Serial volumetric intravascular ultrasound assessment of native coronary artery versus saphenous vein grafts in-stent restenosis lesions after conventional catheter-based treatment.
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Publications and source records attributed to Augusto D Pichard.
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OBJECTIVES: This study reports the outcome of patients who failed intracoronary radiation therapy (IRT) for the treatment of in-stent restenosis (ISR). BACKGROUND: Intracoronary radiation therapy has demonstrated a reduction in the recurrence rate of restenosis for patients with ISR. However, 10% to 30% of these patients require repeat intervention to the irradiated site. METHODS: Of 961 patients who were assigned to gamma or beta radiation for the treatment of diffuse ISR, we evaluated the outcome of 282 (29%) consecutive patients who failed IRT and compared them with the 679 (71%) patients who had successful IRT. For patients who failed radiation, the mean time to the first target vessel revascularization (TVR) was 173 +/- 127 days after the index procedure and the total duration of follow-up was 494 +/- 304 days. RESULTS: Patients who failed IRT were younger (60 +/- 10 vs. 63 +/- 11 years, p = 0.002) and had a higher incidence of restenting (51% vs. 41%, p = 0.003). The majority (55%) of the restenotic lesions after IRT failure were focal (< or =10 mm), with a mean lesion length of 11.9 +/- 1.9 mm. Of the 257 patients who had subsequent TVR after failed IRT, 68 (26%) underwent coronary artery bypass grafting and 189 (74%) underwent percutaneous coronary intervention using balloon in 61%, restenting in 26%, atheroablation in 11%, and the cutting balloon in 2% of cases. At six months, 6% of patients died, 1% had Q-wave MI, 17% had repeat TVR, and the overall rate of major adverse cardiac events was 21%. CONCLUSIONS: The predominant angiographic pattern of lesions in patients who failed IRT is focal restenosis, with these lesions responding well to conventional revascularization methods.
Intracoronary gamma radiation is effective in reducing recurrent in-stent restenosis (ISR) involving native coronary arteries. This study compares the effectiveness and safety of intracoronary gamma radiation for the treatment of ISR in saphenous vein grafts (SVGs) versus native coronary arteries. In the Washington Radiation for In-Stent restenosis Trial (WRIST) series of gamma radiation trials, 1,142 patients with ISR (230 in SVG and 912 in native coronary arteries) completed 6-month clinical follow-up. All patients underwent balloon angioplasty, atherectomy, and/or restenting. Different ribbon lengths containing 6 to 23 seeds of iridium-192 were used to cover lesion lengths <80 mm. The prescribed radiation doses were 14 or 15 Gy at 2-mm radial distance from the center of the source. Baseline demographics showed that patients with SVGs were older (65 +/- 13 vs 61 +/- 11 years, p <0.001), more likely male (79% vs 64%, p <0.001), had more multivessel coronary disease (81% vs 50%, p <0.001), and less diffuse lesions (17 +/- 10 vs 24 +/- 12 mm, p <0.001). At 6 months, event-free survival was similar for patients with SVG ISR and native coronary ISR (82% vs 84%, p = 0.35). The SVG ISR population had a low rate of late total occlusion (4.6%) and late thrombosis (3.5%). Thus, treatment of ISR with gamma radiation in SVGs had similar outcome to native coronary arteries. The use of gamma radiation for the treatment of ISR should expand to SVGs.
