Long-term clinical outcomes of drug-eluting stents vs. bare-metal stents in Chinese geriatric patients

Background & Objective Little is known about the relative efficacies of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and bare-metal stents (BMS) in elderly patients. The objective of this study was to evaluate the clinical outcome for geriatric patients who received either DES or BMS. Methods From January 2002 to October 2005, 199 consecutive Chinese geriatric patients (≥ 75 years old) underwent PCI with coronary DES or BMS implantation at our institution. We analyzed the major clinical end points that included all-cause mortality, cardiovascular death, myocardial infarction, target lesion revascularization (TLR), stent thrombosis, and bleeding complications. Results The three-year cumulative rates of all-cause mortality, cardiovascular death, and myocardial infarction were significantly lower in the DES group (6.3%, 3.6%, 5.4%) compared with the BMS group (16.2%, 11.5%, 14.9%; P < 0.05). No significant differences were found in the three-year cumulative rate for target lesion revascularization (6.3% vs. 4.6%, P = 0.61) or stent thrombosis (3.6% vs. 2.3%, P = 0.70). Likewise, there were no statistically significant differences in the cumulative rate for intracranial hemorrhage, or major and minor hemorrhage at three years. Conclusions DES-based PCI was associated with a significant reduction in the three-year cumulative rate of all-cause mortality, cardiovascular death, and myocardial infarction compared with BMS, without increased risk of TLR, stent thrombosis, or bleeding complications at three years in this group of Chinese geriatric patients.     

Prolonged effectiveness of coronary artery bypass surgery versus drug-eluting stents in diabetics with multi-vessel disease: An updated systematic review and meta-analysis

Background

Currently, the appropriateness of percutaneous coronary intervention (PCI) using drug-eluting stents (DES) versus coronary artery bypass grafting (CABG) for patients with diabetes (DM) and multi-vessel disease (MVD) is uncertain due to limited evidence from few randomised controlled trials (RCTs). We aimed to compare the clinical effectiveness of CABG versus PCI-DES in DM-MVD patients using an evidence-based approach.

Methods

A systematic review and meta-analyses were conducted to compare the risk of all-cause mortality, myocardial infarction (MI), repeat revascularisation, cerebrovascular events (CVE), and major adverse cardiac or cerebrovascular events (MACCE).

Results

A total of 1,837 and 3,052 DM-MVD patients were pooled from four RCTs (FREEDOM, SYNTAX, VA CARDS, and CARDia) and five non-randomised studies. At mean follow-up of 3 years, CABG compared with PCI-DES was associated with a lower risk of all-cause mortality and MI in RCTs. By contrast, no significant differences were observed in the mean 3.5-year risk of all-cause mortality and MI in non-randomised trials. However, the risk of repeat revascularisations following PCI-DES compared with CABG was 2.3 (95% CI = 1.8–2.8) and 3.0 (2.3–4.2)-folds higher in RCTs and non-randomised trials, respectively. Accordingly, the risk of MACCE at 3 years following CABG compared with PCI-DES was lower in both RCTs and non-randomised trials [0.65 (: 0.55–0.77); and 0.77 (0.60–0.98), respectively].

Conclusions

Based on our pooled results, we recommend CABG compared with PCI-DES for patients with DM-MVD. Although non-randomised trials suggest no additional survival-, MI-, and CVE- benefit from CABG over PCI-DES, these results should be interpreted with care.     

Percutaneous revascularization strategies in small-vessel disease

Percutaneous coronary intervention (PCI) of small coronary vessels represents a real challenge for myocardial revascularization because of the high risk of stent-restenosis and increased risk of adverse clinical events. Moreover, small coronary arteries supply small myocardial territories therefore questioning the clinical significance of small-vessel stenoses. The definition of small-vessel disease and PCI-strategies used are very heterogeneous across studies. The present review will focus on percutaneous coronary revascularization in patients with small vessel coronary artery disease.     

Safety and efficacy of drug-eluting stents and bare metal stents in acute coronary syndrome

Compared with medical therapy, percutaneous coronary intervention has been shown to reduce the rates of death and recurrent ischemia in patients presenting with acute coronary syndromes (ACS). In the current interventional era, both drug-eluting stents (DES) and bare-metal stents (BMS) have been widely used, despite the fact that the use of DES in the context of ACS was initially an “off-label” indication and that ACS has been associated with stent thrombosis (ST). In contrast to the wealth of data available for the use of DES in patients with ST-elevation myocardial infarction, data regarding the performance of DES in non–ST-elevation ACS is restricted to a handful of registries with conflicting data. The aim of this review was to summarize the safety and efficacy of DES in the entire spectrum of ACS.     

