Five-Year Outcomes in Patients With Chronic Total Coronary Occlusion Treated With Drug-Eluting vs Bare-Metal Stents: A Case-Control Study

Background

Limited data exist on long-term safety and effectiveness of drug-eluting stents (DESs) in true chronic total coronary occlusion (CTO) settings. We evaluated 5-year clinical outcomes of patients with CTO treated successfully with DES vs bare-metal stent (BMS).

Methods

We compared the 5-year clinical outcomes of 156 patients treated with DES implantation with outcomes of a historical cohort of 159 patients treated with BMS. Primary end point was freedom from major adverse cardiac events (MACEs; defined as death, myocardial infarction [MI], and target lesion revascularization [TLR]); secondary end points were freedom from target vessel failure (TVF; combination of target vessel revascularization, MI, and cardiac death) and TLR at 5 years.

Results

After 5 years, the DES group had significantly superior event-free survival from MACE (84% vs 69%; log rank P < 0.001), TVF (71% vs 84%; P = 0.002), and TLR (77% vs 92%; P = 0.0001), compared with the BMS group. The Cox proportional hazards model identified BMS vs DES (adjusted hazard ratio [HR] = 3.37; 95% confidence interval [CI], 1.85-6.17; P = 0.001), final minimal lumen diameter (HR, 0.27; 95% CI, 0.14-0.52; P = 0.0001), and stent length (HR, 1.01; 95% CI, 1.00-1.03; P = 0.03) as independent predictors of MACE at 5-year follow-up. Twelve (7%) and 7 (4%) stent thromboses occurred in the DES and BMS groups (P = 0.23), respectively.

Conclusions

After 5 years, DESs were superior to BMSs in reducing MACE, TVF, and TLR in patients with CTO and should be the preferred strategy.     

Comparison of rotational atherectomy and modified balloons prior to drug-eluting stent implantation for the treatment of heavily calcified coronary lesions

The optimal strategy for lesion preparation in heavily calcified coronary lesions (HCCL) prior to drug-eluting stent (DES) implantation remains debatable. This study sought to compare the performance of rotational atherectomy (RA) and modified balloon (MB)-based strategy in patients with HCCL receiving current-generation DES.This retrospective study comprised 564 consecutive patients who underwent RA (n = 229) or MB (n = 335) for HCCL at our hospital and were treated with DES. Baseline clinical and angiographic data was obtained from our database. Patients were clinically monitored for the occurrence of any adverse events during the hospitalization. One-year follow-up was conducted by either telephone contact or outpatient visits. 1:1 propensity score matching (PSM) was performed to balance the baseline covariates. After PSM, the clinical outcomes between the 2 groups were compared.After PSM, except more target lesion in right coronary artery existing in the RA group (P = .008), no significant statistical differences were shown in regard of the other angiographic and procedural characteristics of the 2 groups. Strategy success rates were all 100% in both groups. In the unadjusted Cox proportional hazard analysis, participants with RA had a significantly lower risk of target lesion revascularization (TLR) (hazard ratio, HR 0.275, 95% confidence intervals, CI 0.119–0.635, P = .003) and major adverse cardiac event (MACE) (HR 0.488, 95% 0.277–0.859, P = .013). After adjusting for potential confounding variables, RA was significantly associated with TLR (HR 0.32, 95% 0.12–0.853, P = .023), but no longer significantly associated with MACE (HR 0.674, 95% 0.329–1.381, P = .282).In patients with HCCL, lesion preparation with RA was safe and could improve strategy success rate. There was lower rate of TLR with RA, however, no significant difference was found in the MACE rate at 1-year follow-up between RA and MB-based strategy.     

