- Email: [email protected]
TCT-96: Marked Reduction Of Operator Radiation Exposure By Using A Patient Lead Cover During Coronary Angiography Or Percutaneous Intervention
http://www.aievolution.com/tct0901/
TUESDAY, SEPTEMBER 22, 2009, 10:00AM - 12:00PM
O R A L A B S T R AC T S
Conclusions: Post-PCI bleeding is a strong independent predictor of long-term mortality in patients undergoing PCI in current clinical practice. Evaluating EDVHOLQH ULVN IDFWRUV IRU EOHHGLQJ DQG FDUHIXOO\ VHOHFWLQJ DQWLWKURPERWLF regimen may improve long-term outcomes.
TCT-95 The Quality of Study Evidence Examined By the FDA In Premarket Approval Of Stents Sanket S. Dhruva, Lisa A. Bero, Rita F. Redberg University of California, San Francisco, San Francisco, CA
TCT-94 Racial Difference in Cardiovascular Outcomes Following Percutaneous Coronary Intervention in a Public Health Service Patient Population Sirikarn Napan, Ramesh Chillal Kashinath, Taweewat Aussawapokee, Maria N.Orig, Sameer Kadri, Suhail Khadra John H. Stroger, Jr. Hospital of Cook County, Chicago, IL Background: 3ULRU VWXGLHV KDYH UHSRUWHG FRQÀLFWLQJ ¿QGLQJV UHJDUGLQJ racial disparities in long-term cardiovascular outcomes after percutaneous coronary intervention (PCI). Our aim was to compare major adverse cardiac HYHQWV 0$&( IROORZLQJ 3&, LQ EODFN YV QRQEODFN SDWLHQWV LQ D 3XEOLF Health Service (PHS) setting. Methods: A cohort of 1,438 consecutive patients undergoing intended PCI at a large public teaching hospital between April 2002 and September 2006 ZHUHIROORZHGIRUWKHGHYHORSPHQWRI0$&(GH¿QHGDVDFRPSRVLWHRIGHDWK myocardial infarction (MI), and urgent target vessel revascularization (TVR). Results:7KHVWXG\SRSXODWLRQFRQVLVWHGRIEODFNVZKLWHV Hispanics, and 16.1% Asians. Overall, 17.4% of patients developed MACE RYHUWKHPHDQIROORZXSRI\HDUV7KHUDWHRI0$&(ZDVVLJQL¿FDQWO\KLJKHU LQEODFNVFRPSDUHGZLWKQRQEODFNV YVORJUDQNS )LJ $IWHUDGMXVWLQJIRUDJHJHQGHUFDUGLRYDVFXODUULVNIDFWRUVVRFLRHFRQRPLF VWDWXV 6(6 DQGRWKHUFRQIRXQGLQJIDFWRUVEODFNUDFHUHPDLQHGDVWURQJDQG independent predictor of MACE (adjusted HR, 1.52; CI, 1.18-1.96; p = 0.001). %ODFNVKDGKLJKHUUDWHVRIGHDWK YVORJUDQNS DQG 0, YVORJUDQNS 7KHUHZHUHQRUDFLDOGLIIHUHQFHVLQ 3-month and 6-month MACE, in-hospital mortality, and TVR.
