Coronary stenting versus coronary bypass surgery in patients with multiple vessel disease and significant proximal LAD stenosis: results from the ERACI II study.

PURPOSE: To compare percutaneous coronary intervention (PCI) using stent implantation versus coronary artery bypass graft (CABG) in patients with multiple vessel disease with involvement of the proximal left anterior descending coronary artery (LAD). METHODS: 230 patients with multiple vessel disease and severe stenosis of the proximal LAD (113 with PCI, 117 with CABG). They were a cohort of patients from the randomised ERACI (Argentine randomized trial of percutaneous transluminal coronary angioplasty versus coronary artery bypass surgery in multivessel disease) II study. RESULTS: Both groups had similar baseline characteristics. There were no significant differences in 30 day major adverse cardiac events (death, myocardial infarction, stroke, and repeat procedures) between the strategies (PCI 2.7% v CABG 7.6%, p = 0.18). There were no significant differences in survival (PCI 96.4% v CABG 95%, p = 0.98) and survival with freedom from myocardial infarction (PCI 92% v CABG 89%, p = 0.94) at 41.5 (6) months' follow up. However, freedom from new revascularisation procedures (CABG 96.6% v PCI 73%, p = 0.0002) and frequency of angina (CABG 9.4% v PCI 22%, p = 0.025) were superior in the CABG group. CONCLUSION: Patients with multivessel disease and significant disease of the proximal LAD randomly assigned in the ERACI II trial to PCI or CABG had similar survival and survival with freedom from myocardial infarction at long term follow up. Repeat revascularisation procedures were higher in the PCI group.

Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS): immediate and long-term follow-up results.

OBJECTIVE: This study sought to compare two strategies of revascularization in patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stenting versus optimal PTCA. A good immediate angiographic result with provisional stenting was considered to occur only if early loss in minimal luminal diameter (MLD) was documented at 30 min post-PTCA angiography. BACKGROUND: Coronary stenting reduces restenosis in lesions exhibiting early deterioration (>0.3 mm) in MLD within the first 24 hours (early loss) after successful PTCA. Lesions with no early loss after PTCA have a low restenosis rate. METHODS: To compare angiographic restenosis and target vessel revascularization (TVR) of lesions treated with coronary stenting versus those treated with optimal PTCA, 116 patients were randomized to stent (n=57) or to optimal PTCA (n=59). After randomization in the PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting). RESULTS: Baseline demographic and angiographic characteristics were similar in both groups of patients. At 7.6 months, 96.6% of the entire population had a follow-up angiographic study: 98.2% in the stent and 94.9% in the PTCA group. Immediate and follow-up angiographic data showed that acute gain was significantly higher in the stent than in the PTCA group (1.95 vs. 1.5 mm; p < 0.03). However, late loss was significantly higher in the stent than the PTCA group (0.63+/-0.59 vs. 0.26+/-0.44, respectively; p=0.01). Hence, net gain with both techniques was similar (1.32< or =0.3 vs. 1.24+/-0.29 mm for the stent and the PTCA groups, respectively; p=NS). Angiographic restenosis rate at follow-up (19.2% in stent vs. 16.4% in PTCA; p=NS) and TVR (17.5% in stent vs. 13.5% in PTCA; p=NS) were similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTCA group (p=NS). Overall costs (hospital and follow-up) were US $591,740 in the stent versus US $398,480 in the PTCA group (p < 0.02). CONCLUSIONS: The strategy of PTCA with delay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PTCA.

Three-year follow-up of the Argentine Randomized Trial of Percutaneous Transluminal Coronary Angioplasty Versus Coronary Artery Bypass Surgery in Multivessel Disease (ERACI).

