Ellen Pinnow

Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions

Bleeding related to percutaneous coronary intervention (PCI) occurs relatively frequently. We retrospectively investigated the incidence, predictors, and prognostic impact of periprocedural bleeding and transfusion in 10,974 patients who underwent PCI. Bleeding definitions were based on Thrombolysis In Myocardial Infarction (TIMI) criteria: (1) major bleeding (n = 588; 5.4%): if patients had a hemorrhagic stroke or if hematocrit decreased >15 points or by 10 to 15 points with clinical bleeding; (2) minor bleeding (n = 1,394; 12.7%): if hematocrit decreased <10 points with clinical bleeding or by 10 to 15 points without clinical bleeding; and (3) no bleeding (n = 8,992; 81.9%): if hematocrit decreased <10 points without clinical bleeding. Patients with major bleeding were older than patients with minor or no bleeding (67.8 +/- 11 vs 65.9 +/- 11 vs 63.6 +/- 11 years, respectively; p <0.001) and more often experienced intraprocedural complications, such as emergency use of an intra-aortic balloon pump (13.6% vs 6.5% vs 2.3%, respectively; p <0.001). Multivariate logistic regression analysis identified the use of an intra-aortic balloon pump (odds ratio [OR] 3.0, p <0.0001), procedural hypotension (OR 2.9, p <0.001), and age >80 years (OR 1.9 compared with age <50 years, p = 0.001) as the strongest predictors for major bleeding. Patients who had major bleeding had higher in-hospital and 1-year mortality compared with patients with minor or no bleeding. Bleeding was an independent predictor of in-hospital death. Thus, periprocedural major bleeding occurs relatively frequently and is associated with adverse outcomes. Patients >80 years of age who experience intraprocedural complications are at particularly high risk.

The impact of obesity on the short-term andlong-term outcomes after percutaneous coronary intervention: the obesity paradox?

OBJECTIVES The purpose of this study was to assess the impact of body mass index (BMI) on the short- and long-term outcomes after percutaneous coronary intervention (PCI). BACKGROUND Obesity is associated with advanced coronary artery disease (CAD). However, the relation between BMI and outcome after PCI remains controversial. METHODS We studied 9,633 consecutive patients who underwent PCI between January 1994 and December 1999. Patients were divided into three groups according to BMI: normal, BMI between 18.5 and 24.9 (n = 1,923); overweight, BMI between 25 and 30 (n = 4,813); and obese, BMI >30 (n = 2,897). RESULTS Obese patients were significantly younger and had consistently worse baseline clinical characteristics than normal or overweight patients, with a higher incidence of hypertension, diabetes, hypercholesterolemia and smoking history (p < 0.0001). Despite similar angiographic success rates among the three groups, normal BMI patients had a higher incidence of major in-hospital complications, including cardiac death (p = 0.001). At one-year follow-up, overall mortality rates were significantly higher for normal BMI patients compared with overweight or obese patients (p < 0.0001). Myocardial infarction and revascularization rates did not differ among the three groups. By multivariate Cox regression analysis, diabetes, hypertension, age, BMI and left ventricular function were independent predictors of long-term mortality. CONCLUSIONS In patients with known CAD who undergo PCI, very lean patients (BMI <18.5) and those with BMI within the normal range are at the highest risk for in-hospital complications and cardiac death and for increased one-year mortality.

Five-year follow-up after intracoronary gamma radiation therapy for In-stent restenosis

