Ticagrelor With or Without Aspirin in High-Risk Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention

BackgroundP2Y₁₂ inhibitor monotherapy with ticagrelor after a brief period of dual antiplatelet therapy can reduce bleeding without increasing ischemic harm after percutaneous coronary intervention (PCI). The impact of this approach among patients with diabetes mellitus (DM) remains unknown.ObjectivesThe purpose of this study was to examine the effect of ticagrelor monotherapy versus ticagrelor plus aspirin among patients with DM undergoing PCI.MethodsThis was a pre-specified analysis of the DM cohort in the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial. After 3 months of ticagrelor plus aspirin, patients were maintained on ticagrelor and randomized to aspirin or placebo for 1 year. The primary endpoint was Bleeding Academic Research Consortium 2, 3, or 5 bleeding. The composite ischemic endpoint was all-cause death, myocardial infarction, or stroke.ResultsPatients with DM comprised 37% (n = 2,620) of the randomized cohort and were characterized by more frequent comorbidities and a higher prevalence of multivessel disease. The incidence of Bleeding Academic Research Consortium 2, 3, or 5 bleeding was 4.5% and 6.7% among patients with DM randomized to ticagrelor plus placebo versus ticagrelor plus aspirin (hazard ratio: 0.65; 95% confidence interval: 0.47 to 0.91; p = 0.012). Ticagrelor monotherapy was not associated with an increase in ischemic events compared with ticagrelor plus aspirin (4.6% vs. 5.9%; hazard ratio: 0.77; 95% confidence interval: 0.55 to 1.09; p = 0.14). In the overall trial population, there was no significant interaction between DM status and treatment group for the primary bleeding or ischemic endpoints.ConclusionsCompared with ticagrelor plus aspirin, the effect of ticagrelor monotherapy in reducing the risk of clinically relevant bleeding without any increase in ischemic events was consistent among patients with or without DM undergoing PCI. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242)     

血管内超声对经皮冠状动脉介入治疗患者预后判断的价值

目的:探讨血管内超声(IVUS)检查对经皮冠状动脉介入治疗(PCI)患者预后判断的价值.方法:选取从2005- 04到2007- 09我院所有接受PCI治疗的患者9 461例,其中IVUS组527例,非IVUS组8 934例.收集所有患者一般临床资料,并进行长期随访,评价IVUS对临床预后的影响.结果:基线上IVUS组左主干病变比例明显高于非IVUS组(38.5% vs.3.9%,P<0.01),差异有统计学意义.住院期间和长期随访结果显示:IVUS组主要不良心脏事件(MACE)发生率均高于非IVUS组(住院期间:4.2% vs.2.0%,P<0.01;长期随访:10.4% vs.7.0%,P<0.01),差异均有统计学意义.Cox回归分析结果提示:IVUS检查不是住院期间和长期随访MACE的独立危险因素(风险比:0.607,95%可信区间:0.119～2.245,P=0.897).对于左主干病变患者,住院期间和长期随访IVUS组的MACE发生率均明显低于非IVUS组(住院期间:2.5% vs.6.6%,P<0.05;长期随访:10.8% vs.18.2%,P<0.05),差异均有统计学意义.结论:对PCI患者常规行IVUS检查可能对预后没有影响,但对于左主干病变患者IVUS检查能改善患者预后.     

Prognostic Value of Baseline Inflammation in Diabetic and Nondiabetic Patients Undergoing Percutaneous Coronary Intervention

