TY - JOUR
T1 - Drug-eluting or bare-metal stents for percutaneous coronary intervention
T2 - 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
N1 - Funding Information:
OV has received personal fees from Boston Scientific, Abbott Vascular, AstraZeneca, Biotronik, and Servier, and non-financial support from Biosensors. PU has acted as a consultant to Biosensors, a stent manufacturing company. LR has received personal fees from Abbott Vascular, Amgen, AstraZeneca, Biotronik, CLS Bhering, Regeneron, and Sanofi, and grants from Abbott Vascular, Heartflow, Regenron, and Sanofi. AWJv'tH has received grants from Medtronic. PWJCS has received personal fees from Abbott, Biosensors, Cardialysis, HeartFlow, Medtronic, Philips/Volcano, Sinomedical Sciences, and Xeltis and consultancy fees from Abbott Laboratories, Biosensors, Cardialysis, Heartflow, Medtronic, Philips/Volcano, Sino Medical Sciences Technology, and Xeltis. MS has acted as a consultant to Abbott Vascular, a stent manufacturing company. RAB has received personal fees from B Braun Melsungen, Biotronik, Micell Technologies, grants and personal fees from Boston Scientific, and grants from Celonova Biosciencers. JMdlTH has received unrestricted grants for research from Amgen, Abbott, Biotronik, and Bristol-Myers Squibb and advisory fees from AstraZeneca, Boston scientific, Daichy, and Medtronic. WW has received grants and personal fees from Biotronik, grants from Medtronic, Mi-Cell, Micro-Port, and Terumo, has acted as a medical advisor for Rede Optimus Research, and is cofounder of Argonauts, an innovation facilitator. PJ serves as an unpaid member of steering groups for trials funded by AstraZeneca, Biotronik, Biosensors, St Jude Medical, and The Medicines Company. SW has received grants from Amgen, Abbott, Bayer, Biotronik, Boston Scientific, Edwards Lifesciences, Medtronic, St Jude Medical, and Terumo. MV has received grants and personal fees from Abbott, AstraZeneca, and Terumo, personal fees from Alvimedica, Amgen, Bayer, Biosensors, Chiesi, Daiichi, Idorsia, and Sankyo, and grants from Medicure. The other authors declare no competing interests.
Publisher Copyright:
© 2019 Elsevier Ltd
PY - 2019/6/22
Y1 - 2019/6/22
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 after
implantation 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 .
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 after
implantation 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 .
KW - ACUTE MYOCARDIAL-INFARCTION
KW - PARTICIPANT DATA
KW - IMPLANTATION
KW - ANGIOGRAPHY
KW - RESTENOSIS
KW - THROMBOSIS
KW - TIROFIBAN
KW - ABCIXIMAB
KW - TRENDS
U2 - 10.1016/S0140-6736(19)30474-X
DO - 10.1016/S0140-6736(19)30474-X
M3 - (Systematic) Review article
SN - 0140-6736
VL - 393
SP - 2503
EP - 2510
JO - Lancet
JF - Lancet
IS - 10190
ER -