William Suddath | Georgetown University (original) (raw)
Papers by William Suddath
JACC: Cardiovascular Interventions, 2014
Ischemic cardiomyopathy with depressed left ventricular ejection fraction (LVEF) is predictive of... more Ischemic cardiomyopathy with depressed left ventricular ejection fraction (LVEF) is predictive of death after percutaneous coronary intervention (PCI), but its association with stent thrombosis (ST) and the need for repeat revascularization is less clearly defined. In total 5,377 patients undergoing PCI were retrospectively evaluated. Multivariable Cox proportional hazards regression and competitive outcome analysis were employed. The primary end point was 1-year major adverse cardiac events (all-cause death, Q-wave myocardial infarction, ST, and target lesion revascularization [TLR]). Individual end points of ST and of TLR were also evaluated. Patients with normal LVEF (>50%) were compared to those with mild (41% to 50%), moderate (25% to 40%), and severe (<25%) decreases in LVEF. Patients with abnormal LVEF were older and more commonly diabetic and had renal insufficiency and heart failure syndrome (p <0.001 for all variables). These patients demonstrated more angiographically complex lesions and less frequently received a drug-eluting stent. The primary end point was significantly increased in patients with lower LVEF (9.7% for normal LVEF vs 20.6% for severely decreased LVEF, p <0.001). ST occurred more frequently in these patients (1.4% for normal LVEF vs 6% for severely decreased LVEF, p <0.001), but clinically driven TLR did not significantly change across LVEF categories. After adjustment, only moderate and severe LVEF decreases (i.e., LVEF <40%) demonstrated an association with major adverse cardiac events and with the individual outcome of ST. Subgroup analysis of patients receiving only a drug-eluting stent or a bare-metal stent demonstrated no statistically significant differences for the probability of ST. In conclusion, decreased LVEF is not associated with clinically driven TLR but does increase the risk of ST. Patients with LVEF <40% appear to be at significantly higher risk for ST and therefore might benefit from interventional and pharmacologic strategies aimed at minimizing this risk.
The Registry Experience at the Washington Hospital Center with Drug-Eluting Stents (REWARDS) stud... more The Registry Experience at the Washington Hospital Center with Drug-Eluting Stents (REWARDS) study includes unselected patients with coronary artery disease treated with sirolimus-eluting stents (SESs; n = 2,392) or paclitaxel-eluting stents (PES; n = 1,119). This study aimed to examine the long-term safety profile of the 2 stents in a &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;real-world&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; population, especially in relation to stent thrombosis, and to compare differences in the diabetic cohort. Patients were followed for 3 years with regard to major adverse cardiac events (MACEs), including death, Q-wave myocardial infarction, and target lesion revascularization. Rates of stent thrombosis were also studied. Baseline characteristics were similar between stents. Although MACE rates at 3 years were similar (SES 28.1% vs PES 28.9%, p = 0.62), there was a significant difference in unadjusted rates of target lesion revascularization (SES 15.6% vs PES 12.6%, p = 0.03), death (SES 15.7% vs PES 19.0%, p = 0.02), and Q-wave myocardial infarction (SES 0.8% vs PES 2.1%, p = 0.003). After multivariable Cox regression to adjust for confounders, there was no significant difference in overall MACEs. Incidence of stent thrombosis was higher in the SES group (SES 2.2% vs PES 1.6%, p = 0.22), but this was not statistically significant (hazard ratio 1.6, 95% confidence interval 0.8 to 2.9, p = 0.17). Overall, diabetics had a higher MACE rate, but there was no difference between insulin- and noninsulin-dependent diabetics. In conclusion, at 3 years, PES and SES achieved similar results in MACEs and stent thrombosis. This should foster confidence that SES or PES can be compared to second-generation drug-eluting stents without concerns for safety or efficacy.
The American Journal of Cardiology, 2011
Compared to paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs), a paucity of da... more Compared to paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs), a paucity of data exists regarding the clinical outcome of everolimus-eluting stents (EESs) in unselected patients with the entire spectrum of obstructive coronary artery disease. The present study cohort included 6,615 consecutive patients at Washington Hospital Center who underwent coronary artery stent implantation with EESs (n = 519), PESs (n = 2,036), or SESs (n = 4,060). Patients who received bare metal stents, zotarolimus-eluting stents, or 2 different drug-eluting stent types were excluded. The analyzed clinical end points were death, death or Q-wave myocardial infarction, target lesion revascularization (TLR), target vessel revascularization, definite stent thrombosis, and major adverse cardiac events, defined as the composite of death, Q-wave myocardial infarction, or TLR at 1 year. The groups were well matched for the conventional risk factors for coronary artery disease, except for systemic hypertension, which differed among the groups. The unadjusted end points for EESs and PESs were death (4.5% vs 7.1%; p = 0.03), TLR (3.4% vs 4.6%; p = 0.24), target vessel revascularization (5.6% vs 7.1%; p = 0.46), death or Q-wave myocardial infarction (4.5% vs 7.4%; p = 0.02), and definite stent thrombosis (0.0% vs 0.7%; p = 0.09). The unadjusted end points for EES and SES were death (4.5% vs 5.2%; p = 0.45), TLR (3.4% vs 5.8%; p = 0.3), target vessel revascularization (5.6% vs 8.6%; p = 0.05), death or Q-wave myocardial infarction (4.5% vs 5.4%; p = 0.39), and definite stent thrombosis (0.0% vs 1.08%; p = 0.003). The rates of major adverse cardiac events were similar among the 3 groups. After multivariate analysis, the rate of death or Q-wave myocardial infarction between the EES and PES groups was no longer significant (hazard ratio 1.14, 95% confidence interval 0.59 to 2.20, p = 0.70). In conclusion, the results of the present study suggest the use of EES in routine clinical practice is both safe and effective but offers no clinically relevant advantage in terms of hard end points compared to PES or SES.
