Abstract 11320: Long-Term Stent-Related and Patient-Related Outcomes of Second-Generation Everolimus-Eluting Xience V Stents versus Zotarolimus-Eluting Resolute Stents in Real-World Practice: Three Year Results From the Multicenter Prospective EXCELLENT and RESOLUTE-Korea Registries

Background: Long term outcomes are imperative to confirm safety of drug-eluting stents. There have been two randomized controlled trials comparing everolimus-eluting stents (EES) and Resolute zotarolimus-eluting stents (ZES-R). To date, long-term clinical outcomes of these stents were limited to only one report which has recently reported 4-year comparisons of these stents. Therefore, more evidences are needed regarding long-term clinical outcomes of the second generation stents. This study compared the long-term clinical outcomes of EES with ZES-R in “all-comer” cohorts up to 3-year follow-up. Methods: The EXCELLENT and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with EES and 1,998 with ZES-R. Target lesion failure and patient-related composite events were compared in crude and propensity score matched analyses. Results: Of 5054 patients, 3830 patients (75.8%) had off label indication (2217 with EES and 1613 with ZES-R). The stent-related outcome (189 [6.2%] vs. 127 [6.4%], p=0.812) and the patient-related outcome (420 [13.7%] vs. 250 [12.5%], p=0.581) did not differ between EES and ZES-R respectively at 3 year, which was corroborated by similar results from the propensity score-matched cohort (HR 0.92, 95% CI 0.70-1.20, p=0.523 and 0.85, 95% CI 0.70-1.02, p=0.081, for stent and patient related outcomes, respectively). The rate of definite or probable stent thrombosis up to 3 years (22 [0.7%] vs. 10 [0.5%], p=0.370) was also similar. The rate of stent thrombosis was very low and comparable between the two stents (3 [0.1%] vs. 1 [0.1%], p=0.657). In multivariate analysis, chronic renal failure (adjusted HR 3.615, 95% CI 2.440-5.354, p<0.001) and off label indication (adjusted HR 1.782, 95% CI 1.169-2.718, p=0.007) were the strongest predictors of target lesion failure. Conclusion: In this robust real world registry with unrestricted use of EES and ZES-R, both stents showed comparable safety and efficacy at 3-year follow-up. Overall incidences of target lesion failure and definite stent thrombosis, including very late stent thrombosis, were low, even in the patients with off label indications, suggesting excellent long term safety and sustained efficacy of both types of second generation drug-eluting stents.

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Abstract 12022: Long-Term Clinical Outcomes of Everolimus-Eluting Stents versus Sirolimus-Eluting Stents: Systematic Review and a Meta-Analysis of 14 Randomized Control Trials, Focused on Stent Thrombosis

Circulation ◽

10.1161/circ.130.suppl_2.12022 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

TOSHIAKI TOYOTA ◽

Hiroki Shiomi ◽

Takeshi Morimoto ◽

Takeshi Kimura

Keyword(s):

