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John S Douglas

Publications and source records attributed to John S Douglas.

17 recordsLinked to original sources
PubMed2006

Integrated coronary revascularization with drug-eluting stents: immediate and seven-month outcome.

OBJECTIVE: We sought to demonstrate the safety and feasibility of an integrated coronary revascularization strategy that combines minimally invasive left internal thoracic artery to left anterior descending coronary artery anastomosis with drug-eluting stent implantation to non-left anterior descending coronary artery lesions. METHODS: Over 18 months, 47 consecutive patients with multivessel coronary artery disease underwent thoracoscopic harvesting of the left internal thoracic artery to graft the left anterior descending coronary artery. Anastomoses were constructed by hand, off-pump, and under direct vision through a 4-cm non-rib-spreading, muscle-sparing chest incision. Non-left anterior descending coronary artery lesions were then treated percutaneously using sirolimus- or paclitaxel-eluting stents. Angiographic follow-up was performed in all patients. RESULTS: Within the first 90 days of hospitalizations, there were no deaths, myocardial infarctions, neurologic events, or wound complications. Forty patients underwent left internal thoracic artery to left anterior descending coronary artery grafting, and 7 patients underwent left internal thoracic artery to left anterior descending coronary artery/diagonal sequential grafting for a total of 54 anastomoses. Angiographic patency scores were FitzGibbon A 96.2% (52/54) and FitzGibbon A + B 100% (54/54). A total of 65 drug-eluting stents were implanted in 61 non-left anterior descending coronary artery coronary lesions of which 49.1% (30/61) were type B2 or C lesions, including 5 left main lesions. Diabetes was present in 53.2% of patients (25/47). At a mean follow-up time of 7.0 +/- 4.8 months, the target lesion or vessel repeat revascularization rate was 6.6% (4/61) for drug-eluting stents and 1.9% (1/54) for left internal thoracic artery to left anterior descending coronary artery grafting. One anastomosis required balloon dilation, but no patients have required repeat coronary artery bypass grafting. CONCLUSIONS: Integrated coronary revascularization using drug-eluting stents is feasible and safe. There are sufficient data to justify a randomized comparison of integrated coronary revascularization with standard coronary artery bypass grafting.

Adult↗
PubMed2006

Reduced 6-month resource use and costs associated with cilostazol in patients after successful coronary stent implantation: results from the Cilostazol for RESTenosis (CREST) trial.

BACKGROUND: The CREST trial demonstrated that after successful coronary stent implantation, the 6-month rate of target vessel revascularization (TVR) was similar (15.4% vs 16%, P = .90) for the 2 treatment groups, but restenosis rate was lower (22.0% vs 34.5%, P = .002) in cilostazol-treated patients. We sought to evaluate resource use, cost, and cost-effectiveness of cilostazol in CREST. METHODS: A total of 705 patients were randomized to cilostazol 100 mg twice daily (n = 354) versus placebo (n = 351) for 6 months. Resources included rehospitalizations, medications, and outpatient services. Costs were determined from the Medicare fee schedule. Cilostazol was priced at 1.64 dollars a day. Base-case cost and cost-effectiveness analysis was performed for the entire population using TVR as a measure of effectiveness. Sensitivity analysis was conducted among 526 patients because restenosis data were available only for this patient population. A bootstrap resample approach (5000 samples) was used to obtain confidence intervals for cost differences. RESULTS: For the entire population, costs of rehospitalizations, concomitant medications, outpatient tests, and physician or emergency department visits were lower during follow-up for cilostazol-treated patients. Overall, total 6-month follow-up costs remained 447 dollars lower for cilostazol (4178 dollars vs 4625 dollars), although this difference did not reach significance (95% CI -1458 dollars to 515 dollars). Cilostazol is likely a cost-saving strategy (similar rate of TVR and lower costs). Sensitivity analysis showed that cilostazol is likely a dominant strategy (lower restenosis rate and costs, 85% dominant, 88.9% <1000 dollars per restenosis averted). CONCLUSIONS: Treatment with cilostazol is likely a cost-saving or dominant strategy in patients with successful coronary bare metal stent implantation. Cilostazol may offer a low-cost alternative to restenosis prevention in patients who do not receive drug-eluting stents.

Adult↗
PubMed2006

Impact of diabetes on five-year outcomes after vein graft interventions performed prior to the drug-eluting stent era.

