Spontaneous Coronary Artery Dissection (SCAD) from an Interventionalist Perspective.

PURPOSE OF REVIEW: Spontaneous coronary artery dissection (SCAD) is an increasingly recognized cause of acute coronary syndrome (ACS), particularly among women < 50 years of age. Here, we aim to review the pathogenesis of SCAD, discuss SCAD as an initial manifestation of systemic arterial disease, and highlight invasive strategies as well as unique challenges in the care of women with SCAD. RECENT FINDINGS: A paradigm shift has occurred in the care of SCAD patients in the past decade as recommendations for conservative management have become widespread. Invasive interventions are reserved for patients with hemodynamic compromise or active ischemia due to increased periprocedural complications and failure rates. Certain patient populations have been identified for larger territory infarcts and proximal disease including patients with known connective tissue disease, premenopausal women, and patients with pregnancy-associated SCAD (P-SCAD). Current recommended management of SCAD is conservative. Despite a growing awareness of SCAD and its known association with systemic arteriopathies in women, evidence-based data remains scarce. Future studies focused on identifying genetic factors, optimal medical therapy after SCAD, and techniques to minimize interventional complications are needed.

SCAI expert consensus update on best practices in the cardiac catheterization laboratory: This statement was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) in April 2021.

The current document commissioned by the Society for Cardiovascular Angiography and Interventions (SCAI) and endorsed by the American College of Cardiology, the American Heart Association, and Heart Rhythm Society represents a comprehensive update to the 2012 and 2016 consensus documents on patient-centered best practices in the cardiac catheterization laboratory. Comprising updates to staffing and credentialing, as well as evidence-based updates to the pre-, intra-, and post-procedural logistics, clinical standards and patient flow, the document also includes an expanded section on CCL governance, administration, and approach to quality metrics. This update also acknowledges the collaboration with various specialties, including discussion of the heart team approach to management, and working with electrophysiology colleagues in particular. It is hoped that this document will be utilized by hospitals, health systems, as well as regulatory bodies involved in assuring and maintaining quality, safety, efficiency, and cost-effectiveness of patient throughput in this high volume area.

Impact of pre-hospital electrocardiograms on time to treatment and one year outcome in a rural regional ST-segment elevation myocardial infarction network.

BACKGROUND: Pre-hospital electrocardiograms (ECGs) are believed to reduce time to reperfusion in ST Segment Elevation Myocardial Infarction (STEMI) patients. Little is known of their impact on clinical outcomes in a rural setting. Geisinger regional STEMI network provides percutaneous coronary intervention (PCI) care to over a 100-mile radius in rural central Pennsylvania. METHODS: A retrospective analysis identified 280 consecutive STEMI patients treated with PCI between 1/1/09 and 8/31/11. Comparison between two STEMI groups was performed: 205 patients who were taken by the emergency medical system (EMS) to the nearest hospital (a non-PCI center), underwent an ECG revealing a STEMI, and were transported immediately to Geisinger Medical Center (GMC) for PCI (transfer group) versus 75 patients in whom a pre-hospital ECG was obtained and who were transported by EMS directly to Geisinger for PCI, bypassing the nearest hospital that did not perform PCI (the pre-hospital ECG group). RESULTS: Analysis of baseline characteristics revealed that the pre-hospital ECG cohort was older (65 vs. 60 years); had a higher percentage of previous myocardial infarctions (MI) (28% vs. 15%), heart failure (11% vs. 4%), and prior PCI (23% vs. 13%; p < 0.05 all comparisons). Median time from EMS contact to pre-hospital ECG in the pre-hospital ECG group was 5 minutes; from pre-hospital ECG to the GMC ED was 34 minutes. Median time from first medical contact (EMS contact) to reperfusion (device activation) was 79 versus 157 minutes (P < 0.001), respectively in pre-hospital ECG vs. transfer groups. Mortality in the two groups at 1 year was 4.1% in the pre-hospital ECG group versus 8.3% in the transfer group (P-value = 0.34). After adjusting for the difference in age between the two groups, the 62% reduction in 1 year mortality associated with having obtained a pre-hospital ECG was still not statistically significant (P-value = 0.19). CONCLUSION: In a rural regional STEMI network, pre-hospital ECGs decreased time from first medical contact to reperfusion by 50% and were associated with an excellent clinical outcome at 1 year. © 2016 Wiley Periodicals, Inc.

Women in interventional cardiology: Update in percutaneous coronary intervention practice patterns and outcomes of female operators from the National Cardiovascular Data Registry®.