It Is Not Mandatory to Use Triple Rather Than Dual Anti-Platelet Therapy After a Percutaneous Coronary Intervention With a Second-Generation Drug-Eluting Stent

It has been shown that triple antiplatelet therapy with cilostazol results in better clinical outcomes than dual therapy in patients treated with a first-generation drug-eluting stent (DES); however, it is unclear whether triple antiplatelet therapy has a similar efficacy after the implantation of second-generation DES.In the COACT (Cath Olic medical center percutAneous Coronary in Tervention) registry, 1248 study subjects who underwent percutaneous coronary intervention with an everolimus- or zotarolimus-eluting stent (Endeavor, Xience V, or Promus) were analyzed. The patients were divided into 2 groups after propensity score matching (n = 724; M = 422 [58.3%]; mean age = 66.1 ± 11.0 years): Group 1: patients treated with dual antiplatelet drugs (aspirin and clopidogrel; n = 362; M = 213 [58.8%]; mean age = 65.6 ± 11.7 years); Group 2: patients treated with triple antiplatelet drugs (aspirin, clopidogrel, and cilostazol; n = 362; M = 209 [57.7%]; mean age = 65.6 ± 11.7 years). The mean follow-up duration was 13 ± 10 months, and the cumulative incidence of major cardiovascular events (MACE) was 6.3% in Group 1 and 7.7% in Group 2. There were no significant differences in MACE (death, nonfatal myocardial infarction, and stroke) between the 2 groups (OR, 1.210; 95% CI: 0.772–1.898; P = 0.406). Kaplan–Meier curves for MACE did not show any survival benefit for triple antiplatelet therapy, even in patients with acute coronary syndrome.In patients treated with a second-generation DES implantation, there is no added clinical benefit to using triple rather than dual antiplatelet therapy.     

Comparison of first- and second-generation drug-eluting stent efficacies for treating left main and/or three-vessel disease: a propensity matched study

The efficacy of second-generation drug-eluting stent (DES) for the treatment of left main disease (LM) and/or three vessel disease (3VD) remains unclear. We compared 2-year outcomes of second- versus first -generation DES implantation among patients with LM and/or 3VD and to assess the differential of risk by complexity of coronary artery disease using synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) scores. Between April 2007 and December 2012, 341 patients with LM and/or 3VD were treated by percutaneous coronary intervention; 154 with first-generation DES and 137 with second-generation DES. After propensity matching, 101 patients remained in each group. The rate of target lesion revascularization (TLR) and major adverse cardiac event (MACE) were compared. TLR and MACE at 2 years were more common in the first- compared with second-generation DES group (TLR 19.8 vs. 8.9 %; p = 0.016, MACE 24.8 vs. 10.9 %; p = 0.008). In patients with low (0–22) and intermediate (23–32) SYNTAX scores, TLR and MACE tended to occur more often with first-generation DES group. In patients with high SYNTAX scores (≧33), TLR and MACE were significantly more common with first-generation DES group (TLR 29.0 vs. 11.1 %; p = 0.035, MACE 35.5 vs. 13.9 %; p = 0.034). Compared with first-generation DES, second-generation DES proved beneficial in reducing risk of TLR and MACE in patients with LM and/or 3VD, particularly among those with high SYNTAX scores (≧33).     

ST-segment elevation versus non-ST-segment elevation myocardial infarction in current smokers after newer-generation drug-eluting stent implantation

We compared the 2-year major clinical outcomes between ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) in patients who are current smokers who underwent successful percutaneous coronary intervention (PCI) with newer-generation drug-eluting stents (DESs). The availability of data in this regard is limited.A total of 8357 AMI patients were included and divided into 2 groups: the STEMI group (n = 5124) and NSTEMI group (n = 3233). The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined as all-cause death, recurrent myocardial infarction (re-MI), or coronary repeat revascularization. The secondary endpoints were the cumulative incidences of the individual components of MACE and stent thrombosis (definite or probable).After propensity score-matched (PSM) analysis, 2 PSM groups (2250 pairs, C-statistics = 0.795) were generated. In the PSM patients, both for 1 month and at 2 years, the cumulative incidence of MACE (P = .183 and P = .655, respectively), all-cause death, cardiac death, re-MI, all-cause death or MI, any repeat revascularization, and stent thrombosis (P = .998 and P = .341, respectively) was not significantly different between the STEMI and NSTEMI groups. In addition, these results were confirmed using multivariate analysis.In the era of contemporary newer-generation DESs, both during 1 month and at 2 years after index PCI, the major clinical outcomes were not significantly different between the STEMI and NSTEMI groups confined to the patients who are current smokers. However, further research is needed to confirm these results.     