The aim of this study was to compare 6-month clinical outcomes of patients with in-stent restenosis (ISR) involving the ostium treated with intracoronary radiation therapy (IRT) compared to placebo therapy, and also to nonostial lesions treated with IRT. Coronary interventions in ostial lesions have a high rate of recurrence of restenosis. The impact of IRT on ostial ISR has been inadequately characterized. We assessed patients enrolled in gamma (192-iridium) and beta (90-yttrium, 32-phosphorus) radiation trials for ISR at the Washington Hospital Center. Of patients receiving IRT, 105 (8%) patients had ostial ISR and 1,289 (92%) patients had nonostial ISR. Twenty-seven patients had ostial ISR and received placebo therapy. Baseline demographic and angiographic and procedural details were similar, except ostial IRT patients had a trend toward shorter lesions (15.4 +/- 10.8 vs. 24.1 +/- 12.2 mm; P < 0.001) and had a higher rate of saphenous vein graft disease (46% vs. 19%; P < 0.001) compared to nonostial IRT patients. At 6 months, ostial lesions treated with IRT for ISR had a reduced rate of target lesion revascularization (TLR) compared to ostial lesions treated with placebo (15% vs. 43%; P = 0.004). Outcomes at 6 months were similar for the ostial and nonostial IRT groups including TLR (15% vs. 14%; P = 0.80) and composite major adverse cardiac events (18% vs. 15%; P = 0.46). Intracoronary radiation therapy is effective for ostial in-stent restenotic lesions and should be comfortably used for this challenging anatomic location.
Restenting at the time of intracoronary radiation therapy (IRT) for in-stent restenosis (ISR) potentially increases the risk of late total occlusion (LTO) of the treated vessel. Prolonged antiplatelet therapy with clopidogrel (6 months) has been shown to be effective in reducing LTO risk. The purpose of this study was to assess the impact of restenting on clinical outcomes following IRT for ISR with 6 months of clopidogrel. We retrospectively evaluated 1,275 patients with 6-months clinical follow-up who were enrolled in radiation trials for ISR using gamma- and beta-emitters conducted at Washington Hospital Center. Patients were analyzed according to whether additional stents were deployed at the time of IRT. The predominant indication for restenting was to optimize the final angiographic result in the event of tissue prolapse or to cover edge dissections. All patients received a minimum of 6 months of clopidogrel. Baseline clinical and angiographic characteristics were similar between the restented and nonrestented groups. Radiation was delivered successfully in all cases. At 6 months, patients treated with additional stents and IRT had a significantly higher rate of target vessel revascularization than patients without additional stents (24.6% vs. 18.7%; P = 0.011). Restenting caused more frequent late thrombosis, late total occlusion, and Q-wave myocardial infarction than no restenting (4.0% vs. 2.2%, P = 0.09; 6.1% vs. 4.3%, P = 0.14; and 1.9% vs. 0.4%, P = 0.009, respectively). Restenting for the treatment of ISR is associated with increased adverse events and should be avoided after intracoronary radiation therapy for in-stent restenosis, as restenting results in a higher recurrence rate and the potential for increased late total occlusion.
In the modern era, radial artery graft is being used with increasing frequency to replace saphenous vein as a conduit for coronary artery bypass surgery. Several reports have shown encouraging early results of radial grafts compared to saphenous grafts. Despite these advantages, radial artery graft failure requiring revascularization does occur. We report on the clinical, angiographic, and technical characteristics and the follow-up results of 22 patients who underwent percutaneous intervention of radial grafts.
In patients with chronic renal insufficiency, further decline in renal function (DRF) after percutaneous coronary intervention (PCI) is accompanied not only by adverse in-hospital events but also by increased risk of mortality and myocardial infarction at 1 year. This analysis was undertaken to determine if patients with normal renal function who develop DRF after PCI have a comparable increase in risk of death and myocardial infarction at 1 year, and whether this risk is independent of in-hospital complications (death, myocardial infarction, urgent coronary artery bypass grafting). We performed a retrospective analysis of all patients from a single center who underwent successful PCI with no major in-hospital complications who had pre-PCI serum creatinine (SCr) </= 1.2 mg/dl and no history of renal insufficiency. One-year follow-up was obtained by mail or telephone. There were 5,967 consecutive patients who met the inclusion criteria. Of these, 208 (3.5%) developed DRF (an increase in SCr >/= 50% of baseline). They were more likely to be older, female, non-Caucasian, diabetic and/or hypertensive. They reported more prior cerebral or peripheral vascular events. They had undergone more complex PCI and were exposed to more radiographic contrast than the 96.5% who did not develop DRF. After adjustment for baseline variables, DRF remained an independent predictor of 1-year mortality, myocardial infarction, and target vessel revascularization. In patients without prior renal impairment, DRF post-PCI is rare but is associated with an increased risk of late adverse cardiac events similar to that in chronic renal insufficiency patients.