OBJECTIVES: The purpose of this study was to report the 3-year follow-up results of the ERACI trial (Argentine Randomized Trial of Percutaneous Transluminal Coronary Angioplasty Versus Coronary Artery Bypass Surgery in Multivessel Disease). BACKGROUND: Although coronary angioplasty has been used with increased frequency in patients with multivessel coronary artery disease, its value, compared with bypass graft surgery, has not been established. Thus, controlled, randomized clinical trials such as the ERACI are needed. METHODS: In this trial 127 patients who had multivessel coronary artery disease and clinical indication of myocardial revascularization were randomized to undergo coronary angioplasty (n = 63) or bypass surgery (n = 64). The primary end point of this study was event-free survival (survival with freedom from myocardial infarction, angina and new revascularization procedures) for both groups of patients at 1, 3 and 5 years of follow-up. RESULTS: Freedom from combined cardiac events (death, Q-wave myocardial infarction, angina and repeat revascularization procedures) was significantly greater for the bypass surgery group than the coronary angioplasty group (77% vs. 47%; p < 0.001). There were no differences in overall (4.7% vs. 9.5%; p = 0.5) and cardiac (4.7% vs. 4.7%; p = 1) mortality or in the frequency of myocardial infarction (7.8% vs. 7.8%; p = 0.8) between the two groups. However, patients who had bypass surgery were more frequently free of angina (79% vs. 57%; p < 0.001) and required fewer additional reinterventions (6.3% vs. 37%; p < 0.001) than patients who had coronary angioplasty. CONCLUSIONS: 1) Freedom from combined cardiac events at 3-year follow-up was greater in patients who had bypass surgery than in those who had coronary angioplasty. 2) The coronary angioplasty group had a higher incidence of recurrence of angina and the need for repeat revascularization procedures. 3) Cumulative cost at 3-year follow-up was greater for the bypass surgery group than for the coronary angioplasty group.

La infiltración de macrófagos en las lesiones coronarias primarias está asociada con reestenosis luego de la intervención coronaria percutánea / Macrophage infiltration in primary coronary plaque tissue is associated with restenosis after percutaneous coronary intervention

Se le realizó aterectomía direccional coronaria de la lesión culposa a 50 pacientes sintomáticos por angina inestable. Se tiñeron las muestras obtenidas con hematoxilina-eosina, tinción tricrómica y con anticuerpos monoclonales antimacrófagos humanos (Kp-1). El seguimiento angiográfico fue de 16 ñ 2 semanas. Treinta pacientes evolucionaron a reestenosis y 20 pacientes sin reestenosis (grupo control). El porcentaje de áreas ricas en macrófagos fue significativamente mayor en las placas de pacientes con reestenosis (19 ñ 3 por ciento) que en las placas sin reestenosis (10,3 ñ 3 por ciento) (p= 0,005). Este incremento del contenido de macrófagos sugiere que células inflamatorias estarían involucradas en el complejo mecanismo de la reestenosis luego de la intervención coronaria percutánea (AU)

La infiltración de macrófagos en las lesiones coronarias primarias está asociada con reestenosis luego de la intervención coronaria percutánea / Macrophage infiltration in primary coronary plaque tissue is associated with restenosis after percutaneous coronary intervention

Se le realizó aterectomía direccional coronaria de la lesión culposa a 50 pacientes sintomáticos por angina inestable. Se tiñeron las muestras obtenidas con hematoxilina-eosina, tinción tricrómica y con anticuerpos monoclonales antimacrófagos humanos (Kp-1). El seguimiento angiográfico fue de 16 ñ 2 semanas. Treinta pacientes evolucionaron a reestenosis y 20 pacientes sin reestenosis (grupo control). El porcentaje de áreas ricas en macrófagos fue significativamente mayor en las placas de pacientes con reestenosis (19 ñ 3 por ciento) que en las placas sin reestenosis (10,3 ñ 3 por ciento) (p= 0,005). Este incremento del contenido de macrófagos sugiere que células inflamatorias estarían involucradas en el complejo mecanismo de la reestenosis luego de la intervención coronaria percutánea

Time course and mechanism of early luminal diameter loss after percutaneous transluminal coronary angioplasty.

