Trends in Modifiable Risk Factors Amongst First Presentation ST Elevation Myocardial Infarction Patients in a Large Longitudinal Registry.

BACKGROUND: Recent studies suggest that the risk factor profile of patients presenting with ST elevation myocardial infarction (STEMI) is changing. AIM: The aim is to determine if there has been a shift of cardiovascular risk factors to cardiometabolic causes in the first presentation STEMI population. METHOD: We analysed data from a STEMI registry from a large tertiary referral percutaneous coronary intervention centre to determine the prevalence and trends of the modifiable risk factors of hypertension, diabetes, smoking and hypercholesterolaemia. PARTICIPANTS: Consecutive first presentation STEMI patients between January 2006 to December 2018. RESULTS: Among the 2,366 patients included (mean age 59, SD 12.66, 80% male) the common risk factors were hypertension (47%), hypercholesterolaemia (47%) current smoking (42%) and diabetes (27%). Over the 13 years, patients with diabetes (20% to 26%, OR 1.09 per year, CI 1.06-1.11, p<0.001) and patients with no modifiable risk factors increased (9% to 17%, OR 1.08, CI 1.04-1.11, p<0.001). Concurrently there was a fall in prevalence of hypercholesterolaemia, (47% to 37%, OR 0.94 per year, CI 0.92-0.96, p<0.001) and smoking (44% to 41%, OR 0.94, CI 0.92-0.96, p<0.001) but no significant change in rates of hypertension (53% to 49%, OR 0.99, CI 0.97-1.01, p=0.25). CONCLUSION: The risk factor profile of first presentation STEMI has changed over time with a reduction in smoking and a concurrent rise in patients with no traditional risk factors. This suggests the mechanism of STEMI may be changing and further investigation of potential causal factors is warranted for the prevention and management of cardiovascular disease.

Low Incidence of Ischemic Stroke Associated With Thrombus Aspiration in STEMI Patients Undergoing Primary PCI.

BACKGROUND: Thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) was recommended to minimize distal embolization and to reduce thrombus burden prior to PPCI. Subsequent randomized trials showed no mortality benefit from TA and suggested an increased risk of stroke up to 180 days following TA, although it was not obvious that the procedure alone caused the strokes. METHODS AND RESULTS: This study retrospectively analyzed the periprocedural stroke rate in a series of STEMI patients treated with TA and PPCI at a single, large, tertiary hospital, where a rigorous uniform protocol of aspiration was used in all patients. Of 3734 patients, 1404 patients (38%; group 1) underwent TA as part of the PPCI procedure and 2330 patients (62%; group 2) did not undergo TA. There were no significant clinical differences between the 2 groups. In total, there were 20 strokes (0.54%), with 3 (0.2%) occurring in group 1, and 17 (0.7%) occurring in group 2 (P=.04). The majority of strokes occurred within 5 days of the procedure, and 3 (0.08%) were hemorrhagic. There were 22 intraprocedural deaths (0.6%), related to cardiogenic shock. There were no intraprocedural strokes. CONCLUSIONS: Very low stroke rates immediately post STEMI were seen in patients undergoing TA and PPCI in this real-world study. TA can be performed safely in STEMI patients undergoing PPCI with a short-term stroke risk equivalent to risk without TA. Further studies may be needed to explain the increased incidence of late stroke noted after TA and elucidate causative mechanisms.

Transcatheter versus surgical aortic valve replacement: a systematic review and meta-analysis of randomised and non-randomised trials.

