Variability in maximal suggested door-in-door-out time for hospitals transferring patients for primary angioplasty in STEMI.

OBJECTIVES: We derived a formula for maximal suggested door-in-door-out time (DIDO) for hospitals that do not perform primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). BACKGROUND: Efforts to minimize DIDO at non-PCI hospitals can improve door-to-balloon time (D2B). Targeting a maximal suggested DIDO for a transferring hospital can influence reperfusion strategy. METHODS: We examined time to treatment intervals for 193 STEMI patients who underwent primary PCI at our hospital. D2B in transferred patients (D2BT ) was divided into 3 intervals: transferring hospital DIDO, inter-hospital transport time, and interventional time. We defined maximal suggested DIDO as the maximum DIDO that would allow PCI with D2BT ≤ 120 minutes. RESULTS: D2B was higher in transfer compared to on-site patients (147 ± 52 vs. 75 ± 44 minutes, P < 0.0001). In transfer patients, treatment time intervals were: DIDO 80 ± 42 minutes, transport time 37 ± 18 minutes, interventional time 35 ± 16 minutes. The greatest variability in D2BT was related to DIDO. We estimated that maximal suggested DIDO = [120 - (transport time plus interventional time)]. Using a fixed interventional time of 40 minutes, we simplified this as: maximal DIDO = 80 - transport time. Maximal suggested DIDO for 4 transferring hospitals in our network ranged from 1 to 65 minutes. DIDO under the hospital-specific threshold was the strongest predictor of achieving D2BT <120 minutes. CONCLUSIONS: Transferring hospitals' maximal suggested DIDO is variable, and can be calculated from inter-hospital transport time. Instead of a universal target DIDO (e.g., <30 minutes), maximal suggested DIDO can be calculated individually for each non-PCI hospital within a STEMI network.

Glycosylated hemoglobin and outcomes in diabetic patients with acute myocardial infarction after successful revascularization with stent placement: findings from the guthrie health off-label stent (GHOST) investigators.

OBJECTIVE: We evaluated the influence of glycemic control on cardiovascular outcomes in diabetic patients with acute myocardial infarction (AMI) who underwent successful percutaneous coronary intervention (PCI) with stent placement. BACKGROUND: In patients presenting with AMI, diabetic status confers adverse cardiovascular outcomes after PCI. However, the influence of glycemic control on outcomes after successful PCI is less well studied. METHODS: We examined 231 consecutive diabetes mellitus (DM) patients with AMI who underwent successful primary PCI and had evaluation of glycosylated hemoglobin (HbA1c) from 30 days before to 90 days after AMI. Patients were categorized in 2 groups, controlled DM with HbA1c ≤ 7.0 (N = 83, 36%) and uncontrolled DM with HbA1c > 7.0 (N = 148, 64%). We assessed 12-month cardiovascular outcomes in study groups. RESULTS: Uncontrolled diabetics were younger, tended to be less hypertensive, and had higher baseline glomerular filtration rate and final vessel diameter compared to controlled diabetics. Uncontrolled DM patients had similar major adverse cardiovascular events (MACE; composite of all-cause death, MI, target vessel revascularization [TVR], and stent thrombosis [ST]; 20% vs. 30%, log-rank P = 0.54), death (8.8% vs. 12%, P = 0.40), MI (8.8% vs. 9.6%, P = 0.76), TVR (9.5% vs. 8.4%, P = 0.95), and ST (3.4% vs. 4.8%, P = 0.54) as the controlled diabetics. In Cox regression analysis, after adjustment for baseline differences, glycemic control had no independent influence on study outcomes. CONCLUSION: Glycemic control, determined by HbA1c, does not seem to influence cardiovascular outcomes in diabetic patients with AMI after successful stent placement.

Long-term safety and effectiveness of drug-eluting stents compared to bare metal stents following successful PCI in non-ST-elevation myocardial infarction: findings from the Guthrie Health Off-Label StenT (GHOST) Registry.

