Department of Error: Correction of: Drug-eluting or bare-metal stents for percutaneous coronary intervention : a systematic review and individual patient data meta-analysis of randomised clinical trials

Raffaele Piccolo; Kaare H. Bonaa; Orestis Efthimiou; Olivier Varenne; Baldo Oliva; Philip Urban; Christoph Kaiser; Wouter Remkes; Lorenz Raber; Adam de Belder; Arnoud van 't Hof; Goran Stankovic; Pedro A. Lemos; Tom Wilsgaard; Jorg Reifart; Alfredo E. Rodriguez; Expedito E. Ribeiro; Patrick W. Serruys; Alex Abizaid; Manel Sabate; Robert A. Byrne; Jose M. de la Torre Hernandez; William Wijns; Peter Juni; Stephan Windecker; Marco Valgimigli

doi:10.1016/S0140-6736(19)31324-8

Department of Error: Correction of: Drug-eluting or bare-metal stents for percutaneous coronary intervention : a systematic review and individual patient data meta-analysis of randomised clinical trials

Raffaele Piccolo, Kaare H. Bonaa, Orestis Efthimiou, Olivier Varenne, Baldo Oliva, Philip Urban, Christoph Kaiser, Wouter Remkes, Lorenz Raber, Adam de Belder, Arnoud van 't Hof, Goran Stankovic, Pedro A. Lemos, Tom Wilsgaard, Jorg Reifart, Alfredo E. Rodriguez, Expedito E. Ribeiro, Patrick W. Serruys, Alex Abizaid, Manel SabateRobert A. Byrne, Jose M. de la Torre Hernandez, William Wijns, Peter Juni, Stephan Windecker, Marco Valgimigli

Research output: Contribution to journal › Erratum / corrigendum / retractions › Academic

Abstract

Background
New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear.

Methods
We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes afterimplantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520.

Findings
We obtained individual data for 26616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8)years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84,95% CI 0·78–0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71–0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78–1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88–1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50–0·80, p<0·001) and target-vessel revascularisation (0·55, 0·50–0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year.

Interpretation
The performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year .

Original language	English
Pages (from-to)	2492
Journal	Lancet
Volume	393
Issue number	10190
DOIs	https://doi.org/10.1016/S0140-6736(19)31324-8
Publication status	Published - 2019

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10.1016/S0140-6736(19)31324-8

1 (Systematic) Review article

Drug-eluting or bare-metal stents for percutaneous coronary intervention: a systematic review and individual patient data meta-analysis of randomised clinical trials
Piccolo, R., Bonaa, K. H., Efthimiou, O., Varenne, O., Oliva, B., Urban, P., Kaiser, C., Remkes, W., Raber, L., de Belder, A., van 't Hof, A., Stankovic, G., Lemos, P. A., Wilsgaard, T., Reifart, J., Rodriguez, A. E., Ribeiro, E. E., Serruys, P. W., Abizaid, A. & Sabate, M. & 6 others, Byrne, R. A., de la Torre Hernandez, J. M., Wijns, W., Juni, P., Windecker, S. & Valgimigli, M., 22 Jun 2019, In: Lancet. 393, 10190, p. 2503-2510 8 p.
Research output: Contribution to journal › (Systematic) Review article › peer-review

Cite this

Piccolo, R., Bonaa, K. H., Efthimiou, O., Varenne, O., Oliva, B., Urban, P., Kaiser, C., Remkes, W., Raber, L., de Belder, A., van 't Hof, A., Stankovic, G., Lemos, P. A., Wilsgaard, T., Reifart, J., Rodriguez, A. E., Ribeiro, E. E., Serruys, P. W., Abizaid, A., ... Valgimigli, M. (2019). Department of Error: Correction of: Drug-eluting or bare-metal stents for percutaneous coronary intervention : a systematic review and individual patient data meta-analysis of randomised clinical trials. Lancet, 393(10190), 2492. https://doi.org/10.1016/S0140-6736(19)31324-8

