Dataset Information

Bifurcation strategies using second-generation drug-eluting stents on clinical outcomes in diabetic patients.

ABSTRACT:

Background

Diabetes mellitus (DM) is a critical risk factor for the pathogenesis and progression of coronary artery disease, with a higher prevalence of complex coronary artery disease, including bifurcation lesions. This study aimed to elucidate the optimal stenting strategy for coronary bifurcation lesions in patients with DM.

Methods

A total of 905 patients with DM and bifurcation lesions treated with second-generation drug-eluting stents (DES) from a multicenter retrospective patient cohort were analyzed. The primary outcome was the 5-year incidence of target lesion failure (TLF), which was defined as a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization.

Results

Among all patients with DM with significant bifurcation lesions, 729 (80.6%) and 176 (19.4%) were treated with one- and two-stent strategies, respectively. TLF incidence differed according to the stenting strategy during the mean follow-up of 42 ± 20 months. Among the stent strategies, T- and V-stents were associated with a higher TLF incidence than one-stent strategy (24.0 vs. 7.3%, p < 0.001), whereas no difference was observed in TLF between the one-stent strategy and crush or culotte technique (7.3 vs. 5.9%, p = 0.645). The T- or V-stent technique was an independent predictor of TLF in multivariate analysis (hazard ratio, 3.592; 95% confidence interval, 2.117-6.095; p < 0.001). Chronic kidney disease, reduced left ventricular ejection fraction, and left main bifurcation were independent predictors of TLF in patients with DM.

Conclusion

T- or V-stenting in patients with DM resulted in increased cardiovascular events after second-generation DES implantation.

Clinical trial registration

https://clinicaltrials.gov/ct2/show/NCT03068494?term=03068494&draw=2&rank=1, identifier: NCT03068494.

SUBMITTER: Cha JJ

PROVIDER: S-EPMC9811589 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

Bifurcation strategies using second-generation drug-eluting stents on clinical outcomes in diabetic patients.

Cha Jung-Joon JJ Hong Soon Jun SJ Kim Ju Hyeon JH Lim Subin S Joo Hyung Joon HJ Park Jae Hyoung JH Yu Cheol Woong CW Kang Jeehoon J Kim Hyo-Soo HS Gwon Hyeon-Cheol HC Chun Woo Jung WJ Hur Seung-Ho SH Han Seung Hwan SH Rha Seung-Woon SW Chae In-Ho IH Jeong Jin-Ok JO Heo Jung Ho JH Yoon Junghan J Park Jong-Seon JS Hong Myeong-Ki MK Doh Joon-Hyung JH Cha Kwang Soo KS Kim Doo-Il DI Lee Sang Yeub SY Chang Kiyuk K Hwang Byung-Hee BH Choi So-Yeon SY Jeong Myung Ho MH Song Young Bin YB Choi Ki Hong KH Nam Chang-Wook CW Koo Bon-Kwon BK Lim Do-Sun DS

Frontiers in cardiovascular medicine 20221221

<h4>Background</h4>Diabetes mellitus (DM) is a critical risk factor for the pathogenesis and progression of coronary artery disease, with a higher prevalence of complex coronary artery disease, including bifurcation lesions. This study aimed to elucidate the optimal stenting strategy for coronary bifurcation lesions in patients with DM.<h4>Methods</h4>A total of 905 patients with DM and bifurcation lesions treated with second-generation drug-eluting stents (DES) from a multicenter retrospective ...[more]

