Dual antiplatelet therapy reduces stroke but increases bleeding at the time of carotid endarterectomy

Journal Journal of Vascular Surgery
Jones DW, Goodney PP, Conrad MF, Nolan BW, Rzucidlo EM, Powell RJ, Cronenwett JL, Stone DH
Year Published 2016
Link to publication



Controversy persists regarding the perioperative management of clopidogrel among patients undergoing carotid endarterectomy (CEA). This study examined the effect of preoperative dual antiplatelet therapy (aspirin and clopidogrel) on in-hospital CEA outcomes.


Patients undergoing CEA in the Vascular Quality Initiative were analyzed (2003-2014). Patients on clopidogrel and aspirin (dual therapy) were compared with patients taking aspirin alone preoperatively. Study outcomes included reoperation for bleeding and thrombotic complications defined as transient ischemic attack (TIA), stroke, or myocardial infarction. Secondary outcomes were in-hospital death and composite stroke/death. Univariate and multivariable analyses assessed differences in demographics and operative factors. Propensity score-matched cohorts were derived to control for subgroup heterogeneity.


Of 28,683 CEAs, 21,624 patients (75%) were on aspirin and 7059 (25%) were on dual therapy. Patients on dual therapy were more likely to have multiple comorbidities, including coronary artery disease (P < .001), congestive heart failure (P < .001), and diabetes (P < .001). Patients on dual therapy were also more likely to have a drain placed (P < .001) and receive protamine during CEA (P < .001). Multivariable analysis showed that dual therapy was independently associated with increased reoperation for bleeding (odds ratio [OR], 1.71; 95% confidence interval [CI], 1.20-2.42; P = .003) but was protective against TIA or stroke (OR, 0.61; 95% CI, 0.43-0.87; P = .007), stroke (OR, 0.63; 95% CI, 0.41-0.97; P = .03), and stroke/death (OR, 0.66; 95% CI, 0.44-0.98; P = .04). Propensity score matching yielded two groups of 4548 patients and showed that patients on dual therapy were more likely to require reoperation for bleeding (1.3% vs 0.7%; P = .004) but less likely to suffer TIA or stroke (0.9% vs 1.6%; P = .002), stroke (0.6% vs 1.0%; P = .04), or stroke/death (0.7% vs 1.2%; P = .03). Within the propensity score-matched groups, patients on dual therapy had increased rates of reoperation for bleeding regardless of carotid symptom status. However, asymptomatic patients on dual therapy demonstrated reduced rates of TIA or stroke (0.6% vs 1.5%; P < .001), stroke (0.4% vs 0.9%; P = .01), and composite stroke/death (0.5% vs 1.0%; P = .02). Among propensity score-matched patients with symptomatic carotid disease, these differences were not statistically significant.


Preoperative dual antiplatelet therapy was associated with a 40% risk reduction for neurologic events but also incurred a significant increased risk of reoperation for bleeding after CEA. Given its observed overall neurologic protective effect, continued dual antiplatelet therapy throughout the perioperative period is justified. Initiating dual therapy in all patients undergoing CEA may lead to decreased neurologic complication rates.

Sex-Based Assessment of Patient Presentation, Lesion Characteristics, and Treatment Modalities in Patients Undergoing Peripheral Vascular Intervention

Journal Circulation: Cardiovascular Interventions
Ramkumar N, Suckow BD, Brown JR, Sedrakyan A, Cronenwett JL, Goodney PP
Year Published 2018
Link to publication



Limited evidence suggests that women and men might be treated differently for peripheral arterial disease.
This analysis evaluated sex-based differences in disease presentation and its effect on treatment modality among patients
who underwent endovascular treatment for peripheral arterial disease.


Using national registry data from the Vascular Quality Initiative between 2010 and 2013, we
examined patient, limb, and artery characteristics by sex through descriptive statistics. We studied 26750 procedures
performed in 23820 patients to treat 30545 limbs and 44804 arteries. Women presented at an older age (69 versus 67
years; P<0.001) and were less often current or former smokers (72% versus 85%; P<0.001). Transatlantic Inter-Society
Consensus classification was similar among men and women (Transatlantic Inter-Society Consensus C or D: 37% in men
versus 37% in women; P=0.81), as was mean occlusion length (4.5 cm in men versus 4.6 cm in women; P=0.04), even
after accounting for lesion location. Women more frequently underwent treatment for rest pain (11% in men versus 16%
in women; P<0.001) versus claudication (59% in men versus 53% in women; P<0.001) or tissue loss (28% in men versus
27% in women; P=0.75). Treatment modality did not differ by sex but was associated with disease severity (P for trend
<0.001) and lesion location (P for trend <0.001).


Women undergo peripheral endovascular intervention for peripheral arterial disease at an older age with
critical limb ischemia. Treatment modalities do not vary by sex but are determined by disease severity and site. Although
there exist sex differences in presentation, these differences do not lead to differential treatment for women with peripheral
arterial disease.