Cardiovascular Revascularization Medicine, 2015
We report the case of a large right renal arteriovenous fistula (AVF) in a 74-year old woman who ... more We report the case of a large right renal arteriovenous fistula (AVF) in a 74-year old woman who presented with heart failure. Transthoracic echocardiography revealed normal left ventricular size and systolic function (ejection fraction 60-65%), moderately dilated right ventricle with severely depressed systolic function, and severe pulmonary hypertension. Right heart catheterization confirmed the elevated pulmonary pressures and showed a high cardiac output. Physical examination was remarkable for a right flank bruit. An abdominal ultrasound revealed an AVF originating from the distal right renal artery and dilated suprarenal inferior vena cava and hepatic veins. These findings were confirmed with an abdominal MRI. Percutaneous endovascular closure of the right renal AVF was successfully performed, with immediate reduction of pulmonary pressures and normalization of cardiac output. The patient&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s symptoms improved, and a post intervention echocardiogram revealed normalization of right ventricular size.
Cardiovascular Revascularization Medicine, 2015
There is paucity of data regarding the clinical outcome of second generation drug- eluting stents... more There is paucity of data regarding the clinical outcome of second generation drug- eluting stents (DES) post rotational atherectomy (RA) for heavily calcified coronary lesions (HCCL). The study cohort comprised 99 (116 lesions) consecutive patients who underwent RA for HCCL at our institution and received either a first generation DES (40 patients, 53 lesions) or a second generation DES (59 patients, 63 lesions). The analyzed clinical parameters were the 12-month rates of death (all cause and cardiac), Q-wave MI, target lesion revascularization (TLR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, Q-wave MI, or TLR. The two groups were well matched for their baseline characteristics except for a lower left ventricular ejection fraction in the second generation DES group (46.0±23.0% vs. 55.0±9.0%; p=0.02). The group receiving second generation DES had more type C lesions (81.0% vs. 58.8%; p=0.01), shorter stent length (19.9±6.1 mm vs. 22.7±7.3 mm; p=0.04) and was more likely to undergo stent postdilatation (52.4% vs. 23.1%; p=0.001). The 1-year analyzed clinical parameters were similar in the two groups: all cause death (8.5% vs. 10.3%; p=1.0), cardiac death (8.5% vs. 2.5%; p=0.40), Q-wave MI (0% vs. 0%), TLR (3.6% vs. 2.7%; p=1.0), ST (0% vs. 0%), and MACE (11.9% vs. 12.8%; p=1.0). The 1-year MACE-free survival rate was also similar in the two cohorts. The use of second generation DES, following RA for HCCL, is associated with similar short and long-term clinical outcomes to first generation DES.
Circulation. Cardiovascular interventions, 2015
We appreciate the interest and comments from Drs De Rosa and Indolfi in regard to our article. 1 ... more We appreciate the interest and comments from Drs De Rosa and Indolfi in regard to our article. 1 As stated in our article, neoatherosclerosis, which leads to late neointima formation, is seen across all 3 generations of metallic stents. It is our impression that the neointima of second-generation drug-eluting stents (DES) is less vulnerable and, as a result, associated with fewer events when compared with first-generation DES. Although vessel caging is also common across the 3 generations of metal stents, it is only one component of the mechanism for restenosis. Neoatherosclerosis has been frequently implicated as the final pathway of late failure for both DES and bare-metal stents. 2 This widespread occurrence of neoatherosclerosis across stent generations may in fact explain the similarities in clinical presentation of in-stent restenosis and lead to the vulnerable stent. It remains to be seen whether neoatherosclerosis is independently associated with stent type and whether it carries an equal risk of vulnerability across stent generations.
background: Recent 30-day readmission risk models do not included African-Americans (AA), who are... more background: Recent 30-day readmission risk models do not included African-Americans (AA), who are at increased risk for adverse events following PCI, and thus increased risk for readmission. We evaluate the impact of AA race on 30-day readmission risk for adverse events.