Influence of hemodialysis duration on mid-term clinical outcomes in hemodialysis patients with coronary artery disease after drug-eluting stent implantation

Accelerated atherosclerosis in prolonged maintenance hemodialysis (HD) has been recognized; however, whether HD duration is associated with poor clinical outcome in HD patients with coronary artery disease (CAD) after drug-eluting stent (DES) implantation is unknown. We evaluated the impact of HD duration on clinical outcomes in HD patients with CAD after DES implantation. Between April 2007 and December 2012, 168 angina pectoris patients (320 de novo lesions) on HD were treated with DES. Major adverse cardiovascular events (MACE) and target lesion revascularization (TLR) were investigated at 3 years according to the HD duration (≤3 years, 83 patients; >3 years, 85 patients). The incidence of MACE was significantly higher in the long HD duration group (25.3 vs. 50.6 %; P = 0.001). Especially, sudden cardiac death (SCD) was significantly higher in the long HD duration group (3.6 vs. 16.5 %; P = 0.006). On the other hand, the rates of TLR were similar between the two groups (12.0 vs. 14.1 %; P = 0.69). Cox’s proportional hazard analysis revealed that HD duration (HR 1.08 per year, 95 % CI 1.03–1.13, P = 0.002), β-blocker use (0.28, 0.17–0.46, P < 0.001), and diabetes mellitus (2.10, 1.23–3.56, P = 0.007) were independent predictors of MACE. Longer HD duration did not affect TLR; however, SCD was significantly higher in the long HD duration group.     

Comparison between sirolimus- and paclitaxel-eluting stents for the treatment of older patients affected by coronary artery disease: results from a single-center allcomers registry

The treatment of elderly patients with coronary artery disease (CAD) is challenging because this population is complex and greatly expanding. Drug-eluting stents (DES) generally improve the outcome in high-risk cases. We evaluated the clinical impact of different first-generation DES, i.e., sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), in this context. A prospective, nonrandomized, single-center, allcomers registry consecutively enrolling all patients aged ≥75 years eligible for percutaneous coronary intervention (PCI) with DES was carried out. Only one type of DES was implanted per protocol for each patient. Two groups were identified according to the type of implanted stent, i.e., SES and PES. The primary end point encompassed major adverse cardiac events (MACE), including death, myocardial infarction, and target lesion revascularization (TLR). The secondary end point encompassed the rate of definite/probable stent thrombosis and target vessel revascularization (TVR). From June 2004 to May 2008, 151 patients were enrolled. Among them, 112 (74.2%) received SES and 39 (25.8%) received PES. Baseline clinical characteristics were similar, while few angiographic features (ostial location, stent diameter, proximal reference vessel diameter) showed minor differences. At the median follow-up of 22.6 months, primary and secondary end points did not significantly differ in terms of MACE (SES 12.5% vs PES 20.5%, P = 0.3), death (SES 5.4% vs PES 7.7%, P = 0.7), myocardial infarction (SES 4.5% vs PES 10.3%, P = 0.2), TLR (SES 2.7% vs PES 2.6%, P = 1.0), stent thrombosis (SES 1.8% vs PES 5.1%, P = 0.3), and TVR (SES 1.8% vs PES 0%, P = 0.6). In this real-world population of elderly patients treated by DES–PCI for CAD, the overall efficacy and safety have been excellent in both DES, and the choice between SES and PES did not influence the clinical outcome.     

Resultado del tratamiento percutáneo de la reestenosis de stents farmacoactivos: ¿depende de si el stent tenía o no recubrimiento polimérico?

