Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial.

BACKGROUND: In the treatment of de-novo coronary small vessel disease, drug-coated balloons (DCBs) are non-inferior to drug-eluting stents (DESs) regarding clinical outcome up to 12 months, but data beyond 1 year is sparse. We aimed to test the long-term efficacy and safety of DCBs regarding clinical endpoints in an all-comer population undergoing percutaneous coronary intervention. METHODS: In this prespecified long-term follow-up of a multicentre, randomised, open-label, non-inferiority trial, patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention were randomly assigned 1:1 to DCB or second-generation DES and followed over 3 years for major adverse cardiac events (ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation [TVR]), all-cause death, probable or definite stent thrombosis, and major bleeding (Bleeding Academic Research Consortium bleeding type 3-5). Analyses were performed on the full analysis set according to the modified intention-to-treat principle. Dual antiplatelet therapy was recommended for 1 month after DCB and 6 months after DES with stable symptoms, but 12 months with acute coronary syndromes. The study is registered with ClinicalTrials.gov, NCT01574534 and is ongoing. FINDINGS: Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients were randomly assigned to the DCB group (n=382) or the DES group (n=376). The Kaplan-Meier estimate of the rate of major adverse cardiac events was 15% in both the DCB and DES groups (hazard ratio [HR] 0·99, 95% CI 0·68-1·45; p=0·95). The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83). Rates of all-cause death were very similar in DCB versus DES patients (both Kaplan-Meier estimate 8%, HR 1·05, 95% CI 0·62-1·77; p=0·87). Rates of probable or definite stent thrombosis (Kaplan-Meier estimate 1% vs 2%; HR 0·33, 95% CI 0·07-1·64; p=0·18) and major bleeding (Kaplan-Meier estimate 2% vs 4%, HR 0·43, 95% CI 0·17-1·13; p=0·088) were numerically lower in DCB versus DES, however without reaching significance. INTERPRETATION: There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years. FUNDING: Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B Braun Medical.

Nonemergency PCI at hospitals with or without on-site cardiac surgery.

BACKGROUND: Emergency surgery has become a rare event after percutaneous coronary intervention (PCI). Whether having cardiac-surgery services available on-site is essential for ensuring the best possible outcomes during and after PCI remains uncertain. METHODS: We enrolled patients with indications for nonemergency PCI who presented at hospitals in Massachusetts without on-site cardiac surgery and randomly assigned these patients, in a 3:1 ratio, to undergo PCI at that hospital or at a partner hospital that had cardiac surgery services available. A total of 10 hospitals without on-site cardiac surgery and 7 with on-site cardiac surgery participated. The coprimary end points were the rates of major adverse cardiac events--a composite of death, myocardial infarction, repeat revascularization, or stroke--at 30 days (safety end point) and at 12 months (effectiveness end point). The primary end points were analyzed according to the intention-to-treat principle and were tested with the use of multiplicative noninferiority margins of 1.5 (for safety) and 1.3 (for effectiveness). RESULTS: A total of 3691 patients were randomly assigned to undergo PCI at a hospital without on-site cardiac surgery (2774 patients) or at a hospital with on-site cardiac surgery (917 patients). The rates of major adverse cardiac events were 9.5% in hospitals without on-site cardiac surgery and 9.4% in hospitals with on-site cardiac surgery at 30 days (relative risk, 1.00; 95% one-sided upper confidence limit, 1.22; P<0.001 for noninferiority) and 17.3% and 17.8%, respectively, at 12 months (relative risk, 0.98; 95% one-sided upper confidence limit, 1.13; P<0.001 for noninferiority). The rates of death, myocardial infarction, repeat revascularization, and stroke (the components of the primary end point) did not differ significantly between the groups at either time point. CONCLUSIONS: Nonemergency PCI procedures performed at hospitals in Massachusetts without on-site surgical services were noninferior to procedures performed at hospitals with on-site surgical services with respect to the 30-day and 1-year rates of clinical events. (Funded by the participating hospitals without on-site cardiac surgery; MASS COM ClinicalTrials.gov number, NCT01116882.).

Door-to-balloon time and mortality among patients undergoing primary PCI.

