Cardiovascular Outcomes in Patients with Drug Eluting Stents Undergoing Non-cardiac Surgery Boston Scientific Interventional Fellow, Royal Jubilee Hospital, Victoria, British Columbia Lecturer in Cardiology, Centre for Cardiovascular Science, University of Edinburgh, Edinburgh NL Cruden , SA Harding, AD Flapan, C Graham, S Wild, R Slack, J Pell, DE Newby
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Cardiovascular Outcomes in Patients with Drug Eluting Stents Undergoing Non-cardiac
Surgery
Boston Scientific Interventional Fellow, Royal Jubilee Hospital, Victoria, British Columbia
Lecturer in Cardiology, Centre for Cardiovascular Science, University of Edinburgh, Edinburgh
NL Cruden, SA Harding, AD Flapan, C Graham, S Wild, R Slack, J Pell, DE Newby
MY CONFLICTS OF INTEREST ARE
I am currently undertaking an Interventional Fellowship supported by Boston Scientific.
“Trading Restenosis for Thrombosis”
Shuchman. NEJM 2006;355:1949-1952
Non-cardiac Surgery and Stent Thrombosis
Mortality and Non-cardiac SurgeryAuthors Year Type Time Period Patients
(n)DES(%)
Time from PCI to Surgery
Mortality Rate (%)
Kaluza et al 2000 RetrospectiveNon-randomised
1996 - 1998 40 0 <42d 21.4
Wilson et al 2003 RetrospectiveNon-randomised
1990 - 2000 207 0 <60d 3.4
Sharma et al 2004 RetrospectiveNon-randomised
1995 - 2000 47 0 <90d 18.4
Reddy et al 2005 RetrospectiveNon-randomised
1999 - 2004 56 0 ns 8.6
Leibowitz et al 2006 RetrospectiveNon-randomised
1995 - 2002 94 0 <90d 14.6
Vicenzi et al 2006 ProspectiveNon-randomised
2001 - 2004 103 ns <1y 5.7
Compton et al 2006 RetrospectiveNon-randomised
2003 - 2006 38 100 ns 2.5
Schouten et al 2006 RetrospectiveNon-randomised
1999 - 2005 192 52 <2y 3.1
Nuttall et al 2008 RetrospectiveNon-randomised
1990 - 2005 899 0 <1y 3.4
Rabbitts et al 2008 RetrospectiveNon-randomised
2003 - 2006 520 100 <2y 2.6
Adapted from Riddell et al. Circulation 2007;116:e378-382.
Adapted from Rabbitts et al. Anesthesiology 2008;109:596-604.
Aims
• To compare ischaemic cardiac outcomes in patients treated with DES or BMS undergoing non-cardiac surgery
• To examine the relationship between time from stent implantation to non-cardiac surgery and peri-operative cardiac outcomes
Methods
• Record Linkage
• Scottish Coronary Revascularisation Register
• Scottish Hospital Admissions Database– Patients undergoing PCI in Scotland between 1st
April 2003 and 31st March 2007 who subsequently underwent non-cardiac surgery.
• Follow-up until 31/07/2007
Methods
• Primary Endpoint:– In-hospital Death, MI or any IHD event (defined by
ICD code)
• Secondary Endpoints– In-hospital Death– In-hospital MI (defined by ICD code)
• Data analysis– Unpaired t-test or Mann-Whitney– Chi-squared or Fishers exact test– Multivariate Logistical Regression Model
Results
• 17,799 patients underwent 19,541 PCIs
• 1,953 patients who received a coronary stent subsequently underwent non-cardiac surgery
• Previous Coronary Bypass Grafting OR 1.55 [1.07-2.26]
• Increasing Age OR 1.22 [1.06-1.39] for every 10 years
When is it safe to operate?
Summary
• The risk of ischaemic cardiac events in patients with DES undergoing non-cardiac surgery does not differ from patients treated with BMS.
• In keeping with previous data, peri-operative cardiovascular risk is greatest where surgery is performed within 4-6 weeks of coronary stent implantation.
Limitations
• Retrospective
• Non-randomised
• No data on anti-platelet therapy
Thank you
Scott Harding
Andrew Flapan
David Newby
Contributors to the Scottish Revascularisation Register (R Slack, J Pell)
WTCRF Edinburgh (C Graham, S Wild)
Chief Scientist Office (Health Services Research Grant CZG/2/375)
Surgical Procedures by Type
Primary Stent Type Frequency Percentage
CYPHER 140 24.6
TAXUS 389 68.2
ENDEAVOUR 27 4.8
DES NOT SPECIFIED 14 2.4
Drug Eluting Stents Used
Power Calculation
• Based on observed event rate of 10% in patients with BMS undergoing non-cardiac surgery and assuming a sample size of 1000 (n=500 in DES and BMS groups respectively)
• This study would have 80% power to detect a 5% absolute difference in the combined primary endpoint between the BMS and DES groups at the 0.05 significance level.