One-year clinical outcomes in patients with very small coronary artery disease treated with drug-eluting stents: An observational study in the Indian population

Percutaneous coronary intervention (PCI) in very small vessel coronary arteries is challenging due to adverse short-term as well as long-term outcomes. This single-arm, open-label, observational study assessed 1-year clinical outcomes of drug-eluting stents (DES) in Indian patients undergoing PCI for symptomatic very small-calibre coronary artery disease. It enrolled 66 Indian patients with 74 very small coronary artery lesions (reference vessel diameter: ≥2.0 and ≤ 2.25 mm); eligible for implantation with 2.25 mm DES. The primary endpoint of major adverse cardiovascular events (MACE) was 3.0% indicating favourable 1-year clinical outcomes of DES in very small coronary artery lesions in Indian patients.     

Safety and effectiveness of percutaneous coronary intervention using rotational atherectomy and new-generation drug-eluting stents for calcified coronary artery lesions in patients with chronic kidney disease

AimCoronary artery calcification is an important factor influencing revascularisation outcomes in patients with chronic kidney disease (CKD). Lesion preparation using rotational atherectomy (RA) may help adequately modify calcified plaques and facilitate the achievement of optimal clinical outcomes in these patients. In this study, we assessed the safety and effectiveness of percutaneous coronary intervention (PCI) using RA followed by new-generation drug-eluting stent (DES) implantation in patients with CKD and calcified coronary artery disease (CAD).Methods and resultsFrom November 2014 to October 2019, a total of 203 patients with calcified CAD who underwent RA followed by second- or third-generation DES implantation at our centre were included in the study. Mild, moderate, and severe CKD was present in 38%, 55.5%, and 6.5% of the patients, respectively. Diffused coronary calcifications were present in 85%. Procedural success was 97.5% with minimal periprocedural complications. In-stent restenosis occurred in one patient (0.5%); major adverse cardiovascular and cerebrovascular events were reported in 22 patients (10.8%); cardiac death occurred in eight patients during follow-up.ConclusionPercutaneous coronary intervention using RA followed by second- or third-generation DES implantation is feasible and safe with high procedural success and low in-stent restenosis in CKD patients with calcified coronary lesions.     

Comparison of sirolimus-, paclitaxel-, and everolimus-eluting stent in unprotected left main coronary artery percutaneous coronary intervention

ObjectivesThis retrospective study evaluated the outcomes of patients who underwent unprotected left main coronary artery (ULMCA) percutaneous coronary intervention (PCI) with different types of drug-eluting stents (DES).BackgroundThe standard of care for patients with ULMCA is coronary artery bypass surgery. However, current guidelines recommend PCI in clinical conditions where there is an increased risk of adverse surgical outcomes. Clinical outcomes of patients undergoing ULMCA PCI with different types of drug-eluting stents (DES) are unknown.MethodsData from a multicenter international registry, which included 239 consecutive patients from four institutions who ULMCA PCI with DES, were collected.ResultsThere were 42 patients receiving paclitaxel-eluting stent (PES), 158 patients receiving sirolimus-eluting stent (SES), and 39 patients receiving everolimus-eluting stent (EES). There was no statistical difference in major adverse cardiovascular events, cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis among PES, SES, and EES at 30 days and 1 year.ConclusionsThere are no differences in clinical events among patients receiving PES, SES, and EES for ULMCA disease.     

Safety and efficacy of degradable vs. permanent polymer drug-eluting stents: A meta-analysis of 18,395 patients from randomized trials

Background

Degradable polymer drug-eluting stents (DP-DES) represent a promising strategy to improve the delayed healing and hypersensitive reaction in the vessel. However, the efficacy and safety of DP-DES vs. permanent polymer drug-eluting stents (PP-DES) are less well defined. The aim of this meta-analysis was to compare the total, short (< 30 days), mid (30 days–1 year) and long (> 1 year) term outcomes of DP-DES vs. PP-DES.

Methods

PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for randomized clinical trials to compare any of approved DP- and PP-DES. Efficacy endpoints were target-lesion revascularization (TLR) and in-stent late loss (ISLL). Safety endpoints were death, myocardial infarction (MI), and composite of definite and probable stent thrombosis (ST).

