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Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications - CADILLAC
Description:
The goals of the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial were to compare the efficacy of stenting without abciximab to percutaneous transluminal coronary angioplasty (PTCA) without abciximab, and stenting without abciximab to PTCA plus abciximab in patients with acute myocardial infarction (MI).
Hypothesis:
Two primary hypotheses were prespecified: Stenting without abciximab is superior to PTCA without abciximab, and stenting without abciximab is not inferior to PTCA plus abciximab.
Study Design
Study Design:
Patients Screened: 2681
Patients Enrolled: 2082
Mean Patient Age: Median age 60
Patient Populations:
Native coronary artery vessel with a lesion <64 mm in length and reference diameter of 2.5-4.0 mm on angiography, age ≥18 years, >30 minutes but <12 hours of symptoms consistent with acute MI, and the presence of ST-segment elevation in at least two contiguous leads or left bundle branch block
Exclusions:
Angiographic findings that indicated noninterventional (medical or surgical) management was the proper approach, multivessel angioplasty was required during the index procedure, or if prespecified anatomical conditions were present that would reduce the likelihood of successful stenting; cardiogenic shock (defined as systolic blood pressure <80 mm Hg for >30 minutes or the need for intravenous pressors or intra-aortic balloon counterpulsation); had a history of bleeding diathesis or allergy to the study drug; had undergone major surgery within six weeks; had gastrointestinal or genitourinary bleeding within the preceding six months; had a cerebrovascular event within the preceding two years or had any permanent residual neurologic defect; had a history of leukopenia, thrombocytopenia, or hepatic or renal dysfunction; had recently received a thrombolytic agent; had a noncardiac illness associated with a life expectancy of <1 year; or participating in another study
Primary Endpoints:
Composite of death from any cause, reinfarction, repeated intervention or revascularization of the target vessel as a result of ischemia, or disabling stroke within six months after the index procedure
Drug/Procedures Used:
Patients underwent angiography to determine if they met the angiographic inclusion/exclusion criteria. Once criteria were met, patients were randomized to one of four interventional strategies in a two-by-two factorial design: PTCA alone (n=518), PTCA plus abciximab (n=528), stenting alone (n=512), or stenting plus abciximab (n=524).
Concomitant Medications:
Prior to catheterization, patients received aspirin, ticlopidine (500 mg) or clopidogrel (300 mg), a 5000-U bolus of heparin, and a beta-blocker IV.
Principal Findings:
The primary end point of death, reinfarction, ischemic-driven target vessel revascularization (TVR), or stroke at six months occurred in 20.0% in the PTCA alone arm, 16.5% in the PTCA + abciximab arm, 11.5% in the stent alone arm, and 10.2% in the stent + abciximab arm (p<0.001), satisfying the criteria for the two primary hypotheses: stenting alone was superior to PTCA alone (p<0.001), and stenting alone was not inferior to PTCA plus abciximab (p<0.001 for noninferiority).
There were no significant differences among the four arms for the individual components of the composite of death (4.5% vs. 2.5% vs. 3.0% vs. 4.2%, p=0.23), reinfarction (1.8% vs. 2.7% vs. 1.6% vs. 2.2%, p=0.64), or disabling stroke (0.2% vs. 0.2% vs. 0.4% vs. 0.4%, p=0.88; all comparisons PTCA alone vs. PTCA + abciximab vs. stent alone vs. stent + abciximab, respectively). The difference in the composite end point was driven by the difference in ischemic-driven TVR (15.7% vs. 13.8% vs. 8.3% vs. 5.2%, p<0.001). Similar results occurred in the prespecified subgroups.
Among the 636 patients who underwent seven-month angiographic follow-up, restenosis was 40.8% in the PTCA arms and 22.2% in the stent arms (p<0.001). Reocclusion of the infarct-related artery was present in 11.3% and 5.7%, respectively (p=0.01).
Interpretation:
Among patients with acute MI, treatment with stenting alone was superior to PTCA alone, and stenting alone was not inferior to PTCA plus abciximab for the primary composite end point of death, reinfarction, ischemic-driven TVR, or stroke at six months. The reduction in the primary end point was driven primarily by the reduction in TVR.
Results were similar to the Stent-PAMI trial, with a reduction associated with stenting in the primary end point, which was driven primarily by TVR. Cost-effectiveness data are pending.
References:
Stone GW, Grines CL, Cox DA, et al. Comparison of angioplasty with stenting, with or without abciximab, in acute myocardial infarction. N Engl J Med. 2002;346:957-66.
Keywords: Myocardial Infarction, Stroke, Platelet Aggregation Inhibitors, Pyridinolcarbamate, Bundle-Branch Block, Coronary Vessels, Immunoglobulin Fab Fragments, Angioplasty, Balloon, Coronary, Stents
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