Category: 43. TCT@ACC-i2: Complex Patients, Diabetes, Renal Insuficiency
Percutaneous coronary intervention (PCI) of complex lesions (i.e., American College of Cardiology... more Percutaneous coronary intervention (PCI) of complex lesions (i.e., American College of Cardiology/American Heart Association class type C) remains challenging and the outcome may be compromised. The use of intravascular ultrasound (IVUS) to guide PCI was suggested to improve outcome. A cohort of 1,984 patients who underwent PCI to type C lesions in our center from April 2000 to March 2010 was identified. Using propensity score matching with clinical and angiographic characteristics, we identified 637 patients who underwent IVUS guidance and 637 patients who had only angiographic guidance PCI. Major adverse cardiovascular events (MACE), a composite end-point of all-cause mortality, Q-wave myocardial infarction and target lesion revascularization, were compared between the 2 groups. After propensity score matching, baseline clinical and angiographic characteristics were well matched. Patients undergoing IVUS-guided PCI had less predilatation and more postdilatation, and were treated more often with cutting balloon. Final diameter stenosis was significantly smaller in the IVUS-guided group (3 ± 11% vs. 7 ± 19%, P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001), resulting in higher angiographic success compared with the non-IVUS-guided group (97.9% vs. 94.8%, P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). The incidence of MACE was significantly lower in the IVUS-guided group compared to the angiography-guided group (11.0% vs. 15.6%, P = 0.017) as was cardiac death (1.9% vs. 4.4%, P = 0.010). IVUS-guided PCI for complex type C lesions is associated with better outcome and should be considered for these lesions.
Cardiovascular Revascularization Medicine, 2015
The aim of this study was to compare the safety and efficacy of everolimus-eluting stent (EES), s... more The aim of this study was to compare the safety and efficacy of everolimus-eluting stent (EES), sirolimus-eluting stent (SES), and plain old balloon angioplasty (POBA) for the treatment of SES in-stent restenosis (S-ISR). The optimal treatment for drug-eluting in-stent restenosis remains controversial. The study cohort comprised 310 consecutive patients (444 lesions) who presented with S-ISR to our institution and underwent treatment with EES (43 patients), SES (102), or POBA (165). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac event (MACE) defined as the composite of death, MI, or TLR at 1-year. The three groups were well matched for the conventional risk factors for coronary artery disease except for smoking. The 1-year analyzed clinical parameters were similar in the three groups: MACE (EES=14%, SES=18%, POBA=20%; p=0.65), death (EES=2.3%, SES=6.2%, POBA=6.1%; p=0.61), MI (EES=4.8%, SES=2.1%, POBA=2.5%; p=0.69), TLR (EES=11.9%, SES=12.1%, POBA=24%; p=0.78), and TVR (EES=11.9%, SES=24.8%, POBA=22.2%; p=0.23). There were no cases of definite ST. MACE-free rate was significantly lower in patients with recurrent in-stent restenosis (log-rank p=0.006). Presentation with acute MI, number of treated lesions and a previous history of MI were found to be independent predictors of MACE. In patients presenting with S-ISR, treatment with implantation of an EES, SES, or POBA is associated with similar clinical outcomes. Patients presenting with recurrent ISR may have a poorer clinical outcome.
Cardiovascular revascularization medicine : including molecular interventions
To assess the safety and efficacy everolimus-eluting stents (EES) compared with first-generation ... more To assess the safety and efficacy everolimus-eluting stents (EES) compared with first-generation drug-eluting stents (DES) in patients with acute myocardial infarction (MI) undergoing primary percutaneous coronary intervention (PCI). EES have been associated with improved clinical outcomes compared to paclitaxel-eluting stents (PES) and with similar outcomes compared to sirolimus-eluting stents (SES). A total of 520 patients who presented with ST-elevation myocardial infarction (STEMI) from 2003 to 2013, who underwent primary PCI with DES, were retrospectively analyzed. Of these, 247 received SES, 136 PES, and 137 EES. Patients were followed up to 2 years for major adverse cardiac events (MACE). Univariate and multivariate models detected correlates to outcome. EES implantation, compared with PES and SES, resulted in comparable rates of MACE (8.8% vs. 16.2%, p=0.06 and 8.8% vs. 12.6%, respectively, p=0.26), stent thrombosis, MI, and target lesion revascularization. Patients who rece...
Cardiovascular Revascularization Medicine, 2014
This study aims to establish if transfer distance impacts the outcome of ST-elevation myocardial ... more This study aims to establish if transfer distance impacts the outcome of ST-elevation myocardial infarction (STEMI) patients transferred to a percutaneous coronary intervention (PCI). Regional emergency care systems were designed to decrease delays in reperfusion of patients but the effect of transfer distance on outcome is less established. We compare the characteristics and outcomes of STEMI patients transferred from a distance &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;25 miles (GT25) to those transferred from distances ≤25 miles (LT25) by utilizing data from a regional STEMI care network in the greater Washington DC area. Within the transferred patients (n=1065), 609 patients (57%) were transferred from GT25 (median distance 36 miles), while 456 (43%) were transferred from LT25 (median distance 13 miles). Most of the baseline characteristics between the groups were similar. Door-to-balloon (DTB) was defined as the time elapsed from the presentation to the center without PCI capability to flow restoration in the culprit artery. No differences were noted in the median DTB (GT25: 158min [122-213] vs. 149 [118-219]; p=0.5) or in in-hospital mortality (8% vs. 7.2%; p=0.617). By implementing the regional STEMI care network, a constant decrease in DTB was noted throughout its years of operation. For STEMI patients presenting to a non-PCI capable center, a network care system for PCI mitigates the distance factor on DTB time. This is turn translates into comparable outcomes.
