Abstract 12989: Generalizability of Quantitative Angiographic In-Segment Late Lumen Loss Imaging in Eastern and Western Populations: Can We Facilitate Global Drug Eluting Stent Evaluation?

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Vaishnavi Radhakrishnan ◽  
John C Allen ◽  
Rebecca Fisher ◽  
Weng Kit Lye ◽  
Robert W Harrison ◽  
...  
Keyword(s):  
Coronary Angiography ◽  
Propensity Score ◽  
Quantitative Coronary Angiography ◽  
Drug Eluting Stents ◽  
Drug Eluting Stent ◽  
Meaningful Difference ◽  
Late Lumen Loss ◽  
Drug Eluting ◽  
East And West

Background: Regulators require mechanistic observations of late lumen loss (LLL) in evaluating new drug eluting stents (DES). Redundant requirements for follow-up catheterization across regulatory jurisdictions worldwide could be reduced if independent core laboratory quantitative coronary angiography (QCA) findings were generalizable. Our study aim was to assess comparability of QCA LLL in East (Japan, China) and West (N. America, Europe) pts using the world’s largest compilation of late follow-up QCA data. Hypothesis: The propensity adjusted mean difference in QCA in-segment LLL between East and West is ≤0.4mm, with 95% confidence. Methods: All available data from 4 manufacturers (7157 pts, 29 trials) reporting 6-12mo QCA LLL were compiled. East vs West were compared unadjusted and via propensity score (PS) quartiles that adjusted for 26 clinical descriptive and anatomic variables affecting QCA LLL. Of the 7157 pts, 6163 (86%) had complete covariable profiles and comprised the analysis set. Based on consensus of experts and regulators, a clinically meaningful difference between East and West mean IS-LLL was prospectively set at 0.4mm. Results: Of 6163 pts, 4134 were West and 2029 East, including 2304 paclitaxel, 1455 everolimus, 1562 zotarolimus, 440 sirolimus and 402 biolimus exposures. Unadjusted and adjusted IS-LLL (Mean±SD) was 0.25±0.47 (W) and 0.08±0.41 (E), and 0.24±0.45 (W) and 0.13±0.45 (E), respectively; differences (95% CI) were 0.17 (0.15, 0.19) and 0.12 (0.08, 0.16), respectively. PS-adjusted IS-LLL is shown the Figure. All differences were ≤ 0.4mm. Conclusion: In the world’s largest compilation of protocol follow-up across multiple DES platforms, QCA LLL appears generalizable and sufficiently predictive across East and West pts in both unadjusted and adjusted comparisons. This suggests that global DES evaluations can be facilitated by reducing the need for redundant invasive late catheterization across regulatory jurisdictions.

scholarly journals Comparison of Intravascular Imaging and Quantitative Coronary Angiography to Evaluate Neointimal Proliferation after Complex Lesion Stenting

2009 ◽  
Vol 63 (4-5) ◽  
pp. 168-173
Author(s):  
Sanda Jēgere ◽  
Inga Narbute ◽  
Indulis Kumsārs ◽  
Iveta Mintāle ◽  
Iļja Zakke ◽  
...  
Keyword(s):  
Coronary Angiography ◽  
Quantitative Coronary Angiography ◽  
Drug Eluting Stent ◽  
Intravascular Imaging ◽  
Chronic Total Occlusions ◽  
Neointimal Proliferation ◽  
Drug Eluting ◽  
Ivus Image ◽  
Uncovered Stent

Comparison of Intravascular Imaging and Quantitative Coronary Angiography to Evaluate Neointimal Proliferation after Complex Lesion Stenting Unlike quantitative coronary angiography (QCA), intravascular imaging methods allow direct visualisation of the arterial wall. Our goal was to determine several intravascular ultrasound (IVUS) and optical coherence tomography (OCT) parameters of neointimal proliferation and stent endothelisation after complex lesion intervention compared to QCA. We examined 261 patients who had underwent percutaneous intervention with bare metal (BMS) or drug eluting stent (DES) implantation for complex coronary lesions and had IVUS or OCT images at six-month follow-up. Percent diameter stenosis (QCA) was 25.2 ± 16.0 in BMS vs 21.7 ± 17.4 in DES (P < 0.05). Percent neointimal volume obstruction (IVUS) was 19.5 ± 14.4 in BMS vs. 5.8 ± 7.7 in DES (P < 0.001). A moderate correlation was observed between QCA and IVUS with an r value of 0.384 overall, 0.472 for BMS and 0.416 for DES (P < 0.001 for all). In patients with chronic total occlusions (n = 161) QCA was similar in BMS and DES patients (P > 0.05) while IVUS showed less neointima in DES (P < 0.05). Total number of uncovered stent struts per OCT image was 0.4 ± 0.8 while per IVUS image 1.2 ± 1.5 (P < 0.001). In conclusion, angiographic indexes correlate with volumetric intravascular parameters. Although IVUS was more sensitive than QCA to assess neointimal proliferation, the assessment of stent endothelisation was more precise using OCT.

