Assisted care as a baseline patient risk characteristic affecting the outcome of transcatheter aortic valve insertion.

BACKGROUND: Objective measures of frailty have not been well defined as risk factors for a poor outcome after transcatheter aortic valve insertion. We hypothesized that assisted care as a baseline patient characteristic was a simple objective measure of frailty. We reviewed our experience to assess for an association between assisted care and outcome of operation. METHODS: We retrospectively reviewed the records of 597 patients operated with transcatheter aortic valve insertion from November 2008 through July 2015. The study cohort included patients with a dichotomous baseline characteristic of receiving assisted care (AC group, n = 60, 10.1%) or not receiving assisted care (NC group, n = 537, 89.9%). The endpoints of the study were operative stroke/death and 1-year survival. RESULTS: The age of the patients was 80.6 ± 9.0 years, male sex was present in 349 (58.5%), and STS predicted risk of mortality was 9.2 ± 6.2%. Alternate access was used in 26 (43.3%) patients in the AC care group and in 220 (41.0%) in the NC group (P = 0.724). Operative stroke/death occurred in 4 (6.7%) patients in the AC group and in 25 (4.7%) in the NC group (P = 0.492). Mortality at 1 year in the AC group was 14.8 ± 5.2% and in the NC group was 12.9 ± 1.7%; (P = 0. 250). CONCLUSIONS: Assisted care as a baseline patient characteristic does not result in increased operative stroke/death or 1-year mortality in patients following transcatheter aortic valve insertion. Assisted care should not by itself preclude operation. © 2016 Wiley Periodicals, Inc.

Co-registration of angiography and intravascular ultrasound images through image-based device tracking.

OBJECTIVES: To determine the feasibility of automated co-registration of angiography and intravascular ultrasound (IVUS) to facilitate integration of these two imaging modalities in a synchronous manner. BACKGROUND: IVUS provides cross-sectional imaging of coronary arteries but lacks overview of the vascular territory provided by angiography. Co-registration of angiography and IVUS would increase utility of IVUS in the clinical setting. METHODS: Forty-nine consecutive patients undergoing surveillance for cardiac allograft vasculopathy with angiography and IVUS of the left anterior descending artery (LAD) were enrolled. A pre-IVUS angiogram of the LAD was performed followed by an ECG-triggered fluoroscopy (ECGTF) during IVUS pullback at 0.5 mm/s using an automatic pullback device. ECGTF was used to track the IVUS catheter during pullback and establish a spatial relationship to the pre-IVUS angiogram. Angio-IVUS co-registration was performed with a research prototype (Siemens Healthcare, Germany) and accuracy was evaluated by distance mismatch between angiography and IVUS images at vessel bifurcations. RESULTS: Median age was 54 (44.5, 67) years. The population was 82.6% male with minimal risk factors. The median (IQR) co-registration distance mismatch measured at 108 bifurcations in 42 (85%) patients was 0.35 (0.00-1.16) mm. Seven patients were excluded due to inappropriate data acquisition (n = 3) and failure of tracking (n = 4), e.g., due to overlapping sternal wires. Estimated effective radiation dose for ECGTF was 0.09 mSv. CONCLUSION: This study demonstrates the feasibility of angio-IVUS co-registration which may be used as a clinical tool for localizing IVUS cross-sections along an angiographic roadmap. © 2015 Wiley Periodicals, Inc.

Filter neuroprotection of a single patent internal carotid artery during transapical aortic valve implantation.

The finding of a mobile calcific plaque attached to the aortic valve cusp during transcatheter aortic valve implantation (TAVI/TAVR) necessitated utilization of an embolic protection device, for cerebral protection. We report the urgent but successful deployment of such a filter in a patient with a single patent internal carotid artery. Although stroke rates observed in first-generation TAVI trials were higher than those reported following conventional open aortic valve replacement, adjunctive neuroprotective measures, particularly in patients with a large amount of threatened cerebral territory, may minimize potential neurologic injury.

Long-term outcomes of fractional flow reserve-guided vs. angiography-guided percutaneous coronary intervention in contemporary practice.