We evaluated our experience with percutaneous coronary intervention (PCI) of internal mammary artery (IMA) grafts. From the institution's database we identified 288 patients with 311 IMA lesions. Of these, 82 (26.4%) had stents placed during PCI. Angiographic success was 92%. Mortality at 1 month was 1.7%, myocardial infarction (MI) 15.7%, and target lesion revascularization (TLR) 0.4%. Cumulative 1-year event rates were mortality 6.4%, MI 20.4%, and TLR 8.0%. TLR rates were significantly higher in the stented lesions than lesions treated with angioplasty alone (19.2% vs. 4.9%; P = 0.004). The higher TLR rate in stented lesions was most apparent at the anastomotic site (25.0% vs. 4.2%; P = 0.006). Percutaneous revascularization of IMA grafts can be performed safely with high procedural success and excellent short- and long-term results. Stenting, particularly at the anastomotic site, was associated with significantly greater rates of TLR than angioplasty alone.
BACKGROUND: Vascular brachytherapy (VBT) reduces in-stent restenosis (ISR). However, additional stenting at the time of radiation may be associated with a worse outcome. METHODS AND RESULTS: Intravascular ultrasound (IVUS) was performed after VBT and at 6 months follow-up in 79 native artery ISR patients treated with gamma-radiation who participated in the Washington Radiation for In-Stent restenosis Trial (WRIST), Gamma-1, and Angiorad Radiation Technology for In-Stent restenosis Trial in Coronaries (ARTISTIC) trials. Patients were treated with (192)Ir at 14 or 15 Gy at 2 mm from the source. Additional stents were used to treat the ISR lesions in 45 patients; these patients were then compared with the 34 patients treated without restenting. Paired measurements included stent, lumen, and intimal hyperplasia volumes. After the VBT procedure, intimal hyperplasia volume was smaller in the group treated with additional stents (54 +/- 33 mm(3) vs 34 +/- 33 mm(3), P =.012), but minimal lumen area was similar between the 2 groups (4.3 +/- 1.5 mm(2) vs 4.7 +/- 1.4 mm(2) respectively, P = NS). Between the time of the VBT procedure and follow-up, intimal hyperplasia volume increased by 27 +/- 19 mm(3) in the restented group and by 9 +/- 21 mm(3) in the group treated without additional stents (P =.014). At 6 months, intimal volume was similar in the 2 groups, but minimal lumen area was slightly smaller in the group treated with additional stents (3.4 +/- 1.8 mm(2) vs 4.2 +/- 1.7 mm(2), P =.053). Patients treated with additional stents had more target lesion revascularizations than the group treated without additional stents (38% vs 15%, P =.02). CONCLUSIONS: Additional stenting reduces intimal hyperplasia within the stents acutely. However, it compromises the benefit of VBT by promoting higher intimal regrowth within months after radiation.
BACKGROUND: Percutaneous coronary intervention in patients with chronic renal insufficiency (CRI) and native coronary artery disease is often problematic, marred by increased morbidity and mortality rates and a high incidence of restenosis and revascularization. However, little is known about the effect of CRI in patients who have undergone prior coronary artery bypass graft surgery and then undergo saphenous vein graft (SVG) intervention. METHODS: We analyzed the inhospital and 1-year outcomes of 1265 consecutive patients with normal renal function and varying degrees of renal insufficiency who underwent percutaneous SVG intervention and divided them into 4 groups on the basis of the calculated creatinine clearance (CrCl): group 1, CrCl > or =70 mL per minute (n = 626); group 2, CrCl 50 to 69 mL per minute (n = 357); group 3, CrCl 30 to 49 mL per minute (n = 228); and group 4, CrCl <30 mL per minute (n = 54). Patients undergoing dialysis replacement therapy were excluded from the study. RESULTS: Patients with lower CrCl more often were older, female, had diabetes mellitus, and had worse left ventricular function. Angiographic baseline characteristics were comparable among the 4 groups. Overall immediate procedural success was similar for all groups. Patients with a low CrCl had significantly higher inhospital overall and cardiac mortality rates (P <.001), including a significantly higher incidence of myocardial infarction, vascular complications, pulmonary edema, and renal function deterioration. At 1-year follow-up, the overall mortality rates remained significantly higher in patients with decreased CrCl, with an incremental rise in overall mortality rate associated with lower renal function (P <.001). CONCLUSIONS: This study suggests that renal function is a primary determinate of short- and long-term survival in patients undergoing percutaneous SVG intervention and that there is a clear relationship between CrCl and cardiovascular outcome.
