First experience with hybrid percutaneous transmyocardial laser revascularization and angioplasty in patients with lesions at high risk for restenosis: Results of a phase I feasibility study.

BACKGROUND: Prior studies have suggested that percutaneous transmyocardial laser revascularization (PTMR) may be effective as a sole treatment modality in reducing angina in patients with severe coronary artery disease and no revascularization alternatives. The safety and efficacy of the hybrid or adjunctive use of PTMR during the same procedure as percutaneous intervention (PCI) has not previously been reported. METHODS: A US phase I feasibility study was therefore performed to determine whether PTMR performed in the same myocardial territory as PCI is able to ameliorate symptomatic recurrence from restenosis. RESULTS: After successful and uncomplicated PCI in 26 patients with class III-IV angina and lesion(s) at high risk for restenosis, PTMR was performed in the same myocardial territories subtended by the treated vessel(s). Major periprocedural adverse events (death, Q-wave myocardial infarction, and bypass surgery) occurred in 3 (11.5%) patients, as the result of subacute vessel closure in 2 patients, and tamponade in the third. Cumulative 6-month mortality rate was 19.2%, including 2 late deaths between 3 and 4 months after discharge (1 death caused by late stent closure and 1 unexplained death during sleep.) Late repeat revascularization for restenosis in the PCI plus PTMR treated target vessel was required in 19.2% of patients, and an additional 11.5% of patients had class III-IV angina at 6-month follow-up. CONCLUSIONS: These data demonstrate that in a patient population at high risk for restenosis, recently created PTMR channels are not protective against severe ischemia caused by acute vessel closure and that late symptomatic restenosis after PCI may still frequently occur despite PTMR in the same region.

Effect of thromboxane A2 blockade on clinical outcome and restenosis after successful coronary angioplasty. Multi-Hospital Eastern Atlantic Restenosis Trial (M-HEART II)

BACKGROUND: Antithromboxane therapy with aspirin reduces acute procedural complications of coronary angioplasty (PTCA) but has not been shown to prevent restenosis. The effect of chronic aspirin therapy on long-term clinical events after PTCA is unknown, and the utility of more specific antithromboxane agents is uncertain. The goal of this study was to assess the effects of aspirin (a nonselective inhibitor of thromboxane A2 synthesis) and sulotroban (a selective blocker of the thromboxane A2 receptor) on late clinical events and restenosis after PTCA. METHODS AND RESULTS: Patients (n = 752) were randomly assigned to aspirin (325 mg daily), sulotroban (800 mg QID), or placebo, started within 6 hours before PTCA and continued for 6 months. The primary outcome was clinical failure at 6 months after successful PTCA, defined as (1) death, (2) myocardial infarction, or (3) restenosis associated with recurrent angina or need for repeat revascularization. Neither active treatment differed significantly from placebo in the rate of angiographic restenosis: 39% (73 of 188) in the aspirin-assigned group, 53% (100 of 189) in the sulotroban group, and 43% (85 of 196) in the placebo group. In contrast, aspirin therapy significantly improved clinical outcome in comparison to placebo (P = .046) and sulotroban (P = .006). Clinical failure occurred in 30% (49 of 162) of the aspirin group, 44% (73 of 166) of the sulotroban group, and 41% (71 of 175) of the placebo group. Myocardial infarction was significantly reduced by antithromboxane therapy: 1.2% in the aspirin group, 1.8% in the sulotroban group, and 5.7% in the placebo group (P = .030). CONCLUSIONS: Thromboxane A2 blockade protects against late ischemic events after angioplasty even though angiographic restenosis is not significantly reduced. While both aspirin and sulotroban prevent the occurrence of myocardial infarction, overall clinical outcome appears superior for aspirin compared with sulotroban. Therefore, aspirin should be continued for at least 6 months after coronary angioplasty.

Multi-Hospital Eastern Atlantic Restenosis Trial. II: A placebo-controlled trial of thromboxane blockade in the prevention of restenosis following coronary angioplasty.

Since platelet interactions appear to play an important role in the development of restenosis, attenuation of thromboxane-mediated reactions may improve the long-term outcome following coronary angioplasty. Phase II of the Multi-Hospital Eastern Atlantic Restenosis Trial (M-HEART) is a prospective, randomized, placebo-controlled study of thromboxane blockade in the prevention of restenosis following successful coronary angioplasty. Two forms of thromboxane blockade are evaluated: aspirin (a nonspecific inhibitor of thromboxane synthesis) and sulotroban (a specific thromboxane receptor antagonist). The design of this multicenter trial and the rationale for use of sulotroban in the prevention of restenosis are reviewed in this report.

Restenosis after coronary angioplasty: a multivariate statistical model to relate lesion and procedure variables to restenosis. The M-HEART Investigators.

