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J Am Coll Cardiol, 1998; 32:305-310
© 1998 by the American College of Cardiology Foundation
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CLINICAL STUDIES

Sustained benefit of stenting chronic coronary occlusion: long-term clinical follow-up of the Stenting in Chronic Coronary Occlusion (SICCO) study

Per Anton Sirnes, MD, Svein Golf, MD, PhDa, Yngvar Myreng, MD, PhDa, Per Mølstad, MD, PhDa, Per Albertsson, MD, PhD*, Arild Mangschau, MD, PhD{dagger}, Knut Endresen, MD, PhD{ddagger} and John Kjekshus, MD, PhD{ddagger}

a The Feiring Heart Clinic, Feiring, Norway
* Sahlgrenska University Hospital, Göteborg, Sweden
{dagger} Ullevål Hospital, Oslo, Norway
{ddagger} National Hospital, Oslo, Norway

Manuscript received December 18, 1997; revised manuscript received April 6, 1998, accepted April 23, 1998.

Address for correspondence: Dr. Per Anton Sirnes, The Feiring Heart Clinic, N-2093 Feiring, Norway
psirnes{at}online.no


   Abstract
Top
 Abstract
Methods
 Results
 Discussion
 References
 
Objectives. This study assessed the long-term clinical outcome of stenting chronic occlusions.

Background. In the Stenting in Chronic Coronary Occlusion (SICCO) study, patients were randomized to additional stent implantation (n = 58) or not (n = 59) after successful recanalization and dilation of a chronic coronary occlusion. Palmaz-Schatz stents were used with full anticoagulation. The previously published 6-month angiographic follow-up results showed reduction of the restenosis rate from 74% to 32%.

Methods. The primary end point was the occurrence of major adverse cardiac events (cardiac death, lesion-related acute myocardial infarction, repeat lesion-related revascularization or angiographic documentation of reocclusion).

Results. Late clinical follow-up was obtained in all patients at 33 ± 6 months. Major adverse cardiac events occurred in 14 patients (24.1%) in the stent group compared with 35 patients (59.3%) in the percutaneous transluminal coronary angioplasty (PTCA) group (odds ratio 0.22, 95% confidence interval 0.10 to 0.49, p = 0.0002). Target vessel revascularization (including failed PTCA attempts) was performed in 24% of the stent group and in 53% of the PTCA group (p = 0.002). There were no events in the stent group after 8 months, whereas events continued to occur in the PTCA group. By multivariate analysis, allocation to the PTCA group, left anterior descending coronary artery lesion and lesion length were significantly related to the development of major adverse cardiac events.

Conclusions. These data demonstrate the long-term safety and clinical benefit of stenting recanalized chronic occlusions. There is a continued risk of late clinical events related to nonstented lesions. Implantation of an intracoronary stent should therefore be considered after successful opening of a chronic coronary occlusion.

Abbreviations and Acronyms
  AMI = acute myocardial infarction
  CI = confidence interval
  DS = diameter stenosis
  LAD = left anterior descending coronary artery
  MLD = minimal lumen diameter
  OR = odds ratio
  PTCA = percutaneous transluminal coronary angioplasty
  SICCO = Stenting in Chronic Coronary Occlusion
  TLR = target lesion revascularization
  TVR = target vessel revascularization

Although 60% to 70% of chronic coronary occlusions can be successfully opened by percutaneous transluminal coronary angioplasty (PTCA) (1), concerns have been raised about the usefulness of this approach in view of the high restenosis rate and possible complications (2–6).

As recently shown in the Stenting in Chronic Coronary Occlusion (SICCO) study (7) that stenting improves the angiographic outcome after PTCA of chronic coronary occlusions, with a reduction in the 6-month restenosis rate from 74% to 32% in the group with additional stent implantation compared with the group treated with angioplasty only. Several studies (8–10) indicate that the patency of the treated vessel is important for the long-term clinical outcome in these patients However, there are few reports on the long-term clinical outcome after stenting of chronic coronary occlusions. Accordingly, we wanted to investigate whether the initial advantage observed in the stent group in the SICCO trial at the 6-month angiographic follow-up was maintained during a longer follow-up of further clinical events.


   Methods
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 Abstract
 Methods
Results
 Discussion
 References
 
The SICCO study was a randomized, controlled, multicenter trial of 117 patients investigating the effect of additional intracoronary stenting after successful angioplasty of chronic coronary occlusions. Patients were recruited between March 1994 and May 1995. The inclusion criteria for the SICCO study are shown in Table 1. The current study reports the long-term clinical follow-up results of this patient cohort.