BACKGROUND: Contrast-induced nephropathy (CIN) is a recognized complication after percutaneous interventions (PCI). We sought to determine the impact of gender on incidence and clinical outcome of CIN. METHODS AND RESULTS: Of a total 8,628 patients who underwent PCI, there were 1,431 (16.5%) who developed CIN (defined as > 25% rise in creatinine after PCI). Patients were followed clinically for one year. CIN was present in 23.6% of female versus 17.4% of male patients (p < 0.0001). Multivariate analysis showed that female gender (OR = 1.4, 95% CI = 1.25 1.60; p < 0.0001), pre-PCI chronic renal failure (CRF) (OR= 1.8, 95% CI = 1.53 2.10, p < 0.0001), diabetes mellitus (OR = 1.5, 95% CI = 1.34 1.70; p < 0.0001), age (OR = 1.01, 95% CI = 1.01 1.02, p < 0.0001), and hypertension (OR = 1.2, 95% CI = 1.06 1.36, p = 0.0035) were independent predictors of CIN. Clinical outcomes after CIN were examined in patients with or without CRF. Among patients without CRF who developed CIN, females (n = 465) had higher rates of one-year mortality, and MACE comparing to males (n = 710) without CRF (14% vs. 10% mortality, 36% vs. 30% MACE; p = 0.05 and 0.06, respectively). In patients with CRF who developed CIN, we found no significant gender differences in one-year clinical events (37% vs. 36% mortality, 42% vs. 45% MACE; p = 0.8 and 0.6, respectively). By multivariate analysis only baseline CRF, diabetes, age, functional NYHA IV class were identified as independent predictors of one-year mortality in patients with CIN after PCI. CONCLUSIONS: Female gender is an independent predictor of CIN development after PCI and a marker of worse 1-year mortality after CIN in patients without baseline CRF. After CIN is developed, pre-PCI CRF, diabetes mellitus, age, severe heart failure (not gender) are independent predictors of one-year mortality.
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BACKGROUND: Intracoronary gamma-radiation reduces recurrent in-stent restenosis (ISR). Late thrombosis was attenuated with 6 months of aspirin and clopidogrel. We aimed to find out whether 12 months of aspirin plus clopidogrel is superior to a strategy of 6 months after radiation therapy for patients with ISR. METHODS AND RESULTS: One hundred twenty consecutive patients with diffuse ISR in native coronaries and vein grafts with lesions <80 mm in length underwent PTCA, laser ablation, or rotational atherectomy. Additional stents were placed in 39 patients (33%). After the intervention, a ribbon with different trains of radioactive 192Ir seeds was positioned to cover the treated site, and a dose of 14 Gy to 2 mm was prescribed. Patients were discharged with clopidogrel and aspirin for 12 months and followed up clinically. The cardiac clinical event rates at 15 months were compared with the gamma-treated (n=120) patients of the WRIST PLUS study (only 6 months of antiplatelet therapy). Whereas the late thrombosis rates were similar (3.3% for the group given 12 months of antiplatelet therapy versus 4.2% for the group given 6 months, P=0.72), the group treated with 12 months of antiplatelet therapy had a rate of 21% for major adverse cardiac events and 20% for target-lesion revascularization compared with 36% (P=0.01) and 35% (P=0.009), respectively, in patients who were treated with only 6 months of clopidogrel. CONCLUSIONS: Twelve months of clopidogrel is superior to 6 months in reducing overall major cardiac events and revascularization rates at 15 months for patients with ISR treated with gamma-radiation. At least 12 months of clopidogrel therapy should be recommended for patients undergoing radiation therapy for ISR.