PMID: 36620646

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Project description:ObjectivesTo investigate the safety and efficacy of durable polymer drug eluting stents (DES) and biodegradable polymer biolimus eluting stents (biolimus-ES).DesignNetwork meta-analysis of randomised controlled trials.Data sources and study selectionMedline, Google Scholar, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) database search for randomised controlled trials comparing at least two of durable polymer sirolimus eluting stents (sirolimus-ES) and paclitaxel eluting stents (paclitaxel-ES), newer durable polymer everolimus eluting stents (everolimus-ES), Endeavor and Resolute zotarolimus eluting stents (zotarolimus-ES), and biodegradable polymer biolimus-ES.Primary outcomesSafety (death, myocardial infarction, definite or probable stent thrombosis) and efficacy (target lesion and target vessel revascularisation) assessed at up to one year and beyond.Results60 randomised controlled trials were compared involving 63,242 patients with stable coronary artery disease or acute coronary syndrome treated with a DES. At one year, there were no differences in mortality among devices. Resolute and Endeavor zotarolimus-ES, everolimus-ES, and sirolimus-ES, but not biodegradable polymer biolimus-ES, were associated with significantly reduced odds of myocardial infarction (by 29-34%) compared with paclitaxel-ES. Compared with everolimus-ES, biodegradable polymer biolimus-ES were associated with significantly increased odds of myocardial infarction (by 29%), while Endeavor zotarolimus-ES and paclitaxel-ES were associated with significantly increased odds of stent thrombosis. All investigated DES were similar with regards to efficacy endpoints, except for Endeavor zotarolimus-ES and paclitaxel-ES, which were associated with significantly increased the odds of target lesion and target vessel revascularisations compared with other devices. Direction of results beyond one year did not diverge from the findings for up to one year follow-up. Bayesian probability curves showed a gradient in the magnitude of effect, with everolimus-ES and Resolute zotarolimus-ES offering the highest safety profiles.ConclusionsThe newer durable polymer everolimus-ES and Resolute zotarolimus-ES and the biodegradable polymer biolimus-ES maintain the efficacy of sirolimus-ES; however, for safety endpoints, differences become apparent, with everolimus-ES and Resolute zotarolimus-ES emerging as the safest stents to date.

Project description:Background Percutaneous coronary intervention of calcified lesions was associated with worse outcomes in the era of bare-metal and first-generation drug-eluting stents. Data on percutaneous coronary intervention of calcified lesions with newer-generation drug-eluting stents are scarce. Therefore, we investigated the impact of lesion calcification on clinical outcomes in patients undergoing percutaneous coronary intervention with a bioresorbable-polymer sirolimus-eluting stent or a durable-polymer everolimus-eluting stent. Methods and Results Patients (n=2361) from BIOFLOW II, IV, and V trials were categorized into moderate/severe versus none/mild lesion calcification by a core laboratory. End points were target-lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or target-lesion revascularization) and probable/definite stent thrombosis at 2 years. The agreement in calcification assessment between the operator and the core laboratory was weak (weighted κ, 0.23). Patients with moderate/severe calcification (n=303; 16%) had higher TLF (13.5% versus 8.4%; P=0.003) and stent thrombosis rates (2.1% versus 0.2%; P<0.0001), whereas target-lesion revascularization was not different between the groups (5.0% versus 3.9%; P=0.302). After adjustment, calcification did not emerge as an independent predictor of TLF (adjusted hazard ratio [aHR], 1.37; 95% CI, 0.89-2.08; P=0.148) but did for target-vessel myocardial infarction (aHR, 1.66; 95% CI, 1.03-2.68; P=0.037). TLF rates were similar between bioresorbable-polymer sirolimus-eluting stent and durable-polymer everolimus-eluting stent (12.6% versus 15.4%, P=0.482) in moderate/severe calcification. In none/mild calcification, the bioresorbable-polymer sirolimus-eluting stent showed lower TLF (7.5% versus 10.3%, P=0.045). Conclusions With newer-generation drug-eluting stents, moderate/severe lesion calcification was not associated with more TLF after adjustment for the higher risk of patients with coronary calcification, whereas the rate of target-vessel myocardial infarction was higher. The bioresorbable-polymer sirolimus-eluting stent and durable-polymer everolimus-eluting stent were equally effective and safe in calcified lesions. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01356888, NCT01939249, NCT02389946.

