European Heart Journal Advance Access originally published online on June 7, 2005
European Heart Journal 2005 26(15):1564-1565; doi:10.1093/eurheartj/ehi347
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Facilitation of primary PCI with ReoPro: reply
Second Department of Internal Medicine
Division of Cardiology
University of Medicine
Vienna
Austria
Third Department of Medicine
Cardiology and Emergency Medicine
Wilhelminen Hospital
Vienna
Austria
Tel: +431 49150 2301
Fax: +43 1 49150 2309
E-mail address: kurt.huber{at}wienkav.at
The corrected TIMI frame count (CTFC) method has been prospectively validated as providing independent risk stratification above and beyond the conventional TIMI flow grades.1 In myocardial infarction studies including patients with an occluded infarct-related artery, a frame count of 100, a value that is the 99th percentile of that for patent vessels, is imputed to an occluded vessel.1 As recommended by Gibson et al.,1 a CTFC of 100 was scored for TIMI grades 0–1 flow of the infarct-related artery in the ReoPro-BRIDGING study,2 similar to that seen in other studies, e.g. the SPEED, TIMI 4, 10A, 10B, and 14 trials. A sample-size calculation for only those patients having TIMI flow grade 2 or 3 in a STEMI study with primary percutaneous coronary intervention (pPCI), where a majority of the patients has occluded infarct-related artery at the time of the qualifying angiography, would have resulted in a serious bias.
The upstream therapy with abciximab prior to pPCI does not replace the thrombolytic therapy and pPCI; of course, the pre-pPCI CTFC was higher in our study than in thrombolysis studies. However, as we pointed out,2 no data concerning the CTFC values before and after abciximab treatment exist. Therefore, we used already published findings and our own data on the normal values and standard deviations, with the CTFC value as accepted difference between an infarct-related artery treated with thrombolysis and normal arteries. Thereby, we did not assume that abciximab therapy would result in 100% flow restoration.
Comparisons of randomized studies with a similar design have revealed similar initial TIMI flow 3 grades in the respective control groups, i.e. 2% in the study of Zorman et al., 7.9% in ERAMI trial, and 7% in ReoPro-BRIDGING study. The combined TIMI flow 2+3 (not given separately) was 48% in REOMOBILE and 33% in ReoPro-BRIDGING studies.
The TIMI flow scoring is limited by a relatively high interobserver variability and its categorical nature, as we pointed out in our study.2 If we recalculate the difference between the groups with regard to TIMI flow 3, also using the combined TIMI flow 2+3, as in other studies,3,4 the difference between the groups in ReoPro-BRIDGING study remains statistically significant, similar to that seen in the meta-analysis of Montalescot et al.,3 but different from the On-TIME study,4 where the TIMI 3 flow was not different, whereas the combined TIMI 2+3 flow was different between the groups.
We are aware that our study was underpowered with regard to the clinical endpoint of the study,2 and that clinical conclusion based on surrogate parameters should be interpreted with caution. We are, however, sure that the primary endpoints of our study were assessed correctly, as cited earlier.
References
- Gibson CM, Murphy SA, Rizzo MJ, Ryan KA, Marble SJ, McCabe CH, Cannon CP, Van de Werf F, Braunwald E. Relationship between TIMI frame count and clinical outcomes after thrombolytic administration. Circulation 1999;99:1945–1950.
[Abstract/Free Full Text] - Gyöngyösi M, Domanovits H, Benzer W, Haugk M, Heinisch B, Sodeck G, Hödl R, Gaul G, Bonner G, Wojta J, Laggner A, Glogar D, Huber K for the ReoPro-Bridging Study Group. Use of abciximab prior to primary angioplasty in STEMI results in early recanalization of the infarct-related artery and improved myocardial tissue reperfusion—results of the Austrian multi-centre randomized ReoPro-BRIDGING Study. Eur Heart J 2004;25:2125–2133.
[Abstract/Free Full Text] - Montalescot G, Borentain M, Payot L, Collet JP, Thomas D. Early vs late administration of glycoprotein Iib/IIIa inhibitors in primary percutaneous coronary intervention of acute ST-segment elevation myocardial infarction. A meta-analysis. JAMA 2004;292:362–366.
[Abstract/Free Full Text] - Van't Hof AWJ, Ernst N, de Boer MJ, de Winter R, Boersma E, Bunt T, Petronio S, Gosseling ATM, Jap W, Hollak F, Hoorntje JCA, Suryapranata H, Dambrink JHE, Zijlstra F on behalf of the On-TIME study group. Facilitation of primary coronary angioplasty by early start of a glycoprotein 2b/3a inhibitor: results of the ongoing tirofiban in myocardial infarction evaluation (On-TIME trial). Eur Heart J 2004;25:837–846.
[Abstract/Free Full Text]
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