BACKGROUND: The long-term safety and effectiveness of drug-eluting stents (DES) versus bare metal stents (BMS) in non-ST-segment elevation myocardial infarction (NSTEMI) beyond 2 years after percutaneous coronary intervention (PCI) is unknown. METHODS: We studied 674 NSTEMI patients who underwent successful PCI with DES (n = 323) or BMS (n = 351). The primary study end-points were time to occurrence of death or nonfatal recurrent myocardial infarction (MI), and stent thrombosis (ST). Secondary end-points included time to occurrence of target vessel revascularization (TVR) and any major adverse cardiovascular event (MACE, defined as the composite of death, MI, ST, TVR). RESULTS: The DES and BMS groups were well matched except that DES patients received dual antiplatelet therapy for a longer duration and had smaller final vessel diameter. In survival analysis, at a mean follow-up of 1333 ± 659 days after PCI, the DES group had similar incidence of death/myocardial infarction (24% vs. 27%, log rank p = 0.23) and ST (4.0% vs. 2.6%, p = 0.18) as the BMS group. The DES patients had lower incidence of TVR (8.1% vs. 17%, p = 0.0018) but similar MACE (26% vs. 37%, p = 0.31). In multivariable analysis, DES vs. BMS implantation showed no significant impact on death/myocardial infarction [adjusted hazards ratio (HR) 1.0, 95% confidence intervals (CI) 0.7-1.4], ST (HR 1.7; CI 0.7 - 4.0), or MACE (HR 0.8; CI 0.6 - 1.1). However, TVR was lower in the DES group (HR 0.4; CI 0.3 - 0.7). CONCLUSION: In patients presenting with NSTEMI, DES implantation appears to be as safe as BMS implantation at long-term follow-up. In addition, DES are effective in reducing TVR compared to BMS.

Drug-eluting stents in patients with chronic kidney disease: a prospective registry study.

BACKGROUND: Chronic kidney disease (CKD) is strongly associated with adverse outcomes after percutaneous coronary intervention (PCI). There are limited data on the effectiveness of drug-eluting stents (DES) in patients with CKD. METHODOLOGY/PRINCIPAL FINDINGS: Of 3,752 consecutive patients enrolled in the Guthrie PCI Registry between 2001 and 2006, 436 patients with CKD - defined as a creatinine clearance <60 mL/min - were included in this study. Patients who received DES were compared to those who received bare metal stents (BMS). Patients were followed for a mean duration of 3 years after the index PCI to determine the prognostic impact of stent type. Study end-points were all-cause death, myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis (ST) and the composite of major adverse cardiovascular events (MACE), defined as death, MI or TVR. Patients receiving DES in our study, by virtue of physician selection, had more stable coronary artery disease and had lower baseline risk of thrombotic or restenotic events. Kaplan-Meier estimates of proportions of patients reaching the end-points were significantly lower for DES vs. BMS for all-cause death (p = 0.0008), TVR (p = 0.029) and MACE (p = 0.0015), but not MI (p = 0.945) or ST (p = 0.88). Multivariable analysis with propensity adjustment demonstrated that DES implantation was an independent predictor of lower rates of all-cause death (hazard ratio [HR] 0.48, 95% confidence interval [CI] 0.25-0.92), TVR (HR 0.50, 95% CI 0.27-0.94) and MACE (HR 0.62, 95% CI 0.41-0.94). CONCLUSIONS: In a contemporary PCI registry, selective use of DES in patients with CKD was safe and effective in the long term, with lower risk of all-cause death, TVR and MACE and similar risk of MI and ST as compared with BMS. The mortality benefit may be a result of selection bias and residual confounding, or represent a true finding; a hypothesis that warrants clarification by randomized clinical trials.

The influence of anemia after percutaneous coronary intervention on clinical outcomes.

BACKGROUND: Although the consequences of bleeding after percutaneous coronary intervention (PCI) are well documented, there are no data on the impact of post-PCI anemia (PPA) on clinical outcomes. METHODS: We evaluated the incidence, predictors, and prognostic implications of PPA on clinical outcomes in 1415 PCI procedures. We compared clinical outcomes of patients with PPA (ie, nadir post-PCI hemoglobin < 10 gm/dL) vs without PPA. In patients with PPA, we assessed the influence of thrombolysis in myocardial infarction (TIMI; major or minor) bleeding, drop in hemoglobin by > or = 3 gm/dL, and use of blood transfusions on outcomes. RESULTS: Post-PCI anemia developed in 124 (8.8%) patients. Of these, 50 (40%) suffered TIMI (major or minor) bleeding, 68 (55%) had a hemoglobin drop of > or = 3 gm/dL, and 39 (32%) patients received blood transfusions. Compared to patients without PPA, those with PPA had greater incidence of 6 month death (6.5% vs 1.7 %, p = 0.003), 6 month major adverse cardiovascular event (MACE; death, reinfarction, or target vessel revascularization; 27.3% vs 14.5%, p = 0.0006), and long-term mortality (25.8% vs 8.7 %, p or = 3 gm/dL, and use of blood transfusions did not impact outcomes. CONCLUSION: We found that PPA is common, occurs frequently in the absence of bleeding or significant drop in hemoglobin, and connotes poor long-term outcomes.