OBJECTIVES: To examine the practice patterns and outcomes of percutaneous coronary intervention (PCI) procedures performed by female interventional cardiologists in the United States (U.S.). BACKGROUND: Little is known about the prevalence, volume, case mix, and outcomes of PCI procedures performed by female interventional cardiologists. METHODS: Using data from the National Cardiovascular Data Registry(®) , we performed a retrospective study of 2,465,685 PCI procedures performed at 1,431 U.S. hospitals between July 1, 2009 and June 30, 2013. Interventionalist sex was ascertained from the National Provider Identifier number of each operator. RESULTS: Women accounted for only 4% (412/9,179) of interventional cardiologists in the U.S., and performed 3% (n = 70,009) of all PCI procedures during the time period studied. Forty-one percent of female interventionalists operated at an institution with no other female operators. Female interventionalists performed a median of 48 PCI procedures per year (interquartile range: 22-87). Of the cases performed by female interventionalists, 77% were performed on patients with acute coronary syndrome, 3% on patients with cardiogenic shock, and 16% on call. In-hospital mortality was low (1.8%), and was not significantly different between female operators with high (≥50 cases/year) versus low (1.95% vs. 1.75%, unadjusted P = 0.12, adjusted OR: 1.03, 95% CI: 0.84-1.27) annual procedure volume. CONCLUSIONS: Female interventional cardiologists remain uncommon in contemporary U.S. practice. Performing only a very small proportion of PCI cases, female interventionalists are often low-volume operators, yet no significant differences in patient mortality were observed in low- versus high-volume operators.

Does Preoperative Platelet Function Predict Bleeding in Patients Undergoing Off Pump Coronary Artery Bypass Surgery?

OBJECTIVE: We sought to examine the relationship between preoperative platelet function and perioperative bleeding in patients undergoing CABG. BACKGROUND: There are many ways to measure platelet aggregability. Little is known about their correlations with one another, or with bleeding. METHODS: We prospectively studied 50 patients undergoing a first isolated off-pump CABG. Thirty-four were exposed to a thienopyridine prior to surgery; 16 were not. Preoperative platelet function was measured by VerifyNow®, TEG®, AggreGuide™, Plateletworks®, vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and light transmission aggregometry. Bleeding was assessed 2 ways: drop from pre- to nadir postoperative hematocrit, and chest tube drainage. Correlation coefficients were calculated using Spearman's rank-order correlation. RESULTS: Mean age was 62 years. Patient characteristics and surgical details were similar between the thienopyridine-exposed and non-exposed patients. The correlation coefficients between the 4 point-of-care platelet function measurements and hematocrit change ranged from -0.2274 to 0.2882. Only Plateletworks® correlated with drop in hematocrit (r = 0.2882, P = 0.0470). The correlation coefficients between each of the 4 point-of-care platelet function tests and the chest tube drainage were also poor, ranging from -0.3073 to 0.2272. Both AggreGuide™ (r = -0.3073, P = 0.0317) and VASP (r = -0.3187, P = 0.0272) were weakly but significantly correlated with chest tube drainage. The correlation among the 4 point-of-care platelet function measurements was poor, with coefficients ranging from -0.2504 to 0.1968. CONCLUSIONS: We observed little correlation among 4 platelet function tests, and between those assays and perioperative bleeding defined 2 different ways. Whether any of these assays should be used to guide decision making in individual patients is unclear.

Safety of coronary angiography and percutaneous coronary intervention via the radial versus femoral route in patients on uninterrupted oral anticoagulation with warfarin.