Background—The Washington Radiation for In-Stent Restenosis Trial is a double-blinded randomized study evaluating the effects of intracoronary radiation therapy (IRT) in patients with in-stent restenosis (ISR). Methods and Results—One hundred thirty patients with ISR (100 native coronary and 30 vein grafts) underwent percutaneous transluminal coronary angioplasty, laser ablation, rotational atherectomy, or additional stenting (36% of lesions). Patients were randomized to either 192-Iridium IRT or placebo, with a prescribed dose of 15 Gy to a 2-mm radial distance from the center of the source. Angiographic restenosis (27% versus 56%, P =0.002) and target vessel revascularization (26% versus 68%, P <0.001) were reduced at 6 months in patients treated with IRT. Between 6 and 60 months, patients treated with IRT compared with placebo had more target lesion revascularization (IRT, 21.6% versus placebo, 4.7%; P =0.04) and target vessel revascularization (IRT, 21.5% versus placebo, 6.1%; P =0.03). At 5 years, the major adverse cardiac event rate was significantly reduced with IRT (46.2% versus 69.2%, P =0.008). Conclusions—In the Washington Radiation for In-Stent Restenosis Trial, patients with ISR treated with IRT using 192-Iridium had a reduction in the need for repeat target lesion and vessel revascularization at 6 months and 5 years.

Intravascular Ultrasound Analysis of Infarct-Related and Non–Infarct-Related Arteries in Patients Who Presented With an Acute Myocardial Infarction

Background Previous studies have reported diffuse destabilization of atherosclerotic plaques in acute myocardial infarction (AMI). Methods and Results We used intravascular ultrasound (IVUS) to assess 78 coronary arteries (38 infarct‐related arteries [IRAs] with culprit and nonculprit lesions and 40 non‐IRAs) from 38 consecutive AMI patients. IVUS analysis included qualitative and quantitative measurements of reference and lesion external elastic membrane (EEM), lumen, and plaque plus media (P&M) area. Positive remodeling was defined as lesion/mean reference EEM>1.0. Culprit lesions were identified by a combination of ECG, wall motion abnormalities (ventriculogram or echocardiogram), scintigraphic perfusion defects, and coronary angiogram. Culprit lesions contained more thrombus (23.7% versus 3.4% in nonculprit IRA plaques and 3.1% in non‐IRA plaques; P<0.0011). Culprit lesions were predominantly hypoechoic (63.2% versus 37.9% of nonculprit IRA plaques and 28.1% of non‐IRA plaques; P=0.0022). Culprit lesions were longer (17.5±10.1, 9.8±4.0, and 10.3±5.7 mm, respectively; P<0.0001), had larger EEM area (15.0±6.0, 11.5±5.7, and 12.6±5.6 mm2, respectively; P±0.0353) and P&M area (13.0±6.0, 7.5±3.7, 9.3±4.3 mm2, respectively; P<0.0001), smaller lumens (2.0±0.9,4.1±3.1, and 3.4±2.5mm2, respectively; P=0.0009), and more positive remodeling (79.4%, 59.0%, and 50.8%, respectively; P=0.0155). The frequency of plaque rupture/dissection was greater in culprit, nonculprit IRA, and non‐IRA plaques in AMI patients than in a control group of chronic stable angina patients with multivessel IVUS imaging. Conclusions Culprit plaques have more markers of instability (thrombus, positive remodeling, and large plaque mass); however, these markers of instability are not typically found elsewhere. This suggests that the vascular event in AMI patients is determined by local pre‐event lesion morphologies. (Circulation. 2003;107:2889‐2893.)

Prolonged Antiplatelet Therapy to Prevent Late Thrombosis After Intracoronary γ-Radiation in Patients With In-Stent Restenosis Washington Radiation for In-Stent Restenosis Trial Plus 6 Months of Clopidogrel (WRIST PLUS)