BACKGROUND: Stroke associated with percutaneous coronary intervention (PCI) is an infrequent although devastating complication. We investigated the incidence, predictors, and prognostic impact of periprocedural stroke in unselected patients undergoing PCI. METHODS AND RESULTS: A total of 9662 patients who underwent 12 407 PCIs between January 1990 and July 1999 were retrospectively studied. Stroke was diagnosed in 43 patients (0.38% of procedures). Patients with stroke were older (72+/-11 versus 64+/-11 years, P<0.001), had lower left ventricular ejection fraction (42+/-12 versus 46+/-13%, P=0.04) and more diabetes (39.5% versus 27.2%, P=0.07), and experienced a higher rate of intraprocedural complications necessitating emergency use of intra-aortic balloon pump (IABP) (23.3% versus 3.3%, P<0.001). In-hospital mortality (37.2% versus 1.1%, P<0.001) and 1-year mortality (56.1% versus 6.5%, P<0.001) were higher in patients with stroke. Compared with hemorrhagic stroke, patients with ischemic stroke had higher rate of in-hospital major adverse cardiac events (57.1% versus 25%, P=0.037). Multivariate logistic regression analysis identified emergency use of IABP as the strongest predictors for stroke (OR=9.6, CI 3.9 to 23.9, P<0.001), followed by prophylactic use of IABP (OR=5.1), age >80 years (OR=3.2, compared with age <50 years), and vein graft intervention (OR=2.7). CONCLUSIONS: Stroke associated with contemporary PCI is associated with substantial increased mortality. Elderly patients who experience intraprocedural complications necessitating the use of IABP are at particularly high risk.
OBJECTIVES: The purpose of this study was to examine the effect of intracoronary radiation therapy (IRT) in diabetic patients with in-stent restenosis (ISR). BACKGROUND: Diabetic patients are at an increased risk for restenosis, repeat revascularization procedures and late mortality after percutaneous coronary interventions and stenting. Intracoronary radiation therapy, utilizing both gamma and beta-emitters, has been shown to reduce the rate of ISR. METHODS: The study group consisted of 749 consecutive patients with ISR who were treated with either IRT or placebo in randomized trials and registries at our center. Diabetic patients (252 radiation and 51 placebo) were compared with nondiabetic patients (371 radiation and 75 placebo). RESULTS: In-hospital outcomes were similar between diabetic and nondiabetic patients treated with and without radiation. At six-month clinical and angiographic follow-up, there was a significant reduction in the binary restenosis (63.8% vs. 15.7%, p < 0.0001), target lesion revascularization (66.7% vs. 17.6%, p < 0.0001) and target vessel revascularization (TVR) (70.6% vs. 22.9%, p < 0.0001) rates in diabetic patients treated with radiation compared to placebo. Comparisons between the placebo arms detected a trend towards higher restenosis (63.8% vs. 48.4% p = 0.13) and TVR (70.6% vs. 56.0%, p = 0.14) in diabetic versus nondiabetic patients. In contrast, diabetic and nondiabetic patients treated with IRT experienced similar restenosis (15.6% vs. 10.7% p = 0.33) and TVR (22.9% vs. 28.2% p = 0.41) rates. CONCLUSIONS: In diabetic patients with ISR, intracoronary radiation significantly reduced the recurrence of ISR compared to placebo. Additionally, similar rates of restenosis and revascularization procedures were achieved in irradiated diabetic and nondiabetic patients. In view of these results, IRT should be considered as a valuable therapeutic alternative in all diabetic patients with ISR.
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