Showing papers in "Jacc-cardiovascular Interventions in 2008"
TL;DR: The use of r-PCI is rare in contemporary clinical practice, but it is associated with a rate of procedural success similar to the femoral approach and with lower rates of bleeding and vascular complications, even among high-risk groups.
Abstract: Objectives Our goal was to compare trends in the prevalence and outcomes of the radial and femoral approaches to percutaneous coronary intervention (PCI) in contemporary clinical practice. Background There are few current data on the use and outcomes of the radial approach to PCI (r-PCI) in clinical practice. Methods Data from 593,094 procedures in the National Cardiovascular Data Registry (606 sites; 2004 to 2007) were analyzed to evaluate trends in use and outcomes of r-PCI. Logistic regression was used to evaluate the adjusted association between r-PCI and procedural success, bleeding complications, and vascular complications. Outcomes in elderly patients, women, and patients with acute coronary syndrome were specifically examined. Results Although the proportion of r-PCI procedures has recently increased, it only accounts for 1.32% of total procedures (n = 7,804). Compared with the femoral approach, the use of r-PCI was associated with a similar rate of procedural success (adjusted odds ratio: 1.02 [95% confidence interval: 0.93 to 1.12]) but a significantly lower risk for bleeding complications (odds ratio: 0.42 [95% confidence interval: 0.31 to 0.56]) after multivariable adjustment. The reduction in bleeding complications was more pronounced among patients l75 years old, women, and patients undergoing PCI for acute coronary syndrome. Conclusions The use of r-PCI is rare in contemporary clinical practice, but it is associated with a rate of procedural success similar to the femoral approach and with lower rates of bleeding and vascular complications, even among high-risk groups. These results suggest that wider adoption of r-PCI in clinical practice may improve the safety of PCI.
541 citations
TL;DR: In the International Registry of Acute Aortic Dissection, the less invasive nature of endovascular treatment seems to provide better in-hospital survival in patients with acute type B dissection; larger randomized trials or comprehensive registries are needed to access impact on outcomes.
Abstract: Objectives Impact on survival of different treatment strategies was analyzed in 571 patients with acute type B aortic dissection enrolled from 1996 to 2005 in the International Registry of Acute Aortic Dissection. Background The optimal treatment for acute type B dissection is still a matter of debate. Methods Information on 290 clinical variables were compared, including demographics; medical history; clinical presentation; physical findings; imaging studies; details of medical, surgical, and endovascular management; in-hospital clinical events; and in-hospital mortality. Results Of the 571 patients with acute type B aortic dissection, 390 (68.3%) were treated medically, 59 (10.3%) with standard open surgery and 66 (11.6%) with an endovascular approach. Patients who underwent emergency endovascular or open surgery were younger (mean age 58.8 years, p l 0.001) than their counterparts treated conservatively, and had male preponderance and hypertension in 76.9%. Patients submitted to surgery presented with a wider aortic diameter than patients treated by interventional techniques or by medical therapy (5.36 ± 1.7 cm vs. 4.62 ± 1.4 cm vs. 4.47 ± 1.4 cm, p = 0.003). In-hospital complications occurred in 20% of patients subjected to endovascular technique and in 40% of patients after open surgical repair. In-hospital mortality was significantly higher after open surgery (33.9%) than after endovascular treatment (10.6%, p = 0.002). After propensity and multivariable adjustment, open surgical repair was associated with an independent increased risk of in-hospital mortality (odds ratio: 3.41, 95% confidence interval: 1.00 to 11.67, p = 0.05). Conclusions In the International Registry of Acute Aortic Dissection, the less invasive nature of endovascular treatment seems to provide better in-hospital survival in patients with acute type B dissection; larger randomized trials or comprehensive registries are needed to access impact on outcomes.
384 citations
TL;DR: There was a significant increase in the frequency of LBBB after percutaneous insertion of the aortic valvar prosthesis, and patients with pre-existing right bundle branch block may be at risk for the development of complete heart block and subsequent need for pacing.
Abstract: Objectives In this retrospective study, we examined the incidence of post-procedural conduction abnormalities and the need for pacing in patients undergoing percutaneous implantation of the aortic valve Background Safety and feasibility studies have suggested anecdotally the occurrence of conduction abnormalities and requirements for pacing after percutaneous implantation of the aortic valve Methods We examined the standard 12-lead electrocardiograms (ECGs) of 40 consecutive patients in whom a CoreValve Revalving System (CoreValve, Paris, France) was implanted between November 2005 and March 2008 We examined the 12-lead ECG before treatment, after treatment, and at 1-month follow-up We documented the requirements for temporary or permanent pacemaking Results The mean age of patients was 82 ± 7 years Post-procedural mortality at 72 h was 0% There was a significant increase in the frequency of left bundle branch block (LBBB) after percutaneous aortic valve replacement (15% before treatment vs 55% after treatment, p = 0001) Although the incidence of LBBB had decreased after follow-up of 1 month, it did not reach statistical significance, with the proportion decreasing from 55% to 48% (p = 063) The only 2 patients with pre-treatment right bundle branch block became dependent on temporary pacing immediately after valve implantation and subsequently needed permanent pacing A temporary and permanent pacemaker was required in 20% and 18% of patients, respectively Conclusions In this study, there was a significant increase in the frequency of LBBB after percutaneous insertion of the aortic valvar prosthesis Patients with pre-existing right bundle branch block may be at risk for the development of complete heart block and subsequent need for pacing
353 citations
TL;DR: The rationale and methods for Door-to-Balloon (D2B): An Alliance for Quality, an international effort organized by the American College of Cardiology in partnership with the American Heart Association and 37 other organizations to rapidly translate research about how best to achieve outstanding D2B times for patients with ST-segment elevation myocardial infarction into practice are described.