Clinical Outcomes ◽

Stent Thrombosis ◽

Controlled Trial ◽

Meta Analysis ◽

Target Lesion ◽

Pooled Analysis ◽

Significant Difference ◽

Artery Disease

Background: We sought to compare the long-term clinical outcomes between everolimus-eluting stent (EES) and sirolimus-eluting stents (SES) with a meta-analysis method. The long-term clinical outcomes, especially stent thrombosis (ST), after EES versus SES implantation has not been clearly defined among trials directly comparing the 2 types of stents. Methods: We searched PubMed, Cochrane database, and ClinicalTrials.gov. for trials comparing outcomes between EES (Xience V/Promus) and SES (Cypher select/Cypher select plus) in patients with native coronary artery disease using randomized controlled trial (RCT) design. We selected the article reporting the longest follow-up outcomes from each RCT. The outcome measure was all-cause death, myocardial infarction (MI), definite ST, and target-lesion revascularization (TLR). ST was further classified as those occurring early (<=30 days), late (30-365 days), or very late (<365 days). Results: We identified 14 RCT comparing EES and SES including 2 trials reporting the longest follow-up outcomes as a pooled analysis. We analyzed 13,434 randomly assigned patients with the weighted follow-up period of 2.1 years (Follow-up <=1-year: 7 trials, and 3191 patients; >1-year: 7 trials, and 10243 patients). EES as compared to SES was associated with significantly lower risks for overall ST, and early ST (pooled odds ratio (OR) 0.49, 95% confidence interval (CI) 0.30-0.81, P=0.01, and OR 0.42, 95% CI 0.18-0.99, P=0.046, respectively), while there was no significant difference in the risk for late ST and very late ST (OR 0.49, 95% CI 0.17-1.43, P=0.19, and OR 0.66, 95% CI 0.23-1.85, P=0.43, respectively). EES as compared to SES was also associated with significantly lower risks for TLR (OR 0.84, 95% CI 0.71-0.99, P=0.04). There was no significant difference in the risk for all-cause death, and MI between EES and SES. (OR 0.91, 95% CI 0.78-1.07, P=0.11, and OR 0.92, 95% CI 0.75-1.13, P=0.44, respectively). Conclusions: In the current meta-analysis of 14 RCT directly comparing EES with SES, implantation of EES as compared to SES implantation was associated with significantly lower risk for definite ST and TLR.

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Risk Factors and Long-Term Clinical Outcomes of Second-Generation Drug-Eluting Stent Thrombosis

Circulation Cardiovascular Interventions ◽

10.1161/circinterventions.119.007822 ◽

2019 ◽

Vol 12 (6) ◽

Cited By ~ 9

Author(s):

Shoichi Kuramitsu ◽

Masanobu Ohya ◽

Tomohiro Shinozaki ◽

Hiromasa Otake ◽

Kazunori Horie ◽

...

Keyword(s):

Risk Factors ◽

Clinical Outcomes ◽

Stent Thrombosis ◽

Second Generation ◽

Drug Eluting Stent ◽

Drug Eluting

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Abstract 3137: Long-term Outcomes Following Sirolimus-Eluting Stent Implantation for Off Label Indications

Circulation ◽

10.1161/circ.116.suppl_16.ii_704 ◽

2007 ◽

Vol 116 (suppl_16) ◽

Author(s):

John Cosgrave ◽

Tiziana Claudia Aranzulla ◽

Asif Qasim ◽

Azeem Mohamed Latib ◽

Gloria Melzi ◽

...

Keyword(s):

Myocardial Infarction ◽

Stent Thrombosis ◽

Randomized Trials ◽

Statistical Significance ◽

Chronic Total Occlusions ◽

Off Label ◽

Repeat Revascularization ◽

Label Indication

Introduction: Only limited long term data exist following SES implantation and these primarily come from the randomized trials which enrolled highly selected patients. Due to the risk of stent thrombosis long term safety concerns exist particularly following off label SES implantation. Hypothesis: Off label implantation of SES has a favorable long term safety profile. Methods: All consecutive patients successfully treated with SES prior to March 2003 were considered for analysis. The endpoints analyzed were MACE, death, myocardial infarction (MI), target vessel revascularization (TVR) and target lesion revascularization (TLR) and late stent thrombosis. We considered the following as off-label indications: ostial lesions, chronic total occlusions, bifurcations, left main stem lesions, saphenous vein grafts, internal mammary artery, ejection fraction < 30 %, restenotic lesions. Results: Our cohort comprised 445 patients with 954 lesions. At least one off label indication was present in 322 (72%) of patients and 161 (36.2%) had more than 1 off label indication (Table ). Median clinical follow-up was 4.4 years and 78% of patients had at least 4 years of follow-up. There was a trend towards a higher MACE rate in the off-label group due in the main to a significantly higher repeat revascularization rate. There were no differences in the incidence of death or myocardial infarction. The overall rate of late thrombosis was similar to that seen in the literature (1–2%) and while there was a slightly higher number in the off-label group this did not reach statistical significance. Conclusions: In our experience off label implantation of SES is associated with higher MACE rates due to the increased need for repeat revascularization. This can be explained by the complexity of this cohort with a large number of lesion types not included in randomized trials. Of note long term safety is acceptable with no difference in death or MI when compared to on-label indications. Follow-up clinical events in the two groups

