Tetsuya Ishikawa

Significantly lower incidence of early definite stent thrombosis of drug-eluting stents after unrestricted use in Japan using ticlopidine compared to western countries using clopidogrel: a retrospective comparison with western mega-studies.

BACKGROUND AND OBJECTIVESnThe incidence of definite stent thrombosis (ST) after use of drug-eluting stents (DES), as defined by the Academic Research Consortium, is known to be lower in Japan than in western countries. However, a statistical difference in the incidence of early definite ST (EDST) associated with the unrestricted use of DES has not yet been documented. Therefore, the incidence of EDST in our Japanese institute after unrestricted use of DES was retrospectively compared with those reported in western mega-studies.nnnMETHODS AND RESULTSnDuring the 40 months from August 2004 to November 2007 (before approval of clopidogrel in Japan), DES were implanted in 3605 lesions in 1885 patients in our institute; lesion- and patient-associated percentages of DES use were 95.2% and 94.7%, respectively. Mean stent length per lesion was 33.2 mm, emergent procedures and ST-elevation myocardial infarctions made up 33.7% and 16.4% of the procedures, respectively, intravascular ultrasonography was used 96.0% of the time, a distal protection device for acute coronary syndrome was used 68.7% of the time, and the mean maximum inflation pressure was 19.5 atm. EDST was observed in five lesions (0.139%) in four patients (0.212%). The incidence of patient-associated EDST at our center was significantly lower than in four western mega-studies (0.736%, 66 of 8970 patients; 0.634%, 149 of 23,500; 0.595%, 52 of 8402; 0.997%, 20 of 2006) (p<0.05, <0.01, <0.05, <0.01, respectively, using a chi(2)-test).nnnCONCLUSIONnDue to differences in procedural approaches in Japan, the incidence of EDST after unrestricted use of DES was significantly lower than in western countries.

Retrospective comparison of clinical and angiographic outcomes after primary stenting using sirolimus-eluting and bare-metal stents in nonrandomized consecutive 568 patients with first ST-segment elevated myocardial infarctions

BACKGROUND AND PURPOSEnThe long-term safety and efficacy of primary stenting using drug-eluting stents (DES) in patients with ST-segment elevation myocardial infarction (STEMI) are not fully understood in Japan. Therefore, we retrospectively examined the midterm clinical and angiographic outcomes in STEMI patients after primary stenting using sirolimus-eluting stents (SES) in a clinical setting through a historical comparison with those of bare-metal stents (BMS).nnnMETHODS AND RESULTSnThe study design was a retrospective, nonrandomized, and single-center study. The clinical outcomes for 568 consecutive patients who presented within 12 h of their first STEMI and who were treated with BMS (n = 198; 184 STEMIs from June 2003 to August 2004 and 14 STEMIs from September 2004 to May 2007) or SES (n = 370; from August 2004 to May 2007) at our medical center in Japan were retrospectively investigated in February 2010. The incidence of post-discharge events (comprising cardiac death and nonfatal recurrent MI) after SES placement (3.9%) was not significantly different from that after BMS placement (6.7%). SES was not related to the risk of post-discharge events (mean follow-up for SES, 1327 ± 415 days; BMS, 1818 ± 681 days) (hazard ratio of 0.369 at 95% CI, 0.119-1.147, p = 0.085). The incidence of definite stent thromboses after SES placement (0.54%) was not significantly higher than that after BMS placement (0%). The incidence of binary in-stent restenosis (% diameter stenosis of more than 50% at secondary angiography) after SES placement (8.3%) was significantly lower than that after BMS placement (25.7%; p < 0.001).nnnCONCLUSIONSnFrom the present historical comparison of SES and BMS, we conclude that primary stenting using SES in a clinical setting has favorable clinical and angiographic outcomes in Japanese STEMI patients.

Post-discharge clinical and angiographic outcomes of patients presenting within 48 h of STEMI treated with paclitaxel- or sirolimus-eluting stents

BACKGROUND AND PURPOSEnThe purpose of the present study was to examine the mid-term clinical and angiographic outcomes of patients with ST-segment elevation myocardial infarction (STEMI) who presented within 48 h and received paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES).nnnMETHODS AND RESULTSnThis study was a retrospective, non-randomized, single-center study. The post-discharge clinical outcomes of 357 consecutive patients who presented within 48 h of their first STEMI and received PES (n=163) or SES (n=194) between February 2007 and February 2009 were analyzed in May 2011. The incidence of post-discharge events (i.e. cardiac death and non-fatal recurrent MI) after PES placement (0.6%) did not significantly differ from that after SES placement (1.5%). Treatment with PES was not related to the risk of adverse events post-discharge (mean follow-up period for PES placement, 1170±243 days; hazard ratio, 0.346; 95% CI, 0.036-3.371; p=0.361). No definite stent thromboses developed after treatment with PES or SES. The incidence of binary in-stent restenosis (stenosis of more than 50% of the diameter at secondary angiography performed 10-18 months after the initial procedure) after PES placement (17.1%) was significantly higher than that after SES placement (4.8%; p<0.001). PES placement was an independent predictor of binary in-stent restenosis (odds ratio, 3.892; 95% CI, 1.470-10.30; p=0.006).nnnCONCLUSIONSnRetrospective examination of the post-discharge clinical course after placement of PES and SES showed favorable midterm clinical outcomes among Japanese STEMI patients treated within 48h of onset. However, SES treatment resulted in superior angiographic outcomes compared to PES.

Does Treatment of Impaired Glucose Tolerance Improve Cardiovascular Outcomes in Patients with Previous Myocardial Infarction

PurposeWe evaluated the effects of an alpha-glucosidase inhibitor, voglibose, on cardiovascular events in patients with a previous myocardial infarction (MI) and impaired glucose tolerance (IGT).MethodsThis prospective, randomized, open, blinded-endpoint study was conducted in 112 hospitals and clinics in Japan in 3000 subjects with both previous MI and IGT receiving voglibose (0.6xa0mg/day, nxa0=xa0424) or no drugs (nxa0=xa0435) for 2xa0years. The Data and Safety Monitoring Board (DSMB) recommended discontinuation of the study in June 2012 after an interim analysis when the outcomes of 859 subjects were obtained. The primary endpoint was cardiovascular events including cardiovascular death, nonfatal MI, nonfatal unstable angina, nonfatal stroke, and percutaneous coronary intervention/coronary artery bypass graft. Secondary endpoints included individual components of the primary endpoint in addition to all-cause mortality and hospitalization due to heart failure.ResultsThe age, ratio of males, and HbA1C were 65 vs. 65xa0years, 86 vs. 87%, and 5.6 vs. 5.5% in the groups with and without voglibose, respectively. Voglibose improved IGT; however, Kaplan–Meier analysis showed no significant between-group difference with respect to cardiovascular events [12.5% with voglibose vs. 10.1% without voglibose for the primary endpoint (95% confidence interval, 0.82–1.86)]; there were no significant differences in secondary endpoints.ConclusionAlthough voglibose effectively treated IGT, no additional benefits for cardiovascular events in patients with previous MI and IGT were observed. Voglibose may not be a contributing therapy to the secondary prevention in patients with MI and IGT.Trial RegistrationClinicaltrials.gov number: NCT00212017