BackgroundThere is a paucity of data on the prognostic value of high-sensitivity C-reactive protein (hsCRP) levels in diabetic and nondiabetic patients undergoing percutaneous coronary intervention (PCI).MethodsAll patients with known baseline hsCRP undergoing PCI at a single tertiary care centre from 2010 to 2017 were included. High hsCRP was defined as > 3 mg/L. Known causes of elevated hsCRP levels and hsCRP > 10 mg/L represented exclusion criteria. The 1-year primary outcome was major adverse cardiovascular events (MACE), including all-cause mortality, myocardial infarction (MI), and target-vessel revascularisation (TVR).ResultsAmong a total of 11,979 patients included, high hsCRP levels were observed in 24.7% of patients without diabetes and 29.8% of patients with diabetes (P < 0.001). Both diabetics and nondiabetics with high hsCRP levels had increased rates of MACE compared with their counterparts with low hsCRP (diabetics: adjusted hazard ratio [aHR] 1.58, 95% CI 1.27-1.96; nondiabetics: aHR 1.45, 95% CI 1.13-1.86; P interaction = 0.981) primarily driven by increased rates all-cause deaths (diabetics: aHR 2.32, 95% CI 1.42-3.80; nondiabetics: aHR 3.14, 95% CI 1.74-5.65; P interaction = 0.415). Although high hsCRP levels were associated with increased rates of TVR (aHR 1.35, 95% CI 1.04-1.75) and MI (aHR 1.86, 95% CI 1.18-2.93) only in patients with diabetes, no significant interactions were observed between inflammation and diabetes (P interaction = 0.749 and 0.602, respectively).ConclusionsPatients undergoing PCI with high levels of hsCRP, defined as > 3 mg/L, have worse ischemic outcomes regardless of diabetes status.     

Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Patients With Diabetes Undergoing Percutaneous Coronary Intervention

BackgroundDiabetes was reported to be associated with an impaired response to clopidogrel.ObjectivesThe aim of this study was to evaluate the safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) in patients with diabetes undergoing percutaneous coronary intervention (PCI).MethodsA subgroup analysis was conducted on the basis of diabetes in the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2) Total Cohort (N = 5,997) (STOPDAPT-2, n = 3,009; STOPDAPT-2 ACS [Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 for the Patients With ACS], n = 2,988), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT with aspirin and clopidogrel after cobalt-chromium everolimus-eluting stent implantation. The primary endpoint was a composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) or bleeding (TIMI [Thrombolysis In Myocardial Infarction] major or minor) endpoints at 1 year.ResultsThere were 2,030 patients with diabetes (33.8%) and 3967 patients without diabetes (66.2%). Regardless of diabetes, the risk of 1-month DAPT relative to 12-month DAPT was not significant for the primary endpoint (diabetes, 3.58% vs 4.12% [HR: 0.87; 95% CI: 0.56-1.37; P = 0.55]; nondiabetes, 2.46% vs 2.49% [HR: 0.99; 95% CI: 0.67-1.48; P = 0.97]; P_interaction = 0.67) and for the cardiovascular endpoint (diabetes, 3.28% vs 3.05% [HR: 1.10; 95% CI: 0.67-1.81; P = 0.70]; nondiabetes, 1.95% vs 1.43% [HR: 1.38; 95% CI: 0.85-2.25; P = 0.20]; P_interaction = 0.52), while it was lower for the bleeding endpoint (diabetes, 0.30% vs 1.50% [HR: 0.20; 95% CI: 0.06-0.68; P = 0.01]; nondiabetes, 0.61% vs 1.21% [HR: 0.51; 95% CI: 0.25-1.01; P = 0.054]; P_interaction = 0.19).ConclusionsClopidogrel monotherapy after 1-month DAPT compared with 12-month DAPT reduced major bleeding events without an increase in cardiovascular events regardless of diabetes, although the findings should be considered as hypothesis generating, especially in patients with acute coronary syndrome, because of the inconclusive result in the STOPDAPT-2 ACS trial. (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 [STOPDAPT-2], NCT02619760; Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 for the Patients With ACS [STOPDAPT-2 ACS], NCT03462498)     

Incremental Prognostic Value of Post-Intervention Pd/Pa in Patients Undergoing Ischemia-Driven Percutaneous Coronary Intervention