scholarly journals Safety and Efficacy of Second-Generation Drug-Eluting Stents in Real-World Practice: Insights from the Multicenter Grand-DES Registry

2020 ◽  
Vol 2020 ◽  
pp. 1-9 ◽  
Author(s):  
You-Jeong Ki ◽  
Kyung Woo Park ◽  
Jeehoon Kang ◽  
Chee-Hoon Kim ◽  
Jung-Kyu Han ◽  
...  
Keyword(s):  
Propensity Score ◽  
Stent Thrombosis ◽  
Real World ◽  
Coronary Intervention ◽  
Drug Eluting Stents ◽  
Drug Eluting Stent ◽  
Safety And Efficacy ◽  
Drug Eluting ◽  
Composite Outcomes

Objective. In this study, we sought to compare the efficacy and safety of the Xience Prime/Xience V/Promus EES and Biomatrix/Biomatrix Flex/Nobori BES with resolute integrity/resolute ZES using the grand drug-eluting stent (Grand-DES) registry. Background. Currently, new-generation drug-eluting stents (DESs) are used as the standard of care in patients undergoing percutaneous coronary intervention. No study has simultaneously compared everolimus-eluting stent (EES), biolimus-eluting stent (BES), and zotarolimus-eluting stent (ZES). Methods. Stent-related composite outcomes (target lesion failure) and patient-related composite outcomes were compared in crude and propensity score-matched analysis. Results. Of the 17,286 patients in the Grand-DES group, 5,137, 2,970, and 4,990 patients in the EES, BES, and ZES groups completed a three-year follow-up. In the propensity score-matched cohort, the stent-related outcome (EES vs. BES vs. ZES; 5.9% vs. 6.7% vs. 7.1%, P=0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P=0.232) were similar among the three groups, at 3 years. The rate of definite or probable stent thrombosis (0.6% vs. 0.8% vs. 0.5%, P=0.549) was similar. In the multivariate analysis, chronic kidney disease was the strongest predictor of stent thrombosis (adjusted hazard ratio 3.178; 95% confidence interval 1.621–6.229; P<0.001). Conclusions. In this robust real-world registry with unrestricted use of EES, BES, and ZES, the three stent groups showed comparable safety and efficacy at the 3-year follow-up.

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.

Abstract P108: Assessing Utility of Drug-Eluting Stents in Coronary Patients Aged 85 Years and Older

2011 ◽  
Vol 4 (suppl_2) ◽  
Author(s):  
Daniel E Forman ◽  
Samip Vasaiwala ◽  
Traecy S Silbaugh ◽  
Ann Lovett ◽  
Sharon-Lise T Normand ◽  
...  
Keyword(s):  
Propensity Score ◽  
Propensity Score Matching ◽  
Mortality Rates ◽  
Vital Statistics ◽  
Current Evidence ◽  
Drug Eluting Stents ◽  
Entire Cohort ◽  
Target Vessel Revascularization ◽  
Drug Eluting

Background: Very old (VO) adults (≥85 years) are intrinsically susceptible to coronary heart disease (CHD) and are often treated with coronary stents. While current evidence supports use of drug-eluting stents (DES), generalizability to VO remains controversial, especially given high age-associated bleeding risks from long-term dual antiplatelet therapy. Methods: We identified all VO CHD patients who received stents between April 1, 2003 and September 30, 2006 at all non-federal hospitals in Massachusetts (MA) (N=1619), and completed 2-year follow-up on the entire cohort. Patients were classified as DES-treated if stents were all drug-eluting and BMS-treated if stents were all bare-metal (those receiving DES and BMS were excluded). Mortality rates were determined from vital statistics records. New myocardial infarction (MI) and subsequent bleeding (requiring hospitalization) were determined using ICD-9 codes. Repeat target vessel revascularization (TVR) was determined from the MA database. Risk-adjusted cumulative incidence was estimated using propensity score matching based on 57 clinical, procedural, hospital, and insurance variables. Results: During the study period, 1145 and 474 VO patients received DES and BMS respectively. Unadjusted 2-year mortality rates were 23.8% vs. 35.0% (DES vs. BMS, p<0.0001). Risk-adjusted (propensity score matching [665 DES:343 BMS]) 2-year DES vs. BMS rates were 25.4% vs. 32.4% (hazard ratio [HR] 0.69, 95% confidence interval [CI] 0.51, 0.93; p=0.01) for mortality and 9.8 vs.16.9% (HR 0.51, 95% CI 0.35, 0.76; p=0.001) for MI. Risk-adjusted 2-year rates of bleeding (13.6% vs. 12.5%, HR 1.08, 95% CI 0.73, 1.59; p=0.72) and TVR (5.7% vs. 8.7%, HR 0.62, 95% CI 0.38, 1.02; p=0.06) were similar in patients treated with DES vs. BMS. Conclusions: In a large, unrestricted, state dataset of VO CHD patients with mandated follow-up, DES were associated with reduced 2-year mortality and MI compared with a matched BMS subset, without an increased hazard of bleeding.

Sign in / Sign up

Export Citation Format

Share Document