OBJECTIVE: The aim of this study was to evaluate the differences in 5-year outcomes among diabetic and nondiabetic patients undergoing saphenous vein graft (SVG) percutaneous coronary intervention (PCI) prior to the era of distal protection and drug-eluting stents. BACKGROUND: PCI of native coronary arteries is known to be associated with higher rates of adverse outcomes in diabetic patients compared to nondiabetic patients. However, the impact of diabetes on long-term outcomes after SVG interventions is not as well established. We conducted an evaluation of 5-year outcomes after SVG PCI in the two decades prior to the availability of distal protection devices and drug-eluting stents. METHODS: Data on 2,556 subjects (1,780 nondiabetic and 776 diabetic) undergoing SVG PCI at Emory Hospital from 1981 to 2001 were collected and entered into a computerized database and analyzed for adverse cardiovascular outcomes. RESULTS: Compared to the nondiabetic group, the diabetic group had worse 1-year (87.7% vs. 94.9%; p < 0.0001) and 5-year survival rates (62.9% vs. 78.5%; p < 0.0001). In the subset of patients receiving stents, 5-year survival remained significantly worse in the diabetic group (78.2% vs. 87.1%; p = 0.009). After multivariate analysis, diabetes was an independent predictor of 5-year mortality (hazard ratio = 1.8; 95% CI = 1.5-2.5; p < 0.0001). CONCLUSION: Diabetic patients undergoing vein graft PCI prior to the distal protection and drug-eluting stent era had significantly worse long-term outcomes compared to nondiabetic patients. The effect on long-term outcomes using these newer devices in diabetic subjects undergoing SVG PCI must be established for a true assessment of their impact.

Angioplasty, Balloon, Coronary↗
PubMed2005

Role of adjunct pharmacologic therapy in the era of drug-eluting stents.

The success of percutaneous coronary intervention (PCI) has historically been limited by a relatively high rate of restenosis, a response of the coronary artery to trauma induced during PCI. Bare-metal stents, by providing a supportive intravascular scaffolding, have significantly reduced the incidence of restenosis compared with traditional balloon PCI. However, significant loss of lumen within the bare-metal device (in-stent restenosis) occurs in 10-30% of patients within 6 months of the procedure. The recent introduction of drug-eluting stents, permitting local delivery of high concentrations of immunosuppressive or anti-proliferative agents, promises to prevent the processes underlying restenosis. Although these devices have been successful in providing an incremental reduction in rates of restenosis, they are expensive. To date, clinical trials of pharmacologic treatment have failed to demonstrate a clinically significant impact on restenosis. Recently, results of the Cilostazol for Restenosis (CREST) trial, a randomized, double-blind study, show that cilostazol reduces the risk of restenosis in patients who receive bare-metal stents, including high-risk patients. Effective adjunct pharmacologic therapy to prevent in-stent restenosis, therefore, remains desirable, particularly in patients receiving bare-metal stents, and potentially in patients receiving drug-eluting stents who are at high risk for restenosis (i.e., those with diabetes, long lesions, and small vessels).

Angioplasty, Balloon, Coronary↗
PubMed2005

Coronary stent restenosis in patients treated with cilostazol.

BACKGROUND: Restenosis after implantation of coronary artery stents remains a significant clinical problem. We undertook a randomized, double-blind, placebo-controlled trial to determine whether cilostazol, a drug that suppresses intimal proliferation, would reduce renarrowing in patients after stent implantation in native coronary arteries. METHODS AND RESULTS: We assigned 705 patients who had successful coronary stent implantation to receive, in addition to aspirin, cilostazol 100 mg BID or placebo for 6 months; clopidogrel 75 mg daily was administered to all patients for 30 days. Restenosis was determined by quantitative coronary angiography at 6 months. The minimal luminal diameter at 6 months for cilostazol-treated patients was 1.77 mm for the analysis segment (stent plus 5-mm borders) compared with 1.62 mm in the placebo group (P=0.01). Restenosis, defined as > or =50% narrowing, occurred in 22.0% of patients in the cilostazol group and in 34.5% of the placebo group (P=0.002), a 36% relative risk reduction. Restenosis was significantly lower in cilostazol-treated diabetics (17.7% versus 37.7%, P=0.01) and in those with small vessels (23.6% versus 35.2%, P=0.02), long lesions (29.9% versus 46.6%, P=0.04), and left anterior descending coronary artery site (19.3% versus 39.8%, P=0.001). There was no difference in bleeding, rehospitalization, target-vessel revascularization, myocardial infarction, or death. CONCLUSIONS: Treatment with the drug cilostazol resulted in a significantly larger minimal luminal diameter and a significantly lower binary restenosis rate compared with placebo-treated patients. These favorable effects were apparent in patients at high risk for restenosis.

Aged↗
PubMed2004

Comparison of outcomes of percutaneous coronary intervention of ostial versus nonostial narrowing of the major epicardial coronary arteries.

