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FOCUS ISSUE: DRUG-ELUTING STENTS

Two-Year Clinical Follow-Up After Sirolimus-Eluting Versus Bare-Metal Stent Implantation Assisted by Systematic Glycoprotein IIb/IIIa Inhibitor Infusion in Patients With Myocardial Infarction

Results From the STRATEGY Study

Marco Valgimigli, MD, PhD^_*,,_*, Gianluca Campo, MD^_*, Chiara Arcozzi, MD^_*, Patrizia Malagutti, MD^_*, Roberto Carletti, MD^_*, Fabrizio Ferrari, MD^_*, Dario Barbieri, MD^_*, Giovanni Parrinello, PhD, Gianfranco Percoco, MD^_* and Roberto Ferrari, MD, PhD^_*,

^_* Institute of Cardiology, University of Ferrara, Ferrara, Italy
Cardiovascular Research Centre, Salvatore Maugeri Foundation, IRCCS Gussago, Brescia, Italy
Medical Statistics Unit, University of Brescia, Brescia, Italy.

Manuscript received October 31, 2006; revised manuscript received December 11, 2006, accepted January 1, 2007.

^_* Reprint requests and correspondence: Dr. Marco Valgimigli, University of Ferrara, Cardiovascular Institute, Arcispedale S. Anna, C.rso Giovecca 203, 44100 Ferrara, Italy. (Email: vlgmrc{at}unife.it).

Objectives: We sought to investigate whether the previously reported midterm clinical benefit of planned sirolimus-eluting stent (SES) implantation in patients with ST-segment elevation myocardial infarction (STEMI) was maintained over a 24-month time period. Moreover, the distribution of clinical events in relation to thienopyridine discontinuation was thoroughly investigated.

Background: No randomized data are currently available on the safety/benefit profile of SES in this subset of patients beyond 12 months.

Methods: Between March 2003 and April 2004, 175 patients with STEMI were randomly allocated to tirofiban infusion followed by SES or abciximab plus bare-metal stent (BMS). Complete follow-up information up to 720 days was available for all patients.

Results: The cumulative incidence of death, myocardial infarction (MI), or target vessel revascularization (TVR) remained lower in the tirofiban-SES compared with the abciximab-BMS group at 2 years (24.2% vs. 38.6%, respectively; hazard ratio [HR] 0.56 [95% confidence interval (CI) 0.33 to 0.98]; p = 0.038). The composite of death/MI was similar in the tirofiban-SES (16.1%) and the abciximab-BMS groups (20.5%, HR 0.77 [95% CI 0.38 to 1.55]; p = 0.43) while the need for TVR was markedly reduced (9.8% vs. 25.5%, respectively; HR 0.34 [95% CI 0.16 to 0.77]; p = 0.01) in the tirofiban-SES arm. The rate of confirmed, probable, or possible stent thrombosis did not differ in the 2 groups, nor the incidence of death/MI after thienopyridine discontinuation.

Conclusions: The midterm clinical benefit of planned SES implantation assisted by tirofiban infusion in STEMI patients was mainly carried over after 2 years with no overall excess of late adverse events after thienopyridine discon-tinuation.

Abbreviations and Acronyms   BMS = bare-metal stent   CI = confidence interval   DES = drug-eluting stent   HR = hazard ratio   MACE = major adverse cardiovascular events   MI = myocardial infarction   PCI = percutaneous coronary intervention   PHM = proportional hazards model   SES = sirolimus-eluting stent   ST = stent thrombosis   STEMI = ST-segment elevation myocardial infarction   TVR = target vessel revascularization

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