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TCT-358: Comparison of Sirolimus-Eluting Stents with Paclitaxel-Eluting Stents in Unselected Patients with Acute ST-Segment Elevation Myocardial Infarction
http://www.aievolution.com/tct0901/
TUESDAY, SEPTEMBER 22, 2009, 8:00AM - 10:00AM
Drug Eluting Stents
with TIMI myocardial perfusion grade (TMPG) considering TMPG 0-1 (closed microvascularization) and TMPG 2-3 (open microvascularization). Results: 23% of patients were diabetics and presented a higher incidence RIRWKHUFDUGLRYDVFXODUULVNIDFWRUVDQGPXOWLYHVVHOGLVHDVHFRPSDUHGZLWK no diabetics (53.6% vs 37.2%, p=0.002). In the coronary artery responsible RI WKH LQIDUFWLRQ WKHUH ZHUH QR VLJQL¿FDQW GLIIHUHQFHV FRQVLGHULQJ 7,0, JUDGHHSLFDUGLDOÀRZEHIRUHDQGDIWHUUHSHUIXVLRQEHWZHHQWKHWZRJURXSV Nevertheless, TMPG 0-1 was more frequent in diabetic group (25.9% vs 4.7%, p=0.001). This closed microvascularization was associated with a lower resolution of ST segment (36.4% vs 96%, p= 0.001), a higher incidence of QRQUHÀRZSKHQRPHQRQ YVS DQGDKLJKHULQFLGHQFHRI FRPELQHGHYHQWVDIWHUD\HDURIIROORZXS GHDWKLQIDUFWLRQVWURNHDQGQHHG of a new revascularization) 30% vs 13 %, p= 0.02). Conclusions: diabetes is associated with a diminished myocardial perfusion GHVSLWHWKHSURFHGXUDOVXFFHVVDQGGHVSLWHD¿QDOÀRZ7,0,LQSDWLHQWVZLWK STEMI. This is associated with a worse prognosis in the follow-up.
(Abstract Nos 360-443) TCT-360 Comparison of Sirolimus-Eluting NEVOTM Stents with Paclitaxeleluting Taxus LieberteTM stents in De Novo Native Coronary Artery Lesions : Intravascular Ultrasound Results From the Reselution I Trial Hiromasa Otake, Takao Shimohama, Junya Ako, Katsuhisa Waseda, Yasuhiro Honda, Peter J Fitzgerald Stanford University, Palo Alto, CA Background: The NEVOTM Stent (NEVO) is a novel cobalt-chromium stent with a focal formulation strategy consists of reservoirs for a bioresorbable polylactic-co-glycolic acid polymer to elute sirolimus. The Res-elution I is a multicenter, randomized, controlled trial comparing NEVO to Paclitaxeleluting Taxus Liberte TM stent (PES) in de novo native coronary artery lesions. Methods: IVUS was performed in a subset of Res-elution I trial enrolling a total of 100 patients (52 NEVO in 50 patients; 52 PES in 50 patients). Serial IVUS imaging was performed at baseline and at 6-months follow-up. Volume index (volume/length) was calculated for vessel (VVI), peri-plaque (PVI), neointima (NVI), and lumen (LVI). %NIV was calculated as neointimal volume / stent volume x 100. To assess the cross-sectional severities of luminal narrowing, max. %Cross-sectional narrowing (%CSN: neointimal area / stent area×100) was calculated for each lesion. Late lumen area loss was calculated as minimum lumen area (MLA) at post-stenting - MLA at follow-up. Late LQFRPSOHWHVWHQWDSSRVLWLRQ ,6$ ZDVGH¿QHGDVVHSDUDWLRQRIDWOHDVWVWUXW from the vessel wall where post-stent IVUS revealed well apposition. Results: Among patients available for 3D-IVUS analysis at follow-up 1(92 Q 3(6 Q 1(92 VKRZHG VLJQL¿FDQWO\ OHVV QHRLQWLPDO proliferation, resulting in less late lumen area loss and smaller max. %CSN WKDQ3(6 7DEOH 6HULDO,986DQDO\VLVUHYHDOHGVLJQL¿FDQWO\JUHDWHUSRVLWLYH vessel remodeling in PES than in NEVO (Table). At baseline, the incidence of tissue prolapse, edge dissections, and ISA were similar between NEVO and PES. At follow-up, WKH LQFLGHQFH RI ODWH ,6$ ZDV QRW VLJQL¿FDQWO\ different between NEVO and PES (Table).
