Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease

doi:10.1056/NEJMoa1607991

Randomized Controlled Trial

. 2016 Sep 29;375(13):1242-52.

doi: 10.1056/NEJMoa1607991. Epub 2016 Aug 29.

Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease

Kaare H Bønaa¹, Jan Mannsverk¹, Rune Wiseth¹, Lars Aaberge¹, Yngvar Myreng¹, Ottar Nygård¹, Dennis W Nilsen¹, Nils-Einar Kløw¹, Michael Uchto¹, Thor Trovik¹, Bjørn Bendz¹, Sindre Stavnes¹, Reidar Bjørnerheim¹, Alf-Inge Larsen¹, Morten Slette¹, Terje Steigen¹, Ole J Jakobsen¹, Øyvind Bleie¹, Eigil Fossum¹, Tove A Hanssen¹, Øystein Dahl-Eriksen¹, Inger Njølstad¹, Knut Rasmussen¹, Tom Wilsgaard¹, Jan E Nordrehaug¹; NORSTENT Investigators

Collaborators, Affiliations

Collaborators

NORSTENT Investigators:
B Bendz, C H Eek, K Endresen, A Hervold, K Lunde, M Petersen, A Ragnarsson, S I Simonsen, O G Solberg, I J Saastad, R Skårdal, A Tofte, L Aaberge, K H Bønaa, O Dahl-Eriksen, A Iqbal, S A Lillevik, J Mannsverk, V Sandvik, T Steigen, T Trovik, A M Fosnes, S G Helleland, R Moer, Y Myreng, P Mølstad, O Rødevand, A B Solvang, S Stavnes, K Ytre-Arne, A Al-Ani, K Hegbom, M Heigert, O M Leiren, A M Myraunet, M Slette, H Vik-Mo, T Vindsetmo, R Wiseth, M S Ananiassen, M Brekke, E Fossum, E Gjønnæss, Y Haig, O Johansen, N E Kløw, O Meyerdierks, M Nesheim, K H Stensæth, M Søkjer, M R Aas, O Bleie, E Eriksen, E Hjørnevik, K Kuiper, J E Nordrehaug, O Nygård, E Packer, M Salem, R Pettersen, S Rotevatn, C Spjelkavik, V Tuseth, K Vikenes, A Øksnes, I J Gilberg, P Gunnes, O J Jakobsen, U Køpp, T Larsen, I Skarpnes, M Uchto, S Barvik, N Bogale, V V S Bonarjee, S Ditlefsen, A-I Larsen, T Melberg, D W Nilsen, H Svalestad, J E Nordrehaug, R Wiseth, L Aaberge, Y Myreng, N E Kløw, D W Nilsen, T Trovik, M Uchto, B Bendz, S Stavnes, O Nygård, R Bjørnerheim, A-I Larsen, M Slette, T Steigen, O J Jakobsen, E Fossum, K H Bønaa, J Mannsverk, I Njølstad, K E Larsby, B Schive, A Skogsholm, A Kristensen, A Knygh Brekk, A Miroslawska, C Van Den Heuvel, E Øygard Fosse, E Holme, H J Hansen, H Åsegard, R Mathiesen Hald, S Skarstad, T Larsen, K Rasmussen, L Thuesen, P W Serruys, Aa Tverdal, B Gravrok, A K Knitnes, S Andersen, H H Jacobsen, T Aa Digre, T Wilsgaard, T A Hanssen, K H Bønaa

Affiliation

¹ From the Department of Community Medicine (K.H.B., I.N., T.W.) and the Department of Clinical Medicine (T.S., T.A.H., K.R.), University of Tromsø-the Arctic University of Norway, and the Department of Cardiology, University Hospital of North Norway (J.M., T.T., T.S., T.A.H., Ø.D.-E., K.R.), Tromsø, the Departments of Public Health and General Medicine (K.H.B.) and Circulation and Medical Imaging (R.W.), Norwegian University of Science and Technology, and the Clinic for Heart Disease, St. Olav's University Hospital (K.H.B., R.W., M.S.), Trondheim, the Departments of Cardiology (L.A., B.B., E.F.), Radiology, (N.-E.K.), and Heart Disease (R.B.), Oslo University Hospital, and the Faculty of Medicine, University of Oslo (N.-E.K., B.B.), Oslo, the Department of Cardiology, Feiring Heart Clinic, Feiring (Y.M., S.S.), the Department of Heart Disease, Haukeland University Hospital (O.N., Ø.B.), and the Department of Clinical Science, University of Bergen (O.N., D.W.N., A.-I.L., J.E.N.), Bergen, the Department of Cardiology, Stavanger University Hospital, Stavanger (D.W.N., A.-I.L., J.E.N.), and the Department of Medicine, Sørlandet Hospital, Arendal (M.U., O.J.J.) - all in Norway.