Abstract: Objectives We sought to describe the rationale and methods for Door-to-Balloon (D2B): An Alliance for Quality, an international effort organized by the American College of Cardiology in partnership with the American Heart Association and 37 other organizations to rapidly translate research about how best to achieve outstanding D2B times for patients with ST-segment elevation myocardial infarction (STEMI) into practice. Background The D2B time, the time between hospital arrival and primary percutaneous coronary intervention for patients with STEMI, is strongly associated with the likelihood of survival, yet the majority of patients are not treated within the guideline-recommended time of ≤90 min. Recent research has revealed key and underused strategies that are associated with achieving faster D2B times. Methods The D2B Alliance has enrolled approximately 1,000 hospitals. Its goal is to achieve a D2B time of ≤90 min for at least 75% of non-transferred patients. The key strategies chosen by the D2B Alliance include having the emergency medicine physician activate the catheterization laboratory with a single call, having the team prepared within 20 to 30 min of the call; rapid data feedback; a team-based approach; and administrative support. The use of a pre-hospital electrocardiogram by emergency medical services personnel to activate the catheterization laboratory was also noted as an additional optional strategy. The project has many approaches to promote participation and adoption of effective strategies. An evaluation component is also described. Conclusions The design of the D2B: An Alliance for Quality, a novel campaign to improve D2B time, is described.
288 citations
TL;DR: A marked decline in the incidence of major femoral bleeding after PCI over the past decade is noted, and Mortality associated with these bleeding complications and with blood transfusion remains a significant issue.
Abstract: Objectives The purpose of this study was to evaluate secular trends and factors associated with major femoral bleeding after percutaneous coronary intervention (PCI) in routine clinical practice during the past decade and to assess the impact of these complications on outcomes including mortality. Background Significant changes in patient demographic data, adjunctive pharmacotherapy, and access site management have occurred during the coronary stent era. Trends in major vascular complications after PCI during this time have not been well characterized. Methods Consecutive patients who underwent transfemoral PCI from 1994 to 2005 at the Mayo Clinic (n = 17,901) were studied. Patients were divided into 3 groups: Group 1 (1994 to 1995, n = 2,441); Group 2 (1996 to 1999, n = 6,207); and Group 3 (2000 to 2005, n = 9,253). Results The incidence of major femoral bleeding complications decreased (from 8.4% to 5.3% to 3.5%; p l 0.001). Reductions in sheath size, intensity and duration of anticoagulation with heparin, and procedure time were observed (p l 0.001), and multivariate analysis confirmed each as an independent predictor of complications (p l 0.001). Adverse outcomes of major femoral bleeding included prolonged hospital stay (mean 4.5 vs. 2.7 days; p l 0.0001) and increased requirement for blood transfusion (39% vs. 4.7%; p l 0.0001). Major femoral bleeding and blood transfusion were both associated with decreased long-term survival, driven by a significant increase in 30-day mortality (p l 0.001 for both). Conclusions We noted a marked decline in the incidence of major femoral bleeding after PCI over the past decade. Mortality associated with these bleeding complications and with blood transfusion remains a significant issue.
266 citations
TL;DR: This state-of-the art review discusses how to assess the validity of RCTs and OS that yield different conclusions regarding the relative merit of competing treatments/interventions.
Abstract: The 2 primary types of studies that are used to test new drugs or procedures or compare competing drugs or types of procedures are randomized clinical trials (RCTs) and observational studies (OS). Although it would appear that RCTs always trump OS because they eliminate selection bias, there are many possible limitations to both types of studies, and these limitations must be carefully assessed when comparing the results of RCTs and OS. This state-of-the art review describes these limitations and discusses how to assess the validity of RCTs and OS that yield different conclusions regarding the relative merit of competing treatments/interventions.
250 citations
TL;DR: Dedicated bifurcation stents are an exciting new technology that may further simplify the management of b ifurcation PCI and change some of these concepts.
Abstract: The percutaneous treatment of coronary bifurcations has moved past an important milestone in that the 1- versus 2-stent debate appears to have been resolved. The provisional approach of implanting one stent on the main branch should be the default approach in most bifurcations lesions. Selection of the most appropriate strategy for an individual bifurcation is important. Some bifurcations require 1 stent, whereas others require the stenting of both branches. Irrespective of whether a 1- or 2-stent strategy is chosen, the results after bifurcation percutaneous coronary intervention (PCI) have dramatically improved. Dedicated bifurcation stents are an exciting new technology that may further simplify the management of bifurcation PCI and change some of these concepts.
245 citations
TL;DR: Assessing TnI72h after primary PCI is a simple, effective method to estimate infarct size, LVEF, and potentially useful for risk stratification.
Abstract: Objectives We sought to determine the best cardiac biomarker to predict infarct size, left ventricular ejection fraction (LVEF), and clinical outcome in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Background The cardiac biomarkers, creatine kinase (CK), CK-MB, and troponins T and I are routinely measured after myocardial infarction. However, their correlation with functional and clinical outcomes after PCI for STEMI is not well established. Methods In the EVOLVE (EValuation Of MCC-135 for Left VEntricular Salvage in Acute Myocardial Infarction) trial, patients were randomized to receive intracellular calcium modulator as adjunct to primary PCI for first large STEMI. Cardiac biomarker levels were determined in 378 patients before PCI and serially up to 72 h. Single-photon emission computed tomography was performed after 5 and 30 days, and patients were monitored up to 180 days. Results All single time-point, peak, and area under time-concentration curve of CK, CK-MB, and troponins T and I after PCI significantly correlated with infarct size and LVEF. In particular, 72-h troponin I (TnI72h) correlated strongly with 5-day and 30-day infarct size (r g 0.70; p l 0.001). A TnI72h threshold g55 ng/ml was 90% sensitive for large infarct size (≥10%) and low LVEF (≤40%) with specificities of 70% and 52%, respectively (c = 0.88, 0.81; p l 0.001). The highest TnI72h tertile was associated with increased 180-day composite clinical events (23% vs. 23% vs. 42%; p = 0.001) and independently predicted adverse events (hazard ratio = 2.3; p = 0.01). Conclusions Assessing TnI72h after primary PCI is a simple, effective method to estimate infarct size, LVEF, and potentially useful for risk stratification.
214 citations
TL;DR: As with conventional AVR surgery, transcatheter AVR may result in impaired atrioventricular conduction, and Physicians and patients should be aware of the potential for AV block and pacemaker dependence.