INTRODUCTION: Many patients deemed inoperable for surgical aortic valve replacement (SAVR) have been treated successfully by transcatheter aortic-valve replacement (TAVR). This meta-analysis is designed to evaluate the performance of TAVR in comparison with SAVR. METHODS: A systematic search was conducted using MEDLINE, PubMed, EMBASE, Current Contents Connect, the Cochrane library, Google Scholar, Science Direct and Web of Science. Original data were abstracted from each study and used to calculate a pooled OR and 95% CI. RESULTS: Among three randomised controlled trials (RCTs), differences between the two cohorts were not statistically significant for the frequency of stroke (OR=1.94, 95% CI=0.813 to 4.633), incidence of myocardial infarction (MI), (OR=0.765, 95% CI=0.05 to 11.76) 30-day mortality rate, 1-year mortality rate (0.82, 95% CI=0.62 to 1.09) and acute kidney injury incidence rate. The non-RCTs demonstrated that the TAVR group had an amplified frequency aortic regurgitation at discharge (OR=5.465, 95% CI=3.441 to 8.680). While differences between the two cohorts were not statistically significant for the incidence of MI (OR=0.697, 95% CI=0.22 to 2.21), stroke (OR=0.575, 95% CI=0.263 to 1.259), acute renal failure requiring haemodialysis (OR=0.943, 95% CI=0.276 to 3.222), 30-day mortality (OR=0.869, 95% CI=0.621 to 1.216) and the need for a pacemaker (OR=1.832, 95% CI=0.869 to 3.862), a lower incidence of patients needing transfusion (OR=0.349, 95% CI=0.121 to 1.005) and new-onset atrial fibrillation (OR=0.296, 95% CI=0.124 to 0.706) was seen in the TAVR group. CONCLUSIONS: Randomised and observational evidence adjusted on the baseline patient's characteristics finds a similar risk for 30 days mortality, 1-year mortality, stroke, MI and acute kidney injury in TAVR and SAVR.

Quantification of scientific output in cardiovascular medicine: a perspective based on global data.

AIMS: We sought to explore whether global and regional scientific output in cardiovascular medicine is associated with economic variables and follows the same trend as medicine and as science overall. METHODS AND RESULTS: We registered the number of documents, number of citations, citations per document and the h-index for the first 50 countries according to the h-index (a measure to evaluate both the productivity and impact of the publications) in cardiovascular medicine. Economic variables (gross domestic product [GDP] per capita, % expenditure of the GDP in research and development [R&D] and health) were obtained from the World Bank, the UNESCO, and the World Health Organization. In total, the scientific output in cardiology showed the same position as in medicine and science overall (mean difference vs. medicine -0.9±5.3º, p=0.25 vs. science -0.7±5.3º, p=0.39). We found significant correlations between the h-index and the % GDP expenditure in R&D (r=0.67, p<0.001), and the % GDP expenditure in health (r=0.71, p<0.0001). Overall, there was a 21.4% (interquartile range 3.7; 55.0) increase in the % GDP expenditure in R&D between 1996 and 2007. Emerging economies showed the larger growth in % GDP expenditure in health and R&D. CONCLUSIONS: The global situation of scientific output in cardiovascular medicine is highly polarised and closely related to economic indicators. Emergent economies, with higher rates of GDP growth and increasingly larger expenditures for R&D and healthcare, are expected to show a visible escalation in the scientific global picture in the near future.

Effect of reperfusion time on inducible ventricular tachycardia early and spontaneous ventricular arrhythmias late after ST elevation myocardial infarction treated with primary percutaneous coronary intervention.

BACKGROUND: Prompt thrombolytic reperfusion reduces postinfarct ventricular electrical instability after ST elevation myocardial infarction (STEMI). OBJECTIVE: The purpose of this study was to examine the relationship between reperfusion time and inducible ventricular tachycardia (VT) early and spontaneous ventricular arrhythmias (VAs) late after primary percutaneous coronary intervention (PCI) for STEMI. METHODS: Consecutive patients were recruited if they (1) had no prior coronary disease, (2) had been reperfused with primary PCI, (3) had postinfarct ejection fraction ≤40%, and (4) had undergone cardiac electrophysiologic study (n = 128). Three groups were compared according to reperfusion time: early (≤3 hours, n = 26), intermediate (>3-5 hours, n = 45), or delayed reperfusion (>5 hours, n = 57). Spontaneous VA was a composite endpoint of sudden death or defibrillator-treated VA. RESULTS: Mean ejection fraction (33% ± 5%, 31% ± 6%, and 31% ± 7%, P = .41) and peak creatinine kinase (P = .37) were similar between groups. VT was inducible in 11.5%, 17.8%, and 36.8% of patients in the early, intermediate, and delayed reperfusion groups, respectively (P = .003). At 2 years, the incidence of spontaneous VA was 0%, 8.9%, and 14% in the early, intermediate, and delayed reperfusion groups, respectively (P = .025). By multivariable analysis, delayed reperfusion conferred a sixfold increase in the odds of inducible VT (P = .01). Although inducible VT was the strongest predictor of spontaneous VA (hazard ratio 14.31, P = .001), delayed reperfusion conferred a threefold increase in risk when inducible VT was excluded from the multivariable model (P = .035). CONCLUSION: Reperfusion time is a critical determinant of postinfarct ventricular electrical instability early and late after STEMI treated with primary PCI.