Introduction and objectivesOutcomes of patients undergoing percutaneous intervention for drug-eluting stent (DES) restenosis are poorer than those in patients with bare-metal stent restenosis. It is unknown if this is related to the presence of polymer coating. We sought to compare outcomes after interventions for in-stent restenosis (ISR) of polymer-free DES vs durable polymer DES.MethodsPatients enrolled in the ISAR-TEST 5 randomized trial who underwent repeat percutaneous intervention for ISR during follow-up were included. Angiographic outcomes at 6 to 8 months and clinical outcomes at 2 years were analyzed and compared between 2 groups according to whether the restenosed stent was a polymer-free or a durable polymer DES. Multivariate analysis was used to adjust for differences between groups.ResultsA total of 326 patients with ISR were included: 220 with ISR in polymer-free DES and 106 with ISR in durable polymer DES. Angiographic follow-up was available for 83.4% of patients. No difference was observed in recurrent binary restenosis between the 2 groups (31.7% vs 27.0%; P = .38; P_adjusted = .29). At 2 years, the composite of death, myocardial infarction, or repeat target lesion revascularization were similar between the 2 groups (35.7% vs 34.0%; HR = 1.04, 95%CI, 0.70-1.55; P = .83; P_adjusted = .79). The rate of repeat target lesion revascularization was also similar in the 2 groups (29.8% vs 31.5%; HR = 0.91, 95%CI, 0.60-1.39; P = .68; P_adjusted = .62).ConclusionsIn patients undergoing reintervention for DES-ISR, we found no evidence of differences in outcomes according to whether the restenosed stent was a polymer-free or durable polymer DES.     

Safety and efficacy of biodegradable polymer-coated biolimus-eluting stents

BackgroundUsing drug eluting stents with a biodegradable polymer ensures that both the drug and coating are absorbed from the stent surface after completing their functions, which may reduce the need for prolonged antiplatelet therapy and decrease the risk of late stent thrombosis.ObjectivesOur study sought to compare the safety and efficacy of a biolimus-eluting stent (with biodegradable polymer) with a well-established sirolimus- or paclitaxel-eluting stent (with durable polymers).MethodsWe undertook a prospective, randomized, comparative study that included 145 patients with chronic stable coronary artery diseases or acute coronary syndromes. The patients were randomized for treatment with either biolimus-eluting (n = 62) or sirolimus/paclitaxel-eluting (n = 83) stents. The study endpoint was a composite of major adverse cardiac events (MACE) within 2 years. Angiographic follow-up was scheduled at the end of the study or earlier if clinically indicated.ResultsAt the two-year follow-up, a biodegradable polymer biolimus-eluting stent showed comparable safety and efficacy to permanent polymer DES(5[8.1%] patients in the biolimus group vs.8[9.6%] in the sirolimus/paclitaxel group, p = 0.7). The incidence of mortality, myocardial infarction, cerebrovascular accident and target lesion revascularization was similar for both stent types. Furthermore, the incidence of stent thrombosis was statistically non-significant between both the groups.ConclusionThe use of a biodegradable polymer-based DES (biolimus-eluting) demonstrated satisfactory efficacy and safety profiles with low MACE and stent thrombosis rates up to 2 years compared with other non-biodegradable polymer-based DES.     

药物洗脱支架置入治疗不同时期冠状动脉支架内再狭窄对比研究

目的 比较药物洗脱支架(DES)治疗早期(≤1年)、晚期(＞1年)支架内再狭窄病变(ISR)患者的长期临床疗效。方法 收集2008年10月至2011年12月在北京安贞医院因ISR接受DES置入治疗并完成临床随访的患者资料,根据DES术后发生ISR的时间是否大于1年分为早期ISR组与晚期组。比较两组组患者术后1年的主要不良心血管事件［MACE,包括全因死亡、心肌梗死(MI)和靶病变再次血运重建(TLR)］。结果 早期ISR组入选患者80例,晚期ISR组入选患者124例。早期ISR组不稳定型心绞痛发生率明显低于晚期ISR组,差异有统计学意义(27.5%对63.7%,P<0.01);其余基线资料差异无统计学意义(P>0.05)。两组在病变部位、病变类型、病变长度方面比较差异均无统计学意义(P>0.05)。早期ISR组MACE发生率明显高于晚期ISR组(30%对15.3%,P<0.01),其中早期ISR组TLR明显高于晚期ISR组,差异有统计学意义(26.3%对12.1%,P<0.01)。结论 DES治疗ISR患者安全有效,但治疗早期ISR组病变TLR发生率高于晚期ISR组。     

Long-term outcomes of biodegradable polymer versus durable polymer drug-eluting stents in patients with diabetes a pooled analysis of individual patient data from 3 randomized trials

Background

There is ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. Biodegradable polymer drug-eluting stents (BP-DES) may potentially improve clinical outcomes in these high-risk patients. We sought to compare long-term outcomes in patients with diabetes treated with biodegradable polymer DES vs. durable polymer sirolimus-eluting stents (SES).

