Polymer‐free versus permanent polymer‐coated drug eluting stents for the treatment of coronary artery disease: A meta‐analysis of randomized trials

Background

Polymer‐free drug eluting stents (PF‐DES) were developed, in part, to overcome risk of late ischemic events observed with permanent polymer‐coated DES (PP‐DES). However, trial results are inconsistent with longer‐term safety and efficacy of PF‐DES remaining unknown. We performed a meta‐analysis of randomized trials assessing outcomes of patients receiving PF‐DES versus PP‐DES for treatment of coronary artery disease (CAD).

Methods

Electronic searches were performed for randomized trials comparing outcomes between PF‐DES and PP‐DES. Trials reporting major adverse cardiovascular events (MACE), myocardial infarction (MI), stent thrombosis (ST), all‐cause death, target lesion/vessel revascularization (TLR/TVR), and late lumen loss (LLL) were included. Analyses were performed at longest follow‐up and landmarked beyond 1‐year.

Results

Twelve trials (6,943 patients) were included. There was no significant difference in MACE between PF‐DES and PP‐DES at longest follow‐up (Odds Ratio [OR] 0.96, 95%CI 0.85‐1.10, P = 0.59) or landmark analysis beyond 1‐year (OR 0.96, 95%CI 0.76‐1.20, P = 0.70). Although PF‐DES were associated with a significant reduction in all‐cause death (OR 0.85, 95%CI 0.72‐1.00, P < 0.05), this effect was not present on landmark analysis beyond 1‐year (OR 0.89, 95%CI 0.73‐1.10, P = 0.30). There were no differences observed for MI (OR 1.00, 95%CI 0.77‐1.28, P = 0.99) or ST (OR 0.95, 95%CI 0.54‐1.68, P = 0.86), with similar efficacy outcomes including TVR (OR 1.07, 95%CI 0.91‐1.26, P = 0.42), TLR (OR 1.03, 95%CI 0.88‐1.21, P = 0.68) and angiographic LLL (pooled mean difference 0.01 mm, 95%CI ?0.08 to 0.11, P = 0.76).

Conclusions

PF‐DES are as safe and efficacious as PP‐DES for the treatment of patients with CAD, but do not significantly reduce late ischemic complications.

     

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.     

Three‐year outcome of drug‐eluting stent implantation for coronary artery bifurcation lesions

Objectives: To compare the very long‐term clinical outcomes of bifurcation lesions using the crush and the simultaneous kissing stent (SKS) techniques. Background: A variety of two‐stent techniques have been used to treat coronary artery bifurcation lesions in the drug‐eluting stent era, but the long‐term clinical outcome of these approaches is not known. Methods: A total of 74 consecutive patients underwent bifurcation stenting using either the crush or SKS techniques. Mean patient age was 66.91 ± 11.3 years; 26% were diabetic, and the left anterior descending/diagonal bifurcation was the most frequently treated lesion (68%). Results: In‐hospital outcomes were not significantly different between groups. Over a median follow‐up of 3.3 years, 1 patient in the SKS group and 3 patients in the crush group died (P = ns). Probable stent thrombosis leading to death according to the Academic Research Consortium definition occurred in 1 patient in the crush group. Mortality in the remaining 3 patients was noncardiac. Target lesion revascularization (TLR) occurred in 14 patients (40%) in the SKS group and 5 patients (12.8%) in the crush group (P = 0.015). Survival free from major adverse cardiac events (MACE) was significantly less in the SKS group and predominantly driven by TLR (60 vs. 88%, P = 0.001). Conclusions: In conclusion, over a median of 3.3 years of follow‐up, TLR and MACE are significantly lower in bifurcation lesions treated with the crush technique when compared with the SKS technique. Definite or probable stent thrombosis is rare with either technique. © 2009 Wiley‐Liss, Inc.     

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.     

