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COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
Strut coverage and vessel wall response to zotarolimus-eluting and bare-metal stents implanted in patients with ST-segment elevation myocardial infarction: the OCTAMI (Optical Coherence Tomography in Acute Myocardial Infarction) Study.
JACC. Cardiovascular Interventions 2010 June
OBJECTIVES: Using optical coherence tomography, we assessed the proportion of uncovered struts at 6-month follow-up in zotarolimus-eluting stents (ZES), specifically Endeavor (Medtronic CardioVascular, Santa Rosa, California) stents, and identical bare-metal stents (BMS) implanted in patients with ST-segment elevation myocardial infarction (STEMI).
BACKGROUND: Sirolimus- and paclitaxel-eluting stents implanted in STEMI have been associated with delayed healing and incomplete strut coverage. ZES are associated with a more complete and uniform strut coverage in stable patients, but whether this holds true also after STEMI is unknown.
METHODS: Forty-four patients with STEMI who underwent primary PCI were randomized to ZES or BMS (3:1 randomization). Angiographic, intravascular ultrasound, and optical coherence tomography follow-up was conducted at 6 months and clinical follow-up at 1 year. All images were analyzed by an independent core laboratory that was blind to stent assignments.
RESULTS: There were no differences between ZES and BMS in percentage of uncovered struts (median: 0.00% [interquartile range (IQR): 0.00% to 1.78%] vs. 1.98% [IQR: 0.21% to 7.33%], p = 0.13), maximum length of uncovered segments (0.00 [IQR: 0.00 to 1.19] mm vs. 1.38 [IQR: 0.65 to 3.30] mm, p = 0.10), percentage of malapposed struts (0.00% [IQR: 0.00% to 0.23%] vs. 0.15% [IQR: 0.00% to 5.81%], p = 0.16), and maximum length of malapposed segments (0.00 [IQR: 0.00 to 0.67] mm vs. 0.33 [IQR: 0.00 to 2.55] mm, p = 0.20). Neointimal response was similar between ZES and BMS (332 [IQR: 240 to 429] microm vs. 186 [IQR: 136 to 348] microm, p = 0.99) and evenly distributed. No late acquired malapposition was observed in both groups. There were no deaths, myocardial infarction, or stent thromboses at 1 year.
CONCLUSIONS: This optical coherence tomography study found no difference in strut coverage and similar vessel response to ZES, when compared with identical BMS, implanted during primary percutaneous coronary intervention in STEMI patients. (Six-Month Coverage and Vessel Wall Response of the Zotarolimus Drug-Eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography [OCTAMI]; NCT00704561).
BACKGROUND: Sirolimus- and paclitaxel-eluting stents implanted in STEMI have been associated with delayed healing and incomplete strut coverage. ZES are associated with a more complete and uniform strut coverage in stable patients, but whether this holds true also after STEMI is unknown.
METHODS: Forty-four patients with STEMI who underwent primary PCI were randomized to ZES or BMS (3:1 randomization). Angiographic, intravascular ultrasound, and optical coherence tomography follow-up was conducted at 6 months and clinical follow-up at 1 year. All images were analyzed by an independent core laboratory that was blind to stent assignments.
RESULTS: There were no differences between ZES and BMS in percentage of uncovered struts (median: 0.00% [interquartile range (IQR): 0.00% to 1.78%] vs. 1.98% [IQR: 0.21% to 7.33%], p = 0.13), maximum length of uncovered segments (0.00 [IQR: 0.00 to 1.19] mm vs. 1.38 [IQR: 0.65 to 3.30] mm, p = 0.10), percentage of malapposed struts (0.00% [IQR: 0.00% to 0.23%] vs. 0.15% [IQR: 0.00% to 5.81%], p = 0.16), and maximum length of malapposed segments (0.00 [IQR: 0.00 to 0.67] mm vs. 0.33 [IQR: 0.00 to 2.55] mm, p = 0.20). Neointimal response was similar between ZES and BMS (332 [IQR: 240 to 429] microm vs. 186 [IQR: 136 to 348] microm, p = 0.99) and evenly distributed. No late acquired malapposition was observed in both groups. There were no deaths, myocardial infarction, or stent thromboses at 1 year.
CONCLUSIONS: This optical coherence tomography study found no difference in strut coverage and similar vessel response to ZES, when compared with identical BMS, implanted during primary percutaneous coronary intervention in STEMI patients. (Six-Month Coverage and Vessel Wall Response of the Zotarolimus Drug-Eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography [OCTAMI]; NCT00704561).
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