Tej N Sheth1, Olli A Kajander2, Shahar Lavi2, Ravinay Bhindi2, Warren J Cantor2, Asim N Cheema2, Goran Stankovic2, Kari Niemelä2, Madhu K Natarajan2, Olga Shestakovska2, Rachel Tittarelli2, Brandi Meeks2, Sanjit S Jolly2. 1. From the Population Health Research Institute, McMaster University and Hamilton Health Science, Hamilton, Canada (T.N.S., M.K.N., O.S., R.T., B.M., S.S.J.); Heart Hospital, Tampere University Hospital and School of Medicine, University of Tampere, Tampere, Finland (O.A.K., K.N.); London Health Sciences Centre, London, Canada (S.L.); Royal North Shore Hospital, Sydney, Australia (R.B.), Southlake Regional Health Centre, University of Toronto, Newmarket, Canada (W.J.C.); St. Michael's Hospital, Toronto, Canada (A.N.C.); and Clinical Center of Serbia, Belgrade, Serbia (G.S.). shetht@mcmaster.ca. 2. From the Population Health Research Institute, McMaster University and Hamilton Health Science, Hamilton, Canada (T.N.S., M.K.N., O.S., R.T., B.M., S.S.J.); Heart Hospital, Tampere University Hospital and School of Medicine, University of Tampere, Tampere, Finland (O.A.K., K.N.); London Health Sciences Centre, London, Canada (S.L.); Royal North Shore Hospital, Sydney, Australia (R.B.), Southlake Regional Health Centre, University of Toronto, Newmarket, Canada (W.J.C.); St. Michael's Hospital, Toronto, Canada (A.N.C.); and Clinical Center of Serbia, Belgrade, Serbia (G.S.).
Abstract
BACKGROUND:Patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction are at increased risk for adverse events. It is unclear if image guidance by optical coherence tomography (OCT) can improve outcomes in these patients. We compared OCT-guided versus angiography-guided primary PCI for ST-segment-elevation myocardial infarction among patients in the Thrombectomy Versus PCI Alone (TOTAL) trial. METHODS AND RESULTS:Among 10 732 patients enrolled in the TOTAL trial, OCT was used for PCI guidance as a part of a prospective substudy in 214 patients. Using 2:1 propensity matching, we identified 428 patients in the trial who had PCI performed withangiography guidance alone. The primary outcome was a composite of cardiovascular death, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. Secondary outcomes included final in-stent angiographic minimum lumen diameter, procedure time, and contrast dose. The final in-stent angiographic minimum lumen diameter was 2.99±0.48 mm in the OCT-guided group versus 2.79±0.47 mm in the angiography-guided group (P<0.0001). OCT- and angiography-guided PCI had a median (interquartile range) procedure time of 58 (47, 71) minute versus 38 (28, 52) minute (P<0.0001) and total contrast dose of 239.7±81.1 mL versus 193.3±78.6 mL (P<0.0001). The primary outcome was observed in 7.5% of the OCT-guided group versus 9.8% of the angiography-guided group (hazard ratio, 0.76; 95% confidence interval, 0.43-1.34; P=0.34). CONCLUSIONS:OCT-guided primary PCI for ST-segment-elevation myocardial infarction was associated with a larger final in-stent minimum lumen diameter. There was no significant difference in clinical outcomes at 1 year; however, the study was underpowered to detect a treatment effect. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01149044.
RCT Entities:
BACKGROUND:Patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction are at increased risk for adverse events. It is unclear if image guidance by optical coherence tomography (OCT) can improve outcomes in these patients. We compared OCT-guided versus angiography-guided primary PCI for ST-segment-elevation myocardial infarction among patients in the Thrombectomy Versus PCI Alone (TOTAL) trial. METHODS AND RESULTS: Among 10 732 patients enrolled in the TOTAL trial, OCT was used for PCI guidance as a part of a prospective substudy in 214 patients. Using 2:1 propensity matching, we identified 428 patients in the trial who had PCI performed with angiography guidance alone. The primary outcome was a composite of cardiovascular death, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. Secondary outcomes included final in-stent angiographic minimum lumen diameter, procedure time, and contrast dose. The final in-stent angiographic minimum lumen diameter was 2.99±0.48 mm in the OCT-guided group versus 2.79±0.47 mm in the angiography-guided group (P<0.0001). OCT- and angiography-guided PCI had a median (interquartile range) procedure time of 58 (47, 71) minute versus 38 (28, 52) minute (P<0.0001) and total contrast dose of 239.7±81.1 mL versus 193.3±78.6 mL (P<0.0001). The primary outcome was observed in 7.5% of the OCT-guided group versus 9.8% of the angiography-guided group (hazard ratio, 0.76; 95% confidence interval, 0.43-1.34; P=0.34). CONCLUSIONS: OCT-guided primary PCI for ST-segment-elevation myocardial infarction was associated with a larger final in-stent minimum lumen diameter. There was no significant difference in clinical outcomes at 1 year; however, the study was underpowered to detect a treatment effect. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01149044.
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