Drug-eluting stents versus bare metal stents prior to noncardiac surgery.

BACKGROUND: The safety of drug-eluting stents (DES) vs. bare metal stents (BMS) in the perioperative setting, a heightened state of inflammation and thrombosis is not well defined. METHODS: All adults undergoing noncardiac surgical (NCS) procedures within 1 year following percutaneous coronary intervention (PCI) in Massachusetts between April 1, 2004, and September 30, 2007, were identified from an administrative claims database. Patients were divided into those who received BMS vs. DES at index PCI. Primary net clinical outcome was death, myocardial infarction (MI) or bleeding within 30 days of NCS. Primary clinical outcome was 30-day death or MI. RESULTS: Among 8,415 (22% BMS) patients that satisfied our inclusion criteria, 1,838 BMS patients were matched with 3,565 DES patients with similar propensity scores. In the DES cohort, the 30-day primary net clinical outcome rate was lower with longer time from PCI to NCS (P = 0.02) with lowest rates if NCS was performed after 90 days from PCI (event rate 8.57, 7.53, 5.21, and 5.75% for 1-30, 31-90, 91-180, and 181-365 days from PCI to NCS). However, in the BMS cohort, the event rate was uniformly high regardless of the time from PCI to NCS (P = 0.60) (event rate 8.20, 6.56, 8.05, and 8.82% for 1-30, 31-90, 91-180, and 181-365 days from PCI to NCS). There was no significant difference between DES and the BMS group for 30-day primary net clinical outcome (6.64 vs. 7.89%; P = 0.10), but there was a 26% lower odds of primary clinical outcome (OR = 0.74, 95% CI 0.58-0.94) with DES when compared with BMS, driven mainly by differences in event rates when NCS was performed >90 days post PCI. CONCLUSION: DES implantation was not associated with higher adverse events after NCS. Moreover, the incidence of adverse events following NCS was lower when NCS was performed >90 days post-DES implantation suggesting that it may not be necessary to wait until 12 months post PCI with DES before NCS.

Early results of Massachusetts healthcare reform on racial, ethnic, and socioeconomic disparities in cardiovascular care.

BACKGROUND: Insured adults receive invasive cardiovascular procedures more frequently than uninsured adults. We examined the impact of healthcare reform in Massachusetts on use of coronary revascularization procedures and in-hospital and 1-year mortality by race/ethnicity, education, and sex. METHODS AND RESULTS: Using hospital claims data, we compared differences in coronary revascularization rates (coronary artery bypass grafting or percutaneous coronary intervention) and in-hospital mortality by race/ethnicity, education, and sex among Massachusetts residents aged 21 to 64 years hospitalized with a principal discharge diagnosis of ischemic heart disease before (November 1, 2004, to July 31, 2006) and after (December 1, 2006, to September 30, 2008) reform; 1-year mortality was calculated for those undergoing revascularization. Adjusted logistic regression assessed 24 216 discharges before reform and 20 721 discharges after reform. Blacks had 30% lower odds of receiving coronary revascularization than whites in the prereform period. Compared with whites in the postreform period, blacks (odds ratio=0.73; 95% confidence interval, 0.63-0.84) and Hispanics (odds ratio= 0.84; 95% confidence interval, 0.74-0.97) were less likely and Asians (odds ratio=1.29; 95% confidence interval, 1.01-1.65) were more likely to receive coronary revascularization. Patients living in more educated communities, men, and persons with private insurance were more likely to receive coronary revascularization before and after reform. Compared with the prereform period, the adjusted odds of in-hospital mortality were higher in patients living in less-educated communities in the postreform period. No differences in 1-year mortality by race/ethnicity, education, or sex for revascularized patients were observed before or after reform. CONCLUSIONS: Reducing insurance barriers to receipt of coronary revascularization procedures has not yet eliminated preexisting demographic and educational disparities in access to these procedures.

Instrumental variable analysis to compare effectiveness of stents in the extremely elderly.

