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Miscellaneous Complex PCI Ida I Thursday, April 29, 2010 11:30 AM 12:30 PM (Abstract nos. AS-35–38) AS-35 Five-Year Outcomes after Drug-Eluting Stent versus Coronary Artery Bypass Grafting for Unprotected Left Main Coronary Artery Disease. Duk-Woo Park, Jong-Young Lee, Won-Jang Kim, Soo-Jin Kang, Seung-Whan Lee, Young-Hak Kim, Cheol Whan Lee, Jae-Joong Kim, Seong-Wook Park, Seung-Jung Park. Asan Medical Center, Seoul, Republic of Korea. Background: Although numerous studies have compared the treatment effects of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), the long-term (5-year) outcomes among pa- tients with unprotected left main coronary artery (LMCA) disease who underwent PCI with drug-eluting stents (DES) or CABG have not been evaluated. Methods: Between January 2003 and April 2004, 395 patients with unprotected LMCA disease underwent DES implantation (n 176) or CABG (n 219). The primary safety endpoints were all-cause mor- tality and the composite of death, Q-wave myocardial infarction (MI), or stroke, and the primary efficacy endpoint was target vessel revas- cularization (TVR). Results: The unadjusted, 5-year rates of death (5.9% for DES vs 11.2% for CABG; p 0.03) and the composite of death, Q-wave MI, or stroke (10.0% for DES vs 19.1% for CABG; p 0.004) were significantly lower in patients who received DES than in those who underwent CABG. However, after adjustment for baseline risk factors, the overall risks of death (hazard ratio 0.73; 95% confidence interval [CI] 0.28 –1.90; p 0.52) and the composite of death, Q-wave MI, or stroke (hazard ratio 0.84; 95% CI 0.41–1.72; p 0.63) were similar between the 2 groups. The rate of revascularization was significantly higher in the DES than in the CABG group (hazard ratio 7.17, 95% CI 2.69 –19.10; p 0.001). Conclusion: For the treatment of unprotected LMCA disease, PCI with DES implantation showed equivalent long-term (5-year) mortality and rates of death, Q-wave MI, or stroke but a higher rate of repeat revascularization compared with CABG. AS-36 Independent U.S. Validation of the British Columbia Percutaneous Coronary Intervention Risk Score. Rohit Khurana 1 , Sharon-Lise Normand 2 , Treacy Silbaugh 2 , Karin Humphries 1 , Min Gao 1 , Lilllian Ding 1 , Ann Lovett 2 , David Cohen 3 , Jaap Hamburger 1 . 1 Division of Cardiology, Vancouver General Hospital, University of British Columbia, Vancouver, Canada; 2 Harvard Medical School, Boston, Massachusetts, USA; 3 Saint Luke’s Mid America Heart Institute, Kansas, USA. Background: Derivation of the British Columbia (BC) percutaneous coronary intervention (PCI) risk score (accessible at www.bcpci.org) to predict 30-day post-PCI mortality was recently published to meet the need for risk assessment in this era of complex coronary intervention. The BC PCI model was derived and internally validated using registry data (n 32,899) collected from Jan 2000 to Dec 2005. The purpose of this follow-up study was to validate the BC PCI score in an external cohort. Methods: The BC PCI risk score was evaluated using 36,341 consecutive patients undergoing native vessel PCI (elective, emergent) between Jan 2005 and Sept 2007 in all non-federal Massachusetts, USA, hospitals. Data was prospectively collected by Massachusetts Data Analysis Center (Mass-DAC) with each contributing center using the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) instrument. Simple logistic regression modeling was used in the validation with the coefficients of the BC-PCI model. The area under the receiver operating characteristic curve (AUC) was calculated to quantify accuracy of the BC-PCI risk score in the Mass- DAC registry. Results: The cohort included 69% male patients, 3.9% having left main disease, and 15% with ongoing ST-segment elevation MI. Death occurred in 2.05% (n 745) of patients. Multivariate logistic regres- sion analysis identified risk factors for 30-day mortality that were similar to the risk factors developed in the BC PCI model. The AUC in a simple logistic regression model including only the BC PCI score was 0.87. For every 1-point increase in the BC PCI score, the odds of 30-day mortality was twice that of no increase Conclusion: This independent evaluation by Mass-DAC, Harvard Medical School, confirms the BC PCI score robustly and accurately predicts 30-day post-PCI mortality in a diverse unselected cohort of patients, providing further validation for its international applicability. AS-37 Sodium Bicarbonate in Saline Infusion Is Worse for the Prevention of Contrast-Induced Nephropathy than Saline Infusion Alone: A Randomized Single-Center Study. David Zemanek, Simon Celeryn, Petr Hajek, Martin Maly, Josef Veselka. University Hospital Motol, Prague, Czech Republic. Background: Contrast-induced nephropathy (CIN) is one of the most serious complications of catheterizations with intraarterial administra- tion of contrast agent. Many drugs have been proposed to prevent renal impairment, but the final view is unclear. There several studies com- pared isotonic solution of sodium bicarbonate with isotonic saline infusion with various results. Isotonic saline infusion is more effective than hypotonic. We wanted to determine whether a new protocol with sodium bicarbonate in isotonic saline infusion is more effective than saline infusion alone. Methods: We performed a single-center randomized study to com- pare hydration with infusion of 8.4% sodium bicarbonate 5 times diluted in 0.9% sodium chloride (group A) and 0.9% sodium chloride alone (group B) in a high-risk patient group (baseline creatinine level 133 mol/L) undergoing a catheterization procedure. All procedures (both diagnostic and interventional) were elective for stable coronary and peripheral artery disease. Hydration was started 3 hours before (3ml/kg/h) and followed by an infusion of 1 ml/kg/h for 6 hours after procedure. All patients received 600 mg of N-acetylcysteine orally twice a day. Serum creatinine was assessed at the time of hospital admission and 24 and 48 hours after the procedure. Primary endpoint was renal function measured by serum creatinine levels, secondary was 16B The American Journal of Cardiology APRIL 28 –29 2010 ANGIOPLASTY SUMMIT ABSTRACTS/Oral O R A L A B S T R A C T S Thursday, April 29, 2010