Results

The meta-analysis included 19 RCTs (n = 18,395) with interesting results. As compared with DES, there was a significantly reduced very late ST (OR [95% CI] = 0.42 [0.24–0.77], p = 0.852) and ISLL (OR [95% CI] = − 0.07 [− 0.12–0.02], p = 0.000) in DP-DES patients. However, there were no differences between DP-DES and PP-DES for other safety and efficiency outcomes, except that the stratified analysis showed a significant decreased TLR with DP-DES as compared to paclitaxel-eluting stent (OR [95% CI] = 0.41 [0.20–0.81], p = 0.457).

Conclusions

DP-DES are more effective in reducing very late ST and ISLL, as well as comparable to PP-DES with regard to death, TLR and MI. Further large RCTs with long-term follow-up are warranted to better define the relative merits of DP-DES.     

Simultaneous late stent thrombosis in two coronary arteries following drug-eluting stent implantation

Late stent thrombosis has emerged as an infrequent but serious complication of drug-eluting stent (DES) implantation. Premature cessation of dual antiplatelet therapy is the most common risk factor for its occurrence. In the era of multivessel stenting with DES, there is a potential for multivessel late stent thrombosis following cessation of dual antiplatelet therapy. We present a rare case of a patient who sustained simultaneous late stent thromboses in DESs implanted in two coronary arteries as a result of premature cessation of dual antiplatelet therapy.     

Comprehensive Meta-Analysis on Drug-Eluting Stents versus Bare-Metal Stents during Extended Follow-up

Background

Several observational reports have documented both increased and decreased cardiac mortality or Q-wave myocardial infarction with drug-eluting stents compared with bare-metal stents.

Methods

We sought to evaluate the safety and efficacy of drug-eluting stents compared with bare-metal stents early after intervention (<1 year) and late (>1 year) among a broad population of patients, using a meta-analysis of randomized clinical trials.

Results

We identified 28 trials with a total of 10,727 patients and a mean follow-up of 29.6 months. For early outcomes (<1 year), all-cause mortality for drug-eluting stents versus bare-metal stents was 2.1% versus 2.4% (risk ratio [RR] 0.91, [95% confidence interval (CI), 0.70-1.18]; P = .47), non-Q-wave myocardial infarction was 3.3% versus 4.4% (RR 0.78 [95% CI, 0.61-1.00]; P = .055), target lesion revascularization was 5.8% versus 18.4% (RR 0.28 [95% CI, 0.21-0.38]; P <.001), and stent thrombosis was 1.1% versus 1.3% (RR 0.87 [95% CI, 0.60-1.26]; P = .47). For late outcomes (>1 year), all-cause mortality for drug-eluting stents versus bare-metal stents was 5.9% versus 5.7% (RR 1.03 [95% CI, 0.83-1.28]; P = .79), target lesion revascularization was 4.0% versus 3.3% (RR 1.22 [95% CI, 0.92-1.60]; P = .16), non-Q-wave myocardial infarction was 1.6% versus 1.2% (RR 1.36 [95% CI, 0.74-2.53]; P = .32) and stent thrombosis was 0.7% versus 0.1% (RR 4.57 [95% CI, 1.54-13.57]; P = .006).

Conclusions

There was no excess mortality with drug-eluting stents. Within 1 year, drug-eluting stents appear to be safe and efficacious with possibly decreased non-Q-wave myocardial infarction compared with bare-metal stents. After 1 year, drug-eluting stents still have similar mortality, despite increased stent thrombosis. The reduction in target lesion revascularization with drug-eluting stents mainly happens within 1 year, but is sustained thereafter.     

Ultra-thin everolimus-eluting stents in atherosclerotic lesions: Three years follow-up with subgroup analysis of ultra-long stents