To assess the time course and mechanism of early minimal luminal diameter (MLD) loss, serial angiographic observations were performed. Seventy-four patients (with 74 severe narrowings [ > or = 70%]) with acute ischemic syndromes who had an early loss in MLD of > 0.3 mm at 24 hours after percutaneous transluminal coronary angioplasty (PTCA) also underwent 1 hour post-PTCA angiography. In 12 consecutive patients with early loss 1 hour after PTCA, angioscopy was also performed to assess the mechanism of early loss. The percent diameter stenosis for the 74 lesions was 16.8 +/- 8.4% immediately after PTCA, 35.1 +/- 14.2% 1 hour after PTCA (p < 0.002 vs immediately after), and 41.4 +/- 13.2% at 24 hours (p < 0.10 vs 1 hour after). The MLD also showed similar differences: 2.6 +/- 0.3 mm immediately after to 2.0 +/- 0.4 mm 1 hour after(p < 0.002) to 1.8 +/- 0.4 mm 24 hours after PTCA (p < 0.10 vs 1 hour). In 60 patients (81%), the > 0.3 mm loss was detected 1 hour after PTCA. These 60 patients had no further decreases in MLD at 24 hours (1.9 +/- 0.4 vs 1.8 +/- 0.4 mm at 1 and 24 hours, respectively, p = NS). Adequate angioscopic images available in 11 patients showed that red thrombus was present in 1, minor or multiple dissection in 5, and neither thrombus nor dissection in 5 other patients (consistent with early wall recoil). Thus, in narrowings demonstrating early loss in MLD at 24 hours, 81% showed that the early loss occurred within 1 hour after PTCA. Early loss is not related to thrombus but usually to dissection or recoil.

Coronary stenting decreases restenosis in lesions with early loss in luminal diameter 24 hours after successful PTCA.

BACKGROUND: Early loss of minimal luminal diameter (MLD) after successful percutaneous transluminal coronary angioplasty (PTCA) is associated with a higher incidence of late restenosis. METHODS AND RESULTS: Sixty-six patients (66 lesions) with > 0.3 mm MLD loss at 24-hour on-line quantitative coronary angiography were randomized into two groups: 1, Gianturco-Roubin stent (n = 33) and 2, Control, who received medical therapy only (n = 33). All lesions were suitable for stenting. Baseline demographic, clinical, and angiographic characteristics were similar in the two groups. Restenosis (> or = 50% stenosis) for the overall group occurred in 32 of 66 patients (48.4%) at 3.6 +/- 1-month follow-up angiography. Restenosis was significantly greater in group 2 than in group 1 (75.7% versus 21.2%, P < .001). Vascular complications (21.2% versus 0%) and length of hospital stay (7.3 +/- 1 versus 2.4 +/- 0.5 days, P < .01) were higher for the stent group. Although at follow-up there were no differences in mortality or incidence of acute myocardial infarction between the two groups, patients in the control group had a higher incidence of repeat revascularization procedures (73% versus 21%, P < .001). CONCLUSIONS: In patients with successful PTCA but reduced luminal diameter demonstrated by repeat angiography at 24 hours, the Gianturco-Roubin stent appears to reduce angiographic restenosis at follow-up.

Argentine randomized trial of percutaneous transluminal coronary angioplasty versus coronary artery bypass surgery in multivessel disease (ERACI): in-hospital results and 1-year follow-up. ERACI Group.

OBJECTIVES: This study was designed to compare freedom from combined cardiac events (death, angina, myocardial infarction) at 1-, 3- and 5-year follow-up in patients with multivessel disease randomized to either percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery. BACKGROUND: Percutaneous transluminal coronary angioplasty has been an effective approach in patients with coronary artery disease, but its role in patients with multivessel coronary artery disease is still controversial. METHODS: One-hundred twenty-seven patients with multivessel disease and lesions suitable for either form of therapy were randomized to either coronary artery bypass grafting (n = 64) or coronary angioplasty (n = 63). In this study we report the immediate results and freedom from combined cardiac events at 1-year follow-up. RESULTS: Demographic, clinical and angiographic characteristics were similar in both groups. There were no differences in in-hospital deaths, frequency of periprocedure myocardial infarction or need for emergency revascularization procedures between the two groups. At 1-year follow-up, there were no differences in mortality or in the incidence of myocardial infarction between the groups. However, patients treated with coronary artery bypass grafting were more frequently free of angina, reinterventions and combined cardiac events than were patients treated with coronary angioplasty (83.5% vs. 63.7%, p < 0.005). In-hospital cost and cumulative cost at 1-year follow-up were greater for the coronary artery bypass grafting than for the coronary angioplasty group. CONCLUSIONS: No significant differences were found in major in-hospital complications between patients treated with coronary artery bypass grafting or coronary angioplasty. Although at 1-year follow-up there were no differences in survival and freedom from myocardial infarction, patients in the coronary artery bypass grafting group were more frequently free from angina, reinterventions and combined events than were patients in the coronary angioplasty group.

