Arthur Riba

A randomized trial comparing primary angioplasty with a strategy of short-acting thrombolysis and immediate planned rescue angioplasty in acute myocardial infarction: the PACT trial ☆

OBJECTIVES The study evaluated the efficacy and safety of a short-acting reduced-dose fibrinolytic regimen to promote early infarct-related artery (IRA) patency during the inherent delay experienced by infarct patients referred for angioplasty as the principal recanalization modality. BACKGROUND Previous approaches using long-acting, full-dose thrombolytic infusions rarely showed benefit, but they did increase adverse event rates. METHODS Following aspirin and heparin, 606 patients were randomized to a 50-mg bolus of recombinant tissue-type plasminogen activator (rt-PA) (alpha half-life 4.5 min) or to placebo followed by immediate angiography with angioplasty if needed. The end points included patency rates on catheterization laboratory (cath lab) arrival, technical results when PTCA (percutaneous transluminal coronary angioplasty) was performed, complication rates, and left ventricular (LV) function by treatment assignment and time to restored patency following angioplasty. RESULTS Patency on cath lab arrival was 61% with rt-PA (28% Thrombolysis in Myocardial Infarction trial [TIMI]-2, 33% TIMI-3), and 34% with placebo (19% TIMI-2, 15% TIMI-3) (p = 0.001). Rescue and primary PTCA restored TIMI-3 in closed arteries equally (77%, 79%). No differences were observed in stroke or major bleeding. Left ventricular function was similar in both treatment groups, but convalescent ejection fraction (EF) was highest with a patent IRA (TIMI-3) on cath lab arrival (62.4%) or when produced by angioplasty within an hour of bolus (62.5%). However, in 88% of angioplasties, the delay exceeded 1 h: convalescent EF 57.3%. CONCLUSIONS Tailored thrombolytic regimens compatible with subsequent interventions lead to more frequent early recanalization (before cath arrival), which facilitates greater LV function preservation with no augmentation of adverse events.

Trends in Door-to-Balloon Time and Mortality in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

BACKGROUND In patients with acute ST-elevation myocardial infarction (STEMI) who are undergoing percutaneous coronary intervention, current guidelines for reperfusion therapy recommend a door-to-balloon (DTB) time of less than 90 minutes. Considerable effort has focused on reducing DTB time with the assumption that a reduction in DTB time translates into a significant reduction in mortality; however, the clinical impact of this effort has not been evaluated. Therefore, our objective was to determine whether a decline in DTB time in patients with STEMI was associated with an improvement in clinical outcomes. METHODS We assessed the yearly trend in DTB time for 8771 patients with STEMI who were undergoing primary percutaneous coronary intervention from 2003 to 2008 as part of the Blue Cross Blue Shield of Michigan Cardiovascular Consortium and correlated it with trends in in-hospital mortality. Patients were stratified according to risk of death using a mortality model to evaluate whether patient risk factors affect the relationship between DTB time and mortality. RESULTS Median DTB time decreased each year from 113 minutes in 2003 to 76 minutes in 2008 (P < .001), and the percentage of patients who were revascularized with a DTB time of less than 90 minutes increased from 28.5% in 2003 to 67.2% in 2008 (P < .001). In-hospital mortality remained unchanged at 4.10% in 2003, 4.02% in 2004, 4.40% in 2005, 4.42% in 2006, 4.73% in 2007, and 3.62% in 2008 (P = .69). After the differences in baseline characteristics were adjusted for, there was no difference in the standardized mortality ratios (SMRs) across the study period (SMR, 1.00; 95% confidence interval [CI], 0.74-1.26 in 2003 compared with SMR, 0.95; 95% CI, 0.77-1.13 in 2008). CONCLUSIONS There has been a dramatic reduction in median DTB time and increased compliance with the related national guideline. Despite these improvements, in-hospital mortality was unchanged over the study period. Our results suggest that a successful implementation of efforts to reduce DTB time has not resulted in the expected survival benefit.

The relative safety and efficacy of abciximab and eptifibatide in patients undergoing primary percutaneous coronary intervention: insights from a large regional registry of contemporary percutaneous coronary intervention.

