Outcome of different reperfusion strategies in patients with former contraindications to thrombolytic therapy: a comparison of primary angioplasty and tissue plasminogen activator. Primary Angioplasty in Myocardial Infarction (PAMI) Investigators.

High-risk patients have been excluded from most thrombolytic trials because of concern over hemorrhagic complications or lack of efficacy. However, based on several recent studies suggesting that patients with relative thrombolytic contraindications may also benefit from reperfusion, recommendations have been made to broadly expand the eligibility criteria for thrombolytic therapy, despite higher absolute complication rates. Primary percutaneous transluminal coronary angioplasty (PTCA) may be an attractive alternative for patients presenting at appropriately equipped hospitals who would otherwise remain at high risk after thrombolytic therapy. In the Primary Angioplasty in Myocardial Infarction (PAMI) trial, 395 patients with acute myocardial infarction were randomized to tissue plasminogen activator (t-PA) or primary PTCA. Conditions were present in 151 patients (38%) which formerly would have contraindicated thrombolytic therapy (age > 70 yr, symptom duration > 4 hr, or prior bypass surgery). In-hospital mortality was 4.3-fold higher in patients with former thrombolytic contraindications compared to lytic-eligible patients (8.6% vs. 2.0%, P = .002). Lytic-eligible patients treated with t-PA and PTCA had similar in-hospital mortality (1.7% vs. 2.4%, P = NS). In contrast, both in-hospital (2.9% vs. 13.2%, P = .025) and 6-mo mortality (2.9% vs. 15.7%, P = .009) were significantly reduced in patients with former thrombolytic contraindications treated by primary PTCA compared to t-PA. By logistic regression analysis, treatment by PTCA rather than t-PA was the strongest predictor of survival in patients with former thrombolytic contraindications. We conclude that patients with conditions formerly contraindicating thrombolytic therapy constitute a high-risk group with significant morbidity and mortality after lytic reperfusion. Our data suggest that patients with former contraindications to thrombolytic therapy may benefit by preferential management with primary PTCA without antecedent thrombolysis.

Coronary angioplasty versus repeat coronary artery bypass grafting for patients with previous bypass surgery.

OBJECTIVES: We attempted to determine the relative risks and benefits of percutaneous transluminal coronary angioplasty (PTCA) and repeat coronary artery bypass grafting (re-CABG) in patients with previous coronary bypass surgery (CABG). BACKGROUND: Due to an expanding population of patients with surgically treated coronary artery disease and the natural progression of atherosclerosis, an increasing number of patients with previous CABG require repeat revascularization procedures. Although there are randomized comparative data for CABG versus medical therapy and, more recently, versus PTCA, these studies have excluded patients with previous CABG. METHODS: We retrospectively analyzed data from 632 patients with previous CABG who required either elective re-CABG (n = 164) or PTCA (n = 468) at a single center during 1987 through 1988. The PTCA and re-CABG groups were similar with respect to gender (83% vs. 85% male), age > 70 years (21% vs. 23%), mean left ventricular ejection fraction (46% vs. 48%), presence of class III or IV angina (70% vs. 63%) and three-vessel coronary artery disease (77% vs. 74%). RESULTS: Complete revascularization was achieved in 38% of patients with PTCA and 92% of those with re-CABG (p < 0.0001). The in-hospital complication rates were significantly lower in the PTCA group: death (0.3% vs. 7.3%, p < 0.0001) and Q wave myocardial infarction (MI) (0.9% vs. 6.1%, p < 0.0001). Actuarial survival was equivalent at 1 year (PTCA 95% vs. re-CABG 91%) and 6 years (PTCA 74% vs. re-CABG 73%) of follow-up (p = 0.32). Both procedures resulted in equivalent event-free survival (freedom from dealth or Q wave MI) and relief of angina; however, the need for repeat percutaneous or surgical revascularization, or both, by 6 years was significantly higher in the PTCA group (PTCA 64% vs. re-CABG 8%, p < 0.0001). Multivariate analysis identified age > 70 years, left ventricular ejection fraction < 40%, unstable angina, number of diseased vessels and diabetes mellitus as independent correlates of mortality for the entire group. CONCLUSIONS: In this nonrandomized series of patients with previous CABG requiring revascularization, an initial stategy of either PTCA or re-CABG resulted in equivalent overall survival, event-free survival and relief of angina. PTCA offers lower procedural morbidity and mortality risks, although it is associated with less complete revascularization and a greater need for subsequent revascularization procedures.

Influence of acute myocardial infarction location on in-hospital and late outcome after primary percutaneous transluminal coronary angioplasty versus tissue plasminogen activator therapy.

In the Primary Angioplasty in Myocardial Infarction trial, 395 patients with acute myocardial infarction (AMI) were prospectively randomized to tissue plasminogen activator (tPA) or primary percutaneous transluminal coronary angioplasty (PTCA). In 138 patients with anterior wall AMI, in-hospital mortality was significantly reduced by treatment with PTCA compared with tPA (1.4% vs 11.9%, p = 0.01). PTCA also resulted in lower rates of death or reinfarction (1.4% vs 18.0%, p = 0.0009), recurrent myocardial ischemia (11.3% vs 28.4%, p = 0.01), and stroke (0.0% vs 6.0%, p = 0.037) in anterior wall AMI. The independent beneficial effect of treatment with primary PTCA rather than tPA in anterior wall AMI was confirmed by multivariate analysis and interaction testing. The in-hospital mortality of 257 patients with nonanterior wall AMI was similar after PTCA and tPA (3.2% vs 3.8%, p = 0.82). Compared with tPA, however, primary PTCA resulted in a markedly lower rate of recurrent myocardial ischemia (9.7% vs 27.8%, p = 0.0002), fewer unscheduled catheterization and revascularization procedures, and a shorter hospital stay (7.0 vs 8.6 days, p = 0.01) in nonanterior wall AMI. Thus, compared with tPA, primary PTCA in patients with anterior wall AMI results in significantly improved survival, with lower rates of stroke, reinfarction, and recurrent myocardial ischemia. In nonanterior wall AMI, treatment with PTCA and tPA results in similar early mortality, although PTCA-treated patients have a more stable hospital course characterized by reduced recurrent ischemia, fewer subsequent invasive procedures, and earlier discharge.

Lovastatin plus probucol for prevention of restenosis after percutaneous transluminal coronary angioplasty.

Combination lovastatin and probucol reduced total cholesterol (27%) and low-density lipoprotein levels (30%), but did not prevent restenosis or clinical events during the first 6 months after percutaneous transluminal coronary angioplasty.

Results of direct percutaneous transluminal coronary angioplasty in octogenarians.

Direct percutaneous transluminal coronary angioplasty (PTCA) has emerged as effective reperfusion therapy for acute myocardial infarction; however, few data exist on its use in octogenarians. Thrombolytic therapy in this age group has reduced early mortality from approximately 30% to 20%, but is associated with an increased risk of stroke and major hemorrhage. We analyzed the acute and long-term results of direct PTCA performed on patients aged > or = 80 years at our institution between 1980 and 1993. The study group consisted of 55 patients (mean patient age 83.3 +/- 2.3 years). Infarcts were anterior in 27 patients (49%). Cardiogenic shock was present in 6 patients (11%). The mean time to reperfusion was 4.3 +/- 2.8 hours. Direct PTCA was successful in 53 patients (96%). There were no emergent bypass operations. In-hospital death occurred in 9 patients (16%), including 4 of 6 (67%) presenting in cardiogenic shock and 5 of 49 (10%) who were hemodynamically stable on presentation. Repeat PTCA for recurrent ischemia was performed in 6 patients (11%). There were no strokes during hospitalization. Bleeding complications requiring blood transfusion were present in 4 patients (7%). Thirty-day mortality was 16% and 1-year actuarial survival was 67%. Direct PTCA in patients aged > or = 80 years can be performed safely with a high procedural success rate. The clinical outcome with PTCA in this high risk subset of patients compares favorably with that reported previously for both thrombolytic and medical therapy.