PMID: 27572953
DOI: 10.1056/NEJMoa1607991

Free article

Randomized Controlled Trial

Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease

Kaare H Bønaa et al. N Engl J Med. 2016.

Free article

. 2016 Sep 29;375(13):1242-52.

doi: 10.1056/NEJMoa1607991. Epub 2016 Aug 29.

Authors

Collaborators

NORSTENT Investigators:
B Bendz, C H Eek, K Endresen, A Hervold, K Lunde, M Petersen, A Ragnarsson, S I Simonsen, O G Solberg, I J Saastad, R Skårdal, A Tofte, L Aaberge, K H Bønaa, O Dahl-Eriksen, A Iqbal, S A Lillevik, J Mannsverk, V Sandvik, T Steigen, T Trovik, A M Fosnes, S G Helleland, R Moer, Y Myreng, P Mølstad, O Rødevand, A B Solvang, S Stavnes, K Ytre-Arne, A Al-Ani, K Hegbom, M Heigert, O M Leiren, A M Myraunet, M Slette, H Vik-Mo, T Vindsetmo, R Wiseth, M S Ananiassen, M Brekke, E Fossum, E Gjønnæss, Y Haig, O Johansen, N E Kløw, O Meyerdierks, M Nesheim, K H Stensæth, M Søkjer, M R Aas, O Bleie, E Eriksen, E Hjørnevik, K Kuiper, J E Nordrehaug, O Nygård, E Packer, M Salem, R Pettersen, S Rotevatn, C Spjelkavik, V Tuseth, K Vikenes, A Øksnes, I J Gilberg, P Gunnes, O J Jakobsen, U Køpp, T Larsen, I Skarpnes, M Uchto, S Barvik, N Bogale, V V S Bonarjee, S Ditlefsen, A-I Larsen, T Melberg, D W Nilsen, H Svalestad, J E Nordrehaug, R Wiseth, L Aaberge, Y Myreng, N E Kløw, D W Nilsen, T Trovik, M Uchto, B Bendz, S Stavnes, O Nygård, R Bjørnerheim, A-I Larsen, M Slette, T Steigen, O J Jakobsen, E Fossum, K H Bønaa, J Mannsverk, I Njølstad, K E Larsby, B Schive, A Skogsholm, A Kristensen, A Knygh Brekk, A Miroslawska, C Van Den Heuvel, E Øygard Fosse, E Holme, H J Hansen, H Åsegard, R Mathiesen Hald, S Skarstad, T Larsen, K Rasmussen, L Thuesen, P W Serruys, Aa Tverdal, B Gravrok, A K Knitnes, S Andersen, H H Jacobsen, T Aa Digre, T Wilsgaard, T A Hanssen, K H Bønaa

Affiliation

¹ From the Department of Community Medicine (K.H.B., I.N., T.W.) and the Department of Clinical Medicine (T.S., T.A.H., K.R.), University of Tromsø-the Arctic University of Norway, and the Department of Cardiology, University Hospital of North Norway (J.M., T.T., T.S., T.A.H., Ø.D.-E., K.R.), Tromsø, the Departments of Public Health and General Medicine (K.H.B.) and Circulation and Medical Imaging (R.W.), Norwegian University of Science and Technology, and the Clinic for Heart Disease, St. Olav's University Hospital (K.H.B., R.W., M.S.), Trondheim, the Departments of Cardiology (L.A., B.B., E.F.), Radiology, (N.-E.K.), and Heart Disease (R.B.), Oslo University Hospital, and the Faculty of Medicine, University of Oslo (N.-E.K., B.B.), Oslo, the Department of Cardiology, Feiring Heart Clinic, Feiring (Y.M., S.S.), the Department of Heart Disease, Haukeland University Hospital (O.N., Ø.B.), and the Department of Clinical Science, University of Bergen (O.N., D.W.N., A.-I.L., J.E.N.), Bergen, the Department of Cardiology, Stavanger University Hospital, Stavanger (D.W.N., A.-I.L., J.E.N.), and the Department of Medicine, Sørlandet Hospital, Arendal (M.U., O.J.J.) - all in Norway.