BACKGROUND: Current guidelines for the treatment of ST-segment elevation myocardial infarction recommend a door-to-balloon time of 90 minutes or less for patients undergoing primary percutaneous coronary intervention (PCI). Door-to-balloon time has become a performance measure and is the focus of regional and national quality-improvement initiatives. However, it is not known whether national improvements in door-to-balloon times have been accompanied by a decline in mortality. METHODS: We analyzed annual trends in door-to-balloon times and in-hospital mortality using data from 96,738 admissions for patients undergoing primary PCI for ST-segment elevation myocardial infarction from July 2005 through June 2009 at 515 hospitals participating in the CathPCI Registry. In a subgroup analysis using a linked Medicare data set, we assessed 30-day mortality. RESULTS: Median door-to-balloon times declined significantly, from 83 minutes in the 12 months from July 2005 through June 2006 to 67 minutes in the 12 months from July 2008 through June 2009 (P<0.001). Similarly, the percentage of patients for whom the door-to-balloon time was 90 minutes or less increased from 59.7% in the first year to 83.1% in the last year (P<0.001). Despite improvements in door-to-balloon times, there was no significant overall change in unadjusted in-hospital mortality (4.8% in 2005-2006 and 4.7% in 2008-2009, P=0.43 for trend) or in risk-adjusted in-hospital mortality (5.0% in 2005-2006 and 4.7% in 2008-2009, P=0.34), nor was a significant difference observed in unadjusted 30-day mortality (P=0.64). CONCLUSIONS: Although national door-to-balloon times have improved significantly for patients undergoing primary PCI for ST-segment elevation myocardial infarction, in-hospital mortality has remained virtually unchanged. These data suggest that additional strategies are needed to reduce in-hospital mortality in this population. (Funded by the National Cardiovascular Data Registry of the American College of Cardiology Foundation.).

Drug-coated balloon treatment of coronary artery disease: a position paper of the Italian Society of Interventional Cardiology.

Drug-coated balloons are a new tool for the treatment of patients with coronary artery disease. The main feature of this technology is a rapid and homogenous transfer of an antiproliferative drug (paclitaxel) to the vessel wall just at the time of balloon inflation, when neointimal proliferation, in response to angioplasty, is the highest. Moreover, drug-coated balloons share adjuntive advantages over stents: the absence of permanent scaffold and polymer, the respect of the original coronary anatomy, and limited inflammatory stimuli, thereby allowing for short-term dual antiplatelet therapy. To this day, a lot of devices are available in the market, with limited scientific data for the vast majority of them. Thus, the Italian scientific society of interventional cardiologists GISE decided to coordinate the efforts of a group of reknown experts on the field, in order to obtain a Position Paper on the correct use of drug-coated balloons in all the settings of coronary artery disease, giving a class of indication to each one, based on the clinical evidence. This Position Paper represents a quick reference for operators, investigators, and manufactures to promote the understanding and the correct use of the drug-coated balloon technology in everyday clinical practice.

Use of risk assessment analysis by failure mode, effects, and criticality to reduce door-to-balloon time.

STUDY OBJECTIVE: The Centers for Medicare & Medicaid Services currently endorses a door-to-balloon time of 90 minutes or less for patients presenting to the emergency department (ED) with ST-segment elevation myocardial infarction. Recent evidence shows that a door-to-balloon time of 60 minutes significantly decreases inhospital mortality. We seek to use a proactive risk assessment method of failure mode, effects, and criticality analysis (FMECA) to evaluate door-to-balloon time process, to investigate how each component failure may affect the performance of a system, and to evaluate the frequency and the potential severity of harm of each failure. METHODS: We conducted a 2-part study: FMECA of the door-to-balloon time system and process of care, and evaluation of a single institution's door-to-balloon time operational data using a retrospective observational cohort design. A multidisciplinary group of FMECA participants described the door-to-balloon time process to then create a comprehensive map and table listing all process steps and identified process failures, including their frequency, consequence, and causes. Door-to-balloon time operational data were assessed by "on" versus "off" hours. RESULTS: Fifty-one failure points were identified across 4 door-to-balloon time phases. Of the 12 high-risk failures, 58% occurred between ECG and catheterization laboratory activation. Total door-to-balloon time during on hours had a median time of 55 minutes (95% confidence interval 46 to 60 minutes) compared with 77 minutes (95% confidence interval 68 to 83 minutes) during off hours. CONCLUSION: The FMECA revealed clear areas of potential delay and vulnerability that can be addressed to decrease door-to-balloon time from 90 to 60 minutes. FMECAs can provide a robust assessment of potential risks and can serve as the platform for significant process improvement and system redesign for door-to-balloon time.

