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CLINICAL STUDIES

A comparison of systematic stenting and conventional balloon angioplasty during primary percutaneous transluminal coronary angioplasty for acute myocardial infarction

Luc Maillard, MD, PhD^a, Martial Hamon, MD^*, Khalife Khalife, MD, Philippe Gabriel Steg, MD, FACC, Farzin Beygui, MD, Jean-Leon Guermonprez, MD^||, Christian M. Spaulding, MD^¶, Jean-Marc Boulenc, MD^#, Janusz Lipiecki, MD^**, Antoine Lafont, MD, PhD, Philippe Brunel, MD, Gilles Grollier, MD, Rene Koning, MD^||||, Pierre Coste, MD^¶¶, Xavier Favereau, MD^##, Bernard Lancelin, MD^***, Eric Van Belle, MD, PhD, Patrick Serruys, MD, PhD, FACC, Jean-Pierre Monassier, MD^*, Philippe Raynaud, MD^a for the STENTIM-2 Investigators

^a CHU Tours, Tours, France
^* CH Mulhouse, Mulhouse, France
CH Metz, Metz, France
CHU Bichat, Paris, France
CHU Necker, Paris, France
^|| CHU Broussais, Paris, France
^¶ CHU Cochin, Paris, France
^# Clinique St. Joseph, Colmar, France
^** CHU Clermont-Ferrand, Clermont-Ferrand, France
CHU Boucicaut, Paris, France
CHU Nantes, Nantes, France
CHU Caen, Caen, France
^|||| CHU Rouen, Rouen, France
^¶¶ CHU Bordeaux, Bordeaux, France
^## CMC Parly 2, Le Chesnay, France
^*** CC Marie Lannelongue, Le Plessis Robinson, France
CHU Lille, Lille, France
University Hospital Rotterdam Dijkzigt, Thorax Center, Rotterdam, The Netherlands

Manuscript received August 9, 1999; revised manuscript received December 10, 1999, accepted February 3, 2000.

Reprint requests and correspondence: Dr. Luc Maillard, Unité de Cardiologie Interventionnelle, Hôpital Trousseau, 37044 Tours Cedex, France
luc.maillard{at}med.univ-tours.fr

OBJECTIVES

In a multicenter, randomized trial, systematic stenting using the Wiktor stent was compared to conventional balloon angioplasty with provisional stenting for the treatment of acute myocardial infarction (AMI).

BACKGROUND

Primary angioplasty in AMI is limited by in-hospital recurrent ischemia and a high restenosis rate.

METHODS

A total of 211 patients with AMI <12 h from symptom onset, with an occluded native coronary artery, were randomly assigned to systematic stenting (n = 101) or balloon angioplasty (n = 110). The primary end point was the binary six-month restenosis rate determined by core laboratory quantitative angiographic analysis.

RESULTS

Angiographic success (Thrombolysis in Myocardial Infarction [TIMI] flow grade 3 and residual diameter stenosis <50%) was achieved in 86% of the patients in the stent group and in 82.7% of those in the balloon angioplasty group (p = 0.5). Compared with the 3% cross-over in the stent group, cross-over to stenting was required in 36.4% of patients in the balloon angioplasty group (p = 0.0001). Six-month binary restenosis (50% residual stenosis) rates were 25.3% in the stent group and 39.6% in the balloon angioplasty group (p = 0.04). At six months, the event-free survival rates were 81.2% in the stent group and 72.7% in the balloon angioplasty group (p = 0.14), and the repeat revascularization rates were 16.8% and 26.4%, respectively (p = 0.1). At one year, the event-free survival rates were 80.2% in the stent group and 71.8% in the balloon angioplasty group (p = 0.16), and the repeat revascularization rates were 17.8% and 28.2%, respectively (p = 0.1).

CONCLUSIONS

In the setting of primary angioplasty for AMI, as compared with a strategy of conventional balloon angioplasty, systematic stenting using the Wiktor stent results in lower rates of angiographic restenosis.

Abbreviations and Acronyms   AMI = acute myocardial infarction   ECG = electrocardiogram or electrocardiographic   LV = left ventricle or ventricular   PTCA = percutaneous transluminal coronary angioplasty   STENTIM-2 = second STENTing In acute Myocardial infarction study   TIMI = Thrombolysis In Myocardial Infarction trial

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