Background: Stents and their catheters are ubiquitous in clinical practice and KDYHLPSRUWDQWHIIHFWVRQPRUELGLW\DQGPRUWDOLW\\HWOLWWOHLVNQRZQDERXW the type of evidence used by the Food and Drug Administration (FDA) in WKHDSSURYDOSURFHVV:HFKRVHWRVWXG\3UHPDUNHW$SSURYDO 30$ DVLWLV the most stringent type of FDA review process-of stents and related catheters to characterize the type and quality of evidence on which approval is based. Methods: :H SHUIRUPHG D V\VWHPDWLF UHYLHZ RI 30$V IRU KLJKULVN coronary and peripheral stents and catheters that received FDA approval EHWZHHQ-DQXDU\DQG'HFHPEHU:HH[DPLQHGWKHPHWKRGRORJLFDO characteristics considered essential to minimize confounding and bias, as well as the primary endpoints of the 44 studies supporting these PMAs. Results: Thirty-four percent (15/44) of studies used to support recent FDA approval of stents and related catheters were randomized and one-fourth (11/44) were blinded. Sixty-three percent (36/57) of primary endpoints were compared to controls and 33% (12/36) of those controls were retrospective. Seventy-four percent (42/57) of primary endpoints were surrogate measures. Seventy-two percent (41/57) of endpoints were composites, but results for each component were described in just 56% (23/41) of the composites. Seventy percent (32/46) of primary endpoints had a discrepancy between the number of patients enrolled in the study and the number analyzed. The mean followup time for the primary endpoints in these studies was 176 days. Only 7% of the 44 studies were randomized, double-blind studies with real-time controls and at least 80% complete follow-up for both groups for the intention-to-treat analysis of a primary endpoint. Conclusions: There is variability in the type of evidence used by the FDA on which to base approval of stents and related catheters. More consistent study standards would allow better evaluation of safety and effectiveness before approval. TCT-96 Marked Reduction Of Operator Radiation Exposure By Using A Patient Lead Cover During Coronary Angiography Or Percutaneous Intervention Patrick Ohlmann, Pauline Bouyer, Bogdan Radulescu, Luc Mertz, Olivier Morel, Michel Zupan, Francois Bronner, Pierre Bareiss, André Constantinesco Hopitaux Universitaires de Strasbourg, Strasbourg, France
Conclusions:,QWKLV3+6SRSXODWLRQEODFNVZHUHIRXQGWRKDYHZRUVHORQJ term cardiovascular outcomes and mortality following PCI, irrespective RIGLIIHUHQFHVLQEDVHOLQHFDUGLRYDVFXODUULVNIDFWRUV6(6DQGKHDOWKFDUH access. Increased surveillance and enhanced treatment are warranted to LPSURYHWKHVXUYLYDORXWORRNRIWKHVHKLJKULVNSDWLHQWV
38D
Background: Operators and patient radiation exposure during interventional FDUGLRORJ\SURFHGXUHVPD\LQGXFHUDGLDWLRQLQMXU\DQGPD\LQFUHDVHULVNRI cancer. Objectives: To determine the effectiveness of a lead cover placed over the patient abdomen and groins in reducing operator radiation exposure during coronary intervention. Methods: Radiation exposure measurements were performed over an ZHHNV SHULRG LQ SDWLHQWV XQGHUJRLQJ GLDJQRVWLF DQGRU LQWHUYHQWLRQDO coronary procedures. Usual protection of the operator was ensured using D OHDG DSURQ ORZ OHDGHG ÀDSV DQG OHDGHG JODVV (DFK RI WKUHHSURFHGXUHV was realized using a lead cover placed on the patient abdomen. Operator irradiation was assessed by using 3 electronic dosimeters placed over the DSURQRQWKHFKHVWDQGLQWKHEDFN QR RQWKHOHIWDUP QR 3DWLHQW radiation exposure (using the diamentor system), ambiental irradiation (using an electronic dosimeter placed in the room opposite to the Xray tube) and ÀXRURVFRS\WLPHVZHUHUHFRUGHG5HVXOWVDUHSUHVHQWHGLQPHDQ6(0DQG comparisons assessed by student t test. Results: Operator exposure was assessed during 189 procedures (136 coronary angiograms and 53 percutaneous coronary interventions) in 71
The American Journal of Cardiology®
|
September 21-25, 2009
|
TCT Abstracts/ORAL
http://www.aievolution.com/tct0901/
TUESDAY, SEPTEMBER 22, 2009, 10:00AM - 12:00PM
Bifurcations
cases (37%) with the lead cover over the patient (group 1) and in 118 cases (63%) without it (group 2). Fluoroscopy times, dose area products and ambient irradiation were similar with and without the lead cover (4 ± 2 vs 4.1 ± 0.6 min, 55,7 ± 5,8 vs 57,6 ± 4,2 Gy cm2 and 0.7 ± 0.2 vs 0.8 ± 0.1 Sv respectively - p ! +RZHYHURSHUDWRULUUDGLDWLRQZDVPDUNHGO\GHFUHDVHGE\XVLQJWKH lead cover: from 19.2 ± 3.1 to 4.9 ± 0.9 Sv at the chest level (p=0,001), from WR6YDWWKHEDFN S DQGIURPWR 2.2 Sv at the left arm (p=0,019). Conclusions: Using a lead cover placed over the patient is highly effective in attenuating operator scatter radiation exposure during coronary procedure. Such additional protection device might be useful either in the perspective of long duration procedure or in routine use.