Methods

We pooled individual patient-level data from 3 randomized clinical trials (ISAR-TEST 3, ISAR-TEST 4 and LEADERS) comparing biodegradable polymer DES with durable polymer SES. Clinical outcomes out to 4 years were assessed. The primary end point was the composite of cardiac death, myocardial infarction and target-lesion revascularization. Secondary end points were target lesion revascularization and definite or probable stent thrombosis.

Results

Of 1094 patients with diabetes included in the present analysis, 657 received biodegradable polymer DES and 437 durable polymer SES. At 4 years, the incidence of the primary end point was similar with BP-DES versus SES (hazard ratio = 0.95, 95% CI = 0.74–1.21, P = 0.67). Target lesion revascularization was also comparable between the groups (hazard ratio = 0.89, 95% CI = 0.65–1.22, P = 0.47). Definite or probable stent thrombosis was significantly reduced among patients treated with BP-DES (hazard ratio = 0.52, 95% CI = 0.28–0.96, P = 0.04), a difference driven by significantly lower stent thrombosis rates with BP-DES between 1 and 4 years (hazard ratio = 0.15, 95% CI = 0.03–0.70, P = 0.02).

Conclusions

In patients with diabetes, biodegradable polymer DES, compared to durable polymer SES, were associated with comparable overall clinical outcomes during follow-up to 4 years. Rates of stent thrombosis were significantly lower with BP-DES.     

Clinical Impact and Cost-Effectiveness of Coronary Computed Tomography Angiography or Exercise Electrocardiogram in Individuals Without Known Cardiovascular Disease

It is not clear whether screening by coronary computed tomographic angiography (CCTA) and/or exercise electrocardiogram (ECG) can improve clinical outcomes and reduce costs in individuals without known cardiovascular disease (CVD).In total, 71,811 consecutive individuals without known CVD who underwent general health examinations were enrolled. Using propensity-score matching according to screening tests, 1-year clinical outcomes and 6-month total and coronary artery disease–related medical costs were analyzed in separate groups: group 1 (CCTA [n = 2578] vs no screening [n = 5146]), group 2 (exercise ECG [n = 2898] vs no screening [n = 5796]), and group 3 (CCTA and exercise ECG [n = 2003] vs no screening [n = 4006]).There were no significant differences in the composite outcome of death, myocardial infarction, and stroke in each matched group: group 1 (0.35% vs 0.45%, P = 0.501), group 2 (0.14% vs 0.28%, P = 0.157), and group 3 (0.25% vs 0.27%, P = 0.858). However, revascularization was more frequent in the CCTA screening groups: group 1 (2.02% vs 0.45%, P < 0.001) and group 3 (1.40% vs 0.45%, P < 0.001). Matched screening groups had higher 6-month total and coronary artery disease–related medical costs: group 1 ($777 vs $603, P < 0.001 and $177 vs $39, P < 0.001), group 2 ($544 vs $492, P = 0.045 and $12 vs $15, P = 0.611), and group 3 ($705 vs $627, P = 0.090 and $135 vs $35, P < 0.001).In individuals without known CVD, CCTA screening with or without exercise ECG led to more frequent revascularization at the expense of higher medical costs, but did not decrease the 1-year risk of death, myocardial infarction, and stroke.     

Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: Two‐year angiographic and three‐year clinical results from the SPIRIT II study

Background : Little is known about the impact of treatment with drug‐eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus‐eluting stent (EES) in patients with calcified or noncalcified culprit lesions. Methods : The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six‐month and 2‐year angiographic follow‐up and clinical follow‐up up to 3 years were completed. Results : The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6‐month in‐stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia‐driven target lesion revascularization (ID‐TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in‐stent ABR (7.4% vs. 0%, P = 0.08) and ID‐TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID‐TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12). Conclusions: The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley‐Liss, Inc.     

