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(Circulation. 1998;98:642-647.)
© 1998 American Heart Association, Inc.

Clinical Investigation and Reports

Four-Year Follow-up of Palmaz-Schatz Stent Revascularization as Treatment for Atherosclerotic Renal Artery Stenosis

Gerald Dorros, MD; Michael Jaff, DO; Lynne Mathiak, RN; Isa I. Dorros, BA; Adam Lowe, BS; Kelly Murphy, BA; ; Thomas He, PhD

From the William Dorros-Isadore Feuer Interventional Cardiovascular Disease, Foundation Ltd, Milwaukee, Wis (G.D., L.M., I.I.D., T.H.); the Arizona Heart Institute Foundation, Phoenix, Ariz (G.D.); and the Vascular Medicine and Vascular Laboratory, Integrated Cardiovascular Therapeutics, LLC, Woodbury, NY (M.J.).

	Abstract

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Background—Stent revascularization is perceived as superior to balloon angioplasty and surgical revascularization, but the paucity of stent publications precludes even historical comparison with surgical data.

Methods and Results—Palmaz-Schatz stent revascularization of renal artery stenosis was successfully performed on 163 consecutive patients for poorly controlled hypertension or preservation of renal function. Of these, 145 were eligible for 6-month clinical follow-up of the effect of the procedure on renal function, blood pressure control, number of antihypertensive medications, and survival. At 4 years, systolic and diastolic blood pressures significantly decreased (from 166±26 to 148±22 mm Hg and from 86±14 to 80±11 mm Hg, respectively; P<0.05), and blood pressure control was more facile in approximately half of the patients. Creatinine decreased or remained stable in approximately two thirds of the patients. The cumulative probability of survival was 74±4% at 3 years, with few deaths related to end-stage renal disease. Survival was good in patients with normal (92±4%) baseline renal function, fair (74±7%) in those with mildly impaired renal function, and poor (52±7%) in patients with elevated baseline creatinine levels (2.0 mg/dL). The combination of impaired renal function and bilateral disease adversely affected survival.

Conclusions—Renal artery stent revascularization in the presence of normal or mildly impaired renal function had a beneficial effect on blood pressure control and a nondeleterious effect on renal function. Survival was adversely affected by renal dysfunction despite adequate revascularization. Early diagnosis and adequate revascularization before the onset of renal dysfunction could beneficially affect blood pressure control, preserve or prevent deterioration of renal function, and improve patient survival.

Key Words: stents • stenosis • follow-up studies • revascularization

	Introduction

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Atherosclerotic renal artery stenosis may result in accelerated and/or poorly controlled hypertension, deterioration or loss of renal function, and recurrent pulmonary edema.^{1 2 3 4 5 6 7 8} Although surgical revascularization has cured or improved blood pressure control, preserved or stabilized renal function,^{9 10 11 12 13 14 15} and reversed end-stage renal failure,^{16 17 18} its morbidity and mortality rates have been higher than those of stent revascularization.^{19 20 21 22 23 24} Stent revascularization has created the perception of superiority to balloon angioplasty^{25 26 27 28 29 30 31} and surgical revascularization, but the paucity of stent publications precludes even historical comparison with surgical data. This article details the 4-year follow-up of 145 patients 6 months after their procedures who underwent Palmaz-Schatz stent revascularization of 1 stenotic renal artery, as well as its impact on renal function, blood pressure control, and survival.

	Methods

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Between 1990 and 1995, 163 patients underwent primary Palmaz-Schatz (PS204, Johnson and Johnson Interventional Systems) stent deployment in 202 atherosclerotic renal arteries (124 unilateral and 39 bilateral) for poorly controlled hypertension and/or preservation of renal function. Of these, 145 patients had received their stent revascularizations 6 months earlier. The protocol and consent form had been reviewed, approved, and monitored by the Investigational Review Board of St Luke's Medical Center (Milwaukee, Wis).

Patients with renal atherosclerotic artery stenosis had hypertension and/or chronic renal insufficiency and met one or more of the following inclusion criteria: onset of hypertension after 50 years of age; accelerated, severe, or malignant hypertension; poor response to appropriate antihypertensive therapy; poorly controlled hypertension; declining renal function after blood pressure control with pharmacological agents; and stenosis of 1 or both major renal arteries. Patients who underwent the procedure to preserve renal function had a serum creatinine level 1.5 mg/dL on 2 separate measurements. No patient had fibromuscular dysplasia or longitudinal kidney length of <7.0 cm (as measured by ultrasound or renal laminography). Indications for inclusion were not mutually exclusive.

Follow-up data were recorded so that the window for each data point at 6 months was ±1 month; at yearly intervals, ±2 months. Data points outside those windows were not used.

