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PERCUTANEOUS INTERVENTION AND ANTICOAGULATION

Outcome of urgent and elective percutaneous coronary interventions after pharmacologic reperfusion with tenecteplase combined with unfractionated heparin, enoxaparin, or abciximab

Christophe L. Dubois, MD^*, Ann Belmans, MSc^*, Christopher B. Granger, MD, FACC, Paul W. Armstrong, MD, FACC, Lars Wallentin, MD, FACC^||, Paolo M. Fioretti, MD, FACC^¶, José L. López-Sendón, MD, FACC^#, Freek W. Verheugt, MD, FACC^**, Jürgen Meyer, MD, FACC, Frans Van de Werf, MD, FACC^*,* ASSENT-3 Investigators

^* Department of Cardiology, University Hospitals Leuven, Leuven, Belgium
Department of Public Health, Biostatistical Centre, Catholic University Leuven, Leuven, Belgium
Duke Clinical Research Institute, Durham, North Carolina, USA
Department of Cardiology, University of Alberta, Edmonton, Canada
^|| Department of Cardiology, University of Uppsala, Uppsala, Sweden
^¶ Department of Cardiology, Istituto di Cardiologia, Udine, Italy
^# Department of Cardiology, Hospital Gregorio Marañon, Madrid, Spain
^** Department of Cardiology, University Medical Center Nijmegen, Nijmegen, The Netherlands
Department of Cardiology, Johannes Gutenberg-University, Mainz, Germany

Manuscript received January 10, 2003; revised manuscript received March 6, 2003, accepted March 12, 2003.

^* Reprint requests and correspondence: Prof. Frans Van de Werf, Department of Cardiology, University Hospital Gasthuisberg Leuven, Herestraat 49, B 3000 Leuven, Belgium.
Frans.VandeWerf{at}uz.kuleuven.ac.be

OBJECTIVES: The aim of this study was to evaluate percutaneous coronary intervention (PCI) in the Assessment of the Safety and Efficacy of New Thrombolytic Regimens (ASSENT-3) trial.

BACKGROUND: In the ASSENT-3 trial, co-therapy with abciximab (ABC) or enoxaparin (ENOX) reduced ischemic complications after ST-elevation acute myocardial infarction treated with tenecteplase when compared with unfractionated heparin (UFH). The effect of these new co-therapies on the results of PCI is unknown.

METHODS: Clinical outcomes in patients who received co-therapy with ABC, ENOX, or UFH and subsequently underwent an elective (n = 1,064) or urgent (n = 716) PCI in the ASSENT-3 trial were compared.

RESULTS: No significant differences in clinical end points were observed in patients who underwent an elective PCI. A non-significant trend toward fewer in-hospital myocardial re-infarctions was seen with ABC and ENOX when compared with UFH (0.5% vs. 0.6% vs. 1.5%, respectively). The incidence of bleeding complications was similar in the three treatment arms. Significantly fewer ABC- and ENOX-treated patients needed urgent PCI compared with UFH (9.1% vs. 11.9% vs. 14.3%; p < 0.0001), but outcomes in these patients were in general less favorable (30-day mortality: 8.2% vs. 5.4% vs. 4.5%; 1-year mortality: 11.0% vs. 8.5% vs. 5.6%; in-hospital re-infarction: 3.9% vs. 2.5% vs. 2.7%; major bleeding complications: 8.8% vs. 7.0% vs. 3.4%). In pairwise comparisons with UFH, the higher one-year mortality and major bleeding rates after ABC were statistically significant (p = 0.045 and p = 0.012, respectively).

CONCLUSIONS: Clinical outcomes after elective PCI were similar with the three antithrombotic co-therapies studied in ASSENT-3. Although fewer patients needed urgent PCI with ABC and ENOX, clinical outcomes were less favorable in this selected population, especially with ABC.

Abbreviations and Acronyms   ABC = abciximab   AMI = acute myocardial infarction   ASSENT = ASsessment of the Safety and Efficacy of New Thrombolytic Regimens   ENOX = enoxaparin   ICH = intracranial hemorrhage   PCI = percutaneous coronary intervention   TNK-tPA = tenecteplase   UFH = unfractionated heparin

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