AIMS: Fractional flow reserve (FFR) is the reference standard for the assessment of the functional significance of coronary artery stenoses, but is underutilized in daily clinical practice. We aimed to study long-term outcomes of FFR-guided percutaneous coronary intervention (PCI) in the general clinical practice. METHODS AND RESULTS: In this retrospective study, consecutive patients (n = 7358), referred for PCI at the Mayo Clinic between October 2002 and December 2009, were divided in two groups: those undergoing PCI without (PCI-only, n = 6268) or with FFR measurements (FFR-guided, n = 1090). The latter group was further classified as the FFR-Perform group (n = 369) if followed by PCI, and the FFR-Defer group (n = 721) if PCI was deferred. Clinical events were compared during a median follow-up of 50.9 months. The Kaplan-Meier fraction of major adverse cardiac events at 7 years was 57.0% in the PCI-only vs. 50.0% in the FFR-guided group (P = 0.016). Patients with FFR-guided interventions had a non-significantly lower rate of death or myocardial infarction compared with those with angiography-guided interventions [hazard ratio (HR): 0.85, 95% CI: 0.71-1.01, P = 0.06]; the FFR-guided deferred-PCI strategy was independently associated with reduced rate of myocardial infarction (HR: 0.46, 95% CI: 0.26-0.82, P = 0.008). After excluding patients with FFR of 0.75-0.80 and deferring PCI, the use of FFR was significantly associated with reduced rate of death or myocardial infarction (HR: 0.80, 95% CI: 0.66-0.96, P = 0.02). CONCLUSION: In the contemporary practice, an FFR-guided treatment strategy is associated with a favourable long-term outcome. The current study supports the use of the FFR for decision-making in patients undergoing cardiac catheterization.

Predictors of an optimal clinical outcome with alcohol septal ablation for obstructive hypertrophic cardiomyopathy.

BACKGROUND: Alcohol septal ablation has emerged as a therapy for patients with obstructive hypertrophic cardiomyopathy (HCM). However, there are limited data on the predictors of success with the procedure. METHODS: We examined patient characteristics and cardiac morphology as well as procedural data on 166 HCM patients (mean age, 63 years; 43% men), who underwent ablation at Mayo Clinic. Patients were contacted to determine vital status and symptoms to assess the primary endpoint of survival free of death and severe symptoms (New York Heart Association, class III or IV dyspnea). RESULTS: The strongest patient characteristics that predicted clinical success were older age, less severe left ventricular outflow tract gradient, lesser ventricular septal hypertrophy, and a smaller left anterior descending (LAD) diameter. Mitral valve geometry or ventricular septal morphology did not predict outcome. Patients with ≥3 characteristics (age ≥65 years, gradient <100 mmHg, septal hypertrophy ≤18 mm, LAD diameter <4.0 mm) had superior 4-year survival free of death and severe symptoms (90.4%) in comparison to those with two characteristics (81.6%) and ≤1 characteristic (57.5%). Case volume with >50 patients was an independent predictor of survival free of severe symptoms. The volume of alcohol injected, number of arteries injected, or size of septal perforator artery were not predictive of clinical success. CONCLUSIONS: Greater case volume and selection for key patient and anatomic characteristics are associated with superior outcomes with alcohol septal ablation.

Transcatheter aortic valve insertion catastrophe in inoperable patients: should aortic valve replacement be denied?

This paper reports the outcomes of patients initially deemed inoperable for standard aortic valve replacement who received transcatheter aortic valve insertion. Each patient experienced a transcatheter valve insertion complication and was then subsequently reconsidered for urgent standard valve replacement. We review the outcomes of these inoperable patients and discuss recommendations for managing this complication.

Protected carotid stenting in high-risk patients: results of the SpideRX arm of the carotid revascularization with ev3 arterial technology evolution trial.

