Randomized comparison of 9-month stent strut coverage of biolimus and everolimus drug-eluting stents assessed by optical coherence tomography in patients with ST-segment elevation myocardial infarction. Long-term (5-years) clinical follow-up (ROBUST trial).

BACKGROUND: The aim of the study was to compare healing (assessed by optical coherence tomography [OCT]) of biolimus A9 (BES) and everolimus drug-eluting stents (EES) at 9-month follow-up in patients with ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (pPCI). Nine-month clinical and angiographic data were also compared in both groups as well as clinical data at 5 years of follow-up. METHODS: A total of 201 patients with STEMI were enrolled in the study and randomized either to pPCI with BES or EES implantation. All patients were scheduled for 9 months of angiographic and OCT follow-up. RESULTS: The rate of major adverse cardiovascular events (MACE) was comparable at 9 months in both groups (5% in BES vs. 6% in the EES group; p = 0.87). Angiographic data were also comparable between both groups. The main finding at 9-month OCT analysis was the greatly reduced extent of mean neointimal area at the cost of a higher proportion of uncovered struts in the BES group (1.3 mm² vs. 0.9 mm²; p = 0.0001 and 15.9% vs. 7.0%; p = 0.0001, respectively). At 5 years of clinical follow-up the rate of MACE was comparable between both groups (16.8% vs. 14.0%, p = 0.74). CONCLUSIONS: The study demonstrates a very low rate of MACE and good 9-month stent strut coverage of second-generation BES and EES in patients with STEMI. BES showed greatly reduced extent of mean neointimal hyperplasia area at the cost of a higher proportion of uncovered struts when compared to EES. The rate of MACE was low and comparable in both groups at 5 years.

OCT guidance during stent implantation in primary PCI: A randomized multicenter study with nine months of optical coherence tomography follow-up.

AIMS: To assess the possible merits of optical coherence tomography (OCT) guidance in primary percutaneous coronary intervention (pPCI). METHODS AND RESULTS: 201 patients with ST-elevation myocardial infarction (STEMI) were enrolled in this study. Patients were randomized either to pPCI alone (angio-guided group, n=96) or to pPCI with OCT guidance (OCT-guided group, n=105) and also either to biolimus A9 or to everolimus-eluting stent implantation. All patients were scheduled for nine months of follow-up angiography and OCT study. OCT guidance led to post-pPCI optimization in 29% of cases (59% malapposition and 41% dissections). No complications were found related to the OCT study. OCT analysis at nine months showed significantly less in-segment area of stenosis (6% [-11, 19] versus 18% [3, 33]; p=0.0002) in favor of the OCT-guided group. The rate major adverse cardiovascular events were comparable at nine months in both groups (3% in the OCT group versus 2% in the angio-guided group; p=0.87). CONCLUSIONS: This study demonstrates the safety of OCT guidance during pPCI. The use of OCT optimized stent deployment in 1/3 of patients in this clinical scenario and significantly reduced in-segment area of stenosis at nine months of follow-up. Whether such improvements in OCT endpoints will have a positive impact on late clinical outcomes, they demand both a larger and longer-term follow-up study.

Optical coherence tomography-guided primary percutaneous coronary intervention in ST-segment elevation myocardial infarction patients: a pilot study.

BACKGROUND: The objective of our study was to assess whether optical coherence tomography (OCT) guidance could guide intervention to avoid balloon angioplasty and stenting during primary percutaneous coronary intervention. METHODS: One hundred patients with ST-segment elevation myocardial infarction and thrombus-containing lesion were enrolled in this study. Thrombus aspiration was performed in all cases followed by an OCT study. After thrombectomy, no stent was implanted in residual significant stenosis (> 50%) if examination using OCT suggested that the occlusion was mostly thrombotic, provided that the patient was symptom-free and the Thrombolysis in Myocardial Infarction (TIMI) flow was ≥ 2. All patients managed only using thrombectomy underwent 1-week and 9-month angiography and OCT. Patients with significant lesion or those in whom thrombectomy failed to re-establish flow underwent standard treatment. RESULTS: Based on the OCT information, 20 patients (20%) were treated only with aspiration even in the presence of angiographically detected "high-grade stenosis." Angiogram and OCT performed at 1 week and 9 months showed a "normal vessel" without significant stenosis in all 20 cases. There were no cases of major adverse cardiovascular event (including death, myocardial infarction, and target lesion revascularization) during the in-hospital period or at the 12-month follow-up. CONCLUSIONS: The results of our pilot study suggest that ST segment elevation myocardial infarction patients with TIMI 2/3 flow in the angiogram and without significant coronary narrowing using OCT examination (even in the presence of angiographically detected "high-grade stenosis"), in whom thrombus aspiration is performed in addition to optimal medical therapy might benefit only from thrombus aspiration without plain old balloon angioplasty/stenting during primary percutaneous coronary intervention. Validation of these preliminary data in larger randomized studies is warranted.

Randomized comparison of endothelial progenitor cells capture stent versus cobalt-chromium stent for treatment of ST-elevation myocardial infarction. Six-month clinical, angiographic, and IVUS follow-up.

PURPOSE: The aim of this trial was to assess the feasibility and safety of endothelial progenitor cells capture (EPC) stent in the treatment of acute ST-elevation myocardial infarction (STEMI) when compared with cobalt-chromium stents (CoCr). METHODS: Between July 2006 and May 2008, 100 patients with single vessel disease undergoing primary PCI for STEMI were randomly assigned to receive either EPC stent (N = 50) or CoCr stent (N = 50). High-pressure stent implantation was carried out in both groups. Dual antiplatelet treatment was administered for 30 days in both groups. All patients underwent 6-month clinical, angiographic, and IVUS follow-up. RESULTS: The rate of major adverse cardiovascular events (MACEs) at 30 days was comparable in both groups. At 6-month follow-up, the rates of MACEs and TLR in the EPC stent group when compared with CoCr stent were 24% vs.10%; P = 0.06 and 14% vs. 4%; P = 0.08, respectively. There were three cases (6%) of stent thrombosis (ST) in the EPC stent group versus none in CoCr group. CONCLUSION: The use of EPC capture stents in the setting of STEMI is feasible and safe in terms of 30-days outcome. However, at the 6-month follow-up, we found a trend of higher rates of MACE and TLR in the EPC stent capture group compared to CoCr stents. The study does not support the use of EPC capture stents with short duration dual antiplatelet therapy in patients with STEMI. Future randomized studies with large sample sizes would be necessary to demonstrate the safety of such approach. © 2010 Wiley-Liss, Inc.