TCT-358 Comparison of Sirolimus-Eluting Stents with Paclitaxel-Eluting Stents in Unselected Patients with Acute ST-Segment Elevation Myocardial Infarction Youngkeun Ahn1, Myung Ho Jeong1, Shung Chull Chae2, Young Jo Kim3, Jei Keon Chae4, Myeong Chan Cho5, Chong Jin Kim6 1 Chonnam National University Hospital, Gwangju, Republic of Korea2Kyungpook National University Hospital, Daegu, Republic of Korea3Yeungnam University Hospital, Daegu, Republic of Korea4Chonbuk National University Hospital, Jeonju, Republic of Korea5Chungbuk National University Hospital, Chungju, Republic of Korea6Kyunghee University Hospital, Seoul, Republic of Korea Background: Drug-eluting stents (DES) have been shown to reduce the incidence of restenosis and target vessel revascularization (TVR) in clinical randomized studies when compared with bare metal stents (BMS) in patients undergoing elective percutaneous intervention. Limited data are available with the use of DES in patients with acute ST-segment elevation myocardial infarction (STEMI). The aim of this study was to compare the clinical outcomes of patients with acute STEMI treated with sirolimus-eluting stents (SES) vs. paclitaxel-eluting stents (PES). Methods and Results: We recruited 3,148 patients with acute STEMI from 50 high-volume centers with facilities for primary percutaneous coronary intervention (PCI). All were participants in the Korea Acute MI Registry (KAMIR) from Nov 2005 to Dec 2006. Patients who received at least one SES (n=1,784) were retrospectively compared with patients who received one or more PES (n=1,364) during one-year clinical follow-up. According to the propensity score matching, during one-year clinical follow-up, composite major adverse cardiac events (MACE) were 14.4 % in SES- and 17.4 % in PEStreated patients (p=0.154). The one-year rate of target lesion revascularization (TLR) was 2.7 % in SES- and 3.4 % in PES-treated patients (p=0.498). Conclusion: SES and PES had similar clinical outcomes in patients with acute STEMI during one-year clinical outcomes. Long-term follow-up will be needed for further analysis.
NEVO
PES
P Value
Quantitative IVUS results 5.5±11.0
11.5±9.7
0.02
Maximum %CSN, %
13.9±14.3
28.6±17.7
0.0002
Late Lumen Area loss, mm3/mm
0.46±0.89
1.1±1.4
0.03
Delta LVI, mm3/mm
-0.32±0.80
-0.74±0.86
0.046
Delta VVI, mm3/mm
0.36±0.63
1.30±1.36
0.003
Delta PVI,mm3/mm
0.37±0.69
1.08±1.01
0.005 0.23
Qualitative IVUS results Tissue prolapse, %
4.5
0
Edge dissections, %
2.3
0
0.48
Baseline ISA, %
11.4
12.8
>0.99
Late ISA, %
10.5
7.7
0.71
Conclusion: 'HWDLOHG ,986 DQDO\VLV FRQ¿UPHG VLJQL¿FDQWO\ JUHDWHU neointimal suppression with NEVO as compared to PES up to 6 months.
The American Journal of Cardiology®
|
September 21-25, 2009
|
TCT Abstracts/POSTER
133D
P O S T E R A B S T R AC T S
% NIV, %
TUESDAY, SEPTEMBER 22, 2009, 8:00AM - 10:00AM
Drug Eluting Stents
with TIMI myocardial perfusion grade (TMPG) considering TMPG 0-1 (closed microvascularization) and TMPG 2-3 (open microvascularization). Results: 23% of patients were diabetics and presented a higher incidence RIRWKHUFDUGLRYDVFXODUULVNIDFWRUVDQGPXOWLYHVVHOGLVHDVHFRPSDUHGZLWK no diabetics (53.6% vs 37.2%, p=0.002). In the coronary artery responsible RI WKH LQIDUFWLRQ WKHUH ZHUH QR VLJQL¿FDQW GLIIHUHQFHV FRQVLGHULQJ 7,0, JUDGHHSLFDUGLDOÀRZEHIRUHDQGDIWHUUHSHUIXVLRQEHWZHHQWKHWZRJURXSV Nevertheless, TMPG 0-1 was more frequent in diabetic group (25.9% vs 4.7%, p=0.001). This closed microvascularization was associated with a lower resolution of ST segment (36.4% vs 96%, p= 0.001), a higher incidence of QRQUHÀRZSKHQRPHQRQ YVS DQGDKLJKHULQFLGHQFHRI FRPELQHGHYHQWVDIWHUD\HDURIIROORZXS GHDWKLQIDUFWLRQVWURNHDQGQHHG of a new revascularization) 30% vs 13 %, p= 0.02). Conclusions: diabetes is associated with a diminished myocardial perfusion GHVSLWHWKHSURFHGXUDOVXFFHVVDQGGHVSLWHD¿QDOÀRZ7,0,LQSDWLHQWVZLWK STEMI. This is associated with a worse prognosis in the follow-up.