@article{93edf14e8e6f4ff1a3b8935e873150e0,

title = "Department of Error: Correction of: Drug-eluting or bare-metal stents for percutaneous coronary intervention : a systematic review and individual patient data meta-analysis of randomised clinical trials",

abstract = "Background New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear.Methods We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes afterimplantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520.Findings We obtained individual data for 26616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8)years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84,95% CI 0·78–0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71–0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78–1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88–1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50–0·80, p<0·001) and target-vessel revascularisation (0·55, 0·50–0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year.InterpretationThe performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year .",

author = "Raffaele Piccolo and Bonaa, {Kaare H.} and Orestis Efthimiou and Olivier Varenne and Baldo Oliva and Philip Urban and Christoph Kaiser and Wouter Remkes and Lorenz Raber and {de Belder}, Adam and {van 't Hof}, Arnoud and Goran Stankovic and Lemos, {Pedro A.} and Tom Wilsgaard and Jorg Reifart and Rodriguez, {Alfredo E.} and Ribeiro, {Expedito E.} and Serruys, {Patrick W.} and Alex Abizaid and Manel Sabate and Byrne, {Robert A.} and {de la Torre Hernandez}, {Jose M.} and William Wijns and Peter Juni and Stephan Windecker and Marco Valgimigli",

year = "2019",

doi = "10.1016/S0140-6736(19)31324-8",

language = "English",

volume = "393",

pages = "2492",

journal = "Lancet",

issn = "0140-6736",

publisher = "Elsevier B.V.",

number = "10190",

}

Piccolo, R, Bonaa, KH, Efthimiou, O, Varenne, O, Oliva, B, Urban, P, Kaiser, C, Remkes, W, Raber, L, de Belder, A, van 't Hof, A, Stankovic, G, Lemos, PA, Wilsgaard, T, Reifart, J, Rodriguez, AE, Ribeiro, EE, Serruys, PW, Abizaid, A, Sabate, M, Byrne, RA, de la Torre Hernandez, JM, Wijns, W, Juni, P, Windecker, S & Valgimigli, M 2019, 'Department of Error: Correction of: Drug-eluting or bare-metal stents for percutaneous coronary intervention : a systematic review and individual patient data meta-analysis of randomised clinical trials', Lancet, vol. 393, no. 10190, pp. 2492. https://doi.org/10.1016/S0140-6736(19)31324-8

Department of Error: Correction of: Drug-eluting or bare-metal stents for percutaneous coronary intervention : a systematic review and individual patient data meta-analysis of randomised clinical trials. / Piccolo, Raffaele; Bonaa, Kaare H.; Efthimiou, Orestis et al.
In: Lancet, Vol. 393, No. 10190, 2019, p. 2492.

Research output: Contribution to journal › Erratum / corrigendum / retractions › Academic

TY - JOUR

T1 - Department of Error

T2 - Correction of: Drug-eluting or bare-metal stents for percutaneous coronary intervention : a systematic review and individual patient data meta-analysis of randomised clinical trials

AU - Piccolo, Raffaele

AU - Bonaa, Kaare H.

AU - Efthimiou, Orestis

AU - Varenne, Olivier

AU - Oliva, Baldo

AU - Urban, Philip

AU - Kaiser, Christoph

AU - Remkes, Wouter

AU - Raber, Lorenz

AU - de Belder, Adam

AU - van 't Hof, Arnoud

AU - Stankovic, Goran

AU - Lemos, Pedro A.

AU - Wilsgaard, Tom

AU - Reifart, Jorg

AU - Rodriguez, Alfredo E.

AU - Ribeiro, Expedito E.

AU - Serruys, Patrick W.

AU - Abizaid, Alex

AU - Sabate, Manel

AU - Byrne, Robert A.

AU - de la Torre Hernandez, Jose M.

AU - Wijns, William

AU - Juni, Peter

AU - Windecker, Stephan

AU - Valgimigli, Marco

PY - 2019

Y1 - 2019

N2 - Background New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear.Methods We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes afterimplantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520.Findings We obtained individual data for 26616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8)years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84,95% CI 0·78–0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71–0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78–1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88–1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50–0·80, p<0·001) and target-vessel revascularisation (0·55, 0·50–0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year.InterpretationThe performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year .

AB - Background New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear.Methods We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes afterimplantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520.Findings We obtained individual data for 26616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8)years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84,95% CI 0·78–0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71–0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78–1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88–1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50–0·80, p<0·001) and target-vessel revascularisation (0·55, 0·50–0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year.InterpretationThe performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year .

U2 - 10.1016/S0140-6736(19)31324-8

DO - 10.1016/S0140-6736(19)31324-8

M3 - Erratum / corrigendum / retractions

SN - 0140-6736

VL - 393

SP - 2492

JO - Lancet

JF - Lancet

IS - 10190

ER -

Department of Error: Correction of: Drug-eluting or bare-metal stents for percutaneous coronary intervention : a systematic review and individual patient data meta-analysis of randomised clinical trials

Abstract

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Research output

Drug-eluting or bare-metal stents for percutaneous coronary intervention: a systematic review and individual patient data meta-analysis of randomised clinical trials

Cite this