David Hildick-Smith1, Miles W Behan2, Jens F Lassen1, Alaide Chieffo1, Thierry Lefèvre1, Goran Stankovic1, Francesco Burzotta1, Manuel Pan1, Miroslaw Ferenc1, Lorraine Bennett1, Thomas Hovasse1, Mark J Spence1, Keith Oldroyd1, Philippe Brunel1, Didier Carrie1, Andreas Baumbach1, Michael Maeng1, Nicola Skipper1, Yves Louvard1. 1. From the Sussex Cardiac Centre, Brighton and Sussex University Hospitals, United Kingdom (D.H.-S., L.B., N.S.); Edinburgh Heart Centre, United Kingdom (M.W.B.); Department of Cardiology, Aarhus University Hospital, Skejby, Denmark (J.F.L., M.M.); Department of Cardiology, San Raffaele Scientific Institute, Milan, Italy (A.C.); Institute Cardiovasculaire Paris Sud, Hospital Privé Jacques Cartier, Massy, France (T.L., T.H., Y.L.); Department of Cardiology, Clinical Centre of Serbia, Belgrade (G.S.); Medical Faculty, University of Belgrade, Serbia (G.S.); Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy (F.B.); Department of Cardiology, Reina Sofia Hospital, University of Cordoba, Spain (M.P.); University Heart Center Freiburg, Bad Krozingen, Germany (M.F.); Department of Cardiology, Royal Victoria Hospital, Belfast, United Kingdom (M.J.S.); Department of Cardiology, Golden Jubilee National Hospital, Glasgow, United Kingdom (K.O.); Department of Cardiology, Clinique de Fontaine-les-Djon, France (P.B.); Department of Cardiology, Rangueil Hospital, Toulouse, France (D.C.); and Bristol Heart Institute, United Kingdom (A.B.). 2. From the Sussex Cardiac Centre, Brighton and Sussex University Hospitals, United Kingdom (D.H.-S., L.B., N.S.); Edinburgh Heart Centre, United Kingdom (M.W.B.); Department of Cardiology, Aarhus University Hospital, Skejby, Denmark (J.F.L., M.M.); Department of Cardiology, San Raffaele Scientific Institute, Milan, Italy (A.C.); Institute Cardiovasculaire Paris Sud, Hospital Privé Jacques Cartier, Massy, France (T.L., T.H., Y.L.); Department of Cardiology, Clinical Centre of Serbia, Belgrade (G.S.); Medical Faculty, University of Belgrade, Serbia (G.S.); Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy (F.B.); Department of Cardiology, Reina Sofia Hospital, University of Cordoba, Spain (M.P.); University Heart Center Freiburg, Bad Krozingen, Germany (M.F.); Department of Cardiology, Royal Victoria Hospital, Belfast, United Kingdom (M.J.S.); Department of Cardiology, Golden Jubilee National Hospital, Glasgow, United Kingdom (K.O.); Department of Cardiology, Clinique de Fontaine-les-Djon, France (P.B.); Department of Cardiology, Rangueil Hospital, Toulouse, France (D.C.); and Bristol Heart Institute, United Kingdom (A.B.). milesbehan@hotmail.com.
