Impact of chronic renal insufficiency on clinical outcomes in patients undergoing percutaneous coronary intervention with sirolimus-eluting stents versus bare metal stents

Patients with chronic renal insufficiency (CRI) have higher rates of target vessel revascularization and mortality. The efficacy of sirolimus-eluting stents (SESs) to improve the clinical outcomes of these patients is unknown. We investigated the effect of SESs versus bare metal stents (BMSs) on outcomes of patients with CRI. Among the first 1,522 patients treated with SESs, 76 were identified with CRI and 1,446 without CRI. In-hospital and 1- and 6-month clinical outcomes were compared with 153 patients with CRI who were treated with BMSs. Patients with CRI were older, hypertensive, and diabetic and had more previous myocardial infarctions, revascularizations, and decreased left ventricular function (p <0.001). These patients had more saphenous vein graft lesions, were treated with more debulking devices (p <0.003), and had higher rates of in-hospital complications and mortality (p <0.001) compared with those without CRI. Among patients with CRI, treatment with SESs did not affect clinical outcomes at 1 month and was associated with lower incidences of target vessel revascularization (7.1% vs 22.1%, p = 0.02) at 6 months but did not affect other events, including mortality (16.7% vs 14.7% p = 0.89), compared with BMSs. However, treatment with SESs in patients without CRI was associated with significantly lower rates of major adverse cardiac events at 6 months (p <0.001). In conclusion, percutaneous coronary intervention with SESs in patients with CRI is associated with low rates of repeat revascularization compared with BMSs but has no effect on mortality at 6 months.     

Impact of baseline renal function on mortality after percutaneous coronary intervention with sirolimus-eluting stents or bare metal stents

Renal impairment is an important predictor of mortality after percutaneous coronary intervention and may increase the restenosis rate. However, the relation between restenosis and the risk of death in patients who have renal impairment remains unclear. We evaluated the incidences of repeat revascularization and mortality in patients who had renal impairment and those who did not and who received sirolimus-eluting stents or bare stents. A total of 1,080 consecutive patients treated for 1 year had available data to calculate baseline creatinine clearance. Patients received bare stents (first 6 months, n = 543) or sirolimus-eluting stents (last 6 months, n = 537) and were grouped according to the presence or absence of renal impairment (creatinine clearance <60 ml/min). Patients who had renal impairment had a higher mortality rate at 1 year (7.6% vs 2.5%, hazard ratio 3.14, 95% confidence interval 1.68 to 5.88, p <0.01), with no differences in mortality between patients who received bare stents and those who received sirolimus-eluting stents (hazard ratio 0.91, 95% confidence interval 0.49 to 1.68, p = 0.8). The incidence of target vessel revascularization decreased significantly in patients who were treated with sirolimus-eluting stents and did not have renal impairment (hazard ratio 0.59, 95% confidence interval 0.39 to 0.90, p = 0.01) and in those who had decreased renal function (hazard ratio 0.37, 95% confidence interval 0.15 to 0.90, p = 0.03). Thus, sirolimus-eluting stents compared with conventional stents decreased clinical restenosis in patients who had renal impairment. However, this benefit was not paralleled by a decrease in the risk of death in this population. It seems unlikely that restenosis could be a contributing factor that influenced the increased mortality of patients who had impaired renal function.     

Sirolimus-eluting stents for percutaneous coronary intervention in acute myocardial infarction Lesson from a case-controlled comparison of bare metal versus drug-eluting stents in thrombus-laden lesions

BACKGROUND: Given the encouraging results on early restenosis rate with drug-eluting coronary stents, both safety and 6 months outcomes of PCI with sirolimus-eluting stents (SES) in acute myocardial infarction are scarce. METHODS AND RESULTS: Fifty consecutive patients with acute myocardial infarction were subjected to acute PCI with SES and compared to 50 matched control patients who received a bare metal stent (BMS). All patients were followed over 6 months; in addition repeat angiography was obtained in 88.0% of SES and 92.0% of BMS patients. As a result of matching both groups were similar with regard to demographic, clinical, and infarction characteristics, as well as procedural data and adjunctive medication. SES diameter was 3.0 +/- 0.1 versus 3.3 +/- 0.5 mm with BMS, while the length of stented segment was 24 +/- 11 mm with SES versus 16 +/- 8 mm with BMS (p<0.05). No subacute stent thrombosis occurred in either group. At 6 months, all-cause mortality was 2.0% with SES, and 4.0% with BMS (n. s.); reinfarction rate was 2.0% in both groups, but binary restenosis rate (4.0 versus 18.0%; p<0.05) and target vessel revascularization (TVR) were improved with SES (2.0 versus 16.0%; p<0.05) resulting in lower MACE rate of 6.0 versus 22.0% with BMS (p<0.05). CONCLUSION: Placement of SES with PCI for myocardial infarction is feasible and as safe as BMS; 6-month outcome is superior with SES due to the lower rate of both angiographic restenosis and TVR.     