BACKGROUND: Evaluating novel therapies is challenging in the extremely elderly. Instrumental variable methods identify variables associated with treatment allocation to perform adjusted comparisons that may overcome limitations of more traditional approaches. METHODS AND RESULTS: Among all patients aged ≥85 years undergoing percutaneous coronary intervention in nonfederal hospitals in Massachusetts between 2003 and 2009 (n=2690), we identified quarterly drug-eluting stent (DES) use rates as an instrumental variable. We estimated risk-adjusted differences in outcomes for DES versus bare metal stents using a 2-stage least squares instrumental variable analysis method. Quarterly DES use ranged from 15% to 88%. Unadjusted 1-year mortality rates were 14.5% for DES versus 23.0% for bare metal stents (risk difference, -8.5%; P<0.001), an implausible finding compared with randomized trial results. Using instrumental variable analysis, DES were associated with no difference in 1-year mortality (risk difference, -0.8%; P=0.76) or bleeding (risk difference, 2.3%; P=0.33) and with significant reduction in target vessel revascularization (risk difference, -8.3%; P<0.0001). CONCLUSIONS: Using an instrumental variable analysis, DES were associated with similar mortality and bleeding and a significant reduction in target vessel revascularization compared with bare metal stents in the extremely elderly. Variation in use rates may be useful as an instrumental variable to facilitate comparative effectiveness in groups underrepresented in randomized trials.

Long-term clinical outcomes following drug-eluting or bare-metal stent placement in patients with severely reduced GFR: Results of the Massachusetts Data Analysis Center (Mass-DAC) State Registry.

BACKGROUND: Patients with chronic kidney disease have been under-represented in randomized trials of drug-eluting stents relative to bare-metal stents and are at high risk of mortality. STUDY DESIGN: Cohort study with propensity score matching. SETTINGS & PARTICIPANTS: All adults with chronic kidney disease and severely decreased glomerular filtration rate (GFR; serum creatinine >2.0 mg/dL or dialysis dependence) undergoing percutaneous coronary intervention with stent placement between April 1, 2003, and September 30, 2005, at all acute-care nonfederal hospitals in Massachusetts. PREDICTOR: Patients were classified as drug-eluting stent-treated if all stents were drug eluting and bare-metal stent-treated if all stents were bare metal. Patients treated with both types of stents were excluded from the primary analysis. OUTCOMES & MEASUREMENTS: 2-year crude mortality risk differences (drug-eluting - bare-metal stents) were determined from vital statistics records, and risk-adjusted mortality, myocardial infraction (MI), and revascularization differences were estimated using propensity score matching of patients with severely reduced GFR based on clinical and procedural information collected at the index admission. RESULTS: 1,749 patients with severely reduced GFR (24% dialysis dependent) were treated with drug-eluting (n = 1,256) or bare-metal stents (n = 493) during the study. Overall 2-year mortality was 32.8% (unadjusted drug-eluting stent vs bare-metal stent; 30.1% vs 39.8%; P < 0.001). After propensity score matching 431 patients with a drug-eluting stent to 431 patients with a bare-metal stent, 2-year risk-adjusted mortality, MI, and target-vessel revascularization rates were 39.4% versus 37.4% (risk difference, 2.1%; 95% CI, -4.3 to 8.5; P = 0.5), 16.0% versus 19.0% (risk difference, -3.0%; 95% CI, -8.2 to 2.1; P = 0.3), and 13.0% versus 17.6% (risk difference, -4.6%; 95% CI, -9.5 to 0.3; P = 0.06). LIMITATIONS: Observational design, ascertainment of serum creatinine level >2.0 mg/dL and dialysis dependence from case report forms. CONCLUSIONS: In patients with severely decreased GFR, treatment with drug-eluting stents was associated with a modest decrease in target-vessel revascularization not reaching statistical significance and was not associated with a difference in risk-adjusted rates of mortality or MI at 2 years compared with bare-metal stents.

Drug-eluting or bare-metal stenting in patients with diabetes mellitus: results from the Massachusetts Data Analysis Center Registry.

BACKGROUND: Patients with diabetes mellitus (DM) are at high risk for restenosis, myocardial infarction, and cardiac mortality after coronary stenting, and the long-term safety of drug-eluting stents (DES) relative to bare-metal stents (BMS) in DM is uncertain. We report on a large consecutive series of patients with DM followed up for 3 years after DES and BMS from a regional contemporary US practice with mandatory reporting. METHODS AND RESULTS: All adults with DM undergoing percutaneous coronary intervention with stenting between April 1, 2003, and September 30, 2004, at all acute care nonfederal hospitals in Massachusetts were identified from a mandatory state database. According to index admission stent type, patients were classified as DES treated if all stents were drug eluting and as BMS treated if all stents were bare metal; patients treated with both types of stents were excluded from the primary analysis. Mortality rates were obtained from vital statistics records, and myocardial infarction and revascularization rates were obtained from the state database with complete 3 years of follow-up on the entire cohort. Risk-adjusted mortality, myocardial infarction, and revascularization differences (DES-BMS) were estimated with propensity-score matching based on clinical, procedural, hospital, and insurance information collected at the index admission. DM was present in 5051 patients (29% of the population) treated with DES or BMS during the study. Patients with DM were more likely to receive DES than BMS (66.1% versus 33.9%; P<0.001). The unadjusted cumulative incidence of mortality at 3 years was 14.4% in DES versus 22.2% in BMS (P<0.001). Based on propensity-score analysis of 1:1 matched DES versus BMS patients (1476 DES:1476 BMS), the risk-adjusted mortality, MI, and target vessel revascularization rates at 3 years were 17.5% versus 20.7% (risk difference, -3.2%; 95% confidence interval, -6.0 to -0.4; P=0.02), 13.8% versus 16.9% (-3.0%; 95% confidence interval, -5.6 to 0.5; P=0.02), and 18.4% versus 23.7% (-5.4%; confidence interval, -8.3 to -2.4; P<0.001), respectively. CONCLUSIONS: In a real-world diabetic patient population with mandatory reporting and follow-up, DES were associated with reduced mortality, myocardial infarction, and revascularization rates at long-term follow-up compared with BMS.

Long-term clinical outcomes after drug-eluting and bare-metal stenting in Massachusetts.

BACKGROUND: Drug-eluting stents (DES) reduce the need for repeat revascularization, but their long-term safety relative to that of bare-metal stents (BMS) in general use remains uncertain. We sought to compare the clinical outcome of patients treated with DES with that of BMS. METHODS AND RESULTS: All adults undergoing percutaneous coronary intervention with stenting between April 1, 2003, and September 30, 2004, at non-US government hospitals in Massachusetts were identified from a mandatory state database. Patients were classified from the index admission according to stent types used. Clinical and procedural risk factors were collected prospectively. Risk-adjusted mortality, myocardial infarction, and revascularization rate differences (DES-BMS) were estimated through propensity score matching without replacement. A total of 11 556 patients were treated with DES, and 6237 were treated with BMS, with unadjusted 2-year mortality rates of 7.0% and 12.6%, respectively (P<0.0001). In 5549 DES patients matched to 5549 BMS patients, 2-year risk-adjusted mortality rates were 9.8% and 12.0%, respectively (P=0.0002), whereas the respective rates for myocardial infarction and target-vessel revascularization were 8.3% versus 10.3% (P=0.0005) and 11.0% versus 16.8% (P<0.0001). CONCLUSIONS: DES treatment was associated with lower rates of mortality, myocardial infarction, and target-vessel revascularization than BMS treatment in similar patients in a matched population-based study. Comprehensive follow-up in this inclusive population is warranted to identify whether similar safety and efficacy remain beyond 2 years.

Drug-eluting or bare-metal stents for acute myocardial infarction.

BACKGROUND: Studies comparing percutaneous coronary intervention (PCI) with drug-eluting and bare-metal coronary stents in acute myocardial infarction have been limited in size and duration. METHODS: We identified all adults undergoing PCI with stenting for acute myocardial infarction between April 1, 2003, and September 30, 2004, at any acute care, nonfederal hospital in Massachusetts with the use of a state-mandated database of PCI procedures. We performed propensity-score matching on three groups of patients: all patients with acute myocardial infarction, all those with acute myocardial infarction with ST-segment elevation, and all those with acute myocardial infarction without ST-segment elevation. Propensity-score analyses were based on clinical, procedural, hospital, and insurance information collected at the time of the index procedure. Differences in the risk of death between patients receiving drug-eluting stents and those receiving bare-metal stents were determined from vital-statistics records. RESULTS: A total of 7217 patients were treated for acute myocardial infarction (4016 with drug-eluting stents and 3201 with bare-metal stents). According to analysis of matched pairs, the 2-year, risk-adjusted mortality rates were lower for drug-eluting stents than for bare-metal stents among all patients with myocardial infarction (10.7% vs. 12.8%, P=0.02), among patients with myocardial infarction with ST-segment elevation (8.5% vs. 11.6%, P=0.008), and among patients with myocardial infarction without ST-segment elevation (12.8% vs. 15.6%, P=0.04). The 2-year, risk-adjusted rates of recurrent myocardial infarction were reduced in patients with myocardial infarction without ST-segment elevation who were treated with drug-eluting stents, and repeat revascularization rates were significantly reduced with the use of drug-eluting stents as compared with bare-metal stents in all groups. CONCLUSIONS: In patients presenting with acute myocardial infarction, treatment with drug-eluting stents is associated with decreased 2-year mortality rates and a reduction in the need for repeat revascularization procedures as compared with treatment with bare-metal stents.