Randomized comparison of angioplasty of complex coronary lesions at a single center. Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study.

BACKGROUND: The purpose of this study was to test whether coronary revascularization with ablation of either excimer laser or rotational atherectomy can improve the initial angiographic and clinical outcomes compared with dilatation (balloon angioplasty) alone. METHODS AND RESULTS: At a single center, a total of 685 patients with symptomatic coronary disease warranting elective percutaneous revascularization for a complex lesion were randomly assigned to balloon angioplasty (n = 222), excimer laser angioplasty (n = 232), or rotational atherectomy (n = 231). The primary end point was procedural success (diameter stenosis < 50%, absence of death, Q-wave myocardial infarction, or coronary artery bypass surgery). The patients who underwent rotational atherectomy had a higher rate of procedural success than those who underwent excimer laser angioplasty or conventional balloon angioplasty (89% versus 77% and 80%, P = .0019), but no difference was observed in major in-hospital complications (3.2% versus 4.3% versus 3.1%, P = .71). At the 6-month follow-up, revascularization of the original target lesion was performed more frequently in the rotational atherectomy group (42.4%) and the excimer laser group (46.0%) than in the angioplasty group (31.9%, P = .013). CONCLUSIONS: Procedural success of rotational atherectomy is superior to laser angioplasty and balloon angioplasty; however, it does not result in better late outcomes. The role of plaque debulking before balloon dilatation in percutaneous coronary revascularization remains to be fully defined.

Results of Micro stent implantations in coronary lesions of various complexity.

Micro stents appear to be especially suitable for the safe treatment of complex coronary lesions and adverse vessel morphology. Stenting of lesions with type C morphology is associated with a higher restenosis rate than stenting of less complex coronary obstructions.

[Results after coronary bypass operation]. / Ergebnisse nach koronarer Bypass-Operation.

OBJECTIVE: To determine the influence of various risk factors on 30-day postoperative mortality rate of aortocoronary bypass operation at different centres. PATIENTS AND METHODS: Data on 227 patients (179 men, mean age 63 [40-87] years; 48 women, mean age 68 [44-81] years), 219 first operations, 8 second operations) were retrospectively analysed. In all patients the indications for aortocoronary bypass surgery had been established in the last 3 months of 1993. The operations had been performed at six cardiac centres in Germany (five in Hessen [H1-H5]) and in three hospitals elsewhere in Europe outside of Germany (E1-E3). RESULTS: The operative mortality was relatively high (5.3%), 152 patients (67%) presenting with one or more risk factors accounting for an increased perioperative mortality. The mortality rate was significantly higher for: clearly impaired left ventricular function (ejection fraction < 40%): 20 vs 3% with an ejection fraction > or = 40% (P < 0.001); emergency operation: 16.6 vs 2.7% for elective operation (P < 0.001); advanced age (> or = 70 years): 10.9 vs 3.1% for younger patients (P < 0.025); and unstable angina: 9.2 vs 2.9% with stable angina (P < 0.05). Most of the bypasses were done with the internal mammary artery (63.9%, usually combined with venous bypasses (exclusive use of venous bypasses in 35.2%), but the proportion of arterial bypasses differed greatly between centres (96% in H3, 19% in H4). CONCLUSIONS: (1) Aortocoronary bypass operations are done on many patients with important risk factors, resulting in a relatively high 30-day postoperative mortality rate. (2) The proportion of internal mammary artery bypasses markedly differs between centres in Hessen.

[The recanalization of chronic coronary artery occlusions: what factors influence success?]. / Wiedereröffnung chronischer Koronararterienverschlüsse: Welche Faktoren beeinflussen den Erfolg?

Between January 1986 and June 1990, recanalization with guide-wire and balloon angioplasty (PTCA) was attempted in 509 patients (416 men, 93 women; mean age 57.5 +/- 9 years) with chronic coronary artery occlusions. The data recorded were analysed to determine the factors which influenced the outcome. The intervention was initially successful in 284 patients (55.8%; circumflex branch: 50%; right coronary artery: 52%; venous bypass graft: 50%; anterior interventricular branch: 64%). The success rate was markedly reduced if (1) the occlusion had persisted for more than 6 months (9.5%; P < 0.001); (2) occlusion had occurred at or after a vessel kink (28.5%; P < 0.001); (3) there had been no vessel "stump" (36%; P < 0.01) and (4) the occlusion was longer than 10 mm (40.7%; P < 0.05). The success-rate was higher if (1) intracoronary anastomoses were absent (61.2%); (2) occlusion had occurred in a straight vessel (62.6%); (3) there had been a vessel stump (64%); (4) the occlusion had persisted for less than 4 weeks (68.5%) and (5) the length of occlusion was < or = 10 mm (75.8%).-These data indicate that the success of PTCA after chronic coronary artery occlusion depended on the site of occlusion, its duration and length, absence of orthograde collaterals and the presence of a vessel stump. Knowing the extent of these factors helps in delineating the indications.

Randomized trial comparing two devices: the Palmaz-Schatz stent and the Strecker stent in bail-out situations.