The Multi-Hospital Eastern Atlantic Restenosis Trial group obtained follow-up angiography in 510 patients with 598 successfully dilated coronary lesions who were enrolled in a controlled trial of the effects of a single dose of 1 g of methylprednisolone on restenosis after coronary angioplasty. The overall restenosis rate was 39.6%. The strongest univariate relations to the restenosis rate were found for lesion location (saphenous vein graft, 68%; left anterior descending artery, 45%; left circumflex artery and right coronary artery, 32%; p = 0.002); lesion length (less than or equal to 4.6 mm, 33%; greater than 4.6 mm, 45%; p = 0.001); percent stenosis before angioplasty (less than or equal to 73%, 25%; greater than 73%, 43%; p = 0.005), percent stenosis after angioplasty (less than or equal to 21%, 33%; greater than 21%, 46%; p = 0.017) and arterial diameter (less than 2.9 mm, 44%; greater than or equal to 2.9 mm, 34%; p = 0.036). Two multivariate models to predict restenosis probability were developed with use of stepwise logistic regression. The preprocedural model, which included only variables whose values were known before angioplasty, entered lesion length, vein graft location, left anterior descending artery location, percent stenosis before angioplasty, eccentric lesion and arterial diameter. The postprocedural model, which also included variables whose values were known after angioplasty was performed, was similar to the preangioplasty model except that it also entered postangioplasty percent stenosis and "optimal" balloon sizing but did not enter eccentric lesion. These data indicate that the probability of restenosis after angioplasty is determined predominantly by the characteristics of the lesion being dilated. They are consistent with the known intimal proliferative mechanism of restenosis, offer a means of identifying lesions at unusually high or low risk of restenosis, and of predicting the likelihood that a particular lesion will restenose after angioplasty and provide a rationale for stratification by restenosis probability in the design of future studies of restenosis.

Clinical and angiographic determinants of primary coronary angioplasty success. M-HEART Investigators.

Clinical and anatomic determinants of the initial success of percutaneous transluminal coronary angioplasty were prospectively evaluated in 826 patients enrolled in the Multi-Hospital Eastern Atlantic Restenosis Trial (M-HEART). The 639 men and 187 women ranged in age from 31 to 85 years. Successful angioplasty (residual stenosis less than 50% and no major complications) was achieved in 886 (88.6%) of 1,000 lesions. Success rates were uniform among the eight individual centers. Outcome was not influenced by gender, age or other clinical features, including severity and duration of angina, prior myocardial infarction, rest pain, transient ST segment elevation, history of smoking or diabetes. In contrast, procedural outcome was significantly associated with lesion-specific angiographic factors. Stenoses 60% to 74%, 75% to 89%, 90% to 99% and 100% were associated with success rates of 96%, 90%, 84% and 69%, respectively (p less than 0.001). Angioplasty was less successful in calcified than in noncalcified lesions (82% versus 90%, p less than 0.01), in thrombotic than in nonthrombotic lesions (82% versus 90%, p less than 0.05) and in lesions in the right coronary artery than in other vessels (84% versus 90%, p less than 0.01). Outcome was not related to other anatomic variables, including lesion location (proximal versus distal), vessel size, eccentricity, stenosis length or translesional gradient. By multivariate logistic regression, preangioplasty percent stenosis, right coronary artery location and lesion calcification were demonstrated to be significant independent predictors of angioplasty success. Alternative clinical and angiographic variables did not contribute to this regression model.(ABSTRACT TRUNCATED AT 250 WORDS)

Patient-related variables and restenosis after percutaneous transluminal coronary angioplasty--a report from the M-HEART Group.

As part of a randomized prospective study designed to investigate the restenosis process after percutaneous transluminal coronary angioplasty (PTCA), the relation between patient-related variables and restenosis rate was examined. A total of 722 patients had successful PTCA. Angiographic follow-up was scheduled for 6 +/- 2 months after the procedure and achieved in 510 patients (71%), yielding 598 lesions for analysis. The overall restenosis rate was 40%. The rate was higher in patients undergoing early restudy for a clinical event than in those undergoing routinely scheduled follow-up restudy (71 vs 22%, p less than 0.0001). Age, sex, cigarette smoking history, diabetes mellitus and history of previous myocardial infarction were not associated with restenosis rate. Angina duration and severity before PTCA were also unrelated to restenosis rate. In summary, these variables, many of which have been previously implicated in restenosis, were not found to be predictors of restenosis. The decision to perform PTCA in individual patients should not be negatively influenced by the presence of these factors.

A controlled trial of corticosteroids to prevent restenosis after coronary angioplasty. M-HEART Group.

A multicenter, double-blind, placebo-controlled trial was conducted to determine if corticosteroids influence the development of restenosis after successful percutaneous transluminal coronary angioplasty (PTCA). Either placebo or 1.0 g methylprednisolone (steroid) was infused intravenously 2-24 hours before planned PTCA in 915 patients. The PTCA patient success rate was 87% (mean) in the eight centers. There were no differences in clinical or angiographic baseline variables between the two groups. End-point analysis (angiographic restenosis, death, recurrent ischemia necessitating early restudy, and coronary artery bypass graft surgery) showed that there was no significant difference comparing placebo- with steroid-treated patients. Angiographic restudy showed the lesion restenosis rate to be 39% (120 of 307 lesions) after placebo and 40% (117 of 291) after steroid treatment (p = NS). We conclude that pulse steroid pretreatment does not influence the overall restenosis rate after successful PTCA.

Massive prostatic infarction following aortocoronary bypass surgery: a report of two cases.

We present two patients who had massive prostatic infarctions following coronary bypass surgery. Whereas small areas of prostatic infarction are commonly seen in urologic practice, massive infarction is rarely seen. Massive prostatic infarction has been observed under conditions similar to those occurring with bypass surgery, so no claim is made that the condition occurs uniquely in patients who have recently undergone bypass surgery. Since coronary bypass surgery is commonly performed and since the procedure is often done on men with prostatic hyperplasia, we can reasonably expect to see this condition more commonly that we have in the past. It is our hope that others will be alerted to this condition and look for it in patients with prostatism who undergo coronary bypass surgery, other types of cardiac surgery, and any condition where prostatism and hypotension are present and pressor agents are used in treatment.