ObjectivesTo assess the long-term (3 years) safety and efficacy of Tetrilimus everolimus-eluting stent (EES) and subgroup analysis of outcomes of ultra-long (44/48 mm) Tetrilimus EES implantation in patients with long coronary lesions.Material and methodsIn this observational, single-centre, single-arm, investigator-initiated registry, 558 patients who underwent implantation of Tetrilimus EES for the treatment of coronary artery disease were retrospectively included. The primary endpoint was occurrence of any major adverse cardiac event (MACE) at 12 months follow-up (composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR]) and we hereby report 3 years follow-up data. Stent thrombosis was assessed as a safety endpoint. A subgroup analysis of patients with long coronary lesions is also reported.ResultsA total of 558 patients (57.0 ± 10.2 years) received 766 Tetrilimus EES (1.3 ± 0.5 stents/patient) to treat 695 coronary lesions. In subgroup analysis of 143 patients implanted with ultra-long EES, 155 lesions were intervened successfully with only one Tetrilimus EES (44/48 mm) implanted per lesion. At 3 years, event rates of 9.1% MACE with predominance of MI (4.4%), followed by 2.9% TLR and 1.7% cardiac death, and only 1.0% stent thrombosis were reported in overall population, while in a subgroup of patients implanted with ultra-long EES, 10.4% MACE and 1.5% stent thrombosis were reported.ConclusionsThree years clinical outcomes showed favourable long-term safety and excellent performance of Tetrilimus EES in high-risk patients and complex coronary lesions in routine clinical practice, including a subgroup of patients with long coronary lesions, with acceptable primary and safety endpoints.     

Stent thrombosis is not increased following percutaneous coronary intervention in patients with non-insulin dependent diabetes mellitus taking metformin

Objective

Recent studies have suggested that metformin may inhibit endothelialization following limus-eluting stent (LES) placement and may increase the risk of stent thrombosis. Therefore, we assessed the impact of metformin on stent thrombosis and major adverse cardiovascular events (MACE) in non-insulin-dependent diabetes mellitus (NIDDM) patients who receive drug-eluting stents (DES).

Methods

We assessed the impact of metformin and stent type on stent thrombosis, MACE, and death in NIDDM patients following DES placement. Of the 1201 patients included, 74.8% received LES, 25.2% received paclitaxel-eluting stents (PES), and 55% were taking metformin.

Results

There was no difference in stent thrombosis, regardless of stent type or metformin use. While Kaplan–Meier curves demonstrated reduced MACE (p = 0.007) and death (p = 0.006) with metformin use, multivariate analysis demonstrated that stent type and metformin use were not associated with outcome.

Conclusion

In NIDDM patients, metformin use or stent type following DES placement did not increase stent thrombosis and MACE rates.     

聚合物可降解支架对维持性血液透析合并急性冠状动脉综合征患者的疗效

目的探讨聚合物可降解药物洗脱支架(DES)治疗维持性血液透析(MHD)合并急性冠状动脉综合征患者的疗效。方法入选2008年1月至2013年7月沈阳军区总医院血液透析科100例MHD合并急性冠状动脉综合征的患者进行经皮冠状动脉介入治疗(PCI),将患者随机分为两组,置入EXCEL支架(聚合物可降解DES)组50例,置入FIREBIRD支架(普通DES)组50例。其中男61例,女39例,年龄43~74(58.4±9.2)岁。常规行PCI,术后EXCEL组患者服用阿司匹林(100 mg,每日一次)和氯吡格雷(75 mg,每日一次)双联抗血小板治疗(DAPT)6个月,随后长期服用阿司匹林(100 mg,每日一次);FIREBIRD组患者应用阿司匹林(100 mg,每日一次)和氯吡格雷(75 mg,每日一次)12个月,随后长期服用阿司匹林(100 mg,每日一次)。观察术后12个月患者主要不良心脑血管事件(MACCE)和出血事件的发生情况。结果两组患者入院时临床及造影基线资料差异无统计学意义(P0.05),住院期间未发生MACCE。术后12个月内两组患者MACCE发生率差异无统计学意义(P0.05),未发生支架血栓。术后12个月内EXCEL组主要出血1例,为消化道溃疡所致;FIREBIRD组主要出血2例,均为脑出血。FIREBIRD组总出血事件显著高于EXCEL组(P0.05)。结论聚合物可降解DES治疗MHD合并ACS患者有效,应用6个月的DAPT是安全的。     

Twelve-months clinical outcomes of biodegradable polymer-coated sirolimus-eluting coronary stent in real-world patients: A single-center experience.

This study was designed to evaluate the safety and performance of Metafor? SES in real-world patients with coronary artery disease. This was retrospective, single-centre, post-marketing, observational study. The primary endpoint was the occurrence of major adverse cardiac event (MACE). A total of 141 patients (187 lesions) were treated with the study device. The average stent length and diameter was 24.75 ± 9.50 mm and 2.93 ± 0.38 mm, respectively. The cumulative incidence of MACE was 1.42%. No incidence of stent thrombosis was observed at 12-months follow-up. This retrospective study demonstrated favourable safety and performance of Metafor? SES.     

Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a meta-analysis.

AIMS: To evaluate the effect of drug-eluting vs. bare metal stents for the treatment of coronary artery disease on overall, cardiac, and non-cardiac mortalities. METHODS AND RESULTS: We conducted a systematic literature search to identify all randomized controlled trials comparing sirolimus or paclitaxel-eluting stents with bare metal stents and reporting mortality data after at least 1 year of follow-up. Trial data were reviewed and extracted independently by two investigators in an unblinded standardized manner. Seventeen trials including a total of 8221 patients were analysed. Peto's odds ratios (ORs) for total mortality after 1 (n=8221), 2 (n=4631), 3 (n=4105), and 4 (n=1293) years of follow-up were 0.94 [95% confidence interval (CI) 0.66-1.34], 1.11 (95% CI 0.76-1.61), 1.25 (95% CI 0.91-1.73), and 1.46 (95% CI 0.92-2.31), respectively. Corresponding ORs for non-cardiac mortality were 1.07 (95% CI 0.64-1.80), 1.72 (95% CI 1.01-2.94), 1.45 (95% CI 0.93-2.25), and 1.65 (95% CI 0.89-3.10). There was no difference in OR for cardiac mortality among all trials. In sensitivity analyses, sirolimus- but not paclitaxel-eluting stents were associated with an increase in non-cardiac mortality at 2 and 3 years of follow-up. CONCLUSION: Drug-eluting stents for the treatment of coronary artery disease do not reduce total mortality when compared with bare metal stents. Preliminary evidence suggests that sirolimus- but not paclitaxel-eluting stents may lead to increased non-cardiac mortality. Long-term follow-up and assessment of cause-specific deaths in patients receiving drug-eluting stents is mandatory to determine the long-term safety of these devices.     

Drug eluting balloon versus drug eluting stent in percutaneous coronary interventions: Insights from a meta-analysis of 1462 patients

Background

Drug eluting balloons (DEB) have been developed to overcome the limitations of drug eluting stents (DES), but clinic results of various DEB studies are still not consistent. Thus, we performed a meta-analysis to compare outcomes of DEB and DES for the treatment of coronary artery disease (CAD).

Methods

Medline/Web databases were searched for studies comparing DEB and DES for obstructive CAD, reporting late lumen loss (LLL) and rates for overall mortality, myocardial infarction (MI), stent thrombosis (ST) and target lesion revascularization (TLR).

Results

8 studies (1462 patients) were included in the meta-analysis. Compared with DES, DEB treated patients showed non-significantly higher LLL (weighted mean difference [WMD] 0.32, 95% confidence interval [CI] − 0.15 to 0.78, P = 0.18) and non-significantly higher rate of binary restenosis (odds ratio [OR] 1.40 [0.68–2.48], P = 0.36). Mortality (OR 1.13[0.54–2.37], P = 0.74), MI (OR 0.95, [0.50–1.80], P = 0.87), ST (OR 1.12, [0.34–4.19], P = 0.77) and TLR rates (OR 1.19[0.60–2.38], P = 0.61) were similar between the 2 treatments. A pre-specified meta-regression analysis showed that LLL WMD and TLR OR were inversely correlated to the prevalence of diabetes (P < 0.0001) and directly correlated to reference coronary diameters (P < 0.001).

Conclusions

The present meta-analysis showed that compared to DES, DEB use resulted in similar clinical efficacy and safety. Thus DEB could be considered a reasonable alternative to DES for the treatment of CAD in selected clinical settings (Clinicaltrials.gov identifier: NCT01760200).     

Real-world five-year outcomes of FlexyRap? cobalt-chromium rapamycin-eluting stents with biodegradable polymer in patients with de-novo coronary artery disease

BACKGROUND The use of biodegradable polymer drug-eluting stents(BP-DES) has been proven to minimize restenosis and stent thrombosis. The current post-marketing monitoring was observed at the 5-year clinical outcomes of individuals who had been treated with FlexyRap^? DES in the real world.AIM To assess the safety and effectiveness of FlexyRap^? DES at the 5-year follow-up in real-world settings.METHODS Findings from a retrospective, multi-center, observational, post-market cl...