Manual Thrombectomy Optimizes PCI, But No Long-term Benefit in STEMI

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Manual thrombus aspiration during primary percutaneous coronary intervention (PCI) streamlines procedures, resulting in more direct stenting, less postdilatation, and larger and fewer stents compared with conventional primary PCI, according to a study published online May 27, 2014, in Circulation: Cardiovascular Interventions. However, its use did not improve clinical outcomes at 2 years.

Methods
The multicenter EXAMINATION trial randomized STEMI patients who presented within 48 hours and required emergent PCI to everolimus-eluting stents (EES; n = 751) or BMS (n = 747).
For the substudy, Manel Sabaté, MD, PhD, of IDIBAPS (Barcelona, Spain), and colleagues divided patients into 2 groups: those who received manual thrombus aspiration at operator discretion (n = 976) and those who did not (n = 522).

 

Better Revascularization Achieved

Patients in the thrombectomy group were more likely to use GPIs and had a higher rate of direct stenting and a lower rate of postdilatation. Fewer and larger stents were used with thrombus aspiration than standard primary PCI, and initial TIMI flow was lower in that group without any difference observed in final TIMI flow (table 1).

Table 1. Angiographic and Procedural Characteristics

 

Thrombus Aspiration
(n = 976)

Standard Primary PCI
(n = 522)

P Value

GPI Use

59.0%

40.0%

< .001

Direct Stenting

69.2%

43.3%

< .001

Postdilatation

13.0%

18.0%

< .009

Number of Stents

1.35 ± 0.62

1.45 ± 0.71

.005

Maximal Stent Diameter, mm

3.25 ± 0.44

3.11 ± 0.46

< .001

TIMI Flow
Initial
Final

 
0.58 ± 1.04
2.90 ± 0.44

 
1.62 ± 1.28
2.88 ± 0.51

 
< .001
.549

 
There was no difference between the cohorts in terms of the primary endpoint (all-cause death, MI, and any revascularization) at 2 years (P = .122). The lack of difference persisted after multivariate adjustment (adjusted HR 1.0; 95% CI 0.996-1.004; P = .862). Additionally, there was no difference in the device-oriented secondary endpoint (cardiac death, target vessel MI, and clinically driven TLR) between the groups (P = .202). Rates of definite/probable stent thrombosis and major and minor bleeding also were comparable.

Real-World Use Does Not Dovetail with Randomized Trials

“Although randomized trials have demonstrated that manual [thrombus aspiration] improves angiographic and clinical outcomes, in clinical practice, such devices are most often used in those patients presenting with high thrombotic burden,” Dr. Sabaté and colleagues write. “Our study confirms this finding as this device was more frequently used in larger MI with poorer clinical condition.”

The authors note that the study only included manual thrombus aspiration, as “previous studies have demonstrated the superiority in angiographic results of manual [thrombus aspiration] over mechanical thrombectomy.”

They also highlight the cost differences among various thrombectomy devices used in STEMI. “We can hypothesize that the observed reduction in the number of implanted stents and the lower number of angioplasty balloons for predilatation and postdilatation may reduce costs in primary PCI,” the authors write. “Therefore, further studies about the cost-effectiveness implications of the use of manual [thrombus aspiration] in primary PCI are warranted.”

Study Details

Patients in the thrombus aspiration group were younger (P = .007), less often female (P = .025), and less likely to have a previous MI (P = .049) or multivessel disease (P = .007) compared with those who received standard primary PCI.

 


Source:
Fernández-Rodriguez D, Regueiro A, Brugaletta S, et al. Optimization in stent implantation by manual thrombus aspiration in ST-segment elevation myocardial infarction: findings from the EXAMINATION trial. Circ Cardiovasc Interv. 2014;Epub ahead of print.


Disclosure:

  • Dr. Sabaté reports serving as a consultant to and receiving speaker fees from Abbott Vascular and Medtronic. 


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