Predictive value of ST resolution analysis performed immediately versus at ninety minutes after primary percutaneous coronary intervention.

ST segment resolution (STR) predicts epicardial and microvascular reperfusion after primary percutaneous coronary intervention (PPCI) or thrombolysis for ST-elevation myocardial infarction. Immediate restoration of epicardial coronary flow, with improved microvascular perfusion, is much more likely with PPCI. However, the predictive value of immediate STR compared to 90 minutes after PPCI remains unknown. In 622 consecutive patients with ST-elevation myocardial infarction (mean age 59 +/- 13 years), 217 had complete STR immediately after PPCI (group A), 188 had complete STR only at 90 minutes (group B), and 217 had incomplete STR at either point (group C). The primary end point was mortality and adverse cardiovascular events ([MACE] death, nonfatal repeat myocardial infarction, and heart failure). Group A had a greater left ventricular ejection fraction (53%, 47%, and 46%, p <0.001) and lower all-cause mortality (1.8%, 3.2%, and 6%, p = 0.07), lower heart failure (1.8%, 4.3%, and 7.8%, p <0.001), and MACE (5.1%, 9.6%, and 16.1%, p = 0.001) at 30 days compared to groups B and C, respectively. The rate of MACE at 1 year was 7.6%, 17.1%, and 20.2% in groups A, B, and C, respectively (p <0.001). Immediate STR independently predicted MACE (adjusted hazard ratio 0.36, 95% confidence interval 0.21 to 0.61, p = 0.001, group A vs C), and STR at 90 minutes did not. In conclusion, STR analysis performed immediately after PPCI provided superior differentiation for adverse cardiovascular events compared to STR at 90 minutes. Immediate STR should be the contemporary goal of reperfusion with PPCI.

Prognostic impact of Q waves on presentation and ST resolution in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention.

Q waves can develop early in infarction and indicate infarct progression better than symptom duration. ST resolution (STR) is a predictor of reperfusion success. Our aim was to assess the prognostic impact of Q waves on presentation and STR after primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction. The combined end point was of mortality and adverse cardiovascular events (MACE; death, repeat myocardial infarction, or heart failure). Q waves on presentation (Q wave, n = 332; no Q wave, n = 337) was associated with significantly less mean STR, greater incidence of akinetic, dyskinetic, or aneurysmal regional wall motion, lower left ventricular ejection fraction, and worse in-hospital and 1-year MACEs (1 year 24% vs 8.2%, p <0.001). In addition, Q waves on presentation compared to no Q waves were associated with worse 1-year MACE regardless of infarct presentation in < or =3 hours, infarct location, and adequate STR (> or =70%). Q waves on presentation and inadequate STR (<70%), but not symptom duration, were independent predictors of MACE by multivariable analysis (adjusted hazard ratios of 2.7 and 2.4 for Q waves and STR, respectively). Compared to group A (no Q waves on presentation with STR), patients in group B (no Q waves with inadequate STR), group C (Q waves with STR), and group D (Q waves with inadequate STR) had hazard ratios of 3.0, 3.6, and 7.7, respectively (p <0.05) for the occurrence of MACE. In conclusion, assessment of Q-wave status on presentation and STR immediately after PPCI provides a simple and early clinical predictor of outcomes in ST-elevation myocardial infarction.

Effect of prehospital triage on revascularization times, left ventricular function, and survival in patients with ST-elevation myocardial infarction.