Abstract: Objectives Transcatheter aortic valve replacement (AVR) is a promising approach to aortic valve disease. The implications of this new therapy are not entirely known. We describe the potential for the development of new atrioventricular (AV) block. Background Atrioventricular block is a known complication of conventional surgical AVR. Block is presumed to occur as a consequence of surgical trauma to the cardiac conduction tissue during excision of the diseased aortic valve and debridement of the calcified annulus. Whether AV block might occur as a consequence of nonsurgical implantation of an aortic stent valve is unknown. Methods We reviewed our experience with patients undergoing transcatheter AVR using both the percutaneous transarterial and the open-chest direct left ventricular apical ventriculotomy approaches. Patients were considered at high risk for conventional surgery because of comorbidities. Continuous arrhythmia monitoring was performed for at least 48 h after the valve implantation procedure. Patients who developed apparently new, clinically significant AV block were identified. Results Transcatheter AVR was successfully performed in 123 patients. Seventeen of these patients (13.8%) had pre-existing permanent pacemakers. Two patients (1.6%) required pacemaker implantation because of pre-existing intermittent bradycardia. Seven patients (5.7%) developed new and sustained complete AV block requiring pacemaker implantation. An additional 4 patients (3.3%) developed new and sustained left bundle branch block but did not require pacemaker implantation. Conclusions As with conventional AVR surgery, transcatheter AVR may result in impaired atrioventricular conduction. Physicians and patients should be aware of the potential for AV block and pacemaker dependence.
198 citations
TL;DR: This article reviews the published literature on coronary artery aneurysms specifically relating to drug-eluting stents and concludes that the true incidence of coronary aneurYSms in an unselected patient population is still largely unknown.
Abstract: Drug-eluting stents (DES), which locally elute antiproliferative drugs, can dramatically inhibit neointimal growth. However, several pathological studies have indicated that DES may delay healing after vascular injury, and DES implantation may be theoretically associated with a risk of coronary artery aneurysm formation. Coronary aneurysms have been reported from 3 days to up to 4 years after DES implantation procedures, with varying clinical presentations. The incidence of coronary artery aneurysms after DES implantation is low within the first 9 months, with a reported incidence of 0.2% to 2.3%, a rate similar to that reported after bare-metal stent (BMS) implantation (0.3% to 3.9%) in the DES versus BMS randomized trials. However, the true incidence of coronary aneurysms in an unselected patient population is still largely unknown. This article reviews the published literature on coronary artery aneurysms specifically relating to DES.
172 citations
TL;DR: Reductions in the prevalence of adverse procedural factors contributed to the decrease in the incidence of vascular complications, suggesting that strategies to reduce vascular complications can be effective in improving the safety of these procedures.
Abstract: Objectives This study sought to evaluate trends in vascular complications after diagnostic cardiac catheterization (CATH) and percutaneous coronary intervention (PCI) from the femoral artery from 1998 to 2007. Background Vascular complications have been recognized as an important factor in morbidity after CATH and PCI. Whether strategies to reduce vascular complications performed from the femoral artery in the past decade have improved the safety of these procedures, however, is uncertain. Methods A total of 35,016 consecutive diagnostic cardiac catheterization (n = 20,777) and percutaneous coronary intervention procedures (n = 14,239) performed via a femoral access at a single site (Wake Forest University Baptist Medical Center) between 1998 and 2007 were evaluated. Annual rates of vascular complications were evaluated. Covariate effects on the risk of vascular complications were evaluated by logistic regression and risk-adjusted trend analysis. Results Overall, the incidence of any vascular complication decreased significantly for CATH, 1.7% versus 0.2%, and PCI, 3.1% versus 1.0%, from 1998 to 2007, both p l 0.001 for trend. Favorable trends in procedural covariates affecting vascular complications were mainly responsible for the decrease in the incidence of vascular complications, including fewer closure device failures and use of smaller sheath sizes. Conclusions In this large, single-center, contemporary observational study, the safety of CATH and PCI performed from the femoral artery improved significantly from 1998 to 2007. Reductions in the prevalence of adverse procedural factors contributed to the decrease in the incidence of vascular complications, suggesting that strategies to reduce vascular complications can be effective in improving the safety of these procedures.
TL;DR: A head-to-head comparison of plaque observations with multislice computed tomography to virtual histology intravascular ultrasound (VH IVUS) found a good correlation was observed between calcium quantification on MSCT and VH IV US.
Abstract: Objectives The purpose of this study was to perform a head-to-head comparison of plaque observations with multislice computed tomography (MSCT) to virtual histology intravascular ultrasound (VH IVUS). Background The VH IVUS allows in vivo coronary plaque characterization with high spatial resolution. Noninvasively, plaques may be evaluated with MSCT, but limited data are available. Methods A total of 50 patients underwent 64-slice MSCT followed by VH IVUS. The Agatston score was evaluated on MSCT in coronary segments where IVUS was performed. Plaques were classified on MSCT as noncalcified, mixed, and calcified. Four plaque components (fibrotic, fibro-fatty, and necrotic core tissues and dense calcium) were identified on VH IVUS, and the presence of thin-cap fibroatheroma was evaluated. Results A moderate correlation was observed between the Agatston score and calcium volume on VH IVUS (r = 0.69, p l 0.0001). In total, 168 coronary plaques were evaluated (48 [29%] noncalcified, 71 [42%] mixed, 49 [29%] calcified). As compared with calcified plaques, noncalcified plaques contained more fibrotic (60.90 ± 9.21% vs. 54.60 ± 8.33%, p = 0.001) and fibro-fatty tissues (28.11 ± 13.03% vs. 21.37 ± 9.75%, p = 0.006) on VH IVUS. Mixed and calcified plaques contained more dense calcium (7.61 ± 8.94% vs. 2.68 ± 3.01%, p = 0.001; 10.18 ± 6.71% vs. 2.68 ± 3.01%, p l 0.0001, respectively). Thin-cap fibroatheromas were most frequently observed in mixed plaques as compared with noncalcified and calcified plaques (32%, 13%, 8%, p = 0.002, respectively). Conclusions A good correlation was observed between calcium quantification on MSCT and VH IVUS. In addition, plaque classification on MSCT paralleled relative plaque composition on VH IVUS, although VH IVUS provided more precise plaque characterization. Mixed plaques on MSCT were associated with high-risk features on VH IVUS.
TL;DR: The data suggest that PCI for CTO of the LAD, but not LCX or RCA, is associated with improved long-term survival, and may assist in selecting patients for attempted CTO PCI.