Nationwide improvement of door-to-balloon times in patients with acute ST-segment elevation myocardial infarction requiring primary percutaneous coronary intervention with out-of-hospital 12-lead ECG recording and transmission.

STUDY OBJECTIVE: Reducing door-to-balloon times for acute ST-segment elevation myocardial infarction (STEMI) patients has been shown to improve long-term survival. We aim to reduce door-to-balloon time for STEMI patients requiring primary percutaneous coronary intervention by adoption of out-of-hospital 12-lead ECG transmission by Singapore's national ambulance service. METHODS: This was a nationwide, before-after study of STEMI patients who presented to the emergency departments (ED) and required percutaneous coronary intervention. In the before phase, chest pain patients received 12-lead ECGs in the ED. In the after phase, 12-lead ECGs were performed by ambulance crews and transmitted from the field to the ED. Patients whose ECG showed greater than or equal to 2 mm ST-segment elevation in anterior or greater than or equal to 1 mm ST-segment elevation in inferior leads for 2 or more contiguous leads and symptom onset of less than 12 hours' duration were eligible for percutaneous coronary intervention activation before arrival. RESULTS: ECGs (2,653) were transmitted by the ambulance service; 180 (7%) were suspected STEMI. One hundred twenty-seven patients from the before and 156 from the after phase met inclusion criteria for analysis. Median door-to-balloon time was 75 minutes in the before and 51 minutes in the after phase (median difference=23 minutes; 95% confidence interval 18 to 27 minutes). Median door-to-balloon times were significantly reduced regardless of presentation hours. Overall, there was significant reduction in door-to-activation, door-to-ECG, and door-to-cardiovascular laboratory times. No significant difference was found pertaining to adverse events. CONCLUSION: This study describes a nationwide implementation of out-of-hospital ECG transmission resulting in reduced door-to-balloon times, regardless of presentation hours. Out-of-hospital ECG transmission should be adopted as best practice for management of chest pain.

A single center experience with same-day transradial-PCI patients: a contrast with published guidelines.

OBJECTIVES: Our goal was to compare recently published Consensus Statement from the SCAI/ACC on appropriateness for same-day PCI with patient characteristics from a real-world same-day PCI experience in the United States. BACKGROUND: Recent practice statement published by the SCAI /ACC in 2009 describes patients suitable for outpatient PCI procedures. Whether this practice statement reflects actual real-world practice in the setting of advances in transradial catheterization needs further exploration. METHODS: Pre-existing, deidentified, quality assurance data from 100 sequential patients undergoing transradial PCI, and same-day discharge were compared with criteria in SCAI/ACC statement on outpatient PCI. Each had been identified post-PCI as uncomplicated and therefore eligible for same day discharged. Specific attention was placed on whether the patients carried any exclusion to same-day discharge. RESULTS: One hundred six procedures were recorded in 100 patients including 11 women and 89 men, median age 62 (55,71) years all with stable ischemia. Early follow up was done for medication compliance. None were readmitted nor had post-PCI complications. Only 15% met appropriateness criteria for same-day discharge. Older age, distance from the hospital, greater than simple PCI, and the need for specific antiplatelet therapy represented the dominant contraindications to discharge. CONCLUSIONS: Using transradial approaches and structured early follow up by advance practice nurses, same-day discharge can be accomplished successfully in a broad range of patients outside of those suggested by the SCAI/ACC 2009 Consensus Document. Confirmation of these results could result in shorter hospitalizations for US patients and align advances in catheterization technology to optimize heath care delivery.

Staging of multivessel percutaneous coronary interventions: an expert consensus statement from the Society for Cardiovascular Angiography and Interventions.

