Stent-related cardiac events after non-cardiac surgery: drug-eluting stent vs. bare metal stent

For evaluation of post-operative stent associated cardiac events after drug-eluting stent (DES) implantation we analyzed data of 138 patients who underwent non-cardiac surgery after DES implantation and compared the data with those of 101 patients who underwent non-cardiac surgery after bare metal stent (BMS) implantation. Three patients (2.2%) in DES group developed post-operative cardiac events and none in BMS group (p=0.2). One patient died due to suspected stent thrombosis and the other two had myocardial infarction due to angiographically proven stent thrombosis. The time interval between stent implantation and surgery in those with cardiac events was 6, 264, and 367 days, respectively. Our data shows that peri-operative stent-related thrombotic complications can occur long after DES implantation and careful peri-operative monitoring for cardiac events is needed in patients receiving non-cardiac surgery after DES implantation.     

Gender-based outcomes among patients with diabetes mellitus after percutaneous coronary intervention in the drug-eluting stent era

Diabetes mellitus has a greater effect on mortality rates due to coronary artery disease in women than in men. Although women undergoing coronary intervention in general have a higher frequency of adverse outcomes than men, the effect of gender among diabetic patients on clinical outcomes after percutaneous coronary intervention (PCI) has not been well established in the drug-eluting stent (DES) era. We have investigated the impact of gender on long-term clinical outcome in these high risk populations. We enrolled 404 consecutive patients (74 women and 330 men) with diabetes mellitus who underwent elective PCI (85% with DES). We evaluated the incidence of major adverse cardiac events (MACE), which is a composite of total all-cause death, acute coronary syndrome (ACS), and target lesion revascularization (TLR) during a period of 4 years after coronary intervention. The women were significantly older, more likely to have dyslipidemia, and had significantly higher systolic blood pressure and LDL-C values than men. The use of insulin and angiotensin receptor blockers was more frequent among the women (32.4% versus 21.0%, P = 0.04 and 60.8% versus 39.8%, P < 0.01, respectively). The angiographic profiles of both were comparable. At four-year clinical follow-up, cumulative incidence of MACE was identical between the women and the men (16.2% versus 15.5%, P = 0.90; adjusted HR 1.23, 95% CI 0.61-2.50, P = 0.56). Although the baseline characteristics of the women were worse, clinical outcomes did not significantly differ between women and men among diabetic patients after elective PCI.     

Rescue percutaneous coronary intervention early after coronary artery bypass grafting in the drug-eluting stent era

Ten patients underwent rescue percutaneous coronary intervention for myocardial infarction or ischemia soon after coronary artery bypass grafting, and 6 received drug-eluting stents (DESs). Outcomes were limited primarily by bleeding events. There was 1 episode of DES thrombosis after antiplatelet therapy was discontinued due to gastrointestinal hemorrhage. Rescue percutaneous coronary intervention is a feasible approach to reestablish coronary perfusion in the perioperative period, but DESs should be used only after appropriate risk stratification for potential bleeding complications that may require the withdrawal of antiplatelet therapy.     

药物洗脱支架时代冠心病介入治疗策略的思考

药物洗脱支架(drug-eluting stent,DES)的出现拓宽了经皮腔内冠状动脉介入术(PCI)的适应证,使很多原本只能进行搭桥手术的患者也可以采用PCI治疗,对冠心病的治疗策略产生了深远影响.     

