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Randomized Controlled Trial
. 2023 Aug 7;19(5):e394-e401.
doi: 10.4244/EIJ-D-23-00112.

No-reflow after primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction: an angiographic core laboratory analysis of the TOTAL Trial

Marc-André d'Entremont  1   2 , Ashraf Alazzoni  3 , Vladimir Dzavik  4 , Vinoda Sharma  5 , Christopher B Overgaard  6 , Samuel Lemaire-Paquette  1 , Pablo Lamelas  7 , John A Cairns  8 , Shamir R Mehta  2   9 , Madhu K Natarajan  2   9 , Tej N Sheth  2   9 , John-David Schwalm  2   9 , Sunil V Rao  10 , Goran Stankovic  11 , Sasko Kedev  12 , Raul Moreno  13 , Warren J Cantor  6 , Shahar Lavi  14 , Olivier F Bertrand  15 , Michel Nguyen  1 , Étienne L Couture  1 , Sanjit S Jolly  2   9
Affiliations
Randomized Controlled Trial

No-reflow after primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction: an angiographic core laboratory analysis of the TOTAL Trial

Marc-André d'Entremont et al. EuroIntervention. .

Abstract

Background: The optimal strategy to prevent no-reflow in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) is unknown.

Aims: We aimed to examine the effect of thrombectomy on the outcome of no-reflow in key subgroups and the adverse clinical outcomes associated with no-reflow.

Methods: We performed a post hoc analysis of the TOTAL Trial, a randomised trial of 10,732 patients comparing thrombectomy versus PCI alone. This analysis utilised the angiographic data of 1,800 randomly selected patients.

Results: No-reflow was diagnosed in 196 of 1,800 eligible patients (10.9%). No-reflow occurred in 95/891 (10.7%) patients randomised to thrombectomy compared with 101/909 (11.1%) in the PCI-alone arm (odds ratio [OR] 0.95, 95% confidence interval [CI]: 0.71-1.28; p-value=0.76). In the subgroup of patients who underwent direct stenting, those randomised to thrombectomy compared with PCI alone experienced less no-reflow (19/371 [5.1%] vs 21/216 [9.7%], OR 0.50, 95% CI: 0.26-0.96). In patients who did not undergo direct stenting, there was no difference between the groups (64/504 [12.7%] vs 75/686 [10.9%)], OR 1.18, 95% CI: 0.82-1.69; interaction p-value=0.02). No-reflow patients had a significantly increased risk of experiencing the primary composite outcome (cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA Class IV heart failure) at 1 year (adjusted hazard ratio 1.70, 95% CI: 1.13-2.56; p-value=0.01).

Conclusions: In patients with STEMI treated by PCI, thrombectomy did not reduce no-reflow in all patients but may be synergistic with direct stenting. No-reflow is associated with increased adverse clinical outcomes.

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Conflict of interest statement

C.B. Overgaard reports receiving consulting fees from Boston Scientific. J.A. Cairns reports receiving research grants from Medtronic, AstraZeneca, Boston Scientific, and Edwards Lifesciences; consulting fees from Abbott Vascular; and receipt of equipment and materials from AstraZeneca. S. Jolly reports receiving grants from Boston Scientific and honoraria from Penumbra. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. CONSORT diagram for the angiographic core laboratory population according to no-reflow statistics.
Figure 2
Figure 2. Randomised subgroup analysis for no-reflow in the angiographic core laboratory population.
CI: confidence intervals; MI: myocardial infarction; PCI: percutaneous coronary intervention; TIMI: Thrombolysis in Myocardial Infarction
Figure 3
Figure 3. Survivor probability for the composite primary outcome according to reflow status in the angiographic core laboratory population.
A) Unadjusted survivor function and B) adjusted marginal survivor function. CI: confidence interval
Figure 4
Figure 4. Independent predictors of no-reflow in the angiographic core laboratory population.
C-statistic=0.67 (95% CI: 0.63-0.71) for the multivariable logistic regression model. CI: confidence interval; TIMI: Thrombolysis in Myocardial Infarction
See this image and copyright information in PMC

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