Implications of recurrent ischemia after reperfusion therapy in acute myocardial infarction: a comparison of thrombolytic therapy and primary angioplasty.

OBJECTIVES: The purpose of this study was to examine the incidence and implications of recurrent ischemia after different reperfusion strategies in acute myocardial infarction. BACKGROUND: The rates and effects of recurrent ischemia after reperfusion with thrombolytic therapy and with primary percutaneous transluminal coronary angioplasty have not been compared. METHODS: At 12 centers 395 patients presenting within 12 h of the onset of acute myocardial infarction were prospectively randomized to receive recombinant tissue-type plasminogen activator (rt-PA) or primary coronary angioplasty. Sixteen clinical variables were examined by using univariate and multiple logistic regression analysis to identify the predictors of recurrent ischemia. The relation of recurrent ischemic events to patient outcome was analyzed. RESULTS: Recurrent ischemia developed in 76 patients (19.2%) before hospital discharge, resulting in reinfarction in 18 patients (4.6%) and death in 5 (2.6%). Recurrent ischemia occurred in 56 patients (28.0%) after rt-PA but in only 20 patients (10.3%) after coronary angioplasty (p < 0.0001), directly contributing to a higher rate of death or reinfarction (7.5% vs. 3.1%, p = 0.05), catheterization and revascularization procedures and prolonged hospital stay after thrombolysis. By multivariate analysis, treatment with coronary angioplasty rather than rt-PA was the strongest predictor of freedom from recurrent ischemia. Although the incidence of recurrent ischemia after angioplasty and after rt-PA was similar within the 1st 2 days of admission (9.2% vs. 14.5%, p = 0.11), after hospital day 2 recurrent ischemia occurred in only 2 patients who received primary angioplasty compared with 27 patients who received rt-PA (1.1% vs. 13.5%, p < 0.0001). CONCLUSIONS: The development of recurrent ischemia adversely affects patient outcome, increasing morbidity, mortality and resource utilization. The much lower rate of recurrent ischemia after primary coronary angioplasty than after rt-PA results in improved survival without reinfarction and allows a shorter, less complicated hospital stay. Given the extremely low rate of recurrent ischemia after hospital day 2, safe early discharge on day 3 after primary coronary angioplasty should be feasible in selected patients with acute myocardial infarction.

Comparison of in-hospital outcome in men versus women treated by either thrombolytic therapy or primary coronary angioplasty for acute myocardial infarction.

At 12 centers, 395 patients, including 288 men (73%) and 107 women (27%) with acute myocardial infarction (AMI), were prospectively randomized to treatment with tissue plasminogen activator (t-PA) or primary percutaneous transluminal coronary angioplasty (PTCA). Compared with men, women were older (65.7 vs 57.7 years, p < 0.0001), more often had diabetes mellitus (19% vs 10%, p = 0.03), systemic hypertension (54% vs 39%, p = 0.005), prior congestive heart failure (5% vs 0%, p = 0.002), and presented later after symptom onset (229 vs 174 minutes, p = 0.0004). The in-hospital mortality in women was 3.3-fold higher than men (9.3% vs 2.8%, p = 0.005). After adjustment for comorbid baseline characteristics, however, only advanced age independently correlated with mortality. Among t-PA-treated patients, mortality was significantly higher in women than in men (14.0% vs 3.5%, p = 0.006). Intracranial hemorrhage after t-PA was also more common in women than in men (5.3% vs 0.7%, p = 0.037). In contrast, women and men had similar in-hospital mortality after primary PTCA (4.0% vs 2.1%, respectively, p = 0.46). No intracranial bleeding occurred in PTCA-treated patients. A univariate trend was present for reduced in-hospital mortality in women treated with PTCA rather than t-PA (4.0% vs 14.0%, p = 0.07). By multiple logistic regression analysis of 15 clinical variables, treatment with PTCA rather than t-PA, as well as younger age, were independently predictive of in-hospital survival in women.(ABSTRACT TRUNCATED AT 250 WORDS)

Predictors of in-hospital and 6-month outcome after acute myocardial infarction in the reperfusion era: the Primary Angioplasty in Myocardial Infarction (PAMI) trail.