OBJECTIVE: To evaluate access site and other bleeding complications associated with radial versus femoral access in patients receiving oral anticoagulation (OAC) with warfarin. BACKGROUND: Patients receiving OAC with warfarin undergoing coronary angiography and percutaneous coronary intervention (PCI) may have OAC continued despite the risk of bleeding. To what extent arterial access site impacts bleeding in such patients is not well studied. METHODS: Over 6 years, we identified 255 consecutive patients in whom warfarin was continued who underwent coronary angiography with an international normalized ratio >1.8. A total of 97 patients also underwent PCI at the same setting (27% femoral vs 73% radial). The primary outcome was Bleeding Academic Research Consortium bleeds; a secondary end point was frequency of access site complications in the 72 hours post-PCI. Complications were evaluated based on the initial access site attempted. RESULTS: Minimal baseline clinical characteristics differences existed between the groups. International normalized ratio was significantly higher in the radial group (2.42 ± 0.67 vs 2.24 ± 0.49, P = .02). Bivalirudin use was greater during radial PCI than femoral (76% vs 42%, P < .05), whereas unfractionated heparin alone was greater during femoral PCI than radial (46% vs 18%, P < .05). No significant difference was seen in the primary end point between femoral (2.8%) and radial (1.6%, P = .54) during coronary angiography alone. However, PCI via the femoral artery had significantly more Bleeding Academic Research Consortium bleeding (19.2% vs 1.4%, P = .005) and transfusions (15% vs 0%, P = .004) than via the radial artery. Patients who underwent PCI using radial access were less likely to have any vascular or bleeding complications (1% vs 23%, P = .001). CONCLUSIONS: Patients who underwent coronary angiography during uninterrupted OAC had similar bleeding rates regardless of access site. However, when PCI was performed, radial access was associated with fewer bleeding and vascular complications than the femoral approach. CONDENSED ABSTRACT: We retrospectively identified 255 consecutive patients on warfarin who underwent coronary angiography, 97 of whom underwent a percutaneous coronary intervention. The data reveal a reduction in Bleeding Academic Research Consortium bleeds (1.6% vs 8.1%, P = .02) with radial versus femoral access. The radial approach was associated with an overall lower rate of any vascular or bleeding complication than the femoral approach during percutaneous coronary intervention (1% vs 23%, P = .001).

Frequency of coronary angiography and revascularization among men and women with myocardial infarction and their relationship to mortality at one year: an analysis of the Geisinger myocardial infarction cohort.

OBJECTIVES: To determine sex bias in the selection of strategies to evaluate patients with acute myocardial infarction (AMI), and determine if the choice of strategy influences survival. BACKGROUND: Controversy exists regarding the role of female sex in the use of invasive evaluation for AMI and its possible effect on adverse outcomes. METHODS: Electronic health record data from the Geisinger Acute Myocardial Infarction Cohort (GAMIC) was analyzed which included 1,968 men and 1,047 women admitted to the Geisinger Medical Center between January 2001 and December 2006 with acute myocardial infarction (AMI).Multivariate logistic regression analyses were used to determine independent correlates of an invasive evaluation. Multivariate logistic regression modeling stratified on sex was used to determine when invasive evaluation was done and whether there was a correlation with mortality. RESULTS: In unadjusted analyses, male sex was a significant predictor for the use of invasive evaluation (odds ratio = 1.71, 95% CI = [1.46, 2.00]). Adjusted for baseline differences (like age, renal function, co-morbid conditions) multivariate analyses found no significant relationship between male sex and invasive evaluation (OR = 1.02, 95% CI = [0.82, 1.23]). Females in the STEMI group were found to be less revascularized. No difference was observed in the one-year mortality between women and men regardless of invasive evaluation or revascularization. CONCLUSIONS: Sex was not independently associated with the occurrence of an invasive evaluation of a MI. Females in the STEMI group were less revascularized. There was no strong gender effect on survival irrespective of the performance on an invasive evaluation or revascularization.

Middle-of-the-night PCI does not affect subsequent day PCI success and complication rates by the same operator.

OBJECTIVE: To determine the impact of percutaneous coronary interventions (PCI) performed during late-night hours on next day PCI performance by the same interventional cardiologist. BACKGROUND: There is little data regarding the effects of sleep deprivation on interventional cardiologists performing PCIs. METHODS: All primary PCIs from January 1, 2005 to December 31, 2009 between 11 PM and 7 AM were identified. All PCIs performed during the subsequent work day by the same interventionists were included in the sleep-deprived group. All other PCIs were included in the non-sleep-deprived group. Data were entered prospectively into the American College of Cardiology National Cardiovascular Data Registry (NCDR). The two groups were compared with respect to efficacy and safety endpoints. RESULTS: During the 5-year period, 3,944 PCIs were performed by four operators, including 3,644 non-sleep-deprived cases and 167 sleep-deprived cases. The two groups were similar with respect to demographics, comorbidities, and procedural characteristics. There were more intraprocedural deaths in the sleep-deprived group (1.2% vs. 0.2%, P = 0.04); however, the adjusted odds ratio (OR) was nonsignificant (OR = 6.83, 95% confidence interval [CI] = 0.66-39.63, P = 0.11). Excessive bleeding at the arterial access site in the non-sleep-deprived group was more frequent (2.7% vs. 0%, P = 0.02). There were no differences in the combined safety or efficacy endpoints between the two groups. CONCLUSION: In this single-center study, we found no evidence that middle-of-the night procedures adversely affect safety or efficacy of procedures done the next day by the same operator.