The efficacy of sirolimus-eluting stents versus bare metal stents for diabetic patients undergoing elective percutaneous coronary intervention

BACKGROUND: Diabetes mellitus is a well-known risk factor for future adverse cardiac events after coronary intervention with conventional metal stents. In this study, the impact of sirolimus-eluting stents (SES) were evaluated in a consecutive group of diabetic patients undergoing elective percutaneous coronary treatment and compared to a population treated with bare metal stents. METHODS AND RESULTS: From April 2002, a policy of routine SES implantation has been instituted in our hospital. During 1 year of enrollment, a total of 112 consecutive diabetic patients with de novo coronary lesions were electively treated with SES (SES group). A similar group for comparison comprised 118 consecutive patients treated with bare metal stents in the preceding period (the pre-SES group). After 1-year follow-up, the cumulative rate of major adverse cardiac events (death, myocardial infarction, and any repeat revascularization) was 17.3% in the SES group versus 30.2% in the pre-SES group (hazard ratio, 0.54 [95% confidence interval, 0.32-0.91]; p = 0.02), mainly due to a marked reduction in the need for repeat revascularization (10.2% versus 23.5%; hazard ratio, 0.40 [95% confidence interval, 0.21-0.78]; p = 0.007). CONCLUSIONS: Routine utilization of SES for diabetic patients significantly reduces the rate of adverse cardiac events at 1 year compared to bare metal stents.     

Outcomes of intravascular ultrasound-guided percutaneous coronary intervention with drug-eluting stents versus bare metal stents for acute coronary syndrome in octogenarians

The number of percutaneous coronary interventions (PCI) performed for octogenarians with acute coronary syndrome (ACS) continue to increase. The short- and long-term outcomes of intravascular ultrasound (IVUS)-guided PCI with drug-eluting stents (DES) or bare metal stents (BMS) for ACS in octogenarians, however, remain largely unknown. We analyzed clinical outcomes of octogenarians undergoing IVUS-guided PCI for ACS with either DES or BMS. During the study period, a total of 776 patients with ACS underwent IVUS-guided PCI and 75 of them were octogenarians. In-hospital mortality tended to be lower in the DES group than in the BMS group. Between 6 months and 1 year of follow up, treatment with DES compared with BMS tended to result in fewer target lesion revascularizations. Major adverse cardiac events were similar between patients receiving DES and BMS. In octogenarians with ACS treated with IVUS-guided PCI, DES appears as safe as BMS, providing similar short- and long-term outcomes.     

Comparison of bare metal stents versus drug-eluting stents on clinical decision making in patients with previous percutaneous coronary intervention admitted for suspected acute coronary syndrome

To determine whether the decreased rate of restenosis observed with drug-eluting stents (DES) has changed the treatment of patients with recurrent symptoms after stent placement, we compared patients hospitalized with presumed cardiac symptoms within 1 year after placement of either a DES or a bare metal stent (BMS). In this retrospective, single-center study, cases were identified from consecutive patients who received a DES from March 2003 to July 2004 or a BMS from August 2001 to June 2002. No differences were noted in the rate of hospitalization, hospitalization for presumed cardiac symptoms, use of coronary angiography in patients hospitalized for presumed cardiac symptoms, or average interval to hospitalization. In contrast, restenosis and the need for additional revascularization procedures were higher in the BMS group. The primary indication for additional revascularization was restenosis in the BMS group and progression of coronary artery disease in the DES group. In the DES group, the need for revascularization was significantly higher in patients with multi- versus single-vessel coronary artery disease (26% vs 7%, p < 0.05). In conclusion, the rate of hospitalization and use of coronary angiography in patients with recurrent symptoms were similar in patients who received a BMS or DES, despite the decreased rates of restenosis and additional revascularization procedures observed with DESs.     