Early decrease in minimal luminal diameter after successful percutaneous transluminal coronary angioplasty predicts late restenosis.

Eighty-eight patients underwent serial coronary arteriography before, immediately after, 24 hours after and 7 +/- 2 months after successful percutaneous transluminal coronary angioplasty (PTCA) of 102 lesions. Severity of coronary obstruction was measured using quantitative digital angiography. Three groups of lesions were defined when comparing angiograms recorded immediately after and 24 hours after PTCA: group I--lesions with either no change or < or = 10% increase in arterial diameter stenosis after PTCA (n = 71); group II--lesions with > 10% increase in diameter stenosis after PTCA (n = 19); and group III--patients with total occlusion (n = 12). There were no significant differences in the severity of stenosis before or immediately after PTCA among the 3 groups of lesions. Twenty-four hours after PTCA the diameter stenosis was 14.2 +/- 6.3% in group I, 34.7 +/- 8.1% in group II and 100 in group III (p < 0.0001). At 7.1 +/- 2 months after PTCA the diameter stenosis was 21.2 +/- 16.8% in group I, 61.3 +/- 1.1% in group II, and 98.5 +/- 1.3% in group III (p < 0.0001). Restenosis (> or = 50% stenosis diameter) at follow-up per lesion was significantly greater in group II than in group I (73.6 vs 9.8%) (p < 0.0001). Thus, early angiographic study after successful PTCA stratifies lesions into angiographic subsets with low (group I) and high (group II) risk of coronary restenosis.

Echophonocardiography in patients undergoing percutaneous mitral balloon valvotomy (PMV): the learning curve of PMV.

Percutaneous mitral balloon valvotomy (PMV) was performed in 10 female patients with mitral stenosis; their mean age was 31 +/- 1 years. All patients underwent echophonocardiography (Echophono) before and less than 24 hours after PMV1. Cardiac catheterization and Echophono were repeated 10 and 22 months after PMV1. Eight patients with suboptimal results (defined as a post-PMV mitral valve area [MVA]/less than 1.0 cm2 and mean gradient greater than/10 mm Hg) underwent repeat PMV (PMV2) 10 months after PMV1. The Echophono data are correlated with clinical and hemodynamic changes produced by PMV1 and PMV2. MVA increased from 0.6 +/- 0.1 to 1.1 +/- 0.01 cm2 (p = 0.0009) when PMV1 was performed with a mean effective balloon dilating area (EBDA) of 5 +/- 0.19 cm2. MVA increased from 1.0 +/- 0.1 to 1.7 +/- 0.2 cm2 (p = 0.0002) when PMV2 was performed with larger EBDA (6.4 +/- 0.34 cm2). Two factors related to the learning curve account for the superior result of PMV2: (1) use of larger EBDA and (2) optimal position of the balloons parallel to the long axis of the left ventricle. PMV1 resulted in Echophono changes consistent with decreased severity of mitral stenosis: shortening of Q-S1 from 93 +/- 4 to 82 +/- 4 msec (p less than 0.05) and (Q-S1)-(S2-OS) from 1.8 +/- 0.8 to -0.9 +/- 0.6 (p less than 0.01); prolongation of S2-OS from 75 +/- 5 to 91 +/- 5 msec (p less than 0.05) and increase of EF slope from 7 +/- 1 to 17 +/- 4 mm/sec (p less than 0.05). Compared with PMV1, post PMV2 Echophono showed a further decrease in the severity of mitral stenosis: Q-S1 decreased to 78 +/- 3 msec and (Q-S1)-(S2-OS) decreased to -0.5 +/- 0.3 msec. S2-OS increased to 86 +/- 5 msec and EF slope increased to 22 +/- 4 mm/sec. The hemodynamic and Echophono changes produced by PMV1 and PMV2 persisted at the corresponding follow-up studies. There was no evidence of restenosis. Thus Echophono is a simple, low cost method helpful in the evaluation and follow-up of patients undergoing PMV.