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  		Table 1 Selection criteria in SICCO Study

 
Interventional procedure and randomization.   Written informed consent was obtained before start of the procedure from prospective study participants. Provided that they had a fully satisfactory PTCA result, patients were randomized to a control group (n = 59), with no further invasive treatment, or to additional implantation (n = 58) of Palmaz-Schatz stents (Johnson & Johnson Interventional Systems). Patients with stenting were given full anticoagulation with warfarin for 3 months (7). Quantitative coronary angiography was performed before randomization, at the end the procedure and at 6-month follow-up, as previously described (7,11). Reocclusion was defined as a minimal lumen diameter (MLD) of zero and reappearance of occlusion (Thrombolysis in Myocardial Infarction [TIMI] flow grade 0 or 1) at the lesion site. Restenosis was defined as a diameter stenosis (DS) ≥50% at angiographic follow-up.

Long-term follow-up and clinical end points.   According to the protocol, at least 2 years after inclusion the patients were contacted by questionnaire or telephone interview, or both, to check for further events after the 6-month follow-up examination. Anginal symptoms were characterized according to the Canadian Cardiovascular Society classification (12) and were also assessed by a questionnaire (13). Adjunctive information regarding clinical events was obtained from the referring hospital or physician. Event-free survival was calculated from the date of the procedure to the clinical event or the time of the last follow-up contact.

The primary end point of the study was the occurrence of major adverse cardiac events, defined as cardiac death, lesion-related acute myocardial infarction (AMI), repeat lesion-related angioplasty, bypass surgery involving the treated segment or angiographic documentation of reocclusion in nonrevascularized patients. When more than one clinical end point occurred in a patient, the event occurring first was considered for the event-free survival analysis. For composite analysis, all events were considered. Death was considered to be cardiac related, unless proven otherwise.

Patients were considered for further revascularization if they had angina or inducible ischemia related to a coronary lesion, or both. Target vessel revascularization (TVR) was defined as any revascularization that involved the target vessel. Target lesion revascularization (TLR) was defined as a successful revascularization procedure (PTCA or surgical bypass) driven by a stenosis reappearing at the treated site (including 5 mm proximal and distal to the lesion borders). Urgent revascularization was defined as revascularization occurring within 72 h after onset of severe symptoms. AMI was defined as a clinical episode of prolonged chest pain suggestive of acute myocardial infarction and an increase in serum cardiac enzyme levels to at least twice the upper normal limit, or the appearance of one or more new pathologic Q waves in patients not admitted to the hospital.

Statistical methods.   All analyses were performed on an intention to treat principle. Continuous variables are presented as mean ± SD or median (range) and categoric variables as number (percent). Differences between groups were evaluated using the Student t test or the Mann-Whitney U test for continuous variables and by chi-square analysis with the Fisher exact test and odds ratio with 95% confidence intervals for categoric variables. The contribution of clinical, angiographic and procedural variables to the categoric outcome variables of major adverse cardiac events and TVR were evaluated with logistic regression analysis. Continuous variables were checked for linearity in logit by the Box-Tidwell test. The contribution of each variable was first assessed independently by univariate analysis. Variables with a p value ≤0.3 were then entered stepwise into an unconditional logistic regression model. A manual forward selection was performed adding to the model only the factor giving the largest significant difference in log likelihood ratio at each step. The results of logistic regression analysis were given as the odds ratio with 95% confidence interval. The Kaplan-Meier estimate was used to generate survival and event-free curves, and the log-rank test was used to compare the two treatment groups. All reported p values were two-tailed, and a p value <0.05 was considered statistically significant. The computer program used was Systat 7.0 (SPSS, Inc.).


   Results
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 Results
Discussion
 References
 
Clinical and angiographic baseline characteristics, as well as immediate procedural and 6-month angiographic results, have been published previously (7). Stent implantation was unsuccessful in one patient (who later developed restenosis and underwent repeat PTCA). There were no statistical significant differences between the two groups at baseline (Table 2), whereas the angiographic 6-month restenosis rate was 32% in the stent group and 74% in the PTCA group odds ratio [OR] 0.165, 95% confidence interval (CI) 0.07 to 0.37, p < 0.001) (Table 3). Angiographic follow-up was obtained in 97% of patients.


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  		Table 2 Clinical and Angiographic Characteristics

 

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  		Table 3 Clinical Events

 
Major adverse clinical events.   Late clinical follow-up was obtained in all patients at 33 ± 6 months, with ≥28 months of follow-up data available for 94% of patients. The follow-up time in surviving patients was 34 ± 5 months (range 25 to 43). A major adverse clinical event occurred in 14 patients (24.1%) in the stent group compared with 35 in the PTCA group (59.3%) (OR 0.22, 95% CI 0.10 to 0.49, p = 0.0002). Details of clinical events are shown in Table 3. The event-free survival curves of the two study groups are depicted in Figure 1. There were no significant differences between the two groups with respect to angina pectoris class, angina score or use of cardiovascular medications (Table 4).