PURPOSE: A prospective nonrandomized multicenter registry of 160 patients with severe carotid stenosis and high-risk features for carotid endarterectomy was conducted during the 3-month period from March to May 2005. METHODS: Carotid artery stenting (CAS) was performed with the SpideRX™ Embolic Protection System (ev3, Inc., Plymouth, MN, USA) as part of an investigational device exemption from the Food and Drug Administration. RESULTS: The primary end-point of major adverse cardiac and cerebrovascular events at 30 days after CAS was observed in nine patients (5.6%), including death in four patients (2.5%), nonfatal stroke in five patients (3.1%), and nonfatal myocardial infarction in one patient (0.6%). A secondary end-point of technical success (defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%) was achieved in 156 of 160 patients (97.5%). The only independent predictor of death or stroke at 30 days was baseline stenosis severity (P < 0.05). CONCLUSION: CAS with distal embolic protection using the SpideRX™ Embolic Protection System is a reasonable alternative for revascularization of some high-risk patients with severe carotid stenosis.

Long-term outcomes after fractional flow reserve-guided percutaneous coronary intervention in patients with severe coronary stenosis.

OBJECTIVE: To explore the safety and efficacy of FFR-guided percutaneous coronary intervention (PCI) in vessels with severe diameter stenosis. METHODS & RESULTS: Of 1090 patients undergoing fractional flow reserve (FFR) assessment from 2002 to 2009, we identified 167 patients in whom FFR was measured in at least one 70%-89% stenotic lesion. These patients were subdivided into an FFR-defer group (n = 49) if PCI was deferred (FFR > 0.80), and an FFR-perform group (n = 118) if PCI was performed (FFR ≤ 0.80). Comparatively, an additional 1176 patients undergoing PCI in at least one lesion with 70%-89% stenosis but without measurement of FFR served as a control (angiography-guided) group. Clinical outcomes were compared during a median follow-up of 49.0 months. The 5-year Kaplan-Meier estimated revascularization rates were 16% in the FFR-defer group and 33% in the FFR-perform group (P = 0.046). The incidence of major adverse cardiac events were comparable in these two groups (HR = 0.82, 95% CI: 0.37-1.82, P = 0.63). The number of stents placed was significantly lower in the FFR-guided group (0.9 ± 0.8 vs. 1.4 ± 0.8, P < 0.001). CONCLUSIONS: Functional revascularization for lesions with visually severe stenosis is clinically safe and associated with fewer stents use. This study suggests that extending the use of FFR to more severe coronary lesions may be reasonable.

Regional systems of care to optimize timeliness of reperfusion therapy for ST-elevation myocardial infarction: the Mayo Clinic STEMI Protocol.

BACKGROUND: Quality improvement efforts have focused on strategies to improve the timeliness of reperfusion therapy in ST-elevation myocardial infarction patients who present to hospitals with and without percutaneous coronary intervention (PCI) capability. We implemented and evaluated a protocol to optimize the timeliness of reperfusion therapy and to coordinate systems of care for a PCI center and 28 regional hospitals located up to 150 miles away across 3 states. METHODS AND RESULTS: The present study focused on a prospective, observational cohort of 597 patients who presented with ST-segment elevation and within 12 hours of symptom onset to Saint Marys Hospital and 28 regional hospitals up to 150 miles away between May 2004 and December 2006. The Mayo Clinic ST-elevation myocardial infarction protocol implemented strategies to improve timeliness of reperfusion therapy and to coordinate systems of care for transfer between hospitals. The study sample consisted of 258 patients who presented to Saint Marys Hospital and were treated with primary PCI (group A), 105 patients who presented to a regional hospital with symptom onset >3 hours and then were transferred for primary PCI (group B), and 131 patients who presented to a regional hospital with symptom onset <3 hours and were treated with full-dose fibrinolytic therapy (group C). For groups A and B, median door-to-balloon times were 71 and 116 minutes, respectively. Door-to-balloon time <90 minutes was achieved in 75% of group A and 12% of group B. Median door-to-needle time was 25 minutes for group C, and 70% had door-to-needle time <30 minutes. CONCLUSIONS: The Mayo Clinic ST-elevation myocardial infarction protocol demonstrates the feasibility of implementing strategies to optimize the timeliness of reperfusion therapy and the times that can be achieved through coordinated systems of care for ST-elevation myocardial infarction patients presenting to a PCI center (Saint Marys Hospital) and 28 regional hospitals without PCI capability located up to 150 miles away across 3 states.