PMID: 27572953
DOI: 10.1056/NEJMoa1607991

Abstract

Background: Limited data are available on the long-term effects of contemporary drug-eluting stents versus contemporary bare-metal stents on rates of death, myocardial infarction, repeat revascularization, and stent thrombosis and on quality of life.

Methods: We randomly assigned 9013 patients who had stable or unstable coronary artery disease to undergo percutaneous coronary intervention (PCI) with the implantation of either contemporary drug-eluting stents or bare-metal stents. In the group receiving drug-eluting stents, 96% of the patients received either everolimus- or zotarolimus-eluting stents. The primary outcome was a composite of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up. Secondary outcomes included repeat revascularization, stent thrombosis, and quality of life.

Results: At 6 years, the rates of the primary outcome were 16.6% in the group receiving drug-eluting stents and 17.1% in the group receiving bare-metal stents (hazard ratio, 0.98; 95% confidence interval [CI], 0.88 to 1.09; P=0.66). There were no significant between-group differences in the components of the primary outcome. The 6-year rates of any repeat revascularization were 16.5% in the group receiving drug-eluting stents and 19.8% in the group receiving bare-metal stents (hazard ratio, 0.76; 95% CI, 0.69 to 0.85; P<0.001); the rates of definite stent thrombosis were 0.8% and 1.2%, respectively (P=0.0498). Quality-of-life measures did not differ significantly between the two groups.

Conclusions: In patients undergoing PCI, there were no significant differences between those receiving drug-eluting stents and those receiving bare-metal stents in the composite outcome of death from any cause and nonfatal spontaneous myocardial infarction. Rates of repeat revascularization were lower in the group receiving drug-eluting stents. (Funded by the Norwegian Research Council and others; NORSTENT ClinicalTrials.gov number, NCT00811772 .).

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Comment in

Balancing the Evidence Base on Coronary Stents.
Bates ER. Bates ER. N Engl J Med. 2016 Sep 29;375(13):1286-8. doi: 10.1056/NEJMe1610485. Epub 2016 Aug 29. N Engl J Med. 2016. PMID: 27573082 No abstract available.
PCI with drug-eluting stents reduced revascularizations, but not mortality or MI, compared with bare-metal stents.
Hudson M. Hudson M. Ann Intern Med. 2016 Nov 15;165(10):JC52. doi: 10.7326/ACPJC-2016-165-10-052. Ann Intern Med. 2016. PMID: 27842389 No abstract available.
Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease.
Nordrehaug JE, Wiseth R, Bønaa KH. Nordrehaug JE, et al. N Engl J Med. 2016 Dec 29;375(26):2604-2605. doi: 10.1056/NEJMc1613866. N Engl J Med. 2016. PMID: 28029911 No abstract available.
Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease.
Urban P, Oldroyd K, Krackhardt F. Urban P, et al. N Engl J Med. 2016 Dec 29;375(26):2603-4. doi: 10.1056/NEJMc1613866. N Engl J Med. 2016. PMID: 28029912 No abstract available.
Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease.
Farshid A. Farshid A. N Engl J Med. 2016 Dec 29;375(26):2604. doi: 10.1056/NEJMc1613866. N Engl J Med. 2016. PMID: 28029913 No abstract available.
Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease.
Vora AN, Rao SV, Stone GW. Vora AN, et al. N Engl J Med. 2016 Dec 29;375(26):2602. doi: 10.1056/NEJMc1613866. N Engl J Med. 2016. PMID: 28032958 No abstract available.
Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease.
Bangalore S. Bangalore S. N Engl J Med. 2016 Dec 29;375(26):2602-3. doi: 10.1056/NEJMc1613866. N Engl J Med. 2016. PMID: 28032959 No abstract available.
Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease.
Bates ER. Bates ER. N Engl J Med. 2016 Dec 29;375(26):2605. doi: 10.1056/NEJMc1613866. N Engl J Med. 2016. PMID: 28112501 No abstract available.

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Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease

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