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  		Figure 1 Survival without major adverse clinical events (death, AMI, TVR, reocclusion). Solid line = stent group; dashed line = PTCA group.

 

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  		Table 4 Clinical Status at Follow-Up (mean 34 ± 5 months)*

 
Death and myocardial infarction.   There was one cardiac death during the follow-up period. This was a sudden, unexpected death 21 months after PTCA without stenting of the left anterior descending coronary artery (LAD). At angiography after 6 months, 62% DS was found, but this lesion was not redilated because symptoms were minimal. Three patients (one in the stent group and two in the PTCA group) died of colon cancer. Survival for the whole study cohort was thus 97% after 24 months.

A lesion-related uncomplicated inferior myocardial infarction occurred due to occlusion of the right coronary artery 12 days after stenting. There were two cases of AMI related to lesions in other vessels. These occurred in two patients in the PTCA group who experienced an inferior myocardial infarction >30 months after PTCA of LAD occlusions. Both patients had an angiographically documented new occlusion of the right coronary artery. According to our protocol, these two cases were not counted as a major adverse cardiac event.

TLR and TVR.   Successful TLR was performed in 11 patients (19.0%) in the stent group and in 28 patients (47.5%) in the PTCA group (OR 0.26, 95% CI 0.11 to 0.61, p = 0.002). Furthermore, there were two patients in each group in whom an attempt to revascularize a reoccluded vessel by angioplasty failed and in whom operation was not recommended. In addition there were two cases of TVR without lesion recurrence. One patient in the stent group had occlusion of the LAD distal to the stented lesion and underwent bypass surgery 24 days after the index revascularization with an open stent preoperatively. Furthermore, a patient in the PTCA group (with a 40% lesion DS at angiographic follow-up) was treated for a subtotal stenosis of a marginal branch departing from the initial occlusion site in the right coronary artery.

Thus, TVR was attempted in 14 patients (24.1%) in the stent group and in 31 patients (52.5%) in the PTCA group (OR 0.27, 95% CI 0.12 to 0.64, p = 0.002). Details of the revascularization procedures are shown in Table 3, and the evolution of TVR is depicted in Figure 2. Of the 18 patients in the stent group with angiographic restenosis, TVR was performed in 11 (61%) compared with 28 (67%) of the 42 patients in the PTCA group with angiographic restenosis (p = 0.8). Of the seven patients in the stent group who had reocclusion of the treated artery at follow-up angiography, two (29%) did not undergo revascularization. Correspondingly, in the PTCA group 4 (27%) of the 15 patients with a reoccluded artery did not undergo revascularization. No further clinical events occurred in the patients with nonrevascularized reocclusion.



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  		Figure 2 Target vessel revascularization. Solid line= stent group; dashed line = PTCA group.

 
In the stent group there were five patients with a moderate restenosis (not reocclusion) who did not undergo revascularization because symptoms were minimal. No clinical event occurred in any of these patients. In the PTCA group there were 12 patients with nonocclusive restenosis in whom revascularization was deferred because of minimal symptoms. Besides the patient who died after 21 months, increasing clinical symptoms developed in three of these patients, resulting in late repeat PTCA (after 14, 19 and 22 months, respectively). Thus, late clinical events occurred in 33% of patients with untreated moderate restenosis in the PTCA group compared with none in the stent group (p = 0.3).

Subgroup analysis.   The frequency of major adverse cardiac events was 55% in LAD lesions, 38% in left circumflex coronary artery lesions and 31% in right coronary artery lesions (Pearson chi-square = 0.06). There was no significant excess of major adverse cardiac events in diabetic compared with nondiabetic patients (50% vs. 41%), in patients with a target vessel ≥3 or <3 mm (39% vs. 46%) or in patients with an occlusion age ≥3 or <3 months (42 vs. 50%).

The use of lipid-lowering drugs was infrequent (19%) at the start of the study and rose to 52% at long-term follow-up. There was no significant difference between the study groups with respect to the use of lipid-lowering drugs at follow-up (55% and 49% in the PTCA and stent groups, respectively, p = 0.6), nor was there any difference in the rate of major adverse cardiac events among those with and without use of lipid-lowering drugs (44% and 38%, respectively, p = 0.5).

Multivariate analysis.   As shown by Table 5, allocation to PTCA treatment as opposed to additional stent implantation was associated with a fivefold increase in the risk of a clinical event. Other significant predictors for a clinical event were LAD lesion (threefold increase) and lesion length (4% increase for each millimeter over the mean value of 17.5 mm). DS at randomization did not reach significance (OR 1.03, 95% CI 0.99 to 1.07, p = 0.17) when included in the model.


