SICTO: Sirolimus-eluting Stent In Chronic Total Occlusion
SICTO: Sirolimus-eluting Stent In Chronic Total Occlusion
Presenter: Yaron Almagor, MD, Shaare Zedek Medical Center (Jerusalem, Israel)
Revascularization of chronic total coronary artery occlusions remains an important challenge in interventional cardiology. Although the primary crossing rate has improved with the development of new guidewires, patients with total occlusions still have an abrupt closure rate of up to 8% and a high restenosis rate (50% to 70%) after balloon angioplasty alone.
The Sirolimus-eluting Stent In Chronic Total Occlusion (SICTO) study was designed to assess the feasibility and restenosis/reocclusion rates of coronary stenting with the Cypher (Cordis Corporation, Miami, Florida) sirolimus-eluting stent in patients with chronic total occlusion. A total of 25 patients being treated with the Cypher stent were recruited in this nonrandomized, prospective, multicenter study. Patients underwent repeat angiography and intravascular ultrasound (IVUS) at 6-month follow-up.
Results
Baseline clinical and angiographic characteristics of patients enrolled in the trial are shown in Table 1.
Table 1. Baseline Clinical and Angiographic Characteristics
LAD = left anterior descending; LCx = left circumflex; MI = myocardial infarction; RCA = right coronary artery
At 6-month angiographic and IVUS follow-up, the use of the Cypher stent was associated with improvements in reference vessel diameter and minimum lumen diameter (Table 2). In addition, the rate of in-stent late loss was -0.1 ± 0.3 mm and percent stent plaque volume was 13.1 ± 18.4%.
Table 2. 6-Month Angiographic and IVUS Follow-up
IVUS = intravascular ultrasound; MLD = minimum lumen diameter; RVD = reference vessel diameter
The number of events at 6 months was also very low, with no deaths, myocardial infarction, stent thrombosis, or target lesion revascularization. There were 2 cases of target vessel revascularization (8%), which compares quite favorably with historical data documenting restenosis/reocclusion rates as high as 30% to 50% in patients with chronic total occlusions treated with bare metal stents.
Conclusions
Investigators of the SICTO study concluded:
The results presented are very preliminary, but nonetheless encouraging, with regard to chronic total occlusions. I am convinced that there is a large population of patients with chronic total occlusions that have already been treated with drug-eluting stents by interventional cardiologists. Such patients are an attractive target for drug-eluting stents because of the high restenosis rates associated with these types of lesions. Nevertheless, we will need more data.
Revascularization of chronic total coronary artery occlusions remains an important challenge in interventional cardiology. Although the primary crossing rate has improved with the development of new guidewires, patients with total occlusions still have an abrupt closure rate of up to 8% and a high restenosis rate (50% to 70%) after balloon angioplasty alone.
The Sirolimus-eluting Stent In Chronic Total Occlusion (SICTO) study was designed to assess the feasibility and restenosis/reocclusion rates of coronary stenting with the Cypher (Cordis Corporation, Miami, Florida) sirolimus-eluting stent in patients with chronic total occlusion. A total of 25 patients being treated with the Cypher stent were recruited in this nonrandomized, prospective, multicenter study. Patients underwent repeat angiography and intravascular ultrasound (IVUS) at 6-month follow-up.
Results
Baseline clinical and angiographic characteristics of patients enrolled in the trial are shown in Table 1.
Table 1. Baseline Clinical and Angiographic Characteristics
| Characteristic | Patients (n = 25) |
|---|---|
| Clinical | |
| Age (yrs) | 63 |
| Male (n) | 18 |
| Diabetes (%) | 16 |
| Hypercholesterolemia (%) | 80 |
| Hypertension (%) | 60 |
| Smoker (%) | 60 |
| Prior MI (%) | 52 |
| Prior revascularization (%) | 24 |
| Angiographic | |
| Lesion length (mm) | 30.2 ± 12 |
| Reference vessel diameter (mm) | 2.6 ± 0.5 |
| Stent length (mm) | 26.4 ± 11 |
| Number of stents per patient | 2.2 ± 0.6 |
| Target vessel (%) | |
| LAD | 40 |
| LCx | 28 |
| RCA | 32 |
At 6-month angiographic and IVUS follow-up, the use of the Cypher stent was associated with improvements in reference vessel diameter and minimum lumen diameter (Table 2). In addition, the rate of in-stent late loss was -0.1 ± 0.3 mm and percent stent plaque volume was 13.1 ± 18.4%.
Table 2. 6-Month Angiographic and IVUS Follow-up
| Measure | Baseline/Post | 6-month Follow-up |
|---|---|---|
| RVD (mm) | 2.6 ± 0.5 | 2.8 ± 0.6 |
| MLD (mm) | 1.9 ± 0.6 | 2.0 ± 0.7 |
| In-stent stenosis (%) | 15.7 ± 8.6 | 19.3 ± 11.0 |
| Mean stent area | 8.6 ± 1.8 | 8.7 ± 1.7 |
| Mean lumen area | 8.6 ± 1.8 | 8.3 ± 1.7 |
The number of events at 6 months was also very low, with no deaths, myocardial infarction, stent thrombosis, or target lesion revascularization. There were 2 cases of target vessel revascularization (8%), which compares quite favorably with historical data documenting restenosis/reocclusion rates as high as 30% to 50% in patients with chronic total occlusions treated with bare metal stents.
Conclusions
Investigators of the SICTO study concluded:
The Cypher sirolimus-eluting stent was very safe and effective in the treatment of chronic total occlusion, with no cases of target lesion revascularization.
There was a significant inhibition of intimal hyperplasia in these cases.
These preliminary and encouraging data need to be followed in a larger database of patients with chronic total occlusion.
The results presented are very preliminary, but nonetheless encouraging, with regard to chronic total occlusions. I am convinced that there is a large population of patients with chronic total occlusions that have already been treated with drug-eluting stents by interventional cardiologists. Such patients are an attractive target for drug-eluting stents because of the high restenosis rates associated with these types of lesions. Nevertheless, we will need more data.
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