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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Balancing the Risks of Restenosis and Stent Thrombosis in Bare-Metal Versus Drug-Eluting Stents

Results of a Decision Analytic Model

Pallav Garg, MBBS, MSc^_*,, David J. Cohen, MD, MSc^,_*, Thomas Gaziano, MD, MSc and Laura Mauri, MD, MSc^_*,

^_* Divisions of Cardiology and Clinical Biometrics, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
Division of Cardiology and Social Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
Saint Luke's Mid-America Heart Institute, University of Missouri–Kansas City, Kansas City, Missouri
Harvard Clinical Research Institute, Boston, Massachusetts.

Manuscript received September 18, 2007; revised manuscript received November 29, 2007, accepted January 6, 2008.

^_* Reprint requests and correspondence: Dr. David J. Cohen, Saint Luke's Mid America Heart Institute, 4401 Wornall Road, Kansas City, Missouri 64111. (Email: dcohen{at}saint-lukes.org).

Objectives: We sought to define what incremental risk of very late stent thrombosis (VLST) in drug-eluting stents (DES) would outweigh the restenosis benefit.

Background: Although there are robust data on the restenosis benefit of DES versus bare-metal stents (BMS), the incremental risk of stent thrombosis, a rare but serious complication of percutaneous coronary intervention (PCI), is not known with certainty.

Methods: We developed a decision analytic Markov model comparing DES versus BMS strategies for a contemporary PCI population. Procedure-related morbidity and mortality data from published reports were used to derive the model probabilities. Over a range of incremental risk and duration of risk of VLST, we identified the net benefit of DES versus BMS in terms of quality-adjusted life expectancy (QALE).

Results: Under an assumption of equal stent thrombosis rates beyond 1 year, the DES strategy was superior to BMS in terms of QALE (16.262 vs. 16.248 quality-adjusted life years [QALYs], difference = 0.014). Under the alternative assumption of an incremental risk difference of 0.13%/year, the net benefit was substantially reduced (difference = 0.001 QALYs). The threshold excess risk of very late DES thrombosis compared with BMS, above which BMS would be the preferred strategy, was 0.14%/year (over 4 years of follow-up). This threshold increased as the population risk of restenosis increased and decreased as the vulnerable time window lengthened.

Conclusions: A small absolute increase in DES thrombosis compared with BMS after 1 year (>0.14%/year) would result in BMS being the preferred strategy for the overall PCI population. Larger clinical trials with longer follow-up are needed to estimate the risk of late stent thrombosis with greater certainty for existing and new DES.

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CABG = coronary artery bypass graft surgery   DES = drug-eluting stent(s)   PCI = percutaneous coronary intervention   PTCA = percutaneous transluminal coronary angioplasty   QALE = quality-adjusted life expectancy   QALY = quality-adjusted life year   TVR = target vessel revascularization   VLST = very late stent thrombosis

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