Early and mid-term clinical outcomes with the CATANIA coronary stent system vs. bare metal stents in patients with coronary artery disease

BackgroundThe potential for the CATANIA (CAT) stent to be an alternative to both bare-metal stents (BMS) and drug-eluting stents (DES) has been recently demonstrated in the Assessment of The LAtest Non-Thrombogenic Angioplasty stent (ATLANTA) first-in-human study. The aim of the present study was to compare short-term outcomes of patients treated with the CAT stent with those treated with BMS.MethodsBased on an internal registry, the 30-day and 6-month risk-adjusted outcomes for patients who received the CAT stent (n=254) were compared against outcomes of a historical cohort of patients who received BMS (n=552) between January 2001 and December 2001.ResultsAt 30 days, use of BMS vs. the CAT stent resulted in borderline significant differences with respect to major adverse cardiac and cerebrovascular events (MACCE) and cardiac death or myocardial infarction. At 6 months, BMS showed a statistically significant higher adjusted risk of MACCE (HR 2.79, 95% CIs 1.20–6.48, P=.017) and no differences with respect to the subcomponent end points. The cumulative incidence of definite stent thrombosis (Academic Research Consortium defined) at 6 months was 0.39% for the CAT stent and 2.35% for the BMS.ConclusionsThis study confirms the favorable early and mid-term safety profile and the high-level efficacy of the CAT stent in the treatment of de novo coronary lesions seen in the ATLANTA trial. The use of stents with a nanothin Polyzene-F surface treatment provided improved results with respect to BMS and lower risk of acute and subacute stent thrombosis.     

Efficacy of sirolimus-eluting stents compared with bare metal stents for saphenous vein graft intervention

Saphenous vein graft (SVG) intervention is associated with a significantly increased rate of periprocedural complications and late clinical and angiographic restenosis. We examined the efficacy and safety of sirolimus-eluting stents (SESs; Cypher) compared with bare metal stents (BMSs) in SVG intervention. Forty-eight patients who had 50 SVG lesions and underwent standard percutaneous coronary intervention with SESs (SES group) were compared with 57 patients who had 64 SVG lesions and underwent intervention with BMSs (BMS group). All patients received distal protection devices during SVG intervention. In-hospital, 30-day, 6-month, and 1-year clinical outcomes in the 2 groups were compared. Baseline clinical and procedural characteristics were balanced between groups. There were no deaths or Q-wave myocardial infarctions during the index hospitalization, but compared with the BMS group, patients in the SES group had significantly fewer non-Q-wave myocardial infarctions (4% vs 21%, p = 0.01), which was mainly attributed to increased periprocedural creatine kinase-MB levels. At 30-day, 6-month, and 1-year follow-ups, all clinical outcomes were similar between groups. Event-free survival at 1 year was also similar between groups (p = 0.84). In conclusion, the use of SESs in patients who undergo SVG intervention with a distal protection device is clinically safe and feasible but is not associated with decreased clinical events up to 1 year compared with BMSs.     

Comparison of effectiveness of sirolimus-eluting stents versus bare metal stents for percutaneous coronary intervention in patients at high risk for coronary restenosis or clinical adverse events

We evaluated the clinical effect of selective use of sirolimus-eluting stents (SESs) in real-world, high-risk patients. A total of 4,237 consecutive patients who underwent percutaneous coronary intervention (SES, n = 872, bare metal stents [BMSs], n = 3,365) was enrolled in a prospective regional survey. A prespecified high-risk subset of patients was selected on the basis of clinical and angiographic characteristics. A propensity score analysis was performed to compare patients who received SESs with those who received BMSs. Patients in the SES group more often had diabetes and more frequently had previous myocardial infarction or coronary revascularization, type C lesions, and multivessel procedures. Patients who presented with acute myocardial infarction were treated more often with BMSs. At 9 months, the use of SESs was associated with fewer major adverse cardiac events (death, myocardial infarction, or target lesion revascularization; hazard ratio 0.56, 95% confidence interval 0.37 to 0.85) and target lesion revascularizations (hazard ratio 0.43, 95% confidence interval 0.20 to 0.91). This decrease was more evident in a prespecified high-risk subgroup of patients (major adverse cardiac events, 8.0% SES vs 15.6% BMS, hazard ratio 0.45, 95% confidence interval 0.29 to 0.72). We conclude that selective SES use in real-world patients who have high-risk clinical and angiographic characteristics is associated with significant decreases in major adverse cardiac events and repeat revascularizations compared with BMS use.     

