BACKGROUNDThe preferred initial treatment for patients with stable coronary artery disease is the best available medical therapy. We hypothesized that in patients with functionally significant stenoses, as determined by measurement of fractional flow reserve (FFR), percutaneous coronary intervention (PCI) plus the best available medical therapy would be superior to the best available medical therapy alone.METHODSIn patients with stable coronary artery disease for whom PCI was being considered, we assessed all stenoses by measuring FFR. Patients in whom at least one stenosis was functionally significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus the best available medical therapy (PCI group) or the best available medical therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received the best available medical therapy. The primary end point was a composite of death, myocardial infarction, or urgent revascularization.RESULTSRecruitment was halted prematurely after enrollment of 1220 patients (888 who underwent randomization and 332 enrolled in the registry) because of a significant between-group difference in the percentage of patients who had a primary end-point event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P<0.001). The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (1.6% vs. 11.1%; hazard ratio, 0.13; 95% CI, 0.06 to 0.30; P<0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (hazard ratio, 0.13; 95% CI, 0.04 to 0.43; P<0.001). Among patients in the registry, 3.0% had a primary end-point event.CONCLUSIONSIn patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best available medical therapy alone, decreased the need for urgent revascularization. In patients without ischemia, the outcome appeared to be favorable with the best available medical therapy alone. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT01132495.).

Background— The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial was designed to compare optimal medical therapy alone versus optimal medical therapy and percutaneous coronary intervention (PCI) for treatment of patients with stable coronary artery disease and showed equal efficacy for optimal medical therapy with or without PCI. The impact of results from the COURAGE trial on clinical practice is unknown. Methods and Results— We analyzed 26 388 consecutive patients from the Northern New England Cardiovascular Disease PCI Registry who underwent PCI between January 2006 and June 2009. We identified a COURAGE-like patient group as patients who were undergoing (1) an elective procedure; (2) for an indication of stable angina; and (3) on the day of admission (ie, the date of admission was the same as the procedure date). All other PCI patients were placed in an “other indications” cohort. We compared temporal trends in overall volume in PCI for stable angina and for other indications, comparing quarterly time periods before and after release of COURAGE in March 2007. Over the study period, there was a statistically significant decrease in total PCI volume from 2064 in Quarter 1 2006 (before COURAGE) to 1708 in Quarter 3 2007 (after COURAGE) (P<0.01). These trends were sustained through June 2009, with an approximate 16% peak relative reduction in all PCI compared with before COURAGE. As a percentage of all PCI, stable angina reached a high of 20.9% before COURAGE and began to decrease immediately after publication of COURAGE in Quarter 2 2007 to 16.1% (P<0.01). Among patients undergoing PCI for stable angina, there was a significant 26% peak decrease in post-COURAGE PCI volumes compared with pre-COURAGE Quarter 1 2006 (P trend, 0.01), which was maintained through the end of the study period. Conclusions— Publication of results from the COURAGE trial was temporally associated with a significant and sustained decline in the use of PCI to treat patients with stable angina. The long-term impact of this change in practice on patient outcomes remains to be determined.

Background-Women are at a higher risk for bleeding/vascular complications (VC) related to cardiovascular procedures. Although the overall incidence of percutaneous coronary intervention (PCI)-related bleeding/VC has declined, the impact of this decline, specifically in women, is unknown.Methods and Results-We studied 13 653 female and 32 334 male consecutive cases, from 2002 to 2007, in the Northern New England PCI Registry. We sought to (1) compare absolute rates of bleeding/VC in women and men over time, (2) define predictors of bleeding/VC in women and men undergoing PCI, and (3) trend the impact of female gender in predicting bleeding/VC over time. Bleeding/VC was defined as any access-site vessel injury requiring surgical intervention or bleeding requiring transfusion. The overall risk of bleeding/VC was significantly higher in women versus men (4.5 +/- 1.3% versus 1.6 +/- 0.5%; P < 0.004). Over time, there was a significant (P < 0.001) 50% decrease in absolute bleeding/VC rates in both women and men. After adjustment for baseline differences, female gender remained a significant predictor of increased risk in 2007 (odds ratio, 2.6; 95% CI, 1.74 to 3.91). Independent predictors of increased risk of bleeding/VC in women included older age, shock, renal failure, presentation with non-ST-elevation myocardial infraction and larger sheath sizes, whereas the use of fluoroscopy-guided access, closure devices, history of dyslipidemia or prior PCI, and use of bivalirudin were protective.Conclusion-Women undergoing PCI have had a significant decline in bleeding/VC rates during the last 6 years. Despite the improvement in procedural safety, female gender continues to be associated with a > 2-fold risk of bleeding/VC compared with men. (Circ Cardiovasc Intervent. 2009;2:423-429.)

