Abstract 3138: Impact of “Off Label” Utilization of Drug-Eluting Stents on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Intervention

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Probal Roy ◽  
Ashesh N Buch ◽  
Aamir Javaid ◽  
Teruo Okabe ◽  
Vikram Raya ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Cardiac Events ◽  
Off Label ◽  
Repeat Revascularization ◽  
Significant Difference ◽  
Drug Eluting ◽  
Q Wave

Background: The utilization of drug-eluting stents (DES) in “real world” practice has deviated substantially from Food and Drug Administration (FDA) approved indications. The outcomes of patients undergoing intracoronary DES implantation (versus BMS) for non-FDA approved indications has not been determined. Methods : The clinical outcomes of 546 patients undergoing DES implantation for ≥1 non-FDA approved (“Off label”) indication after device approval were assessed. This group was then compared to 546 propensity-matched patients receiving BMS prior to DES approval for the same indications. The primary endpoint was major adverse cardiac events [MACE; death-all cause, non-fatal Q-wave MI and target vessel revascularization (TVR)] at 12 months. Results: Baseline clinical and procedural characteristics were well matched. Patients in the BMS group were more likely to be treated with larger diameter and shorter stents. Though both in-hospital and 30-day all-cause mortality was greater in the DES group, there was no significant difference in cardiac death at both time points. At 30 days all other clinical outcomes were comparable. At 12 months MACE was significantly reduced in the DES group (27.8% vs. 21.4% p=0.014) driven by reductions in repeat revascularization [target lesion revascularization (TLR): 16.4% vs. 7.8% p<0.001, TVR: 20.2% vs.13.1% p<0.003]. There was no significant increase in death and non-fatal Q-wave MI with DES. Conclusions: The utilization of DES for non-FDA approved indications proved to be efficacious and safe when compared to a propensity-matched BMS cohort. These findings support broadening the current FDA indications for DES use.

The Impact of Diabetes Mellitus on Clinical Outcomes after Percutaneous Coronary Intervention with Drug-Eluting Stents for Left Main Distal Bifurcation Lesions in Patients with Chronic Kidney Disease

2020 ◽  
Vol 10 (6) ◽  
pp. 382-391
Author(s):  
Yusuke Watanabe ◽  
Satoru Mitomo ◽  
Toru Naganuma ◽  
Kensuke Takagi ◽  
Satoshi Matsuoka ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Outcomes ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Left Main ◽  
Percutaneous Coronary ◽  
Drug Eluting ◽  
Bifurcation Lesions ◽  
The Impact

<b><i>Background:</i></b> The impact of diabetes mellitus (DM) on clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main (ULM) distal bifurcation lesions in patients with chronic kidney disease (CKD) is poorly understood in the era of drug-eluting stents (DESs). <b><i>Objective:</i></b> We assessed the impact of DM on clinical outcomes after PCI for ULM distal bifurcation lesions in CKD patients compared to patients without DM. <b><i>Methods:</i></b> We identified 1,832 consecutive patients who underwent PCI for ULM lesions at New Tokyo Hospital, Matsudo, Japan, San Raffaele Scientific Institute, Milan, Italy, and EMO-GVM, Centro Cuore Columbus, Milan, Italy between January 2005 and August 2015. Of the 1,832 patients, 1,391 were treated with DESs. We excluded 750 patients without CKD and 89 hemodialysis patients. Finally, 552 patients with CKD were included: 219 with DM (DM group) and 333 without DM (no DM group). The primary endpoint was target lesion failure (TLF) at 5 years. TLF was defined as a composite of cardiac death, target lesion revascularization (TLR), and myocardial infarction. <b><i>Results:</i></b> Patients in the DM group were more likely to have hypertension, dyslipidemia, peripheral artery disease, and lower ejection fraction and were more frequently using insulin for DM. The TLF rate during the follow-up period was significantly higher in the DM than in the no DM group (adjusted hazard ratio [HR] 1.50; 95% confidence interval [CI] 1.06–2.13; <i>p</i> = 0.023). Cardiac mortality was comparable between both groups (adjusted HR 1.11; 95% CI 0.63–1.95; <i>p</i> = 0.71). The TLR rate was significantly higher in the DM group than in the no DM group (adjusted HR 1.69; 95% CI 1.12–2.54; <i>p</i> = 0.012). <b><i>Conclusion:</i></b> DM is strongly associated with adverse event after PCI for ULM distal bifurcation lesions in CKD patients compared to those without DM.