ObjectivesThis study sought to evaluate the prognostic value of post–percutaneous coronary intervention (PCI) distal coronary pressure to aortic pressure ratio (Pd/Pa) in predicting long-term clinical outcomes and to determine whether Pd/Pa combined with fractional flow reserve (FFR) post-intervention provides additional prognostic information superior to either marker alone.BackgroundPost-PCI FFR has been shown to be a predictor of long-term outcomes in numerous studies. The role of post-PCI resting Pd/Pa has not been previously studied in this setting.MethodsConsecutive patients undergoing PCI who had pre- and post-PCI Pd/Pa and FFR were followed for major adverse cardiovascular events (MACE) including death, myocardial infarction, and target vessel revascularization.ResultsA total of 574 patients were followed for 30 months (25th to 75th percentile 18 to 46 months). Using receiver-operating characteristic curve analysis post-stenting FFR cutoff of ≤0.86 had the best predictive accuracy of MACE (17% vs. 23%; log-rank p = 0.02), whereas post-stenting Pd/Pa ≤0.96 was the best predictor of MACE (15% vs. 24%; log rank p = 0.0006). There was a significant interaction between post-PCI Pd/Pa and FFR on MACE risk such that patients with Pd/Pa ≤0.96 and FFR ≤0.86 had the highest event rate (25%), whereas those with Pd/Pa >0.96 and FFR >0.86 had the lowest event rate (15%), which was not different from patients with Pd/Pa >0.96 and FFR ≤0.86 (17%). In a fully adjusted Cox regression analysis, Pd/Pa was an independent predictor of MACE (hazard ratio: 2.07; 95% confidence interval: 1.3 to 3.3; p = 0.002).ConclusionsPost-PCI resting Pd/Pa is a powerful prognostic tool for MACE prediction. It adds complementary and incremental risk stratification over established factors including post-PCI FFR.     

药物洗脱支架置入术后晚期支架内再狭窄患者再次介入治疗的短期预后及危险因素分析

目的:本研究旨在探索老龄和非老龄药物洗脱支架置入术后晚期支架内再狭窄(L-ISR)患者的临床特征,再次经皮冠状动脉介入治疗(PCI)后的短期预后及相关危险因素。方法:共入选218例在我院初次置入药物洗脱支架并于2016年因L-ISR而需要再次入院接受治疗的患者。根据患者年龄分为老龄组(年龄≥65岁,n=77)和非老龄组(年龄<65岁,n=141)。患者的入院特征、临床表现以及介入治疗特点和手术结果等被纳入分析评估,并随访患者PCI后12个月内的主要不良心血管事件(MACE)包括心原性死亡、非致死性心肌梗死及靶病变血运重建(TLR)。结果:L-ISR患者中75.7%的患者因不稳定性心绞痛入院,64.7%的患者再次置入支架。与非老龄组相比,老龄组有更高比例的脑卒中、心房颤动、既往冠状动脉旁路移植术并且支架置入至发现支架内再狭窄的时间更长,体重指数(BMI)更小、冠心病家族史比例更低(P均<0.05)。两组患者入院时的临床症状表现相似,主要表现为不稳定性心绞痛,其他基线资料比较差异均无统计学意义(P均>0.05)。与老龄组患者相比,非老龄组患者的MACE发生率较高,但差异无统计学意义(6.4%vs 3.9%,P=0.546)。多因素回归分析发现,左心室收缩功能障碍(OR=6.317,95%CI:1.145~34.843, P=0.034)是L-ISR患者介入治疗后短期MACE发生的独立危险因素。结论:左心室收缩功能障碍与L-ISR患者短期MACE发生相关。在临床实践中,识别该类人群可能更有助于L-ISR患者的危险分层和二级预防。     

