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Clinical Use of Everolimus-eluting Bioresorbable Vascular Scaffold (BVS) In Treating Coronary Artery Disease
APRIL 23e26, 2013 BMS (neointimal thickness: BMS, 0.44O0.12; SES, 0.42O0.03; PFSES, 0.14O0.11; CS, 0.11O0.06; p<0.005; BMS/SES > CS/ PFSES). At 28 days, both CS and PFSES were associated with reduced neointimal proliferation, whereas SES exhibited increased neointima (neointimal thickness: BMS, 0.62O0.11; SES, 0.63O0.08; PFSES, 0.18O0.06; CS, 0.21O0.06; p<0.005; BMS/SES > CS/PFSES). The histology evaluation was demonstrated the similar results. At 14 days and 28 days, combo stent showed decreased fibrin and inflammation, compared with SES and PFSES. In addition, the combo SES is associated with increased endothelium-dependent relaxation, protected vascular Endothelial Function. Conclusion: The polymer-free sirolimus-eluting stent modified with anti-CD34 antibody demonstrates equivalent early and superior late reduction of intimal proliferation compared with SES in a porcine model. After implantation of combo stent, delayed arterial healing was minimal, and there was no increased inflammation at 28 days compared with SES implantation. The use of combo stents may have a potential short-term benefit over traditional polymeric-coated drugeluting stents.
- AS-048 Clinical Use of Everolimus-eluting Bioresorbable Vascular Scaffold (BVS) In Treating Coronary Artery Disease. Michael Liang, Takashi Kajiya, Chi-Hang Lee, Mark Chan, Swee-Guan Teo, Koo-Hui Chan, Huay-Cheem Tan, Adrian Low. National University Hospital, Singapore, Singapore. Background: Percutaneous coronary intervention (PCI) with the everolimus-eluting bioresorbable vascular scaffold (BVS) has been shown to be effective in treating de novo coronary artery lesions with satisfactory 2 year outcomes comparable to the second generation drug-eluting stents. This technology was recently introduced to our centre in Singapore and the aim of this report is to describe our initial experience with the BVS in a variety of clinical situations with shortterm follow-up. Methods: From the period of July 2011 to September 2012, 35 patients who underwent PCI with intent for BVS implantation were included in the analysis. The pre-procedural reference vessel diameter (RVD) was assessed by quantitative coronary analysis (QCA), intravascular ultrasound (IVUS), or optical coherence tomography (OCT). A RVD of 2.0 to 3.8 mm and lesion length < 28mm was considered suitable for BVS use (single or overlapping). Results: These 35 patients, mean age 54.7 + 11.2 yr, 85.7% (n¼30) male, underwent attempted BVS implantation. Clinical indications were stable angina (48.6%), unstable angina (20.0%), NSTEMI (28.6%), and STEMI (2.9%). 60.0% (n¼21) were hypertensive, 17.1% (n¼6) were diabetics, 71.4% (n¼25) were dyslipidaemic, and 54.3% (n¼19) were smokers. 6 Fr access was used for all of them, with 77.1% via a radial approach. Pre-procedure RVD was assessed by QCA in 80.0 % (n¼28), IVUS in 11.4% (n¼4), and OCT in 8.6% (n¼3). Overall, 45 BVS were successfully implanted in 33 (94.3%) patients (1.4 BVS/patient). Two patients who had left circumflex artery (LCX) stenosis not crossable by the BVS despite aggressive lesion preparation, an equivalent metallic drug eluting stent crossed without difficulty in both cases. Of the 41 lesions intervened, success rate was 100% (22/22) for left anterior descending artery, 100% (11/11) for right coronary artery and 77.5% (6/ 8) for LCX. Pre-procedural RVD was 2.7 + 0.4 mm, diameter stenosis was 77.7 + 13.0%, and lesion length was 17.2 + 6.7 mm. Post-procedural RVD was 3.0 + 0.3mm with residual diameter stenosis of 2.4 + 2.0%. No major adverse cardiac events were documented at 60-days post-procedure. Conclusion: Apart from vessels with non-focal disease, marked tortuosity and angulation, BVS can be successfully deployed in a wide range of clinical presentations with good short-term results.
