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Review
. 2016 Nov 3:355:i5483.
doi: 10.1136/bmj.i5483.

Short term versus long term dual antiplatelet therapy after implantation of drug eluting stent in patients with or without diabetes: systematic review and meta-analysis of individual participant data from randomised trials

Giuseppe Gargiulo  1   2 , Stephan Windecker  1 , Bruno R da Costa  1   3 , Fausto Feres  4 , Myeong-Ki Hong  5 , Martine Gilard  6 , Hyo-Soo Kim  7 , Antonio Colombo  8 , Deepak L Bhatt  9 , Byeong-Keuk Kim  5 , Marie-Claude Morice  6 , Kyung Woo Park  7 , Alaide Chieffo  8 , Tullio Palmerini  10 , Gregg W Stone  11 , Marco Valgimigli  12
Affiliations
Review

Short term versus long term dual antiplatelet therapy after implantation of drug eluting stent in patients with or without diabetes: systematic review and meta-analysis of individual participant data from randomised trials

Giuseppe Gargiulo et al. BMJ. .

Abstract

Objective: To compare clinical outcomes between short term (up to 6 months) and long term (12 months) dual antiplatelet therapy (DAPT) after placement of a drug eluting stent in patients with and without diabetes.

Design: Individual participant data meta-analysis. Cox proportional regression models stratified by trial were used to assess the impact of diabetes on outcomes.

Data source: Medline, Embase, and Cochrane databases and proceedings of international meetings searched for randomised controlled trials comparing durations of DAPT after placement of a drug eluting stent. Individual patient data pooled from six DAPT trials.

Primary outcome: Primary study outcome was one year risk of major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, or definite/probable stent thrombosis. All analyses were conducted by intention to treat.

Results: Six trials including 11 473 randomised patients were pooled. Of these patients, 3681 (32.1%) had diabetes and 7708 (67.2%) did not (mean age 63.7 (SD 9.9) and 62.8 (SD 10.1), respectively), and in 84 (0.7%) the information was missing. Diabetes was an independent predictor of MACE (hazard ratio 2.30, 95% confidence interval 1.01 to 5.27; P=0.048 At one year follow-up, long term DAPT was not associated with a decreased risk of MACE compared with short term DAPT in patients with (1.05, 0.62 to 1.76; P=0.86) or without (0.97, 0.67 to 1.39; P=0.85) diabetes (P=0.33 for interaction). The risk of myocardial infarction did not differ between the two DAPT regimens (0.95, 0.58 to 1.54; P=0.82; for those with diabetes and 1.15, 0.68 to 1.94; P=0.60; for those without diabetes (P=0.84 for interaction). There was a lower risk of definite/probable stent thrombosis with long term DAPT among patients with (0.26, 0.09 to 0.80; P=0.02) than without (1.42, 0.68 to 2.98; P=0.35) diabetes, with positive interaction testing (P=0.04 for interaction), although the landmark analysis showed a trend towards benefit in both groups. Long term DAPT was associated with higher rates of major or minor bleeding, irrespective of diabetes (P=0.37 for interaction).

Conclusions: Although the presence of diabetes emerged as an independent predictor of MACE after implantation of a drug eluting stent, compared with short term DAPT, long term DAPT did not reduce the risk of MACE but increased the risk of bleeding among patients with stents with and without diabetes.

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Conflict of interest statement

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: MV has received research grants from The Medicines Company and Terumo; GG reports research grants from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and from the Cardiopath PhD Program (Federico II University of Naples); DLB is on the advisory boards for Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; board of directors for Boston VA Research Institute, Society of Cardiovascular Patient Care; chair of American Heart Association Quality Oversight Committee; data monitoring committees at Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, Population Health Research Institute; honorariums from American College of Cardiology (senior associate editor, Clinical Trials and News, ACC.org), Belvoir Publications (editor in chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (editor in chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (guest editor; associate editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (chief medical editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (secretary/treasurer), WebMD (CME steering committees); Clinical Cardiology (deputy editor), NCDR-ACTION registry steering committee (vice-chair), VA CART research and publications committee (chair); and has received research funding from Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Forest Laboratories, Ischemix, Medtronic, Pfizer, Roche, Sanofi Aventis, The Medicines Company; royalties from Elsevier (editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); site co-investigator: Biotronik, Boston Scientific, St. Jude Medical; trustee: American College of Cardiology; unfunded research: FlowCo, PLx Pharma, Takeda; other authors report no conflicts of interest.

Figures

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Fig 1 Studies and patients included in analysis of individual patient data. PCI=percutaneous coronary intervention; DES=drug eluting stent
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Fig 2 Ischaemic and bleeding events in patients with and without diabetes. PCI=percutaneous coronary intervention
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Fig 3 Ischaemic and bleeding events in patients with or without diabetes according to long term and short term DAPT. PCI=percutaneous coronary intervention
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Fig 4 Net adverse clinical events in patients with and without diabetes according to long term and short term DAPT in eight randomised trials
See this image and copyright information in PMC

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References

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