Effects of patient characteristics on the efficacy of complete revascularization for treatment of ST-segment elevation myocardial infarction with multivessel disease: A meta-analysis

Background:Several randomized controlled trials (RCTs) have evaluated the efficacy of complete vs culprit-only revascularization for treatment of ST-segment elevation myocardial infarction (STEMI) with multivessel disease. However, the efficacy of complete revascularization vs culprit-only revascularization in some STEMI patient subgroups remains unclear.Methods:We searched PubMed and Embase for related RCTs from the start date of databases to January 3, 2020. The endpoint assessed in this meta-analysis was major adverse cardiac events (MACE). Random-effects meta-analysis was conducted stratified by each of the 5 factors of interest (i.e., sex, age, history of diabetes, ECG infarct location, and the number of arteries with stenosis) to estimate pooled hazard ratio and 95% confidence interval. Random-effects meta-regression was conducted to assess subgroup differences. We examined publication bias by drawing funnel plots and performing Egger test. This meta-analysis is reported according to the PRISMA statement.Results:Six RCTs were included for pooled analysis. Compared with culprit-only revascularization, complete revascularization significantly reduced the risk of MACE (hazard ratio 0.48, 95% confidence interval 0.42–0.55; I² = 0%; P for relative effect < .001). This significant reduction in the risk of MACE exhibited by complete revascularization was observed in most of the subgroups of interest. All of the subgroup effects based on the 5 factors of interest were not statistically significant (P_subgroup ranged from 0.198 to 0.556). Publication bias was not suggested by funnel plots and Egger test.Conclusions:Compared with culprit-only revascularization, complete revascularization significantly reduces the MACE risk in patients with STEMI and multivessel disease, which is independent of sex, age, history of diabetes, ECG infarct location, and the number of arteries with stenosis.     

The efficacy of everolimus-eluting stent implantation in patients with ST-segment elevation myocardial infarction: outcomes of 2-year clinical follow-up

First-generation drug-eluting stents (DES) demonstrated delay in vascular healing and increase in incidence of late and very late stent thrombosis compared with bare-metal stents (BMS). Second-generation DES, however, have shown a reduction of late and very late stent thrombosis compared with first-generation DES. Thus, we decided to evaluate whether the second-generation everolimus-eluting stent (EES) has an advantage over BMS in Japanese patients with ST-segment elevation myocardial infarction (STEMI). This study was conducted in two centers, retrospective, non-randomized and observational design in patients with STEMI. Three-hundred eighty patients were randomly selected to receive EES (198 patients) or cobalt-chromium BMS (182 patients). The primary endpoints were cardiac death, recurrent myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis (ST). At 2 years, the rates of TLR, TVR, and recurrent MI were significantly lower in the EES group than in the BMS group (TLR 1.5 vs. 8.3 %, p < 0.05; TVR 2.5 vs. 9.4 %, p < 0.05; recurrent MI 1.0 vs. 4.1 %, p < 0.05), and the rate of ST was also significantly lower in the EES group than in the BMS group (0.5 vs. 4.3 %, p < 0.05). Thus, major adverse cardiac events defined at the composite cardiac death, MI, TLR, TVR, or ST were significantly lower in EES group than in BMS group (3.0 vs. 9.9 %, p = 0.008). The rate of cardiac death, however, did not differ between both groups. In STEMI patients, EES may be associated with improved outcomes—specifically, a significant reduction in TVR, ST, and recurrent MI compared to BMS throughout 2 years.     