Cardiovascular Revascularization Medicine, 2015
Objectives: This study aimed to analyze the use of everolimus-eluting stents (EES) and paclitaxel... more Objectives: This study aimed to analyze the use of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an unrestricted diabetic population and to compare the performance of these two drug-eluting stents. Background: EES have demonstrated superiority in efficacy when compared to PES in a general population. However, it is controversial whether this superiority holds true in a diabetic population. Methods: From March 2004 to May 2010, 968 patients with consecutive diabetes who underwent percutaneous coronary intervention and implantation of an EES (n 5 388) or PES (n 5 580) at our institution. In-hospital, 1-month, 6-month, and 1-year clinical outcomes were analyzed and compared. Correlates of major adverse cardiac events (MACE) were identified. Results: Baseline clinical characteristics were similar between stent types except for more family history of coronary artery disease in the PES group and more insulin-dependent diabetes and unstable angina at initial diagnosis in the EES group. The PES group had higher number of lesions treated, longer stents used, and a higher proportion of intravascular ultrasound and glycoprotein IIb/IIIa inhibitor use. The EES group had more type C and distal lesions. There was higher target lesion revascularization (TLR)-MACE in the PES group (3.3% vs. 1.0%, P 5 0.03) as well as a higher rate of stent thrombosis (ST) (8 patients vs. 0 in the EES group, P 5 0.03). ST continued to be higher in the PES group at 6 and 12 months and mortality was higher at 12 months in the PES group (9.4% vs. 5.2%, P 5 0.02). After adjustment, no significant differences were found between stent types on Cox regression analysis for hazard ratios at 1-year follow-up of TLR-MACE. Conclusions: In a diabetic population undergoing PCI, the use of an EES compared to PES was associated with lower rates of stent thrombosis; but after adjustment the composite TLR-MACE at 1 year was similar between both stents. V C 2012 Wiley Periodicals, Inc.
Circulation: Cardiovascular Interventions, 2014
Background-Clinical presentation of bare metal stent in-stent restenosis (ISR) in patients underg... more Background-Clinical presentation of bare metal stent in-stent restenosis (ISR) in patients undergoing target lesion revascularization is well characterized and negatively affects on outcomes, whereas the presentation and outcomes of first-and second-generation drug-eluting stents (DESs) remains under-reported. Methods and Results-The study included 909 patients (1077 ISR lesions) distributed as follows: bare metal stent (n=388), first-generation DES (n=425), and second-generation DES (n=96), categorized into acute coronary syndrome (ACS) or non-ACS presentation mode at the time of first target lesion revascularization. ACS was further classified as myocardial infarction and unstable angina. For bare metal stent, first-generation DES and second-generation DES, ACS was the clinical presentation in 67.8%, 71.0%, and 66.7% of patients, respectively (P=0.470), whereas MI occurred in 10.6%, 10.1%, and 5.2% of patients, respectively (P=0.273). The correlates for MI as ISR presentation were current smokers (odds ratio, 3.02; 95% confidence interval [CI], 1.78-5.13; P<0.001), and chronic renal failure (odds ratio, 2.73; 95% CI, 1.60-4.70; P<0.001), with a protective trend for the second-generation DES ISR (odds ratio, 0.35; 95% CI, 0.12-1.03; P=0.060). ACS presentations had an independent effect on major adverse cardiac events (death, MI, and re-target lesion revascularization) at 6 months (MI versus non-ACS: adjusted hazard ratio, 4.06; 95% CI, 1.84-8.94; P<0.001; unstable angina versus non-ACS: adjusted hazard ratio, 1.98; 95% CI, 1.01-3.87; P=0.046). Conclusions-ISR clinical presentation is similar irrespective of stent type. MI as ISR presentation seems to be associated with patient and not device-related factors. ACS as ISR presentation has an independent effect on major adverse cardiac events, suggesting that ISR remains a hazard and should be minimized. (Circ Cardiovasc Interv. 2014;7:768-776.)
Cardiovascular Revascularization Medicine, 2014
Given controversy over anticoagulation regimens for percutaneous coronary intervention (PCI), we ... more Given controversy over anticoagulation regimens for percutaneous coronary intervention (PCI), we performed an updated meta-analysis of randomized controlled trials (RCTs) to compare bivalirudin versus heparin. Medline/Pubmed and Cochrane CENTRAL were searched for all RCTs comparing bivalirudin with provisional glycoprotein IIb/IIIa inhibitor (GPI) use versus heparin with provisional or routine GPI use for PCI. Pooled estimates of 30day outcomes, presented as risk ratios (RR) [95% confidence intervals], were generated with random-effect models. Our analysis included 14 studies with 30,446 patients that were randomized to bivalirudin with provisional GPI use (n=14,869) versus heparin with provisional (n=6451) or routine GPI use (n=9126). There was no significant difference between anticoagulation with bivalirudin compared with heparin for death (RR 0.95 [0.78-1.14]) or myocardial infarction (RR 1.10 [0.97-1.25]). Early stent thrombosis was significantly greater with bivalirudin compared with heparin (RR 1.61 [1.18-2.20], p=0.003), especially in patients undergoing primary PCI (2.15 [1.15-4.03], p=0.02). However, bivalirudin reduced the risk of major bleeding (RR 0.59 [0.51-0.70], p&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;0.0001) and TIMI major bleeding (RR 0.59 [0.48-0.72], p&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;0.0001) compared with heparin. Meta-regression analysis demonstrated that bleeding risk with use of heparin significantly increases with increasing GPI use (p=0.02). Meta-analysis of 14 RCTs with 30,446 patients demonstrated that bivalirudin is associated with higher risk of stent thrombosis but lower risk of major bleeding compared with heparin.
