Predictors of Target Lesion Revascularization and Documented Stent Thrombosis Beyond 30 Days After Sirolimus-Eluting Stent Implantation  Retrospective Analysis in Consecutive 1,070 Angiographic Follow-up Lesions

Murata, Makoto; Ishikawa, Takahiro; Hasuda, Toshio; Okada, Hisayuki; Endo, Akira; Miyanaga, Satoru; Higashitani, Michiaki; Nakano, Yukiko; Kubota, Takeyuki; Nakata, Koutarou; Nagoshi, Tomohisa; Hayashi, Mayuri; Sakamoto, Hiroshi; Oota, Masato; Imai, Kyoichi; Mochizuki, Seibu

doi:10.1253/circj.71.1328

Cited by 25 publications

(47 citation statements)

References 9 publications

(6 reference statements)

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“…18,19) These would be attributable to the present better angiographic outcomes of EES by attenuating the impact of those factors on the present angiographic endpoints. Thus, the present multicenter-study, which recruited more than 3000 lesions followed-up angiographically that included high propensity and complex lesions for ISR treated in a daily practice environment, could first show overall better midterm angiographic outcomes for EES over SES.…”

Section: Discussionmentioning

confidence: 97%

Propensity-Score Matched Comparison of Midterm Angiographic Outcomes of Sirolimus- Versus Everolimus- and Biolimus-Eluting Stents for <i>De Novo</i> Coronary Stenosis

et al. 2017

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SummaryWe conducted propensity-score matched comparisons of midterm angiographic outcomes of sirolimus (SES) versus either everolimus-(EES) or biolimus-(BES) eluting stents after placements for coronary stenosis in a daily practice environment since previous randomized trials did not demonstrate the superiority of EES and BES over SES in terms of midterm angiographic outcomes.The present study was a non-randomized, retrospective, and lesion-based study, recruiting angiographically followed-up lesions within 550 days after successful and elective SES (n = 1793), EES (n = 1303), or BES (n = 324) placement for de novo native coronary stenosis during the period from August 2004 to January 2014 at 6 institutes. The endpoint, as an angiographic surrogate marker of clinical efficacy, was the distribution of in-stent follow-up percent diameter stenosis (%DS) which comprised the percentages of 1) follow-up %DS < 20 and 2) follow-up %DS > 50. Propensityscore matched analyses were conducted to adjust 21 baselines.In 1215 baseline adjusted lesions, the endpoints in the EES group [1) 74.1%, and 2) 4.6%] were significantly different from those in the SES group [57.9%; P < 0.001, 7.2%; P = 0.006, respectively). In 307 baseline adjusted lesions, the endpoints in the BES group [1) 80.5%, 2) 2.0%] were significantly different from those in the SES group [59.3%; P < 0.001, 2) 8.1%; P = 0.001, respectively].The present study is the first to confirm the superiority of midterm angiographic outcomes after the placement of EES and BES over SES for de novo coronary stenosis in a clinical setting. (Int Heart J 2017; 58: 320-327) Key words: Follow-up result, Angioplasty, Binary restenosis, Target lesion revascularization, Late luminal loss E verolimus-eluting stents (EES; Xience and Promus) have exhibited benefits associated with a favorable vascular response compared to sirolimus-eluting stents (SES; Cypher BxV and Select+), owing to their advanced drug-eluting stent (DES) technology that consists of the revised thin and flexible stent platform, anti-thrombogenic fluoropolymer, and drug. 1,2) The biolimus-eluting stent (BES; Nobori) also showed a better midterm intravascular response compared to SES, owing to its properties such as being a biodegradable polymer and the highest lipophilicity among the limus analogues. 3,4) However, despite these advanced aspects of EES and BES compared with the former evidence-based first generation "-limus" DES, that is, SES, prospective randomized trials have not demonstrated significantly better midterm angiographic outcomes for either EES 5,6) or BES 7,8) in terms of binary in-stent restenosis, TLR, or mean magnitude of in-stent late luminal loss compared to those of SES.In the present study, we conducted a retrospective comparison to examine the impact of the advances in coronary stent technology, represented by improved intravascular and pathological findings of either EES or BES over SES 1-4) on the overall midterm angiographic outcomes. For this purpose, 3420 lesions angiographically followed-up ...