老年急性ST段抬高心肌梗死患者应用国产雷帕霉素药物洗脱支架5年临床随访

目的评估老年急性ST段抬高心肌梗死(STEMI)患者应用国产支架的长期安全性。方法入选年龄≥60岁的急性STEMI患者113例,随机分为国产雷帕霉素药物洗脱支架(DES)组56例和金属裸支架(BMS)组57例。随访5年,观察支架内血栓形成和主要心脏不良事件(MACE)发生率情况。结果 5年随访期间,DES组与BMS组病死率分别为7.1%和7.0%(P>0.05);DES组靶病变重建、MACE分别为10.7%、23.2%,BMS组分别为28.1%、42.1%(P<0.05)。DES组支架内血栓、极晚期支架内血栓发生率分别为8.9%、3.6%;BMS组分别为7.0%、1.8%,2组比较差异无统计学意义。结论老年急性STEMI患者应用国产雷帕霉素DES较BMS明显降低MACE,且极晚期血栓发生率无明显升高。     

Efficacy and safety of ticagrelor monotherapy in patients following percutaneous coronary intervention: A systematic review and meta-analysis

Background:We aimed to systematically evaluate the efficacy and safety ticagrelor monotherapy following percutaneous coronary intervention.Methods:Online databases were searched for relevant studies (published between the years 2015 and 2020) comparing 1-month Dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy with 12-month DAPT followed by 12-month aspirin monotherapy following percutaneous coronary intervention. Primary outcomes assessed efficacy whereas secondary outcomes assessed safety. Odds ratios (OR) with 95% confidence intervals (CIs) based on a random effect model were calculated and the analysis was carried out by the RevMan 5.3 software.Results:Only 6 studies were selected for this meta-analytical research. The meta-analysis results: MI(OR:0.96, 95% CI:0.86–1.06, P = .40), stroke (OR:1.04, 95% CI: 0.87–1.25, P = .68), stent thrombosis (OR: 0.91,95% CI:0.76–1.10,P = .32),New-Q Wave (OR:0.85,95% CI: 0.72–1.00, P = .05), all cause death (OR:0.91, 95% CI: 0.87–0.96, P < .0001), death from cardiovascular (OR: 0.76, 95% CI: 0.58–0.99, P = .04), revascularization (OR: 0.93, 95% CI: 0.87–0.99, P = .03). Ticagrelor monotherapy was associated with a significantly lower rate of myocardial Infarction (MI), stroke, stent thrombosis, all cause death, death from cardiovascular and revascularization (OR:0.91,95% CI:0.87–0.96, P < .0001) when compared to DAPT. Besides, DAPT was associated with a significantly higher rate of BARC3 or 5 bleeding (OR:0.85, 95% CI: 0.68–1.06; P = .16) when compared to ticagrelor. When bleeding was further subdivided, minor or major bleeding was also significantly higher with DAPT (OR: 0.72, 95% CI: 0.41–1.27; P = .26). GUSTO moderate or severe bleeding was also significantly higher with DAPT (OR: 0.77, 95% CI: 0.39–1.52; P = .45).Conclusion:Ticagrelor monotherapy after short-term dual-antiplatelet therapy (DAPT) can optimize ischemic and bleeding risks. And, it can reduce the occurrence of events outcome (MI, revascularization, stroke, stent thrombosis).     

The ‘all comer’ Coroflex Please drug-eluting stent registry in Europe and Asia – An overall and transcontinental assessment of the 10-month major adverse cardiac events

BackgroundRandomized trials assess the potential of a medical device in well defined indications while “all comer studies” reveal the device performance in the real clinical environment.AimsThis ‘all comers’ registry assessed the 10-month outcome of the Coroflex^® Please drug-eluting stent in Europe and Asia by clinically driven major adverse cardiac events.MethodsThe Coroflex^® Please Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease. The primary endpoint was clinically driven target lesion revascularization (TLR) at 9 months. Secondary endpoints were technical success, in-hospital outcomes, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) for subgroup analyses.ResultsOf the enrolled 1230 patients (63.6 ± 11.2 years, 33.9% diabetics), 339 (27.6%) had an acute coronary syndrome, 148 (12.1%) STEMI and 191 (15.6%) NSTEMI. After 10.5 ± 3.8 months (follow-up rate 92.8%), the target lesion revascularization rate (TLR) was 7.8% overall, 8.3% in STEMI, and 11.3% in NSTEMI patients. Total MACE was 11.1% and significantly higher in ACS with either diabetes mellitus (22.9%, p = 0.017) or age ≥75 years (25.4%, p = 0.026). In European and Asian patients MI rates (5.2% vs 3.1%, p = 0.135) and cardiac death rates (1.6% vs 0.9%, p = 0.414) were similar. The MACE rate was higher in Europe (13.6% vs 4.7%, p < 0.001) driven by a six times higher TLR rate.ConclusionsTLR and MACE occurred within the range of previously published data. The incidence of MI and cardiac death were not different between Europe and Asia. MACE were higher in Europe driven by target lesion revascularization.     