比较药物洗脱支架和普通支架治疗冠心病合并2型糖尿病的疗效

目的评价药物洗脱支架治疗冠心病合并2型糖尿病的疗效。方法药物洗脱支架组为2002年12月～2004年11月,冠心病合并2型糖尿病患者68例,因冠状动脉内原发病变接受药物洗脱支架置入;对照组为我科经皮冠状动脉介入术资料库中抽取自2001年3月以来冠心病合并2型糖尿病56例,因原发病变置入普通支架。结果术后1年内随访结果,药物洗脱支架组与普通支架组手术成功率相似(分别为97.1%与98.2%,P=1.00);累计1年内发生主要不良心脏事件率分别为19.1%与35.7%(P=0.037,比数比为0.425,95%置信限为0.188～0.961),再次血运重建分别为10.3%与25.0%(P=0.03,比数比0.344,95%置信限0.128～0.925),发生死亡、急性心肌梗死两组无差异。结论冠心病合并2型糖尿病患者常规置入药物洗脱支架安全有效,与普通支架相比,能显著降低1年主要不良心脏事件发生率。     

中国冠心病患者接受不同支架治疗预后的荟萃分析

目的比较中国冠心病患者置入药物洗脱支架(DES)和裸支架(BMS)或西罗莫司洗脱支架(SES)和紫杉醇洗脱支架(PES)之间,临床预后的差别。方法检索数据库,纳入随访时间≥6个月的、比较DES和BMS或SES和PES的临床研究。用STATA 10.0作荟萃分析,比较不同类型支架的临床预后,包括主要心血管不良事件(MACE)、靶病变血运重建(TLR)、靶血管血运重建(TVR)、支架内血栓形成和心肌梗死的发生情况。结果共纳入文献11篇(3780例),随访时间从6个月至3年。与BMS相比,DES可减少MACE(OR=0.471,95%CI0.336～0.662,P<0.001)、减少TVR(OR=0.250,95% CI0.148～0.422,P<0.001),但支架内血栓形成在两组间差异无统计学意义。而SES与PES相比,在MACE、TLR、TVR、支架内血栓、心肌梗死方面差异均无统计学意义。结论药物洗脱支架有效性、安全性高,药物支架中,西罗莫司支架和紫杉醇支架差异无统计学意义。     

Drug-eluting stents in patients on chronic hemodialysis: Paclitaxel-eluting stents vs. limus-eluting stents

BackgroundPatients requiring chronic hemodialysis (HD) are at high risk for restenosis after percutaneous coronary intervention (PCI) with bare metal stents. Outcome data on drug-eluting stent (DES) implantation in HD patients are limited and suggest superiority of paclitaxel-eluting stents (PES) over limus-eluting stents (LES).MethodsIn total, 218 consecutive patients were prospectively enrolled. A comparison of post-PCI outcomes up to 2 years was carried out between patients receiving PES (n = 62) and LES (n = 156; SES n = 112, EES n = 44). The primary end point was 2-year major adverse cardiac events [MACE; death, Q-wave myocardial infarction and target lesion revascularization (TLR)].ResultsBaseline characteristics were comparable. The overall prevalence of diabetes mellitus was 71%. On clinical follow-up to 2 years, MACE rates were similar [PES 32/51 (62.7%) vs. LES 77/132 (58.3%), p = 0.59]; however, clinically-driven revascularization occurred more than twice as frequently in LES patients: TLR [PES 4/36 (11.1%) vs. LES 24/93 (25.8%), p = 0.07] and target vessel revascularization [5/37 (13.5%) vs. 33/96 (34.4%), p = 0.02]. Given that overall mortality was nominally higher for PES patients [31/50 (62.0%) vs. 61/127 (48.0%), p = 0.09], a competing outcome analysis was implemented for TLR against mortality, which demonstrated that the trend for increased TLR with LES was no longer apparent (p = 0.282). On multivariable adjustment, only diabetes mellitus was independently associated with TLR (use of PES was not).ConclusionsPatients on chronic HD experience high rates of clinically driven TLR despite DES implantation. Use of PES does not demonstrate a significant advantage over LES in this population.