UNLABELLED: To assess whether differences in design (geometry, flexibility) and material (electrostatic behavior) may influence the acute and late outcome following intracoronary stent implantation in the treatment of acute or threatened closure after prolonged balloon inflations, 50 patients were randomized to receive either a Palmaz-Schatz stent (n = 25) or a Strecker stent (n = 25). RESULTS: [table: see text] CONCLUSION: Both Palmaz-Schatz and Strecker stents are equally effective in restoring vessel patency in bail-out situations. The incidence of complications is high and similar for both stents if they were used after failed prolonged balloon inflations. Differences in design and material do not seem to influence the results.

[The long-term success after coronary angioplasty in old age]. / Langzeiterfolg nach Koronarangioplastie im Alter.

Long-term results of coronary angioplasty (CAP) were compared between two age-groups of patients. Group 1 had 227 patients (158 men, 69 women) with a mean age of 70 (65-88) years, group 2 had 717 patients (611 men, 106 women), mean age 54 (20-64) years. Unstable angina was more common in group 1 than group 2 (48.9 vs 37.7%, P < 0.05). Multi-vessel disease was present in 50.7% of those in group 1 and 41.9% in group 2. Primary success of CAP was similar in the two groups (group 1: 88.1%, group 2: 90.5%). The long-term effect at the first follow-up angiography 3-4 months after CAP was slightly less favourable in group 1 than 2 (54.9 vs 58.3%; difference not significant). However, there were more patients with unstable angina in group 1. Thus the angiographic long-term results were worse in the older patients (44.6 vs 60.1%; P < 0.05), while there was no difference between the two groups as regards stable angina (64.7 vs 57.2%). After a second CAP (because of recurrence), the long-term angiographic effect was, if anything, slightly better in the older patients (87.0 vs 77.1%). The death-rate (cardiac causes of death) up to one year after CAP was comparable in the two groups (1.7 vs 0.8%), as was the rate of non-fatal myocardial infarction (2.2 vs 1.3%). These data indicate that clinical and angiographic long-term success after CAP is comparable in older and younger patient groups and age alone does not present a higher risk.

[Long-term results of coronary angioplasty in relation to vessel size]. / Langzeiterfolg nach Koronarangioplastie in Abhängigkeit von der Gefässgrösse.

Repeat angiography was performed after 3-4 months in 927 of 1386 consecutive patients (67%) who had a successful percutaneous coronary angioplasty (PTCA) between 1986 and 1988. The degree of coronary artery stenosis was determined angiographically before PTCA, immediately after and 3-4 months later. Patients were assigned to one of four groups according to balloon diameter at dilatation: Group 1: 1.5-2.0 mm; group 2: 2,5 mm; group 3: 3.0 mm; group 4: 3.4-4.2 mm. Vessel wall proliferation occurred in all four groups after PTCA. In patients with angiographically demonstrated recurrence (first recurrence: 308 patients, second recurrence: 43 patients) another balloon dilatation was undertaken and a repeat angiography 3-4 months later. Long-term success rate (less than 50% stenosis) differed significantly according to the post-PTCA vessel diameter: 48% in group 1, 63% in group 2, 66% in group 3 and 80% in group 4 (analysis of variance: P less than 0.001). PTCA thus produces better long-term results in large than in small vessels.

[Acute vascular occlusion caused by percutaneous transluminal coronary angioplasty: early and late results of repeat-PTCA]. / Akuter Gefässverschluss durch perkutane transluminale Koronarangioplastie: Früh- und Spätergebnisse der Re-PTCA.

UNLABELLED: Acute vascular occlusion after percutaneous transluminal coronary angioplasty (PTCA) often necessitates a prompt aortocoronary bypass-operation (CABG). Alternatively, a re-PTCA can be attempted. In 1500 consecutive patients there was acute symptomatic occlusion due to PTCA 5 min to 16 h after the operation in 47 cases (3.1%). An immediate re-PTCA was attempted in all cases. RESULTS: Reopening was successful in 43 of 47 cases (91%): in 15 patients (30%) within 30 min, in 36 patients (68%) within 60 min and in 42 patients (89%) within 90 min. In eight patients there was early re-occlusion 30 min to 20 h after re-PTCA, necessitating acute CABG in four patients. In 35 patients with re-PTCA the vessel remained open. Re-stenosis occurred within 1 to 10 days in 10 patients, and in additional 12 patients after 2-4 months. In most cases an additional PTCA was successful. COMPLICATIONS: Six patients had an emergency CABG (three with an exchange wire as a stent in the dissected coronary artery). Three patients died (one after CABG); 14 patients experienced myocardial infarction (30%) (in three of these 14 the infarct was large). CONCLUSION: Acute vascular occlusion after PTCA can successfully be treated by re-PTCA in four of five cases. However a rate of re-stenosis of about 60% is to be anticipated. Reperfusion with re-PTCA is fast and in these patients with transmural ischemia there are obviously less complications in comparison to emergency CABG after PTCA. 60% of the patients remain symptom free or markedly improved and without infarction or emergency CABG after 4 months.

[The results after prosthetic aortic valve replacement. What effect does old age have?]. / Ergebnisse nach prothetischem Aortenklappenersatz. Welchen Einfluss hat ein hohes Alter?