Percutaneous coronary interventions (PCIs) to treat multivessel coronary artery disease (MVCAD) may involve single-vessel or multivessel interventions, performed in one or more stages. This consensus statement reviews factors that may influence choice of strategy and includes six recommendations to guide decisions regarding staging of PCI. Every patient who undergoes PCI should receive optimal therapy for coronary disease, ideally before starting the procedure. Multivessel PCI at the time of diagnostic catheterization should be considered only if informed consent included the risks and benefits of multivessel PCI and the risks and benefits of alternative treatments. When considering multivessel PCI, the interventionist should develop a strategy regarding which stenoses to treat or evaluate, and their order, method, and timing. This strategy should maximize patient benefits, minimize patient risk, and consider the factors described in this article. For planned multivessel PCI, additional vessel(s) should be treated only if the first vessel is treated successfully and if anticipated contrast and radiation doses and patient and operator conditions are favorable. After the first stage of the planned multistage PCI, the need for subsequent PCI should be reviewed before it is performed. Third party payers and quality auditors should recognize that multistage PCI for MVCAD is neither an indication of poor quality nor an attempt to increase reimbursement when performed according to recommendations in this article.

Quality improvement in the door-to-balloon times for ST-elevation myocardial infarction patients presenting without chest pain.

OBJECTIVE: To assess a quality improvement initiative aimed at minimizing door-to-balloon (DTB) times for ST-elevation myocardial infarction (STEMI) patients presenting without chest pain. BACKGROUND: Timely percutaneous coronary intervention (PCI) is the cornerstone of STEMI care. The absence of chest pain delays PCI. Improvements in DTB times may need to focus on atypical presentation patients. METHODS: We compared DTB times on all STEMI patients admitted through the emergency department who underwent PCI before (Phase I; October 2004-June 2007) and after (Phase II; July 2007-October 2009) the quality improvement effort, which mandated rapid electrocardiogram (ECG) triage for an expanded list of presenting symptoms. RESULTS: In Phase I (69 patient, 60 with chest pain), patients with chest pain had a shorter mean time to first ECG (ECG Interval) by 32.0 min (P < 0.01) and nonsignificantly faster mean DTB time by 42.0 min (P = 0.07) compared to patients who presented without chest pain. In Phase II (62 patients, 56 with chest pain) compared to Phase I, mean ECG interval decreased by 44 min (P = 0.02) and mean DTB time by 99 min (P = 0.01) in patients without chest pain, eliminating the differences in ECG intervals between typical and atypical presentations (12 min vs. 11 min, P = 0.91). Multivariable analysis controlling for on/off hours and patient characteristics confirmed these findings. CONCLUSIONS: A simple modification of emergency room ECG triage protocol, which expands indications for rapid ECG performance, was successful in improving rapid reperfusion for patients with STEMI presenting without chest pain.

Applying the National Institute for Clinical Excellence criteria to patients treated with the Genous™ Bio-engineered R stent™: a sub-study of the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) worldwide registry.

The National Institute for Clinical Excellence (NICE) guidelines recommend the use of bare-metal stents (BMS) in non-complex lesions with a low risk of restenosis (diameter ≥3 mm and lesion length ≤15 mm) and the use of drug-eluting stents (DES) in more complex lesions with a high risk of restenosis (diameter <3.0 mm or lesion length >15 mm). However, the guidelines were created based on studies evaluating BMS and DES only. We performed an analysis of patients undergoing non-urgent percutaneous coronary intervention with the novel endothelial cell capturing stent (ECS). The ECS is coated with CD34(+) antibodies that attract circulating endothelial progenitor cells to the stent surface, thereby accelerating the endothelialization of the stented area. We analyzed all patients enrolled in the worldwide e-HEALING registry that met the NICE criteria for either low-risk or high-risk lesions and were treated with ≥1 ECS. The main study outcome was target vessel failure (TVF) at 12-month follow-up, defined as the composite of cardiac death or MI and target vessel revascularization (TVR). A total of 4,241 patients were assessed in the current analysis. At 12-month follow-up, TVF occurred in 7.0% of the patients with low-risk lesions and in 8.8% of the patients with high-risk lesions (p = 0.045). When evaluating the diabetic patients versus the non-diabetic patients per risk group, no significant differences were found in TVF, MI or TVR in either risk group. The ECS shows good clinical outcomes in lesions carrying either a high or a low risk of restenosis according to the NICE guidelines with comparable rates of cardiac death, myocardial infarction, and stent thrombosis. The TVF rate with ECS was slightly higher in patients with high-risk lesions, driven by higher clinically driven TLR. The risk of restenosis with ECS in patients carrying high-risk lesions needs to be carefully considered relative to other risks associated with DES. Furthermore, the presence of diabetes mellitus did not influence the incidence of TVF in either risk group.