Abstract: Objectives This study compared the survival benefit of opening a chronic total occlusion (CTO) of the left anterior descending (LAD), left circumflex (LCX), or right coronary artery (RCA). Background Previous analyses demonstrate improved survival following successful percutaneous coronary intervention (PCI) for CTO. Methods Eligible patients underwent attempted CTO PCI in a single vessel. Procedural success rates were calculated for each vessel. The primary end point was survival at 5 years, compared across target vessel groups stratified by procedural success. Results There were 2,608 patients included. The LAD was the target vessel in 936 (36%), the LCX in 682 (26%), and the RCA in 990 (38%) patients. Angiographic success rates for LAD were 77%, LCX 76%, and RCA 72%. Baseline demographics and comorbidities were well matched, though there were significantly more males in the LCX compared with LAD or RCA groups (80% vs. 75% and 73%, respectively, p = 0.005). Procedural success compared with failure was associated with improved 5-year survival in the LAD (88.9% vs. 80.2%, p l 0.001) group, but not in the LCX (86.1% vs. 82.1%, p = 0.21) and RCA groups (87.7% vs. 84.9%, p = 0.23). In multivariable analysis, CTO PCI success in the LAD group remained associated with decreased mortality risk (HR: 0.61, 95% CI: 0.42 to 0.89). Conclusions The data suggest that PCI for CTO of the LAD, but not LCX or RCA, is associated with improved long-term survival. This information may assist in selecting patients for attempted CTO PCI.
TL;DR: Benefit of tailored antiplatelet therapy during elective PCI with GP IIb/IIIa antagonist for clopidogrel nonresponders without increased bleeding risk is suggested.
Abstract: Objectives The aim of this study was to assess, in clopidogrel nonresponders undergoing elective percutaneous coronary intervention (PCI), the benefit of adjusted antiplatelet therapy with glycoprotein (GP) IIb/IIIa antagonist administration during PCI for 1-month clinical outcome. Background Numerous biological studies have reported interindividual variability in platelet response to clopidogrel with clinical relevance, and high post-treatment platelet reactivity (adenosine diphosphate-induced aggregation g70%) has been proposed to define nonresponse to clopidogrel. These nonresponders might benefit from tailored antiplatelet therapy. Methods One hundred forty-nine clopidogrel nonresponders referred for elective PCI were prospectively included and randomized to “conventional group” (n = 75) or “active group” with GP IIb/IIIa antagonist (n = 74). All patients received 250-mg aspirin and 600-mg clopidogrel before PCI and platelet testing. Results The rate of cardiovascular events at 1 month was significantly lower in the “active group” than in the “conventional group”: 19% (n = 14) versus 40% (n = 30), p = 0.006, odds ratio: 2.8; 95% confidence interval: 1.4 to 6.0. No patient in either group had post-procedural Thrombolysis In Myocardial Infarction major bleeding or required transfusions. Conclusions The present study suggested benefit of tailored antiplatelet therapy during elective PCI with GP IIb/IIIa antagonist for clopidogrel nonresponders without increased bleeding risk.
TL;DR: The study showed a trend toward improved myocardial perfusion and lower clinical events in patients treated with aspiration and suggested the safety of primary PCI with upfront thrombectomy using a novel device in patients with STEMI.
Abstract: Objectives This study evaluated safety and efficacy of upfront thrombus aspiration during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). Background Distal embolization during primary PCI results in reduced myocardial perfusion and poor clinical outcomes. Methods The VAMPIRE (VAcuuM asPIration thrombus REmoval) study was a prospective, randomized, controlled multicenter trial conducted in 23 institutions. Patients (N = 355) presenting within 24 h of STEMI symptoms onset were randomized to primary PCI with (n = 180) or without (n = 175) upfront thrombus aspiration using Nipro's TransVascular Aspiration Catheter (Osaka, Japan). Results The TransVascular Aspiration Catheter reached the lesion in 100% of cases. It successfully crossed the target obstruction in 86% without any delay in procedure time or time to reperfusion; whereas macroscopic thrombi were removed in 75% of the cases. Procedure success was similar between groups (98.9% vs. 98.3%). There was a trend toward lower incidence of slow or no reflow (primary end point—defined as a Thrombolysis In Myocardial Infarction flow grade l3) in patients treated with aspiration versus conventional primary PCI (12.4% vs. 19.4%, p = 0.07). Rate of myocardial blush grade 3 was higher in the aspiration group (46.0% vs. 20.5%, p l 0.001). Aspiration was most effective in patients presenting after 6 h of symptoms onset (slow flow rate: 8.1% vs. 37.6%, p = 0.01). Conclusions This study suggested the safety of primary PCI with upfront thrombectomy using a novel device in patients with STEMI. The study showed a trend toward improved myocardial perfusion and lower clinical events in patients treated with aspiration. Patients presenting late after STEMI appear to benefit the most from thrombectomy.
TL;DR: Optical coherence tomography detects smaller degrees of ISN more accurately than IVUS and might be a useful method for identifying neointimal coverage of stent struts after DES implantation.
Abstract: Objectives The purpose of this study was to evaluate optical coherence tomography (OCT) for detecting small degrees of in-stent neointima (ISN) after stent implantation compared with intravascular ultrasound (IVUS) Background The importance of detecting neointimal coverage of stent struts has grown with the appreciation of the increased risk for late stent thrombosis after drug-eluting stent (DES) implantation Intravascular ultrasound, the current standard for evaluating the status of DES, lacks the resolution to detect the initial neointimal coverage Optical coherence tomography has greater resolution but has not yet been compared with IVUS in vivo with histological correlation for validation Methods Intravascular ultrasound and OCT were performed with motorized pullback imaging in 6 pigs across 33 stents, 1 month after implantation Each pig was euthanized, and histological measurements of vessel, stent, and lumen dimensions were performed in 3 sections of each stent A small degree of ISN was defined as occupying l30% of the stent area measured with histology The IVUS, OCT, and histological assessment of ISN were compared in matched cross-sections of the stents with a small degree of ISN Results Eleven stents had a small degree of ISN (average ISN area: 126 ± 046 mm 2 , and percent area obstruction: 214 ± 52%) Compared with histology, the diagnostic accuracy of OCT (area under the receiver operating characteristic curve [AUC] = 0967, 95% confidence interval [CI] 0914 to 1019) was higher than that of IVUS (AUC = 0781, 95% CI 0621 to 0838) Conclusions Optical coherence tomography detects smaller degrees of ISN more accurately than IVUS and might be a useful method for identifying neointimal coverage of stent struts after DES implantation
TL;DR: Carriers of the CYP2C19*2 and *4 alleles showed reduced platelet inhibition after a clopidogrel 600-mg loading dose but responded to higher loading and maintenance dose regimens.
