Comparison between diabetic and non-diabetic patients after successful percutaneous coronary intervention for chronic total occlusions in the drug-eluting stent era.

OBJECTIVE: Diabetes mellitus and chronic total occlusions are associated with unfavorable outcome after percutaneous coronary intervention. We sought to assess the clinical and angiographic outcomes of diabetic and non-diabetic patients who underwent successful percutaneous revascularization of chronic total occlusions with drug-eluting stents. METHODS: Baseline clinical and angiographic characteristics, procedural details, nine-month angiographic follow-up and clinical events at 12 months were compared between 75 diabetic and 132 non-diabetic patients included in a clinical trial that randomized successful recanalization of chronic total occlusions to receive sirolimus- or everolimus-eluting stents. RESULTS: In both diabetic and non-diabetic groups there was a favorable non-significantly different angiographic result at nine months, with low in-stent late loss (0.14±0.60 mm vs. 0.25±0.68 mm, p=0.305) and rates of binary restenosis (4.0% vs. 10.6%, p=0.180) and reocclusion (0.0% vs. 2.3%, p=0.334). During follow-up similar survival from death (97.3±1.9% vs. 99.2±0.8%, log-rank p=0.273), acute myocardial infarction (100.0±0.0% vs. 97.7±1.3%, log-rank p=0.192), target vessel revascularization (88.7±3.8% vs. 88.2±2.9%, log-rank p=0.899) and stent thrombosis (100.0±0.0% vs. 97.7±1.3%, log-rank p=0.192) was observed. Furthermore, the presence of more diffuse peripheral and coronary artery disease and higher frequency of calcified lesions in diabetic patients did not lead to significant differences in the approach (20.0% vs. 25.0% radial approach, p=0.413), strategy (6.7% vs. 3.8% retrograde strategy, p=0.353), total stent length (48.1±24.6 mm vs. 49.2±23.9 mm, p=0758) or contrast volume (261.3±116.4 ml vs. 297.4±135.9 ml, p=0.109) required for revascularization. CONCLUSIONS: In the drug-eluting stent era, diabetic and non-diabetic patients have comparable favorable clinical and angiographic outcomes after successful percutaneous revascularization of chronic total occlusions.

Drug-eluting stent thrombosis in the treatment of chronic total coronary occlusions: incidence, presentation and related factors. Data from the CIBELES trial.

INTRODUCTION AND OBJECTIVES: The aim of this study was to analyze the incidence of drug-eluting stent thrombosis (sirolimus or everolimus) in patients with chronic total coronary occlusions (CTO) and to determine its clinical implications and related factors. METHODS: Data from the 12-month follow-up of the 207 patients included in the CIBELES trial with CTO were analyzed. RESULTS: Stent thrombosis occurred in three patients, two definite and one probable (overall thrombosis rate: 1.4%). However, there were no cases of death or Q-wave myocardial infarction. In univariate analysis, patients with a higher incidence of stent thrombosis were those in whom the target vessel was the left anterior descending, who had single-vessel disease, were assigned to treatment with sirolimus-eluting stents, and those with smaller minimum luminal diameter immediately after the procedure. In multivariate analysis, the only independent predictor of stent thrombosis was minimal luminal diameter immediately after the procedure. CONCLUSIONS: The rate of drug-eluting stent thrombosis in patients with CTO is relatively low (1.4%). The only independent predictor of stent thrombosis in this context was minimal luminal diameter after the procedure and the clinical presentation was in all cases relatively benign.

Randomized comparison of sirolimus-eluting and everolimus-eluting coronary stents in the treatment of total coronary occlusions: results from the chronic coronary occlusion treated by everolimus-eluting stent randomized trial.

BACKGROUND: Patients with coronary total occlusions are at especially high risk for restenosis and new revascularizations. Sirolimus-eluting stents dramatically improved the clinical outcome of this subset of patients in randomized trials, but other drug-eluting stents, mainly the everolimus-eluting stent (currently the most frequently used stent), have not yet been evaluated in patients with coronary total occlusions. The objective was to compare the second-generation everolimus-eluting stent with the first-generation sirolimus-eluting stent in patients with coronary total occlusions. METHODS AND RESULTS: A total of 207 patients with coronary total occlusions and estimated time since occlusion >2 weeks were randomized to everolimus- or sirolimus-eluting stent. The primary end point was in-stent late loss at 9-month angiographic follow-up (noninferiority trial). Clinical follow-up was performed at 1 and 12 months. In-stent late loss at 9 months was 0.29±0.60 versus 0.13±0.69 mm in patients allocated to sirolimus- and everolimus-eluting stent, respectively. The observed difference in in-stent late loss between both groups was -0.16 mm (95% confidence interval, 0.04 to -0.36 mm; P for noninferiority <0.01). The rate of binary angiographic restenosis was 10.8% and 9.1% in patients allocated to sirolimus- and everolimus-eluting stent, respectively (P=0.709), whereas the rate of vessel reocclusion was 3.2% and 1.1%, respectively (P=0.339). At 12 months, the rate of major adverse events was 15.9% versus 11.1% with sirolimus- and everolimus-eluting stent, respectively (P=0.335), and probable or definitive stent thrombosis occurred in 3.0% and 0.0% of patients, respectively (P=0.075). CONCLUSIONS: In patients with coronary total occlusions, everolimus-eluting stent is as effective as sirolimus-eluting stent. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00793221.

A randomised comparison between everolimus-eluting stent and sirolimus-eluting stent in chronic coronary total occlusions. Rationale and design of the CIBELES (non-acute Coronary occlusion treated by EveroLimus-Eluting Stent) trial.

Chronic total coronary occlusions constitute a sub-group of lesions at very high risk of restenosis after successful percutaneous coronary intervention. The sirolimus-eluting coronary stent is the only drugeluting stent that has demonstrated to reduce angiographic restenosis and the need for new revascularisation procedures in comparison with bare-metal stents in randomised clinical trials focusing on these lesions. Everolimus-eluting stents have shown to offer optimal angiographic and clinical outcomes in comparison with bare-metal stents and paclitaxel-eluting stents, but no randomised trials have tested the device in chronic total occlusions. The CIBELES (non-acute Coronary occlusIon treated By EveroLimus- Eluting Stent) will randomise 208 patients with chronic total coronary occlusions in 13 centres from Portugal and Spain to receive everolimus- or sirolimus-eluting coronary stents. The primary endpoint will be angiographic in-stent late loss.