OBJECTIVES This study sought to assess whether the use of eptifibatide instead of abciximab is associated with a difference in outcomes of patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). BACKGROUND Pooled data from randomized controlled trials suggest that the use of abciximab may be associated with a survival advantage in patients undergoing primary PCI for acute STEMI. However, a large proportion of patients in the community are treated with eptifibatide, an agent that shares some but not all pharmacological properties with abciximab. METHODS We evaluated the outcomes of 3,541 patients who underwent primary PCI for STEMI from October 2002 to July 2006 in a large regional consortium and who were treated with abciximab (n = 729) or with eptifibatide (n = 2,812). RESULTS There was no difference in the incidence of in-hospital death (4.1% with abciximab vs. 3.5% with eptifibatide, p = 0.39), recurrent myocardial infarction (0.8% vs. 1.2%, p = 0.42), or stroke/transient ischemic attack (0.7% vs. 0.6%, p = 0.80). There was no difference in the need for blood transfusion (12.4% vs. 11.7%, p = 0.61), whereas there was a greater incidence of gastrointestinal bleeding with abciximab (4.8% vs. 2.8%, p = 0.01). In parsimonious risk-adjusted models, no significant difference between abciximab and eptifibatide was observed with respect to any of the outcomes measures. CONCLUSIONS Currently, eptifibatide is used as the adjunct antiplatelet agent in the majority of patients undergoing primary PCI. There is no apparent difference in early outcomes of patients treated with eptifibatide compared with patients treated with abciximab.

Retroperitoneal Hematoma After Percutaneous Coronary Intervention: Prevalence, Risk Factors, Management, Outcomes, and Predictors of Mortality A Report From the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) Registry

OBJECTIVES This study sought to evaluate the prevalence, risk factors, outcomes, and predictors of mortality of retroperitoneal hematoma (RPH) following percutaneous coronary intervention. BACKGROUND Retroperitoneal hematoma is a serious complication of invasive cardiovascular procedures. METHODS The study sample included 112,340 consecutive patients undergoing percutaneous coronary intervention in a large, multicenter registry between October 2002 and December 2007. End points evaluated included the development of RPH and mortality. RESULTS Retroperitoneal hematoma occurred in 482 (0.4%) patients. Of these, 92.3% were treated medically and 7.7% underwent surgical repair. Female sex, body surface area <1.8 m(2), emergency procedure, history of chronic obstructive pulmonary disease, cardiogenic shock, pre-procedural IV heparin, pre-procedural glycoprotein IIb/IIIa inhibitors, adoption of sheath size >or=8-F, and use of vascular closure devices were independent predictors of RPH, whereas the use of bivalirudin was associated with a lower risk. The development of RPH was associated with a higher frequency of post-procedure myocardial infarction (5.81% vs. 1.67%, p < 0.0001), infection and/or sepsis (17.43% vs. 3.00%, p < 0.0001), and heart failure (8.00% vs. 1.63%, p < 0.0001). In-hospital mortality was significantly higher in patients who developed RPH than in patients who did not (6.64% vs. 1.07%, p < 0.0001). Among patients with RPH, independent predictors of death were history of myocardial infarction, cardiogenic shock, pre-procedural creatinine >or=1.5 mg/dl, and left ventricular ejection fraction <50%. CONCLUSIONS Retroperitoneal hematoma is an uncommon complication of contemporary percutaneous coronary intervention associated with high morbidity and mortality. The identification of risk factors for the development of RPH could lead to modification of procedure strategies aimed toward reducing its incidence.