Abstract: Objectives This study assessed the effect of pharmacogenetics on the antiplatelet effect of clopidogrel. Background Variability in clopidogrel response might be influenced by polymorphisms in genes coding for drug metabolism enzymes (cytochrome P450 [CYP] family), transport proteins (P-glycoprotein) and/or target proteins for the drug (adenosine diphosphate–receptor P2Y12). Methods Sixty patients undergoing elective percutaneous coronary intervention in the randomized PRINC (Plavix Response in Coronary Intervention) trial had platelet function measured using the VerifyNow P2Y12 analyzer after a 600-mg or split 1,200-mg loading dose and after a 75- or 150-mg daily maintenance dosage. Polymerase chain reaction–based genotyping evaluated polymorphisms in the CYP2C19, CYP2C9, CYP3A4, CYP3A5, ABCB1, P2Y12, and CES genes. Results CYP2C19*1*1 carriers had greater platelet inhibition 2 h after a 600-mg dose (median: 23%, range: 0% to 66%), compared with platelet inhibition in CYP2C19*2 or *4 carriers (10%, 0% to 56%, p = 0.029) and CYP2C19*17 carriers (9%, 0% to 98%, p = 0.026). CYP2C19*2 or *4 carriers had greater platelet inhibition with the higher loading dose than with the lower dose at 4 h (37%, 8% to 87% vs. 14%, 0% to 22%, p = 0.002) and responded better with the higher maintenance dose regimen (51%, 15% to 86% vs. 14%, 0% to 67%, p = 0.042). Conclusions Carriers of the CYP2C19*2 and *4 alleles showed reduced platelet inhibition after a clopidogrel 600-mg loading dose but responded to higher loading and maintenance dose regimens. Genotyping for the relevant gene polymorphisms may help to individualize and optimize clopidogrel treatment. (Australia New Zealand Clinical Trials Registry; ACTRN12606000129583)
TL;DR: In elective percutaneous coronary intervention patients, a 150-mg/day clopidogrel maintenance dose produces greater inhibition of platelet function than clopilator-stimulated phosphoprotein assay-guided switching to clopinogrel 150 mg/day overcomes low responsiveness in a majority of patients.
Abstract: Objectives We investigated whether maintenance therapy with clopidogrel 150 mg/day produces greater platelet inhibition than the standard 75-mg/day dose and whether the higher maintenance dose increases platelet inhibition in low responders to clopidogrel 75 mg/day. Background Patients show interindividual variability in their platelet response to clopidogrel. Low responders could potentially obtain greater clinical benefit from greater doses of clopidogrel. Methods One hundred fifty-three elective percutaneous coronary intervention patients were randomized to clopidogrel 150 mg/day (n = 58) or 75 mg/day (n = 95) for 4 weeks, with vasodilator-stimulated phosphoprotein assay-guided switching to clopidogrel 150 mg/day after 2 weeks in low responders (platelet reactivity index ≥69%). All patients received aspirin 75 mg/day. Results After 2 weeks, clopidogrel 150 mg/day produced a significantly lower platelet reactivity index than clopidogrel 75 mg/day (43.9 ± 17.3% vs. 58.6 ± 17.7%; p l 0.0001). The proportion of low responders was significantly lower in patients randomized to clopidogrel 150 mg/day than in those randomized to clopidogrel 75 mg/day (8.6% vs. 33.7%; p = 0.0004). In the clopidogrel 75 mg/day group, 64.5% (20 of 31) of low responders became responders after switching to clopidogrel 150 mg/day for 2 weeks. No major bleeds occurred during the study; the incidence of minor bleeds was similar in each treatment group. Conclusions In elective percutaneous coronary intervention patients, a 150-mg/day clopidogrel maintenance dose produces greater inhibition of platelet function than clopidogrel 75 mg/day. In low responders to clopidogrel 75 mg/day, switching to clopidogrel 150 mg/day overcomes low responsiveness in a majority of patients. These findings warrant further clinical evaluation. (VASP-02; EudraCT number: 2004-005230-40).
TL;DR: A hybrid strategy combines the treatments traditionally available only in the catheterization laboratory with those traditionally available in the operating room to offer patients the best available therapies for any given set of cardiovascular lesions to obtain optimal patient outcomes.
Abstract: A hybrid strategy combines the treatments traditionally available only in the catheterization laboratory with those traditionally available only in the operating room to offer patients the best available therapies for any given set of cardiovascular lesions. Examples include hybrid coronary revascularization (coronary artery bypass grafting [CABG]/percutaneous coronary intervention [PCI]) wherein a left internal mammary artery graft is placed on the left anterior descending artery (left anterior descending coronary artery [LAD]) either by minimally invasive or open technique and combined with PCI of non-LAD vessels. Other examples include minimally invasive valve surgery combined with PCI to coronary lesions (valve/PCI), to convert a high-risk valve/CABG into a lower-risk isolated minimally invasive valve procedure. Several questions remain unresolved, such as the order in which surgery and PCI should be performed, the duration of the staging of the 2 procedures, antiplatelet strategies, the costs, and the logistics. Other areas in which hybrid approaches are being developed include hybrid endomyocardial/epicardial atrial fibrillation procedures and hybrid aortic arch debranching combined with endovascular grafting for thoracic aortic procedures. The key requirement in all of these approaches is the need for collaboration between cardiac surgeons, vascular surgeons, and interventional cardiologists to obtain optimal patient outcomes.
TL;DR: In patients with single-vessel, proximal LAD disease, survival was similar in CABG-assigned and PCI-assignment patients; CABGs was significantly more effective in relieving angina and led to fewer repeat revascularizations.