Hospital-based strategies contributing to percutaneous coronary intervention time reduction in the patient with ST-segment elevation myocardiaI infarction: a review of the "system-of-care" approach.

A myriad of hospital-wide initiatives have been implemented with the goal of decreasing door-to-balloon time. Much of the evidence behind the common strategies used is unknown; multiple strategies have been suggested in the reduction to the use of this important time-sensitive intervention. Among 8 primary strategies, 2 have substantial evidence to support their implementation in the attempt to reduce door-to-balloon time in ST-segment elevation myocardial infarction (STEMI), including emergency physician activation of the cardiac catheterization laboratory and prehospital activation of the STEMI alert process. Two strategies have moderate evidence to support their use, including real-time data feedback to team members and team-based approach to STEMI management. The remaining 4 strategies have no quantitative evidence to support their use, including single call to a central paging system, expecting the cardiac catheterization laboratory personnel to arrive within 20 minutes of activation, attending cardiologist on site (within the hospital), and senior management commitment to the project. Although all the STEMI systems of care reviewed are associated with a decreased in time to treatment, only a few have sufficient quantitative evidence to support their implementation. To be effective, the movement to decrease time to treatment of STEMI at any hospital must be composed of an institutional response that includes multiple disciplines. Success also requires active participation from nurses, members of the catheterization team, and hospital leadership.

Reduced door-to-balloon times in acute ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention.

BACKGROUND: Primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI) significantly reduces mortality and morbidity, particularly when door-to-balloon (D2B) time is < 90 min. We sought to minimize preventable delays by instituting an on-site cardiology team-based approach in the emergency department (ED). METHODS: The on-site group comprised 146 consecutive patients with STEMI undergoing primary PCI after implementation of the on-site strategy. This new patient care model was compared with the conventional care administered before instituting the on-site cardiology team-based strategy in ED, which included 90 patients (interim group) receiving primary PCI at a catheterization room in the same building as the ED, and 147 patients (pre-on-site group) undergoing primary PCI at a catheterization room two blocks away from the ED. RESULTS: Median D2B time decreased from 107 min in the pre-on-site group to 72 min in the interim group, and to 47 min in the on-site group, respectively (p < 0.001). The percentage of D2B times < 90 min increased from 34% to 78% and 96%, respectively among the three groups (p < 0.001). Hospitalization costs were significantly reduced in the on-site and interim vs. pre-on-site groups ($5944, $5999, and $6581, respectively; p = 0.008). In-hospital mortality did not differ significantly among the three groups (4.8%, 2.2%, and 6.1%, respectively; p = 0.387). CONCLUSIONS: Institution of an on-site cardiology team-based approach in the ED significantly reduces D2B time in STEMI patients eligible for primary PCI.

Impact of hospital proportion and volume on primary percutaneous coronary intervention performance in England and Wales.

AIMS: To quantify the determinants of primary percutaneous coronary intervention (PCI) performance in England and Wales between 2004 and 2007. METHODS AND RESULTS: All 8653 primary PCI cases admitted to acute hospitals in England and Wales as recorded in the Myocardial Ischaemia National Audit Project (MINAP) 2004-2007. We studied the impact of the volume of primary PCI cases (hospital volume) on door-to-balloon (DTB) times and the proportion of patients treated with primary PCI (hospital proportion) on 30-day mortality and employed regression analysis to identify reasons for DTB time variations with a multilevel component to express hospital variation. The proportion of patients receiving primary PCI increased from 5% in 2004 to 20% in 2007. Median DTB times reduced from 84 min in 2004 to 61 min in 2007. Median DTB times decreased as the number of primary PCI procedures increased. The 30-day all-cause mortality rate for hospitals performing primary PCI on >25% of ST-elevation myocardial infarction patients [5.0%; 95% confidence interval (CI): 3.9-6.1%] was almost double that of hospitals performing primary PCI on more than 75% (2.7%; 95% CI: 2.0-3.5%). Time-of-day, year of admission, sex, and diabetes significantly influenced DTB times. Hospital variation was evident by a hospital-level DTB time standard deviation of 12 min. CONCLUSIONS: There was a large variation in DTB times between the best and worst performing hospitals. Although patient-related factors impacted upon DTB times, the volume and proportion of patients undergoing primary PCI were significantly associated with delay and early mortality-hospitals with the highest proportion of primary PCI had the lowest mortality.