Room 132 (Abstract Nos 97-104) TCT-97 Sirolimus-eluting and Paclitaxel-eluting Stents for the Treatment of Coronary Bifurcations: Results From the COBIS (COronary BIfurcation Stenting) Registry Young Bin Song, Hyeon-Cheol Gwon, Joo-Yong Hahn, Jin-Ho Choi, Seung-Hyuk Choi, Sang Hoon Lee, Sang Min Kim, Jong Chun Nah, Hyun Jong Lee, Joon Hyouk Choi, the COBIS Investigators Samsung Medical Center, Seoul, Republic of Korea Background: 6HYHUDO VWXGLHV KDYH FRPSDUHG WKH HI¿FDF\ RI VLUROLPXV eluting stents (SES) and paclitaxel-eluting stents (PES). However, there are limited data regarding the comparison of these two stents for the treatment of bifurcation lesions. We aimed to compare the long-term clinical outcomes of patients treated with SES or PES for coronary bifurcation lesions. Methods: Data on all percutaneous coronary interventions for coronary bifurcation lesions in 16 South Korean hospital centers were collected EHWZHHQ-DQXDU\DQG-XQH:HFRPSDUHGPDMRUDGYHUVHFDUGLDF events [MACEs: cardiac death, myocardial infarction (MI), or target lesion UHYDVFXODUL]DWLRQ 7/5 @ LQ ZKROH SDWLHQWV DQG LQ SDLUV JHQHUDWHG E\ propensity-score matching. Results: We evaluated 1033 patients with non-left main bifurcation lesions treated with SES and 562 patients with PES. There were 101 events (6.3%) during a median follow-up of 22.2 months (interquartile range, 14.5 to 32.0). Treatment with SES was associated with a lower incidence of MACEs (HR 0.56; 95% CI 0.37-0.83; p<0.01) and TLR (HR 0.53; 95% CI 0.33-0.84; p<0.01), but not of cardiac death (HR 3.01; 95% CI 0.67-13.64; p=0.13) and cardiac death or MI (HR 0.69; 95% CI 0.34-1.41; p=0.31). After propensityscore matching, patients with SES had still fewer MACEs and TLR than those with PES (HR 0.37; 95% CI 0.17-0.81; p<0.01 and HR 0.37; 95% CI 0.16-0.85; S UHVSHFWLYHO\ 7KHUHZDVQRVLJQL¿FDQWGLIIHUHQFHLQWKHRFFXUUHQFHV of periprocedural MI and stent thrombosis between SES and PES groups (14.7% versus 17.3%, p=0.21, and 0.7% versus 0.7%, p=0.94, respectively). Conclusions: In patients with bifurcation lesions, the use of SES results in better long-term outcomes than PES, primarily by decreasing the rates of revascularization. TCT-98 Intravascular Ultrasound Assessment of Crush versus Culotte Coronary Bifurcation Stenting Technique. A substudy from the Nordic Stent Technique Study Lisette Okkels Jensen1, Sanda Jegere2, Indulis Kumsars2, Inga Narbute2, Dace Sondore2, Karlis Trusinskis2, Jens F Lassen3, Leif Thuesen3, Andrejs Erglis2 1 Odense University Hospital, Odense, Denmark2Latvian Centre of Cardiology, Riga, Latvia3Aarhus University Hospital, Skejby, Denmark Background: In a number of coronary bifurcation lesions, both the main vessel (MV) and the side branch (SB) need stent coverage. The aim of the study was to compare stent cross sectional area (CSA) and intimal hyperplasia in bifurcation lesions treated with the crush or the culotte bifurcation stent technique. Methods: Eighty-six patients with bifurcation lesions (randomised to crushstenting or culotte-stenting in the Nordic Stent Technique Study) underwent follow up with intravascular ultrasound (IVUS) at 8-month follow up. IVUS ZDVSHUIRUPHGLQERWKWKH6%DQGWKH09LQDOOOHVLRQV3XOOEDFNVZHUH analyzed proximal and distal to the bifurcation and at the bifurcation. We
The American Journal of Cardiology®
|
September 21-25, 2009
|
TCT Abstracts/ORAL
39D
O R A L A B S T R AC T S
Tuesday, September 22, 2009, 10:00 am – 12:00 pm
TUESDAY, SEPTEMBER 22, 2009, 10:00AM - 12:00PM
O R A L A B S T R AC T S
Conclusions: Post-PCI bleeding is a strong independent predictor of long-term mortality in patients undergoing PCI in current clinical practice. Evaluating EDVHOLQH ULVN IDFWRUV IRU EOHHGLQJ DQG FDUHIXOO\ VHOHFWLQJ DQWLWKURPERWLF regimen may improve long-term outcomes.