Abstract: Objectives This study sought to systematically compare the effectiveness of percutaneous coronary intervention and coronary artery bypass surgery in patients with single-vessel disease of the proximal left anterior descending (LAD) coronary artery. Background It is uncertain whether percutaneous coronary interventions (PCI) or coronary artery bypass grafting (CABG) surgery provides better clinical outcomes among patients with single-vessel disease of the proximal LAD. Methods We searched relevant databases (MEDLINE, EMBASE, and Cochrane from 1966 to 2006) to identify randomized controlled trials that compared outcomes for patients with single-vessel proximal LAD assigned to either PCI or CABG. Results We identified 9 randomized controlled trials that enrolled a total of 1,210 patients (633 received PCI and 577 received CABG). There were no differences in survival at 30 days, 1 year, or 5 years, nor were there differences in the rates of procedural strokes or myocardial infarctions, whereas the rate of repeat revascularization was significantly less after CABG than after PCI (at 1 year: 7.3% vs. 19.5%; at 5 years: 7.3% vs. 33.5%). Angina relief was significantly greater after CABG than after PCI (at 1 year: 95.5% vs. 84.6%; at 5 years: 84.2% vs. 75.6%). Patients undergoing CABG spent 3.2 more days in the hospital than those receiving PCI (95% confidence interval: 2.3 to 4.1 days, p l 0.0001), required more transfusions, and were more likely to have arrhythmias immediately post-procedure. Conclusions In patients with single-vessel, proximal LAD disease, survival was similar in CABG-assigned and PCI-assigned patients; CABG was significantly more effective in relieving angina and led to fewer repeat revascularizations.
TL;DR: Successful CTO PCI increases hyperemic MBF as early as 24 h after the procedure, with a greater and earlier improvement in regional contractility than after non-CTO PCI, despite a greater likelihood of irreversible injury in CTO segments.
Abstract: Objectives We sought to investigate temporal changes in contractility and hyperemic and resting myocardial blood flow (MBF) in dependent and remote myocardium after percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) by using cardiovascular magnetic resonance (CMR) imaging. Background Data about the physiological consequences of revascularization of CTOs are limited. The use of CMR allows investigation of the regional effects of revascularization on MBF and left ventricular contractility. Methods We prospectively recruited 3 patient groups: 17 patients scheduled for CTO PCI, 17 scheduled for PCI of a stenosed but nonoccluded coronary artery (non-CTO), and 6 patients with CTO who were not scheduled for revascularization. All patients undergoing PCI underwent CMR imaging l24 h before PCI, with repeat CMR imaging 24 h and 6 months after PCI. Each CMR scan consisted of cine, perfusion, and delayed enhancement imaging. Regional hyperemic and resting MBF, wall thickening, and transmural extent of infarction were calculated. Results In both intervention groups, hyperemic MBF in treated segments increased 24 h after PCI compared with baseline: CTO group, 2.1 ± 0.2 ml/min/g versus 1.4 ± 0.2 ml/min/g (p l 0.01); non-CTO group, 2.5 ± 0.2 ml/min/g versus 1.6 ± 0.2 ml/min/g (p l 0.01). This improvement persisted 6 months after PCI (p l 0.01 for both groups). Contractility in treated segments was improved at 24 h and 6 months after CTO PCI but only at 6 months after non-CTO PCI. In both intervention groups, treated segments no longer had reduced MBF or contractility compared with remote segments. In patients with untreated CTO segments, MBF and wall thickening did not improve at follow-up. Conclusions Successful CTO PCI increases hyperemic MBF as early as 24 h after the procedure, with a greater and earlier improvement in regional contractility than after non-CTO PCI, despite a greater likelihood of irreversible injury in CTO segments.
TL;DR: Side-branch ostial stenosis after crush stenting was minimized by mini-crush deployment, 2-step kissing post-dilation, and the use of stents with larger cell size.
Abstract: Objectives This study provides insights into “crush” coronary bifurcation stenting through imaging of bench deployments. Background Although the strategy of provisional side-branch stenting is widely accepted for suitable bifurcation lesions, there is no consensus on the best option for elective stenting with 2 stents. The crush technique has the potential to scaffold and apply the drug to the side-branch ostium where restenosis is most common. Methods Sequential steps of crush stent deployment and post-dilation were undertaken in silicone phantoms and recorded on cine angiography and microcomputed tomography. We assessed the effect of deployment strategies, post-dilation strategies, and cell size on side-branch ostial area. Results Side-branch ostial coverage by metal struts was 53% (95% confidence interval [CI]: 46 to 59) after 1-step kissing post-dilation and was reduced by 2-step kissing post-dilation to 33% (95% CI: 28 to 37; p l 0.0001). Although the residual stenosis after the classical crush strategy was 47% (95% CI: 39 to 53), it was 36% (95% CI: 31 to 40; p = 0.002) after mini-crush deployment. Stents with larger cell size (g3.5 mm diameter) had a residual stenosis of 37% (95% CI: 32 to 42) after crush deployment that was less than the residual stenosis for stents with smaller cell size (52%; 95% CI: 44 to 60; p l 0.0001). Conclusions Side-branch ostial stenosis after crush stenting was minimized by mini-crush deployment, 2-step kissing post-dilation, and the use of stents with larger cell size. It is unknown if optimizing stent deployment at bifurcation lesions will reduce clinical stent thrombosis and restenosis.
TL;DR: Although coronary angioscopy remains a specialized research tool, it might allow us to evaluate plaque vulnerability, and there was a significant negative correlation between yellow color intensity and fibrous cap thickness.
Abstract: Objectives The purpose of this study was to assess the relationship between plaque color evaluated by coronary angioscopy and fibrous cap thickness estimated by optical coherence tomography (OCT) in vivo. Background Yellow color intensity of coronary plaque evaluated by coronary angioscopy might be associated with plaque vulnerability. Methods Seventy-seven coronary artery plaques in patients with acute coronary syndrome were observed by angioscopy and OCT. Plaque color was graded as white, light yellow, yellow, or intensive yellow. Results There were significant differences among the groups classified by plaque color with respect to the fibrous cap thickness estimated by OCT: 389 ± 74 μm in white plaques, 228 ± 51 μm in light yellow plaques, 115 ± 28 μm in yellow plaques, and 59 ± 14 μm in intensive yellow plaques (p l 0.0001). In Spearman rank-order correlation analysis, there was a significant negative correlation between yellow color intensity and fibrous cap thickness (p l 0.0001). Furthermore, 80% of intensive yellow plaques were thin cap fibroatheroma with a cap thickness of ≤65 μm. Conclusions The plaque color in coronary angioscopy was determined by the fibrous cap thickness, which was assessed by OCT. Although coronary angioscopy remains a specialized research tool, it might allow us to evaluate plaque vulnerability.
TL;DR: The initial benefits of ASA were maintained during follow-up and the survival estimates at 1, 5, and 8 years were 97%, 92%, and 89%, respectively.