Outcomes of percutaneous coronary intervention (PCI) of the ostia of the major epicardial coronary arteries in the modern era of stenting have not been clearly defined. We evaluated data from all PCIs performed from 1998 to 2001 in the proximal segments of the major epicardial coronary arteries entered into a large cardiac database and compared ostial with nonostial PCI outcomes. Of 2,484 patients who underwent PCI of a proximal coronary artery (left anterior descending, left circumflex, or right coronary), 223 patients had ostial narrowing and 2,261 patients had proximal, nonostial narrowing. Baseline characteristics were similar between the 2 groups, except that patients with ostial narrowing tended to be older and have shorter narrowings than did patients with nonostial narrowings. Stenting occurred in 89% of all patients and was similar in patients with ostial or nonostial narrowings. Procedural success was the same for ostial and nonostial PCI (96% vs 95%, p = 0.95). One-year event-free survival rate was lower in patients who underwent ostial PCI (69% vs 80%, p = 0.0019), largely due to a greater need for repeat PCI (19% vs 10%, p <0.0001). Multivariate analysis showed that ostial location, age, angina class, and number of diseased vessels were independent predictors of the occurrence of cardiac events. PCI of ostial narrowings of the major epicardial coronary arteries was relatively safe. However, at 1 year, patients who underwent ostial PCI had an increased rate of repeat revascularization compared with patients who underwent nonostial, proximal PCI.

Aged↗
PubMed2004

Methods for the economic and quality of life supplement to the cilostazol for RESTenosis (CREST) trial.

OBJECTIVE: To determine economic and quality of life outcomes for the Cilostazol for RESTenosis (CREST) trial, which is investigating the efficacy of cilostazol vs. placebo in preventing post-stent restenosis. DESIGN: CREST is a prospective, multicenter, randomized, placebo-controlled, double-blind trial. SETTING: 20 clinical sites; the Emory Center for Outcomes Research (ECOR) will serve as the economic and data coordinating center. PATIENTS: 705 patients (>18 years) who have undergone successful, uncomplicated placement of an intracoronary stent in a native coronary artery. INTERVENTION: Cilostazol (100 mg twice daily) or placebo for 6 months. OUTCOME MEASURES COSTS: Primary endpoint, total direct medical costs at 6 months; secondary endpoints, initial hospital costs and follow-up costs. QOL: Health-related quality of life (QOL) will be assessed using the EQ-5D and the Seattle Angina Questionnaire at baseline and at 1, 3, and 6 months. Cost-effectiveness analysis: Preliminary data show that cilostazol is clinically superior to placebo and if the mean cost for the cilostazol arm is higher than that for placebo, cost-effectiveness analysis will be determined for the cost per episode of restenosis prevented, the cost per episode of major clinical and angiographic endpoints averted, and the cost per quality-adjusted life-years gained.

Angioplasty, Balloon, Coronary↗
PubMed2003

Ethnic differences in the presentation, treatment strategy, and outcomes of percutaneous coronary intervention (a report from the National Heart, Lung, and Blood Institute Dynamic Registry).

Information about the impact of race/ethnicity on adverse outcomes after percutaneous coronary intervention (PCI) in the modern era is limited. Using consecutive patients from the National Heart, Lung, and Blood Institute Dynamic Registry, this study investigated differences in clinical presentation, treatment strategy, and acute and long-term outcomes in 3,669 white, 446 black, 301 Hispanic, and 201 Asian patients who underwent PCI. All comparisons were made to whites. Blacks were more likely than whites to be younger, women, and to present with a higher prevalence of cardiovascular risk factors (hypertension, diabetes, and smoking). Hispanics tended to be younger, hypertensive, diabetic, and to be undergoing their first cardiovascular procedure. Asians were, on average, younger, men, and presented more often with hypertension and diabetes than whites. Although the rate of stent implantation was significantly lower in blacks compared with whites (63% vs 74%, p <0.001), angiographic and procedural success rates were high (> or =95%) and did not differ by race/ethnicity. In-hospital mortality (0.2% vs 1.7%, p <0.05) and death/myocardial infarction (MI)/coronary artery bypass grafting (CABG) (3.1% vs 5.5%, p <0.05) were lower in blacks. All other in-hospital complications were similar to whites. At 1 year, there were no statistical differences in cumulative adverse event rates by ethnicity; however by 2 years there was a modestly higher mortality rate (adjusted RR 1.87; 95% confidence interval 1.15 to 3.04) and adverse event rate (death/MI, death/MI/CABG) among black patients. Thus, although differences in patient demographics, clinical presentation, angiographic characteristics and treatment strategies did not impact the incidence of acute and 1-year adverse outcomes of non-whites, there appears to be a significant reduction in event-free survival among blacks by 2 years.

Age Distribution↗
PubMed2003

Rationale and design of the randomized, multicenter, cilostazol for RESTenosis (CREST) trial.