Drug-eluting stents in octogenarians: early and intermediate outcome.

BACKGROUND: Large randomized controlled trials have demonstrated that percutaneous coronary intervention with the routine use of drug-eluting stents is safe and effective. However, octogenarians are usually excluded from these trials. METHODS: We analyzed 2453 consecutive patients who underwent DES implantation at the Mayo Clinic (Rochester, MN). The patients were classified in 2 age groups: patients > or = 80 years of age < or = 79 years of age. RESULTS: Patients > or = 80 years old had significantly more adverse baseline characteristics including more comorbid conditions and more severe extensive coronary artery disease. Procedural success was high irrespective of the age group--97% in patients > or = 80 years of age versus 98% in the younger patients. Multivariate analysis demonstrated that age of > or = 80 years was significantly associated with inhospital major adverse cardiac events (MACEs) (P = .004). In addition, among inhospital survivors, octogenarians also had higher follow-up MACE rates (P < .001). At 12 months of follow-up, patients > or = 80 years of age had a mortality of 8.9% versus 3.0% for the younger patients (P < .001). The older patients also had more recurrent myocardial infarction (5.2% vs 2.6%, P = .019). However, there was no significant difference in 12-month target lesion revascularization (4.5% vs 4.9% [> or = 80 years of age vs < or = 79 years of age]) or coronary artery bypass grafting (1.8% vs 1.3% [> or = 80 years of age vs < or = 79 years of age]). After age-sex adjustment, life expectancy of octogenarians was similar to that of the general population (P = .78). CONCLUSION: This study showed that drug-eluting stent implantation in octogenarians has high initial procedural success rates compared with the younger patients despite having more severe baseline risk characteristics. During follow-up, death and overall MACE rates remain higher in octogenarians but target lesion revascularization rates are similar.

Safety and efficacy of drug-eluting stent for ST-segment elevation myocardial infarction in an unselected consecutive cohort.

OBJECTIVE: The objective of this study is to investigate the clinical outcome of a large cohort of patients with ST-segment elevation myocardial infarction (STEMI) treated with drug-eluting stents (DES) compared to bare metal stents (BMS). BACKGROUND: Several randomized controlled trials have demonstrated that PCI with the routine use of DES is safe and effective in patients with STEMI. However as randomized trials have strict inclusion criteria, further studies in unselected patient populations are needed. METHODS: We performed a retrospective cohort analysis of the Mayo Clinic PCI database. A total of 552 consecutive STEMI patients who underwent a DES implantation between May 2003 and April 2006 were included in the study and compared to 557 who had BMS for STEMI earlier. No specific patient subsets were excluded. RESULTS: Procedural success was achieved in 532 patients (96%). During initial hospitalization, 16 patients (2.9%) died and 8 (1.5%) suffered from a recurrent myocardial infarction. The median follow-up was 23 months (IQR: 13-27 months). At 12 months post discharge, the rate of target lesion revascularization and death were 2.9% and 3.7%, respectively, and survival free of major adverse cardiac events (MACE) was 90.9%. These rates were similar to or lower than those of patients treated for STEMI with BMS prior to the availability of DES. CONCLUSION: DES are safe and effective in the treatment of STEMI in an unselected cohort; 90.9% of patients are free of MACE at 12 months post discharge.

Ambulation 1 hour after diagnostic cardiac catheterization: a prospective study of 1009 procedures.