Shorter reperfusion times lead to better outcomes in patients with ST-elevation myocardial infarction (STEMI). We assessed the efficacy of prehospital triage with bypass of community hospitals and early activation of the cardiac catheterization team on revascularization times, left ventricular (LV) ejection fraction, and survival. Patients with STEMI (624) were divided into 3 groups determined by site of triage: ambulance field triage (163), interventional center emergency department (202), and 3 community hospital emergency departments (259). Compared with community hospital and interventional center triages, ambulance field triage resulted in a significant median decrease in door-to-balloon times of 68 and 27 minutes, respectively (p <0.001). LV ejection fraction was highest in the field triage group (52 +/- 13%) compared with the interventional center (49 +/- 12%) and community hospital (48 +/- 12%, p = 0.017) groups. Thirty-day mortality was lowest in the ambulance field group (3%) compared with the interventional facility (11%) and community hospital (4%, p = 0.007) groups. There was a significant difference in long-term survival with up to 30-month follow-up among the 3 triage groups (p = 0.041). With time-dependent Cox regression modeling the difference in survival was significant only during the first week after STEMI (p = 0.020). Every extra minute of symptom onset to reperfusion time was associated with a relative risk of long-term mortality of 1.003 (95% confidence interval 1.000 to 1.006, p = 0.027). In conclusion, field triage of patient with STEMI decreased revascularization times, which preserved LV function, and improved early survival.

Clinical and electrocardiographic correlates of normal coronary angiography in patients referred for primary percutaneous coronary intervention.

This study sought to determine the prevalence as well as clinical and electrocardiographic correlates of patients referred for primary percutaneous coronary intervention (PCI) who had angiographically normal coronary arteries. Data for 690 consecutive patients with ST-elevation myocardial infarction (STEMI) referred for primary PCI within a metropolitan area health service were reviewed. Characteristics of patients with angiographically normal coronary arteries (n = 87; 13%) were compared with patients with angiographically shown culprit lesions (control group; n = 594). Nine patients with significant coronary disease, but no identifiable culprit lesion, were excluded. Electrocardiograms (ECGs) from both groups were reviewed by 2 cardiologists blinded to angiographic findings. Patients in the normal coronaries group were younger and had fewer risk factors. On expert review of ECGs, 55% of patients in the normal coronaries group had ST-elevation criteria for STEMI (vs 93% in the control group; p <0.001), but the ECG was considered consistent with a diagnosis of STEMI by both observers in only 33% (vs 92% in the control group; p <0.001). Left branch bundle block independently correlated with normal coronary arteries on multivariate analysis (odds ratio for STEMI 0.016, 95% confidence interval 0.004 to 0.064, p <0.001). The discharge diagnosis in the normal coronaries group was predominantly pericarditis (n = 72; 83%). In conclusion, the prevalence of angiographically normal coronary arteries in patients referred for primary PCI was 13%. Electrocardiographic correlation suggested that this can be reduced by adherence to conventional electrocardiographic criteria for STEMI diagnosis and review of ECGs by experienced clinicians.

Two-year outcome of the use of paclitaxel-eluting stents in aorto-ostial lesions.

BACKGROUND: Percutaneous treatment of stenoses involving aorto-ostial lesions is technically demanding and has been associated with lower procedural success and poorer clinical and angiographic outcomes when compared with non-ostial lesions. This study evaluated the immediate and long-term (2-year) outcome of aorto-ostial stenoses treated with paclitaxel-eluting stents (PES). METHODS: From February 2003 to December 2004, a total of 76 consecutive patients with 76 lesions underwent percutaneous intervention with PES for aorto-ostial lesions (right coronary artery, 37; left main, 26; saphenous vein graft, 13). All patients were clinically followed for the occurrence of major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR) or target vessel revascularization (TVR). RESULTS: All stents (1.7/lesion) were successfully deployed. Three lesions (3.9%) were pre-treated with debulking devices. Thirty-seven lesions (48.7%) were post-dilated with non-compliant balloons (balloon/artery ratio, 1.2). Stents were positioned protruding into the aortic lumen in 29 lesions (38.2%). Cumulative 2-year event-free survival was 68.4%. There was one angiographically-proven stent thrombosis occurring 427 days after TLR for restenosis after the index procedure. The restenosis rate at 7 months (median) was 20.0% and in-stent late lumen loss was 0.48 mm in 40 patients with angiographic follow-up. CONCLUSIONS: Utilization of PES in this complex lesion subset is feasible and associated with favorable angiographic results at 7 months. However, the gradual increase in later events up to 2 years suggests that aorto-ostial disease remains problematic even in the era of drug-eluting stents.

Adverse clinical events in patients treated with sirolimus-eluting stents: the impact of Type D personality.

