Z Kardiol 89:508–512 (2000) Steinkopff Verlag 2000 R E VA S K U L A R IS AT IO N S S T R AT E G I E N Perkutane transluminale
Zusammenfassung Die Behand-
Summary In cases with protected
Koronarangioplastie – Ergebnisse
des Deutschen PTCA-Registers
In Gedenken an meinen großen Lehrerund Vorbild Prof. Dr. med. K.-L. Neuhaus grafts to either left coronary artery.
Dr. med. S. Miketic´ (✉) · J. Carlsson Medizinische Klinik IIKlinikum Lippe-Detmold ¨ sselwo¨rter PTCA –
Key words PTCA –
as an integrated assessment of the coronary angiogra-phy, reports of the procedure and the clinical course.
According to the American Heart Association/American Procedure-related death was defined as normal blood College of Cardiology (AHA/ACC) Guidelines coron- flow (thrombolysis in myocardial infarction grade 3) in ary angioplasty is absolutely contraindicated if “there is both left coronary arteries with normal ventricular ex- a significant obstruction (> 50%) in the left main coro- cursions before the start of the intervention or compro- nary artery and this main segment is not protected by at mised blood flow (thrombolysis in myocardial infarc- least one nonobstructed bypass graft to the left anterior tion grade < 3) in either left coronary artery with de- descending or left circumflex artery” (12). The long- pressed heart excursions after the intervention. Death term experiences of the Coronary Artery Surgery Study despite PTCA was defined as technically successful in- (CASS) Registry (12) and the Coronary Artery Bypass tervention and lethal outcome. Start of the intervention Graft Surgery Trialists Collaboration (17) showed the was defined as passage of the left main stenosis with superiority of surgical treatment as compared to medical treatment concerning the overall mortality. Despitethese guidelines and study results, advances in operatorexperience, improvements of angioplasty technique and new angioplasty devices have extended the indicationof coronary angioplasty even to left main coronary ar- Data are reported as mean ± standard deviation (SD).
tery stenosis (7, 8). The aim of the current investigation Continuous variables were compared by using Student’s was to determine the in-hospital outcome of patients un- t-test for independent symples. The Wilcoxon test was dergoing left main angioplasty in the PTCA registry of used for categorical variables. A Chi-square test or Fischer’s exact test (for cells < 5) was used to determine Krankenhausa¨rzte (ALKK)” study group.
the 2-tailed statistical significance of associations in 2-by-2 tables. Different variables were tested for indepen-dent correlation with death by multiple regression anal- ysis. P values < 0.05 were considered to indicate statisti-cal significance. Data management and analysis were The previously described PTCA registry of German performed by the STATISTICA for Windows software community hospitals represents approximately one third package release 5.0 (StatSoft, Inc. Tulsa).
of all angioplasty procedures performed in Germany(16). Each angioplasty procedure was included on anintention-to-treat basis. The procedures registered as left main angioplasty were reviewed together with data con-cerning the in-hospital outcome in a core laboratory in Between October 1992 and September 1997, 580 pro- Detmold, Germany. The review of all angiograms was spectively announced angioplasty procedures were reg- performed by two senior cardiologists blinded to the istered as left main angioplasties in 68 German commu- procedural and the in-hospital outcome unless the nity hospitals organized in the ALKK (Arbeitsge- course of the patient could be gathered from the angio- meinschaft Leitender Kardiologischer Krankenhaus- Angiography, procedural and clinical outcome of all 580 procedures were requested for evaluation in a core laboratory in Detmold, Germany 320 (55%) completeprocedures were made available for evaluation. Of Left main protection was graded as the following: un- these, 58 (18%) were interventions of proximal left protected left main stenosis without collateral flow or anterior descending or proximal left circumflex arteries.
open bypass grafts to the left anterior descending or to The remaining 262 procedures were either angioplasty the left circumflex artery, partially protected left main of protected left main stenosis or emergency left main stenosis with collateral flow to the left anterior descend- interventions in patients with an acute myocardial in- ing or to the left circumflex artery, and protected left farction or cardiogenic shock. The data of these 262 main stenosis with nonobstructed bypass vessels to the procedures were compared to 141 454 non-left main an- left anterior descending or left circumflex artery.