"Code STEMI" protocol helps in achieving reduced door-to-balloon times in patients presenting with acute ST-segment elevation myocardial infarction during off-hours.

BACKGROUND: Door-to-balloon (D2B) time is conceived as a crucial parameter for evaluating the quality of acute ST-segment elevation myocardial infarction (STEMI) care. Ideally, primary percutaneous intervention should be performed within 90 min of hospital arrival. OBJECTIVES: We sought to determine the impact of emergency physician-activated "Code STEMI" protocol on door-to-balloon times during off-hours. METHODS: Patients were divided into two study groups: one group consisted of 27 STEMI patients who presented during off-hours in the pre-Code STEMI period (January to December 2006) and the second group consisted of 60 STEMI patients admitted during off-hours when Code STEMI was fully operational (January 2007 to December 2008). The primary objective was to compare median D2B times in both the study groups. Secondary parameters of interest included the individual components of D2B time, peak serum troponin levels, peak creatine kinase total levels, all-cause in-hospital mortality, 6-month all-cause mortality, and 12-month all-cause mortality. RESULTS: With the implementation of "Code STEMI" protocol, the median D2B time during off-hours dropped to 77 min (interquartile range [IQR] 67-95), representing a 52-min improvement (p = 0.0001). ECG-to-catheterization laboratory time demonstrated absolute reduction of 16 min. Median peak troponin-I levels dropped from 62 ng/mL (IQR 23-142) to 25 ng/mL (IQR 7-43; p < 0.002). No statistically significant differences were perceived in all-cause mortality among the study groups. CONCLUSIONS: Implementation of "Code STEMI" protocol at our institution significantly reduced D2B times for STEMI during off-hours.

Impact of intravascular ultrasound and final kissing balloon dilatation on long-term clinical outcome in percutaneous revascularization with 1-stent strategy for left main coronary artery stenosis in drug-eluting stent era.

BACKGROUND: It remains uncertain whether intravascular ultrasound (IVUS) use and final kissing balloon (FKB) dilatation would be standard care of percutaneous coronary intervention (PCI) with a simple 1-stent technique in unprotected left main coronary artery (LMCA) stenosis. This study sought to investigate the impact of IVUS use and FKB dilatation on long-term major adverse cardiac events (MACEs) in PCI with a simple 1-stent technique for unprotected LMCA stenosis. METHODS: Between June 2006 and December 2012, 255 patients who underwent PCI with 1 drug-eluting stent for LMCA stenosis were analyzed. Mean follow-up duration was 1663 ± 946 days. Long-term MACEs were defined as death, nonfatal myocardial infarction (MI) and repeat revascularizations. RESULTS: During the follow-up, 72 (28.2%) MACEs occurred including 38 (14.9%) deaths, 21 (8.2%) nonfatal MIs and 13 (5.1%) revascularizations. The IVUS examination and FKB dilatation were done in 158 (62.0%) and 119 (46.7%), respectively. IVUS use (20.3 versus 41.2%; log-rank P < 0.001), not FKB dilatation (30.3 versus 26.5%; log-rank P = 0.614), significantly reduced MACEs. In multivariate analysis, IVUS use was a negative predictor of MACEs [hazards ratio 0.51; 95% confidence interval (CI) 0.29-0.88; P = 0.017], whereas FKB dilatation (hazard ratio 1.68; 95% CI, 1.01-2.80; P = 0.047) was a positive predictor of MACEs. In bifurcation LMCA stenosis, IVUS use (18.7 versus 48.0%; log-rank P < 0.001) significantly reduced MACEs. In nonbifurcation LMCA stenosis, FKB dilatation showed a trend of increased MACEs (P = 0.076). CONCLUSION: IVUS examination is helpful in reducing clinical events in PCI for LMCA bifurcation lesions, whereas mandatory FKB dilatation after the 1-stent technique might be harmful in nonbifurcation LMCA stenosis.