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Section: Discussionmentioning

confidence: 97%

Propensity-Score Matched Comparison of Midterm Angiographic Outcomes of Sirolimus- Versus Everolimus- and Biolimus-Eluting Stents for <i>De Novo</i> Coronary Stenosis

et al. 2017

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“…The lack of reports showing long-term clinical outcomes of late reperfusion in STEMI patients using both DES and BMS, including invasive therapy, plays a role in these guidelines. The present paper sought to evaluate the safety and efficacy of widelyspread late reperfusion in STEMI patients using emergent procedures based on recent advances in operator skill and PCI modalities in Japan, where the incidence of severe cardiac events, such as stent thrombosis, is less frequent than that observed in Western countries (2,3,7,8). The present study reflects the clinical setting and included high-risk patients with complex lesions consistently related to cardiac events and binary restenosis, such as those with cardiac dysfunction, Killip 3-4 classifications, severe calcification, LAD ostium and thrombus-containing lesions.…”

Section: Discussionmentioning

confidence: 99%

“…However, the Japanese Circulation Society (JCS) guidelines for the management of STEMI patients state that there is little evidence for the long-term safety of drug-eluting stent (DES) use for primary stenting in STEMI patients (6). Therefore, it is necessary to examine the long-term safety of SES for the treatment of STEMI patients in Japan, where the incidence of severe cardiac events, such as stent thrombosis, is less frequent than that observed in Western countries (2,3,7,8).…”

Section: Introductionmentioning

confidence: 99%

Comparison of Long-term Clinical and 1-Year Angiographic Outcomes after Primary Stenting (-12 hours) and Late Reperfusion (12 hours-) using Sirolimus-eluting Stents for ST-segment Elevated Myocardial Infarctions: A Propensity Score Matching Analysis

et al. 2013

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Objective We compared the long-term clinical and 1-year angiographic outcomes in ST-segment elevation myocardial infarction (STEMI) patients who presented between 12 to 48 hours after symptom onset and underwent emergent procedures (late reperfusion) using sirolimus-eluting stents (SES; Cypher Bx Velocity) with those of primary stenting patients who presented within 12 hours. Methods The study design was a retrospective, nonrandomized single-center study in which the investigations were conducted in October 2012 following the enrollment of consecutive STEMI patients treated with late reperfusion (n=75) and primary stenting using SES (n=386) between September 2004 and May 2007. The incidence of the primary end points (cardiac death, nonfatal recurrent MI and definite stent thrombosis) after late reperfusion (6.7%; mean follow-up, 2,176±742 days) was not significantly different from that observed after primary stenting (8.5%; 2,237±722 days) (p=0.59). The incidence of the secondary end point (binary in-stent restenosis: % diameter stenosis greater than 50% on secondary angiography at approximately one year) after late reperfusion (11.1%, n=54) was not statistically different from that observed after primary stenting (8.0%, n=276) (p=0.45). Using a propensity score matching analysis, the incidences of the primary (6.7%, n=75) and secondary (11.3%, n=53) end points after late reperfusion were not found to be significantly different from those observed after primary stenting (8.0% and 9.4%) (p=0.75 and 0.75, respectively). Conclusion The present small study showed the long-term clinical and 1-year angiographic outcomes after late reperfusion using SES for STEMI patients in emergent procedures in daily practice to be statistically equivalent to those observed after primary stenting using SES for STEMI patients.