OBJECTIVES: This study examined the predictors of in-hospital and 6-month outcome after different reperfusion strategies in acute myocardial infarction. BACKGROUND: Thrombolytic therapy and primary angioplasty are both widely applied as reperfusion modalities in patients with myocardial infarction. Although it is accepted that restoration of early patency of the infarct-related artery can reduce mortality and salvage myocardium, the optimal reperfusion strategy remains controversial, and the predictors of outcome in the reperfusion era have been incompletely characterized. METHODS: At 12 centers, 395 patients presenting within 12 h of onset of acute transmural myocardial infarction were prospectively randomized to receive tissue-type plasminogen activator (t-PA) or undergo primary angioplasty without antecedent thrombolysis. Sixteen clinical variables were examined with univariate and multiple logistic regression analysis to identify the predictors of clinical outcome. RESULTS: By univariate analysis, in-hospital mortality was increased in the elderly, women, patients with diabetes and in patients treated with t-PA as opposed to angioplasty. Only advanced age and treatment by t-PA versus angioplasty independently correlated with increased in-hospital mortality (6.5% vs. 2.6%, respectively, p = 0.039 by multiple logistic regression analysis). Similarly, the only variables independently related to in-hospital death or nonfatal reinfarction were advanced age and treatment by t-PA versus angioplasty (12.0% vs. 5.1%, p = 0.02). The reduction in in-hospital death or reinfarction with angioplasty versus t-PA was particularly marked in patients > or = 65 years of age (8.6% vs. 20.0%, p = 0.048). Furthermore, primary management with angioplasty versus t-PA was the most powerful multivariate correlate of freedom from recurrent ischemic events (10.3% vs. 28.0%, p = 0.0001). The independent beneficial effect of angioplasty on freedom from death or reinfarction was maintained at 6-month follow-up (8.2% vs. 17.0%, p = 0.02). CONCLUSIONS: In the reperfusion era, the two most powerful determinants of freedom from death, reinfarction and recurrent ischemia after myocardial infarction are young age and treatment by primary angioplasty.

Directional atherectomy of left main stenoses.

Balloon angioplasty (PTCA) of left main (LM) stenoses is limited by frequent clinical restenosis. Directional coronary atherectomy (DCA) may be an effective alternative to PTCA due to its ability to achieve a greater postprocedural luminal diameter when treating bulky, eccentric plaques and aorto-ostial lesions. We analyzed the acute and long-term results following 24 DCA procedures in 22 patients with "protected" LM lesions. Acute success (residual stenosis < or = 40%, no major ischemic complications) was 88% overall, 100% in 13 planned procedures, and 73% in 11 adjunctive DCA procedures that followed suboptimal PTCA. Mean LM stenosis was reduced from 86% to 13% (P < 0.01). There were no procedural complications directly attributed to DCA. At a mean of 24 +/- 3 months, the clinical restenosis rate was 16%, survival was 100%, and event-free survival (freedom from death, MI, or repeat lesion-related interventions) was 89%. We conclude that DCA in protected LM lesions (1) can achieved excellent angiographic results with low procedural complication rates, (2) may succeed where PTCA yields suboptimal results, and (3) may provide late clinical outcomes superior to those of balloon angioplasty.

Coronary angioplasty versus bypass surgery in patients > 70 years old matched for ventricular function.

