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Optimal Angioplasty versus Primary Stenting - OPUS
Description:
Routine vs. provisional stenting for mortality in coronary disease.
Hypothesis:
Routine stenting for all patients getting percutaneous interventions would decrease death, cardiovascular events, and cost, compared to the strategy of optimal PTCA and provisional stenting.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 479
Mean Patient Age: 61
Female: 25
Mean Ejection Fraction: 60%
Patient Populations:
Age 21-81
Stable or unstable angina or myocardial infarction > 24 hours ago
>70% stenosis
Lesion <20mm in length and >3.0mm in diameter
Exclusions:
Multiple-vessel disease
Ostial lesions
Primary Endpoints:
Combined cardiovascular events (death, MI, and target vessel revascularization) at 6 months
Secondary Endpoints:
Death, myocardial infarction, target vessel revascularization, coronary artery bypass surgery, and cost.
Drug/Procedures Used:
Routine vs. provisional stenting following optimal PTCA. Provisional stenting was defined as the need to use a stent when any of the following conditions were met: threatened closure, dissection, or >20% residual stenosis. The Palmaz-Schatz stent was the stent most frequently used, although other models could be chosen.
Concomitant Medications:
All patients received aspirin and ticlopidine. Abciximab (Reopro) and intravascular ultrasound were both permitted.
Principal Findings:
In the study population, 44% of patients had a previous myocardial infarction and 18% of subjects were diabetics. Patients were randomized into two groups: routine stenting for 230 patients versus balloon angioplasty with provisional stenting for 249 patients. Provisional stenting occurred in 37% of the optimal angioplasty group. Abciximab was used in only 13% of all patients. Events were measured at 6 months and routine angiography was not performed.
The primary endpoint, combined cardiovascular events at 6 months, showed a statistically significant benefit for the routine stenting group (6.1%) when compared to the optimal angioplasty group (14.9%).
The secondary outcome measures of target vessel revascularization and cost also showed a statistically significant advantage of the routine stent group (4.0% and $10,206) compared to the optimal angioplasty with provisional stenting group (10.0% and $10,490).
The following secondary outcome measures all showed a trend towards benefit in the routine stent group that was statistically insignificant: death (0.4% vs 1.2%), myocardial infarction (1.7% vs 2.4%), and coronary artery bypass graft surgery (1.3% vs 3.9%).
Interpretation:
Despite the frequent and increasing use of coronary angioplasty and stent placement, it is unclear whether the typical coronary artery lesion that is amenable to percutaneous revascularization should routinely receive a stent. There are certain advantages and disadvantages of stents compared to simple balloon angioplasty. Stents are easy to use and have a lower restenosis rate, but have the following problems: increased intimal proliferation, difficulty in treating in-stent restenosis when it occurs, higher cost, and increased restenosis in lesions that are >20mm in length or <3mm in diameter. Simple balloon angioplasty allows one to treat restenosis, long lesions, and small vessels with better success, but there is a higher rate of restenosis. The OPUS trial found that cardiovascular events and cost are reduced when routine stenting is the initial approach to percutaneously treating coronary lesions that meet the above angiographic criteria.
References:
1. Presented at the ACC 48th Scientific Sessions, New Orleans, LA, 1999
Keywords: Outcome Assessment, Health Care, Myocardial Infarction, Constriction, Pathologic, Coronary Vessels, Immunoglobulin Fab Fragments, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Diabetes Mellitus, Stents
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