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Stenting in Chronic Coronary Occlusion - SICCO
Description:
Stenting vs. PTCA for death/MI/revasc in chronic total occlusions.
Hypothesis:
To examine whether stenting improves long-term results after recanalization of chronic coronary occlusions.
Study Design
Study Design:
Patients Screened: 3,080
Patients Enrolled: 119
Mean Follow Up: 2 years
Mean Patient Age: 58
Female: 18
Mean Ejection Fraction: 63%
Patient Populations:
>18 years old
PTCA of occluded native coronary artery
Exclusions:
Occlusions < 2 weeks old
Unable to tolerate anticoagulation
Participation in another clinical trial
Judged unlikely to return for follow-up angiography
Lesion reference diameter < 2.5mm
Indication for stenting (major dissection, elastic recoil > 50%)
Previously dilated segments
Lesions treated with devices other than conventional or perfusion balloons
Complex anatomy
Poor distal runoff
Angiographically visible thrombus adjacent to occlusion site
Primary Endpoints:
Rate of restenosis at 6 months
Major clinical adverse events (cardiac death, cerebrovascular accident, myocardial infarction, target lesion bypass surgery or target lesion redilatation)
Secondary Endpoints:
Rate of reocclusion, changes in MLD and percent stenosis
Drug/Procedures Used:
Palmaz-Schatz stents vs. balloon PTCA
Concomitant Medications:
ASA and calcium antagonists; stented patients received dipyridamole and warfarin anticoagulation for 3 months.
Principal Findings:
Clinical and angiographic follow-ups were conducted at six months. MLD at follow-up was 1.92 ± 0.95 mm for the stent group and 1.11 ± 0.78 mm for the angioplasty group. Restenosis developed in 32% of stented patients and in 74% of patients treated with PTCA only. The reocclusion rate was 26% for the PTCA group and 12% for the stent group.
Long-term (after 2 years) follow-up was conducted using questionnaires and clinical data from hospitals. The incidence of MACE was 59% for the PTCA group and 24% for the stent group. The incidence of TVR was 53% for the PTCA group and 24% for the stent group.
Interpretation:
The investigators concluded that there is a superior long-term clinical result after stenting of chronic occlusions as compared to angioplasty alone. After the initial 6 months, there were few events in stented patients. Events continued to occur in the angioplasty group, especially in those patients with poor angiographic results. The limitations of this study include the use of dipyridamole and warfarin anticoagulants, the use of first-generation stents, and lumenogram-selected revascularizations. The study's strengths include the length of the follow-up and the use of a "real world" scenario, in that the patients all had acceptable PTCA results before randomization.
References:
1. J Am Coll Cardiol 1996; 28(6):1444-51. Final Results
2. J Am Coll Cardiol 1998; 32(2):305-310. Long-term follow-up
Keywords: Follow-Up Studies, Warfarin, Fibrinolytic Agents, Angioplasty, Hirudins, Stents, Research Personnel, Recombinant Proteins, Surveys and Questionnaires, Coronary Vessels, Coronary Occlusion, Dipyridamole
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