Left ventricular function was classified as normal Baseline data and angiographic characteristics are (ejection fraction > 65%), middly impaired (ejection shown in Table 1. Patients in the left main PTCA group fraction 45–65%), or severely impaired (ejection frac- were older and had more often three-vessel disease as tion < 45%). Classification of cause of death was done compared with the non-left main patient cohort. The Zeitschrift fu¨r Kardiologie, Band 89, Heft 6 (2000) Steinkopff Verlag 2000 Table 1 Baseline characteristics
Table 3 Clinical outcome of all patients with unprotected left main
Table 4 Clinical outcome in patients with partially protected left
Table 2 Clinical outcome of all patients
Table 5 Clinical outcome in patients with protected left main
* Patients with acute myocardial infarction at the time of PTCA are distribution of the stenosis type according to the AHA/ACC guidelines was similar in both groups. Left ventri-cular function was more frequently impaired in the left the left main (Table 6). Patients who underwent left main PTCA group. In 28.3%, left ventricular angiogra- main agioplasty for stable angina had a lower mortality phy was not performed because of cardiogenic shock.
as compared with those with unstable angina (Table 6).
The overall procedure-related mortality is summarized The highest mortality was found in patients presenting in Table 2. The degree of left main protection influenced with acute myocardial infarction (Table 6). One patient clinical outcome as follows: the procedure-related mortal- died because of fulminant pulmonary embolism two ity in patients without any left main protection was 9.1% weeks after the procedure; one patient died from a car- (Table 3), in patients with collaterals 4.8% (Table 4) and cinoma of the pancreas six montsh later.
0.5% (Table 5) with open bypass grafts to either left cor- The multivariate regression analysis identified the onary artery whereas the procedural mortality of the non- degree of left main protection (p < 0.001), indication for left main angioplasty cohort was 0.4%.
angioplasty (p < 0.001) and left ventricular function There was also a difference in procedure-related (p = 0.002) as independent predictors for procedure-re- mortality depending on the indication for angioplasty of Table 6 Clinical outcome dependent on the indication for angioplas-
Considering the patient characteristics, the poor out- come of this highest risk group was not unexpected.
Even in cases presenting with acute myocardial infarc- tion and cardiogenic shock the intervention seems to be problematic. Mortality is per se high in these patients (52.3%) and is burdened by an additional procedure-re- lated mortality of 9.1%. The question arises whether further lives could have been saved by avoiding coron- ary interventions and by transferrin such patients to Patients with partially protected left main stenosis who underwent coronary angioplasty had a lower mor-tality compared to those without any left main protec-tion, but had a significantly higher incidence of majorin-hospital events as compared with the non-left main With our registry data it could be demonstrated that An angiographically proven stenosis of the left main patients with open bypass grafts to either left coronary coronary artery without protection by a nonobstructed artery undergoing left main angioplasty had a compar- bypass graft is considered to be a contraindication for able procedure-related and in-hospital mortality as com- coronary angioplasty (12). Coronary artery bypass sur- pared to the non-left main angioplasty cohort. These gery has been shown to improve survival of patients findings are in accordance with the largest published se- with left main stenosis (1, 17), although these patients ries by O’Keefe et al. reporting a high survival rate respresent the highest risk group for bypass surgery (90% at 3 years) after angioplasty of 127 protected and with an overall operative mortality of 3.5% (2). Techni- unprotected left main coronary arteries (10).