Age-based differences of percutaneous coronary intervention in the drug-eluting stent era

INTRODUCTION: Limited data are available on contemporary percutaneous coronary intervention (PCI) practice patterns and outcomes in elderly patients. The objective of this study was to evaluate "real-world" PCI in elderly and nonelderly patients during the first year of availability of drug-eluting stents (DES) in the United States market (May 1, 2003-April 30, 2004). METHODS: One thousand one hundred sixty-six consecutive patients (272 elderly [age > or =75 years] and 894 nonelderly [age <75 years]) having PCI for de novo coronary artery disease (CAD) at Dartmouth-Hitchcock Medical Center were included in this study. Primary outcome measures of this study were in-hospital major adverse cardiac events (MACE-death, new MI, urgent revascularization). Secondary end points included acute renal failure, respiratory failure, and vascular complications. RESULTS: Elderly patients had higher MACE (8.5% vs 1.5%, P < or = 0.001), unadjusted in-hospital mortality (7.4% vs 0.8%, P < or = 0.001), in-hospital cardiac arrest (1.5% vs 0.3%, P = 0.03), requirements for assisted blood pressure support (13.2% vs 7.0%, P = 0.0001), respiratory failure (2.2% vs 0.9%, P = 0.08), acute renal failure (2.9% vs 0.8%, P = 0.005), and vascular complications (10.3% vs 5.5%, P = 0.005) than their nonelderly counterparts. Higher MACE rates persisted in the elderly despite correction for baseline differences using multivariate regression modeling. CONCLUSIONS: Advanced age remains a predictor of adverse outcomes attending PCI even in the contemporary era in which DES are available. This study highlights the need for further progress and investigation to optimize outcomes of PCI in the elderly.     

Gender-based differences of percutaneous coronary intervention in the drug-eluting stent era.

OBJECTIVES: The purpose of this study is to provide insights into percutaneous coronary intervention (PCI) performed in women in the United States by evaluating gender-based PCI-practice patterns and outcomes. BACKGROUND: Limited "real world" contemporary data exist on how the introduction of DES has impacted PCI in women. METHODS AND RESULTS: Patients (359 women, 807 men) with de novo coronary artery disease having PCI (1,166) were evaluated during the first year, since the introduction of DES in the United States market (May 1, 2003 to April 30, 2004). Women were more likely to be older, hypertensive, obese, diabetic, and have heart failure. Men were more likely to be smokers and have more vessels with obstructive coronary artery disease. PCI procedural success rates, number of vessels attempted, percentage DES utilization, and in-hospital major adverse cardiac events (MACE; death, new myocardial infarction, urgent revascularization) were similar for both genders. However, women had significantly higher unadjusted mortality (3.9% versus 1.6%, P = 0.01), cumulative vascular complications (12.0% versus 4.2%, P < 0.0001), and renal failure (2.5% versus 0.7%, P = 0.01). After adjustment for confounding variables, mortality was similar between genders, but a significant association with vascular complications and trend toward higher rates of renal failure persisted in women. CONCLUSIONS: In this study of the modern era of PCI with DES utilization, in-hospital MACE is similar between men and women. However, the differences in baseline comorbidities and the proclivity for vascular and renal complications highlight the need for further investigation and improvements to optimize outcomes of PCI in women.     

Coronary artery bypass surgery versus percutaneous coronary intervention with drug-eluting stent implantation in patients with multivessel coronary disease

BACKGROUND: Drug-eluting stents (DES) constitute a major breakthrough in restenosis prevention after percutaneous coronary intervention (PCI). This study compared the clinical outcomes of PCI using DES versus coronary artery bypass graft (CABG) in patients with multivessel coronary artery disease (MVD) in real-world. METHODS: From January 2003 to December 2004, 466 consecutive patients with MVD underwent revascularization, 235 by PCI with DES and 231 by CABG. The study end-point was the incidence of major adverse cardiovascular events (MACEs) at the first 30 days after procedure and during follow-up. RESULTS: Most preoperative characteristics were similar in the two groups, but left main disease (24.7% vs 2.6%, P<0.001) and three-vessel disease (65% vs 54%, P = 0.02) were more prevalent in CABG group. The number of coronary lesions was also greater in CABG group (3.7 +/- 1.1 vs 3.3 +/- 1.1, P<0.001). Despite higher early morbidity (3.9% vs 0.8%, P = 0.03) associated with CABG, there were no significant differences in composite MACEs at the first 30 days between the two groups. During follow-up (mean 25+/-8 months), the incidence of death, myocardial infarction, or cerebrovascular event was similar in both groups (PCI 6.3% vs CABG 5.6%, P = 0.84). However, bypass surgery still afforded a lower need for repeat revascularization (2.8% vs 10.4%, p = 0.001). Consequently, overall MACE rate (14.5% vs 7.9%, P = 0.03) remained higher after PCI. CONCLUSION: PCI with DES is a safe and feasible alternative to CABG for selected patients with MVD. The reintervention gap was further narrowed in the era of DES. Aside from restenosis, progression of disease needs to receive substantial emphasis.     