Comparison of long-term outcomes of bare metal or drug-eluting stent implantation in standard versus off-label coronary narrowings.

Previous studies have shown impressive short- and medium-term outcomes from drug-eluting stent (DES) implantation in coronary artery disease. We assessed long-term outcomes from DES versus bare metal stent (BMS) implantation in standard and off-label lesions. In 2,345 patients who survived event-free for > or = 30 days after stent implantation for standard (n = 1,540, 66%) or off-label (805, 34%) lesions, we assessed time to occurrence of death, myocardial infarction (MI), death or MI, stent thrombosis, target vessel revascularization (TVR), and major adverse cardiovascular events (defined as composite of all study outcomes). Comparisons were made between standard and off-label lesion subsets and between DES and BMS in lesion subsets. Multivariable differences in outcomes between DES versus BMS were assessed using propensity-adjusted proportional hazards regression. Median follow-up duration was 3.4 years. Stenting of off-label lesions was associated with uniformly worse outcomes than stenting of standard lesions. After adjustment for lesion classification, propensity to receive DES, and baseline differences, DES implantation was associated with statistically significant decreases in death (adjusted hazard ratio 0.71, 95% confidence interval 0.51 to 0.98), TVR (hazard ratio 0.58, 95% confidence interval 0.39 to 0.85 for off-label subset; hazard ratio 0.33, 95% confidence interval 0.24 to 0.46 for standard subset), and major adverse cardiovascular events (hazard ratio 0.51, 95% confidence interval 0.42 to 0.61), without increase in MI, death/MI, or stent thrombosis. Elective TVR occurred in 272 patients and resulted in only 1 early death. In conclusion, compared with BMS, use of DES is associated with clinical benefit in standard and off-label lesions at late follow-up. Decrease in elective TVR does not explain the apparent mortality benefit from DES implantation.

Occurrence, predictors, and outcomes of post-percutaneous coronary intervention thrombocytopenia in an unselected population.

OBJECTIVES: We sought to determine the occurrence, predictors, and prognostic impact of post-percutaneous coronary intervention (post-PCI) thrombocytopenia on an unselected real-world patient population. BACKGROUND: Thrombocytopenia after PCI has been shown to portend worse prognosis in clinical trials. The significance of post-PCI thrombocytopenia has not previously been examined outside the clinical trial setting. METHODS: The study cohort consisted of 1,302 consecutive patients with normal baseline platelet count (150 x 10(9)/L). Post-PCI thrombocytopenia was defined as nadir platelet count <100 x 10(9)/L or a drop >50% from baseline. The primary outcomes were in-hospital and 6-month rates of death and major adverse cardiovascular events (MACE), and the secondary outcomes were bleeding, need for blood transfusion, and length of hospital stay. Logistic regression was performed to identify independent predictors. RESULTS: Post-PCI thrombocytopenia developed in 41 patients (occurrence 3.1%). Independent predictors were baseline creatinine clearance (odds ratio [OR] 1.02 for every unit decrease, 95% confidence interval [CI] 1.01-1.03, P=0.001), failed PCI (OR 3.8, CI 1.6-9.4, P=0.003), and use of intraaortic balloon pump (OR 2.8, CI 1.1-6.8, P=0.024). All study outcomes were significantly higher in patients with post-PCI thrombocytopenia. Post-PCI thrombocytopenia independently predicted MACE at 6 months (hazard ratio 2.7, CI 1.3-5.5, P=0.0069) and all the secondary outcomes. CONCLUSIONS: Post-PCI thrombocytopenia occurred in 3.1% of patients in an unselected real-world population and carried a significant detrimental impact on prognosis. Failed PCI was the strongest correlate identified.

Clinical outcomes following drug-eluting versus bare metal stent implantation for lesion subsets excluded from pivotal clinical trials: findings from the GHOST Study (Guthrie Health System Off-Label StenT Study).