Abstract 13853: Routine Follow Up Coronary Angiography versus Clinical Follow Up Only in Patients With Dyslipidemia Following Percutaneous Coronary Intervention With Drug-eluting Stents: 3-year Clinical Follow Up Results

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Seung Woon Rha ◽  
Byoung Geol Choi ◽  
Se Yeon Choi ◽  
Jae Kyeong Byun ◽  
Jin Oh Na ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Coronary Angiography ◽  
Coronary Intervention ◽  
Drug Eluting Stents ◽  
Control Group ◽  
Cardiac Events ◽  
Repeat Revascularization ◽  
Percutaneous Coronary ◽  
Drug Eluting

Background: It is unclear whether the routine follow up (FU) coronary angiography (CAG) regardless of patient’s symptoms after successful percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) in patients (pts) with dyslipidemia is beneficial or not. Methods: The study population consisted of 554 consecutive dyslipidemia pts underwent PCI with unrestricted utilization of DESs from January 2004 to May 2011. Routine FU CAG was performed between 6 to 9 months following index PCI and was decided by individual physician’s discretion. Rests of the pts were clinically followed and ischemic driven events were captured. Clinical events including mortality, myocardial infarction and clinically driven PCI before 9 months were excluded in both groups. Cumulative clinical outcomes up to 3 years were compared between the Routine CAG group (n=329 pts) and the Clinical FU group (n= 225 pts). To adjust potential confounders, a propensity score matched (PSM) analysis was performed using the logistic regression model. Results: After PSM analysis, 2 propensity-matched groups (165 pairs, n = 330 pts, C-statistic=0.718) were generated and, the baseline characteristics of the two groups were balanced. At 3 years, the incidence of repeat revascularization and major adverse cardiac events (MACEs) was higher in the Routine CAG group than the control group (Table). Conclusions: Despite the expected beneficial effects, routine FU CAG following index PCI with DESs in dyslipidemia pts was associated with higher incidence of repeat PCI and MACE up to 3 years.

scholarly journals Clinical Outcomes of Dialysis Patients Treated with Drug-Eluting Stent for Left Main Distal Bifurcation Lesions

2021 ◽  
Vol 11 (2) ◽  
pp. 99-108
Author(s):  
Yusuke Watanabe ◽  
Satoru Mitomo ◽  
Ozan M. Demir ◽  
Kuan-Liang Liu ◽  
Ying-Chang Tung ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
High Volume ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Drug Eluting Stent ◽  
Left Main ◽  
Cardiac Events ◽  
Drug Eluting ◽  
Bifurcation Lesions ◽  
Target Lesion Failure

<b><i>Aims:</i></b> We assessed clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main coronary artery (ULMCA) distal bifurcation lesions using drug-eluting stents (DES) in hemodialysis (HD) patients compared to non-HD patients. <b><i>Methods and Results:</i></b> We identified 1,858 consecutive patients who underwent PCI for ULMCA distal bifurcation lesions at 4 high-volume centers in Japan, Italy, and Taiwan between January 2005 and December 2015. Of them, 1,416 patients were treated with DES including 113 HD patients and 1,303 non-HD patients. The primary end point was target lesion failure (TLF) defined as a composite of cardiac death, target lesion revascularization (TLR), and myocardial infarction. HD patients were more likely to be younger and have diabetes mellitus, dyslipidemia, peripheral artery disease, lower ejection fraction, and higher EuroSCORE. TLF rate at 3 years was significantly higher in HD group than in non-HD group (adjusted hazard ratio [HR] 2.43 [1.75–3.38], <i>p</i> &#x3c; 0.001). Cardiac mortality and TLR rate were also significantly higher in HD group than in non-HD group (adjusted HR 3.85 [2.34–6.34], <i>p</i> &#x3c; 0.001, and HR 2.10 [1.41–3.14], <i>p</i> &#x3c; 0.001, respectively). <b><i>Conclusions:</i></b> HD was strongly associated with adverse cardiac events after PCI for ULMCA distal bifurcation lesions with DES.

scholarly journals Efficacy and Safety of Dual-Drug-Eluting Stents for de Novo Coronary Lesions in South Korea—The Effect Trial

2020 ◽  
Vol 10 (1) ◽  
pp. 69
Author(s):  
Jung-Joon Cha ◽  
Gi Chang Kim ◽  
Seung Ho Hur ◽  
Jang Ho Bae ◽  
Jae Woong Choi ◽  
...  
Keyword(s):  
South Korea ◽  
Clinical Outcomes ◽  
Stent Thrombosis ◽  
De Novo ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Efficacy And Safety ◽  
Stent Restenosis ◽  
Drug Eluting

Background: Drug-eluting stents (DESs) are commonly used in percutaneous coronary intervention (PCI) procedures; however, complications including in-stent restenosis and stent thrombosis are significant challenges. The dual-DES is a stent that elutes two drugs to target various stages of the restenosis reaction. This study investigated the safety and efficacy of dual-DES in clinical practice. Methods: This study included 375 patients who underwent PCI with Cilotax™ or DXR™ dual-DESs at one of 13 centers in South Korea. The primary endpoint was target lesion failure (TLF) within 1 year. The secondary endpoints were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and stent thrombosis. Results: The rates of TLF in dual-DESs (3.7%) were comparable to those reported in conventional DES. In addition, the DXR™ group had a significantly lower rate of TLF than the Cilotax™ group. In multivariate analysis, the DXR™ group had a lower risk of TLF (adjusted hazard ratio (HR) 0.30, 95% CI 0.09–0.92, p = 0.036) and MI (adjusted HR 0.16, 95% CI 0.03–0.82, p = 0.027) than the Cilotax™ group. Conclusion: Dual-DESs had similar clinical outcomes regarding efficacy and safety as conventional DES. Among the dual-DES, the DXR™ stent as a new generation dual-DES had more favorable clinical outcomes than the Cilotax™ stent.