OBJECTIVES: This study compared the relative risks and benefits of coronary angioplasty and coronary artery bypass graft surgery in patients > 70 years old. BACKGROUND: Few objective, comparative data exist to guide the clinician in the decision to use bypass surgery or angioplasty in elderly patients. METHODS: The study was a case-control, retrospective analysis of 195 consecutive patients who underwent bypass surgery in 1987 and 1988 and were compared with a concurrent cohort of 195 coronary angioplasty-treated patients. The groups were matched for left ventricular function, age and gender mix. RESULTS: The in-hospital morbidity and mortality rates were significantly lower in the coronary angioplasty-treated patients. Mean postprocedural hospital stay was 4.8 and 14.3 days for angioplasty and surgical group patients, respectively (p < 0.001). In-hospital death occurred in 2% of angioplasty-treated patients compared with 9% of surgically treated patients (p = 0.007). Serious in-hospital stroke occurred in no patient in the angioplasty group and in 5% of patients in the surgical group (p < 0.0001). Q wave infarction occurred in 1% of angioplasty-treated patients and 6% of bypass-treated patients (p = 0.01). The 5-year actuarial survival rate was similar in the two groups: 63% in the angioplasty group, 65% in the bypass group (p = NS). However, surgical group patients experienced less recurrent angina, required fewer repeat revascularization procedures and had fewer Q wave infarctions during follow-up compared with angioplasty group patients. CONCLUSIONS: When performed in patients > 70 years old, angioplasty and coronary bypass surgery result in similar long-term survival rates but otherwise distinctly different clinical courses.

Initial and long-term outcome of 83 patients after balloon angioplasty of totally occluded bypass grafts.

OBJECTIVES: This study was designed to evaluate the safety and short- and long-term results of coronary angioplasty of totally occluded bypass grafts in patients with clinical conditions other than acute myocardial infarction. BACKGROUND: Total occlusion of bypass grafts after coronary artery surgery often causes recurrent ischemia. The safety and results of percutaneous transluminal coronary angioplasty in occluded bypass grafts are controversial. METHODS: All patients with dilation of a totally occluded bypass graft attempted between 1981 and 1991 were retrospectively identified from a data base. Patients treated in the setting of an acute myocardial infarction were excluded. Eighty-three patients met these criteria and constitute the study group. Hospital records, office charts and procedural reports were reviewed in all patients to supplement details available in the data base. RESULTS: The time from bypass surgery to attempted coronary angioplasty ranged from 1 to 226 months (mean time 88 months). The mean (+/- SD) duration of graft occlusion was 31 +/- 46 days (range 1 to 180). In 27 attempts the bypass graft was the only site dilated, and in 56 attempts (68%) one to six other sites (n = 101) were dilated. Angiographic success (< or = 40% residual lumen stenosis) was achieved in 61 grafts (73%) and 98 of the additional sites (97%) (p < 0.001). Major complications included one procedural death and two Q wave infarctions. Follow-up for a mean of 32 months demonstrated a 1- and 3-year actuarial survival rate of 94% and 80%, respectively. At 3 years, only 34% of patients were free of repeat angioplasty or surgery. CONCLUSIONS: Angioplasty of totally occluded bypass grafts can be successful in the majority of selected patients, although major complications can occur. Strategies for sustained patency are needed to improve the long-term results.

Primary angioplasty for acute myocardial infarction in 1,000 consecutive patients. Results in an unselected population and high-risk subgroups.

