A comparative analysis of major clinical outcomes using drug‐eluting stents versus bare metal stents in diabetic versus nondiabetic patients

Objectives: We aim to explore the clinical outcome of drug‐eluting stents (DES) versus bare‐metal stents (BMS) implantation in diabetics versus nondiabetic patients. Background: Diabetic patients sustain worse long‐term clinical outcomes after percutaneous coronary interventions (PCI) when compared with nondiabetics. The use of DES decreases the rate of repeat revascularization in this population but data concerning long‐term clinical benefits, such as myocardial infarction (MI) or mortality is scant. Methods: We analyzed data from a comprehensive registry of 6,583 consecutive patients undergoing PCI at our center. A propensity score was used for analysis of outcomes and for matching (DES vs. BMS). Outcome parameters were total mortality, MI, repeat target vessel revascularization (TVR) rates, and risk‐adjusted event‐free survival. Within this cohort, we identified 2,571 nondiabetic patients and these were compared with 1,826 diabetic coronary patients. Results: Mean and median follow up time was 3 and 3.25 years, respectively. Overall, diabetics had higher rates of major‐adverse cardiovascular events (MACE) at 4 years compared with nondiabetics (23.03 vs. 31.96 P > 0.001). DES use was associated with lower rates of TVR in both groups [diabetics hazard ratio (HR) = 0.56, 95% confidence interval (CI): 0.42–0.76, P < 0.001, nondiabetics HR = 0.73, 95% CI: 0.55–0.97, P = 0.03] while sustained decreased rates of both mortality and MI were evident solely among diabetics (HR = 0.71, 95% CI: 0.56–0.89, P = 0.004 in diabetic vs. HR = 0.88, 95% CI: 0.69–1.13, P = 0.3). Conclusions: In a “real‐world,” unselected population and extended clinical use, DES in diabetics was associated with sustained decreased rates of MI, death, TVR, and MACE while this benefit was attenuated in the nondiabetic population. © 2011 Wiley‐Liss, Inc.     

Cost‐effectiveness of percutaneous coronary intervention with cobalt‐chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta‐analysis of randomized trials

• The diagnosis, surveillance, and management of infrapopliteal critical limb ischemia remain inconsistent among clinicians.
• This study demonstrates that using an absolute ankle pressure of >73 mm Hg or an absolute toe pressure increase of 1 mm Hg or greater post endovascular intervention in patients with infrapopliteal critical limb ischemia may be predictive of a reduction in target limb revascularization, amputation, and death.
• This study highlights the need for vascular societies to come together to promote standardized screening, surveillance, and treatment paradigms for this complex population.

     

Polymer‐free drug‐eluting stents for coronary artery disease

Polymer‐free drug‐eluting stents (PF‐DES) were designed with the expectation of avoiding late restenosis and thrombosis related to the polymer used in traditional DES platforms. Furthermore, due to similarities with bare metal stents after drug elution, PF‐DES has been considered as particularly suitable for patients at high bleeding risk. A variety of PF‐DES platforms have been clinically tested. Despite their theoretical advantages, PF platforms showed comparable clinical outcomes with modern permanent‐ or biodegradable polymer‐based DES up to 5 years after implantation. Use of more biocompatible polymers on the modern DES platforms is one of the reasons therefore. Their improved safety profile allows already less intensive antithrombotic regimes after DES. Hence, nowadays PF‐DES platforms can be considered as one of many DES options for percutaneous treatment of coronary artery disease.

     

Sustained clinical safety and efficacy of a biodegradable‐polymer coated sirolimus‐eluting stent in “real‐world” practice: Three‐year outcomes of the CREATE (multi‐center registry of EXCEL biodegradable polymer drug eluting stents) study

Background: The CREATE is a post‐marketing surveillance multicenter registry that demonstrated satisfactory angiographic and clinical (at 18 months) outcomes of a biodegradable polymer based sirolimus‐eluting stent (EXCEL, JW Medical System, Weihai, China) for the treatment of patients in routine clinical practice. Objectives: To evaluate the three‐year clinical safety and efficacy outcomes in patients enrolled in the CREATE study. Methods: A total of 2077 all comers have been enrolled in the CREATE study at 59 centers from four countries. Recommended antiplatelet regimen was clopidogrel and aspirin for six months followed by chronic aspirin therapy. The prespecified primary outcome was the rate of major adverse cardiac events (MACE) at 12, 18, and 36 months. Results: Clinical follow‐up was completed in 2025 (97.5%) patients at three years. The average duration of clopidogrel treatment was 199.8 ± 52.7 days and 80.5% of discharged patients discontinued clopidogrel at six months. The cumulative rate of MACE was 4.5% and the rate of stent thrombosis was 1.53% at three years. At six months to three years, prolonged clopidogrel therapy (>6 months) was not beneficial in reducing cumulative hazards of MACE (3.4% vs. 3.1%, log rank P = 0.725) or stent thrombosis (1.5% vs. 0.6%, log rank P = 0.053). Conclusions: This study demonstrates sustained three‐year clinical safety and efficacy of biodegradable polymer‐based sirolimus‐eluting stents when used with six months of dual antiplatelet therapy in a “real‐world” setting. © 2011 Wiley Periodicals, Inc.     