BACKGROUND: Little is known about the impact of psychological risk factors on cardiac prognosis in the drug-eluting stent era. We examined whether the distressed personality (Type D) moderates the effect of percutaneous coronary intervention with sirolimus-eluting stent implantation on adverse clinical events at 2-year follow-up. Type D is an emerging risk factor in patients with cardiovascular disease. DESIGN: Prospective follow-up study. METHODS: Three hundred and fifty-eight patients with ischemic heart disease, who consecutively underwent percutaneous coronary intervention with sirolimus-eluting stent as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital registry, completed the Type D Scale (DS14) post-percutaneous coronary intervention (PCI). The end-point was a composite of death and non-fatal myocardial infarction 2 years after PCI. RESULTS: At follow-up, there were 22 events (12 deaths and 11 myocardial infarctions). Type D patients had a greater than two-fold risk of an event at follow-up compared with non-Type D patients (10.4 vs. 4.4%, P=0.031). In multivariable analysis, Type D remained an independent predictor of adverse outcome (hazard ratio: 2.61; 95% confidence interval: 1.12-6.09; P=0.027) adjusting for sex, age, and history of coronary artery disease, multivessel disease, diabetes, hypercholesterolemia, hypertension, renal impairment and smoking. Previous cardiac history was also an independent predictor of death or myocardial infarction (hazard ratio: 2.83; 95% confidence interval: 1.00-7.96; P=0.049). CONCLUSIONS: Type D personality moderated the effect of percutaneous coronary intervention on hard clinical events despite treatment with the latest innovation in interventional cardiology. The inclusion of psychological risk factors in general and personality factors in particular may optimize risk stratification in the drug-eluting stent era.

Impaired health status in Type D patients following PCI in the drug-eluting stent era.

BACKGROUND: Drug-eluting stenting reduces restenosis post-percutaneous coronary intervention (PCI), but subgroups of patients may not benefit optimally from this procedure. We examined the impact of Type D personality on health status over time and the clinical relevance of Type D as a predictor of impaired health status at 12 months in unselected post-PCI patients. METHODS: Consecutive patients (n=692) participating in the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry completed the Type D Scale at 6 months and the Short Form Health Survey 36 (SF-36) at 6 and 12 months post-PCI. RESULTS: Although there was a significant improvement in health status over time (p<0.001), Type D patients reported a substantially lower score on all health status domains of the SF-36 compared with non-Type D patients (p<0.001). Type D personality was an independent predictor of impaired health status on all SF-36 sub domains at 12 months except for physical functioning, adjusting for baseline demographic and clinical variables and health status at 6 months. In these adjusted analyses, Type D personality increased the likelihood of impaired health status at 12 months post-PCI from 60% (OR: 1.60; 95% CI: 1.04-2.46) to almost 300% (OR: 3.99; 95% CI: 2.52-6.32), varying among the parameters analyzed. CONCLUSIONS: Type D personality was associated with impaired health status in post-PCI patients treated in the drug-eluting stent era. The role of personality factors as determinants of clinical outcome and health status should not be overlooked as these factors may have much explanatory power.

Anxiety enhances the detrimental effect of depressive symptoms on health status following percutaneous coronary intervention.

OBJECTIVE: We examined whether anxiety has incremental value to depressive symptoms in predicting health status in patients undergoing percutaneous coronary intervention (PCI) treated in the drug-eluting stent era. METHODS: A series of consecutive patients (n=692) undergoing PCI as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital registry completed the Hospital Anxiety and Depression Scale at 6 months and the Short-Form Health Survey (SF-36) at 6 and 12 months post-PCI. RESULTS: Of 692 patients, 471 (68.1%) had no symptoms of anxiety nor depression, 62 (9.0%) had anxiety only, 59 (8.5%) had depressive symptoms only, and 100 (14.5%) had co-occurring symptoms. There was an overall significant improvement in health status between 6 and 12 months post-PCI (P<.001); the interaction effect for time by psychological symptoms was also significant (P=.003). Generally, patients with co-occurring symptoms reported significantly poorer health status compared with the other three groups (Ps <.001). Patients with co-occurring symptomatology were also at greater risk of impaired health status on six of the eight subdomains of the SF-36 compared with the other three symptom groups, adjusting for baseline characteristics and health status at 6 months. CONCLUSION: Patients with co-occurring symptoms of anxiety and depression reported poorer health status compared with anxious or depressed-only patients and no-symptom patients, showing that anxiety has incremental value to depressive symptoms in identifying PCI patients at risk for impaired health status treated in the drug-eluting stent era.