JACC: Cardiovascular Interventions, 2014
Ischemic cardiomyopathy with depressed left ventricular ejection fraction (LVEF) is predictive of... more Ischemic cardiomyopathy with depressed left ventricular ejection fraction (LVEF) is predictive of death after percutaneous coronary intervention (PCI), but its association with stent thrombosis (ST) and the need for repeat revascularization is less clearly defined. In total 5,377 patients undergoing PCI were retrospectively evaluated. Multivariable Cox proportional hazards regression and competitive outcome analysis were employed. The primary end point was 1-year major adverse cardiac events (all-cause death, Q-wave myocardial infarction, ST, and target lesion revascularization [TLR]). Individual end points of ST and of TLR were also evaluated. Patients with normal LVEF (>50%) were compared to those with mild (41% to 50%), moderate (25% to 40%), and severe (<25%) decreases in LVEF. Patients with abnormal LVEF were older and more commonly diabetic and had renal insufficiency and heart failure syndrome (p <0.001 for all variables). These patients demonstrated more angiographically complex lesions and less frequently received a drug-eluting stent. The primary end point was significantly increased in patients with lower LVEF (9.7% for normal LVEF vs 20.6% for severely decreased LVEF, p <0.001). ST occurred more frequently in these patients (1.4% for normal LVEF vs 6% for severely decreased LVEF, p <0.001), but clinically driven TLR did not significantly change across LVEF categories. After adjustment, only moderate and severe LVEF decreases (i.e., LVEF <40%) demonstrated an association with major adverse cardiac events and with the individual outcome of ST. Subgroup analysis of patients receiving only a drug-eluting stent or a bare-metal stent demonstrated no statistically significant differences for the probability of ST. In conclusion, decreased LVEF is not associated with clinically driven TLR but does increase the risk of ST. Patients with LVEF <40% appear to be at significantly higher risk for ST and therefore might benefit from interventional and pharmacologic strategies aimed at minimizing this risk.
The Registry Experience at the Washington Hospital Center with Drug-Eluting Stents (REWARDS) stud... more The Registry Experience at the Washington Hospital Center with Drug-Eluting Stents (REWARDS) study includes unselected patients with coronary artery disease treated with sirolimus-eluting stents (SESs; n = 2,392) or paclitaxel-eluting stents (PES; n = 1,119). This study aimed to examine the long-term safety profile of the 2 stents in a &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;real-world&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; population, especially in relation to stent thrombosis, and to compare differences in the diabetic cohort. Patients were followed for 3 years with regard to major adverse cardiac events (MACEs), including death, Q-wave myocardial infarction, and target lesion revascularization. Rates of stent thrombosis were also studied. Baseline characteristics were similar between stents. Although MACE rates at 3 years were similar (SES 28.1% vs PES 28.9%, p = 0.62), there was a significant difference in unadjusted rates of target lesion revascularization (SES 15.6% vs PES 12.6%, p = 0.03), death (SES 15.7% vs PES 19.0%, p = 0.02), and Q-wave myocardial infarction (SES 0.8% vs PES 2.1%, p = 0.003). After multivariable Cox regression to adjust for confounders, there was no significant difference in overall MACEs. Incidence of stent thrombosis was higher in the SES group (SES 2.2% vs PES 1.6%, p = 0.22), but this was not statistically significant (hazard ratio 1.6, 95% confidence interval 0.8 to 2.9, p = 0.17). Overall, diabetics had a higher MACE rate, but there was no difference between insulin- and noninsulin-dependent diabetics. In conclusion, at 3 years, PES and SES achieved similar results in MACEs and stent thrombosis. This should foster confidence that SES or PES can be compared to second-generation drug-eluting stents without concerns for safety or efficacy.
The American Journal of Cardiology, 2011
Compared to paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs), a paucity of da... more Compared to paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs), a paucity of data exists regarding the clinical outcome of everolimus-eluting stents (EESs) in unselected patients with the entire spectrum of obstructive coronary artery disease. The present study cohort included 6,615 consecutive patients at Washington Hospital Center who underwent coronary artery stent implantation with EESs (n = 519), PESs (n = 2,036), or SESs (n = 4,060). Patients who received bare metal stents, zotarolimus-eluting stents, or 2 different drug-eluting stent types were excluded. The analyzed clinical end points were death, death or Q-wave myocardial infarction, target lesion revascularization (TLR), target vessel revascularization, definite stent thrombosis, and major adverse cardiac events, defined as the composite of death, Q-wave myocardial infarction, or TLR at 1 year. The groups were well matched for the conventional risk factors for coronary artery disease, except for systemic hypertension, which differed among the groups. The unadjusted end points for EESs and PESs were death (4.5% vs 7.1%; p = 0.03), TLR (3.4% vs 4.6%; p = 0.24), target vessel revascularization (5.6% vs 7.1%; p = 0.46), death or Q-wave myocardial infarction (4.5% vs 7.4%; p = 0.02), and definite stent thrombosis (0.0% vs 0.7%; p = 0.09). The unadjusted end points for EES and SES were death (4.5% vs 5.2%; p = 0.45), TLR (3.4% vs 5.8%; p = 0.3), target vessel revascularization (5.6% vs 8.6%; p = 0.05), death or Q-wave myocardial infarction (4.5% vs 5.4%; p = 0.39), and definite stent thrombosis (0.0% vs 1.08%; p = 0.003). The rates of major adverse cardiac events were similar among the 3 groups. After multivariate analysis, the rate of death or Q-wave myocardial infarction between the EES and PES groups was no longer significant (hazard ratio 1.14, 95% confidence interval 0.59 to 2.20, p = 0.70). In conclusion, the results of the present study suggest the use of EES in routine clinical practice is both safe and effective but offers no clinically relevant advantage in terms of hard end points compared to PES or SES.