Abstract: Objectives This study sought to determine the long-term outcome of alcohol septal ablation (ASA). Background There are inadequate data on the long-term outcome of ASA for symptomatic hypertrophic obstructive cardiomyopathy (HOCM). Methods Six hundred and twenty-nine patients were enrolled consecutively (1996 to 2007) and 98.4% (n = 619) underwent ASA with 92% follow-up in 2007. Evaluation included deaths, procedural complications, pacemaker requirement, repeat ASA, and myectomy/valve surgery. Follow-up parameters included angina (Canadian Cardiovascular Society score), dyspnea (New York Heart Association functional class), exercise time, and echocardiographic indices (septal thickness, ejection fraction, resting and provoked gradients). Results Ethanol (2.6 ± 1.0 ml) was injected into 1.3 ± 0.5 septal arteries, inducing a septal infarct. Complications included death 1% (n = 6), permanent pacemaker requirement 8.2% (n = 52), coronary dissection 1.3% (n = 8), and worsening mitral regurgitation 0.3% (n = 2). The mean follow-up was 4.6 ± 2.5 years (range: 3 months to 10.2 years). During follow-up, New York Heart Association functional class decreased from 2.8 ± 0.6 to 1.2 ± 0.5 (p l 0.001); Canadian Cardiovascular Society angina score decreased from 2.1 ± 0.9 to 1.0 ± 0 (p l 0.001); and exercise time increased from 4.8 ± 3.3 to 8.2 ± 1.0 (p l 0.001) min. The resting and provoked left ventricular outflow tract gradients decreased progressively (p l 0.001) and remained low during follow-up. The septal thickness decreased from 2.1 ± 0.5 cm to 1.0 ± 0.1 cm (p l 0.001) and the ejection fraction decreased from 68 ± 9% to 62 ± 3% (p l 0.001). The survival estimates at 1, 5, and 8 years were 97%, 92%, and 89%, respectively. Conclusions The initial benefits of ASA were maintained during follow-up.
TL;DR: The propensity-adjusted risk of mortality for treatment of ULMCA disease does not differ between PCI- and CABG-treated groups, and there appears to be sufficient equipoise that a randomized clinical trial to compare the techniques would not be ethically contraindicated.
Abstract: Objectives The purpose of this study was to compare outcomes for drug-eluting stents (DES) and coronary artery bypass graft (CABG) surgery in patients with unprotected left main coronary artery (ULMCA) stenosis. Background Expert guidelines recommend coronary artery bypass graft (CABG) surgery for the treatment of significant stenosis of the unprotected left main coronary artery (ULMCA) if the patient is eligible for CABG; however, treatment by percutaneous coronary intervention (PCI) is common. Methods Details of patients (n = 343, ages 69.9 ± 11.9 years) undergoing coronary revascularization for ULMCA stenosis (April 2003 to January 2007) were recorded. A total of 223 patients were treated with CABG (mean [interquartile range]: follow-up 600 [226 to 977) days) and 120 by PCI (follow-up 362 [192 to 586) days). The hazard ratios (HRs) for death and major adverse cardiovascular and cerebrovascular events (MACCE) were calculated incorporating propensity score adjustment. Survival comparisons were conducted in propensity-matched subjects (n = 134), and in low- and high-risk subjects for CABG. Results Patients treated by PCI were more likely to be ≥75 years of age (49% vs. 33%; p = 0.005), and of greater surgical risk (Parsonnet score 17.2 ± 11.2 vs. 13.0 ± 9.3; p l 0.001) than patients treated by CABG. Overall, the propensity-adjusted HR for death was not statistically different (HR 1.93, 95% confidence interval [CI] 0.89 to 4.19, p = 0.10), but MACCE was greater in the PCI group (HR 1.83, 95% CI 1.01 to 3.32, p = 0.05). In propensity-matched individuals, neither survival nor MACCE-free survival were different. Survival was equivalent among low-risk candidates, but PCI had a tendency to inferior survival in high-risk candidates (Ellis category IV, log-rank p = 0.05). Interaction testing, however, failed to demonstrate a difference in outcomes of the 2 revascularization techniques as a function of baseline risk assessment. Conclusions Overall, the propensity-adjusted risk of mortality for treatment of ULMCA disease does not differ between PCI- and CABG-treated groups. There appears to be sufficient equipoise that a randomized clinical trial to compare the techniques would not be ethically contraindicated.
TL;DR: In stable low-risk CAD, PCI+MT may improve long-term prognosis more effectively than MT, and the cumulative risk of death plus acute coronary syndrome was significantly smaller inPCI+MT.
Abstract: Objectives This study sought to determine whether initial medical therapy (MT) only or percutaneous coronary intervention plus medical therapy (PCI+MT) is better for patients with low-risk stable coronary artery disease (CAD) indicated for intervention in Japan. Background Several multicenter studies have suggested that in the above patients, an initial management strategy of PCI+MT does not reduce the long-term risk of cardiovascular events more effectively than initial MT only. Methods We conducted a randomized comparative study (JSAP [Japanese Stable Angina Pectoris] study) in the previously mentioned patients. Results The patients were randomized to PCI+MT (n = 192) or initial MT only group (n = 192), and the patient characteristics were very similar in the 2 groups. During the 3.3-year follow-up, there was no significant difference in the cumulative death rate between PCI+MT (2.9%) and MT (3.9%). However, the cumulative risk of death plus acute coronary syndrome was significantly smaller in PCI+MT. Conclusions In stable low-risk CAD, PCI+MT may improve long-term prognosis more effectively than MT.
TL;DR: The purpose of this study was to evaluate the safety of dual antiplatelet therapy in patients in whom long-term anticoagulation with warfarin is recommended, and to identify the optimal antithrombotic strategy after percutaneous coronary intervention for patients receiving AC.