A procedural success was defined as complete if the residual stenosis was <50% and as a failure if the residual stenosis was 50% or if any complication mandated surgical intervention. Inability to dilate or cross the lesion was a technical failure. All patients were studied with intent-to-treat statistical analysis.

Blood pressure response was assessed by multiple observations of the systolic and diastolic pressures before and after the procedure and categorized (Table 2) as follows: "cure" if the patient's diastolic blood pressure was 90 mm Hg and/or systolic blood pressure was 160 mm Hg when pretreatment diastolic pressure was >90 mm Hg and/or systolic pressure was >160 mm Hg while the patient took no antihypertensive medication; "improved" if the diastolic pressure decreased 15% or the systolic pressure decreased 10% while the patient was taking the same number of antihypertensive medications, the diastolic pressure remained the same or decreased <15%, or the systolic pressure remained the same or decreased <10% and the patient was taking fewer antihypertensive medications; and "no improvement" if the aforementioned criteria were not met.

View this table: [in this window] [in a new window]   Table 2. Blood Pressure Response During 4-Year Follow-up

Renal function was assessed by serum creatinine measurements, with a creatinine of >1.4 mg/dL considered abnormal and indicative of renal dysfunction. Patients were then stratified into 3 groups: group 1 (normal renal function, 1.4 mg/dL), group 2 (mild to moderate dysfunction, 1.5 to 1.9 mg/dL), and group 3 (severe dysfunction, 2.0 mg/dL). Procedural effect was defined as follows: a decrease in serum creatinine (>0.2 mg/dL) represented an improvement, a value ±0.2 mg/dL of baseline was considered unchanged, and an increase of >0.2 mg/dL represented a deterioration.

A periprocedure-related death was defined as that related directly or indirectly to the procedure. Death unrelated to the procedure was defined as a mortality that occurred after a technically successful and uncomplicated procedure and was referable to a preprocedure comorbidity.

The stent deployment technique, medication regimen specifically related to the procedure, and methodology of follow-up have been published.^{20 24}

A paired comparison used, at each interval, the patient's follow-up value compared with the baseline value. The life table (actuarial) methodology was used to determine survival, and a Cox regression hazard model assessed the impact of selected variables on survival. A value of P<0.05 was considered statistically significant.

	Results

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Primary Palmaz-Schatz stent deployment revascularized atherosclerotic stenotic renal arteries in 163 patients (82 men, 81 women; mean age, 67±10 years; Table 1). Procedural indications (not mutually exclusive) were poorly controlled hypertension in 121 patients (74%) and preservation of renal function in 95 patients (58%) (baseline creatinine 1.5 mg/dL). Stent revascularization was successful in 201 of 202 stenotic renal arteries (99%), 124 of 124 unilateral (100%) and 77 of 78 bilateral (99%). Comparison of the unilateral and bilateral cohorts revealed no difference in baseline demographics or extent of renal dysfunction (36% of bilateral and 33% of unilateral patients had a baseline creatinine >2.0 mg/dL). In 187 of 201 of revascularized arteries (93%), a <5% residual luminal diameter stenosis remained. Procedural complications encountered included 3 deaths (1 procedurally related [<1%] and 2 related to antecedent multisystem organ failure despite uneventful, successful procedures), 21 episodes of contrast-induced renal failure (13%), and 2 cases of retroperitoneal hemorrhage (1%). No myocardial infarction, emergency renal artery bypass surgery, or nephrectomy occurred. At hospital discharge, 160 patients (98%) were clinically improved, of whom 145 were eligible for 6 month follow-up.

View this table: [in this window] [in a new window]   Table 1. Patient Demographics, Indication, and Procedural Data1

The blood pressure response (Table 2) at 1 year detailed that only 1% of patients were cured, 42% were improved, and 54% had no improvement; this trend continued during the 4 years of follow-up; ie, 50% of patients had blood pressure improvement.

Follow-up (Table 3) demonstrated a durable and statistically significant improvement in blood pressure control (systolic, 166±26 to 148±22 mm Hg; diastolic, 86±14 to 80±11 mm Hg; P<0.05), as well as for previously poorly controlled hypertensive patients (systolic, 176±21 to 160±22 mm Hg; diastolic, 89±12 to 81±12 mm Hg; P<0.05). The number of antihypertensive medications tended to decrease (2.2±1.3 to 1.8±0.9 at 2 years; P<0.05).

View this table: [in this window] [in a new window]   Table 3. Renal Artery Stents: Follow-up on Effects on Hypertension1

Creatinine levels (Table 4) after unilateral or bilateral stent revascularization repeatedly demonstrated that approximately two thirds of unilateral stenosis patients had improved or stable renal function (Table 5 and Figure 1), whereas one third of such patients had progression of their renal dysfunction with an increase in their creatinine by >0.2 mg/dL above baseline. The bilateral cohort showed that 75% had stable or improved renal function and only 25% had deterioration of renal function.