OBJECTIVE: To study the safety of a protocol that allows ambulation 1 hour after diagnostic cardiac catheterization with a transfemoral approach using a 5F catheter system. PATIENTS AND METHODS: A total of 1005 consecutive patients (1009 procedures) undergoing outpatient diagnostic cardiac catheterization with a transfemoral approach using a 5F catheter system at the Mayo Clinic in Rochester, Minn, were included in this study from January 1, 2004, to August 31, 2005. All patients underwent standard manual compression to achieve hemostasis and were ambulated after 1 hour of bed rest. RESULTS: The mean age of the patients was 64.5 years, and 62% were male. Minor vascular complications occurred in 33 procedures (3.3%), Including 14 hematomas (1.4%) less than 4 cm and 19 cases of rebleeding (1.9%) that required repeated manual compression. Only 1 patient (0.1%) had a hematoma greater than 4 cm. No patient had a major complication, such as surgical repair, red blood cell transfusion, retroperitoneal bleeding, formation of an arteriovenous fistula or pseudoaneurysm, arterial occlusion, or an infection. CONCLUSIONS: Ambulation 1 hour after diagnostic cardiac catheterization with a transfemoral approach using a 5F catheter system is safe and associated with low rates of vascular complications. This strategy may improve patient comfort, reduce resource utilization, and be preferable to use of vascular closure devices.

"Broken heart syndrome" after separation (from OxyContin).

We describe a 61-year-old woman with "broken heart syndrome" (Takotsubo-like cardiomyopathy) after abrupt postsurgical withdrawal of OxyContin. Her medical history was remarkable for long-term opiold dependence associated with the treatment of multi-Joint degenerative osteoarthritis. The patient presented to the emergency department 1 day after discharge from the hospital following total knee arthroplasty revision with acute-onset dyspnea and mild chest pain. She had precordial ST-segment elevation characteristic of acute myocardial infarction and elevated cardiac biomarkers. Emergency coronary angiography revealed no major coronary atherosclerosis. However, the left ventricular ejection fraction was severely decreased (26%), and new regional wall motion abnormalities typical of broken heart syndrome were noted. In addition to resuming her opioid therapy, she was treated supportively with bilevel positive airway pressure, diuretic therapy, morphine, aspirin, metoprolol, enalaprilat, intravenous heparin, nitroglycerin infusion, and dopamine infusion. Ventricular systolic function recovered completely by the fourth hospital day. To our knowledge, broken heart syndrome after opioid withdrawal has not been reported previously in an adult. Our case illustrates the importance of continuing adequate opiate therapy perioperatively in the increasing number of opioid-dependent patients to prevent potentially life-threatening complications such as broken heart syndrome.

Clinical Outcomes After Transapical and Transfemoral Transcatheter Aortic Valve Insertion: An Evolving Experience.

BACKGROUND: Prior publications note increased adverse events after transapical compared with transfemoral access transcatheter aortic valve insertion (TAVI). We reviewed our TAVI experience to understand the differences in baseline patient characteristics and outcomes associated with the two access methods. METHODS: The records were reviewed of 567 patients who underwent transfemoral (n = 351, 61.9%) and transapical (n = 216, 38.1%) TAVI from November 2008 through July 2015. RESULTS: Compared with patients who underwent transfemoral access, the patients who underwent transapical access were older (82.0 ± 7.5 versus 79.6 ± 9.7 years; p = 0.006), had more peripheral vascular disease (78.2% versus 54.7%; p < 0.001), more previous coronary artery bypass graft operations (50.9% versus 32.5%; p < 0.001), and higher Society of Thoracic Surgeons predicted risk of mortality (9.4% ± 5.4% versus 8.8% ± 6.5%; p = 0.032). In-hospital and 30-day mortality rates, however, were similar between the two groups (transapical, n = 7, 3.2%; transfemoral, n = 13, 3.7%; p = 0.772). Follow-up echocardiography in 547 (100.0%) surviving patients at a median of 182 days (interquartile range, 35 to 420) demonstrated less paravalvular regurgitation grade of moderate or greater in patients who underwent transapical access (transapical, n = 6, 2.9%; transfemoral, n = 35, 10.4%; p = 0.001) but similar ejection fraction in the two groups (transapical, 55.4% ± 12.2%; transfemoral, 55.9% ± 13.0%; p = 0.419). Mortality rates at 1 year (transapical, 19.2% ± 3.0%; transfemoral,14.7% ± 3.2%) and 4 years (transapical, 47.4% ± 6.4%; transfemoral, 42.7% ± 4.9%) were also similar between the two groups (p = 0.342). CONCLUSIONS: Transapical and transfemoral transcatheter aortic valve insertions result in similar operative and longer term mortality rates, despite differences in baseline patient risk. The findings support the concept that access does not influence treatment-related mortality rates.