Background—Intracoronary &ggr;-radiation reduces recurrent in-stent restenosis. Late thrombosis (>30 days after radiation therapy) is identified as a serious complication. The Washington Radiation for In-Stent Restenosis Trial (WRIST) PLUS, which involved 6 months of treatment with clopidogrel and aspirin, was designed to examine the efficacy and safety of prolonged antiplatelet therapy for the prevention of late thrombosis. Methods and Results—A total of 120 consecutive patients with diffuse in-stent restenosis in native coronary arteries and vein grafts with lesions <80 mm underwent percutaneous coronary transluminal angioplasty, laser ablation, and/or rotational atherectomy. Additional stents were placed in 34 patients (28.3%). After the intervention, a closed-end lumen catheter was introduced into the artery, 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 6 months and followed angiographically and clinically. All patients but one tolerated the clopidogrel. The late occlusion and thrombosis rates were compared with the &ggr;-radiation-treated (n=125) and the placebo patients (n=126) from the WRIST and LONG WRIST studies (which involved only 1 month of antiplatelet therapy). At 6 months, the group receiving prolonged antiplatelet therapy had total occlusion and late thrombosis rates of 5.8% and 2.5%, respectively; these rates were lower than those in the active &ggr;-radiation group and similar to those in the placebo historical control group. Conclusions—Six months of clopidogrel and aspirin and a reduction in re-stenting for patients with in-stent restenosis treated with &ggr;-radiation is well tolerated and associated with a reduction in the late thrombosis rate compared with a similar cohort treated with only 1 month of clopidogrel and aspirin.

Stroke Complicating Percutaneous Coronary Interventions Incidence, Predictors, and Prognostic Implications

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.

Incidence, management, and outcome of coronary artery perforation during percutaneous coronary intervention

We have analyzed the incidence, management, and outcome of 84 cases of coronary artery perforation in patients who underwent percutaneous coronary intervention at our institution. This complication was more frequent in female patients and in patients who underwent lesion modification with atheroablative devices. A total of 8 patients (9.5%) died after the procedure. They were usually older and had a higher incidence of cardiac tamponade; a larger percentage of these patients underwent emergency surgery than those who survived.

Percutaneous coronary intervention-associated nephropathy foreshadows increased risk of late adverse events in patients with normal baseline serum creatinine

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. Cathet Cardiovasc Intervent 2003;59:338–343.

Intracoronary radiation therapy improves the clinical and angiographic outcomes of diffuse in-stent restenotic lesions: Results of the Washington Radiation for In-Stent Restenosis Trial for long lesions (Long WRIST) studies

Background—The Washington Radiation for In-Stent Restenosis Trial for long lesions (Long WRIST) was designed to determine the safety and efficacy of vascular brachytherapy for the treatment of diffuse in-stent restenosis. Methods and Results—A total of 120 patients with diffuse in-stent restenosis in native coronary arteries (lesion length, 36 to 80 mm) were randomized for either radiation with 192Ir with 15 Gy at 2 mm from the source axis or placebo. After enrollment, 120 additional patients with the same inclusion criteria were treated with 192Ir with 18 Gy and included in the Long WRIST High Dose registry. Antiplatelet therapy was initially prescribed for 1 month and was extended to 6 months in the last 60 patients of the Long WRIST High Dose registry. At 6 months, the binary angiographic restenosis rate was 73%, 45%, and 38% in the placebo, 15 Gy, and 18 Gy radiated groups, respectively (P <0.05). At 1 year, the primary clinical end point of major cardiac events was 63% in the placebo group and 42% in the radiated group with 15 Gy (P <0.05). The major cardiac event rate was further reduced with 18 Gy (22%;P <0.05 versus 15 Gy). Late thrombosis was 12%, 15%, and 9% in the placebo group, 15 Gy group with 1 month of antiplatelet therapy, and 18 Gy group with 6 months of antiplatelet therapy, respectively. Conclusions—Vascular brachytherapy with 192Ir is safe and reduces the rate of recurrent restenosis in diffuse in-stent restenosis. The efficacy of vascular brachytherapy on angiographic and clinical outcomes is enhanced with a radiation dose of 18 Gy and prolonged antiplatelet therapy.

Predictors of Coronary Arterial Remodeling Patterns in Patients With Myocardial Ischemia

Preangioplasty intravascular ultrasound in 81 patients showed that adaptive remodeling occurred in 35% and constrictive remodeling in 34%. Multivariate analysis showed that smoking and fibrocalcific plaques were associated with constrictive remodeling, whereas small vessel size and hypercholesterolemia were associated with adaptive remodeling.