View this table: [in this window] [in a new window]   Table 4. Renal Artery Stents and Effects on Renal Function: Serum Creatinine

View this table: [in this window] [in a new window]   Table 5. Renal Artery Stents: Follow-up of Unilateral and Bilateral Disease Patients

View larger version (16K): [in this window] [in a new window]   Figure 1. Actuarial analysis of renal artery stent revascularization patients as categorized by baseline serum creatinine at the time of procedure.

The 3-year cumulative probability of survival for all patients was 74±4%, with only 4 deaths related to end-stage renal disease (Table 6). Patients with unilateral disease had a 77±4% survival, which was statistically better than the 65±9% survival of patients with bilateral disease. Survival was adversely influenced (P<0.05) by both worsening renal function and bilateral renal artery stenosis despite successful stent revascularization. Patients with mild to moderate renal dysfunction (Figure 2) had a survival probability of 79±9% if the stenosis was unilateral and 63±17% (P<0.05) if it was bilateral. Patients with severe baseline renal dysfunction had a 51±8% survival, independent of whether or not the patient had unilateral or bilateral disease.

View this table: [in this window] [in a new window]   Table 6. Renal Stent Follow-up: Survival as Related to Baseline Creatinine and Extent of Renal Artery Stenosis

View larger version (13K): [in this window] [in a new window]   Figure 2. Actuarial analysis of renal artery stent patients and analysis of whether stent revascularization involved 1 (unilateral) or both (bilateral) kidneys.

The Cox regression hazard model was applied to 10 risk factors (70 years of age, female sex, poorly controlled hypertension, chronic renal failure, renal artery stenosis in patients with creatinine <1.5 mg/dL, bilateral versus unilateral renal artery stenosis, solitary kidney with renal artery stenosis, single-vessel and multivessel coronary disease, and diabetes mellitus), but only 2 factors (a baseline creatinine 1.5 mg/dL and diabetes mellitus) were independently predictive (P<0.0008) of survival (Table 7). The variables of age 70 years and poorly controlled hypertension were close to significance (P<0.07). The renal dysfunction cohort had a 5-times-greater risk of death than patients with normal creatinine levels (<1.5 mg/dL), and the presence of diabetes increased the risk of dying 2.5 times (Table 7).

View this table: [in this window] [in a new window]   Table 7. Cox Regression Hazard Model1

	Discussion

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Atherosclerotic renal artery stenosis occurs much more frequently than previously considered in patients with mild or moderate hypertension, end-stage renal disease, and diffuse atherosclerosis, and this obstructive process is progressive: stenoses become occlusions^{3 4} in 15% of cases, and renal function deteriorates in 10% to 20% of cases,⁴ and the more severe the initial stenosis, the more likely is the progression to occlusion,³ which correlated with a loss of renal mass.³² Furthermore, the first manifestation of renal artery stenosis is cardiac dysfunction: flash pulmonary edema, congestive heart failure, or unstable angina.^{7 8}

Renovascular disease is a significant cause of renal failure, with its presence having the worst effect on prognosis.⁵ Mailloux et al,⁶ detailing 683 patients on hemodialysis, demonstrated that patients with renal artery stenosis as the cause of the end-stage renal disease had the poorest survival (5- and 10-year survivals of 18% and 5%, respectively) among all causes of end-stage renal disease other than diabetic glomerulosclerosis. Although renal artery stenosis is a well-recognized cause of secondary hypertension, revascularization has until recently been looked on with skepticism as a method to preserve renal function in patients with chronic renal insufficiency, despite the demonstration that restoration of renal artery blood flow has led to termination of dialysis.^{16 17 18} In the review of Hallett et al¹¹ of 652 renal artery surgeries, the 98 patients (15%) with creatinine levels 2.0 mg/dL and surgical correction of their renal artery stenosis (stenoses) had an operative mortality of 7.1%. Although the surgical procedure was effective in lowering blood pressure and stabilizing or lowering the creatinine levels in 55% of patients, the 5-year survival was 64%.

In 1994, Cambria et al⁹ reported on the surgical revascularization of 323 atherosclerotic renal arteries in 285 patients, 47% of whom had normal renal function (baseline creatinine 1.5 mg/dL). The operative mortality was 5.6% (8.1% when the procedure involved the aorta and 4.1% in procedures that avoided the aorta). Their 5.6% overall operative mortality rate, 5.0% early graft failure rate, and 5.3% need for reoperation were consistent with and comparable to other surgical series and represented the standard by which other therapies were to be judged. As a point of reference, his patient cohort demographics (mean age, 64 years; 30% of patients 70 years of age; 50% incidence of baseline renal insufficiency; 54% incidence of coronary artery disease) were similar to those of the stent revascularization cohort presented here.