Bivalirudin versus unfractionated heparin during percutaneous coronary intervention.

BACKGROUND: Whether bivalirudin is superior to unfractionated heparin in patients with stable or unstable angina who undergo percutaneous coronary intervention (PCI) after pretreatment with clopidogrel is unknown. METHODS: We enrolled 4570 patients with stable or unstable angina (with normal levels of troponin T and creatine kinase MB) who were undergoing PCI after pretreatment with a 600-mg dose of clopidogrel at least 2 hours before the procedure; 2289 patients were randomly assigned in a double-blind manner to receive bivalirudin, and 2281 to receive unfractionated heparin. The primary end point was the composite of death, myocardial infarction, urgent target-vessel revascularization due to myocardial ischemia within 30 days after randomization, or major bleeding during the index hospitalization (with a net clinical benefit defined as a reduction in the incidence of the end point). The secondary end point was the composite of death, myocardial infarction, or urgent target-vessel revascularization. RESULTS: The incidence of the primary end point was 8.3% (190 patients) in the bivalirudin group as compared with 8.7% (199 patients) in the unfractionated-heparin group (relative risk, 0.94; 95% confidence interval [CI], 0.77 to 1.15; P=0.57). The secondary end point occurred in 134 patients (5.9%) in the bivalirudin group and 115 patients (5.0%) in the unfractionated-heparin group (relative risk, 1.16; 95% CI, 0.91 to 1.49; P=0.23). The incidence of major bleeding was 3.1% (70 patients) in the bivalirudin group and 4.6% (104 patients) in the unfractionated-heparin group (relative risk, 0.66; 95% CI, 0.49 to 0.90; P=0.008). CONCLUSIONS: In patients with stable and unstable angina who underwent PCI after pretreatment with clopidogrel, bivalirudin did not provide a net clinical benefit (i.e., it did not reduce the incidence of the composite end point of death, myocardial infarction, urgent target-vessel revascularization, or major bleeding) as compared with unfractionated heparin, but it did significantly reduce the incidence of major bleeding. (ClinicalTrials.gov number, NCT00262054.)

Complications related to access site after percutaneous coronary interventions: are the adverse events underreported?

OBJECTIVES: The primary objective was to compare the NCDR rate of four access site related complications (arteriovenous fistula, pseudoaneurysm, retroperitoneal bleed, and blood transfusion) with that obtained independently within a Quality Improvement (QI) Database. The secondary objective was to determine the in-hospital mortality related to these complications. BACKGROUND: NCDR is the most comprehensive database of post-PCI patients and a method by which hospitals are compared for quality of care and outcomes. The collected data include in-hospital events only, therefore reporting for same day and/or early discharges may fail to capture adverse events. We hypothesized that the actual rate of complications post-PCI may be higher than the rate reported in NCDR. METHODS: Adverse events following PCIs were collected in a QI database. We compared the rate of four above mentioned complications between NCDR and our QI database for the time period between January 1, 2005 and December 31, 2008. RESULTS: A total of 3,940 PCIs were performed on 3,430 patients in the four-year interval. The incidence of the combined endpoint of the four adverse events was 4.1% (161 events) in NCDR, vs. 4.7% (186 events) in QI database, a 13% higher yield. There was significantly higher in-hospital mortality in the complication group with regards to both all cause (4.7% vs. 1.1%, P < 0.0001) and cardiovascular mortality (2.7% vs. 1%, P = 0.046). CONCLUSIONS: Access site related complications occurred 13% more than what was reported in NCDR and were associated with a greater than fourfold increase in in-hospital mortality.

SCAI consensus document on occupational radiation exposure to the pregnant cardiologist and technical personnel.

Concerns regarding radiation exposure and its effects during pregnancy are often quoted as an important barrier preventing many women from pursuing a career in Interventional Cardiology. Finding the true risk of radiation exposure from performing cardiac catheterization procedures can be challenging and guidelines for pregnancy exposure have been inadequate. The Women in Innovations group of Cardiologists with endorsement of the Society for Cardiovascular Angiography and Interventions aim to provide guidance in this publication by describing the risk of radiation exposure to pregnant physicians and cardiac catheterization personnel, to educate on appropriate radiation monitoring and to encourage mechanisms to reduce radiation exposure. Current data do not suggest a significant increased risk to the fetus of pregnant women in the cardiac catheterization laboratory and thus do not justify precluding pregnant physicians from performing procedures in the cardiac catheterization laboratory. However, radiation exposure among pregnant physicians should be properly monitored and adequate radiation safety measures are still warranted.