The Role of Balloon Aortic Valvuloplasty in Patients With Aortic Valve Stenosis and Society of Thoracic Surgeons Risk of 15% or Higher.

BACKGROUND: Extreme-risk patients (ie, Society of Thoracic Surgeons [STS] risk 15% or higher) with severe aortic valve stenosis may not obtain mortality benefit from aortic valve replacement (AVR). We reviewed our experience with this group of patients to better understand our triage process and outcomes. METHODS: We performed a retrospective review of 97 patients with severe aortic valve stenosis and STS risk of 15% or higher treated from 2008 through 2013. The median patient age was 85 years (minimum, 44; maximum, 97 years), and 47 patients (48.5%) were male. The STS risk of mortality was 19.8% (minimum, 15.1%; maximum, 60.9%). Patients were assigned to treatment groups based on the first aortic valve intervention of balloon aortic valvuloplasty (BAV group, 66 [68%]) or de novo AVR (d-AVR group, 31 [32%]). RESULTS: Patients in the BAV group were sicker, with a reduced ejection fraction (0.35 vs 0.57; p = 0.002) and greater prevalence of urgent/emergency operative status (32% vs 10%; p = 0.004) compared with those in the d-AVR group. After BAV, 33 patients (50%) demonstrated clinical improvement and went on to receive subsequent staged AVR after a median of 64 days (minimum, 3; maximum, 390 days). The mortality rate at 2 years was worse in the BAV group (57.3% ± 6.3%) than in the d-AVR group (29.5% ± 8.3%; p = 0.015), but was similar in patients who received BAV followed by staged AVR and de novo AVR (p = 0.426). CONCLUSIONS: BAV may triage select patients with STS risk 15% or higher who are questionable candidates for AVR. Patients with clinical improvement after BAV experience benefit from staged AVR.

Trends and predictors of smoking cessation after percutaneous coronary intervention (from Olmsted County, Minnesota, 1999 to 2010).

Smoke-free ordinance implementation and advances in smoking cessation (SC) treatment have occurred in the past decade; however, little is known about their impact on SC in patients with coronary artery disease. We conducted a retrospective cohort study of 2,306 consecutive patients from Olmsted County, Minnesota, who underwent their first percutaneous coronary intervention (PCI) from 1999 to 2009, and assessed the trends and predictors of SC after PCI. Smoking status was ascertained by structured telephone survey 6 and 12 months after PCI (ending in 2010). The prevalence of smoking in patients who underwent PCI increased nonsignificantly from 20% in 1999 to 2001 to 24% in 2007 to 2009 (p = 0.14), whereas SC at 6 months after PCI decreased nonsignificantly from 50% (1999 to 2001) to 49% (2007 to 2009), p = 0.82. The 12-month quit rate did not change significantly (48% in 1999 to 2001 vs 56% in 2007 to 2009, p = 0.38), even during the time periods after the enactment of smoke-free policies. The strongest predictor of SC at 6 months after PCI was participation in cardiac rehabilitation (odds ratio [OR] 3.17, 95% confidence interval [CI] 2.05 to 4.91, p <0.001), older age (OR 1.42 per decade, 95% CI 1.16 to 1.73, p <0.001), and concurrent myocardial infarction at the time of PCI (OR 1.77, 95% CI 1.18 to 2.65, p = 0.006). One-year mortality was lower in the group of smokers compared with never smokers (3% vs 7%, p <0.001). In conclusion, SC rates have not improved after PCI over the past decade in our cohort, despite the presence of smoke-free ordinances and improved treatment strategies. Improvements in delivery of systematic services aimed at promoting SC (such as cardiac rehabilitation) should be part of future efforts to improve SC rates after PCI.