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Long-Term Follow-Up of Drug-Eluting Stents When Inserted for On- and Off-Label Indications

The American Journal of Cardiology ◽

10.1016/j.amjcard.2007.07.013 ◽

2007 ◽

Vol 100 (11) ◽

pp. 1619-1624 ◽

Cited By ~ 33

Author(s):

Asif Qasim ◽

John Cosgrave ◽

Azeem Latib ◽

Antonio Colombo

Keyword(s):

Drug Eluting Stents ◽

Off Label ◽

Long Term Follow Up ◽

Drug Eluting

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P45945-years clinical outcomes of patients underwent percutaneous coronary intervention for calcified lesions with rotational atherectomy and second-generation drug eluting stent

European Heart Journal ◽

10.1093/eurheartj/ehz745.0979 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

K Ogata ◽

H Koiwaya ◽

K Shinzato ◽

Y Goriki ◽

G Yoshioka ◽

...

Keyword(s):

Risk Factors ◽

Percutaneous Coronary Intervention ◽

Clinical Outcomes ◽

Second Generation ◽

Coronary Intervention ◽

Drug Eluting Stent ◽

Diabetic Mellitus ◽

Percutaneous Coronary ◽

Drug Eluting

Abstract Background Percutaneous coronary Intervention (PCI) with rotational atherectomy (RA) was useful for severe calcified lesions. However, the long-term clinical outcomes of PCI with second-generation drug eluting stent (DES) following RA has been still unclear. Purpose The purpose of this study was to investigate the long-term clinical outcomes of RA followed by second-generation DES. Methods We retrospectively enrolled 254 consecutive patients treated with second-generation DES following RA. The primary outcome was the cumulative 5-year incidence of MACE, defined as cardiac death, myocardial infarction, clinically-driven target lesion revascularization and definite stent thrombosis. Results The incidence of MACE was 22.8% at 5-years. Multivariate analysis showed 3 predictors of MACE, hemodialysis, diabetic mellitus and extremely angulated lesions (>90°).Significantly higher MACE was observed in the high-risk (≥2 risk factors) group, compared with the low-risk (2< risk factors) group (68.7% vs. 18.7%, P<0.001, Figure). Multivariate analysis for MACE at 5 year Hazard ratio (95% Confidence Interval) P-value Diabetic Mellitus 2.58 (1.35–4.91) 0.004 Hemodialysis 4.57 (1.64–12.76) 0.004 extremely angulated (>90°) 3.08 (1.06–8.93) 0.04 Kaplan-Meier curves for 5-years MACE Conclusions The long-term clinical outcomes of PCI for severely calcified lesions was acceptable. However, the clinical outcomes of patients classified high risk cohort was unsatisfactory.

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124Impact of intimal tracking for recanalization of CTO lesions on long-term clinical outcomes

European Heart Journal ◽

10.1093/eurheartj/ehz747.0040 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

S Kano ◽

K Nasu ◽

M Habara ◽

T Shimura ◽

M Yamamoto ◽

...