OBJECTIVES: We assessed outcomes of patients undergoing drug-eluting stent (DES) vs. bare metal stent (BMS) implantation for complex lesions excluded from pivotal clinical trials of DES. BACKGROUND: Although DES improve target vessel revascularization (TVR) and major adverse cardiovascular events (MACE) compared to BMS in randomized trials, data on safety and efficacy of DES in complex lesions are insufficient. METHODS: In a single-center registry of 1,354 patients who underwent stent implantation for complex lesions between July 2001 and December 2005, we compared the incidence of death, death or myocardial infarction (MI), stent thrombosis [definite or probable by the Academic Research Consortium (ARC) criteria], TVR, and MACE between patients who received DES (n = 483) versus those who received BMS (n = 871). Mean duration of follow-up was 494 versus 838 days in DES and BMS groups, respectively. RESULTS: Clinical outcomes in DES versus BMS groups were as follows: death 5.2% versus 11.5% (log-rank P = 0.042); death/MI 11.2% versus 16.7% (P = 0.47), stent thrombosis 2.9% versus 2.6% (P = 0.61), TVR 6.6 versus 18.5% (P < 0.0001), MACE 14.9% versus 29.7% (P = 0.0002), respectively. After adjustment for baseline differences, DES implantation was associated with lower TVR (adjusted hazards ratio HR = 0.38, 95% CI 0.26-0.56, P < 0.0001) and MACE (HR = 0.56, CI 0.42-0.74, P < 0.0001) without significant impact on other outcomes. In 933 patients who underwent DES (n = 483) or BMS (n = 450) implantation in the year 2003 or later, DES implantation similarly lowered TVR and MACE without affecting other outcomes. CONCLUSIONS: Our findings support the safety and efficacy of DES in patient subsets excluded from pivotal randomized clinical trials of DES.

Major adverse noncardiac events after PCI as predictors of long-term mortality.

BACKGROUND: Studies of percutaneous coronary intervention (PCI) routinely report major adverse cardiovascular events (MACE), but not major adverse noncardiac events (MANE) after PCI. MANE, such as post-PCI bleeding and contrast nephropathy, adversely influence survival, but are not recognized as a standard composite of complications. We assessed the feasibility and prognostic utility of deriving a composite of MANE. METHODS: In 985 consecutive patients who underwent PCI, we estimated the incidence and prognostic impact of in-hospital MACE (myocardial infarction [MI] target vessel revascularization, or stroke) and MANE (defined as thrombolysis in myocardial infarction [TIMI], bleeding [major or minor], or contrast nephropathy) and their impact on long-term survival. RESULTS: The incidence of MANE was >6-fold greater than MACE (9.5% vs 1.5%). Independent correlates of MANE included age, female gender, peripheral vascular disease, lower left ventricular ejection fraction, and use of an intraaortic balloon pump (IABP) during PCI. Of 973 patients who survived the index hospitalization, death occurred in 169(17%) at a median follow-up of 4.0 years. MANE (but not MACE) showed a significant relation with survival; 34 of 85 patients with MANE compared to 135 of 888 patients without MANE died during follow-up (40% vs 15%, log-rank P < 0.0001). After adjustment for several baseline clinical features, the occurrence of MANE was independently associated with a significant increase in long-term mortality (adjusted hazards ratio [HR]= 1.72, CI = 1.05-2.83) and myocardial infarction (adjusted HR = 3.43, CI = 1.55-7.58). CONCLUSIONS: After PCI, MANE are common and carry grave long-term prognostic significance. Our findings emphasize the need to monitor and report MANE, in addition to MACE, in PCI-related trials.

A comparison of contemporary definitions of contrast nephropathy in patients undergoing percutaneous coronary intervention and a proposal for a novel nephropathy grading system.

Contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) has multiple definitions. We attempted to identify the optimal definition of CIN. In 985 patients undergoing PCI (derivation group), we assessed the prognostic significance of 4 commonly used contemporary definitions of CIN (increases in serum creatinine after PCI [deltaCr] >1.0 mg/dl, >0.5 mg/dl, and >25% after PCI; and the American College of Cardiology National Cardiovascular Data Registry definition) with respect to 6-month major adverse cardiovascular events (MACEs) and all-cause mortality (at 863 +/- 324 days). Incidence of CIN ranged widely (2.0% to 15%) depending on the definition used. Only 2 definitions (deltaCr >0.5 mg/dl, >25%) consistently correlated with study outcomes. Using these 2 definitions, we devised a new grading system (grade 0 deltaCr 25% but 0.5 mg/dl). Nephropathy grades (0 vs 1 vs 2) showed significant correlation with 6-month MACEs (12.4 vs 19.4 vs 28.6%, p = 0.003) and all-cause mortality (10.2 vs 10.4 vs 40.9%, p <0.0001). In multivariate analyses, the grading system showed an independent association with MACEs and mortality. The prognostic value of nephropathy grades was prospectively confirmed in an independent validation group of 539 patients. In conclusion, of the 4 contemporary definitions of CIN, only deltaCr >25% and >0.5 mg/dl consistently predicted adverse events after PCI. By unifying these 2 definitions, we devised a novel nephropathy grading system that is predictive of 6-month MACEs and all-cause mortality after PCI.