Study of Safety and Efficacy of Novel Sirolimus-Eluting Stent Incorporating Properties of Drug Coating Balloon Among Real World Patients Focusing Younger Population (<35 years)

ObjectiveAim of study was to evaluate safety and efficacy of abluminal Mitigator DES + Sirolimus Eluting Stent (Envision Scientific, Surat, India) incorporating novel technology of fusion coating of bioresorbable polymer on both abluminal surface of stent and exposed parts of balloon among real world patients specially focusing younger patients (<35 years).Method1293 patients received Mitigator DES + at LPS Institute of Cardiology, Kanpur, India. Primary outcome was target lesion failure (TLF)- composite of cardiovascular death, target vessel myocardial infarction (TVMI), and target lesion revascularization (TLR) and secondary end points including peri-procedural device failure (failure of stent delivery, change of stent, stent fracture), target vessel failure (TVF), and patient oriented composite end point (POCE)-composite of all deaths, MI, and revascularization and stent thrombosis (ST) at 1-year follow-up.ResultYounger population comprised of 374 (29%) patients. Various indications of interventions were STEMI (n = 614; 47.4%), NSTEMI (n = 416; 32.2%), UA (n = 161; 12.5%), and CCS (n = 102; 7.9%). TLF at 1 year in young and overall population were 3.4% and 3.5% respectively which was driven by TVMI and TLR in 1.3% and 1.1% patients respectively. POCE was observed in 9.5% in each group mainly contributed by any revascularization (3.9%). Device failure was significantly lower in young group than overall population (1.3% vs. 2.2%; p = 0.04) which was mainly driven by stent delivery (1.1%) and edge dissection (0.5%). Definite and probable ST was 1.3% and 1.7% respectively which was not significant. Young patients showed insignificantly lower TLF, TVF, ST and POCE and significantly lower device failure (1.3% vs. 2.6%; p = 0.04) when compared to patients >35 years. On multivariate regression analysis, complex lesion, in-stent restenosis, failure of stent delivery and edge dissection were independent predictors of events or device success rate.ConclusionMitigator DES+™ is safe among real world patients, including young population.     

Treatment of saphenous vein graft lesions with drug-eluting stents: immediate and midterm outcome

OBJECTIVES: The purpose of the present report was to evaluate clinical and angiographic outcomes of drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions. BACKGROUND: The safety and efficacy of DES implantation for the treatment SVG lesions remains uncertain. METHODS: We evaluated in-hospital and six-month outcomes in 61 consecutive patients treated with DES in SVG lesions from March 2002 to March 2004 (DES group), as compared to 89 consecutive patients treated with bare-metal stents (BMS) in the 24 months immediately before the introduction of DES (BMS group). Major adverse cardiac events (MACE) including death, myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR) were recorded in-hospital and at six-month follow-up. RESULTS: The rate of in-hospital MACE was similar between the two groups (6.6% vs. 5.6%, p = 1.0). Cumulative MACE at six months was 11.5% in the DES group and 28.1% in the BMS group (p = 0.02). The DES group had a significantly lower incidence of in-segment restenosis (10.0% vs. 26.7%, p = 0.03), TLR (3.3% vs. 19.8%, p = 0.003), and TVR (4.9% vs. 23.1%, p = 0.003). By Cox regression analysis, diabetes (hazard ratio [HR]: 3.03; 95% confidence interval [CI]: 1.33 to 6.90; p = 0.008), usage of BMS (HR: 2.53; 95% CI: 1.07 to 5.97; p = 0.03), and age of SVG (HR: 1.10; 95% CI: 1.02 to 1.19; p = 0.02) were identified as predictors of MACE at six-month follow-up. CONCLUSIONS: Compared to BMS implantation, DES implantation in SVG lesions appears safe with favorable and improved mid-term outcomes.