The state of the excimer laser for coronary intervention in the drug-eluting stent era

ObjectivesThis study aims to determine how excimer laser coronary atherectomy (ELCA) performs in the drug-eluting stent (DES) era.BackgroundFor more than 20 years, ELCA has been used for coronary intervention. With developments in the coronary intervention field, the role of ELCA is in question.MethodsThe study includes 119 patients with 124 lesions who underwent percutaneous coronary intervention (PCI) with ELCA in our institution from January 2004 to May 2011.ResultsThe main indications for ELCA use were saphenous vein graft (SVG) (45 lesions), acute myocardial infarction (AMI) (7 lesions), chronic total occlusion (CTO) (32 lesions), in-stent restenosis (ISR) (15 lesions), and calcified de-novo lesions (25 lesions). High success rates were recorded for the SVG, AMI, CTO, ISR, and calcified lesion indications (91.1%, 85.7%, 93.8%, 86.7%, and 80%; respectively). ELCA related complications were reported in 10 patients (8%); four dissections, three no-reflow phenomena, two perforations, and one thrombus formation.ConclusionELCA is an alternative solution with acceptable performance in the treatment of complex coronary lesions not ideally suitable for balloon angioplasty.     

RESTEM: a percutaneous coronary intervention 'real world' registry in the drug-eluting stent era

Sirolimus-eluting stents (SESs) reduce the rate of in-stent restenosis in selected cases. Their performance in more complex patients and their impact on the final clinical outcome of these patients, however, remains uncertain. RESTEM Registry (REgistro delle PCI in era di STEnt Medicati), a prospective multicenter registry collecting all percutaneous coronary interventions (PCIs) performed over 20 months and monitored up to 2 years, includes 5524 consecutive patients treated with bare metal stent (BMS) (72%), sirolimus-eluting stent (SES) (15%), combined BMS+SES (4%), or other techniques (9%). The combination of death, acute myocardial infarction (AMI), unstable angina and revascularizations had been chosen as primary endpoint. One-year multivariate analysis shows no significant advantage of SES in combined clinical events, a slight benefit in primary endpoint [18.5 vs. 25.0% BMS=odds ratio (OR) 0.78) and revascularizations (13.6 vs. 20.4% BMS=OR 0.74], a consistent advantage when only target vessel revascularizations (TVRs) are considered (5.5 vs. 10.5% BMS=OR 0.52). The two-year adjusted results confirm a significant advantage of SES in TVR (8.3 vs. 13.7% BMS=OR 0.65), a slight benefit for revascularizations (18.3 vs. 25.6% BMS=OR 0.76), without reducing mortality and other clinical events; these data refute the benefit on primary endpoint observed at 12 months (25.8 vs. 32.4% BMS=OR 0.84). After analyzing events recorded during the first and second year follow-up periods separately, the incidence of many of them favors SES in the first year, yet appear independent of the technique utilized in the second. RESTEM results confirming SES's capacity to reduce TVR without reduction of other clinical events, suggest that this advantage is limited to the first year after PCI, and show no evidence of excess of deaths, AMIs and late thrombosis following SES implantation described in recent meta-analyses.     