Long-Term Clinical Outcomes of Silzone Era St. Jude Medical Mechanical Heart Valves

Journal Journal of Heart Valve Disease
Authors Brennan JM, Zhao Y, Williams J, O’Brien S, Dokholyan R, Gammie J, Edwards F, Loyo-Berrios N, Canos D, Gross T, Marinac-Dabic D, Peterson E.
Year Published 2015
Link to publication



Since the voluntary recall of St. Jude Medical (SJM) Silzone impregnated heart valves, no large-scale study has examined their long-term outcomes.


Using Medicare-linked records from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (1993-2004), the clinical outcomes were evaluated through eight years among those patients who received SJM mechanical heart valves during the Silzone era (March 1998 to December 1999; n = 3,775), relative to those in both the pre-Silzone era (January 1993 to February 1998; n = 13,570) and the post-Silzone era (January 2000 to December 2004; n = 6,882). An inverse probability weighting was used to balance the observed differences in case mix.


During the Silzone era, 79% of all implanted mechanical heart valves were manufactured by SJM. By eight years post-implantation, the most common adverse events in this Medicare-linked cohort (median age 71 years) were death (43.5%) and thromboembolism (14.7%), while valve reoperation (1.7%) and endocarditis (1.4%) were less common. Patients treated during the Silzone era experienced a lower associated risk of mortality to eight years than those in both the pre-Silzone era (adjusted hazards ratio (HR) 0.93, 95% confidence interval (CI) 0.88-0.98) and post-Silzone era (adjusted HR 0.92, CI 0.67-0.98), while the adjusted eight-year risks of reoperation, thromboembolism and endocarditis were similar across the three eras for the overall cohort and among both aortic valve and mitral valve patients.


Medicare patients who received SJM mechanical heart valves during the Silzone era experienced similar clinical outcomes as those treated before or after the Silzone era. These data do not substantiate continued public health concerns associated with Silzone era valve prostheses among older individuals.

Hospice use following implantable cardioverter-defibrillator implantation in older patients: results from the National Cardiovascular Data Registry

Journal Circulation
Authors Kramer D, Reynolds M, Normand S-L, Parzynski C, Spertus J, Mor V, Mitchell S.
Year Published 2016
Link to publication



Older recipients of implantable cardioverter-defibrillators (ICDs) are at increased risk for short-term mortality in comparison with younger patients. Although hospice use is common among decedents aged >65, its use among older ICD recipients is unknown.

Methods and Results—

Medicare patients aged >65 matched to data in the National Cardiovascular Data Registry – ICD Registry from January 1, 2006 to March 31, 2010 were eligible for analysis (N=194 969). The proportion of ICD recipients enrolled in hospice, cumulative incidence of hospice admission, and factors associated with time to hospice enrollment were evaluated. Five years after device implantation, 50.9% of patients were either deceased or in hospice. Among decedents, 36.8% received hospice services. The cumulative incidence of hospice enrollment, accounting for the competing risk of death, was 4.7% (95% confidence interval [CI], 4.6%–4.8%) within 1 year and 21.3% (95% CI, 20.7%–21.8%) at 5 years. Factors most strongly associated with shorter time to hospice enrollment were older age (adjusted hazard ratio, 1.77; 95% CI, 1.73–1.81), class IV heart failure (versus class I; adjusted hazard ratio, 1.79; 95% CI, 1.66–1.94); ejection fraction <20 (adjusted hazard ratio, 1.57; 95% CI, 1.48–1.67), and greater hospice use among decedents in the patients’ health referral region.


More than one-third of older patients dying with ICDs receive hospice care. Five years after implantation, half of older ICD recipients are either dead or in hospice. Hospice providers should be prepared for ICD patients, whose clinical trajectories and broader palliative care needs require greater focus.

Geographic and temporal variation in implanted electric devices to treat heart failure

Journal Journal of the American Heart Association
Authors L.A. Hatfield, D. B. Kramer, M. Volya, M. Reynolds, and S-L. T. Normand
Year Published 2016
Link to publication



Cardiac implantable electric devices are commonly used to treat heart failure. Little is known about temporal and geographic variation in use of cardiac resynchronization therapy (CRT) devices in usual care settings.

Methods and Results

We identified new CRT with pacemaker (CRT‐P) or defibrillator generators (CRT‐D) implanted between 2008 and 2013 in the United States from a commercial claims database. For each implant, we characterized prior medication use, comorbidities, and geography. Among 17 780 patients with CRT devices (median age 69, 31% women), CRT‐Ps were a small and increasing share of CRT devices, growing from 12% to 20% in this study period. Compared to CRT‐D recipients, CRT‐P recipients were older (median age 76 versus 67), and more likely to be female (40% versus 30%). Pre‐implant use of β‐blockers and angiotensin‐converting enzyme inhibitors or angiotensin II receptor blockers was low in both CRT‐D (46%) and CRT‐P (31%) patients. The fraction of CRT‐P devices among all new implants varied widely across states. Compared to the increasing national trend, the share of CRT‐P implants was relatively increasing in Kansas and relatively decreasing in Minnesota and Oregon.


In this large, contemporary heart failure population, CRT‐D use dwarfed CRT‐P, though the latter nearly doubled over 6 years. Practice patterns vary substantially across states and over time. Medical therapy appears suboptimal in real‐world practice.