(Abstract Nos 360-443) TCT-360 Comparison of Sirolimus-Eluting NEVOTM Stents with Paclitaxeleluting Taxus LieberteTM stents in De Novo Native Coronary Artery Lesions : Intravascular Ultrasound Results From the Reselution I Trial Hiromasa Otake, Takao Shimohama, Junya Ako, Katsuhisa Waseda, Yasuhiro Honda, Peter J Fitzgerald Stanford University, Palo Alto, CA Background: The NEVOTM Stent (NEVO) is a novel cobalt-chromium stent with a focal formulation strategy consists of reservoirs for a bioresorbable polylactic-co-glycolic acid polymer to elute sirolimus. The Res-elution I is a multicenter, randomized, controlled trial comparing NEVO to Paclitaxeleluting Taxus Liberte TM stent (PES) in de novo native coronary artery lesions. Methods: IVUS was performed in a subset of Res-elution I trial enrolling a total of 100 patients (52 NEVO in 50 patients; 52 PES in 50 patients). Serial IVUS imaging was performed at baseline and at 6-months follow-up. Volume index (volume/length) was calculated for vessel (VVI), peri-plaque (PVI), neointima (NVI), and lumen (LVI). %NIV was calculated as neointimal volume / stent volume x 100. To assess the cross-sectional severities of luminal narrowing, max. %Cross-sectional narrowing (%CSN: neointimal area / stent area×100) was calculated for each lesion. Late lumen area loss was calculated as minimum lumen area (MLA) at post-stenting - MLA at follow-up. Late LQFRPSOHWHVWHQWDSSRVLWLRQ ,6$ ZDVGH¿QHGDVVHSDUDWLRQRIDWOHDVWVWUXW from the vessel wall where post-stent IVUS revealed well apposition. Results: Among patients available for 3D-IVUS analysis at follow-up 1(92 Q 3(6 Q 1(92 VKRZHG VLJQL¿FDQWO\ OHVV QHRLQWLPDO proliferation, resulting in less late lumen area loss and smaller max. %CSN WKDQ3(6 7DEOH 6HULDO,986DQDO\VLVUHYHDOHGVLJQL¿FDQWO\JUHDWHUSRVLWLYH vessel remodeling in PES than in NEVO (Table). At baseline, the incidence of tissue prolapse, edge dissections, and ISA were similar between NEVO and PES. At follow-up, WKH LQFLGHQFH RI ODWH ,6$ ZDV QRW VLJQL¿FDQWO\ different between NEVO and PES (Table).
TCT-358 Comparison of Sirolimus-Eluting Stents with Paclitaxel-Eluting Stents in Unselected Patients with Acute ST-Segment Elevation Myocardial Infarction Youngkeun Ahn1, Myung Ho Jeong1, Shung Chull Chae2, Young Jo Kim3, Jei Keon Chae4, Myeong Chan Cho5, Chong Jin Kim6 1 Chonnam National University Hospital, Gwangju, Republic of Korea2Kyungpook National University Hospital, Daegu, Republic of Korea3Yeungnam University Hospital, Daegu, Republic of Korea4Chonbuk National University Hospital, Jeonju, Republic of Korea5Chungbuk National University Hospital, Chungju, Republic of Korea6Kyunghee University Hospital, Seoul, Republic of Korea Background: Drug-eluting stents (DES) have been shown to reduce the incidence of restenosis and target vessel revascularization (TVR) in clinical randomized studies when compared with bare metal stents (BMS) in patients undergoing elective percutaneous intervention. Limited data are available with the use of DES in patients with acute ST-segment elevation myocardial infarction (STEMI). The aim of this study was to compare the clinical outcomes of patients with acute STEMI treated with sirolimus-eluting stents (SES) vs. paclitaxel-eluting stents (PES). Methods and Results: We recruited 3,148 patients with acute STEMI from 50 high-volume centers with facilities for primary percutaneous coronary intervention (PCI). All were participants in the Korea Acute MI Registry (KAMIR) from Nov 2005 to Dec 2006. Patients who received at least one SES (n=1,784) were retrospectively compared with patients who received one or more PES (n=1,364) during one-year clinical follow-up. According to the propensity score matching, during one-year clinical follow-up, composite major adverse cardiac events (MACE) were 14.4 % in SES- and 17.4 % in PEStreated patients (p=0.154). The one-year rate of target lesion revascularization (TLR) was 2.7 % in SES- and 3.4 % in PES-treated patients (p=0.498). Conclusion: SES and PES had similar clinical outcomes in patients with acute STEMI during one-year clinical outcomes. Long-term follow-up will be needed for further analysis.
NEVO
PES
P Value
Quantitative IVUS results 5.5±11.0
11.5±9.7
0.02
Maximum %CSN, %
13.9±14.3
28.6±17.7
0.0002
Late Lumen Area loss, mm3/mm
0.46±0.89
1.1±1.4
0.03
Delta LVI, mm3/mm
-0.32±0.80
-0.74±0.86
0.046
Delta VVI, mm3/mm
0.36±0.63
1.30±1.36
0.003
Delta PVI,mm3/mm
0.37±0.69
1.08±1.01
0.005 0.23
Qualitative IVUS results Tissue prolapse, %
4.5
0
Edge dissections, %
2.3
0
0.48
Baseline ISA, %
11.4
12.8
>0.99
Late ISA, %
10.5
7.7
0.71
Conclusion: 'HWDLOHG ,986 DQDO\VLV FRQ¿UPHG VLJQL¿FDQWO\ JUHDWHU neointimal suppression with NEVO as compared to PES up to 6 months.
The American Journal of Cardiology®
|
September 21-25, 2009
|
TCT Abstracts/POSTER
133D
P O S T E R A B S T R AC T S
% NIV, %