Cardiovascular Revascularization Medicine, 2015
We report the case of a large right renal arteriovenous fistula (AVF) in a 74-year old woman who ... more We report the case of a large right renal arteriovenous fistula (AVF) in a 74-year old woman who presented with heart failure. Transthoracic echocardiography revealed normal left ventricular size and systolic function (ejection fraction 60-65%), moderately dilated right ventricle with severely depressed systolic function, and severe pulmonary hypertension. Right heart catheterization confirmed the elevated pulmonary pressures and showed a high cardiac output. Physical examination was remarkable for a right flank bruit. An abdominal ultrasound revealed an AVF originating from the distal right renal artery and dilated suprarenal inferior vena cava and hepatic veins. These findings were confirmed with an abdominal MRI. Percutaneous endovascular closure of the right renal AVF was successfully performed, with immediate reduction of pulmonary pressures and normalization of cardiac output. The patient&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s symptoms improved, and a post intervention echocardiogram revealed normalization of right ventricular size.
Cardiovascular Revascularization Medicine, 2015
There is paucity of data regarding the clinical outcome of second generation drug- eluting stents... more There is paucity of data regarding the clinical outcome of second generation drug- eluting stents (DES) post rotational atherectomy (RA) for heavily calcified coronary lesions (HCCL). The study cohort comprised 99 (116 lesions) consecutive patients who underwent RA for HCCL at our institution and received either a first generation DES (40 patients, 53 lesions) or a second generation DES (59 patients, 63 lesions). The analyzed clinical parameters were the 12-month rates of death (all cause and cardiac), Q-wave MI, target lesion revascularization (TLR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, Q-wave MI, or TLR. The two groups were well matched for their baseline characteristics except for a lower left ventricular ejection fraction in the second generation DES group (46.0±23.0% vs. 55.0±9.0%; p=0.02). The group receiving second generation DES had more type C lesions (81.0% vs. 58.8%; p=0.01), shorter stent length (19.9±6.1 mm vs. 22.7±7.3 mm; p=0.04) and was more likely to undergo stent postdilatation (52.4% vs. 23.1%; p=0.001). The 1-year analyzed clinical parameters were similar in the two groups: all cause death (8.5% vs. 10.3%; p=1.0), cardiac death (8.5% vs. 2.5%; p=0.40), Q-wave MI (0% vs. 0%), TLR (3.6% vs. 2.7%; p=1.0), ST (0% vs. 0%), and MACE (11.9% vs. 12.8%; p=1.0). The 1-year MACE-free survival rate was also similar in the two cohorts. The use of second generation DES, following RA for HCCL, is associated with similar short and long-term clinical outcomes to first generation DES.
Circulation. Cardiovascular interventions, 2015
We appreciate the interest and comments from Drs De Rosa and Indolfi in regard to our article. 1 ... more We appreciate the interest and comments from Drs De Rosa and Indolfi in regard to our article. 1 As stated in our article, neoatherosclerosis, which leads to late neointima formation, is seen across all 3 generations of metallic stents. It is our impression that the neointima of second-generation drug-eluting stents (DES) is less vulnerable and, as a result, associated with fewer events when compared with first-generation DES. Although vessel caging is also common across the 3 generations of metal stents, it is only one component of the mechanism for restenosis. Neoatherosclerosis has been frequently implicated as the final pathway of late failure for both DES and bare-metal stents. 2 This widespread occurrence of neoatherosclerosis across stent generations may in fact explain the similarities in clinical presentation of in-stent restenosis and lead to the vulnerable stent. It remains to be seen whether neoatherosclerosis is independently associated with stent type and whether it carries an equal risk of vulnerability across stent generations.
background: Recent 30-day readmission risk models do not included African-Americans (AA), who are... more background: Recent 30-day readmission risk models do not included African-Americans (AA), who are at increased risk for adverse events following PCI, and thus increased risk for readmission. We evaluate the impact of AA race on 30-day readmission risk for adverse events.
Category: 43. TCT@ACC-i2: Complex Patients, Diabetes, Renal Insuficiency
Percutaneous coronary intervention (PCI) of complex lesions (i.e., American College of Cardiology... more Percutaneous coronary intervention (PCI) of complex lesions (i.e., American College of Cardiology/American Heart Association class type C) remains challenging and the outcome may be compromised. The use of intravascular ultrasound (IVUS) to guide PCI was suggested to improve outcome. A cohort of 1,984 patients who underwent PCI to type C lesions in our center from April 2000 to March 2010 was identified. Using propensity score matching with clinical and angiographic characteristics, we identified 637 patients who underwent IVUS guidance and 637 patients who had only angiographic guidance PCI. Major adverse cardiovascular events (MACE), a composite end-point of all-cause mortality, Q-wave myocardial infarction and target lesion revascularization, were compared between the 2 groups. After propensity score matching, baseline clinical and angiographic characteristics were well matched. Patients undergoing IVUS-guided PCI had less predilatation and more postdilatation, and were treated more often with cutting balloon. Final diameter stenosis was significantly smaller in the IVUS-guided group (3 ± 11% vs. 7 ± 19%, P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001), resulting in higher angiographic success compared with the non-IVUS-guided group (97.9% vs. 94.8%, P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). The incidence of MACE was significantly lower in the IVUS-guided group compared to the angiography-guided group (11.0% vs. 15.6%, P = 0.017) as was cardiac death (1.9% vs. 4.4%, P = 0.010). IVUS-guided PCI for complex type C lesions is associated with better outcome and should be considered for these lesions.