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“…10,[22][23][24][25][26] The target lesion and stent delivery route CAC scores were also included. As shown in Table 3 summarizing multivariate analysis, the CAC score of the stent delivery route was independently associated with restenosis (odds ratio of 6.804, P<0.05), although CAC score of the target lesion was not.…”

Section: Comparisons Of Calcification Score Analysismentioning

confidence: 99%

“…However, the restenosis rate following SES implantation was still low, 7.3% in this study, which was comparable to that observed in many other studies. [8][9][10]22,23 Recently, SES application has been spreading widely, for example, for the left main lesion; 11 thus, it has become more important to clarify the factors associated with restenosis of SES, even though the prevalence is low.…”

Section: Restenosis Following Sesmentioning

confidence: 99%

Significant Association of Coronary Artery Calcification in Stent Delivery Route With Restenosis After Sirolimus-Eluting Stent Implantation

Mori

Yasuda

Kataoka

et al. 2009

Circ J

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oronary artery calcification (CAC) is an active and regulated process that resembles bone formation and chronic inflammation mediated by osteogenic cytokines and atherosclerotic stimuli. [1][2][3][4] Calcified lesions are refractory to percutaneous coronary intervention (PCI) with a high rate of restenosis following bare-metal stent (BMS) implantation. 5 Sirolimus-eluting stent (SES) has been proven to markedly reduce the rate of restenosis after PCI, and therefore, has revolutionized interventional cardiology. 6-10 Its application is spreading to complex, high-risk subsets of patients and lesions including left main diseases. 11 Therefore, it is clinically important to determine the factors that affect SES efficacy.Recently, Kuriyama et al reported a case of polymer damage of an SES that could not be delivered to a severely calcified lesion. 12 Because factors determining SES efficacy include the type of stent, coating matrix, drug and vessel walls, 13,14 CAC might cause inadequate diffusion of sirolimus to the vessel wall. Therefore, in this study, we investigated the impact of CAC on SES efficacy by calcification score analysis. Methods Study PopulationFrom April 2004 to September 2005, 1,081 patients underwent PCI in our facility at the National Cardiovascular Center, Suita, Japan. Among these, 549 patients with angina pectoris or silent myocardial ischemia were treated with BMS or other devices such as balloon angioplasty, rotational atherectomy or directional coronary atherectomy owing to planned surgery, intolerance for long-term dual anti-platelet therapy and a large vessel of over 4.0 mm diameter. Also, 191 patients with acute coronary syndrome were treated with BMS because, in the Osaka area, the reimbursement committee of the health insurance organization recommends that SES should not be used for patients with acute coronary syndrome. The remaining 341 patients were treated with SES and therefore included in this study. All patients gave written informed consent. Coronary Angiography and PCI ProcedureIn patients with recurrent chest pain and/or with electrocardiographic and/or scintigraphic evidence of myocardial ischemia, selective coronary angiography was performed in multiple projections after administration of intracoronary Background: Sirolimus-eluting stent (SES) has revolutionized interventional cardiology. Its application is spreading to complex, high-risk subsets of patients and lesions. Therefore, it is important to determine the factors associated with post-SES restenosis. Methods and Results:The study investigated 341 patients with angina pectoris, in whom SES was implanted. The coronary artery calcification (CAC) degree was assessed using the angiographic scoring system as follows: 0, none; 1, blocky or spotty calcification; 2, linear calcification compromising 1 side of the arterial lumen; 3, linear calcification found unidirectionally compromising both sides of the arterial lumen; 4, linear calcification found bidirectionally compromising both sides of the arterial lumen; and 5, blanke...

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Predictors of Target Lesion Revascularization and Documented Stent Thrombosis Beyond 30 Days After Sirolimus-Eluting Stent Implantation Retrospective Analysis in Consecutive 1,070 Angiographic Follow-up Lesions

Cited by 25 publications

References 9 publications

Propensity-Score Matched Comparison of Midterm Angiographic Outcomes of Sirolimus- Versus Everolimus- and Biolimus-Eluting Stents for <i>De Novo</i> Coronary Stenosis

Propensity-Score Matched Comparison of Midterm Angiographic Outcomes of Sirolimus- Versus Everolimus- and Biolimus-Eluting Stents for <i>De Novo</i> Coronary Stenosis

Comparison of Long-term Clinical and 1-Year Angiographic Outcomes after Primary Stenting (-12 hours) and Late Reperfusion (12 hours-) using Sirolimus-eluting Stents for ST-segment Elevated Myocardial Infarctions: A Propensity Score Matching Analysis

Significant Association of Coronary Artery Calcification in Stent Delivery Route With Restenosis After Sirolimus-Eluting Stent Implantation

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