Risk of noncardiac surgery after coronary drug-eluting stent implantation

We examined the records of 38 patients who underwent 41 major and 18 minor noncardiac surgeries after successful drug-eluting stent (DES) implantation (57% sirolimus-eluting stents and 43% paclitaxel-eluting stents) at the Dallas Veterans Affairs Medical Center from April 2003 to January 2006. The mean patient age was 62 +/- 9 years, and all patients were men. A total of 41 major noncardiac surgeries (34% abdominal, 22% vascular, 17% genitourinary, and 27% other) were performed in 28 patients a median of 260 days after DES implantation. Also, 18 minor noncardiac surgeries (44% skin surgery, 44% injections, and 12% other) were performed in 10 patients a median of 297 days after DES implantation. No major adverse cardiac events or death occurred during or after the 41 major (0%, 95% confidence interval 0% to 9%) and 18 minor noncardiac (0%, 95% confidence interval 0% to 19%) surgeries. In conclusion, although our data were limited by the small sample size, they suggest a low risk of major cardiac complications in patients undergoing noncardiac surgery after coronary DES implantation.     

老年慢性肾功能不全患者冠状动脉内药物洗脱支架术远期疗效

目的观察>65岁慢性肾功能不全患者行冠状动脉内药物洗脱支架术的远期疗效。方法将585例年龄> 65岁行冠状动脉介入治疗(PCI)的患者,根据肌酐清除率分为慢性肾功能不全组(355例)和对照组(230例),前者又分药物脱支架组和普通金属支架组,记录各例患者住院期一般资料、冠状动脉造影和PCI情况及随访期所有原因死亡、中风和主要心脏不良事件。比较药物洗脱支架和普通金属支架对慢性肾功能不全组患者的临床疗效。结果与对照组比较,慢性肾功能不全组患者年龄增大,体重减轻,女性、吸烟和不稳定性心绞痛较多。平均随访17个月,慢性肾功能不全组较对照组所有原因病死率(8．17％和3．48％,P<0．05)和心源性病死率(6．48％和2．17％, P<0．05)显著增高,但主要心脏不良事件(13．80％和10．86％,P>0．05)及靶血管再次血运重建率(5．63％和6．08％,P>0．05)无显著差异。慢性肾功能不全组中,药物洗脱支架组(224例)较普通金属支架组(131例)主要心脏不良事件发生率(8．92％和19．84％,P<0．05)和靶血管再次血运重建率(3．12％和9．92％,P<0．05)显著减少,但心源性死亡(4．91％和8．39％,P>0．05)和所有原因死亡(6．25％和11．45％,P>0．05)发生率无显著性差异。结论年慢性肾功能不全患者行PCI术后死亡率增加;与普通金属支架比较,药物洗脱支架可以显著降低靶血管再次血运重建和主要心脏不良事件发生率,但对心源性死亡和所有原因死亡无明显影响。     

Potential shift from coronary bypass surgery to percutaneous coronary intervention for multivessel disease and its economic impact in the drug-eluting stent era

BACKGROUND: Drug-eluting stents (DES) may promote percutaneous coronary intervention (PCI) procedures in patients traditionally referred for coronary artery bypass graft (CABG) surgery and may save money. OBJECTIVES: The purpose of the present study was to quantify the potential shift from CABG surgery to multivessel PCI in the DES era and to model the economic consequences. METHODS: Based on predefined criteria, the feasibility of PCI was evaluated in patients with multivessel coronary artery disease who underwent CABG surgery before the availability of DES at the Centre Hospitalier de l'Université de Montréal's Notre-Dame Hospital (Montreal, Quebec). Modelling was used to evaluate the potential cost savings using multivessel PCI instead of CABG surgery. Equal one-year outcomes in both groups were assumed, with the exception of a 10% repeat revascularization (RR) rate in the DES group and a 4% RR rate in the CABG group. The impact of those assumptions was evaluated using 1000 Monte Carlo simulations. RESULTS: The authors retrospectively evaluated that, of 289 patients who underwent CABG without concomitant valve surgery between January and December 2003, only 22 patients (8%) were good candidates for multivessel DES implantation. The procedures would have involved an average of 3.6 DES per patient. The average cost per revascularization procedure was $14,402 with surgery and $11,220 for multivessel DES implantation (using $2,200 DES), leading to a savings of $3,182 per patient. However, after including RR procedures, PCI would only have been associated with savings of $812 per surgery avoided. Monte Carlo analysis revealed that surgery may be less expensive than PCI in 36% of patients. CONCLUSIONS: Most patients who underwent CABG surgery in 2003 were retrospectively judged to be ineligible for multivessel PCI with DES. In the rare eligible patient, multivessel PCI with DES is not expected to produce savings to health care costs in Canada unless the DES purchase cost continues to decrease.     

