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J Am Coll Cardiol, 2004; 43:1954-1958, doi:10.1016/j.jacc.2004.01.045 © 2004 by the American College of Cardiology Foundation |
* Department of Interventional Cardiology, Erasmus MC, Rotterdam, the Netherlands
Manuscript received October 29, 2003; revised manuscript received January 15, 2004, accepted January 19, 2004.
* Reprint requests and correspondence: Dr. Patrick W. Serruys, Department of Interventional Cardiology, Thoraxcentre Bd 404, Dr Molewaterplein 40, NL-3015 GD Rotterdam, the Netherlands.
p.w.j.c.serruys{at}erasmusmc.nl
| Abstract |
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BACKGROUND: Long-term results after percutaneous coronary intervention (PCI) in the treatment of CTOs is hindered by a significant rate of restenosis and reocclusion. In the treatment of relatively simple nonocclusive lesions, SESs have shown dramatically reduced restenosis rates compared with bare metal stents (BMS), but whether these results are more widely applicable is unknown.
METHODS: From April 2002, all patients at our institution were treated with SES as the device of choice during PCI. During the first six months, 563 patients were treated solely with SES, with treatment of a de novo CTO in 56 (9.9%). This CTO cohort was compared with a similar group of patients (n = 28) treated in the preceding six-month period with BMS.
RESULTS: At one year, the cumulative survival-free of major adverse cardiac events was 96.4% in the SES group versus 82.8% in the BMS group, p < 0.05. At six-month follow-up, 33 (59%) patients in the SES group underwent angiography with a binary restenosis rate (>50% diameter stenosis) of 9.1% and in-stent late loss of 0.13 ± 0.46 mm. One patient (3.0%) at follow-up was found to have reoccluded the target vessel.
CONCLUSIONS: The use of SESs in the treatment of chronic total coronary occlusions is associated with a reduction in the rate of major adverse cardiac events and restenosis compared with BMS.
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In the treatment of relatively simple lesions, sirolimus-eluting stents (SES) markedly reduce the restenosis rate, with continued benefit documented up to two years follow-up (10,11). Whether these results can be extrapolated to more complex lesions such as CTOs has yet to be determined. We sought to evaluate the effectiveness of the SES in a consecutive series of patients with at least one de novo CTO compared with a similar series treated with bare metal stents (BMS).
| Methods |
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CTO definition. Chronic occlusion was defined as an occlusion on angiography with no antegrade filling of the distal vessel other than via collaterals. All patients included had a native vessel occlusion estimated to be at least one month's duration (9) based on either a history of sudden chest pain, a previous acute myocardial infarction in the same target vessel territory, or the time between the diagnosis made on coronary angiography and PCI.
Length of occlusion. The length of occlusion was measured by quantitative coronary angiography either utilizing antegrade filling via collaterals, or assessment of the retrograde collateral filling. This was achieved by catheterizing both the left and right coronary arteries, and making a simultaneous injection to delineate the distance between the site of occlusion and the most proximal part of the vessel filled retrogradely.
Follow-up. Patients were followed up prospectively and evaluated for survival-free of major adverse cardiac events (MACE) using questionnaires and telephone enquiries; MACE was predefined as: 1) death; 2) nonfatal myocardial infarction; or 3) repeat target vessel revascularization (TVR). The diagnosis of acute myocardial infarction required an elevation of creatine kinase to twice the upper limit of normal, together with a rise in creatine kinase-MB fraction. Target vessel revascularization was defined as either surgical or percutaneous reintervention driven by significant (>50%) luminal narrowing within the treated vessel, and was undertaken in the presence of either anginal symptoms or objective evidence of ischemia.
Angiographic analysis. Quantitative analysis in those SES patients with follow-up angiography was undertaken in three coronary segments: in-stent (encompassing the entire length of stented segment), and the 5-mm proximal and distal edge segments either side of the in-stent segment. The target lesion comprised the in-stent plus the proximal and distal edge segments. Binary restenosis was defined as >50% diameter stenosis within the target lesion. Late lumen loss was calculated from the difference in minimal lumen diameter between postprocedure and follow-up.
Statistical analysis. Discrete variables are presented as percentages and compared with Fisher exact test. Continuous variables are expressed as mean ± SD and compared with Student t test. Survival-free of adverse events was calculated according to the Kaplan-Meier method. The log-rank test was used to compare MACE-free survival between the two groups. All tests were two-tailed, and a p value of <0.05 was considered statistically significant.
| Results |
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| Discussion |
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To our knowledge, this is the first report regarding the efficacy of SES in CTOs, a subset of patients previously excluded from other protocols and, importantly, at increased risk of developing restenosis after conventional stent implantation (3). Of the patients who underwent follow-up angiography, both the in-stent and proximal 5-mm segments analyzed showed an encouraging late loss of 0.13 ± 0.46 mm and 0.10 ± 0.80 mm, respectively. The distal 5 mm actually showed an overall benefit, with enlargement of the vessel (late loss, 0.06 ± 0.54 mm).
In addition to the angiographic data, the clinical follow-up is very encouraging. Importantly, there were no significant differences in baseline demographics between the SES and BMS groups, and all procedures were carried out in the same center by the same operators. There was an episode of subacute thrombosis in the SES group, but there appears to be an underlying mechanical cause with underexpansion of the stent documented on intravascular ultrasound. The restenosis rate for BMS is known to be inversely related to the postprocedural minimal lumen diameter and the number of stents utilized (18). In the current study, although the mean diameter of stent used was significantly greater in the BMS cohort (related to a maximum available SES diameter of 3.0 mm) with free utilization of postdilation, the postprocedural minimal lumen diameter was not significantly different between the two groups. The majority of events related to TVR, with, at one year, a significantly higher rate of survival free of MACE of 96.4% in the SES group versus 82.8% in the BMS group.
Four major randomized trials have demonstrated the efficacy of stent implantation over balloon-only angioplasty in the treatment of CTOs, reducing the six-month restenosis rate from 68% to 74%, to 32% to 55% (58). Compared with this historical data, our study suggests that the SES confers a marked further advantage with a significantly lower binary restenosis rate of 9.1% (p < 0.05) (Fig. 2). In addition, we had only one patient (3.0%) with vessel reocclusion, compared with rates of between 8% to 12% in the same published trials utilizing BMS. A recent study of the clinical results of 376 patients discharged from hospital without an adverse event after successful intervention of a CTO showed, at one-year follow-up, a MACE rate of 12.2% (19); our results are, therefore, quite remarkable, with a MACE-free survival rate of 96.4%.
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Conclusions. The use of SESs in the treatment of complex patients with CTOs is associated with a reduction in the rate of MACE and restenosis compared with BMS.
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