Taking the National Guideline for Care of Acute Myocardial Infarction to the Bedside: Developing the Guideline Applied in Practice (GAP) Initiative in southeast Michigan

BACKGROUND The Guideline Applied in Practice (GAP) program was developed in 2000 to improve the quality of care by improving adherence to clinical practice guidelines. For the first GAP project, the American College of Cardiology (ACC) partnered with the Southeast Michigan Quality Forum Cardiovascular Subgroup and the Michigan Peer Review Organization (MPRO) to develop interventions that might facilitate the use of the ACC/AHA Acute Myocardial Infarction (AMI) guideline in the practice setting. Ten Michigan hospitals participated in implementing the project, which began in March 2000. DESIGNING THE PROJECT The project developed a multifaceted intervention aimed at key players in the care delivery triangle: the physician, nurse, and patient. Intervention components included a project kick-off presentation and dinner, creation and implementation of a customized tool kit, identification and assignment of local nurse and physician opinion leaders, grand rounds site visits, and measurement before and after the intervention. IMPLEMENTING THE PROJECT The GAP project experience suggests that hospitals are enthusiastic about partnering with ACC to improve quality of care; partners can work together to develop a program for guideline implementation; rapid-cycle implementation is possible with the GAP model; guidelines and quality indicators for AMI are well accepted; and hospitals can adapt the national guideline for care into usable tools focused on physicians, nurses, and patients. DISCUSSION Important structure and process changes--both of which are required for successful QI efforts--have been demonstrated in this project. Ultimately, the failure or success of this initiative will depend on an indication that the demonstrated improvement in the quality indicators is sustained over time.

Radionuclide angiographic exercise left ventricular performance in chronic aortic regurgitation: Relationship to resting echographic ventricular dimensions and systolic wall stress index

Forty-five patients with chronic aortic regurgitation (AR) underwent first-pass radionuclide angiocardiography (RNA) at rest and during upright bicycle exercise, as well as M-mode echocardiography at rest. Abnormal left ventricular (LV) exercise reserve, defined by the absolute change in ejection fraction (EF), was present in 16 of 45 patients (36%). Seven of ten patients with abnormal resting EF (less than 50%) and three of seven symptomatic patients had normal LV exercise responses. Patients with normal LV exercise reserve by RNA had LV dimensions by echo at end diastole (5.9 +/- 0.2 vs 6.5 +/- 0.3 cm, p = NS) and end systole (3.9 +/- 0.2 vs 4.4 +/- 0.3 cm, p = NS) comparable to those in patients wht abnormal LV exercise reserve. However, the mean corrected LV end-diastolic (LVED) radius/wall thickness ratio was significantly greater in AR patients with abnormal LV exercise reserve than in those with normal LV exercise reserve (395 +/- 15 vs 315 +/- 16, p less than 0.01). There data suggest that resting echocardiographic LV dimensions as well as the corrected echo LVED radius/wall thickness ratio have a variable relationship to RNA LV exercise performance in patients with chronic AR.

Trends and disparities in referral to cardiac rehabilitation after percutaneous coronary intervention

BACKGROUND Despite the known benefits of cardiac rehabilitation in patients with coronary artery disease, referral rates to rehabilitation programs remain low. We determined the incidence and determinants of cardiac rehabilitation referral rates for patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS The incidence and predictors of referral to cardiac rehabilitation were assessed among 145,661 consecutive patients undergoing PCI and surviving to hospital discharge across 31 hospitals in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium between 2003 and 2008. The 6-year cardiac rehabilitation referral rate was 60.2%. Younger age, male gender, white race, and presentation with acute or severe disease (ie, acute myocardial infarction [AMI] in the previous 24 hours and ST-elevation myocardial infarction) were associated with increased referral to rehabilitation (all P < .0001). Most medical comorbidities were associated with decreased referral. Referral rates for cardiac rehabilitation were below the rates of other AMI quality-of-care indicators and more variable across hospital sites. Race-specific referral rates differed significantly in the lowest referring hospitals (P < .0001) but not in the highest referring hospitals (P = .16). Women had a 0.7% relative decrease in referral as compared to men (P = .0188) in the highest referring hospitals but a 26.7% relative decrease in referral in the lowest referring hospitals (P = .02). CONCLUSIONS Over one third of patients undergoing PCI are not referred for cardiac rehabilitation. Referral rates are below the rates of other AMI quality-of-care performance measures and more variable across sites. Racial and gender disparities in referral to rehabilitation exist but are concentrated at the lowest referring hospitals.

Imaging experimental infective endocarditis with indium-111-labeled blood cellular components.