Background-Randomized trials comparing coronary artery bypass graft surgery (CABG) with percutaneous coronary interventions (PCIs) for patients with multivessel coronary disease (MVD) report similar long-term survival for CABG and PCI. These studies used a highly selected population of patients and providers, and their results may not be generalizable to actual care. Our goal in this study was to compare long-term survival of MVD patients treated with CABG vs PCI in contemporary practice.Methods and Results-From our northern New England registries of consecutive coronary revascularizations, we identified 10 198 CABG and 4295 PCI patients with MVD who may have been eligible for either procedure between 1994 and 2001. Vital status was obtained by linkage to the National Death Index. Proportional-hazards regression was used to calculate hazard ratios (HRs) for survival in CABG vs PCI patients after adjustment for comorbidities and disease characteristics. CABG patients were older; had more comorbidities, more 3-vessel disease, and lower ejection fractions; and were more completely revascularized. Adjusted long-term survival for patients with 3-vessel disease was better after CABG than PCI (HR, 0.60; P < 0.01) but not for patients with 2-vessel disease (HR, 0.98; P=0.77). The survival advantage of CABG for 3-vessel disease patients was present in all patient populations, including women, diabetics, and the elderly and in the era of high stent utilization.Conclusions-In contemporary practice, survival for patients with 3-vessel coronary disease is better after CABG than PCI, an observation that patients and physicians should carefully consider when deciding on a revascularization strategy.

OBJECTIVES We sought to determine whether the changing practice of interventional cardiology has been associated with improved outcomes for women, and how these outcomes compare with those for men.BACKGROUND Previous work from the early 1990s suggested women are at a higher risk than men for adverse outcomes after percutaneous coronary interventions (PCIs).METHODS From 1994 to 1999 data were collected on 33,666 consecutive hospital admissions for a PCI in Northern New England. Multivariate models were used to adjust for diffierences in case-mix across year of procedure when comparing outcomes. Direct standardization was used to calculate adjusted rates.RESULTS From 1994 to 1999, the case-mix worsened for both women and men, although women had more co-morbidities than did men throughout the period. Stent use increased over time (> 75% in 1999). Concomitantly, the need for emergency coronary artery bypass graft surgery (CABG) decreased significantly (p(trend) less than or equal to 0.001; in 1999: 0.06% for women, 0.05% for men). Although the emergency CABG rates were higher for women at the beginning of the study, by the end, they were comparable (adjusted odds ratio 1.34, 95% confidence interval 0.76 to 2.38, p = 0.315). The myocardial infarction (MI) rates decreased over time for both women (by 29.7%, p(trend) = 0.378) and men (by 37.6%, p(trend) = 0.009) and did not differ by gender. The mortality rates did not decrease significantly over time and were not significantly different between the genders (mean 1.21% for women, 1.06% for men; p = 0.096).CONCLUSIONS Concurrent with the changing practice of PCI, and despite treating sicker patients, there have been important improvements in post-PCI CABG and MI rates for women, as well as for men. Unlike in earlier years, there are no longer significant differences in outcomes by gender. (C) 2002 by the American College of Cardiology Foundation.

“Ad hoc” percutaneous coronary interventions (PCIs)—those performed immediately after diagnostic catheterization—have been reported in earlier studies to be safe with a suggestion of higher risk in certain subgroups. Despite increasing use of this strategy, no data are available in recent years with new device technology. We studied use of an ad hoc strategy in a large regional population to determine its use and outcomes compared with staged procedures. A database from the 6 centers performing PCIs in northern New England and 1 center in Massachusetts was analyzed. During 1997, excluding only patients requiring emergency procedures or those with a prior PCI, 4,136 PCIs were performed, 1,748 (42.3%) of these being ad hoc procedures. Patients having ad hoc procedures were less likely to have peripheral vascular disease, renal failure, prior myocardial infarction, or coronary artery bypass surgery, congestive heart failure, or poor left ventricular function, and more likely to have received preprocedural intravenous heparin or nitroglycerin or to have required an urgent procedure. Narrowings treated during ad hoc procedures were less frequently types B and C or in saphenous vein grafts. Adjusted rates of clinical success were not different between ad hoc and non-ad hoc procedures (93.7% vs 93.6%); there was no difference in the incidence of death (0.6% vs 0.5%), emergency (0.9% vs 0.8%) or any (1.4% vs 0.8%) coronary artery bypass surgery, or myocardial infraction (2.6% vs 2.0%). As currently practiced in our region, ad hoc intervention is used selectively with outcomes similar for ad hoc and non-ad hoc procedures.