TCT-95 The Quality of Study Evidence Examined By the FDA In Premarket Approval Of Stents Sanket S. Dhruva, Lisa A. Bero, Rita F. Redberg University of California, San Francisco, San Francisco, CA
TCT-94 Racial Difference in Cardiovascular Outcomes Following Percutaneous Coronary Intervention in a Public Health Service Patient Population Sirikarn Napan, Ramesh Chillal Kashinath, Taweewat Aussawapokee, Maria N.Orig, Sameer Kadri, Suhail Khadra John H. Stroger, Jr. Hospital of Cook County, Chicago, IL Background: 3ULRU VWXGLHV KDYH UHSRUWHG FRQÀLFWLQJ ¿QGLQJV UHJDUGLQJ racial disparities in long-term cardiovascular outcomes after percutaneous coronary intervention (PCI). Our aim was to compare major adverse cardiac HYHQWV 0$&( IROORZLQJ 3&, LQ EODFN YV QRQEODFN SDWLHQWV LQ D 3XEOLF Health Service (PHS) setting. Methods: A cohort of 1,438 consecutive patients undergoing intended PCI at a large public teaching hospital between April 2002 and September 2006 ZHUHIROORZHGIRUWKHGHYHORSPHQWRI0$&(GH¿QHGDVDFRPSRVLWHRIGHDWK myocardial infarction (MI), and urgent target vessel revascularization (TVR). Results:7KHVWXG\SRSXODWLRQFRQVLVWHGRIEODFNVZKLWHV Hispanics, and 16.1% Asians. Overall, 17.4% of patients developed MACE RYHUWKHPHDQIROORZXSRI\HDUV7KHUDWHRI0$&(ZDVVLJQL¿FDQWO\KLJKHU LQEODFNVFRPSDUHGZLWKQRQEODFNV YVORJUDQNS )LJ $IWHUDGMXVWLQJIRUDJHJHQGHUFDUGLRYDVFXODUULVNIDFWRUVVRFLRHFRQRPLF VWDWXV 6(6 DQGRWKHUFRQIRXQGLQJIDFWRUVEODFNUDFHUHPDLQHGDVWURQJDQG independent predictor of MACE (adjusted HR, 1.52; CI, 1.18-1.96; p = 0.001). %ODFNVKDGKLJKHUUDWHVRIGHDWK YVORJUDQNS DQG 0, YVORJUDQNS 7KHUHZHUHQRUDFLDOGLIIHUHQFHVLQ 3-month and 6-month MACE, in-hospital mortality, and TVR.
