LIPSIA: No Rush for Treatment of High-Risk NSTEMI Patients

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An immediate invasive approach in high-risk patients with non-ST-segment elevation myocardial infarction (NSTEMI) provides no advantage over a delayed or selective strategy, according to randomized trial data published online November 21, 2011, ahead of print in the European Heart Journal.

For the multicenter LIPSIA-NSTEMI (Leipzig Immediate versus early and late PercutaneouS coronary Intervention triAl in NSTEMI) study, Holger Thiele, MD, of the University of Leipzig (Leipzig, Germany), and colleagues randomized 602 NSTEMI patients to an immediate (< 2 hours; n = 201), early (10-48 hours; n = 200), or selective invasive approach (initial medical treatment; n = 201). All patients were pretreated with unfractionated heparin. Baseline characteristics were well balanced among the treatment groups.

Timing Did Not Matter

Virtually all patients assigned to immediate or early intervention underwent angiography compared with 85% of those in the selective group (P < 0.001). No difference was found among the groups for the primary endpoint, peak CK-MB activity during the index hospitalization, or for estimated infarct size based on area under the curve of CK-MB release (table 1).

Table 1. Comparison of Peak CK-MB by Intervention Timing

 

Immediate

Early

Selective

P Value

Peak CK-MB, U/L

0.94

0.78

0.91

0.18

CK-MB Area Under the Curve, U/L/h

30.7

25.9

28.0

0.18


At 6 months, patients undergoing immediate intervention had a lower rate of refractory ischemia but a higher rate of nonfatal MI compared with the early and selective strategy groups. There were no differences among the arms for the combined endpoints of death and nonfatal MI; death, nonfatal MI, and refractory ischemia; or death, nonfatal MI, refractory ischemia, and rehospitalization for unstable angina (table 2).

Table 2. Six-Month Outcomes by Intervention Timing

 

Immediate

Early

Selective

P Value

Nonfatal MI

16.5%

10%

8%

0.02

Refractory Ischemia

0

6.5%

10%

< 0.001

Death and Nonfatal MI

21%

16%

14.5%

0.20

Death, Nonfatal MI, Refractory Ischemia

21%

21.5%

22%

0.97

Death, Nonfatal MI, Refractory Ischemia, Rehospitalization for Unstable Angina

26%

26.5%

24.5%

0.89


Patients in the immediate and early invasive groups had shorter hospital stays than patients in the selective group (4 days each vs. 5 days; P < 0.001). No differences were seen in the incidence of various types of bleeding.

“In NTEMI patients, an immediate invasive approach does not offer an advantage over an early or a selective invasive approach with respect to large [MIs] as defined by peak CK-MB levels,” the researchers conclude.

Data Are Confirmatory

In a telephone interview with TCTMD, John Bittl, MD, of the Central Florida Heart Center (Ocala, FL), said that the current data reinforce what is known from prior similar studies such as ABOARD and ICTUS. The ABOARD study (Montalescot G, et al. JAMA. 2009;302:947-954), for example, found no difference between immediate and early strategies in patients with NSTEMI, he said.

“Although this study is different in that it had 3 arms instead of 2, the main message is the same, that the timing of invasive evaluation for most patients with NSTEMI can be flexible,” said Dr. Bittl. Thus, these data are more confirmatory than practice changing, he concluded.

 


Source:
Thiele H, Rach J, Klein N, et al. Optimal timing of invasive angiography in stable non-ST-elevation myocardial infarction: The Leipzig Immediate versus early and late PercutaneouS coronary Intervention triAl in NSTEMI (LIPSIA-NSTEMI Trial). Eur Heart J. 2011;Epub ahead of print.

 

 

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Disclosures
  • The LIPSIA-NSTEMI trial was supported in part by free tirofiban medication from MSD SHARP &amp; DOHME GmbH and Iroko Pharmaceuticals.
  • Drs. Thiele and Bittl report no relevant conflicts of interest.

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