脉搏波传导速度与冠状动脉介入治疗患者的临床预后关系

目的:探讨脉搏波传导速度(PWV)与冠心病行经皮冠状动脉介入治疗术(PCI)患者的临床预后的关系.方法:连续性入选我院心内科2005-01至2005-05间145例因冠心病行PCI治疗的住院患者,平均年龄(65.4±10.5)岁,测定患者住院期间的PWV和收集其他临床资料.根据患者PWV值将患者分为3组,PWV<10 m/s组(n=67),12m/s>PWV≥10m/s组(n=46)和PWV≥12 m/s组(n=32).随访患者PCI术后30天和术后3年心血管不良事件(心源性死亡,再发心肌梗死,再发心绞痛和继发心力衰竭)的发生情况.结果:3组患者基线临床资料比较除收缩压外差异均无统计学意义,PCI术后30天内3组患者的心血管不良事件发生率分别为0,2.2%和0,3组间差异无统计学意义.PCI术后3年时随访,患者心血管不良事件发生率3组分别为9.5%,17.1%和32.1%,其中PWV≥12 m/s组心血管不良事件发生率最高,与PWV<10 m/s组比较差异有统计学意义(P<0.05).结论:PWV快的冠心病患者PCI治疗后远期心血管不良事件的发生率有所增加,PWV对PCI术后患者远期心血管不良事件的发生有一定的预测价值.     

冠心病合并糖尿病患者置入药物洗脱支架和裸金属支架2年临床观察

目的:评价冠心病合并糖尿病患者成功置入药物洗脱支架(DES)和裸金属支架(BMS)2年后的有效性和安全性。方法:本研究入选了2004-04至2006-10在我院行择期支架置入术的冠心病合并糖尿病患者1565例。入选患者分为DES组(n=1317)和BMS组(n=248例)。随访资料包括术后30天、1年和2年的死亡、心肌梗死、血栓、靶病变血运重建和靶血管血运重建。本研究比较了DES和BMS两组间各种临床事件累积发生率的差异,同时通过倾向性评分调整后的Cox比例风险模型比较两组术后2年的临床随访结果。结果:DES和BMS两组患者术后2年出现学术研究联合会(ARC)定义的支架内血栓形成率差异无统计学意义,但DES组术后30天明确血栓形成率显著低于BMS组(0.08%比0.81%,P=0.016)。术后2年与BMS相比,DES组靶病变血运重建率[3.88%比10.89%;风险比0.159(95%可信区间:0.151～0.444),P0.0001]和靶血管血运重建率[5.48%比11.69%;风险比0.383(95%可信区间:0.232～0.633),P0.0001]的风险均显著降低,差异均有统计学意义。两组间全因死亡率、心肌梗死发生率及全因死亡/心肌梗死发生率差异均无统计学意义。结论:对于冠心病合并糖尿病患者而言,与置入BMS相比,使用DES可以显著降低靶病变血运重建率和靶血管血运重建率,但是全因死亡率、心肌梗死发生率和血栓形成率的差异均无统计学意义。     

过氧化物酶体增殖物活化受体γ激动剂对冠心病患者介入治疗后血浆炎症因子水平的影响

目的:探讨过氧化物酶体增殖物活化受体(PPAR)γ激动剂对伴有糖尿病的冠心病患者在冠状动脉介入治疗后血浆炎症因子水平的影响.方法:用随机方法将40例伴有糖尿病的冠心病患者在冠状动脉介入治疗后分为口服PPARy激动剂马来酸罗格列酮(RSG)试验组(n=20)和对照组(n=20),随访6个月,用酶联免疫吸附法测定患者介入治疗前和RSG治疗后6个月的血浆C-反应蛋白、巨噬细胞炎症蛋白-1水平,并观察血糖、胰岛素水平、胰岛素抵抗指数、糖基化血红蛋白-A.血脂水平的改变.结果:6个月时试验组血浆C-反应蛋白、巨噬细胞炎症蛋白-l水平均比治疗前和对照组低,试验组RSG治疗前后比较、与对照组比较均有显著性差异,相关分析提示C-反应蛋白、巨噬细胞炎症蛋白-1的降低幅度与血糖水平呈负相关(C-反应蛋白r=-0.45,P＜0.001;巨噬细胞炎症蛋白-1 r=-0.42,P＜0.01),与血脂水平无相关.试验组6个月时血浆空腹血糖、胰岛素水平、胰岛素抵抗指数、糖基化血红蛋白-A1c分别降低到(7.3±0.2)mmol/L、(9.2±0.5)mIU/L、4.1±0.3、(6.8±0.2)%,治疗前、后自身对照及与对照组比较均有显著性差异.结论:RSG在提高胰岛素的敏感性、改善糖代谢的同时,能够降低糖尿病伴冠心病患者血浆C-反应蛋白、巨噬细胞炎症蛋白-1水平.     

