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Worsening Clinical Outcome with Increasing Number of So-Called Off-Label or Unapproved Indications for Use of Drug Eluting Stents

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World Journal of Cardiovascular Diseases 2016年第7期6卷 224-234页

作者： Anders M. Galløe ulrik abildgaard Henning Kelbæk Niels Bligaard Jørgen L. Jeppesen Leif Thuesen Peter R. Hansen Department of Cardiology Zealand University Hospital Roskilde Denmark Department of Cardiology Copenhagen University Hospital Gentofte Denmark Department of Cardiology Copenhagen University Hospital Bispebjerg Denmark Department of Medicine Copenhagen University Hospital Glostrup Denmark Department of Cardiology Aalborg University Hospital Aalborg Denmark

Objective: We explored the impact of increasing number of off-label patient and lesion character-istics on 5-year clinical outcome following implantation of first generation drug eluting stents. Furthermore we tried to assess if stent performance might be improved if the off-label character-istics present were taken into account to guide the stent brand selection. Design: A total of 2888 coronary lesions treated with first generation drug eluting stents were classified for eventual presence of 18 different off-label characteristics and correlated to the 5-year clinical outcome by multiple stepwise Cox regression analysis. Results: The composite of cardiac death, myocardial infarction and target vessel revascularization (major adverse cardiac event, MACE) was 16.7% in cases with zero off-label characteristics and showed a stepwise increased rate up to 32.7% in cases with 5 off-label characteristics. The MACE rate for the sirolimus eluting stent appears to be 10% lower than the paclitaxel stent group and it may be further reduced by 10% - 18% if the off-label characteristics present in each case were taken into account to guide the stent brand selection. Conclusion: With increasing number of concomitantly appearing off-label characteristics there is a stepwise increase in MACE rate. The MACE rate may be reduced if the off-label characteristics were used to guide the stent brand selection.

关键词： Drug Eluting Stents

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A Modified Treatment Failure Classification System with Complete and Exhaustive Accounting of Any Adverse Events Related to the Previous Percutaneous Coronary Intervention

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World Journal of Cardiovascular Diseases 2014年第9期4卷 405-415页

作者： Anders MGalloe Jorgen LJeppesen Soren Boesgaard John Godtfredsen Niels Bligaard Jens FLassen Henning Kelbaek Anders Junker Jan Ravkilde Peter Riis Hansen Carsten TLarsen Ghita BStephansen ulrik abildgaard Department of Cardiology Copenhagen University HospitalRoskildeDenmark Department of Medicine Copenhagen University HospitalGlostrupDenmark Department of Cardiology Copenhagen University HospitalRigshospitaletDenmark Department of Cardiology Copenhagen University HospitalHerlevDenmark Department of Cardiology Copenhagen University HospitalGentofteDenmark Department of Cardiology Aarhus University HospitalSkejbyDenmark Department of Cardiology Odense University HospitalDenmark Department of Cardiology Aalborg University HospitalDenmark

Objectives: To determine the clinical outcome related to treatment failure of the percutaneous coronary intervention (PCI) itself. Background: When considering the addition of PCI to the medical treatment of angina, it is necessary to know the balance between the benefit and the risk of the PCI itself, but the latter remains unknown. The usual outcome measures are imprecise because they contain events unrelated to the previous PCI and because some events clearly caused by PCI treatment failures are omitted. Methods: In total, 2098 unselected patients were randomized to receive either sirolimus-(n = 1065) or paclitaxel-(n = 1033) eluting coronary stents and followed for five years in the SORT OUT II. Any death, cardiac death, myocardial infarction (MI), stent thrombosis and documented stenosis was classified and combined to a “patient oriented clinical outcome” (POCO), the classical “major adverse cardiac events” (MACE) and the new “PCI-treatment oriented clinical outcome” (TOCO). Results: POCO occurred in 746 patients (35.6%), MACE in 467 patients (22.3%) and TOCO in 293 patients (14.0%), thus TOCO amounted to 39% of the POCO and to 63% of the MACE. Conclusion: By introduction of the present PCI treatment failure classification system, the clinical outcome of PCI-treatment itself may be credulously estimated by the rate of TOCO and eventually PCI is substantially better than what might be perceived from the classically used POCO and MACE rates.

关键词： PCI Angina Clinical Outcome

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