Cost-effectiveness of the unrestricted use of sirolimus-eluting stents vs. bare metal stents at 1 and 2-year follow-up: results from the RESEARCH Registry.

AIMS: To assess the cost-effectiveness of sirolimus-eluting stents (SESs) compared with bare metal stents (BMSs) as the default strategy in unselected patients treated in the Rapamycin Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) Registry at 1 and 2-years following the procedure. METHODS AND RESULTS: A total of 508 consecutive patients with de novo lesions exclusively treated with SES were compared with 450 patients treated with BMS from the immediate preceding period. Resource use and costs of the index procedure, and clinical outcomes were prospectively recorded over a 2-year follow-up period. Follow-up costs were measured as unit costs per patient based on the incidence of clinically driven target vessel revascularization (TVR), to obtain cumulative costs at 1 and 2-years. Cost-effectiveness was measured as the incremental cost-effectiveness ratio (ICER) per TVR avoided. The use of SES cost euro 3,036 more per patient at the index procedure, driven by the price of SES. Follow-up costs after 1-year were euro 1,089 less with SES when compared with BMS, due to less TVR, resulting in a net excess cost of euro 1,968 per patient in the SES group, and reduced by a further euro 100 per patient in the second year. The incidence of death or myocardial infarction between groups was similar at 1 and 2 years. Rates of TVR in the SES and BMS groups were 3.7% vs. 10.4%, P<0.01 at 1 year, respectively; and 6.4% vs. 14.7%, P<0.001 at 2 years. The ICER per TVR avoided was euro 29,373 at 1 year, and euro 22,267 at 2 years. CONCLUSION: The use of SES, while significantly beneficial in reducing the need for repeat revascularization, was more expensive and not cost-effective in the RESEARCH registry at either 1 or 2-years when compared with BMS. On the basis of these results, in an unselected population with 1 year of follow-up, the unit price of SES would have to be euro 1,023 in order to be cost-neutral.

Three-year clinical follow-up of the unrestricted use of sirolimus-eluting stents as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry.

Sirolimus-eluting stents (SESs) have been shown to decrease restenosis compared with bare metal stents (BMSs). Currently, there are limited data on the long-term efficacy of these devices in a real-world patient population. Furthermore, the potential of a late restenotic phenomenon has not yet been excluded. From April to October 2002, 508 consecutive patients with de novo lesions exclusively treated with SESs were enrolled and compared with 450 patients treated with BMSs in the preceding 6 months (control group). Patients in the SES group more frequently had multivessel disease and type C lesions, received more stents, and had more bifurcation stenting. After 3 years, the cumulative incidence of major adverse cardiac events (comprising death, myocardial infarction, and target vessel revascularization) was significantly lower in the SES group compared with the pre-SES group (18.9% vs 24.7%, hazards ratio 0.73, 95% confidence interval 0.56 to 0.96, p = 0.026). The 3-year risk of target lesion revascularization was 7.5% in the SES group versus 12.6% in the pre-SES group (hazards ratio 0.57, 95% confidence interval 0.38 to 0.87, p = 0.01). In conclusion, the unrestricted use of SESs is safe and superior to the use of BMSs. The beneficial effects, reported after 1 and 2 years in reducing major adverse cardiac events, persisted with no evidence of a clinical late restenotic "catch-up" phenomenon.

Risk factors for impaired health status differ in women and men treated with percutaneous coronary intervention in the drug-eluting stent era.

OBJECTIVES: In patients treated with percutaneous coronary intervention (PCI) in the drug-eluting stent era, we compared women's and men's health status 6 and 12 months post-PCI and investigated whether predictors of poor health status at 12 months are similar for women and men. METHODS: Consecutive patients (n=692; 28% women) treated with PCI completed the 36-item Short-Form Health Survey (SF-36) 6 and 12 months post-PCI. RESULTS: There was a significant improvement in health status over time (P<.001), but women experienced a significantly poorer health status compared with men (P<.001) at 6 and 12 months, adjusting for differences in baseline characteristics and health status at 6 months. Predictors of impaired health status were generally different for women and men. In women, the predominant predictors were previous coronary artery bypass graft (CABG) surgery, renal impairment, and older age; in contrast, in men, older age was associated with better functioning. In women, previous CABG was associated with a 4-15 fold increased risk of impaired health status. Health status at 6 months was a predictor of all SF-36 domains at 12 months in both women and men. CONCLUSIONS: Women reported poorer health status compared with men 6 and 12 months post-PCI, and predictors of impaired health status generally differed for women and men. Further studies examining risk factors for adverse outcomes for women and men separately, which will lead to better risk stratification in research and clinical practice, are warranted.

The SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) study: design, rationale, and run-in phase.

BACKGROUND: Changes in the treatment of coronary artery disease both surgically and percutaneously have rendered the major randomized trials historical. Furthermore, the restrictive criteria of previous trials excluded most patients treated in daily practice. Although coronary surgery is still considered the current, evidence-based, gold-standard treatment of left main (LM) and 3-vessel coronary disease, the added benefit of drug-eluting stents has further expanded the use of percutaneous coronary intervention (PCI) beyond less complex populations in daily practice. STUDY DESIGN: The 1500-patient, prospective, multicenter, multinational (European and North American), randomized SYNTAX study with nested registries will enroll "all-comers." Consecutive patients with de novo 3-vessel disease (3VD) and/or LM disease will be screened for eligibility by the Heart Team (composed of an interventionalist, a cardiac surgeon, and the study coordinator) at each site and then allocated to either (1) the randomized cohort, if comparable revascularization can be achieved by either PCI or coronary artery bypass surgery (CABG), or (2) to one of the nested registries for CABG-ineligible patients (PCI registry) or for PCI-ineligible patients (CABG registry). Randomized patients will be stratified based on LM disease and diabetes by site. The primary end point for the randomized comparison is noninferiority of major adverse cardiac and cerebral events between the 2 groups at 1 year. To adequately project the expected enrollment rate per site, a run-in phase was mandated for each site interested in participating in the trial. Both cardiothoracic and interventional cardiology departments within the same institution were asked to complete a questionnaire regarding their frequency of treatment of LM and 3VD over a retrospective 3-month period. IMPLICATIONS: By replacing most traditional inclusion and exclusion criteria with the real-world decision between the cardiothoracic surgeon and the interventionalist, this study will define the roles of CABG and PCI using drug-eluting stents in the contemporary management of LM and 3VD. Results of the run-in phase were used by the steering committee to determine eligibility and to project enrollment for each site.

Long-term outcomes after stenting of bifurcation lesions with the "crush" technique: predictors of an adverse outcome.

OBJECTIVES: The purpose of this study was to evaluate predictors of an adverse outcome after "crush" bifurcation stenting. BACKGROUND: The "crush" technique is a recently introduced strategy with limited data regarding long-term outcomes. METHODS: We identified 231 consecutive patients treated with drug-eluting stent implantation with the "crush" technique for 241 de novo bifurcation lesions. Clinical follow-up was obtained in 99.6%. RESULTS: The in-hospital major adverse cardiac event (MACE) rate was 5.2%. At 9 months, 10 (4.3%) patients had an event consistent with possible post-procedural stent thrombosis. Survival free of target lesion revascularization (TLR) was 90.3%; the only independent predictor of TLR was left main stem (LMS) therapy (odds ratio [OR] 4.97; 95% confidence interval [CI] 2.00 to 12.37, p = 0.001). Survival free of MACE was 83.5% and independent predictors of MACE were LMS therapy (OR 3.79; 95% CI 1.76 to 8.14, p = 0.001) and treatment of patients with multivessel disease (OR 4.21; 95% CI 0.95 to 18.56, p = 0.058). Angiographic follow-up was obtained in 77% of lesions at 8.3 +/- 3.7 months. The mean late loss of the main vessel and side branch were 0.30 +/- 0.64 mm and 0.41 +/- 0.67 mm, respectively, with binary restenosis rates of 9.1% and 25.3%. Kissing balloon post-dilation significantly reduced the side branch late lumen loss (0.24 +/- 0.50 mm vs. 0.58 +/- 0.77 mm, p < 0.001). CONCLUSIONS: The crush technique of bifurcation stenting with drug-eluting stents is associated with favorable outcomes for most lesions; however, efficacy appears significantly reduced in LMS bifurcations, and further research is needed before the technique can be routinely recommended in this group. Furthermore, the incidence of possible stent thrombosis is of concern and requires further investigation. Kissing balloon post-dilatation is mandatory to reduce side branch restenosis.