Impact of Stent Types on In-Hospital Outcomes of Patients With Cancer Undergoing Percutaneous Coronary Intervention: A Nationwide Analysis

BackgroundCardiovascular disease and cancer frequently coexist, and patients with cancer are at increased risk of cardiovascular events, including myocardial infarction and stroke. However, the impact of stent types on in-hospital outcomes of patients with malignancy is largely unknown.MethodsPatients with concomitant diagnosis of cancer undergoing PCI between January 2005 and December 2014 were identified in the National Inpatient Sample. They were then categorized into those who have undergone coronary stenting with bare-metal stent (BMS) or drug-eluting stent (DES). Primary outcomes were in-hospital mortality and stent thrombosis. Adjusted and unadjusted analysis was employed on appropriate variables of interest.Results8755 patients were included in the BMS group and 11,611 patients in the DES group. Following propensity matching, 4313 patients were randomly selected in both groups using a 1:1 ratio. There was high use of BMS stent in cancer patient (BMS 43.0%, DES 57.0%) compared to general population (BMS 23.2%, DES 76.8%). When comparing BMS to DES group, there was no statistically significant difference in mortality (4.7% vs. 3.8%, p = 0.097), acute kidney injury (11.3% vs. 10.6%, p = 0.425), bleeding complications (3.50% vs. 3.45%, p = 0.914), and length of hospital stay (5.4% vs. 5.2%, p = 0.119). However, an increased incidence of stent thrombosis was observed in the DES group (4.26% vs. 3.01%, p = 0.002).ConclusionA higher incidence of BMS placement was noted in patients with cancer than in the general population. Paradoxically there was a high incidence of stent thrombosis in the DES group without increasing mortality.     

Association Between Drug-Eluting Stent Type and Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing Percutaneous Coronary Intervention

Background

The comparative efficacy of first- vs second-generation drug-eluting stents (DESs) in patients with chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI) is unknown.

Methods

A retrospective analysis of consecutive patients undergoing PCI at a tertiary PCI center from 2007-2011 was performed, with linkage to administrative databases for long-term outcomes. CKD was defined as creatinine clearance (CrCl) < 60 mL/min. Propensity matching by multivariable scoring method and Kaplan-Meier analyses were performed.

Results

Of 6481 patients with available CrCl values undergoing a first PCI during the study period, 1658 (25%) had CKD. First- and second-generation DESs were implanted in 320 (19.3%) and 128 (7.7%) patients with CKD, respectively. At 2 years, no significant differences were observed between first-generation (n = 126) and second-generation (n = 126) propensity-matched DES cohorts for the outcomes of death (19% vs 16%; P = 0.51), repeat revascularization (10% vs 10%; P = 1.00), and major adverse cardiovascular and cerebrovascular events (MACCE) (36% vs 37%; P = 0.90). The 2-year Kaplan-Meier survival was also similar (P = 0.77). In patients with CKD, second-generation DES type was not an independent predictor for death (P = 0.49) or MACCE (P = 1.00).

Conclusions

Although the use of first- and second-generation DESs was associated with similar 2-year safety and efficacy in patients with CKD, our results cannot rule out a beneficial effect of second- vs first-generation DESs owing to small sample size. Future studies with larger numbers of patients with CKD are needed to identify optimal stent types, which may improve long-term clinical outcomes.     