Data were retrospectively analysed of 149 consecutive patients with aortic valve stenosis (91 males and 58 females; mean age 64 [27-86] years) who had a prosthetic valve implanted between 1986 and 1988. The overall operative mortality rate was 3.4%, the one-year mortality rate was 4.7%. Operative mortality rate for those aged 27-74 years was 1.7% (2 of 120), but 10.3% (3 of 29) for those aged 75 to 86 years (P less than 0.05). None of the patients in clinical grade III (NYHA classification) died within 30 days of the operation. Among those in grade IV the operative mortality rate was 15.8% (3 of 19) for those aged 75-86, but 4.0% (2 of 50) for those aged below 75 years (P less than 0.05). Valve replacement in symptomatic aortic stenosis with a prosthetic valve is today the method of choice. Operative mortality rate is low, even for patients of advanced age, particularly if the operation is done early.

[Long-term success of coronary angioplasty after repeated treatment]. / Langzeiterfolg der Koronarangioplastie nach wiederholten Eingriffen.

To ascertain the long-term results after second and third angioplasties for coronary stenosis the coronary angiograms from 1504 consecutive patients with coronary heart disease (1211 men, 293 women, mean age 57 [27-82] years) were retrospectively surveyed. A good initial response (at least 20% reduction in stenosis) was achieved in 295 out of 306 second angioplasties (95.5%), and in all 36 third angioplasties. Viewed overall, these results are significantly better (P less than 0.005) than those achieved at the initial angioplasty (1386 out of 1504 patients; 92.2%). The reduction in the severity of the stenosis achieved at the second angioplasty (from 86 to 24%) and at the third angioplasty (from 86 to 26%) was the same as at the first angioplasty (from 88 to 28%). Serious complications after the first angioplasty were infrequent (death in 0.2%, emergency bypass in 0.4%, myocardial infarction in 0.5%), and no complications were noted after second and third angioplasties. A good long-term outcome (at least 20% reduction in stenosis at 3-4 months) was slightly more frequent after the second and third angioplasties (103 out of 170 [60.6%] and 14 out of 17 patients, respectively) than after the first intervention (532 out of 926 patients; 57.5%). In keeping with these results, the degree of stenosis found at follow-up angiography was significantly lower (first intervention 54.8%, second intervention 50.3%, third intervention 36.9%). There were only 57 patients (3.8%) who ultimately required operative treatment. These figures indicate that the probability of a good long-term outcome from coronary angioplasty increases each time the stretching operation is repeated. Only a very small proportion of patients will require bypass surgery.

[Treatment of coronary heart disease in the aged. When balloon dilatation, when surgery?]. / Behandlung der koronaren Herzkrankheit im Alter. Wann Ballondilatation, wann Operation?

Data from 3029 consecutive patients (2474 men, 555 women, mean age 59 [20-88] years) in whom coronary heart disease had been diagnosed by coronary angiography were studied with the object of identifying those patients in the older age group who are suitable for treatment by balloon angioplasty. There were 884 patients with a mean age of 70 (65-88) years, and 2145 patients with a mean age of 54 (20-64) years. Single vessel disease was less common in older patients (30% vs 44%; P less than 0.001), double vessel disease was equally common in both groups (28% vs 30%) and triple vessel disease was commoner in the elderly group (42% vs 26%; P less than 0.001). For elderly patients with single vessel disease conservative treatment was chosen in 50%, angioplasty in 49% and operative treatment in only 1%. Of elderly patients with involvement of two arteries, 44% were treated conservatively, 40% by angioplasty and 16% surgically. Of elderly patients with triple artery disease, 23% were treated conservatively, 8% by angioplasty and 69% operatively. This pattern was similar to that among younger patients. The success rate and the incidence of complications after percutaneous transluminal coronary angioplasty were similar in both age groups. In elderly patients with disease of only one or two coronary arteries the prospects of success and the risks are comparable to those in younger patients, but patients with triple artery disease often need bypass surgery.

[Protective function of collaterals in percutaneous transluminal coronary angioplasty]. / Die Schutzfunktion von Kollateralen während perkutaner transluminaler Koronarangioplastie.

UNLABELLED: With increasing application of PTCA, it will become necessary to identify patients (p) who can be dilated without expensive surgical standby. In 82 p with angina pectoris and stress-induced ischemia and without transmural myocardial infarction, the following parameters were measured during coronary angioplasty (PTCA): angina pectoris (AP), epicardial ST-segment displacement (via long wire), and aortic pressure. In 26 p, the affected vessel showed retrograde filling (A) via collaterals (CL). In 24 p CL were identified without retrograde filling (B) and 32 p were without CL (C). The balloon was inflated three to eight times over periods of 30 to 90 s. [table; see text] CONCLUSIONS: In vessel occlusion caused by PTCA, a myocardial infarction will occur in more than 80% of p without visible CL, and rarely in the presence of CL. Therefore, PTCA of vessels with retrograde filling appears safe. Furthermore randomized studies are necessary to determine if strict surgical standby is required in such cases.