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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
Thursday, April 29, 2010
O R A L
Miscellaneous
A B S T R A C T S
Thursday, April 29, 2010 11:30 AM⬃ 12:30 PM
Complex PCI Ida I
(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 patients 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 mortality and the composite of death, Q-wave myocardial infarction (MI), or stroke, and the primary efficacy endpoint was target vessel revascularization (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 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,
16B
Massachusetts, USA; 3Saint 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 MassDAC 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 regression 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 administration of contrast agent. Many drugs have been proposed to prevent renal impairment, but the final view is unclear. There several studies compared 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 compare 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 ⱖ133 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
The American Journal of Cardiology姞 APRIL 28 –29 2010 ANGIOPLASTY SUMMIT ABSTRACTS/Oral
Thursday, April 29, 2010 the occurrence of CIN (defined as an absolute increase of the creatinine level at least 44 mol/L– 0.5 mg/dL) or a relative increase ⱖ25 % over the baseline level). Results: We included 84 patients in this study (group A, 41 pts; group B, 43 pts). We did not find any statistical difference between the 2 groups for age, sex, body surface area, baseline creatinine, hypertension, diabetes, and the amount of contrast agent used. Serum creatinine levels were not statistically different between the groups in time; however, we observed a significant improvement in renal function for both groups 24 hours after procedure, but only for group B after 48 hours (Table). We decided to prematurely stop this study because of this fact. The secondary endpoint occurred only in 1 patient in group A (NS).
Conclusion: These results suggest that the use of sodium bicarbonate in saline infusion as a prophylactic form of hydration is worse than hydration with isotonic saline infusion alone to preserve renal function after the administration of contrast agents.
AS-38 Radial Anomalies in the Transradial Access in Percutaneous Coronary Intervention: Characteristics and Results of 7 Years of Experience. Alejandro Rodriquez1, Rodrigo Estevez1, Jorge Salgado1, Eduardo Barge1, Guillermo Aldama1, Ramon Calvino1, Jose Manuel Vazquez1, Pablo Pinon1, Nicolas Vazquez1, Alfonso Castro1. 1Hospital Universitario de A Corun˜a, A Corun˜a, Spain.
Background: Previous studies have demonstrated the feasibility and safety of using the radial artery as an access path for coronary angiography (CA). In fact, some centers use this as routine access in both diagnostic and interventional coronary procedures. Anatomic variations of the radial have been related to failure of transradial approach in the setting of percutaneous coronary intervention (PCI). The purpose of our study was to assess the rate and features of radial anatomic variations and its influence on the outcome of PCI. Methods: This was a cohort-based study including 12,098 consecutive patients submitted to CA in our hospital from 2001 to 2007. Definitions: radial loop: tortuous at radial level of 360° angle; high radial origin (HRO): origin of radial artery at the level other than the humeral or axillary artery; significant tortuous at radial level (STRL): angulations present at radial artery over 45°; retroesophageal right subclavian artery (RRS): aberrant origin of subclavian artery in the portion distal and posterior of the aortic arch in retroesophageal position. Results: The mean patient age was 64.5 ⫾ 11.5, 25% women; 7.4% had a ST-elevation myocardial infarction (STEMI), and 39% underwent PCI. We identified 267 (2.2%) abnormalities, including 77 (0.6%) loops, 18 (0.1%) HRO, 32 (0.3%) RRS artery (lusoria), and 147 (1.2%) that showed a significant tortuous configuration at the radial level. The presence of radial artery anomalies was related to more frequent change of route (32% vs 4.4%, p ⬍0.001), a greater procedure duration (33 ⫾ 24 vs 48 ⫾ 31 min, p ⬍0.001), higher fluoroscopic times, and a higher contrast volume (204 ⫾ 146 vs 245 ⫾ 175 mL, p ⬍0.001). However, in those cases that underwent PCI, radial anomalies were not associated to a lower rate of success (97.1% vs 96.9%, p ⫽ NS). Conclusion: The rate of radial anomalies found in our cohort of patients who underwent CA was low and associated with change of vascular access, greater procedure and fluoroscopic times, and the use of a higher contrast volume. Interestingly, the rate of PCI success was not penalized by radial anomalies.