OBJECTIVES The purpose of this study was to examine the relationship between annual operator volume and outcomes of percutaneous coronary interventions (PCIs) using contemporaneous data.BACKGROUND The 1997 American College of Cardiology (ACC)/American Heart Association task force based their recommendation that interventionists perform greater than or equal to 75 procedures per year to maintain competency in PCI on data collected largely in the early 1990s. The practice of interventional cardiology has since changed with the availability of new devices and drugs.METHODS Data were collected from 1994 through 1996 on 15,080 PCIs performed during 14,498 hospitalizations by 47 interventional cardiologists practicing at the five high volume (>600 procedures per hospital per year) hospitals in northern New England and one Massachusetts-based institution that support these procedures. Operators were categorized into terciles based on their annualized volume of procedures. Multivariate regression analysis was used to control for case-mix. In-hospital outcomes included death, emergency coronary artery bypass graft surgery (eCABG), non-emergency CABG (non-eCABG), myocardial infarction (MI), death and clinical success (greater than or equal to 1 attempted lesion dilated to <50% residual stenosis and no death, CABG or MI).RESULTS Average annual procedure rates varied across terciles from low = 68, middle = 115 and high = 209. After adjusting for case-mix, clinical success rates were comparable across terciles (low, middle and high terciles: 90.9%, 88.8% and 90.7%, p(trend) = 0.237), as were all the adverse outcomes including death (low-risk patients = 0.45%, 0.41%, 0.71%, p(trend) = 0.086; high-risk patients = 5.68%, 5.99%, 7.23%, p(trend) = 0.324), eCABG (1.74%, 2.05%, 1.75%, p(trend) = 0.733) and MI (2.57%, 1.90%, 1.86%, p(trend) = 0.065).CONCLUSIONS Using current data, there is no significant relationship between operator Volumes averaging greater than or equal to 68 per year and outcomes at high Volume hospitals. Future efforts should be directed at determining the generalizability of these results. (C) 1999 by the American College of Cardiology.

We sought to determine whether there is a relation between operator volume and outcomes for percutaneous coronary interventions (PCIs).A 1993 American College of Cardiology/American Heart Association task force stated that cardiologists should perform > or = 75 procedures/year to maintain competency in PCIs; however, there were limited data available to support this statement.Data were collected from 1990 through 1993 on 12,988 PCIs (12,118 consecutive hospital admissions) performed by 31 cardiologists at two hospitals in New Hampshire and two in Maine and one hospital in Massachusetts supporting these procedures. Operators were categorized into terciles based on annualized volume of procedures. Univariate and multivariate regression analyses were used to control for case-mix. Successful outcomes included angiographic success (all lesions attempted dilated to < 50% residual stenosis) and clinical success (at least one lesion dilated to < 50% residual stenosis and no adverse outcomes). In-hospital adverse outcomes included coronary artery bypass graft surgery (CABG), myocardial infarction (MI) and death.After adjustment for case-mix, higher angiographic (low, middle and high terciles: 84.7%, 86.1% and 90.3%, p-trend 0.006) and clinical success rates (85.8%, 88.0% and 90.7%, p-trend 0.025), with fewer referrals to CABG (4.54%, 3.75% and 2.49%, p-trend <0.001), were seen as operator volume increased. There was a trend toward higher MI rates for high volume operators (2.00%, 1.98% and 2.57%, p-trend 0.06); all terciles had similar in-hospital mortality rates (1.09%, 0.96% and 1.05%, p-trend 0.8).There is a significant relation between operator volume and outcomes in PCIs. Efforts should be directed toward understanding why high volume operators are more successful and encounter fewer adverse outcomes.

We report on 521 patients ≥ 80 years old (AGED) from a regional, populationbased study of 12,902 hospitalizations for PTCA between 10/89-12/93. Over this time period, the proportion of AGED doubled to 4.4%. Compared to younger patients, AGED were more likely female, had fewer cardiac risk factors and more severe coronary disease. They had more urgent procedures and more complex lesion type. AGED clinical success was 91.36%. Their risk of nonfatal MI or CABG was similar to younger patients.Age ≤ 5960-6970–79 ≥ 80Empty Cell(n = 5591)(n = 3968)(n = 2822)(n = 521)Female (%)22.433.245.556.5†Smokers (%)47.627.216.010.4†Multiwvessel disease (%)31.939.845.157.9†Lesion type B/C (%)50.753.053.459.6†Priority urgent (%)57.558.661.972.2†Nonfatal MIlCABG (%)4.595.094.53519Death (%)0.270.761.913.45†Clinical Success* (%)95.1494.1593.5691.36†Multivariate OR Death (%)12.466.339.09†P < 001*(no MI/CABG/Death and ≥ 1 lesions dilated. P < 001 (no MI/CABG/Death and ≥ 1 lesions dilated. Their risk of death was substantially increased and remained increased in a multivariate model controlling for risk factors. We conclude that clinical success following PTCA for the AGED is good. However, they have an increased risk of fatal outcomes following PTCA. This information may be helpful in counseling the rapidly growing number of AGED patients contemplating PTCA.

outcomes included coronary artery bypass graft surgery (CABG), myocardial infarction (MI) and death. Results. After adjustment for case-mix, higher angiographic (low, middle and high terciles: 84.7%, 86.1% and 90.3%, p-trend 0.006) and clinical success rates (85.8%, 88.0% and 90.7%, p-trend 0.025), with fewer referrals to CABG (4.54%, 3.75% and 2.49%, p-trend <0.001), were seen as operator volume increased. There was a trend toward higher MI rates for high volume operators (2.00%, 1.98% and 2.57%, p-trend 0.06); all terciles had similar in-hospital mortality rates (1.09%, 0.96% and 1.05%, p-trend 0.8).