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- AS-063

The Efficacy of Everolimus-eluting Stent(EES) Implantation inPatients with Acute Coronary Syndrome: Outcomes of 2-yearClinical Follow-up. Hideki Yano1, Shigeo Horinaka2,Mayuko Ishikawa1, Toshihiko Ishimitsu2. 1Nasu Red Cross Hospital,Tochigi, Japan; 2Dokkyo Medical University, Tochigi, Japan.

Background: Drug-eluting stents (DES) are increasingly used fortreatment of acute coronary syndrome (ACS), but there are fewcomparisons of outcomes of second generation DES with long termoutcomes. Our objective is to compare the efficacy and safety of theXIENCE V� EES and the MULTI-LINK VISION� cobalt chromiumstent (CCS) which has same platform in the setting of primary inter-vention for ACS including STEMI.

Methods: Consecutive 316 patients with ACS (192 patients withSTEMI), who were treated with EES (142 patients) and CCS (174patients). Within ten months angiographic follow-up results and 2-yearclinical follow-up outcomes were compared between 2 groups.

Results: The prevalence of diabetes and Chronic kidney diseasewere higher, the stent length was longer (21.9+/-9.6 vs. 18.4+/-10.3,p<0.05), and late loss was smaller in EES than in CCS group (0.25 �0.28 vs. 0.55 � 0.40). However, % binary restenosis (3.4 vs. 10.9%,p<0.05), TLR (3.4% vs. 9.7%, p<0.05), MI (1.7% vs.4.8%, p<0.05)and stent thrombosis (1.7% vs. 4.2%, p<0.05) were significantly higherin CCS than in EES group. We had many STEMI patients between twogroups, then we investigated the clinical same outcomes. Similarly,TLR and MACE rate were lower in EES than in CCS group (TLR; 3.8%vs. 10.2%, MACE; 6.2% vs. 13.6%; p<0.05).

Conclusion: EES implantation in patients with ACS (includingSTEMI) inhibited 1-year MACE including TLR, MI and ST withoutincreasing mortality compared with CCS implantation.

- AS-065

Everolimus Versus Biolimus-eluting Stents: A Propensity ScoreMatching Analysis of 1.5-year Clinical and AngiographicOutcomes. Tetsuya Ishikawa, Yosuke Nakano, Makoto Mutoh.Saitama Prefecture Cardiovascular Respilatory Center, Kumagaya,Japan.

Background: The goal of this study was to compare the efficacyamong second-generation drug-eluting stents (DES) (everolimus-(EES: Xience V / Promus) with biolimus- (BES: Nobori) elutingstents) for native coronary stenosis, because the direct comparison ofthe outcomes between those 2nd-generation DESs were not fullyunderstood.

Methods: From our single-center cohort except the cases of death onarrive, 1.5-year clinical outcomes of EES (n¼891) was compared withthat of BES group (n¼352). In addition, 1-year angiographic outcomesafter the treatment using EES (n¼451) was compared with that of BES(n¼113). A propensity score matching analysis was applied to adjustthe differences among baselines, and 107 cases of each arm werecompared to estimate the angiographic outcomes.

Results: The percentages of 1.5-year cardiac event (cardiac deathand non-fatal MI) were only a few in both stent groups without late andvery late definite ST. More than half cases of cardiac death were due toin-hospital mortality of STEMI cases. The percentage of 1-year binaryin-stent restenosis (in-stent % diameter stenosis more than 50 at followup angiogram) of EES group (0.9%) was not significantly different fromBES group (1.9%) with the very low rates (p¼0.56).

Conclusion: The initial 1.5-yr clinical outcomes of EES and BESwere considered to be acceptable. From this propensity score matchinganalysis, second-generation DESs (EES and BES) showed the excellent

The American Journal of Cardiology� APRIL 23e26, 2013 AN

1-year angiogrhaphic outcomes for native coronary stenosis with thestatistical equivalency. From the present non-inferior outcomes ofNobori, clinical and angiographic outcomes of Nobori had to be furtherexamined in the following wide-spread use for complex lesions.

- AS-159

550-day Clinical and Angiographic Outcomes After theImplantation of Paclitaxel- and Sirolimus-eluting Stents for DeNovo Coronary Complex Lesions in Japanese Patients.Tetsuya Ishikawa, Yosuke Nakano, Makoto Mutoh.Saiatma Cardiovascular Respiratory Center, Kumagaya, Japan.

Background: We retrospectively analyzed the midterm clinical andangiographic outcomes after the implantation of paclitaxel- (PES,TAXUS Liberte) and sirolimus- (SES, Cypher Bx Velocity) elutingstents in Japanese patients with complex coronary lesions.