- AS-049 Outcomes of “Full Metal Jacket” Using Everolimus-eluting or Sirolimus-eluting Stents Implantations. Hyun Woo Park, Young-Rak Cho, Uk Jo, Seung Mo Kang, Jung-Min Ahn, Jong-Young Lee, Won-Jang Kim, Duk-Woo Park, Soo-Jin Kang, Seung-Whan Lee, Young-Hak Kim, Cheol Whan Lee, Seong-Wook Park, Seung-Jung Park. Asan Medica Center, Seoul, Korea (Republic of). Background: Objectives: To evaluate the long term prognosis of multiple overlapping stent implantations. There has been limited data about clinical outcomes of very long stent implantation, particularly using second generation everolimuseluting stent (EES). Methods: From the IRIS-DES Registry, we identified 645 patients in whom a coronary stenosis was treated with 60mm of overlapping drug-eluting stents: 269 patients with EES and 376 patients were treated with sirolimus-eluting stents (SES). Major adverse cardiac events (MACE) were defined as the composite of death, myocardial infarction (MI: periprocedural or spontaneous) or target vessel revascularization (TVR). Results: At target lesion, the average stent number was 2.70.7, and the average stent length was 76.314.8 mm. At 2-year clinical follow up, the rate of MACE, death, spontaneous MI, TVR, and stent thrombosis were 21.7%, 2.6%, 1.3%, 3.8%, and 0.3% respectively. Although 96 patients (14.9%) suffered from periprocedural MI, periprocedural MI was not independently associated with death, spontaneous MI or TVR (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.31-1.89, p¼0.57). In addition, there were no statistical differences between EES and SES implantation in adjusted risks of MACE (HR, 1.32; 95% CI 0.90-1.94, p¼0.16), death or MI (HR, 1.44; 95% CI 0.95-2.18, p¼0.09), and TVR (HR 0.79, 95% CI 0.32-1.99, p¼0.62). Conclusion: For diffuse long coronary stenosis, multiple overlapping stent implantations appear to be safe and effective, irrespective of stent type (EES or SES). However, periprocedural MI was frequently occurred, but was not associated with the increases of adverse clinical outcomes.
- AS-051 Comparison of Zotarolimus-eluting Stents with Sirolimus-eluting and Everolimuseeluting Stents in Patients with Long Coronary Artery Lesions Intimal Hyperplasia and Vascular Changes Assessed by Volumetric Intravascular Ultrasound Analysis. Young-Rak Cho, Hyun Woo Park, Uk Jo, Seung Mo Kang, Jung-Min Ahn, Jong-Young Lee, Won-Jang Kim, Duk-Woo Park, Soo-Jin Kang, Seung-Whan Lee, Young-Hak Kim, Cheol Whan Lee, Seong-Wook Park, Seung-Jung Park. Asan Medical Center, Seoul, Korea (Republic of). Background: As a substudy of the large, randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With DrugEluting Stent-III) trial comparing first- and second-generation drugeluting stents, we sought to investigate intimal hyperplasia (IH) and vascular changes using volumetric intravascular ultrasound analysis. Methods: Complete angiographic and volumetric intravascular ultrasound data immediately after stenting and at 9-month follow-up were available in 260 patients with 287 lesions: 137 sirolimus-eluting stents (SES), 61 everolimus-eluting stents (EES), and 89 zotarolimus-eluting stents (ZES). External elastic membrane, stent, lumen, and peristent plaque volumes (external elastic membrane minus stent) were normalized by stent length. Results: Normalized IH volumes were calculated calculated as [IH volume/stent length] was greater in EES than sirolimus (0.70.4mm2 vs 0.50.4mm2, p <0.05), whereas normalized IH volume in ZES was not significantly different from SES (0.5 0.4mm2 vs 0.5 0.4mm2).
The American Journal of Cardiologyâ APRIL 23e26, 2013 ANGIOPLASTY SUMMIT ABSTRACTS/Oral
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O R A L A B S T R A C T S
- AS-048 Clinical Use of Everolimus-eluting Bioresorbable Vascular Scaffold (BVS) In Treating Coronary Artery Disease. Michael Liang, Takashi Kajiya, Chi-Hang Lee, Mark Chan, Swee-Guan Teo, Koo-Hui Chan, Huay-Cheem Tan, Adrian Low. National University Hospital, Singapore, Singapore. Background: Percutaneous coronary intervention (PCI) with the everolimus-eluting bioresorbable vascular scaffold (BVS) has been shown to be effective in treating de novo coronary artery lesions with satisfactory 2 year outcomes comparable to the second generation drug-eluting stents. This technology was recently introduced to our centre in Singapore and the aim of this report is to describe our initial experience with the BVS in a variety of clinical situations with shortterm follow-up. Methods: From the period of July 2011 to September 2012, 35 patients who underwent PCI with intent for BVS implantation were included in the analysis. The pre-procedural reference vessel diameter (RVD) was assessed by quantitative coronary analysis (QCA), intravascular ultrasound (IVUS), or optical coherence tomography (OCT). A RVD of 2.0 to 3.8 mm and lesion length < 28mm was considered suitable for BVS use (single or overlapping). Results: These 35 patients, mean age 54.7 + 11.2 yr, 85.7% (n¼30) male, underwent attempted BVS implantation. Clinical indications were stable angina (48.6%), unstable angina (20.0%), NSTEMI (28.6%), and STEMI (2.9%). 60.0% (n¼21) were hypertensive, 17.1% (n¼6) were diabetics, 71.4% (n¼25) were dyslipidaemic, and 54.3% (n¼19) were smokers. 6 Fr access was used for all of them, with 77.1% via a radial approach. Pre-procedure RVD was assessed by QCA in 80.0 % (n¼28), IVUS in 11.4% (n¼4), and OCT in 8.6% (n¼3). Overall, 45 BVS were successfully implanted in 33 (94.3%) patients (1.4 BVS/patient). Two patients who had left circumflex artery (LCX) stenosis not crossable by the BVS despite aggressive lesion preparation, an equivalent metallic drug eluting stent crossed without difficulty in both cases. Of the 41 lesions intervened, success rate was 100% (22/22) for left anterior descending artery, 100% (11/11) for right coronary artery and 77.5% (6/ 8) for LCX. Pre-procedural RVD was 2.7 + 0.4 mm, diameter stenosis was 77.7 + 13.0%, and lesion length was 17.2 + 6.7 mm. Post-procedural RVD was 3.0 + 0.3mm with residual diameter stenosis of 2.4 + 2.0%. No major adverse cardiac events were documented at 60-days post-procedure. Conclusion: Apart from vessels with non-focal disease, marked tortuosity and angulation, BVS can be successfully deployed in a wide range of clinical presentations with good short-term results.