Keyword(s):

Clinical Outcomes ◽

Cox Regression ◽

Target Lesion ◽

Hazard Ratio ◽

Rank Test ◽

Total Occlusion ◽

Significant Difference ◽

The Impact

Abstract Background For recanalization of coronary chronic total occlusion (CTO) lesions, subintimal guidewire tracking in both antegrade and retrograde approaches are commonly used. Purpose This study aimed to assess the impact of subintimal tracking on long-term clinical outcomes after recanalization of CTO lesions. Methods Between January 2009 and December 2016, 474 CTO lesions (434patients) were successfully recanalized in our center. After guidewire crossing in a CTO lesion, those lesions were divided into intimal tracking group (84.6%, n=401) and subintimal tracking group (15.4%, n=73) according to intravascular ultrasound (IVUS) findings. Long-term clinical outcomes including death, target lesion revascularization (TLR), target vessel revascularization (TVR) were compared between the two groups. In addition, the rate of re-occlusion after successful revascularization was also evaluated. Results The median follow-up period was 4.7 years (interquartile range, 2.8–6.1). There was no significant difference of the rate of cardiac death between the two groups (intimal tracking vs. subintimal tracking: 7.0% vs. 4.1%; hazard ratio, 0.61; 95% confidence interval [CI], 0.19 to 2.00; p=0.41), TLR (14.3% vs. 16.2%; hazard ratio, 1.34; 95% CI, 0.71 to 2.53; p=0.37), and TVR (17.5% vs. 20.3%; hazard ratio, 1.27; 95% CI, 0.72 to 2.23; p=0.42). However, the rate of re-occlusion was significantly higher in the subintimal tracking group than intimal tracking group at 3-years re-occlusion (4.2% vs. 14.5%; log-rank test, p=0.002, Figure). In the multivariate COX regression, subintimal guidewire tracking was an independent predictor of re-occlusion after CTO recanalization (HR: 5.40; 95% CI: 2.11–13.80; p<0.001). Figure 1 Conclusions Subintimal guidewire tracking for recanalization of coronary CTO was associated with significantly higher incidence of target lesion re-occlusion during long-term follow-up period.

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P1966Impact of coronary artery calcification on long-term outcomes after implantation of first and second-generation drug-eluting stents: a patient-level analysis of 18 randomized trials

European Heart Journal ◽

10.1093/eurheartj/ehz748.0712 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

P Guedeney ◽

B Claessen ◽

R Mehran ◽

G Mintz ◽

M Liu ◽

...

Keyword(s):

Randomized Trials ◽

Second Generation ◽

Composite Endpoint ◽

Target Lesion ◽

Drug Eluting Stents ◽

Patient Level ◽

Drug Eluting ◽

Long Term Impact ◽

First And Second Generation

Abstract Background Available data on the long-term impact of coronary artery calcification (CAC) after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) are limited. Purpose We evaluated the long-term impact of CAC on outcomes after PCI and the respective performance of first- and second-generation DES. Methods We pooled patient-level data from 18 randomized trials evaluating DES categorized according to the presence of angiographic core lab-confirmed moderate or severe CAC in any target lesion. Outcome measures of interest were the patient-oriented composite endpoint (POCE; death, myocardial infarction [MI], or any revascularization), the device-oriented composite endpoint of target lesion failure (TLF; cardiac death, target vessel MI or ischemia-driven target lesion revascularization), and definite or probable stent thrombosis (ST). Multivariable Cox proportional regression with study as a random effect was used to assess 5-year outcomes. Results A total of 19,833 patients were included. Moderate or severe CAC was present in 6211 (31.3%) patients and associated with increased 5-year risk of the POCE (adjHR 1.12, 95% CI 1.05–1.20, p<0.001), TLF (adjHR 1.21, 95% CI 1.09–1.35, p<0.001), and a trend for greater ST (adjHR 1.24, 95% CI 0.99–1.54, p=0.06). In patients with CAC, second-generation DES were associated with a reduction in the 5-year risk of TLF and ST, and a trend for reduced POCE compared with first-generation DES (Table). Conclusion In this large-scale study, target lesion moderate or severe CAC was associated with adverse patient- and device-related outcomes at 5 years, risks that were reduced but not eliminated with second-generation DES. Acknowledgement/Funding This investigator-sponsored study was funded by Abbott Vascular.

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