Background: Stents and their catheters are ubiquitous in clinical practice and KDYHLPSRUWDQWHIIHFWVRQPRUELGLW\DQGPRUWDOLW\\HWOLWWOHLVNQRZQDERXW the type of evidence used by the Food and Drug Administration (FDA) in WKHDSSURYDOSURFHVV:HFKRVHWRVWXG\3UHPDUNHW$SSURYDO 30$ DVLWLV the most stringent type of FDA review process-of stents and related catheters to characterize the type and quality of evidence on which approval is based. Methods: :H SHUIRUPHG D V\VWHPDWLF UHYLHZ RI 30$V IRU KLJKULVN coronary and peripheral stents and catheters that received FDA approval EHWZHHQ-DQXDU\DQG'HFHPEHU:HH[DPLQHGWKHPHWKRGRORJLFDO characteristics considered essential to minimize confounding and bias, as well as the primary endpoints of the 44 studies supporting these PMAs. Results: Thirty-four percent (15/44) of studies used to support recent FDA approval of stents and related catheters were randomized and one-fourth (11/44) were blinded. Sixty-three percent (36/57) of primary endpoints were compared to controls and 33% (12/36) of those controls were retrospective. Seventy-four percent (42/57) of primary endpoints were surrogate measures. Seventy-two percent (41/57) of endpoints were composites, but results for each component were described in just 56% (23/41) of the composites. Seventy percent (32/46) of primary endpoints had a discrepancy between the number of patients enrolled in the study and the number analyzed. The mean followup time for the primary endpoints in these studies was 176 days. Only 7% of the 44 studies were randomized, double-blind studies with real-time controls and at least 80% complete follow-up for both groups for the intention-to-treat analysis of a primary endpoint. Conclusions: There is variability in the type of evidence used by the FDA on which to base approval of stents and related catheters. More consistent study standards would allow better evaluation of safety and effectiveness before approval. TCT-96 Marked Reduction Of Operator Radiation Exposure By Using A Patient Lead Cover During Coronary Angiography Or Percutaneous Intervention Patrick Ohlmann, Pauline Bouyer, Bogdan Radulescu, Luc Mertz, Olivier Morel, Michel Zupan, Francois Bronner, Pierre Bareiss, André Constantinesco Hopitaux Universitaires de Strasbourg, Strasbourg, France
Conclusions:,QWKLV3+6SRSXODWLRQEODFNVZHUHIRXQGWRKDYHZRUVHORQJ term cardiovascular outcomes and mortality following PCI, irrespective RIGLIIHUHQFHVLQEDVHOLQHFDUGLRYDVFXODUULVNIDFWRUV6(6DQGKHDOWKFDUH access. Increased surveillance and enhanced treatment are warranted to LPSURYHWKHVXUYLYDORXWORRNRIWKHVHKLJKULVNSDWLHQWV
38D
Background: Operators and patient radiation exposure during interventional FDUGLRORJ\SURFHGXUHVPD\LQGXFHUDGLDWLRQLQMXU\DQGPD\LQFUHDVHULVNRI cancer. Objectives: To determine the effectiveness of a lead cover placed over the patient abdomen and groins in reducing operator radiation exposure during coronary intervention. Methods: Radiation exposure measurements were performed over an ZHHNV SHULRG LQ SDWLHQWV XQGHUJRLQJ GLDJQRVWLF DQGRU LQWHUYHQWLRQDO coronary procedures. Usual protection of the operator was ensured using D OHDG DSURQ ORZ OHDGHG ÀDSV DQG OHDGHG JODVV (DFK RI WKUHHSURFHGXUHV was realized using a lead cover placed on the patient abdomen. Operator irradiation was assessed by using 3 electronic dosimeters placed over the DSURQRQWKHFKHVWDQGLQWKHEDFN QR RQWKHOHIWDUP QR 3DWLHQW radiation exposure (using the diamentor system), ambiental irradiation (using an electronic dosimeter placed in the room opposite to the Xray tube) and ÀXRURVFRS\WLPHVZHUHUHFRUGHG5HVXOWVDUHSUHVHQWHGLQPHDQ6(0DQG comparisons assessed by student t test. Results: Operator exposure was assessed during 189 procedures (136 coronary angiograms and 53 percutaneous coronary interventions) in 71
The American Journal of Cardiology®
|
September 21-25, 2009
|
TCT Abstracts/ORAL
http://www.aievolution.com/tct0901/
TUESDAY, SEPTEMBER 22, 2009, 10:00AM - 12:00PM
Bifurcations
cases (37%) with the lead cover over the patient (group 1) and in 118 cases (63%) without it (group 2). Fluoroscopy times, dose area products and ambient irradiation were similar with and without the lead cover (4 ± 2 vs 4.1 ± 0.6 min, 55,7 ± 5,8 vs 57,6 ± 4,2 Gy cm2 and 0.7 ± 0.2 vs 0.8 ± 0.1 Sv respectively - p ! +RZHYHURSHUDWRULUUDGLDWLRQZDVPDUNHGO\GHFUHDVHGE\XVLQJWKH lead cover: from 19.2 ± 3.1 to 4.9 ± 0.9 Sv at the chest level (p=0,001), from WR6YDWWKHEDFN S DQGIURPWR 2.2 Sv at the left arm (p=0,019). Conclusions: Using a lead cover placed over the patient is highly effective in attenuating operator scatter radiation exposure during coronary procedure. Such additional protection device might be useful either in the perspective of long duration procedure or in routine use.
