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CLINICAL RESEARCH: TREATMENT OF ACUTE INFARCTION WITH PCI

Outcomes of optimal or "stent-like"balloon angioplasty in acutemyocardial infarction: the CADILLAC trial

David A. Cox, MD, FACC^*,*, Gregg W. Stone, MD, FACC, Cindy L. Grines, MD FACC, Thomas Stuckey, MD, FACC, David J. Cohen, MD^||, James E. Tcheng, MD, FACC^¶, Eulogio Garcia, MD^#, Giulio Guagliumi, MD^**, Robert S. Iwaoka, MD, FACC^*, Martin Fahy, MSc, Mark Turco, MD, FACC, Alexandra J. Lansky, MD, FACC, John J. Griffin, MD, FACC, Roxana Mehran, MD, FACC CADILLAC Investigators

^* Mid Carolina Cardiology, Charlotte, North Carolina, USA
The Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, New York, New York, USA
William Beaumont Hospital, Royal Oak, Michigan, USA
Moses Cone Memorial Hospital, Greensboro, North Carolina, USA
^|| Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
^¶ Duke Clinical Research Institute, Durham, North Carolina, USA
^# Hospital Gregorio Maranon, Madrid, Spain
^** Ospedali Riuniti di Bergamo, Bergamo, Italy
Doylestown Hospital, Doylestown, Pennsylvania, USA
Virginia Beach General Hospital, Virginia Beach, Virginia, USA

Manuscript received January 2, 2003; revised manuscript received March 14, 2003, accepted April 17, 2003.

^* Reprint requests and correspondence: Dr. David A. Cox, Mid Carolina Cardiology, 1718 E. Fourth St., Suite 501, Charlotte, North Carolina 28204, USA.
dcox{at}mccardiology.com

OBJECTIVES: We sought to compare outcomes between patients with acute myocardial infarction (AMI) undergoing percutaneous transluminal coronary angioplasty (PTCA) with an optimal or "stent-like" result versus patients who underwent routine stent placement.

BACKGROUND: Recent studies in patients with AMI undergoing stent implantation have suggested that PTCA may no longer be a relevant treatment modality for stent eligible lesions. However, whether routine stent placement is superior or necessary when an optimal PTCA or "stent-like" result is achieved is unknown.

METHODS: In the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial, 2,082 patients with AMI were randomly assigned to undergo PTCA alone, PTCA + abciximab, stenting alone, or stenting + abciximab. Outcomes were compared in patients achieving an optimal acute PTCA result (residual core laboratory diameter stenosis <30% without significant dissection) versus those assigned to routine stenting.

RESULTS: Optimal PTCA was achieved in 40.7% of patients randomized to balloon angioplasty, including 38.5% and 42.7% assigned to PTCA alone and PTCA + abciximab, respectively. Ischemic target vessel revascularization (TVR) at 30 days occurred more frequently after optimal PTCA than routine stenting (5.1% vs. 2.3%, p = 0.007). The one-year composite adverse event rate (death, reinfarction, disabling stroke, or TVR) was greater after optimal PTCA than routine stenting (21.9% vs. 13.8%, p < 0.001), driven largely by increased rates of ischemic TVR (19.1% vs. 9.1%, p < 0.001); no significant differences were present in the rates of death, reinfarction, or disabling stroke between the two groups. Angiographic restenosis also was more common with optimal PTCA than routine stenting (36.2% vs. 22.2%, p = 0.003). Even a post-PTCA diameter stenosis of <20% (realized in 12% of patients) did not result in outcomes equivalent to stenting.

CONCLUSIONS: Even if an optimal result is achieved after primary PTCA in AMI, early and late outcomes can be further improved with routine stent implantation.

Abbreviations and Acronyms   AMI   acute myocardial infarction   CADILLAC   Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications   NHLBI   National Heart, Lung, and Blood Institute   PCI   percutaneous coronary intervention   PTCA   percutaneous transluminal coronary angioplasty   TIMI   Thrombolysis In Myocardial Infarction   TVR   target vessel revascularization

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