药物洗脱支架的临床研究进展

药物洗脱支架通过释放一种或多种生物活性物质至血流和周围组织,抑制炎症反应和细胞增殖、延缓血管内皮化,使经皮冠状动脉介入术(PCI)术后的支架再狭窄率显著降低,并大大拓展了PCI的适应证,为冠心病患者带来了福音.本文就目前临床使用的两种药物洗脱支架(雷帕霉素、紫杉醇)的临床研究进展作一介绍.     

Late adverse events after drug-eluting stent implantation

Stents that elute antiproliferative drugs prevent restenosis after percutaneous coronary artery revascularization, reducing the need for repeat procedures. Randomized trials in low-risk patients supported initial regulatory approval for drug-eluting stents (DES). In 2006, metaanalyses of long-term outcomes from these trials associated DES use with adverse events, believed to be attributable to late stent thrombosis, occurring more than 9 months after the initial procedure. This article appraises these late adverse effects and illustrates the power and shortcomings of large national registries, focused, well-conducted clinical trials, and meta-analyses of clinical trial data. This timely, robust evidence base reflects an alignment of academic, industry, and public health priorities.     

Long-term predictors of mortality after percutaneous coronary intervention in the era of drug-eluting stents

The aim was to examine timing, causes, and predictors of death during long-term follow-up after contemporary percutaneous coronary intervention (PCI) using a large multicenter Australian registry. The cohort consisted of 10,682 consecutive patients from the Melbourne Interventional Group registry undergoing PCI (February 2004 through November 2009). For the first time in Australia, long-term mortality rates of a PCI cohort were defined by linkage to the National Death Index database. The cohort (mean age 64 ± 12 years) comprised 75% men, 24% diabetics, 59% with multivessel disease, 4.4% with renal failure, 25% with ST-elevation myocardial infarction (STEMI), 2.5% with cardiogenic shock, and 5.1% with heart failure. Drug-eluting stents (DES) were used in 43% of cases. Mean follow-up was 3.2 ± 0.5 years. In-hospital, 30-day, 12-month, and long-term (3.2 ± 0.5 years) mortalities were 1.6% (80% cardiac), 2.1% (79%), 3.9% (61%), and 8.2% (50%), respectively. Independent predictors of long-term mortality included age (hazard ratio 1.05, 95% confidence interval 1.04 to 1.06), cardiogenic shock (4.58, 3.60 to 5.83), renal failure (3.14, 2.58 to 3.82), previous heart failure (1.97, 1.60 to 2.41), STEMI (1.79, 1.47 to 2.18), peripheral vascular disease (1.72, 1.4 to 2.11), non-STEMI (1.58, 1.32 to 1.90), multivessel disease (1.47, 1.24 to 1.74), current smoking (1.39, 1.12 to 1.71), diabetes (1.36, 1.16 to 1.59), and cerebrovascular disease (1.33, 1.06 to 1.60, p <0.01 for all comparisons). DES deployment appeared protective against late mortality (hazard ratio 0.85, 0.73 to 0.99, p = 0.04); however, after 30 days, there was no difference in mortality rates between those who received a bare metal stent and those who received a DES. In conclusion, different clinical variables such as renal and heart failure predicted long-term mortality after PCI, whereas DES use in this large registry was not associated with late mortality risk.