Drug-eluting stents or balloon angioplasty for drug-eluting stent-associated restenosis: An observational follow-up study of first-time versus repeated restenosis

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.

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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 ◽

10.1161/circ.130.suppl_2.12989 ◽

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.

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Long-term luminal change after drug-eluting stent implantation: Serial angiographic follow-up study of the ZEST randomized trial

Catheterization and Cardiovascular Interventions ◽

10.1002/ccd.24379 ◽

2012 ◽

Vol 81 (2) ◽

pp. 274-282 ◽

Cited By ~ 4

Author(s):

Gyung-Min Park ◽

Duk-Woo Park ◽

Yong-Giun Kim ◽

Sung Won Cho ◽

Byung-Joo Sun ◽

...

Keyword(s):

Randomized Trial ◽

Stent Implantation ◽

Drug Eluting Stent ◽

Follow Up Study ◽

Drug Eluting

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Effect and Significant of Hyperlipoproteinemia on Stent Thrombosis in Patients with Implanted Drug-Eluting Stents: The 5-Year Follow Up Study

The American Journal of the Medical Sciences ◽

10.1016/j.amjms.2021.05.012 ◽

2021 ◽

Author(s):

Maja Stojanovic ◽

Violeta Iric Cupic

Keyword(s):

Stent Thrombosis ◽

Drug Eluting Stents ◽

Follow Up Study ◽

Drug Eluting

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Drug-eluting stents for treatment of focal infrapopliteal lesions

VASA ◽

10.1024/0301-1526/a000170 ◽

2012 ◽

Vol 41 (2) ◽

pp. 90-95 ◽

Cited By ~ 10

Author(s):

Rastan ◽

Noory ◽

Zeller

Keyword(s):

Limb Salvage ◽

Bare Metal Stents ◽

Target Lesion ◽

Drug Eluting Stents ◽

Metal Stents ◽

Target Lesion Revascularisation ◽

Randomized Studies ◽

Drug Eluting ◽

The Mean

We have investigated the role of drug-eluting stents on patency rates after treatment of focal infrapopliteal lesions in patients with intermittent claudication and critical limb ischemia. Reports indicate that drug-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. A Pub Med, EMBASE, Cochrane database review search of non-randomized studies investigating patency rates, target lesion revascularisation rates, limb salvage rates and mortality rates in an up to 3-year follow-up period after drug-eluting stent placement was conducted. In addition, preliminary results of randomized studies comparing drug-eluting stents with bare-metal stents and plain balloon angioplasty in treatment of focal infrapopliteal lesions were included in this review. A total of 1039 patients from 10 non-randomized and randomized studies were included. Most commonly used drug-eluting stents were sirolimus-eluting. The mean follow-up period was 12.6 (range 8 - 24). The mean 1-year primary patency rate was 86 ± 5 %. The mean target lesion revascularization rate and limb salvage rate was 9.9 ± 5 % and 96.6 %±4 %, respectively. Results from non-randomized and preliminary results from prospective, randomized trials show a significant advantage for drug-eluting stents in comparison to plain balloon angioplasty and bare-metal stents concerning target lesion patency and in parts target lesion revascularisation. No trial reveals an advantage for drug-eluting stents with regard to limb salvage and mortality.

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