Clinical outcome of drug‐eluting versus bare‐metal stents in patients with calcified coronary lesions: a meta‐analysis

Zhang, B.-C.; Wang, C.; Li, W.-H.; Li, D.-Y.

doi:10.1111/imj.12622

Cited by 9 publications

(6 citation statements)

References 22 publications

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“…Not surprisingly, adverse ischemic event were higher in patients with BMS compared with DES, and the use of BMS was identified as an independent predictor of MACE and TVR. Reported previously, 26 this finding reiterates the dismal outcomes of BMS compared with DES when used in highly complex (i.e., heavily calcified) lesions. This finding also underlines the even more favorable results of lesion preparation using OAS, especially if only DES (specifically second generation) were used.…”

Section: Discussionsupporting

confidence: 75%

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial)

Généreux

Lee

Kim

et al. 2015

The American Journal of Cardiology

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Percutaneous coronary intervention of severely calcified lesions has historically been associated with major adverse cardiac event (MACE) rates as high as 30%. In the ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial, treatment of de novo severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) resulted in low rates of procedural and 30-day adverse ischemic events. The long-term results from this trial have not been reported. We sought to determine the 1-year outcomes after orbital atherectomy of severely calcified coronary lesions. ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with severely calcified lesions usually excluded from randomized trials. OAS utilizes a centrifugal differential sanding mechanism of action for plaque modification prior to stent implantation. After OAS drug-eluting stents were implanted in 88.2% of the patients. The primary safety end point was 30-day MACE, the composite of cardiac death, myocardial infarction, or target vessel revascularization [TVR]. The present analysis reports the 1-year follow-up results from ORBIT II. One-year data were available in 433 of 443 patients (97.7%), with median follow-up time of 16.7 months. The 1-year MACE rate was 16.4%, including cardiac death (3.0%), myocardial infarction (9.7%), and target vessel revascularization (5.9%). The 1-year target lesion revascularization rate was 4.7%, and stent thrombosis occurred in 1 patient (0.2%). Independent predictors of 1-year MACE and target vessel revascularization were diameter stenosis at baseline and the use of bare-metal stents. In patients with severely calcified lesions who underwent percutaneous coronary intervention, the use of OAS was associated with low rates of 1-year adverse ischemic events compared with historical controls. This finding has important clinical implications for the selection of optimum treatment strategies for patients with severely calcified lesions.

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Section: Discussionsupporting

confidence: 75%

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial)

Généreux

Lee

Kim

et al. 2015

The American Journal of Cardiology

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“…There was no between‐stent difference in various safety endpoints, such as cardiac death, target vessel myocardial infarction, and stent thrombosis. Overall, clinical adverse event rates were low as compared to previous studies that assessed patients treated in severely calcified coronary lesions, 2,5,10,12 which may be partly related to the high rate of stent postdilation and the high‐balloon pressures applied.…”

Section: Discussionmentioning

confidence: 56%

“…All these factors contribute to the increased risk of cardiovascular events (e.g., lesion recurrence and repeated revascularization) that have been reported for calcified target lesions 6,9,10 . Although coronary calcification increases the rate of target lesion recurrence in DES, 11 early generation DES improved clinical outcome as compared to bare‐metal stents 12,13 . Newer DES include devices with biodegradable polymers and thinner struts 14 that have shown excellent results in randomized clinical trials that assessed broad patient populations 15‐19 .…”

Section: Introductionmentioning

confidence: 99%

Three contemporary thin‐strut drug‐eluting stents implanted in severely calcified coronary lesions of participants in a randomized all‐comers trial

Buiten

Ploumen

Zocca

et al. 2020

Cathet Cardio Intervent

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Objective The objective was to assess the 2‐year clinical performance of three drug‐eluting stents in all‐comer patients with severely calcified coronary lesions. Background Severe lesion calcification increases cardiovascular event risk after coronary stenting, but there is a lack of data on the clinical outcome of all‐comers with severely calcified lesions who were treated with more recently introduced drug‐eluting stents. Methods The BIO‐RESORT trial (http://clinicaltrials.gov: NCT01674803) randomly assigned 3,514 all‐comer patients to biodegradable polymer Synergy everolimus‐eluting stents (EES) or Orsiro sirolimus‐eluting stents (SES), versus durable polymer Resolute Integrity zotarolimus‐eluting stents (ZES). In a post hoc analysis, we assessed 783 patients (22.3%) with at least one severely calcified target lesion. Results At 2‐year follow‐up (available in 99% of patients), the main composite endpoint target vessel failure occurred in 19/252 (7.6%) of the EES and in 33/265 (12.6%) of the ZES‐treated patients (p = .07). Target vessel failure occurred in 24/266 (9.1%) of the SES‐treated patients (vs. ZES: p = .21). There was a difference in target vessel revascularization, which was required in EES in 6/252 (2.4%) patients and in ZES in 20/265 (7.7%) patients (p = .01); the target vessel revascularization rate in SES was 9/266 (3.4%, vs. ZES: p = .04). Multivariate analysis showed that implantation of EES, but not SES, was independently associated with lower target vessel revascularization rates than in ZES. Conclusions In BIO‐RESORT participants with severely calcified target lesions, treatment with EES was associated with a lower 2‐year target vessel revascularization rate than treatment with ZES.

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“…Estudos mostram que os stents farmacológicos são capazes de reduzir a revascularização da lesão-alvo em até 56% em pacientes com lesões calcificadas, com bons resultados de segurança em longo prazo. [27][28][29] Esses dados podem avançar com os stents de nova geração, que apresentam melhorias em relação ao perfil da malha e dos polímeros. 29,30 Esses achados, associados às recomendações das diretrizes, 31 justificam o aumento significativo encontrado no uso de stents farmacológicos ao longo dos anos em nossa análise.…”

Section: Discussionunclassified

Time profile of percutaneous coronary interventions in calcified lesions

Nascimento¹,

Castro²,

Castro³

2019

J Transcat Intervent

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Clinical outcome of drug‐eluting versus bare‐metal stents in patients with calcified coronary lesions: a meta‐analysis

Abstract: DES significantly reduces TLR rates as compared with BMS in patients with calcified coronary lesions, with non-significant differences in terms of stent thrombosis, cardiac death and MI.

Cited by 9 publications

References 22 publications

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial)

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial)

Three contemporary thin‐strut drug‐eluting stents implanted in severely calcified coronary lesions of participants in a randomized all‐comers trial

Time profile of percutaneous coronary interventions in calcified lesions

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