneously published online (Lancet 2015 Oct 13 doi: 10.1016/ S0140-6736[15]00448-1).

“Based on these endpoints, manual thrombectomy can no longer be recommended as a primary strategy in these patients,” Dr. Jolly said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

Despite the unequivocal findings, it’s unclear when clinicians will completely embrace TOTAL’s results, noted Dr. Jolly of McMaster University, Hamilton, Ont.

“Unfortunately, practice has not changed with these findings. It often takes time for new evidence to get translated into the clinic, although some of my colleagues have told me that the results are giving them pause, causing them to use less thrombus aspiration. But interventional cardiologists are very visually driven. If we see something, we want to take it out. So it may take some time for these to be adopted,” he said.

The Thromwbectomy With PCI Versus PCI Alone in Patients With STEMI (TOTAL) trial randomized 10,723 patients to percutaneous coronary intervention with or without routine manual thrombectomy. The primary outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association class IV heart failure within 180 days. The key safety outcome was stroke within 30 days.

The TOTAL results showed no difference in the primary outcome between thrombectomy and PCI patients (6.9% vs. 7%) (N Engl J Med. 2015 Apr 9;372[15]:1389-98).

Rates of cardiovascular death were similar (3% in each group) as were those for a combination of the primary outcome plus stent thrombosis or revascularization (10% in each group). Patients who had a thrombectomy were twice as likely to have a stroke within 30 days, although the absolute numbers were small (0.7% vs. 0.3%; HR, 2.06).

The 1-year follow-up study provided important perspective about the long-term risks and benefits of the two strategies.

There was no difference in the rate of the composite endpoint, which occurred in 7.8% of each group. Cardiovascular death occurred in 3.6% of the thrombectomy group and 3.8% of the PCI-alone group. There were similar rates of recurrent heart attack (2.5% vs. 2.3%), cardiogenic shock (1.9% vs. 2.1%), and class IV heart failure (2.1% vs. 1.9%).

The finding of significantly elevated stroke risk at 30 days was also present at 1 year, occurring in 1.2% of the thrombectomy patients and 0.7% of the PCI-alone patients (HR, 1.66; P = .015). The risk of a combination of stroke or transient ischemic attack was also increased significantly, by 65%, occurring in 1.4% and 0.9%, respectively (HR, 1.65; P = .008).

To further confirm the findings, Dr. Jolly also presented a meta-analysis of all-cause mortality in 20,352 patients involved in 16 studies comparing PCI plus thrombectomy with PCI alone. The meta-analysis also found that routine thrombectomy conferred no mortality benefit over PCI.

It did, however, confirm a 43% increased risk of stroke in PCI plus thrombectomy vs. PCI alone, at 0.9% and 0.6% (P = .03).

TOTAL was funded by the Canadian Institutes of Health Research, the Canadian Network and Centre for Trials Internationally, and Medtronic. Dr. Jolly received grants from Medtronic during the study.

[email protected]

On Twitter @Alz_Gal

Routine manual thrombectomy during percutaneous coronary intervention offers no significant long-term benefit over PCI alone for patients with acute ST-segment–elevation myocardial infarction.

In fact, thrombectomy was associated with a 66% increase in stroke risk in the year following a heart attack, Dr. Sanjit Jolly reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

A 1-year analysis of the TOTAL trial confirmed the study’s recently published 1-month findings: Routine thrombectomy isn’t any better than PCI alone in the clinical outcomes of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure.

As it was at 1 month, however, stroke at 1 year was significantly more common; it occurred in 60 patients (1.2%) in the thrombectomy group and 36 (0.7%) in the PCI-alone group, for an increase in risk of 66% (P = .015).

The findings were simultaneously published online (Lancet 2015 Oct 13 doi: 10.1016/ S0140-6736[15]00448-1).

“Based on these endpoints, manual thrombectomy can no longer be recommended as a primary strategy in these patients,” Dr. Jolly said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

Despite the unequivocal findings, it’s unclear when clinicians will completely embrace TOTAL’s results, noted Dr. Jolly of McMaster University, Hamilton, Ont.

“Unfortunately, practice has not changed with these findings. It often takes time for new evidence to get translated into the clinic, although some of my colleagues have told me that the results are giving them pause, causing them to use less thrombus aspiration. But interventional cardiologists are very visually driven. If we see something, we want to take it out. So it may take some time for these to be adopted,” he said.

The Thromwbectomy With PCI Versus PCI Alone in Patients With STEMI (TOTAL) trial randomized 10,723 patients to percutaneous coronary intervention with or without routine manual thrombectomy. The primary outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association class IV heart failure within 180 days. The key safety outcome was stroke within 30 days.

The TOTAL results showed no difference in the primary outcome between thrombectomy and PCI patients (6.9% vs. 7%) (N Engl J Med. 2015 Apr 9;372[15]:1389-98).

Rates of cardiovascular death were similar (3% in each group) as were those for a combination of the primary outcome plus stent thrombosis or revascularization (10% in each group). Patients who had a thrombectomy were twice as likely to have a stroke within 30 days, although the absolute numbers were small (0.7% vs. 0.3%; HR, 2.06).