Abstract: Objectives The purpose of this study was to evaluate the safety of dual antiplatelet therapy in patients in whom long-term anticoagulation (AC) with warfarin is recommended. Background The optimal antithrombotic strategy after percutaneous coronary intervention (PCI) for patients receiving AC is unclear. Methods Consecutive patients who underwent stent implantation and were discharged on triple therapy (defined as the combination of aspirin and thienopyridines and AC) were analyzed. Results Of the 127 patients with 224 lesions, 86.6% were men, with a mean age of 69.9 ± 8.8 years. Drug-eluting stents (DES) were positioned in 71 (55.9%), and bare-metal stents (BMS) were positioned in 56 (44.1%) patients. Atrial fibrillation (AF) was the main indication (59.1%) for AC treatment. The mean triple therapy duration was 5.6 ± 4.6 months, and clinical follow-up was 21.0 ± 19.8 months. During the triple therapy period, 6 patients (4.7%) developed major bleeding complications; 67% occurred within the first month. No significant differences between DES and BMS were observed in the incidence of major (5.6% vs. 3.6%, respectively, p = 1.0) and minor (1.4% vs. 3.6%, respectively, p = 0.57) bleeding and mortality (5.6% vs. 1.8%, respectively, p = 0.39). A significant difference was observed in favor of DES in target vessel revascularization (14.1% vs. 26.8%, p = 0.041). Conclusions While receiving triple therapy, major bleeding occurred in 4.7% of patients; one-half of the events were lethal, and most occurred within the first month.
TL;DR: As compared with BMS, DES showed a similar risk of overall ST, but a higher risk of very late ST, and the rates of death, death/myocardial infarction, and target lesion revasuclarization were significantly lower in the DES group.
Abstract: Objectives The purpose of this study was to evaluate the risk of stent thrombosis (ST), clinical outcomes, and the benefits of extended clopidogrel use after drug-eluting stent (DES) implantation. Background Data are limited regarding uniform evaluation of ST and the influence of clopidogrel continuation beyond 12 months on late events after DES treatment. Methods We identified 7,221 patients who received DES implantation (n = 3,160) or bare-metal stent (BMS) implantation (n = 4,061), and compared long-term adverse outcomes. Additionally, 2,851 patients with DES surviving 12 months without major events were analyzed according to clopidogrel continuation. Results The adjusted-risk of overall ST was similar in the 2 groups. After 1 year, however, DES patients showed a higher risk of ST; definite/probable (hazard ratio [HR]: 3.55, 95% confidence interval [CI]: 1.26 to 9.99). The adjusted-risk of death (HR: 0.60, 95% CI: 0.46 to 0.79), death/myocardial infarction (HR: 0.63, 95% CI: 0.49 to 0.81), and target lesion revascularization (HR: 0.32, 95% CI: 0.24 to 0.43) were significantly lower in the DES group than in the BMS group. Continuing clopidogrel beyond 12 months was not associated with a reduced risk for ST (HR: 0.54, 95% CI: 0.07 to 4.23), death (HR: 1.20, 95% CI: 0.55 to 2.66), or death/myocardial infarction (HR: 1.16, 95% CI: 0.56 to 2.42) after DES implantation. Conclusions As compared with BMS, DES showed a similar risk of overall ST, but a higher risk of very late ST. The rates of death, death/myocardial infarction, and target lesion revasuclarization were significantly lower in the DES group. Clopidogrel continuation beyond 1 year did not appear to reduce ST and clinical events after DES implantation.
TL;DR: How best to assess results and outcomes of percutaneous aortic valve replacement is discussed, which may require a paradigm shift in mindset, and some of the more novel concepts in trial design which may be more suitable in this area are explored.
Abstract: Aortic valve stenosis is increasing in frequency as the population ages. Surgical aortic valve replacement is the gold standard for symptomatic patients with severe aortic valve stenosis. However, in a subset of high-risk patients, the surgical option is excluded due to severe comorbidities. Recently, an alternative to surgical aortic valve replacement--percutaneous aortic valve replacement (PAVR)--has emerged. Since the first PAVR in a human in 2002, the percutaneous heart valves (PHVs) have already undergone several modifications from first generation devices. Currently, there are 2 PHVs in clinical application, a balloon-expandable and a self-expandable PHV, with several others achieving first-in-man application. With the extremely rapid technological advancements, PAVR is probably here to stay. The next steps required would be to formulate goals to assess results and outcomes of PAVR, and plan trials to test their clinical applicability. This article discusses how best to assess results and outcomes, which may require a paradigm shift in mindset. Apart from the randomized controlled trial, some of the more novel concepts in trial design, which may be more suitable in this area, are also explored.
TL;DR: Acute SM was common after SES and BMS stent implantation in ST-segment elevation myocardial infarction patients and late acquired SM is common and generally caused by positive remodeling.
Abstract: Objectives Acute and late stent malapposition (SM) after bare-metal stents (BMS) and sirolimus-eluting stents (SES) in ST-segment elevation myocardial infarction patients were studied. Background Stent thrombosis may be caused by SM after primary percutaneous coronary intervention in ST-segment elevation myocardial infarction patients. Methods Post-procedure and follow-up intravascular ultrasound data were available in 184 out of 310 patients (60%; 104 SES, 80 BMS) included in the MISSION! Intervention Study. To determine the contribution of remodeling and changes in plaque burden to the change in lumen cross-sectional area (CSA) at SM sites, the change in lumen CSA (follow-up minus post-lumen CSA) was related to the change in external elastic membrane CSA (remodeling) and change in plaque and media CSA (plaque burden). Results Acute SM was found in 38.5% SES patients and 33.8% BMS patients (p = 0.51), late SM in 37.5% SES patients and 12.5% BMS patients (p l 0.001). Acquired SM was found in 25.0% SES patients and 5.0% BMS patients (p l 0.001). Predictors of acute SM were reference diameter (SES: odds ratio [OR] 3.49, 95% confidence interval [CI] 1.29 to 9.43; BMS: OR 28.8, 95% CI 4.25 to 94.5) and balloon pressure (BMS: OR 0.74, 95% CI 0.58 to 0.94). Predictors of late SM were diabetes mellitus (SES: OR 0.16, 95% CI 0.02 to 1.35), reference diameter (BMS: OR 19.2, 95% CI 2.64 to 139.7), and maximum balloon pressure (BMS: OR 0.74, 95% CI 0.55 to 1.00). Change in lumen CSA was related to change in external elastic membrane CSA (R = 0.73, 95% CI 0.62 to 0.84) after SES implantation and to change in plaque and media CSA (R = −0.62, 95% CI −0.77 to −0.46) after BMS implantation. After SES implantation, acquired SM was caused by positive remodeling in 84% and plaque reduction in 16% of patients. Conclusions Acute SM was common after SES and BMS stent implantation in ST-segment elevation myocardial infarction patients. After SES implantation, late acquired SM is common and generally caused by positive remodeling. (The MISSION! Intervention Study, ISRCTN62825862)