- AS-049 Outcomes of “Full Metal Jacket” Using Everolimus-eluting or Sirolimus-eluting Stents Implantations. Hyun Woo Park, Young-Rak Cho, Uk Jo, Seung Mo Kang, Jung-Min Ahn, Jong-Young Lee, Won-Jang Kim, Duk-Woo Park, Soo-Jin Kang, Seung-Whan Lee, Young-Hak Kim, Cheol Whan Lee, Seong-Wook Park, Seung-Jung Park. Asan Medica Center, Seoul, Korea (Republic of). Background: Objectives: To evaluate the long term prognosis of multiple overlapping stent implantations. There has been limited data about clinical outcomes of very long stent implantation, particularly using second generation everolimuseluting stent (EES). Methods: From the IRIS-DES Registry, we identified 645 patients in whom a coronary stenosis was treated with 60mm of overlapping drug-eluting stents: 269 patients with EES and 376 patients were treated with sirolimus-eluting stents (SES). Major adverse cardiac events (MACE) were defined as the composite of death, myocardial infarction (MI: periprocedural or spontaneous) or target vessel revascularization (TVR). Results: At target lesion, the average stent number was 2.70.7, and the average stent length was 76.314.8 mm. At 2-year clinical follow up, the rate of MACE, death, spontaneous MI, TVR, and stent thrombosis were 21.7%, 2.6%, 1.3%, 3.8%, and 0.3% respectively. Although 96 patients (14.9%) suffered from periprocedural MI, periprocedural MI was not independently associated with death, spontaneous MI or TVR (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.31-1.89, p¼0.57). In addition, there were no statistical differences between EES and SES implantation in adjusted risks of MACE (HR, 1.32; 95% CI 0.90-1.94, p¼0.16), death or MI (HR, 1.44; 95% CI 0.95-2.18, p¼0.09), and TVR (HR 0.79, 95% CI 0.32-1.99, p¼0.62). Conclusion: For diffuse long coronary stenosis, multiple overlapping stent implantations appear to be safe and effective, irrespective of stent type (EES or SES). However, periprocedural MI was frequently occurred, but was not associated with the increases of adverse clinical outcomes.
- AS-051 Comparison of Zotarolimus-eluting Stents with Sirolimus-eluting and Everolimuseeluting Stents in Patients with Long Coronary Artery Lesions Intimal Hyperplasia and Vascular Changes Assessed by Volumetric Intravascular Ultrasound Analysis. Young-Rak Cho, Hyun Woo Park, Uk Jo, Seung Mo Kang, Jung-Min Ahn, Jong-Young Lee, Won-Jang Kim, Duk-Woo Park, Soo-Jin Kang, Seung-Whan Lee, Young-Hak Kim, Cheol Whan Lee, Seong-Wook Park, Seung-Jung Park. Asan Medical Center, Seoul, Korea (Republic of). Background: As a substudy of the large, randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With DrugEluting Stent-III) trial comparing first- and second-generation drugeluting stents, we sought to investigate intimal hyperplasia (IH) and vascular changes using volumetric intravascular ultrasound analysis. Methods: Complete angiographic and volumetric intravascular ultrasound data immediately after stenting and at 9-month follow-up were available in 260 patients with 287 lesions: 137 sirolimus-eluting stents (SES), 61 everolimus-eluting stents (EES), and 89 zotarolimus-eluting stents (ZES). External elastic membrane, stent, lumen, and peristent plaque volumes (external elastic membrane minus stent) were normalized by stent length. Results: Normalized IH volumes were calculated calculated as [IH volume/stent length] was greater in EES than sirolimus (0.70.4mm2 vs 0.50.4mm2, p <0.05), whereas normalized IH volume in ZES was not significantly different from SES (0.5 0.4mm2 vs 0.5 0.4mm2).
The American Journal of Cardiologyâ APRIL 23e26, 2013 ANGIOPLASTY SUMMIT ABSTRACTS/Oral
23B
O R A L A B S T R A C T S