Transradial arterial access for coronary and peripheral procedures: executive summary by the Transradial Committee of the SCAI.

In response to growing U.S. interest, the Society for Coronary Angiography and Interventions recently formed a Transradial Committee whose purpose is to examine the utility, utilization, and training considerations related to transradial access for percutaneous coronary and peripheral procedures. With international partnership, the committee has composed a comprehensive overview of this subject presented here-with.

SCAI consensus document on occupational radiation exposure to the pregnant cardiologist and technical personnel.

Concerns regarding radiation exposure and its effects during pregnancy are often quoted as an important barrier preventing many women from pursuing a career in Interventional Cardiology. Finding the true risk of radiation exposure from performing cardiac catheterisation procedures can be challenging and guidelines for pregnancy exposure have been inadequate. The Women in Innovations group of Cardiologists with endorsement of the Society for Cardiovascular Angiography and Interventions aim to provide guidance in this publication by describing the risk of radiation exposure to pregnant physicians and cardiac catheterisation personnel, to educate on appropriate radiation monitoring and to encourage mechanisms to reduce radiation exposure. Current data do not suggest a significant increased risk to the foetus of pregnant women in the cardiac catheterisation laboratory and thus do not justify precluding pregnant physicians from performing procedures in the cardiac catheterisation laboratory. However, radiation exposure amongst pregnant physicians should be properly monitored and adequate radiation safety measures are still warranted.

Gender-based issues in interventional cardiology: a consensus statement from the Women in Innovations (WIN) Initiative.

Cardiovascular disease (CVD) is the leading cause of mortality in women, yet studies have suggested that it is often under-recognized. Of particular concern is the apparent suboptimal treatment of women in comparison to men, with less revascularization and use of evidence-based medications. The Women in Innovations group of cardiologists aims to highlight these issues and change perceptions to optimize the treatment of female patients with CVD, to support future research, and to encourage and guide the training of female interventional cardiologists.

Association of an INSIG2 obesity allele with cardiovascular phenotypes is gender and age dependent.

BACKGROUND: The INSIG2 gene has been implicated in cholesterol metabolism and a single nucleotide polymorphism (SNP) near INSIG2 has been shown to be associated with obesity. We sought to determine the relationship of the INSIG2 SNP to cardiovascular disease (CVD) related phenotypes. METHODS AND RESULTS: Nine hundred forty six patients undergoing percutaneous coronary intervention (PCI) in wave 5 of the multicenter NHLBI Dynamic Registry were genotyped using RT-PCR/TaqMan/allelic discrimination for the rs7566605 SNP near the INSIG2 gene. Clinical variables analyzed include demographics, medical history, and procedural details. The prevalence of peripheral vascular disease (PVD) was significantly higher in older men (≥65 years) who were either homozygous or carriers of the obesity/lipid risk allele ("C") compared to non-carriers (odds ratio 3.4, p = 0.013) using a logistic regression model incorporating history of hypercholesterolemia, history of hypertension, cerebrovascular disease, history of diabetes, and BMI. A similar relationship with cerebrovascular disease was found in older (>65) women (odds ratio 3.4, p = 0.013). The INSIG2 SNP was not associated with BMI, nor with other clinical variables. CONCLUSION: Age and gender may influence the association of the INSIG2 obesity SNP with PVD and cerebrovascular disease in patients with pre-existing CVD.

Feasibility and Utility of a Cardiovascular Risk Screening Tool in Women Undergoing Routine Gynecology Evaluation.