The 1-year follow-up study provided important perspective about the long-term risks and benefits of the two strategies.

There was no difference in the rate of the composite endpoint, which occurred in 7.8% of each group. Cardiovascular death occurred in 3.6% of the thrombectomy group and 3.8% of the PCI-alone group. There were similar rates of recurrent heart attack (2.5% vs. 2.3%), cardiogenic shock (1.9% vs. 2.1%), and class IV heart failure (2.1% vs. 1.9%).

The finding of significantly elevated stroke risk at 30 days was also present at 1 year, occurring in 1.2% of the thrombectomy patients and 0.7% of the PCI-alone patients (HR, 1.66; P = .015). The risk of a combination of stroke or transient ischemic attack was also increased significantly, by 65%, occurring in 1.4% and 0.9%, respectively (HR, 1.65; P = .008).

To further confirm the findings, Dr. Jolly also presented a meta-analysis of all-cause mortality in 20,352 patients involved in 16 studies comparing PCI plus thrombectomy with PCI alone. The meta-analysis also found that routine thrombectomy conferred no mortality benefit over PCI.

It did, however, confirm a 43% increased risk of stroke in PCI plus thrombectomy vs. PCI alone, at 0.9% and 0.6% (P = .03).

TOTAL was funded by the Canadian Institutes of Health Research, the Canadian Network and Centre for Trials Internationally, and Medtronic. Dr. Jolly received grants from Medtronic during the study.

[email protected]

On Twitter @Alz_Gal

Routine manual thrombectomy during percutaneous coronary intervention offers no significant long-term benefit over PCI alone for patients with acute ST-segment–elevation myocardial infarction.

In fact, thrombectomy was associated with a 66% increase in stroke risk in the year following a heart attack, Dr. Sanjit Jolly reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

A 1-year analysis of the TOTAL trial confirmed the study’s recently published 1-month findings: Routine thrombectomy isn’t any better than PCI alone in the clinical outcomes of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure.

As it was at 1 month, however, stroke at 1 year was significantly more common; it occurred in 60 patients (1.2%) in the thrombectomy group and 36 (0.7%) in the PCI-alone group, for an increase in risk of 66% (P = .015).

The findings were simultaneously published online (Lancet 2015 Oct 13 doi: 10.1016/ S0140-6736[15]00448-1).

“Based on these endpoints, manual thrombectomy can no longer be recommended as a primary strategy in these patients,” Dr. Jolly said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

Despite the unequivocal findings, it’s unclear when clinicians will completely embrace TOTAL’s results, noted Dr. Jolly of McMaster University, Hamilton, Ont.

“Unfortunately, practice has not changed with these findings. It often takes time for new evidence to get translated into the clinic, although some of my colleagues have told me that the results are giving them pause, causing them to use less thrombus aspiration. But interventional cardiologists are very visually driven. If we see something, we want to take it out. So it may take some time for these to be adopted,” he said.

The Thromwbectomy With PCI Versus PCI Alone in Patients With STEMI (TOTAL) trial randomized 10,723 patients to percutaneous coronary intervention with or without routine manual thrombectomy. The primary outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association class IV heart failure within 180 days. The key safety outcome was stroke within 30 days.

The TOTAL results showed no difference in the primary outcome between thrombectomy and PCI patients (6.9% vs. 7%) (N Engl J Med. 2015 Apr 9;372[15]:1389-98).

Rates of cardiovascular death were similar (3% in each group) as were those for a combination of the primary outcome plus stent thrombosis or revascularization (10% in each group). Patients who had a thrombectomy were twice as likely to have a stroke within 30 days, although the absolute numbers were small (0.7% vs. 0.3%; HR, 2.06).

The 1-year follow-up study provided important perspective about the long-term risks and benefits of the two strategies.

There was no difference in the rate of the composite endpoint, which occurred in 7.8% of each group. Cardiovascular death occurred in 3.6% of the thrombectomy group and 3.8% of the PCI-alone group. There were similar rates of recurrent heart attack (2.5% vs. 2.3%), cardiogenic shock (1.9% vs. 2.1%), and class IV heart failure (2.1% vs. 1.9%).

The finding of significantly elevated stroke risk at 30 days was also present at 1 year, occurring in 1.2% of the thrombectomy patients and 0.7% of the PCI-alone patients (HR, 1.66; P = .015). The risk of a combination of stroke or transient ischemic attack was also increased significantly, by 65%, occurring in 1.4% and 0.9%, respectively (HR, 1.65; P = .008).

To further confirm the findings, Dr. Jolly also presented a meta-analysis of all-cause mortality in 20,352 patients involved in 16 studies comparing PCI plus thrombectomy with PCI alone. The meta-analysis also found that routine thrombectomy conferred no mortality benefit over PCI.

It did, however, confirm a 43% increased risk of stroke in PCI plus thrombectomy vs. PCI alone, at 0.9% and 0.6% (P = .03).

TOTAL was funded by the Canadian Institutes of Health Research, the Canadian Network and Centre for Trials Internationally, and Medtronic. Dr. Jolly received grants from Medtronic during the study.

[email protected]

On Twitter @Alz_Gal