Endovascular abdominal aortic aneurysm repair to facilitate access for transcatheter aortic valve implantation.

Transcatheter aortic valve insertion is an accepted treatment for select patients at high-risk for standard aortic valve insertion. Constraints imposed by the Food and Drug Administration, Centers for Medicare and Medicaid Services, and the PARTNER Trial Executive Committee require a transfemoral approach in certain patients. The presence of aortoiliac aneurysms, occlusive disease, and excessive vessel tortuosity may create difficulties for safe transfemoral access. We report a case in which the limitation of severe iliac artery occlusive disease was overcome by placement of an abdominal aortic endovascular graft that subsequently allowed successful transfemoral access and transcatheter aortic valve implantation.

Sex-related differences in fractional flow reserve-guided treatment.

BACKGROUND: Sex-specific differences affect the evaluation, treatment, and prognosis of coronary artery disease. We tested the hypothesis that long-term outcomes of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) are different between women and men. METHODS AND RESULTS: Consecutive 1090 patients, referred for PCI and undergoing FFR measurements at the Mayo Clinic between October 2002 and December 2009, were included in this registry study. Clinical events were compared between the sexes during a median follow-up of 50.9 months. Of all patients, women had higher FFR adjusted by visual coronary stenosis than men (P=0.03). The Kaplan-Meier percent of major adverse cardiac events at 5 years was 35% in women and 38% in men (P=0.54). Interestingly, in patients undergoing PCI with an FFR <0.75, the incidence of death or myocardial infarction was significantly higher in women than in men (hazard ratio, 2.16; 95% confidence interval, 1.04-4.51; P=0.04). Moreover, compared with patients with FFR >0.80, deferral of PCI for those with FFR between 0.75 and 0.80 was associated with an increased rate of major adverse cardiac events, particularly death or myocardial infarction in women (hazard ratio, 3.25; 95% confidence interval, 1.56-6.74; P=0.002) and revascularization in men (hazard ratio, 2.66; 95% confidence interval, 1.66-4.54; P<0.001). CONCLUSIONS: Long-term outcome differs between women and men undergoing FFR-guided PCI. Our data suggest that the sex-based treatment strategy is necessary to further optimize prognosis of patients with coronary artery disease.

High sensitivity C-reactive protein and outcomes following percutaneous coronary intervention in contemporary practice.

BACKGROUND: High sensitivity C-reactive protein (hsCRP) has been identified as a predictor of adverse cardiovascular outcomes. Whether hsCRP is a useful biomarker for risk stratification in contemporary percutaneous coronary intervention remains unknown. METHODS AND RESULTS: We conducted a prospective study among 513 patients undergoing non-emergency percutaneous coronary intervention and examined the relationship between pre- and postprocedural hsCRP levels and outcomes. The patients were divided according to the median preprocedural hsCRP level (0.3 mg/dL). Patients with high hsCRP had significantly more adverse clinical characteristics. Preprocedural hsCRP level was an independent predictor of periprocedural myocardial infarction (odds ratio per doubling of hsCRP 1.15 [95% confidence interval, 1.01-1.31]; P=0.038). Unadjusted mortality (29.7% versus 9.9%; P<0.001) and the combined end point of death or myocardial infarction (36.5% versus 16.0%, P<0.001) during a follow-up of 5 years were markedly greater in patients with high preprocedural hsCRP. Similar relationships existed for postprocedural hsCRP. However, after multivariable adjustment, neither preprocedural hsCRP levels (hazard ratio per doubling 0.96 [0.92, 1.00]; P=0.066) nor postprocedural hsCRP levels (hazard ratio 0.98 [0.94, 1.02]; P=0.27) were significantly associated with mortality. CONCLUSIONS: High hsCRP is associated with a greater independent risk of periprocedural myocardial infarction, as defined by the universal definition, but is not an independent determinant of mortality after percutaneous coronary intervention. Our findings suggest that routine measurement of hsCRP in patients undergoing percutaneous coronary intervention in contemporary practice is unlikely to be beneficial.