Background: The goals of this multicenter survey were to examine the prevalence and patient awareness of cardiovascular risk factors, and the association between history of adverse pregnancy outcomes (APO­including gestational hypertension, gestational diabetes, and preeclampsia) and prevalence of cardiovascular risks among women presenting to outpatient obstetrics/gynecology (OB/GYN) clinics. Materials and Methods: We surveyed 2,946 female patients attending 16 outpatient OB/GYN clinics across the United States between January 2010 and January 2012. Main outcome measures were self-reported cardiovascular risk factors and symptoms such as angina and dyspnea. Results: Mean age of the patients was 51 ± 13.6 years. Cardiovascular risks and symptoms were highly prevalent (86.0% and 40.1%, respectively). Many patients did not know if they had common risk factors such as hypertension, hypercholesterolemia, or diabetes (18.4%, 32.0%, and 17.9%, respectively). Women with a history of APO were slightly more likely to be aware of common risk factors, including abnormal blood pressure (17% vs. 18.6%), high cholesterol (31.7% vs. 32%), and obesity/elevated body mass index (43.9% vs. 49.7%). Compared with patients with no history of APO, patients with APO (n = 380, 12.9%) were more likely to have risk factors (89.5% vs. 83.9%, p = 0.002) and symptoms (45.5% vs. 39.3%, p = 0.02). Conclusions: Awareness of cardiovascular risk factors and symptoms among all women surveyed in this study was poor, although awareness for some risk factors was relatively higher among patients with APO. This study demonstrates the feasibility of cardiovascular assessment in OB/GYN clinics using a simple questionnaire and its potential role for early recognition and timely intervention.

Efficiency, Safety, and Quality of Life After Transcatheter Aortic Valve Implantation Performed With Moderate Sedation Versus General Anesthesia.

There is growing interest in "minimalist" transcatheter aortic valve implantation (M-TAVI), performed with conscious sedation instead of general anesthesia (GA-TAVI). We assessed the impact of M-TAVI on procedural efficiency, long-term safety, and quality of life (QoL) in 477 patients with severe aortic stenosis (82 years, women 50%, STS 5.0), who underwent M-TAVI (n = 278) or GA-TAVI (n = 199). M-TAVI patients were less likely to have NYHA Class ≥3, valve-in-valve TAVI, and receive self-expanding valves. M-TAVI was completed without conversion to GA in 269 (97%) patients. M-TAVI was more efficient that GA-TAVI including shorter lengths of stay (2 vs 3 days, p <0.0001), higher likelihood of being discharged home (87% vs 72%, p <0.0001), less use of blood transfusions (10% vs 22%, p = 0.0008), inotropes (13% vs 32%, p <0.0001), contrast volume (50 vs 90 ml, p <0.0001), fluoroscopy time (20 vs 24 minute, p <0.0001), and need for >1 valves (0.4 vs 5.5%, p = 0.0004). At 1-month, death/stroke (M-TAVI vs GA-TAVI 4.0 vs 6.5%) and a "safety composite" end point (death, stroke, transient ischemic attack, myocardial infarction, new dialysis, major vascular complication, major or life-threatening bleeding, and new pacemaker: 17.6% vs 21.1%) were similar (p = NS for both). At a median follow-up of 365 days, survival curves showed similar incidence of death/stroke as well as the safety composite end point between the groups. QoL scores were similar at baseline and 1-month after TAVI. In multivariable analyses, M-TAVI showed significant improvements in all parameters of procedural efficiency. In conclusion, M-TAVI is more efficient than GA-TAVI, with similar safety at 1-month and long-term, and similar QoL scores at 1 month.

ST-elevation myocardial infarction patients can be enrolled in randomized trials before emergent coronary intervention without sacrificing door-to-balloon time.

BACKGROUND: Multicenter trials are necessary to compare the effectiveness of new drugs and devices for patients with ST-elevation myocardial infarction (STEMI) percutaneous coronary intervention (PCI). However, enrollment of STEMI patients in clinical trials could be detrimental to patients if it significantly delayed reperfusion therapy. We sought to determine whether STEMI patients treated with PCI could be enrolled in clinical trials without prolonging door-to-balloon times. METHODS: At a single PCI center between October 17, 2004, and December 31, 2007, patients were enrolled in 1 of 4 trials requiring central enrollment and informed consent if (1) a study was actively enrolling, (2) the patient met inclusion/exclusion criteria, (3) and a study nurse was available. Median door-to-balloon times were compared for patients enrolled in clinical trials compared to those not enrolled. RESULTS: Of 581 STEMI patients treated with PCI, 123 were enrolled in clinical trials and 458 were not. For patients transferred for PCI, community hospital door-to-balloon times were similar for research and nonresearch patients (104 vs 108 minutes, P = .4). For patients presenting directly to the PCI center, median door-to-balloon times were similar for research (55 minutes) and nonresearch patients (44 minutes, P = .5) after adjustment for age, culprit artery, and operator. CONCLUSIONS: Patients with STEMI may be enrolled in clinical trials with no significant delay in achieving reperfusion. For patients presenting directly to the PCI center, median door-to-balloon times well under 90 minutes can be achieved even with enrollment into clinical trials.