cal improvement and the development of coronary ar- Several criteria are proposed to select the suitable pa- tery stents (3, 6, 14, 15) enable interventional cardiolo- tient for these interventional procedures (11) because gists to treat even complex coronary lesions, so that in development of easily applicable stent models and im- specific conditions coronary angioplasty of protected or provement in the sent implantation technique (3) with a even unprotected left main stenosis has been performed.
modified anticoagulation regimen (13) led to a lack of Laruelle et al. reported in a small series of elective an- respect for coronary angioplasty among interventional gioplasty in patients with an unprotected left main steno- cardiologists especially in cases with complex lesion sis a procedural mortality of 7.7% and a rate of myocar- morphology (9). Mulitple regression analysis of our dial infarction of 2.8% without stent implantation. Be- data identified left main protection, indication for angio- cause of the high mortality rate the following ten patients plasty and left ventricular function as independent pre- of this study underwent elective stent implantation and dictors for procedure-related mortality. The classifica- had no serious adverse events during the hospital phase tion of the degree of left main protection combined (7). Major in-hospital complications also did not occur with left ventricular function represents an easily appli- in the study of Park et al. performing elective stent im- cable grading system for risk stratification of interven- plantation in selected patients (11). The results of these tions in patients with symptomatic left main stenosis.
two single center studies could not be confirmed eitherby the multicenter registry analysis by Ellis and cowor-kers reporting a procedural mortality of 5.9% with(n = 51) and without (n = 68) stenting (4) or by the results of the present study reporting a procedural mortality of9.1% in unprotected left main stenosis. However, these National guidelines prohibit coronary intervention in pa- investigations have limited comparability because the pa- tients with unprotected left main stenosis (5, 12); there- tients in the studies of Laruelle et al. and Park et al. are fore a randomization between coronary angioplasty and highly selected with normal left ventricular function bypass surgery is not feasible. The study population in whereas the patients in the multicenter registry analysis the present multicenter registry analysis consists of of Ellis et al. were not selected and in the present study emergency patients and elective patients with protected the patients who had an unprotected left main stenosis all presented with acute myocardial infarction. Despite The analysis included only 54.8% of all procedures these differences in the study population a 0% mortality prospectively classified as interventions of left main ste- in interventional cardiology can only be a problem of a nosis. It seems highly unlikely that a protential selec- small study cohort and does not seem realistic.
tion bias led to a higher mortality rate than present in Zeitschrift fu¨r Kardiologie, Band 89, Heft 6 (2000) Steinkopff Verlag 2000 the whole cohort of left main angioplasties. The oppo- the non-left main angioplasty cohort. Patients with un- site is probably true and would therefore underline the protected symptomatic left main stenosis should prefer- ably be transferred to emergency cardiac surgery, be-cause the high procedural mortality discourages percuta-neous cardiac interventions. Even in cases presenting with acute myocardial infarction characterized by a highprimary mortality, coronary interventions should be Patients with symptomatic stenosis of the left main cor- onary artery and nonobstructed bypass vessels to either Furthermore, in our opinion treatment indications left coronary artery may be treated by coronary inter- that are not in accordance with guidelines of several na- vention with a procedure-related mortality and inci- tional committees should not be based on single center dence of myocardial application comparable to that of experiences and small study cohorts.
with left main coronary artery disease.
13. Scho¨mig A, Neumann F-J, Kastrati A, gery on survial patterns in patients with left main coronary artery disease. Report 14. Serruys PW, de Jaegere P, Kiemeneij F, (1998) Stenting of “unprotected” left trasound guidance. Circulation 91:1676– with balloon angioplasty in patients with 15. Topol EJ (1994) Daveats about elective 16. Vogt A, Bonzel T, Harmjanz D, v. Leit- 5. Erbel R, Engel HJ, Ku¨bler W, Meinertz 10. O’Keefe JH Jr, Hartzler GO, Rutherford 17. Yusuf S, Zuckere D, Peduzzi P, Fisher of 10-years result from randomised trials Surgery Trialists Collaboration. Lancet344:563–570


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