In 1996, Cambria et al¹⁰ detailed a 13-year retrospective surgical experience of renal artery reconstruction in 139 patients, 78% with creatinine levels >1.5 mg/dL and 67% with creatinine levels 2.0 mg/dL. The survival of patients with baseline creatinine >2.0 mg/dL was adversely affected by deterioration in renal function despite surgical revascularization, and their survival probability was 52±5% at 5 years, with the univariate predictors of late death being diabetes mellitus, associated abdominal aortic aneurysm, and preoperative congestive heart failure.

The goal of surgical stent revascularization has been restoration of renal artery blood flow to stabilize or improve renal function. However, the high surgical perioperative complication rates and the increased periprocedural mortalities ranging from 2.1% to 6.1%^{14 15 33 34 35} sharply contrast with those of stent revascularization. Furthermore, surgical mortality was adversely affected (9-fold increase) by clinically evident diffuse atherosclerosis.³⁶ However, not all authors would agree that the risks of surgery are that high. Tucker and Labarthe³⁷ detailed only a 0.5% mortality among 182 patients operated on for renovascular hypertension. What is difficult to glean from the published surgical data concerns patients who could potentially achieve the greatest benefit from revascularization, ie, those patients with normal or relatively normal baseline renal function.

Renal artery stent revascularization procedural results have been demonstrated to be superior to balloon angioplasty,^{20 31} as assessed by hemodynamic transstenotic pressure gradient measurements, complication rates, and restenosis rates. The data presented here define its long-term benefits as manifest by significant decreases in the systolic and diastolic blood pressures, more facile blood pressure control, and a reduction in the number of antihypertensive medications. Actuarial analysis demonstrated that survival was adversely influenced by impaired baseline renal function and/or bilateral disease.

Study Limitations
This prospective, nonrandomized observational series has within it the technical limitations of defining "poorly controlled blood pressure." The variability of the primary physician's follow-up blood pressure recording, methodology, and inability to quantify or stratify changes in antihypertensive medication regimens required us to use the number of antihypertensive drugs as an indicator of the difficulty of blood pressure control. The failure to have selective renal vein renin samples obtained before and after the procedure makes it difficult to determine the relationship, if any, between these assays, stent revascularization, and renin-angiotensin regulatory system and to see whether renin assays had a predictive value. The small patient cohort with a solitary kidney and renal artery stenosis precludes the drawing of significant conclusions. The lack of complete angiographic follow-up prevents determination of the incidence of renal artery lesion recurrence, which is a desired end point. However, the dilemmas encountered in attempting to obtain such data, especially with the use of iodinated contrast media in patients with renal disease, are not readily soluble, most pointedly in patients who are clinically well. Furthermore, this paucity of angiography follow-up limits our understanding of the worsening of renal function in patients with normal baseline creatinine after successful revascularization. Was worsening function related to lesion recurrence, progression of concomitant nephrosclerosis, or exposure of the diseased glomeruli to a high arterial pressure which accelerated the disease? This problem could be overcome in future studies using renal duplex scanning.

Conclusions
Revascularization of atherosclerotic renal artery stenosis (stenoses) can be simply, safely, and effectively achieved with balloon-expandable Palmaz-Schatz stents. For the first time, the longitudinal data presented here detail its effects on renal function, blood pressure control, and patient survival. The survival probability of patients with baseline advanced renal insufficiency was dismal compared with those patients with normal, mild, or moderate impairment in baseline renal function, and their outcome worsened in the presence of bilateral disease.

Whereas the appropriate treatment of renal artery stenosis may not yet be agreed on, these data do raise an important issue: The failure to diagnosis renal artery stenosis before end-organ damage has occurred is not a moot point. Because renal artery stenosis appears to be a readily amenable condition simply and safely managed with stent-supported angioplasty, failure of its diagnosis because of a physician's lack of suspicion and use of appropriate diagnostic measures seems unacceptable. This fact could be underscored by the excellent 4-year clinical data of stent revascularized patients without baseline renal insufficiency. Stent revascularization appears preferential to surgical alternatives in patients with an anticipated increased surgical risk on the sole basis of surgical morbidity and mortality rates. Stent revascularization, with its gratifying success rates, acceptable procedural risks, beneficial impact on blood pressure control and renal function, and excellent follow-up results in patients with normal baseline renal function, may become the procedure of choice for atherosclerotic renal artery stenosis, if these data are supported by additional studies.

	Acknowledgments

 
This work was sponsored by the William Dorros-Isadore Feuer Interventional Cardiovascular Disease Foundation Ltd, Milwaukee, Wis. We would like to thank Mary Jashinsky for the secretarial preparation of the manuscript.

	Footnotes

 
Reprint requests to Gerald Dorros, MD, President, Arizona Heart Institute Foundation, 2632 N 20th St, Phoenix, AZ 85006.

Received November 24, 1997; revision received March 25, 1998; accepted April 20, 1998.

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