The American Journal of Cardiology姞 APRIL 28 –29 2010 ANGIOPLASTY SUMMIT ABSTRACTS/Oral
17B
O R A L A B S T R A C T S
O R A L
Miscellaneous
A B S T R A C T S
Thursday, April 29, 2010 11:30 AM⬃ 12:30 PM
Complex PCI Ida I
(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 patients 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 mortality and the composite of death, Q-wave myocardial infarction (MI), or stroke, and the primary efficacy endpoint was target vessel revascularization (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 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,
16B
Massachusetts, USA; 3Saint 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 MassDAC 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 regression 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 administration of contrast agent. Many drugs have been proposed to prevent renal impairment, but the final view is unclear. There several studies compared 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 compare 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 ⱖ133 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
The American Journal of Cardiology姞 APRIL 28 –29 2010 ANGIOPLASTY SUMMIT ABSTRACTS/Oral
Thursday, April 29, 2010 the occurrence of CIN (defined as an absolute increase of the creatinine level at least 44 mol/L– 0.5 mg/dL) or a relative increase ⱖ25 % over the baseline level). Results: We included 84 patients in this study (group A, 41 pts; group B, 43 pts). We did not find any statistical difference between the 2 groups for age, sex, body surface area, baseline creatinine, hypertension, diabetes, and the amount of contrast agent used. Serum creatinine levels were not statistically different between the groups in time; however, we observed a significant improvement in renal function for both groups 24 hours after procedure, but only for group B after 48 hours (Table). We decided to prematurely stop this study because of this fact. The secondary endpoint occurred only in 1 patient in group A (NS).
Conclusion: These results suggest that the use of sodium bicarbonate in saline infusion as a prophylactic form of hydration is worse than hydration with isotonic saline infusion alone to preserve renal function after the administration of contrast agents.
AS-38 Radial Anomalies in the Transradial Access in Percutaneous Coronary Intervention: Characteristics and Results of 7 Years of Experience. Alejandro Rodriquez1, Rodrigo Estevez1, Jorge Salgado1, Eduardo Barge1, Guillermo Aldama1, Ramon Calvino1, Jose Manuel Vazquez1, Pablo Pinon1, Nicolas Vazquez1, Alfonso Castro1. 1Hospital Universitario de A Corun˜a, A Corun˜a, Spain.
Background: Previous studies have demonstrated the feasibility and safety of using the radial artery as an access path for coronary angiography (CA). In fact, some centers use this as routine access in both diagnostic and interventional coronary procedures. Anatomic variations of the radial have been related to failure of transradial approach in the setting of percutaneous coronary intervention (PCI). The purpose of our study was to assess the rate and features of radial anatomic variations and its influence on the outcome of PCI. Methods: This was a cohort-based study including 12,098 consecutive patients submitted to CA in our hospital from 2001 to 2007. Definitions: radial loop: tortuous at radial level of 360° angle; high radial origin (HRO): origin of radial artery at the level other than the humeral or axillary artery; significant tortuous at radial level (STRL): angulations present at radial artery over 45°; retroesophageal right subclavian artery (RRS): aberrant origin of subclavian artery in the portion distal and posterior of the aortic arch in retroesophageal position. Results: The mean patient age was 64.5 ⫾ 11.5, 25% women; 7.4% had a ST-elevation myocardial infarction (STEMI), and 39% underwent PCI. We identified 267 (2.2%) abnormalities, including 77 (0.6%) loops, 18 (0.1%) HRO, 32 (0.3%) RRS artery (lusoria), and 147 (1.2%) that showed a significant tortuous configuration at the radial level. The presence of radial artery anomalies was related to more frequent change of route (32% vs 4.4%, p ⬍0.001), a greater procedure duration (33 ⫾ 24 vs 48 ⫾ 31 min, p ⬍0.001), higher fluoroscopic times, and a higher contrast volume (204 ⫾ 146 vs 245 ⫾ 175 mL, p ⬍0.001). However, in those cases that underwent PCI, radial anomalies were not associated to a lower rate of success (97.1% vs 96.9%, p ⫽ NS). Conclusion: The rate of radial anomalies found in our cohort of patients who underwent CA was low and associated with change of vascular access, greater procedure and fluoroscopic times, and the use of a higher contrast volume. Interestingly, the rate of PCI success was not penalized by radial anomalies.
The American Journal of Cardiology姞 APRIL 28 –29 2010 ANGIOPLASTY SUMMIT ABSTRACTS/Oral
17B
O R A L A B S T R A C T S