Supplementary appendix

Transcription

1 Supplementary appendix This appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Byrne RA, Stone GW, Ormiston J, Kastrati A. Coronary balloon angioplasty, stents, and scaffolds. Lancet 2017; 390:

2 Web appendix to Coronary Balloon Angioplasty, Stents and Scaffolds Robert A. Byrne, 1,2 Gregg W. Stone, 3,4 John Ormiston, 5 Adnan Kastrati 1,2 1 Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; 2 DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany; 3 New York Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA; 4 The Cardiovascular Research Foundation, New York, NY, USA; 5 Mercy Angiography, Auckland, New Zealand Corresponding author: Robert A. Byrne, byrne@dhm.mhn.de 1

3 Tables Web Table 1. Summary of randomized clinical trial data comparing drug eluting stents versus bare metal stents with follow up of at least 2 years Study name Study devices (drug eluting stent) Total enrolment/ latest followup NORSTENT 1 EES and ZES 9013 patients median of 5 years LEADERS FREE 2 BES (PF) 2466 patients 2 year BASKET PROVE 3 EES 2314 patients* 2 years BASKET PROVE II 4 BES (BP) 2291 patients*,** 2 years EXAMINATION 5 EES 1498 patients 5 years Primary endpoint Primary result (hazard ratio [95% CI]) composite of death or MI 0.98 [0.88 to 1.09], P=0.66 composite of cardiac death, MI or stent thrombosis composite of death or MI composite of cardiac death, MI or TVR composite of death, MI, any revascularisation 0.80 [0.64 to 0.99], P= [ ], P= [ ], P= , 95% CI ; P=0 033 Only large scale trials with a follow up of at least 2 years are shown; data from latest available follow up is reported * patients requiring treatment with stent size 3.0 mm ** comparison of BES vs. EES not shown patients presenting with ST segment elevation myocardial infarction BES = biolimus A9 eluting stents; BMS = bare metal stent; BP = biodegradable polymer; EES = everolimus eluting stents; MI = myocardial infarction; PF = polymer free; TVR = target vessel revascularization 2

4 Web Table 2. Design characteristics of select drug coated angioplasty balloons Device Drug Spacer or excipient IN.PACT Falcon Paclitaxel Urea Pantera Lux Paclitaxel butyryl tri hexyl citrate (BTHC) SeQuent Please Paclitaxel Iopromide Devices shown have CE mark approval and published randomized clinical trial data 3

5 References 1. Bonaa KH, Mannsverk J, Wiseth R, et al. Drug Eluting or Bare Metal Stents for Coronary Artery Disease. N Engl J Med Garot P, Morice MC, Tresukosol D, et al. 2 Year Outcomes of High Bleeding Risk Patients After Polymer Free Drug Coated Stents. J Am Coll Cardiol 2017; 69(2): Kaiser C, Galatius S, Erne P, et al. Drug eluting versus bare metal stents in large coronary arteries. N Engl J Med 2010; 363(24): Kaiser C, Galatius S, Jeger R, et al. Long term efficacy and safety of biodegradable polymer biolimuseluting stents: main results of the Basel Stent Kosten Effektivitats Trial PROspective Validation Examination II (BASKET PROVE II), a randomized, controlled noninferiority 2 year outcome trial. Circulation 2015; 131(1): Sabate M, Brugaletta S, Cequier A, et al. Clinical outcomes in patients with ST segment elevation myocardial infarction treated with everolimus eluting stents versus bare metal stents (EXAMINATION): 5 year results of a randomised trial. Lancet 2016; 387(10016):

6 References to support figure 1 1. Forssmann W. [Contrast representation of the cavities of the living right half of the heart]. MMW Munch Med Wochenschr 1931; 78: Cournand A, Riley RL, Breed ES, et al. Measurement of Cardiac Output in Man Using the Technique of Catheterization of the Right Auricle or Ventricle. J Clin Invest 1945; 24(1): Sones FM, Jr., Shirey EK. Cine coronary arteriography. Mod Concepts Cardiovasc Dis 1962; 31: Dotter CT, Judkins MP. Transluminal Treatment of Arteriosclerotic Obstruction. Description of a New Technic and a Preliminary Report of Its Application. Circulation 1964; 30: Simpson JB, Baim DS, Robert EW, Harrison DC. A new catheter system for coronary angioplasty. Am J Cardiol 1982; 49(5): Schatz RA, Palmaz JC, Tio FO, Garcia F, Garcia O, Reuter SR. Balloon expandable intracoronary stents in the adult dog. Circulation 1987; 76(2): Puel J, Joffre F, Rousseau H, et al. [Self expanding coronary endoprosthesis in the prevention of restenosis following transluminal angioplasty. Preliminary clinical study]. Arch Mal Coeur Vaiss 1987; 80(8): Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med 1987; 316(12): Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn 1989; 16(1): Schomig A, Neumann FJ, Kastrati A, et al. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary artery stents. N Engl J Med 1996; 334(17): Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002; 346(23): Serruys PW, Chevalier B, Dudek D, et al. A bioresorbable everolimus eluting scaffold versus a metallic everolimus eluting stent for ischaemic heart disease caused by de novo native coronary artery lesions (ABSORB II): an interim 1 year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet 2015; 385(9962): Scheller B, Hehrlein C, Bocksch W, et al. Treatment of coronary in stent restenosis with a paclitaxelcoated balloon catheter. N Engl J Med 2006; 355(20):