Drug-Eluting vs Bare-Metal Stents in Patients with Chronic Kidney Disease and Coronary Artery Disease: Insights from a Systematic Review and Meta-Analysis

BACKGROUND: Most drug-eluting stent (DES) trials have excluded patients with chronic kidney disease (CKD). The efficacy of DES implantation in patients with CKD is therefore not known. OBJECTIVES: To evaluate the outcomes with DES vs bare-metal stent (BMS) implantation in patients with CKD. METHODS AND RESULTS: MEDLINE, EMBASE, and CENTRAL were searched for studies including at least 100 patients with CKD (estimated glomerular filtration rate ≤60 mL/min/1.73 m2 or on dialysis) treated with DES or BMS and followed for at least 1 month and reporting outcomes of all-cause mortality, cardiovascular (CV) mortality, myocardial infarction (MI), target-vessel revascularization (TVR), and stent thrombosis (ST). Thirty-one studies (5 randomized) with 91,817 participants (49,081 DES and 42,736 BMS) fulfilled the inclusion criteria. DES was associated with lower all-cause mortality (relative risk [RR], 0.77; 95% confidence interval [CI], 0.71-0.84), CV mortality (RR, 0.51; 95% CI, 0.38-0.70), MI (RR, 0.90; 95% CI, 0.86-0.95), TVR (RR, 0.61; 95% CI, 0.47-0.80), and numerically lower ST (RR, 0.75; 95% CI, 0.55-1.01) when compared with BMS. Analysis by study type (RCTs vs non-RCTs) showed similar results for most outcomes (Pinteraction\u3e.05) except all-cause mortality, where there was no difference between DES vs BMS in RCTs (Pinteraction≤.04). The effects were greater with 2nd-generation DES vs BMS (for example, ST: RR, 0.38; 95% CI, 0.20-0.72). CONCLUSIONS: In patients with CKD, the available evidence, largely from observational studies, suggests significantly fewer events with DES vs BMS with even a lower ST rate with 2nd-generation DES. These findings should be tested in large, randomized trials

Relation of drug-eluting stent strut distribution to stent thrombosis in coronary arteries

The distribution of stent struts is critical to drug deposition and, therefore, may affect the amount of neointima and the risk of thrombosis after drug-eluting stent (DES) implantation. The aim of our study was to evaluate stent strut distribution in the setting of a drug-eluting stent thrombosis (ST). We retrospectively analyzed postprocedural intravascular ultrasound (IVUS) images of 13 patients who subsequently developed ST (14 DES thrombotic lesions) and a control group of 27 patients (30 DES lesions) matched for stent type and presence of chronic renal failure. In addition to standard IVUS measurements, visible struts were counted and maximum interstrut angle was measured at 1-mm intervals. Early ST was defined as 30 days after DES deployment. Compared with DES controls, the ST group had a larger maximum interstrut angle (60.8 +/- 8.3 degrees vs 55.7 +/- 4.8 degrees , p = 0.014) and a similar number of stent struts (8.4 +/- 0.6 vs 8.7 +/- 0.6, p = NS). Maximum interstrut angle tended to be larger in late ST than in early ST (66.1 +/- 10.8 degrees vs 57.8 +/- 5.0 degrees , p = 0.071). The incidence of maximum interstrut angles > or =90 degrees and > or =120 degrees observed continuously for > or =2 mm of stent length was higher in the ST group (p = 0.009 and p = 0.096, respectively). In conclusion, DES-treated lesions leading to ST had larger maximum interstrut gaps distributed circumferentially and longitudinally, but a similar number of struts at the time of DES implantation compared with DES controls.6 page(s

Management of coronary disease in patients with advanced kidney disease

© 2020 Massachusetts Medical Society. BACKGROUND Clinical trials that have assessed the effect of revascularization in patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease. METHODS We randomly assigned 777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy had failed. The primary outcome was a composite of death or nonfatal myocardial infarction. A key secondary outcome was a composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. RESULTS At a median follow-up of 2.2 years, a primary outcome event had occurred in 123 patients in the invasive-strategy group and in 129 patients in the conservative-strategy group (estimated 3-year event rate, 36.4% vs. 36.7%; adjusted hazard ratio, 1.01; 95% confidence interval [CI], 0.79 to 1.29; P=0.95). Results for the key secondary outcome were similar (38.5% vs. 39.7%; hazard ratio, 1.01; 95% CI, 0.79 to 1.29). The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P=0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P=0.03). CONCLUSIONS Among patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of death or nonfatal myocardial infarction

Initial invasive or conservative strategy for stable coronary disease

BACKGROUND Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, 121.8 percentage points; 95% CI, 124.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used

Health-status outcomes with invasive or conservative care in coronary disease

BACKGROUND In the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients. METHODS We assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency. RESULTS At baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina). CONCLUSIONS In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline