Outcomes of diabetics receiving bare-metal stents versus drug-eluting stents.

OBJECTIVES: We sought to determine if differences existed in in-hospital outcomes, long-term rates of target vessel revascularization (TVR), and/or long-term mortality trends between patients with diabetes mellitus undergoing percutaneous coronary intervention (PCI) with either a drug-eluting stent(s) (DES) or a bare metal stent(s) (BMS). BACKGROUND: Short- and long-term clinical outcomes of patients with diabetes mellitus undergoing PCI with DES versus BMS remain inconsistent between randomized-controlled trials (RCTs) and observational studies. METHODS: Data were collected prospectively on diabetics undergoing PCI with either DES or BMS from January 2000 to June 2008. Demographic information, medical histories, in-hospital outcomes, and long-term TVR and mortality trends were obtained for all patients. RESULTS: A total of 1,319 patients were included in the study. Diabetics receiving DES had a significant reduction in index admission MACE compared to diabetics receiving BMS. Using multivariable adjustment, after a mean follow-up of 2.5 years (maximum 5 years), diabetics who received DES had a 38% decreased risk of TVR compared to diabetics with BMS [HR 0.62 (95% CI: 0.43-0.90)]; diabetics with DES had an insignificant adjusted improvement in long-term survival compared to diabetics with BMS [HR 0.72 (95% CI: 0.52-1.00)]. These long-term survival and TVR rates were confirmed using propensity scoring. CONCLUSIONS: The use of DES when compared with BMS among diabetics undergoing PCI is associated with significant improvement in long-term TVR, with an insignificant similar trend in all-cause mortality. The long-term results of this observational study are consistent with prior RCTs after adjusting for confounding variables.

The impact of hematocrit drop on long-term survival after cardiac catheterization: insights from the Dartmouth Dynamic Registry.

BACKGROUND: The long-term prognostic implication of post-procedural hematocrit drops in patients undergoing cardiac catheterization outside the clinical trial setting is not well defined. METHODS: Data was prospectively collected from 12,661 patients undergoing diagnostic or interventional cardiac catheterization between July 1998 and July 2006. Patients were divided into three cohorts based upon the degree of hematocrit change: drop greater than 6, drop between 3 and 6, and drop less than 3. In-hospital major adverse events, 30-day mortality, and long-term all-cause mortality were recorded. RESULTS: Patients with larger reductions in hematocrit were more likely to be older, female, and have a higher baseline hematocrit, present with acute myocardial infarction, develop cardiogenic shock, require emergent catheterization, develop retroperitoneal bleeds and large hematomas, receive transfusions, have longer index hospitalizations, develop subacute stent thrombosis, and have higher 30-day and long-term mortality. An increase in long-term mortality was observed with progressive hematocrit drop. This finding is largely driven by early (30 day) mortality, as trends were no longer significant after rezeroing mortality. Hematocrit drop was not an independent risk factor for 30-day mortality. Transfusion and low baseline hematocrit were identified as independent predictors of near and long-term mortality. CONCLUSIONS: Periprocedural bleeding, defined by hematocrit drop, is associated with increased near-term and long-term mortality in patients undergoing diagnostic and therapeutic cardiac catheterization procedures. Long-term mortality is largely driven by up front 30-day mortality. Hematocrit drop was not an independent predictor for near-term mortality. Transfusion and low baseline hematocrit were independent predictors for near and long-term mortality.

Real world, long-term outcomes comparison between paclitaxel-eluting and sirolimus-eluting stent platforms.

We compare real-world, extended target vessel revascularization (TVR)-free survival following percutaneous coronary intervention (PCI) for patients receiving either sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) following an index drug-eluting stent (DES) supported procedure. We analyzed 2,363 consecutive patients having first DES-supported PCI at receiving PES (n = 1,012) or SES (n = 1,332) from April 2004 to July 2006. Baseline clinical and procedural characteristics and in-hospital outcomes were recorded during the time of the index procedure and extended clinical outcomes data were obtained thereafter. TVR and all cause mortality were identified during the study period. Adjusted Kaplan-Meier and Cox's proportional hazard survival methods were performed. TVR-free survival at 2.3 years was 91.3% for SES compared with 88.9% for PES (P = 0.06). Kaplan-Meier survival curves did not significantly differ (adjusted hazard ratio -1.39 [95% CI 0.99-1.97]) between the SES and PES patient cohorts. TVR was similar between the stent platforms at one (96.6% for SES [95% CI 95.3-97.6] vs. 95.7% for PES [95% CI 94.1-96.9]) and two (95.0%[95% CI 93.0-96.4] for SES vs. 93.7% for PES [95% CI 91.6-95.3]) years. Overall survival at 2 years was 96.2% for SES (95% CI 94.7-97.3) and 95.3% for PES (95% CI 93.7-96.5). SES and PES drug-eluting stent platforms have good and similar extended outcomes in this real world registry of unselected patients having PCI.

Classification and atherosclerosis distribution in patients with left main coronary disease.

OBJECTIVE: The purpose of this investigation was to characterize clinical variables and angiographic distribution of coronary atherosclerosis to classify patients with de novo left main (LM) disease in a real-world population presenting for coronary angiography. BACKGROUND: Limited quantitative and angiographic published data exist that provide detailed quantitative information to classify potential target population for elective LM percutaneous coronary intervention (PCI) and guide development of dedicated LM PCI platforms. METHODS: Medical history and clinical presentation were prospectively collected on 177 consecutive patients with LM stenosis > or =50% by coronary angiography. Blinded quantitative coronary angiography (QCA) was performed on all LM stenoses to classify LM-A (ostial), LM-B (nonostial, non-bifurcation), and LM-C (bifurcation involvement). QCA was performed on the left anterior descending (LAD), left circumflex (LCx), and right coronary arteries (RCA) and branches (> or =2.5 mm) to identify lesions with > or =60% stenosis or occlusion. RESULTS: No differences in baseline clinical history or presentation discriminated the distribution patterns of LM stenosis. QCA revealed 66% of LM stenoses were LM-C. Mean LM reference vessel diameter was 4.65 mm and average lesion length was 11.12 mm. Around 88.7% of patients had at least one lesion > or =60% in a major epicardial artery and 32.2% of patients had RCA chronic total occlusion. Right-to-left coronary collateralization was only identified in patients with obstructive stenosis in the LAD or LCx in addition to the LM stenosis. CONCLUSION: Dedicated LM stent platforms may need to be developed to accommodate larger vessel size and bifurcation distributions. A majority of patients with LM stenosis will require adjunctive epicardial vessel PCI to achieve complete anatomic revascularization.

Transient and persistent renal dysfunction are predictors of survival after percutaneous coronary intervention: insights from the Dartmouth Dynamic Registry.

OBJECTIVES: We sought to determine if transient and persistent elevations in creatinine following percutaneous coronary intervention (PCI) resulted in poor survival. BACKGROUND: Limited survival data exist that defines the natural survival history of transient and persistent renal dysfunction following interventional PCI cases. METHODS: Data were collected prospectively on 7,856 consecutive patients undergoing PCI from January 1, 2000 to July 31, 2006. Ninety-three patients were excluded due to pre-PCI dialysis. Patients were stratified into three categories of renal dysfunction: no renal dysfunction from baseline (<0.5 mg/dL increase in creatinine within 48 hr of the procedure), transient renal dysfunction (> or =0.5 mg/dL increase in creatinine within 48 hr with return to normal within 2 weeks), and persistent renal dysfunction (> or =0.5 mg/dL increase in creatinine without returning to normal within 2 weeks of the procedure). Mortality was determined by comparing with the Social Security Death Master File. RESULTS: Median survival was 3.2 years (mean 3.4). Renal dysfunction occurred in 250 patients (0.5 mg/dL increase in creatinine). Survival was significantly different between patients at 1, 3.2, and 7.5 years (P-value < 0.001): no renal dysfunction (95%, 88%, 75%), with transient (61%, 42%, 0%), and with persistent (58%, 44%, 36%) renal dysfunction. Patients with transient or persistent renal dysfunction had a twofold-threefold increased risk of 7.5-year mortality compared with patients with no renal dysfunction. CONCLUSIONS: Both transient and persistent postprocedural renal dysfunction are prognostically significant for mortality during extended follow-up. Renal dysfunction should be closely monitored before and after PCI.

Impact and temporal trends of percutaneous coronary intervention in the drug-eluting stent versus bare metal stent eras.

Limited published data exist about how the introduction of drug-eluting stents (DESs) has affected the technical aspects of percutaneous coronary intervention and in-hospital patient outcomes in clinical practice. A total of 2,215 consecutive patients who underwent percutaneous coronary intervention for de novo coronary artery disease were divided into 2 cohorts: the pre-DES era (May 1, 2002 to April 30, 2003) and the DES era (May 1, 2003 to April 30, 2004). The procedural success rates (94.9% vs 96.4%, respectively; p = 0.075) and the in-hospital major adverse events (6.4% vs 5.7%, respectively; p = 0.53) were similar between the pre-DES and DES eras. The DES percentage of use increased from 49.5% in the first quarter to 84.1% in the final quarter of the first year after the introduction of this technology (p <0.0001). The results of our study have shown that despite more complex percutaneous coronary intervention procedures with tendencies for more complete lesion coverage and anatomic revascularization, the procedural success and in-hospital outcomes have been comparable since the introduction of DESs.

pO2 and regional blood flow in a rabbit model of limb ischemia.

Oxygen tension (pO2) in muscles and regional blood flow were measured in a rabbit model of limb ischemia. pO2 was measured repetitively by EPR oximetry with EMS char in four different muscle groups in the same animals. Blood flow in the same muscles at several time points was measured using microspheres. A linear mixed effects model was developed to analyze the data on pO2 and blood flow. The results suggest that while under normal conditions pO2 in muscles does not depend significantly on blood flow, immediately after arterial occlusion pO2 correlates linearly with blood flow. Within two weeks of occlusion the pO2 is recovered to 45% of baseline. This study demonstrates, for the first time, the applicability of EPR oximetry in animals larger than rodents.

The evaluation of creatinine clearance, estimated glomerular filtration rate and serum creatinine in predicting contrast-induced acute kidney injury among patients undergoing percutaneous coronary intervention.

PURPOSE: The purpose of the study was to compare creatinine clearance (CrCl), estimated glomerular filtration rate (eGFR) and serum creatinine (SCr) in predicting contrast-induced acute kidney injury (CI-AKI), dialysis and death following percutaneous coronary intervention (PCI). METHODS AND MATERIALS: Data were prospectively collected on 7759 consecutive patients within the Dartmouth Dynamic Registry undergoing PCI between January 1, 2000, and December 31, 2006. Renal function was measured at baseline and within 48 h after PCI using three methods: CrCl using the Cockcroft-Gault equation, eGFR using the abbreviated Modification of Diet in Renal Disease equation and SCr. We compared CrCl, eGFR and SCr in predicting CI-AKI, post-PCI dialysis-dependent renal failure and in-hospital mortality. Areas under the receiver operating characteristic curve (ROC) were calculated using logistic regression and tested for equality. RESULTS: On univariable analysis, CrCl [ROC: 0.69; 95% confidence interval (CI): 0.67-0.72] predicted CI-AKI better than eGFR (ROC: 0.67; 95% CI: 0.64-0.70) (P=.013) and SCr (ROC: 0.64; 95% CI: 0.61-0.67) (P<.001). Creatinine clearance (ROC: 0.73; 95% CI: 0.69-0.77) and eGFR (ROC: 0.70; 95% CI: 0.65-0.74) outperformed SCr for predicting in-hospital mortality. On multivariable analysis, CrCl (ROC: 0.77; 95% CI: 0.75-0.80), SCr (ROC: 0.78; 95% CI: 0.76-0.80) and eGFR (ROC: 0.77; 95% CI: 0.75-0.80) predicted CI-AKI well. Creatinine clearance (ROC: 0.88; 95% CI: 0.85-0.90) and eGFR (ROC: 0.87; 95% CI: 0.85-0.90) were strong independent predictors of in-hospital mortality. CONCLUSIONS: Creatinine clearance, eGFR and SCr predict CI-AKI equally well. Creatinine clearance and eGFR are strong independent predictors of in-hospital mortality.

Retrograde techniques and the impact of operator volume on percutaneous intervention for coronary chronic total occlusions an early U.S. experience.

OBJECTIVES: Our purpose was to determine if "Japanese style" technical strategies can be successfully applied in the U.S. practice environment and to better understand the learning curve for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: Procedural technical success remains the major limiting factor for CTO PCI, and has been unchanged over time. METHODS: Demographic, procedural, and outcome data were collected on 636 consecutive patients between January 2005 and March 2008 having CTO PCI (514 antegrade, 122 retrograde attempts) at 2 U.S. medical centers. Operators were divided into 2 groups: higher CTO volume, retrograde operators (ROs) (>75 total CTO PCI cases and >20 retrograde attempts during the study period) and lower CTO volume, nonretrograde operators (NROs) to evaluate the impact of CTO-specific operator case volume and retrograde techniques on procedural outcomes. RESULTS: Two operators met the criteria for RO category and 10 were NRO. ROs performed 395 CTO PCI cases (mean total CTO case experience = 197.5, 60 retrograde) and NROs performed 241 CTO PCI cases (mean total CTO case experience = 24.1, <1 retrograde) during the observed timeframe. The overall technical success was 58.9% for NROs and 75.2% for ROs (p < 0.0001). The technical success rate of NROs did not change, but the technical success for the ROs increased to 90% over time (p < 0.0001 for trend, 94.4% for retrograde and 85.7% for antegrade approaches). Observed major adverse events were similar between ROs and NROs. CONCLUSIONS: Complex antegrade and retrograde "Japanese style" PCI approaches can be applied in the U.S. practice environment with high technical success and low adverse event rates. Higher CTO-specific operator case volume is associated with improved technical success rates.

Interaction of gender and age on post cardiac catheterization contrast-induced acute kidney injury.

The purpose of this study was to determine the relative impact of gender and age on the development of contrast-induced acute kidney injury (CIAKI) after cardiac catheterization. CIAKI is a recognized complication of coronary angiography, but the relative impact of age strata and gender is not well understood. We prospectively enrolled 21,489 consecutive patients undergoing coronary angiography and stratified patients by age and gender into 4 age categories (<50, 51 to 64, 65 to 79, and >80 years). Of those 21,489 patients, 13,127 were included in the study. Men and women were compared within each age category for the development of CIAKI in the period after angiography. The incidence of postprocedural CIAKI and mortality rates among groups were compared. Rates of postcatheterization CIAKI were higher for women compared with men in the 65- to 79-year-old (14.5% vs 11.0%, p <0.001) and >80-year-old (18.7% vs 15.1%, p = 0.048) groups, but no differences were seen in the younger cohorts. In conclusion, geriatric women are at greatest risk for the development of CIAKI after angiography.

Age-based differences of percutaneous coronary intervention in the drug-eluting stent era.

INTRODUCTION: Limited data are available on contemporary percutaneous coronary intervention (PCI) practice patterns and outcomes in elderly patients. The objective of this study was to evaluate "real-world" PCI in elderly and nonelderly patients during the first year of availability of drug-eluting stents (DES) in the United States market (May 1, 2003-April 30, 2004). METHODS: One thousand one hundred sixty-six consecutive patients (272 elderly [age > or =75 years] and 894 nonelderly [age <75 years]) having PCI for de novo coronary artery disease (CAD) at Dartmouth-Hitchcock Medical Center were included in this study. Primary outcome measures of this study were in-hospital major adverse cardiac events (MACE-death, new MI, urgent revascularization). Secondary end points included acute renal failure, respiratory failure, and vascular complications. RESULTS: Elderly patients had higher MACE (8.5% vs 1.5%, P < or = 0.001), unadjusted in-hospital mortality (7.4% vs 0.8%, P < or = 0.001), in-hospital cardiac arrest (1.5% vs 0.3%, P = 0.03), requirements for assisted blood pressure support (13.2% vs 7.0%, P = 0.0001), respiratory failure (2.2% vs 0.9%, P = 0.08), acute renal failure (2.9% vs 0.8%, P = 0.005), and vascular complications (10.3% vs 5.5%, P = 0.005) than their nonelderly counterparts. Higher MACE rates persisted in the elderly despite correction for baseline differences using multivariate regression modeling. CONCLUSIONS: Advanced age remains a predictor of adverse outcomes attending PCI even in the contemporary era in which DES are available. This study highlights the need for further progress and investigation to optimize outcomes of PCI in the elderly.

Gender-based differences of percutaneous coronary intervention in the drug-eluting stent era.

OBJECTIVES: The purpose of this study is to provide insights into percutaneous coronary intervention (PCI) performed in women in the United States by evaluating gender-based PCI-practice patterns and outcomes. BACKGROUND: Limited "real world" contemporary data exist on how the introduction of DES has impacted PCI in women. METHODS AND RESULTS: Patients (359 women, 807 men) with de novo coronary artery disease having PCI (1,166) were evaluated during the first year, since the introduction of DES in the United States market (May 1, 2003 to April 30, 2004). Women were more likely to be older, hypertensive, obese, diabetic, and have heart failure. Men were more likely to be smokers and have more vessels with obstructive coronary artery disease. PCI procedural success rates, number of vessels attempted, percentage DES utilization, and in-hospital major adverse cardiac events (MACE; death, new myocardial infarction, urgent revascularization) were similar for both genders. However, women had significantly higher unadjusted mortality (3.9% versus 1.6%, P = 0.01), cumulative vascular complications (12.0% versus 4.2%, P < 0.0001), and renal failure (2.5% versus 0.7%, P = 0.01). After adjustment for confounding variables, mortality was similar between genders, but a significant association with vascular complications and trend toward higher rates of renal failure persisted in women. CONCLUSIONS: In this study of the modern era of PCI with DES utilization, in-hospital MACE is similar between men and women. However, the differences in baseline comorbidities and the proclivity for vascular and renal complications highlight the need for further investigation and improvements to optimize outcomes of PCI in women.