Cardiovascular Revascularization Medicine, 2015
The aim of this study was to compare the safety and efficacy of everolimus-eluting stent (EES), s... more The aim of this study was to compare the safety and efficacy of everolimus-eluting stent (EES), sirolimus-eluting stent (SES), and plain old balloon angioplasty (POBA) for the treatment of SES in-stent restenosis (S-ISR). The optimal treatment for drug-eluting in-stent restenosis remains controversial. The study cohort comprised 310 consecutive patients (444 lesions) who presented with S-ISR to our institution and underwent treatment with EES (43 patients), SES (102), or POBA (165). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac event (MACE) defined as the composite of death, MI, or TLR at 1-year. The three groups were well matched for the conventional risk factors for coronary artery disease except for smoking. The 1-year analyzed clinical parameters were similar in the three groups: MACE (EES=14%, SES=18%, POBA=20%; p=0.65), death (EES=2.3%, SES=6.2%, POBA=6.1%; p=0.61), MI (EES=4.8%, SES=2.1%, POBA=2.5%; p=0.69), TLR (EES=11.9%, SES=12.1%, POBA=24%; p=0.78), and TVR (EES=11.9%, SES=24.8%, POBA=22.2%; p=0.23). There were no cases of definite ST. MACE-free rate was significantly lower in patients with recurrent in-stent restenosis (log-rank p=0.006). Presentation with acute MI, number of treated lesions and a previous history of MI were found to be independent predictors of MACE. In patients presenting with S-ISR, treatment with implantation of an EES, SES, or POBA is associated with similar clinical outcomes. Patients presenting with recurrent ISR may have a poorer clinical outcome.
Cardiovascular revascularization medicine : including molecular interventions
To assess the safety and efficacy everolimus-eluting stents (EES) compared with first-generation ... more To assess the safety and efficacy everolimus-eluting stents (EES) compared with first-generation drug-eluting stents (DES) in patients with acute myocardial infarction (MI) undergoing primary percutaneous coronary intervention (PCI). EES have been associated with improved clinical outcomes compared to paclitaxel-eluting stents (PES) and with similar outcomes compared to sirolimus-eluting stents (SES). A total of 520 patients who presented with ST-elevation myocardial infarction (STEMI) from 2003 to 2013, who underwent primary PCI with DES, were retrospectively analyzed. Of these, 247 received SES, 136 PES, and 137 EES. Patients were followed up to 2 years for major adverse cardiac events (MACE). Univariate and multivariate models detected correlates to outcome. EES implantation, compared with PES and SES, resulted in comparable rates of MACE (8.8% vs. 16.2%, p=0.06 and 8.8% vs. 12.6%, respectively, p=0.26), stent thrombosis, MI, and target lesion revascularization. Patients who rece...
Cardiovascular Revascularization Medicine, 2014
This study aims to establish if transfer distance impacts the outcome of ST-elevation myocardial ... more This study aims to establish if transfer distance impacts the outcome of ST-elevation myocardial infarction (STEMI) patients transferred to a percutaneous coronary intervention (PCI). Regional emergency care systems were designed to decrease delays in reperfusion of patients but the effect of transfer distance on outcome is less established. We compare the characteristics and outcomes of STEMI patients transferred from a distance &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;25 miles (GT25) to those transferred from distances ≤25 miles (LT25) by utilizing data from a regional STEMI care network in the greater Washington DC area. Within the transferred patients (n=1065), 609 patients (57%) were transferred from GT25 (median distance 36 miles), while 456 (43%) were transferred from LT25 (median distance 13 miles). Most of the baseline characteristics between the groups were similar. Door-to-balloon (DTB) was defined as the time elapsed from the presentation to the center without PCI capability to flow restoration in the culprit artery. No differences were noted in the median DTB (GT25: 158min [122-213] vs. 149 [118-219]; p=0.5) or in in-hospital mortality (8% vs. 7.2%; p=0.617). By implementing the regional STEMI care network, a constant decrease in DTB was noted throughout its years of operation. For STEMI patients presenting to a non-PCI capable center, a network care system for PCI mitigates the distance factor on DTB time. This is turn translates into comparable outcomes.