Primary angioplasty (direct angioplasty without antecedent thrombolytic therapy) has remained an exclusive and consistent method of infarct intervention at our institution over the past 13 years. A total of 1,000 consecutive patients were prospectively enrolled in our primary angioplasty database. Of patients presenting to our group with an acute myocardial infarction, 96% of those eligible received immediate angioplasty. Cardiogenic shock was noted in 79 patients (7.9%). The mean time from pain onset to reperfusion was 5.4 +/- 4.0 hours. Infarct-vessel recanalization was accomplished in 94% of patients. Recanalization rates were similar among the 3 native epicardial coronary systems but were lower in bypass grafts (86%; p < 0.0001). Overall in-hospital mortality was 7.8%; mortality with cardiogenic shock was 44%. Global ejection fraction increased from 49.7% preangioplasty to 57.4% at the time of dismissal. The amount of myocardial salvage was highly dependent on the size of the initial infarction (the largest infarctions benefiting the most). Patients reperfused in < 2 hours experienced a very low mortality (4%) and impressive myocardial salvage. Complications included stroke in 0.5%, significant bleeding in 2.8%, and early reocclusion of the infarct vessel in 13%. Primary angioplasty is broadly applicable to patients presenting with acute myocardial infarction and results in a very high rate of infarct vessel recanalization, with a mortality rate of 7.8%. This strategy may be uniquely effective in patients presenting with cardiogenic shock, large infarctions, contraindications to thrombolytic therapy, and prior bypass surgery.

Failed direct coronary angioplasty for acute myocardial infarction: in-hospital outcome and predictors of death.

OBJECTIVES: The purpose of this study was to compare the mechanisms, predictors and outcome of patients with failed direct coronary angioplasty of the infarct-related artery with those in patients with successful direct angioplasty. BACKGROUND: Direct coronary angioplasty of the infarct-related artery, without antecedent thrombolytic therapy, is an effective treatment for patients with acute myocardial infarction. Concern has been expressed over high mortality rates in patients with failed direct infarct angioplasty. METHODS: All patients treated by angioplasty were prospectively entered into a computer data base. The characteristics and outcome of all patients with failed direct angioplasty were reviewed and compared with those of patients with successful direct angioplasty. RESULTS: Direct angioplasty was successful in 705 (94%) of 750 patients and unsuccessful in 45 (6%). Patients in the failure group were more likely to be in cardiogenic shock (22% vs. 7%, p < 0.003), to have had a previous myocardial infarction (44% vs. 28%, p < 0.03) and to have three-vessel coronary artery disease (44% vs. 23%, p < 0.003). Age, gender, ejection fraction, previous bypass surgery and diabetes mellitus were similar in both groups. Only the presence of multivessel coronary artery disease (p < 0.004) and cardiogenic shock (p < 0.025) were independent predictors of failed direct angioplasty. In-hospital death (31% vs. 4.8%, p < 0.001) and the need for emergency coronary artery bypass surgery (27% vs. 0.5%, p < 0.0001) were more frequent in patients with unsuccessful than in patients with successful direct angioplasty. Patients with failed direct angioplasty and in-hospital death usually had multiple high risk characteristics, including cardiogenic shock (50%), previous myocardial infarction (43%) and multivessel coronary artery disease (93%). CONCLUSIONS: Direct coronary angioplasty is an effective method for establishing reperfusion in acute myocardial infarction. Procedural failure is infrequent, usually occurring in patients with high risk baseline characteristics.

Angioplasty versus bypass surgery for multivessel coronary artery disease with left ventricular ejection fraction < or = 40%.

Patients with multivessel coronary artery disease and left ventricular dysfunction represent a high-risk subgroup in whom coronary artery bypass grafting has been shown to improve survival compared with that of medically treated patients. The comparative benefits and risks of coronary angioplasty and bypass surgery in this subgroup of patients are unclear. This study retrospectively analyzes 100 consecutive patients treated with bypass surgery compared with a matched, concurrent cohort of 100 treated with multivessel angioplasty. Early results favored angioplasty; a hospital stay of 12.8 days was noted in the bypass group compared with 4.3 days in the angioplasty group (p < 0.001). In-hospital mortality rates were similar in the bypass (5%) and angioplasty (3%) groups (p = NS). Stroke was observed significantly more often in the bypass group (7 vs 0%). However, late follow-up favored bypass patients; repeat revascularization procedures and late myocardial infarction occurred more frequently during follow-up in the angioplasty group. During 5-year follow-up, superior relief from disabling angina (99 vs 89%; p = 0.01) and a trend toward improved survival (76 vs 67%; p = 0.09) were observed in the bypass group as compared with the angioplasty group. Multivariate correlates of late mortality included age and incomplete revascularization, but not mode of revascularization. Thus, in patients with multivessel coronary artery disease and left ventricular dysfunction, early results favor angioplasty, whereas late follow-up favors bypass surgery. However, late survival was similar in both groups of patients who were completely revascularized.