Project description:Background and Objectives: The second-generation drug-eluting stents have been used to treat chronic total occlusion lesion. However, there is limited evidence of the clinical outcomes that whether the second-generation drug-eluting stents is superior to first-generation ones in patients with chronic total occlusion lesion undergoing percutaneous coronary intervention. The study aimed to compare the differences in clinical outcomes between the two generations drug-eluting stents in patients with those by a meta-analysis. Methods: PubMed, Embase, the Cochrane library and Web of science databases were systemically searched before March, 2021. Randomized controlled trials and observational studies were included to compare the second-generation drug-eluting stents with the first-generation ones in patients with chronic total occlusion lesion undergoing percutaneous coronary intervention. The clinical outcomes were major adverse cardiac events (MACE), target vessel revascularization, myocardial infarction, all-cause death. Fixed effects models were used to calculate the odds ratio (OR) and 95% confidence interval (CI) of each clinical outcome. Sensitivity analysis was performed to detect potential sources of heterogeneity. Subgroup analyses were used to assess the differential effects. Results: The meta-analysis included eight studies involving 4,583 patients with chronic total occlusion lesion undergoing percutaneous coronary intervention. Pooled analysis showed that the incidence of MACE (OR = 0.68, 95%CI 0.54-0.85, P = 0.0008), target vessel revascularization (OR = 0.70, 95%CI 0.54-0.91, P = 0.007), and myocardial infarction (OR = 0.58, 95%CI 0.37-0.93, P = 0.02) were lower in the second-generation drug-eluting stents compared with the first-generation ones. However, there was not difference in all-cause deaths between two drug-eluting stents (OR = 0.67, 95%CI 0.45-1.01, P = 0.05). Conclusions: The second-generation drug-eluting stents are associated with lower MACE, target vessel revascularization, and myocardial infarction compared with the first-generation ones in patients with chronic total occlusion lesion undergoing percutaneous coronary intervention. The results of this study can provide a reference for the selection of stents in patients with chronic total occlusion lesion. Further randomized controlled trials are needed to verify that the second-generation drug-eluting stents is superior to the first-generation ones in patients with chronic total occlusion (Registered by PROSPERO, CRD42020158406).

Project description:BackgroundThere are few data comparing clinical outcomes of complex percutaneous coronary intervention (CPCI) when using biodegradable polymer drug-eluting stents (BP-DES) or second-generation durable polymer drug-eluting stents (DP-DES). The purpose of this study was to investigate the safety and efficacy of BP-DES and compare that with DP-DES in patients with and without CPCI during a 5-year follow-up.MethodsPatients who exclusively underwent BP-DES or DP-DES implantation in 2013 at Fuwai Hospital were consecutively enrolled and stratified into two categories based on CPCI presence or absence. CPCI included at least one of the following features: unprotected left main lesion, ≥2 lesions treated, ≥2 stents implanted, total stent length >40 mm, moderate-to-severe calcified lesion, chronic total occlusion, or bifurcated target lesion. The primary endpoint was major adverse cardiac events (MACE) including all-cause death, recurrent myocardial infarction, and total coronary revascularization (target lesion revascularization, target vessel revascularization [TVR], and non-TVR) during the 5-year follow-up. The secondary endpoint was total coronary revascularization.ResultsAmong the 7712 patients included, 4882 (63.3%) underwent CPCI. Compared with non-CPCI patients, CPCI patients had higher 2- and 5-year incidences of MACE and total coronary revascularization. Following multivariable adjustment including stent type, CPCI was an independent predictor of MACE (adjusted hazard ratio [aHR]: 1.151; 95% confidence interval [CI]: 1.017-1.303, P = 0.026) and total coronary revascularization (aHR: 1.199; 95% CI: 1.037-1.388, P = 0.014) at 5 years. The results were consistent at the 2-year endpoints. In patients with CPCI, BP-DES use was associated with significantly higher MACE rates at 5 years (aHR: 1.256; 95% CI: 1.078-1.462, P = 0.003) and total coronary revascularization (aHR: 1.257; 95% CI: 1.052-1.502, P = 0.012) compared with that of DP-DES, but there was a similar risk at 2 years. However, BP-DES had comparable safety and efficacy profiles including MACE and total coronary revascularization compared with DP-DES in patients with non-CPCI at 2 and 5 years.ConclusionsPatients underwent CPCI remained at a higher risk of mid- to long-term adverse events regardless of the stent type. The effect of BP-DES compared with DP-DES on outcomes was similar in CPCI and non-CPCI patients at 2 years but had inconsistent effects at the 5-year clinical endpoints.

Dataset Information

Bifurcation strategies using second-generation drug-eluting stents on clinical outcomes in diabetic patients.

Background

Methods

Results

Conclusion

Clinical trial registration

Publications

Bifurcation strategies using second-generation drug-eluting stents on clinical outcomes in diabetic patients.

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