Adherence of catheterization laboratory cardiologists to American College of Cardiology/American Heart Association guidelines for percutaneous coronary interventions and coronary artery bypass graft surgery: what happens in actual practice?

BACKGROUND: The American College of Cardiology and the American Heart Association have issued guidelines for the use of coronary artery bypass graft surgery (CABG) and percutaneous coronary interventions (PCI) for many years, but little is known about the impact of these evidence-based guidelines on referral decisions. METHODS AND RESULTS: A cardiac catheterization laboratory database used by 19 hospitals in New York State was used to identify treatment (CABG surgery, PCI, medical treatment, or nothing) recommended by the catheterization laboratory cardiologist for patients undergoing catheterization with asymptomatic/mild angina, stable angina, and unstable angina/non-ST-elevation myocardial infarction between January 1, 2005, and August 31, 2007. The recommended treatment was compared with indications for these patients based on American College of Cardiology/American Heart Association guidelines. Of the 16 142 patients undergoing catheterization who were found to have coronary artery disease, the catheterization laboratory cardiologist was the final source of recommendation for 10 333 patients (64%). Of these 10 333 patients, 13% had indications for CABG surgery, 59% for PCI, and 17% for both CABG surgery and PCI. Of the patients who had indications for CABG surgery, 53% were recommended for CABG and 34% for PCI. Of the patients with indications for PCI, 94% were recommended for PCI. For the patients who had indications for both CABG surgery and PCI, 93% were recommended for PCI and 5% for CABG surgery. Catheterization laboratory cardiologists in hospitals with PCI capability were more likely to recommend patients for PCI than hospitals in which only catheterization was performed. CONCLUSIONS: Patients with coronary artery disease receive more recommendations for PCI and fewer recommendations for CABG surgery than indicated in the American College of Cardiology/American Heart Association guidelines.

Evaluating the Performance of the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines (CRUSADE) bleeding score in a contemporary Spanish cohort of patients with non-ST-segment elevation acute myocardial infarction.

BACKGROUND: The Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines (CRUSADE) model provides a risk score that predicts the likelihood of major bleeding in patients hospitalized for non-ST-elevation acute myocardial infarction. The aim of the present work was to evaluate the performance of this model in a contemporary cohort of patients hospitalized for non-ST-elevation acute myocardial infarction in Spain. METHODS AND RESULTS: The study subjects were 782 consecutive patients admitted to our center between February 2004 and June 2009 with non-ST-elevation acute myocardial infarction. For each patient, we calculated the CRUSADE risk score and evaluated its discrimination and calibration by the C statistic and the Hosmer-Lemeshow goodness-of-fit test, respectively. The performance of the CRUSADE risk score was evaluated for the patient population as a whole and for groups of patients treated with or without >or=2 antithrombotic medications and who underwent cardiac catheterization or not. The median CRUSADE score was 30 points (range, 18 to 45). A total of 657 patients (84%) were treated with >or=2 antithrombotic, of whom 609 (92.7%) underwent cardiac catheterization. The overall incidence of major bleeding was 9.5%. This incidence increased with the risk category: very low, 1.5%; low, 4.3%; moderate, 7.8%; high, 11.8%; and very high, 28.9% (P<0.001). For the patients as a whole, for the groups treated with or without >or=2 antithrombotics, and for the subgroup treated with >or=2 antithrombotics who did or did not undergo cardiac catheterization, the CRUSADE score showed adequate calibration and excellent discriminatory capacity (Hosmer-Lemeshow P>0.3 and C values of 0.82, 0.80, 0.70, and 0.80, respectively). However, it showed little capacity to discriminate bleeding risk in patients treated with >or=2 antithrombotics who did not undergo cardiac catheterization (C=0.56). CONCLUSIONS: The CRUSADE risk score was generally validated and found to be useful in a Spanish cohort of patients treated with or without >or=2 antithrombotics and in those treated with or without >or=2 antithrombotics who underwent cardiac catheterization. More studies are needed to clarify the validity of the CRUSADE score in the subgroup treated with >or=2 antithrombotics who do not undergo cardiac catheterization.