Abstract
BACKGROUND: For the treatment of coronary bifurcation lesions, a provisional strategy is superior to systematic 2-stent techniques for the most bifurcation lesions. However, complex anatomies with large side branches (SBs) with significant ostial disease length are considered by expert consensus to warrant a 2-stent technique upfront. This consensus view has not been scientifically assessed. METHODS AND RESULTS: Symptomatic patients with large caliber true bifurcation lesions (SB diameter ≥2.5 mm) and significant ostial disease length (≥5 mm) were randomized to either a provisional T-stent strategy or a dual stent culotte technique. Two hundred patients aged 64±10 years, 82% male, were randomized in 20 European centers. The clinical presentations were stable coronary disease (69%) and acute coronary syndromes (31%). SB stent diameter (2.67±0.27 mm) and length (20.30±5.89 mm) confirmed the extent of SB disease. Procedural success (provisional 97%, culotte 94%) and kissing balloon inflation (provisional 95%, culotte 98%) were high. Sixteen percent of patients in the provisional group underwent T-stenting. The primary end point (a composite of death, myocardial infarction, and target vessel revascularization at 12 months) occurred in 7.7% of the provisional T-stent group versus 10.3% of the culotte group (hazard ratio, 1.02; 95% confidence interval, 0.78-1.34; P=0.53). Procedure time, x-ray dose, and cost all favored the simpler procedure. CONCLUSIONS: When treating complex coronary bifurcation lesions with large stenosed SBs, there is no difference between a provisional T-stent strategy and a systematic 2-stent culotte strategy in a composite end point of death, myocardial infarction, and target vessel revascularization at 12 months. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT 01560455.
RCT Entities:
BACKGROUND: For the treatment of coronary bifurcation lesions, a provisional strategy is superior to systematic 2-stent techniques for the most bifurcation lesions. However, complex anatomies with large side branches (SBs) with significant ostial disease length are considered by expert consensus to warrant a 2-stent technique upfront. This consensus view has not been scientifically assessed. METHODS AND RESULTS: Symptomatic patients with large caliber true bifurcation lesions (SB diameter ≥2.5 mm) and significant ostial disease length (≥5 mm) were randomized to either a provisional T-stent strategy or a dual stent culotte technique. Two hundred patients aged 64±10 years, 82% male, were randomized in 20 European centers. The clinical presentations were stable coronary disease (69%) and acute coronary syndromes (31%). SB stent diameter (2.67±0.27 mm) and length (20.30±5.89 mm) confirmed the extent of SB disease. Procedural success (provisional 97%, culotte 94%) and kissing balloon inflation (provisional 95%, culotte 98%) were high. Sixteen percent of patients in the provisional group underwent T-stenting. The primary end point (a composite of death, myocardial infarction, and target vessel revascularization at 12 months) occurred in 7.7% of the provisional T-stent group versus 10.3% of the culotte group (hazard ratio, 1.02; 95% confidence interval, 0.78-1.34; P=0.53). Procedure time, x-ray dose, and cost all favored the simpler procedure. CONCLUSIONS: When treating complex coronary bifurcation lesions with large stenosed SBs, there is no difference between a provisional T-stent strategy and a systematic 2-stent culotte strategy in a composite end point of death, myocardial infarction, and target vessel revascularization at 12 months. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT 01560455.
Authors: Larragem Parsley-Raines; Dominique M Brandt; Dillon L Carr; Sabrina Uhry; Eileen S Alexander; Stephanie A Donauer; Peter J Mallow Journal: J Health Econ Outcomes Res Date: 2019-04-26
Authors: Thomas J Ford; Peter McCartney; David Corcoran; Damien Collison; Barry Hennigan; Margaret McEntegart; David Hildick-Smith; Keith G Oldroyd; Colin Berry Journal: J Am Heart Assoc Date: 2018-05-25 Impact factor: 5.501
Authors: Indulis Kumsars; Niels Ramsing Holm; Matti Niemelä; Andrejs Erglis; Kari Kervinen; Evald Høj Christiansen; Michael Maeng; Andis Dombrovskis; Vytautas Abraitis; Aleksandras Kibarskis; Thor Trovik; Gustavs Latkovskis; Dace Sondore; Inga Narbute; Christian Juhl Terkelsen; Markku Eskola; Hannu Romppanen; Mika Laine; Lisette Okkels Jensen; Mikko Pietila; Pål Gunnes; Lasse Hebsgaard; Ole Frobert; Fredrik Calais; Juha Hartikainen; Jens Aarøe; Jan Ravkilde; Thomas Engstrøm; Terje K Steigen; Leif Thuesen; Jens F Lassen Journal: Open Heart Date: 2020-01-19