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  		Table 5 Predictors for Occurrence of Major Adverse Cardiac Events*

 

   Discussion
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 Abstract
 Methods
 Results
 Discussion
References
 
Although the first intracoronary stents were implanted >10 years ago (14), the long-time safety of these intracoronary devices has only recently been assessed (15–20) and only in previously nonoccluded arteries. There seems to be few clinical events and no further lumen derangement after the initial rise of in-stent restenosis within the first 4 to 8 months (21,22). The present study of the 117 patients with a recanalized chronic occlusion enrolled in the SICCO study assessed the question of whether the superior 6-month angiographic outcome in the stent group would give rise to a long-term clinical benefit. We found that the difference between the two groups was maintained for a period of at least 2 years, with a paucity of late events in the stent group but a gradual increase in clinical events in the PTCA group.

The present study indicates that patients who are treated for a chronic coronary occlusion with additional stent implantation after successful angioplasty have a good prognosis with respect to further lesion-related clinical events. The flat curves after the initial 6 to 8 months in stented chronic occlusions (Figures 1 and 2) are reassuring and indicate that even in chronic occlusions stent implantation seems to palliate the treated segment once the initial hurdles of subacute thrombosis and in-stent restenosis have been passed. After 2 years, 76% of patients in the stent group were event free compared with 41% who had been treated with PTCA only. The current study is thus in accordance with previous studies on long-term follow-up after stent implantation (15–20), although the lesions in these previous reports were generally short stenoses in large vessels.

Most studies on restenosis after PTCA of nonoccluded lesions conclude that the process of restenosis usually occurs within the first 6 months. There are even some studies suggesting the possibility of light regression in moderate restenotic lesions (23,24). However, chronic coronary occlusions have an overall larger tendency to develop restenosis than discrete lesions (1,6) and it is not unusual for restenosis to develop >6 months after the initial PTCA (25,26).

One intriguing finding of the present study was that clinical events continued to occur in the PTCA group long after revascularization induced by the 6-month clinical and angiographic follow-up (Fig. 1 and 2). Because prevention of late vessel remodeling and contraction is the main effect whereby stents reduce restenosis (27,28), it is possible that the continued increase in events in the PTCA group compared with the stent group was caused by continued late vessel remodeling and contraction.

As shown in Figures 1 and 2, the two curves separate only after the follow-up examination at ~6 months. This is not unexpected because patients with recurrent symptoms were generally not referred for unscheduled early angiography as long as they were scheduled for 6-month control angiography free of charge. As reported in the primary publication (7), 57% of stent group patients were free of angina at follow-up compared with 24% of patients in the PTCA group. The revascularizations performed after the control examination were thus the results of a judgment taking into account both clinical and angiographic data. The proportion of patients with angiographic restenosis who underwent revascularization was the same in both groups. The difference in late events was probably not related to the use of lipid-lowering drugs because this was similar in both groups.

We did not find any significant difference between the two treatment groups with respect to the clinical status, angina score or use of cardiovascular medications, possibly because of the greater extent of revascularization in the PTCA group.

Predictors for occurrence of clinical events (Table 5).   Besides the strong effect of stent implantation in preventing clinical events, we also found treatment of LAD lesions and lesion length to be significant predictors for clinical events in the multivariate model. This finding in accordance with other studies (25,29). Neither MLD nor DS at randomization reached statistical significance, which may be an argument against provisional stenting (30) of chronic occlusions. However, the relatively small sample size of the current study may give rise to type II errors in subgroup analyses.

Study limitations.   According to the protocol, we randomized only patients with an acceptable PTCA result after first having excluded patients with occlusions <2 weeks in duration, patients with vascular anatomy judged unfavorable for stenting and patients who needed stenting because of severe dissection or recoil. The results might thus be different in a less selected patient cohort. Despite the limited sample size of our study, we had 97% 6-month angiographic follow-up data and 100% clinical long-term follow-up data. Our results should therefore be applicable to most successfully recanalized chronic occlusions when stenting is considered an option and not unavoidable because of severe dissection or recoil. The introduction of more patent antiplatelet regimens have now nearly abolished subacute stent occlusions. It is thus possible that the difference between the two groups might have been more pronounced had the study been repeated today.

Conclusions and recommendations.   The long-term data from the SICCO study indicate that intracoronary stenting of chronic occlusions is associated with few clinical problems after the first 6 to 8 months, but there seems to be a continued risk of clinical event in patients treated with angioplasty only. Whenever feasible, we therefore recommend intracoronary stenting after the successful opening of a chronic coronary occlusion.


   References
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 Abstract
 Methods
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 Discussion
 References
 

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