Scanning electron microscopic assessment of coating irregularities and their precursors in unexpanded durable polymer‐based drug‐eluting stents

Objectives : To assess and quantify coating irregularities on unexpanded and expanded durable polymer‐based drug‐eluting stents (DES) to gain insights into the origin of coating irregularities. Background: Previous scanning electron microscopy (SEM) studies in various expanded DES revealed differences in frequency and size of coating irregularities between DES types and specific distribution patterns, however, the origin of these irregularities is unclear. Methods: We assessed at bench side a total of 1,200 SEM images obtained in 30 DES samples (15 expanded and 15 unexpanded) of Cypher Select Plus, Taxus Liberté, Endeavor, Xience V, and resolute. Results: For most coating irregularities seen on expanded DES (72%; 23/32), a matching irregularity (n = 18/23) and/or its precursor (n = 11/23) was observed in unexpanded DES. Unexpanded Cypher select showed (small) crater lesions and cracks together with precursors of “peeling.” On unexpanded Taxus Liberté, thinning of polymer, small bare metal areas, wrinkles, and one precursor type were found. Unexpanded endeavor showed cracks, small bare metal areas, crater lesions, and precursors of the latter. Unexpanded Xience V and resolute mainly revealed crater lesions and their precursors. On unexpanded versus expanded DES, there was no difference in measured frequency of coating irregularities and precursors (P = ns) with the exception of more bare metal areas on expanded Taxus Liberte (P = 0.01). Conclusions : Most coating irregularities, or the potential to develop them, are inherent to the unexpanded DES. Important determinants of the formation of coating irregularities may be the stent geometry and the physical properties of the coating, while stent‐balloon interaction plays no major role. © 2011 Wiley Periodicals, Inc.     

Long‐term clinical,angiographic, and intravascular ultrasound outcomes of biodegradable polymer‐coated sirolimus‐eluting stents

Background: The residual drug carriers on drug‐eluting stents (DES) surfaces are considered to be one of the most significant reasons causing late thrombosis. There is no documented data currently available on the safety/benefit profile beyond 6 months of EXCEL stent, a novel sirolimus‐eluting stent with biodegradable polymer coating, in treating patients with coronary artery disease (CHD). Objective: To evaluate the long‐term efficacy and safety of EXCEL stent on treating CHD patients. Methods: Between February and March 2006, a consecutive cohort of complex patients treated with the EXCEL stent was prospectively enrolled in this single‐center registry. Antiplatelet protocol was 6‐month dual antiplatelet therapy with clopidogrel and aspirin followed by aspirin alone indefinitely. The primary outcome was major adverse cardiac events (MACE) at 12 months. Secondary outcomes included in‐segment and in‐stent late lumen loss and binary restenosis rate measured by quantitative coronary angiography (QCA) analysis at 8 months postindex PCI procedure. Results: A total of 100 patients with 153 lesions were included in this analysis. Most lesions (83.0%) were classified as complex (B2/C). At 12 months, four patients (4.0%) experienced MACE, which were four target‐lesion revascularizations due to in‐stent restenosis (ISR). All patients received follow‐up up to 24 ± 0.4 months and no cardiac death, MI, and in‐stent thrombosis occurred during the 6 months of dual antiplatelet therapy or the subsequent 15 months of aspirin treatment alone. QCA analysis of 112 lesions from 75 patients showed 3.6% (4/112) in‐stent lesion restenosis, 5.4% (6/112) in‐segment lesion restenosis, 0.12 ± 0.34 mm in‐stent late lumen loss, and 0.08 ± 0.35 mm in‐segment late lumen loss. Conclusions: In this single‐center experience with complex patients and lesions, the EXCEL^TM stent implantation with 6‐month dual antiplatelet treatment proved to markedly reduce the incidence of 24‐month ISR and MACE. These preliminary findings require further validation by large scale, randomized trials. © 2008 Wiley‐Liss, Inc.     