Abrupt vessel closure after directional coronary atherectomy. The U.S. Directional Atherectomy Investigator Group.

From October 1, 1986 to December 31, 1989 directional coronary atherectomy was performed during 1,020 procedures (1,140 lesions) at 14 clinical centers. Abrupt vessel closure, defined as a total coronary occlusion or subtotal occlusion associated with clinical evidence of myocardial ischemia, occurred in 43 procedures (4.2%). It developed in the catheterization laboratory in 34 patients, but was delayed 1 to 96 h after directional atherectomy in 9 patients. By univariate analysis the incidence of abrupt closure was higher in directional atherectomy of de novo lesions (p less than 0.001), lesions in the right coronary artery (p = 0.001) and diffuse lesions (p = 0.04). The incidence of abrupt closure tended to be lower in directional atherectomy of saphenous vein grafts as opposed to native coronary arteries (1.6% vs. 4.4%; p = 0.08). Clinical findings during abrupt closure included severe angina in 26 patients, myocardial infarction in 17 patients, hypotension in 5 patients and death in 2 patients. Balloon angioplasty was attempted in 32 patients after abrupt vessel closure. In 16 patients balloon angioplasty resulted in initial resolution of the closure episode, although 1 patient died 96 h after the procedure. Fifteen of 16 patients without initial improvement after balloon angioplasty underwent coronary bypass operation; 9 additional patients with abrupt closure were referred directly for bypass operation. It is concluded that abrupt vessel closure develops relatively infrequently after directional coronary atherectomy. In the absence of severe coronary dissection, abrupt closure after directional atherectomy may be effectively managed with balloon angioplasty in some cases, although coronary bypass operation is often required.

Ineffectiveness of colchicine for the prevention of restenosis after coronary angioplasty.

Colchicine, an antimitogenic agent, has shown promise in preventing restenosis after coronary angioplasty in experimental animal models. A prospective trial was conducted involving 197 patients randomized in a 2:1 fashion to treatment with oral colchicine, 0.6 mg twice daily (130 patients), or placebo (67 patients) for 6 months after elective coronary angioplasty. Treatment in all patients began between 12 h before angioplasty and 24 h after angioplasty. Compliance monitoring revealed that 96% of all prescribed pills were ingested. Demographic characteristics were similar in colchicine- and placebo-treated groups. A mean of 2.7 lesions/patient were dilated. Side effects resulted in a 6.9% dropout rate in the colchicine-treated patients. Complete quantitative angiographic follow-up was obtained in 145 patients (74%) with 393 dilated lesions. Quantitative angiographic measurements were obtained in two orthogonal views at baseline before angioplasty and immediately and at 6 months after angioplasty. The quantitative mean lumen diameter stenosis before angioplasty was 67% both in the 152 lesions in the placebo-treated group and in the 241 lesions in the colchicine-treated group; this value was reduced to 24% immediately after angioplasty in the lesions in both treatment groups. At the 6-month angiogram, lesions had restenosed to 47% lumen diameter narrowing in the placebo-treated group compared with 46% in the colchicine-treated group (p = NS). Forty-one percent of colchicine-treated patients developed restenosis in at least one lesion compared with 45% of the placebo-treated group (p = NS). In conclusion, colchicine was ineffective for preventing restenosis after coronary angioplasty.