AS-36: Independent U.S. Validation of the British Columbia Percutaneous Coronary Intervention Risk Score

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Page 1: AS-36: Independent U.S. Validation of the British Columbia Percutaneous Coronary Intervention Risk Score

Miscellaneous

Complex PCI

Ida I

Thursday, April 29, 201011:30 AM� 12:30 PM

(Abstract nos. AS-35–38)

AS-35Five-Year Outcomes after Drug-Eluting Stent versus CoronaryArtery Bypass Grafting for Unprotected Left Main CoronaryArtery Disease. Duk-Woo Park, Jong-Young Lee, Won-Jang Kim,Soo-Jin Kang, Seung-Whan Lee, Young-Hak Kim, Cheol Whan Lee,Jae-Joong Kim, Seong-Wook Park, Seung-Jung Park. Asan MedicalCenter, Seoul, Republic of Korea.

Background: Although numerous studies have compared the treatmenteffects of percutaneous coronary intervention (PCI) and coronary arterybypass grafting (CABG), the long-term (5-year) outcomes among pa-tients with unprotected left main coronary artery (LMCA) disease whounderwent PCI with drug-eluting stents (DES) or CABG have not beenevaluated.

Methods: Between January 2003 and April 2004, 395 patients withunprotected LMCA disease underwent DES implantation (n � 176) orCABG (n � 219). The primary safety endpoints were all-cause mor-tality and the composite of death, Q-wave myocardial infarction (MI),or stroke, and the primary efficacy endpoint was target vessel revas-cularization (TVR).

Results: The unadjusted, 5-year rates of death (5.9% for DES vs11.2% for CABG; p � 0.03) and the composite of death, Q-wave MI,or stroke (10.0% for DES vs 19.1% for CABG; p � 0.004) weresignificantly lower in patients who received DES than in those whounderwent CABG. However, after adjustment for baseline risk factors,the overall risks of death (hazard ratio 0.73; 95% confidence interval[CI] 0.28–1.90; p � 0.52) and the composite of death, Q-wave MI, orstroke (hazard ratio 0.84; 95% CI 0.41–1.72; p � 0.63) were similarbetween the 2 groups. The rate of revascularization was significantlyhigher in the DES than in the CABG group (hazard ratio 7.17, 95% CI2.69–19.10; p �0.001).

