ATLANTA, GA—Thrombectomy given in addition to direct stenting in patients experiencing ST-segment elevation myocardial infarction (STEMI) produces better myocardial perfusion and improves 6-month clinical outcomes compared with stenting alone.
Findings from the multicenter JETSTENT trial, presented Tuesday, March 16, 2010, at the ACC/i2 Summit, support routine thrombectomy use in STEMI patients with evidence of thrombus, according to investigator David Antoniucci, MD, of Careggi Hospital (Florence, Italy).
JETSTENT looked at STEMI patients admitted within 12 hours of symptom onset, excluding those who had received fibrinolysis, had a stroke within the previous 30 days or surgery within the previous 6 weeks, or been previously stented in the infarct-related artery. After angiography and guidewire placement, those with thrombus grade 3 to 5 were randomized to undergo direct stenting alone (n = 245) or stenting plus thrombectomy using the AngioJet (n = 256; MEDRAD, Minneapolis, MN). Abciximab was given to 97% of the thrombectomy group and 98% of the stenting group. Baseline characteristics were similar between groups. Notably, 2.7% of thrombectomy patients and 5.3% of stenting patients had cardiogenic shock, although the difference was not significant.
Better Results with Thrombectomy
The co-primary surrogate endpoint of ST-segment resolution ≥ 50% at 30 minutes occurred more frequently with thrombectomy (85.8%) than with stenting (78.8%; P = 0.043). Regardless of treatment, patients with early ST resolution experienced significantly lower rates of death and MACCE (composite of death, MI, TVR, and stroke) at both 1 and 6 months. But 1-month infarct size, the study’s other co-primary endpoint, did not differ between the thrombectomy and stenting groups (11.8% and 12.7%; P = 0.398).
Compared with stenting alone, thrombectomy significantly reduced MACCE at 1 month (3.1% vs. 6.9%; P = 0.050) and at 6 months (12.0% vs. 20.7%; P = 0.012). Outcomes for death, MI, and TVR appeared to favor thrombectomy, whereas stroke was nearly equal between the 2 treatments.
Logistic regression analysis showed several predictors of ST-segment resolution and MACCE (tables 1 and 2).
Table 1. Predictors of ST-Segment Resolution ≥ 50% at 30 Minutes
|
OR
|
95% CI
|
P Value
|
Randomization to Thrombectomy
|
1.81
|
1.09-3.00
|
0.22
|
Anterior Acute MI
|
0.28
|
0.17-0.46
|
< 0.001
|
Abciximab Use
|
4.28
|
1.22-14.95
|
0.023
|
TIMI 3 Flow
|
2.10
|
1.17-3.80
|
0.013
|
Table 2. Predictors of MACCE at 1 Month
|
OR
|
95% CI
|
P Value
|
Randomization to Thrombectomy
|
0.30
|
0.11-0.80
|
0.017
|
Abciximab Use
|
0.10
|
0.02-0.43
|
0.002
|
TIMI 3 Flow
|
0.16
|
0.06-0.41
|
< 0.001
|
Bleeding
|
9.11
|
2.17-38.17
|
0.003
|
The results of the JETSTENT trial show better myocardial perfusion and 6-month outcomes, thus supporting “the routine use of rheolytic thrombectomy in STEMI patients with evidence of thrombus,” Dr. Antoniucci concluded.
Reassuring Data With Some Caveats
Gregg W. Stone, MD, of Columbia University Medical Center (New York, NY), noted it is worth remembering that JETSTENT was conducted in the context of the AIMI (AngioJet Rheolytic Thrombectomy In Patients Undergoing Primary Angioplasty for Acute Myocardial Infarction) trial, which found an increase in mortality and infarct size after thrombectomy in an unselected population. “So these results are reassuring,” he commented, although he pointed out that the difference in MACCE in JETSTENT is driven by TVR; both MI and death rates were statistically similar between the 2 treatments.
Panelist William W. O’Neill, MD, of the University of Miami (Miami, FL), praised JETSTENT for being very well conducted and said that it refocuses interventionalists on an issue that has been known for 25 years: the problem of thrombus burden and how to effectively treat it in the acute MI setting.
While he approved of the choice of ST-segment resolution for a primary endpoint, Dr. O’Neill was unsurprised at the null finding for infarct size, because most trials have shown “very little incremental benefit for infarct size reduction in non-anterior MI,” which represented 60% of cases in JETSTENT.
The observed reduction in 6-month MACCE is noteworthy, Dr. O’Neil said, because “now we have something that goes along with the TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction] trial, which also demonstrated there was some survival benefit at 1 year.”
Periprocedural Outcomes
Periprocedural success was 93% in both arms and complications were rare, reported Dr. Antoniucci. Major TIMI bleeding occurred in 3.9% of the thrombectomy group and 1.6% of the stenting group (P = 0.123). Thrombectomy-related pacing was observed in 2 patients belonging to that treatment group, while perforation occurred in 1 patient who underwent stenting. Thrombectomy involved significantly longer procedure time (59.5 vs. 46 minutes; P < 0.001) but fewer stents per patients (1.26 vs. 1.40; P = 0.022) and shorter mean stent length (23.7 vs. 25.9 mm; P = 0.050).
Source:
Antoniucci D. Comparison of AngioJET rheolytic thrombectomy before direct infarct artery STENTing in patients with acute myocardial infarction: The JETSTENT trial. Presented at: American College of Cardiology Annual Scientific Session/i2 Summit; March 16, 2010; Atlanta, GA.
Disclosures:
- Dr. Antoniucci reports no relevant conflicts of interest.
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