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 Ն6-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 166Ϯ26 to 148Ϯ22 mm Hg and from 86Ϯ14 to 80Ϯ11 mm Hg, respectively; PϽ0.05), 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 74Ϯ4% at 3 years, with few deaths related to end-stage renal disease. Survival was good in patients with normal (92Ϯ4%) baseline renal function, fair (74Ϯ7%) in those with mildly impaired renal function, and poor (52Ϯ7%) in patients with elevated baseline creatinine levels (Ն2.0 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. (Circulation. 1998;98:642-647.)

Background-In a prospective, nonrandomized, consecutive series of tibioperoneal vessel angioplasty (TPVA), critical limb ischemia (CLI) patients' data were analyzed with regard to immediate and follow-up success. Methods and Results-TPVA was successful in 270 of 284 critically ischemic limbs (95%), with 167 limbs (59%) requiring dilatation of 333 ipsilateral inflow obstructions to access and successfully dilate 486 of 529 (92%) tibioperoneal lesions. A clinical success (relief of rest pain or improvement of lower-extremity blood flow) was attained in 270 limbs at risk (95%). Clinical 5-year follow-up of 215 of 221 successful CLI patients (97%) with 266 successfully revascularized limbs revealed that bypass surgery occurred in 8% and significant amputations in 9% of limbs; 91% of the limbs were salvaged. The cohort's probability of survival was 56%: 58% for Fontaine class III and 33% for class IV patients. Class III compared with class IV patients had significantly (PϽ0.05) fewer surgical bypasses (3% versus 16%) and amputations: above-knee, 1% versus 4%; below-knee, 3% versus 12%; and transmetatarsal, Ͻ1% versus 21%. Conclusions-TPVA, often in combination with inflow lesions, is an effective primary treatment for critical limb ischemia.The poor cumulative survival reflects the existence of severe comorbidities, which could potentially be affected by aggressive and effective cardiovascular diagnostic and therapeutic strategies.

Palmaz-Schatz stent revascularization of renal artery stenosis was successfully performed on 1,058 patients who were entered into a voluntary, multicenter registry. The revascularization procedures were performed because of poorly controlled hypertension, preservation of renal function, and congestive heart failure. All 1,058 patients were eligible for > or =6-month clinical follow-up, which focused on subsequent renal function, blood pressure, number of antihypertensive medications, and survival. At 4-year follow-up, systolic and diastolic blood pressures had significantly decreased (168 +/- 27 mm Hg to 147 +/- 21 mm Hg, and 84 +/- 15 to 78 +/- 12 mm Hg; P < 0.05) and the blood pressure appeared to be more facilely controlled as indicated by the concomitant decrease in number of antihypertensive medications (2.4 +/- 1.1 to 2.0 +/- 1.0; P < 0.05). Serum creatinine had also significantly decreased (1.7 +/- 1.1 to 1.3 +/- 0.8 mg/dl; P < 0.05). The cumulative probability of survival was 74% +/- 3% at 4 years. Survival was good for patients with normal (85% +/- 3%) baseline renal function, fair (78% +/- 5%) with mildly impaired renal function, and poor (49% +/- 5%) with severely impaired renal function (baseline creatinine > or =2.0 mg/dl). The combination of impaired renal function and bilateral disease adversely effected survival (unilateral 55% +/- 6% vs. bilateral 36% +/- 11%; P < 0.05). Renal artery stent revascularization, in the presence of normal or mildly impaired renal function, had a beneficial effect on blood pressure control and on renal function (through stabilization or improvement). Survival was adversely effected by renal dysfunction despite adequate revascularization. Perhaps early diagnosis of renal artery stenosis and adequate revascularization prior to the onset of renal dysfunction could beneficially impact blood pressure control, preserve or prevent deterioration of renal function, and improve patient survival.

A balloon-expandable (Palmaz-Schatz) stainless steel stent was utilized following balloon angioplasty (PTRA) to determine if the obstructive lesion, using quantitative methods (automated measuring the diameter stenosis, and transstenotic peak systolic and mean pressure gradients), was significantly further reduced or abolished. Hemodynamic transstenotic gradient and stenoses measurements were made during 21 renal artery stenting procedures; prior and following PTRA, and subsequent to stent deployment. The stent sizes placed in the renal arteries were 5 mm (19%), 6 mm (67%), and 7 mm (14%). The results were as follows: [table: see text] The balloon-expandable (Palmaz-Schatz) stent significantly further reduced, and in fact effectively abolished, the obstructive renal artery lesion in comparison to balloon angioplasty (PTRA). The stent's effectiveness with regard lesion recurrence, maintenance, and preservation of renal function; cure or improved management of hypertension; and survival will be determined by careful clinic follow-up.