Conclusion: For the treatment of unprotected LMCA disease, PCIwith DES implantation showed equivalent long-term (5-year) mortalityand rates of death, Q-wave MI, or stroke but a higher rate of repeatrevascularization compared with CABG.

AS-36Independent U.S. Validation of the British ColumbiaPercutaneous Coronary Intervention Risk Score.Rohit Khurana1, Sharon-Lise Normand2, Treacy Silbaugh2,Karin Humphries1, Min Gao1, Lilllian Ding1, Ann Lovett2,David Cohen3, Jaap Hamburger1. 1Division of Cardiology,Vancouver General Hospital, University of British Columbia,Vancouver, Canada; 2Harvard Medical School, Boston,

Massachusetts, USA; 3Saint Luke’s Mid America Heart Institute,Kansas, USA.

Background: Derivation of the British Columbia (BC) percutaneouscoronary intervention (PCI) risk score (accessible at www.bcpci.org) topredict 30-day post-PCI mortality was recently published to meet theneed for risk assessment in this era of complex coronary intervention.The BC PCI model was derived and internally validated using registrydata (n � 32,899) collected from Jan 2000 to Dec 2005. The purposeof this follow-up study was to validate the BC PCI score in an externalcohort.

Methods: The BC PCI risk score was evaluated using 36,341consecutive patients undergoing native vessel PCI (elective, emergent)between Jan 2005 and Sept 2007 in all non-federal Massachusetts,USA, hospitals. Data was prospectively collected by MassachusettsData Analysis Center (Mass-DAC) with each contributing center usingthe American College of Cardiology (ACC) National CardiovascularData Registry (NCDR) instrument. Simple logistic regression modelingwas used in the validation with the coefficients of the BC-PCI model.The area under the receiver operating characteristic curve (AUC) wascalculated to quantify accuracy of the BC-PCI risk score in the Mass-DAC registry.

Results: The cohort included 69% male patients, 3.9% having leftmain disease, and 15% with ongoing ST-segment elevation MI. Deathoccurred in 2.05% (n � 745) of patients. Multivariate logistic regres-sion analysis identified risk factors for 30-day mortality that weresimilar to the risk factors developed in the BC PCI model. The AUC ina simple logistic regression model including only the BC PCI score was0.87. For every 1-point increase in the BC PCI score, the odds of30-day mortality was twice that of no increase

Conclusion: This independent evaluation by Mass-DAC, HarvardMedical School, confirms the BC PCI score robustly and accuratelypredicts 30-day post-PCI mortality in a diverse unselected cohort ofpatients, providing further validation for its international applicability.

AS-37Sodium Bicarbonate in Saline Infusion Is Worse for thePrevention of Contrast-Induced Nephropathy than SalineInfusion Alone: A Randomized Single-Center Study.David Zemanek, Simon Celeryn, Petr Hajek, Martin Maly,Josef Veselka. University Hospital Motol, Prague, Czech Republic.

Background: Contrast-induced nephropathy (CIN) is one of the mostserious complications of catheterizations with intraarterial administra-tion of contrast agent. Many drugs have been proposed to prevent renalimpairment, but the final view is unclear. There several studies com-pared isotonic solution of sodium bicarbonate with isotonic salineinfusion with various results. Isotonic saline infusion is more effectivethan hypotonic. We wanted to determine whether a new protocol withsodium bicarbonate in isotonic saline infusion is more effective thansaline infusion alone.

Methods: We performed a single-center randomized study to com-pare hydration with infusion of 8.4% sodium bicarbonate 5 timesdiluted in 0.9% sodium chloride (group A) and 0.9% sodium chloridealone (group B) in a high-risk patient group (baseline creatinine level�133 �mol/L) undergoing a catheterization procedure. All procedures(both diagnostic and interventional) were elective for stable coronaryand peripheral artery disease. Hydration was started 3 hours before(3ml/kg/h) and followed by an infusion of 1 ml/kg/h for 6 hours afterprocedure. All patients received 600 mg of N-acetylcysteine orallytwice a day. Serum creatinine was assessed at the time of hospitaladmission and 24 and 48 hours after the procedure. Primary endpointwas renal function measured by serum creatinine levels, secondary was

16B The American Journal of Cardiology� APRIL 28–29 2010 ANGIOPLASTY SUMMIT ABSTRACTS/Oral

ORAL

ABSTRACTS

Thursday, April 29, 2010