The capability of radionuclide imaging to detect experimental aortic valve infective endocarditis was assessed with indium-111 (111In)-labeled blood cells. Sequential cardiac imaging and tissue distribution studies were obtained in 17 rabbits with infective endocarditis after administration of 111In-platelets and in five after 111In-polymorphonuclear leukocytes. Forty-eight to 72 hours after platelet administration, in vivo imaging demonstrated abnormal 111In uptake in all animals in the region of the aortic valve in an anatomically distinct pattern. Images of the excised heart showed discrete cardiac uptake conforming to the in vivo image and gross pathological examination. 111In platelet uptake in vegetations from the 17 animals averaged 240 ± 41 times greater than that in normal niyocardium and 99 ± 15 times greater uptake in blood. In contrast, 111In-leukocyte cardiac imaging showed no abnormal aortic valve uptake 24 hours after tracer administration and the lesion myocardium activity ratio was only 5 ± 2 (3 ± 1 for lesion/blood activity). Four normal rabbits demonstrated neither positive 111.In platelet scintigraphs nor abnormal cardiac tissue uptake. Likewise, noncellular 111In was not concentrated to any significant extent in three animals with infective endocarditis. This study demonstrates that 111In platelet, but not leukocyte cardiac imaging, is a sensitive technique for detecting experimental infective endocarditis. The imaging data conform to the cellular pathology of the infective endocarditis vegetatio

Technetium-99m stannous pyrophosphate imaging of experimental infective endocarditis.

SUMMARY Technetium-9m stannous pyrophosphate (99mTc-PYP) cardiac scintigraphy was performed in 15 rabbits with experimental Streptococcus sanguis aortic valve infective endocarditis. The animals were imaged five to seven days after the administration of bacteria, and in each case abnormal accumulation of the tracer was visualized in the region of the aortic valve. Three types of cardiac scintigraphic patterns were demonstrated: focal, multifocal and extensive, each correlating well with the anatomical extent of the lesion as defined by gross pathology. Tissue distribution studies demonstrated a 30 ± 5.3 (mean ± SEM) fold excess of radionuclide uptake in the infective endocarditis lesion compared with that of normal myocardium. Imaging of excised hearts from four animals showed an excellent correlation with in vivo imaging as well as gross pathology.Five animals with nonbacterial thrombotic aortic valve endocarditis demonstrated similar scintigraphic and tissue distribution results. In contrast, four normal animals failed to demonstrate abnormal 99mTc-PYP cardiac scintigrams or tissue uptake.This study demonstrates that 99mTc-PYP cardiac scintigraphy is a sensitive technique to detect experimental aortic valve endocarditis.

Contemporary Use of Prasugrel in Clinical Practice Insights From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium

Background— Prasugrel is a recently approved thienopyridine for use in patients with acute coronary syndromes undergoing percutaneous coronary intervention. There are no data on contemporary use of prasugrel in routine clinical practice. Methods and Results— We assessed the patterns of prasugrel use among 55 821 patients who underwent percutaneous coronary intervention and were discharged alive from January 2010 to December 2011 at 44 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium. Potential inappropriate therapy was defined as use in patients who had a history of cerebrovascular disease, weighed <60 kg, or were aged ≥75 years old. Clopidogrel was prescribed to 83% (n=46 574) and 17% (n=9247) of patients received prasugrel on hospital discharge. A steady, linear increase in prasugrel use was seen during the study period, with discharge prescription increasing from 8.4% in quarter 1 of 2010 to 22.3% in quarter 4 of 2011. Of the total cohort, 69.1% of patients presented with acute coronary syndrome, and in this group, 17.2% received prasugrel. Among patients prescribed prasugrel, 28.3% (n=2614) received the medication for indications outside of acute coronary syndromes. One or more known contraindications to the drug were present in 6% to 10% of patients discharged on this agent. Conclusions— There has been a steady increase in the use of prasugrel with the drug being used in ≈22% of patients undergoing percutaneous coronary intervention by study end. Prasugrel use in patients with known contraindications is not uncommon and may be a suitable target for focused quality improvement efforts.