Differential Impact of Type 1 and Type 2 Diabetes Mellitus on Outcomes Among 1.4 Million US Patients Undergoing Percutaneous Coronary Intervention

BackgroundThe aim was to determine the impact of diabetes mellitus (DM) on outcomes after percutaneous coronary intervention (PCI). There is limited data on the impact of DM and its subtypes among patients who underwent PCI during hospitalization.MethodsAll PCI hospitalizations from the National Inpatient Sample (October 2015–December 2018) were stratified by the presence and subtype of DM. Multivariable logistic regression was performed to determine the adjusted odds ratios (aOR) of in-hospital adverse outcomes in type 1 DM (T1DM) and type 2 DM (T2DM) compared to no-DM.ResultsOut of 1,363,800 individuals undergoing PCI, 12,640 (0.9%) had T1DM and 539,690 (39.6%) had T2DM. T1DM patients had increased aOR of major adverse cardiovascular and cerebrovascular events (MACCE) (1.26, 95%CI 1.17–1.35), mortality (1.56, 95%CI 1.41–1.72), major bleeding (1.63, 95%CI 1.45–1.84), and stroke (1.75, 95%CI 1.51–2.02), while T2DM patients had only increased aOR of MACCE (1.02, 95%CI 1.01–1.04), mortality (1.10, 95%CI 1.08–1.13) and stroke (1.22, 95%CI 1.18–1.27), compared to no-DM patients. However, both T1DM and T2DM had lower aOR of cardiac complications (0.87, 95%CI 0.77–0.97 and 0.87, 95%CI 0.85–0.89, respectively), in comparison to no-DM patients. When accounting for the indication, both DM subgroups had higher aOR of MACCE, mortality, and stroke compared to no-DM patients in the acute coronary syndrome setting (p < 0.001, for all), while only increased aOR of stroke (1.59, 95%CI 1.17–2.15 for T1DM and 1.12, 95%CI 1.05–1.20 for T2DM) persisted in the elective setting.ConclusionsPatients with DM who have undergone PCI during hospitalization are more likely to experience adverse in-hospital outcomes, and T1DM patients are a particularly high-risk cohort.     

入院糖化血红蛋白水平对行经皮冠状动脉介入治疗的无糖尿病病史患者远期预后的影响

目的:探讨入院糖化血红蛋白(HbA1C)水平对行经皮冠状动脉介入治疗(PCI)的无糖尿病病史患者临床远期预后的影响。方法:纳入2013年1月至12月在我院行PCI的无糖尿病病史的冠心病患者6944例。根据入院HbA1C水平分为三组:HbA1C<5.7%组、HbA1C 5.7%~6.4%组和HbA1C≥6.5%组。2年随访的主要终点为主要不良心血管事件(MACE),包括死亡、再次心肌梗死和血运重建。分析入院HbA1C水平对行PCI的无糖尿病病史患者临床远期预后的影响。结果:在6944例行PCI的无糖尿病病史患者中,HbA1C<5.7%组1302例(18.75%),HbA1C 5.7%~6.4%组4344例(62.56%),HbA1C≥6.5%组1298例(18.69%)。2年随访结果显示,HbA1C≥6.5%组和HbA1C 5.7%~6.4%组的MACE发生率显著高于HbA1C<5.7%组(11.0%vs 10.5%vs 8.4%,P=0.047)。多因素分析显示:HbA1C 5.7%~6.4%组和HbA1C≥6.5%组发生MACE风险分别是HbA1C<5.7%组的1.262倍(95%CI:1.022~1.559,P=0.031)和1.304倍(95%CI:1.010~1.682,P=0.041)。结论:在接受PCI的无糖尿病病史的冠心病患者中,入院HbA1C水平是2年MACE发生的独立预测因子。