Methods: From May 2006 to April 2011, 2,008 nonrandomized denovo native complex coronary lesions treated with either a PES (753cases) or SES were included. The inclusion criteria for patients withcomplex lesions were those with diabetes, those undergoing hemodial-ysis, and those with a low ejection fraction, as well as subjects who hadlesions with severe calcification, ostiums of the right coronary and leftcircumflex arteries, total stented length more than 60 mm, and whounderwent ablationwith rotablator and the side-branch bifurcation 2-stenttechnique. The subjectswere evaluated for consistent predictors of cardiacevents, binary restenosis and target lesion vascularization of the SES.

Results: The composite primary endpoint percentage (550-daycardiacdeath, nonfatal recurrent myocardial infarction, and definite stentthrombosis) after PES placement was 1.5%, which was significantlylower than that after SES placement (4.9%; p<0.05). After the adjustmentof the baselines by a propensity score matching analysis in 734 cases ineach arm, the incidence of the primary endpoint after PES placement(0.40%) was significantly lower than that after SES placement (3.1%;p<0.05). The incidence of the secondary endpoint (binary restenosis;stenosis>50%of the diameter at the secondary angiographic examinationperformed within 550 days after the procedure) after PES placement(10.9%) was also not significantly different than that after SES placement(12.6%). After the adjustment of the baselines in 503 cases in each arm,the incidence of the secondary endpoint after PES placement (13.5%)wasnot significantly different from that after SES placement (12.3%). Thenumber of stent per lesion was the predictor of binary restenosis (oddsratio of 2.52; 95% confidence interval, 1.61-3.95; p<0.001).

Conclusion: For de novo native complex coronary stenosis, TAXUSLiberte showed the better clinical outcome with the equivalent angio-graphic outcome comparedwith those of SES in a clinical setting in Japan.

- AS-160

Everolimus-eluting vs. Bare Metal Stents in Octogenarians. Resultsfrom the Randomized XIMA (XIence or Vision Stent Managementof Angina in the Elderly) Trial. Jose Maria De La Torre Hernandez,Adam De Belder, Ramon Lopez Palop, David Hildick-Smith,Felipe Hernandez, Peter O’Kane, Federico Gimeno, Martin Thomas,Jose Francisco Diaz, Nick Curzen, Pilar Carrillo Saez, Julian Strange,Eduardo Pinar, James Cotton, Jose Antonio Baz, Dawn Adamson,Iñigo Lozano, Daniel Blackman, Carlos Cuellas, Nicola Skipper,Nina Cooter, Jose Antonio Diarte, David Smith, Josepa Mauri.Hospital Universitario Marques de Valdecilla, Santander, Spain.

Background: There is scarce data on interventional outcomes in octo-genarians. Drug-eluting stents (DES) should be advantageous over baremetal stent (BMS) in reducing restenosis but a higher toleration forrestenosis coulddecreaseDESeffectiveness.Also, the potential downside

GIOPLASTY SUMMIT ABSTRACTS/Oral 29B

APRIL 23e26, 2013

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of DES is the prolonged course of dual antiplatelet therapy (DAPT) ina patient group susceptible to major bleeding.

Methods: We designed a multicentre international randomisedcomparison of Xience DES and Vision BMS in octogenarian patientswith complex coronary disease. Patients with STEMI were excluded.Primary outcome was the combined of death, infarction, target vesselrevascularization (TVR), stroke and major bleeding (TIMI) at one year.Estimated sample size was 329 patients in each group.

Results: 800 patients were recruited in 22 centres across UnitedKingdom and Spain. The patients were well matched between the 2 groupswith only significant differences in prior infarction (21.5% in BMS groupand 29.8% in DES group) and total stent length (2413 mm with BMS and2614 mm with DES). A 68% of patients were treated after and acutecoronary syndrome (ACS).RecommendedDAPTperiodwas1month afterBMS and 12 months after DES. One year outcomes for both groups areshown in the table. In subgroup analysisDESwasmore beneficial inmales,85-90 yrs, stable angina, 2-vessel disease and radial access.

30B The American Journal of Cardiology� APRIL

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N¼401

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N¼399

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Death

7.2% 8.5% 0.5 Infarction 8.7% 4.3% 0.01 TVR 7% 2% 0.0009 Major bleeding 1.7% 2.3% 0.6 Stroke 1.2% 1.5% 0.7 Primary end-point 18.7% 14.5% 0.09

Conclusion: This trial evaluating DES and BMS in octogenarianshas shown at 1 year no difference in mortality between groups, similarrates of major haemorrhage despite differing DAPT regimes andsignificantly lower rates of target vessel revascularization andmyocardial infarction among DES-treated patients.

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