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1.
EuroIntervention ; 10(8): 916-23, 2014 Dec.
Article in English | MEDLINE | ID: mdl-24974806

ABSTRACT

AIMS: To our knowledge, no randomised study has compared rates of uncovered stent struts in everolimus (EES) vs. new-generation zotarolimus-eluting (ZES-R) stents in acute coronary syndrome (ACS). The aim of our study was to evaluate the completeness of neointimal coverage with optical coherence tomography (OCT) in ACS patients treated with drug-eluting stents (DES) comparing EES versus new-generation ZES-R. METHODS AND RESULTS: All eligible ACS patients admitted to four Italian centres with a clinical indication for culprit lesion intervention were randomised 1:1 to EES or ZES-R. The primary study endpoint was the percentage of uncovered stent struts evaluated by optical coherence tomography (OCT) at six months. Secondary endpoints were the percentage of malapposed stent struts, percent neointimal hyperplasia cross-sectional area (CSA) and major adverse cardiac events (MACE) at six months. A total of 60 patients were randomised to EES (n=29) or ZES-R (n=31). No differences were observed in baseline characteristics between the two groups. Overall, 31.7% presented with STEMI, of which 68.4% were anterior. The other patients comprised 41.7% NSTEMI and 26.7% troponin-negative ACS. A mean of 1.3±0.6 lesions were treated per patient, with a mean of 1.3±0.5 stents per lesion. At 30 days there was one sudden death. Six-month OCT analysis was performed in 25 lesions in the EES group and in 24 lesions in the ZES-R group. There was no difference in the primary endpoint of uncovered stent struts between groups (EES 6.42% [3.27, 9.57] vs. ZES-R 7.07% [3.22, 10.92]; p=0.80). Furthermore, there were no differences between groups in the percentage of malapposed stent struts, either with (EES 1.19% [0.34, 2.04] vs. ZES-R 0.85% [0.40, 1.30]; p=0.49) or without coverage (EES 1.06% [0.12, 2.01] vs. ZES-R 0.24% [0.05, 0.44]; p=0.09). Percent neointima CSA was similar in both groups (EES 37.0% [18.6, 55.3] vs. ZES-R 26.6% [18.4, 34.8]; p=0.31). At six-month clinical follow-up, no additional patients died or suffered MI. There were four MACE in the EES group and one in the ZES-R group. CONCLUSIONS: In our study, in patients presenting with ACS, both EES and ZES-R had low percentages of malapposed and uncovered stent struts at six-month OCT analysis.


Subject(s)
Acute Coronary Syndrome/surgery , Coronary Restenosis/prevention & control , Coronary Stenosis/surgery , Coronary Vessels/pathology , Drug-Eluting Stents , Immunosuppressive Agents/therapeutic use , Neointima/pathology , Sirolimus/analogs & derivatives , Acute Coronary Syndrome/etiology , Aged , Coronary Stenosis/complications , Coronary Stenosis/pathology , Everolimus , Female , Humans , Male , Middle Aged , Percutaneous Coronary Intervention , Single-Blind Method , Sirolimus/therapeutic use , Tomography, Optical Coherence
2.
JACC Cardiovasc Interv ; 2(9): 887-91, 2009 Sep.
Article in English | MEDLINE | ID: mdl-19778779

ABSTRACT

OBJECTIVES: We sought to examine the acute and subacute results of carotid stenting performed during live transmissions. BACKGROUND: Teaching courses focusing on live demonstrations of carotid interventions have been the key educational facility for physicians interested in learning state-of-the-art interventional techniques of carotid stenosis treatment. However, starting with the very first live demonstration of interventional procedures, there has been an ongoing discussion whether patients treated during live transmissions are at higher risk. METHODS: Between March 1, 2001, and June 30, 2008, 186 high-grade lesions of the internal carotid artery in 186 patients have been treated by stent implantation during live transmissions to 22 interventional conferences at 3 high-volume centers. Technical success was defined as the ability to perform carotid stent implantation. The combined end point of death, major stroke, minor stroke, or myocardial infarction was defined as primary end point. RESULTS: The procedure was technically successful in 185 of 186 (99.5%) interventions. Seventeen patients had 1 of the following acute in-hospital complications: major stroke in 2 (1.1%), minor stroke in 3 (1.6%), transient ischemic attack in 11 (5.9%), and amaurosis of the ipsilateral eye due to an occlusion of the retinal artery in 1 (0.5%). None of the patients died, and no myocardial infarctions occurred. The composite primary end point occurred in 6 (3.2%) patients. CONCLUSIONS: In this consecutive series of carotid stent cases performed by expert operators during live demonstration courses, the procedural and 30-day clinical outcomes were similar to the results appearing in the contemporary published data.


Subject(s)
Angioplasty , Carotid Stenosis/surgery , Education, Medical/methods , Stents , Videoconferencing , Adult , Aged , Aged, 80 and over , Angioplasty/adverse effects , Angioplasty/education , Angioplasty/instrumentation , Angioplasty/mortality , Blindness/etiology , Carotid Stenosis/mortality , Europe , Female , Humans , Ischemic Attack, Transient/etiology , Male , Middle Aged , Myocardial Infarction/etiology , Risk Assessment , Risk Factors , Stroke/etiology , Time Factors , Treatment Outcome
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