Abstract 17098: Comparison of Angiographic and 1-year Clinical Outcomes between Long Single Stent and Overlapping Double Stent in Patients with Newer Generation Drug-Eluting Stents for Similar Long Lesions

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Naoki Mori ◽  
Masami Nishino ◽  
Naotaka Okamoto ◽  
Akihiro Tanaka ◽  
Takahiro Yoshimura ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
De Novo ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Major Adverse Cardiovascular Events ◽  
Stent Group ◽  
Early Generation ◽  
Drug Eluting ◽  
Double Stent

Background: Although overlapping coronary stents in long lesions by percutaneous coronary intervention are common, some clinical studies revealed adverse clinical and angiographic outcomes of early generation overlapping drug-eluting stents (DES) due to increased drug and polymer toxicity, as compared to non-overlapping or single DES. However, recent clinical reports have shown safety and efficacy outcomes of overlapping newer generation DES, as compared with early generation overlapping DES and newer generation non-overlapping DES. Thus, the purpose of this study was to compare angiographic and 1-year clinical outcomes between long single stent and overlapping double stent in patients treated with newer generation DES for similar long lesions. Methods: We analyzed 8-10 months angiographic and 1-year clinical outcomes of 106 patients treated with everolimus-eluting stent (EES, newer generation DES) in a de novo similar long lesions (≥ 32mm, ≤38mm) by a long single stent or overlapping double stents. We divided our patients into single long stent group and overlapping double stent group. We compared the incidence of in-stent restenosis (ISR), which was defined as more than 50% angiographical stenosis, and analyzed freedom from major adverse cardiovascular events (MACE: defined as the composite of death, myocardial infarction, or target vessel revascularization) and freedom from target lesion revascularization (TLR) at 1 year using Kaplan-Meier method. Results: The incidence of ISR at 8-10 months after stent implantation was similar between long single stent group (n=41) and overlapping double stent group (n= 65). The rate of freedom from MACE and TLR during 1-year were also similar between two groups (figures). Conclusions: According to our study, newer generation DES, EES, provided similar angiographic and 1-year clinical outcomes irrespective of overlap status in long lesions.

scholarly journals One-year clinical and angiographic outcomes after percutaneous coronary interventions in ostial versus distal left main lesions – a retrospective single center study

2019 ◽  
Author(s):  
Tilman Stephan ◽  
Nadine Goldberger ◽  
Mirjam Keßler ◽  
Dominik Felbel ◽  
Manuel Rattka ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Primary Outcome ◽  
Statistical Significance ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Primary Outcome Measure ◽  
Left Main ◽  
Cardiac Events ◽  
Percutaneous Coronary

Abstract Background: Percutaneous coronary intervention (PCI) of left main coronary artery disease (LMD) is associated with appropriate clinical and angiographic outcomes, resulting in a class I recommendation in patients with less complex coronary anatomy. Due to higher SYNTAX scores and worse clinical outcomes, PCI in distal LMD is accomplished with a lower strength of recommendations for revascularization compared to ostial LM lesions. We compare angiographic and clinical outcomes of ostial/midshaft lesions versus distal lesion in LMD after PCI. Methods: This retrospective study included 176 patients with LMD undergoing PCI with drug-eluting stents. The study population was divided into 34 patients with ostial/midshaft LMD and 142 patients with distal LMD. Patients were routinely scheduled for 9 months of angiographic and 12 months of clinical follow-up. Quantitative coronary analysis (QCA) was performed for all lesions, using an 11-segment model. Primary outcome was MACE (major adverse cardiac events) defined as a composite of cardiac death, myocardial infarction and target lesion revascularization (TLR). Results: The primary outcome measure was comparable in both cohorts after 12 months follow-up (20.6% in ostial/midshaft LMD vs. 17.6% in distal LMD, P=0.71). As expected, TLR rates were increased in distal LM lesions compared to ostial LM lesions, but without reaching statistical significance (14.1% vs. 5.9%, P=0.15). Late lumen loss (LLL) in ostial/midshaft LMD was 0.42±0.33mm. In distal LM lesions value for LLL in the main vessel was 0.42±0.97 mm, with the highest values observed in segments adjacent to the bifurcation (0.37±1.13mm and 0.37±0.73 mm). On cox proportional regression analysis LLL in a bifurcation segment (P=0.03, HR 1.68 [1.1-2.7]) and diabetes mellitus (P=0.046, HR 2.77 [1.0-7.5] were independent correlates for occurrence of MACE. Conclusion: PCI of distal LM lesions result in comparable angiographic and clinical outcomes compared to ostial LM lesions. Highest rates for binary restenosis were observed in segments nearest to the bifurcation.

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