Room 132 (Abstract Nos 97-104) TCT-97 Sirolimus-eluting and Paclitaxel-eluting Stents for the Treatment of Coronary Bifurcations: Results From the COBIS (COronary BIfurcation Stenting) Registry Young Bin Song, Hyeon-Cheol Gwon, Joo-Yong Hahn, Jin-Ho Choi, Seung-Hyuk Choi, Sang Hoon Lee, Sang Min Kim, Jong Chun Nah, Hyun Jong Lee, Joon Hyouk Choi, the COBIS Investigators Samsung Medical Center, Seoul, Republic of Korea Background: 6HYHUDO VWXGLHV KDYH FRPSDUHG WKH HI¿FDF\ RI VLUROLPXV eluting stents (SES) and paclitaxel-eluting stents (PES). However, there are limited data regarding the comparison of these two stents for the treatment of bifurcation lesions. We aimed to compare the long-term clinical outcomes of patients treated with SES or PES for coronary bifurcation lesions. Methods: Data on all percutaneous coronary interventions for coronary bifurcation lesions in 16 South Korean hospital centers were collected EHWZHHQ-DQXDU\DQG-XQH:HFRPSDUHGPDMRUDGYHUVHFDUGLDF events [MACEs: cardiac death, myocardial infarction (MI), or target lesion UHYDVFXODUL]DWLRQ 7/5 @ LQ ZKROH SDWLHQWV DQG LQ SDLUV JHQHUDWHG E\ propensity-score matching. Results: We evaluated 1033 patients with non-left main bifurcation lesions treated with SES and 562 patients with PES. There were 101 events (6.3%) during a median follow-up of 22.2 months (interquartile range, 14.5 to 32.0). Treatment with SES was associated with a lower incidence of MACEs (HR 0.56; 95% CI 0.37-0.83; p<0.01) and TLR (HR 0.53; 95% CI 0.33-0.84; p<0.01), but not of cardiac death (HR 3.01; 95% CI 0.67-13.64; p=0.13) and cardiac death or MI (HR 0.69; 95% CI 0.34-1.41; p=0.31). After propensityscore matching, patients with SES had still fewer MACEs and TLR than those with PES (HR 0.37; 95% CI 0.17-0.81; p<0.01 and HR 0.37; 95% CI 0.16-0.85; S UHVSHFWLYHO\ 7KHUHZDVQRVLJQL¿FDQWGLIIHUHQFHLQWKHRFFXUUHQFHV of periprocedural MI and stent thrombosis between SES and PES groups (14.7% versus 17.3%, p=0.21, and 0.7% versus 0.7%, p=0.94, respectively). Conclusions: In patients with bifurcation lesions, the use of SES results in better long-term outcomes than PES, primarily by decreasing the rates of revascularization. TCT-98 Intravascular Ultrasound Assessment of Crush versus Culotte Coronary Bifurcation Stenting Technique. A substudy from the Nordic Stent Technique Study Lisette Okkels Jensen1, Sanda Jegere2, Indulis Kumsars2, Inga Narbute2, Dace Sondore2, Karlis Trusinskis2, Jens F Lassen3, Leif Thuesen3, Andrejs Erglis2 1 Odense University Hospital, Odense, Denmark2Latvian Centre of Cardiology, Riga, Latvia3Aarhus University Hospital, Skejby, Denmark Background: In a number of coronary bifurcation lesions, both the main vessel (MV) and the side branch (SB) need stent coverage. The aim of the study was to compare stent cross sectional area (CSA) and intimal hyperplasia in bifurcation lesions treated with the crush or the culotte bifurcation stent technique. Methods: Eighty-six patients with bifurcation lesions (randomised to crushstenting or culotte-stenting in the Nordic Stent Technique Study) underwent follow up with intravascular ultrasound (IVUS) at 8-month follow up. IVUS ZDVSHUIRUPHGLQERWKWKH6%DQGWKH09LQDOOOHVLRQV3XOOEDFNVZHUH analyzed proximal and distal to the bifurcation and at the bifurcation. We
The American Journal of Cardiology®
|
September 21-25, 2009
|
TCT Abstracts/ORAL
39D
O R A L A B S T R AC T S
Tuesday, September 22, 2009, 10:00 am – 12:00 pm