Restenosis of a segment of diseased coronary artery following metallic stenting is a common clinical problem and a major limitation of the procedure. Systemic pharmacologic interventions to deal with this problem have met with little success. Several small studies suggest that cilostazol, a phosphodiesterase III inhibitor whose pharmacologic properties include antiplatelet, antithrombotic, and vasodilatory effects; a beneficial effect on serum lipids; and in vitro inhibition of smooth muscle cell proliferation, may help prevent platelet aggregation and impede the accumulation of new intimal tissue in the stented artery. The Cilostazol for RESTenosis (CREST) trial will aim to evaluate more definitively the ability of cilostazol to prevent restenosis following uncomplicated stent implantation for de novo coronary artery stenosis. In this randomized, double-blind, multicenter study, 700 patients will receive clopidogrel, aspirin, and either cilostazol or placebo after successful intracoronary stent implantation. The primary endpoint is minimal luminal diameter (MLD) of the first lesion stented after 6 months; secondary endpoints include MLD in all lesions, mean percent diameter stenosis, target lesion revascularization, and major angiographic endpoints. Safety endpoints are abnormal complete blood count and liver function tests at 1, 3, and 6 months. The trial has been initiated, and enrollment is anticipated to be concluded in 2003. Cilostazol has properties that may reduce or avert in-stent coronary restenosis. The CREST trial is a large, rigorously conducted trial that may corroborate the favorable effects of cilostazol on coronary stent restenosis suggested by earlier studies.

Adolescent↗
PubMed2003

Prognostic implication of creatine kinase release after elective percutaneous coronary intervention in the pre-IIb/IIIa antagonist era.

BACKGROUND: The significance of mild elevations in cardiac enzymes after an elective percutaneous coronary intervention (PCI) still remains controversial. We evaluated the significance of creatine phosphokinase level (CPK) elevations in a large cohort of patients who had undergone an elective PCI before the IIb/IIIa receptor antagonist era. METHODS: All patients enrolled in the Emory databank from 1981 to 1996 who had an elective PCI were evaluated. We identified 15,637 patients who met our inclusion and exclusion criteria. Patients were divided into 4 groups on the basis of the magnitude of the CPK elevation noted in the post-PCI period: group I (CPK <250 mg/dL, n = 14,512); group II (CPK 250-500 mg/dL, n = 715); group III (CPK 500-750 mg/dL, n = 164); and group IV (CPK >750 mg/dL, n = 246). RESULTS: CPK elevations were associated with a significant increase in the periprocedure angiographic complications. Angiographic complication rates were 14.6%, 30.5%, 40.2%, and 43.5% in groups I, II, III, and IV, respectively (P <.001). Long-term survival also correlated inversely with the magnitude of CPK elevations. The 10-year survival rates were 73%, 71%, 69%, and 55% in groups I, II, III, and IV, respectively (P <.0001). After multivariate analysis to correct for clinical factors, a CPK elevation of at least 3-times normal (group IV) was found to be an independent predictor of diminished 30-day and long-term survival (hazard ratio 1.84, 95% CI 1.41-2.41, P <.0001). Elevations in CPK <3-times normal (groups II and III) were not independently predictive of poor long-term survival. CONCLUSION: A CPK level >3-times normal after an elective PCI is a strong independent predictor of poor long-term prognosis.

Angioplasty, Balloon, Coronary↗
PubMed2002

Outcomes of repeat revascularization in diabetic patients with prior coronary surgery.

OBJECTIVES: This study evaluated both short- and long-term outcomes of diabetic patients who underwent repeat coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) after initial CABG. BACKGROUND: Although diabetic patients who have multivessel coronary disease and require initial revascularization may benefit from CABG as compared with PCI, the uncertainty concerning the choice of revascularization may be greater for diabetic patients who have had previous CABG. METHODS: Data were obtained over 15 years for diabetic patients undergoing PCI procedures or repeat CABG after previous coronary surgery. Baseline characteristics were compared between groups, and in-hospital, 5-year, and 10-year mortality rates were calculated. Multivariate correlates of in-hospital and long-term mortality were determined. RESULTS: Both PCI (n = 1,123) and CABG (n = 598) patients were similar in age, gender, years of diabetes, and insulin dependence, but they varied in presence of hypertension, prior myocardial infarction, angina severity, heart failure, ejection fraction, and left main disease. In-hospital mortality was greater for CABG, but differences in long-term mortality were not significant (10 year mortality, 68% PCI vs. 74% CABG, p = 0.14). Multivariate correlates of long-term mortality were older age, hypertension, low ejection fraction, and an interaction between heart failure and choice of PCI. The PCI itself did not correlate with mortality. CONCLUSIONS: The increased initial risk of redo CABG in diabetic patients and the comparable high long-term mortality regardless of type of intervention suggest that, except for patients with severe heart failure, PCI be strongly considered in all patients for whom there is a percutaneous alternative.

Aged↗
PubMed2002

Basic stenting.

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Angioplasty, Balloon, Coronary↗