Cardiovascular Revascularization Medicine, 2015
Objectives: This study aimed to analyze the use of everolimus-eluting stents (EES) and paclitaxel... more Objectives: This study aimed to analyze the use of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an unrestricted diabetic population and to compare the performance of these two drug-eluting stents. Background: EES have demonstrated superiority in efficacy when compared to PES in a general population. However, it is controversial whether this superiority holds true in a diabetic population. Methods: From March 2004 to May 2010, 968 patients with consecutive diabetes who underwent percutaneous coronary intervention and implantation of an EES (n 5 388) or PES (n 5 580) at our institution. In-hospital, 1-month, 6-month, and 1-year clinical outcomes were analyzed and compared. Correlates of major adverse cardiac events (MACE) were identified. Results: Baseline clinical characteristics were similar between stent types except for more family history of coronary artery disease in the PES group and more insulin-dependent diabetes and unstable angina at initial diagnosis in the EES group. The PES group had higher number of lesions treated, longer stents used, and a higher proportion of intravascular ultrasound and glycoprotein IIb/IIIa inhibitor use. The EES group had more type C and distal lesions. There was higher target lesion revascularization (TLR)-MACE in the PES group (3.3% vs. 1.0%, P 5 0.03) as well as a higher rate of stent thrombosis (ST) (8 patients vs. 0 in the EES group, P 5 0.03). ST continued to be higher in the PES group at 6 and 12 months and mortality was higher at 12 months in the PES group (9.4% vs. 5.2%, P 5 0.02). After adjustment, no significant differences were found between stent types on Cox regression analysis for hazard ratios at 1-year follow-up of TLR-MACE. Conclusions: In a diabetic population undergoing PCI, the use of an EES compared to PES was associated with lower rates of stent thrombosis; but after adjustment the composite TLR-MACE at 1 year was similar between both stents. V C 2012 Wiley Periodicals, Inc.
Circulation: Cardiovascular Interventions, 2014
Background-Clinical presentation of bare metal stent in-stent restenosis (ISR) in patients underg... more Background-Clinical presentation of bare metal stent in-stent restenosis (ISR) in patients undergoing target lesion revascularization is well characterized and negatively affects on outcomes, whereas the presentation and outcomes of first-and second-generation drug-eluting stents (DESs) remains under-reported. Methods and Results-The study included 909 patients (1077 ISR lesions) distributed as follows: bare metal stent (n=388), first-generation DES (n=425), and second-generation DES (n=96), categorized into acute coronary syndrome (ACS) or non-ACS presentation mode at the time of first target lesion revascularization. ACS was further classified as myocardial infarction and unstable angina. For bare metal stent, first-generation DES and second-generation DES, ACS was the clinical presentation in 67.8%, 71.0%, and 66.7% of patients, respectively (P=0.470), whereas MI occurred in 10.6%, 10.1%, and 5.2% of patients, respectively (P=0.273). The correlates for MI as ISR presentation were current smokers (odds ratio, 3.02; 95% confidence interval [CI], 1.78-5.13; P<0.001), and chronic renal failure (odds ratio, 2.73; 95% CI, 1.60-4.70; P<0.001), with a protective trend for the second-generation DES ISR (odds ratio, 0.35; 95% CI, 0.12-1.03; P=0.060). ACS presentations had an independent effect on major adverse cardiac events (death, MI, and re-target lesion revascularization) at 6 months (MI versus non-ACS: adjusted hazard ratio, 4.06; 95% CI, 1.84-8.94; P<0.001; unstable angina versus non-ACS: adjusted hazard ratio, 1.98; 95% CI, 1.01-3.87; P=0.046). Conclusions-ISR clinical presentation is similar irrespective of stent type. MI as ISR presentation seems to be associated with patient and not device-related factors. ACS as ISR presentation has an independent effect on major adverse cardiac events, suggesting that ISR remains a hazard and should be minimized. (Circ Cardiovasc Interv. 2014;7:768-776.)
Cardiovascular Revascularization Medicine, 2014
Given controversy over anticoagulation regimens for percutaneous coronary intervention (PCI), we ... more Given controversy over anticoagulation regimens for percutaneous coronary intervention (PCI), we performed an updated meta-analysis of randomized controlled trials (RCTs) to compare bivalirudin versus heparin. Medline/Pubmed and Cochrane CENTRAL were searched for all RCTs comparing bivalirudin with provisional glycoprotein IIb/IIIa inhibitor (GPI) use versus heparin with provisional or routine GPI use for PCI. Pooled estimates of 30day outcomes, presented as risk ratios (RR) [95% confidence intervals], were generated with random-effect models. Our analysis included 14 studies with 30,446 patients that were randomized to bivalirudin with provisional GPI use (n=14,869) versus heparin with provisional (n=6451) or routine GPI use (n=9126). There was no significant difference between anticoagulation with bivalirudin compared with heparin for death (RR 0.95 [0.78-1.14]) or myocardial infarction (RR 1.10 [0.97-1.25]). Early stent thrombosis was significantly greater with bivalirudin compared with heparin (RR 1.61 [1.18-2.20], p=0.003), especially in patients undergoing primary PCI (2.15 [1.15-4.03], p=0.02). However, bivalirudin reduced the risk of major bleeding (RR 0.59 [0.51-0.70], p&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;0.0001) and TIMI major bleeding (RR 0.59 [0.48-0.72], p&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;0.0001) compared with heparin. Meta-regression analysis demonstrated that bleeding risk with use of heparin significantly increases with increasing GPI use (p=0.02). Meta-analysis of 14 RCTs with 30,446 patients demonstrated that bivalirudin is associated with higher risk of stent thrombosis but lower risk of major bleeding compared with heparin.