Aneurysm formation after drug‐eluting balloon treatment of drug‐eluting in‐stent restenosis: First case report

A 55‐year‐old male underwent paclitaxel‐eluting stent implantation in a bifurcation lesion of his left anterior descending artery (LAD) during an episode of unstable angina in 2008. A late in‐stent restenosis developed 15 months after implantation of the drug‐eluting stent (DES) and was treated with paclitaxel eluting balloon. Two months later, during angiography for functional assessment of the significance of lesions in the circumflex artery, an aneurysm at the place of drug‐eluting balloon (DEB) inflation was observed. The patient was left on double antiplatelet therapy and scheduled for clinical observation after 3 months and control coronary angiography after 6 months for aneurysm progression follow‐up. © 2012 Wiley Periodicals, Inc.     

Predictors of long‐term outcomes after bypass grafting versus drug‐eluting stent implantation for left main or multivessel coronary artery disease

Background : We assessed predictors of long‐term outcomes after coronary artery bypass grafting (CABG) versus those after percutaneous coronary intervention (PCI) with drug‐eluting stents (DES) in 3,230 patients with left main or multivessel coronary artery disease (CAD). Methods and Results : Data were pooled from the BEST, PRECOMBAT, and SYNTAX trials. Age, chronic kidney disease, chronic obstructive lung disease, left ventricular dysfunction, and peripheral arterial disease (PAD) were common predictors of all‐cause mortality. Diabetes mellitus, previous myocardial infarction (MI), and SYNTAX score were independent predictors of all‐cause mortality in the PCI group, but not in the CABG group. In the CABG group, age was the only risk factor for MI; left ventricular dysfunction, hypertension, and PAD were risk factors for stroke. On the other hand, in the PCI group, incomplete revascularization and previous MI were risk factors for MI; age and previous stroke for stroke. In addition, chronic kidney disease significantly correlated with a composite outcome of death, MI, or stroke in the CABG group, and incomplete revascularization and previous MI in the PCI group. Conclusions : Simple clinical variables and SYNTAX score differentially predict long‐term outcomes after CABG versus those after PCI with DES for left main or multivessel CAD. Those predictors might help to guide the choice of revascularization strategy. © 2017 Wiley Periodicals, Inc.     

Multicenter international registry of unprotected left main coronary artery percutaneous coronary intervention with drug‐eluting stents in patients with myocardial infarction

Background: Patients who present with myocardial infarction (MI) and unprotected left main coronary artery (ULMCA) disease represent an extremely high‐risk subset of patients. ULMCA percutaneous coronary intervention (PCI) with drug‐eluting stents (DES) in MI patients has not been extensively studied. Methods: In this retrospective multicenter international registry, we evaluated the clinical outcomes of 62 consecutive patients with MI who underwent ULMCA PCI with DES (23 ST‐elevation MI [STEMI] and 39 non‐ST‐elevation MI [NSTEMI]) from 2002 to 2006. Results: The mean age was 70 ± 12 years. Cardiogenic shock was present in 24%. The mean EuroSCORE was 10 ± 8. Angiographic success was achieved in all patients. Overall in‐hospital major adverse cardiac event (MACE) rate was 10%, mortality was 8%, all due to cardiac deaths from cardiogenic shock, and one patient suffered a periprocedural MI. At 586 ± 431 days, 18 patients (29%) experienced MACE, 12 patients (19%) died (the mortality rate was 47% in patients with cardiogenic shock), and target vessel revascularization was performed in four patients, all of whom had distal bifurcation involvement (two patients underwent repeat PCI and two patients underwent bypass surgery). There was no additional MI. Two patients had probable stent thrombosis and one had possible stent thrombosis. Diabetes [hazard ratio (HR) 4.22, 95% confidence interval (CI) (1.07–17.36), P = 0.04), left ventricular ejection fraction [HR 0.94, 95% CI (0.90–0.98), P = 0.005), and intubation [HR 7.00, 95% CI (1.62–30.21), P = 0.009) were significantly associated with increased mortality. Conclusions: Patients with MI and ULMCA disease represent a very high‐risk subgroup of patients who are critically ill. PCI with DES appears to be technically feasible, associated with acceptable long‐term outcomes, and a reasonable alternative to surgical revascularization for MI patients with ULMCA disease. Randomized trials are needed to determine the ideal revascularization strategy for these patients. © 2008 Wiley‐Liss, Inc.