Angiographic outcomes with biodegradable polymer and permanent polymer drug‐eluting stents

Background : In the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus‐Eluting Stents (ISAR‐TEST‐4) trial, we demonstrated the noninferiority of biodegradable polymer (BP) sirolimus‐eluting stent to permanent polymer (PP) sirolimus/everolimus‐eluting stent (Cypher/Xience‐V) on the basis of clinical outcomes. In this study, we compare the antirestenotic efficacy of these stents in ISAR‐TEST‐4 patients with paired angiographic studies. Methods : Patients with de novo coronary lesions in native vessels (excluding left main lesions) were randomly assigned to receive a BP stent or a PP stent. Endpoints of interest of this study were in‐stent late lumen loss, in‐segment binary restenosis, and restenosis morphology at 6–8‐month follow‐up angiogram. Results : Of the 2,603 patients (3,372 lesions) enrolled in ISAR TEST‐4 trial, 2,016 patients (2,637 lesions) underwent repeat angiographic examination 6–8 months after randomization: 1,006 patients (1,323 lesions) treated with BP stents and 1,010 patients (1,314 lesions) treated with PP stents. No difference was observed between BP and PP stents in in‐stent late lumen loss (0.24 ± 0.6 vs. 0.26 ± 0.5 mm, respectively, P = 0.49) or in in‐segment binary restenosis (11.6% [153 lesions] vs. 11.8% [155 lesions], P = 0.85). Focal pattern of restenosis was observed in the majority of patients receiving either BP or PP stents. The diffuse pattern of restenosis was observed in 26.8% of patients treated with BP stent and 26.5% of patients treated with PP stent (P = 0.79). Conclusion : Angiographic characteristics of restenosis after BP‐based limus‐eluting stents are similar to those of PP‐based limus‐eluting stents. © 2011 Wiley‐Liss, Inc.     

Outcomes of nonagenarians who undergo percutaneous coronary intervention with drug‐eluting stents

Background : Age is an important predictor of mortality after percutaneous coronary intervention (PCI). The safety and efficacy of PCI with drug‐eluting stents (DES) in nonagenarians have not been extensively studied. Methods : A retrospective analysis of 889 consecutive patients identified 28 (3.1%) nonagenarians who underwent PCI with DES from May 2003 to December 2005 at our institution. Results : The mean age was 92 ± 2 years, 39% were male, and 4% were diabetic. Sirolimus‐eluting stents were used in 79%. A mean of 1.5 ± 0.9 stents/patient were implanted with a total stent length of 31 ± 20 mm. Twenty‐nine percent presented with unstable angina and 39% with myocardial infarction. The angiographic success rate obtained was 100%. The 30‐day mortality rate was 21%. The 6 patients who died within 30 days included 3 patients who had cardiogenic shock and one patient with critical aortic stenosis who died due to complications during percutaneous aortic valvuloplasty. The cumulative survival rate for all nonagenarians at 1 year and 3 years was (68 ± 9)% and (61 ± 9)%. When the four patients who were in extremis on presentation were excluded, there were no in‐hospital deaths, the 30‐day mortality was 8%, and the 1 year and 3 year survival rate was (79 ± 8)% and (71 ± 9)% for the nonagenarians. No patient had definite stent thrombosis. Conclusions : The majority of the nonagenarians who underwent PCI with DES presented with acute coronary syndrome. Percutaneous coronary intervention with DES was safe in nonagenarians as there were no in‐hospital deaths and acceptable 3‐year survival rates when patients who were in extremis on presentation were excluded. The high‐risk profile of these patients and the expected attrition of nonagenarians may contribute to their mortality rates. © 2008 Wiley‐Liss, Inc.     

Complete versus incomplete revascularization with drug‐eluting stents for multi‐vessel disease in stable,unstable angina or non‐ST‐segment elevation myocardial infarction: A meta‐analysis

Objectives

To determine whether drug‐eluting stent (DES) coronary complete revascularization (CR) confers clinical benefit over incomplete revascularization (IR) in patients with multivessel coronary artery disease (MVD).

Background

Clinical benefit of CR over IR in patients with MVD with angina (both stable and unstable) and non‐ST‐segment elevation myocardial infarction (NSTEMI) in DES has not been well studied.

Methods

We conducted a systematic online literature search of PUBMED and EMBASE. Literatures that compared the clinical outcomes between CR and IR with exclusively or majority (>80%) using DES in patients without or included only small portion (<20%) of ST‐segment elevation myocardial infarction or single‐vessel coronary artery disease were included. Hazards ratio (HR) with 95% confidence interval (CI) was calculated with random‐effects model.

Results

No randomized clinical trials were identified. A total of 14 observational studies with total of 41 687 patients (CR 39.6% and IR 60.4%) were included in this meta‐analysis. CR was associated with lower incident of all‐cause mortality (HR 0.71, P = 0.001), major adverse events (HR 0.75, P < 0.001), cardiovascular mortality (HR 0.39, P < 0.001). Meta‐regression analysis showed that CR significantly reduced the risk of all‐cause mortality in advanced age, triple vessel disease and male sub‐groups.

Conclusions

CR with DES conferred favorable outcomes compared to IR in MVD patients with stable, unstable angina or NTEMI. Further research to achieve higher CR in MVD patients may lead to improvement in prognosis in these cohorts.