gms | German Medical Science

24. Jahrestagung der Deutschen Gesellschaft für Arterioskleroseforschung

Deutsche Gesellschaft für Arterioskleroseforschung

18.03. - 20.03.2010, Blaubeuren

The quality of care for patients receiving an outpatient PCI

Meeting Contribution

  • corresponding author A. Foerster - Dr. Pohl foundation professorship "Preventional Cardiology", Center for Internal Medicine, University Hospital Giessen-Marburg, Germany
  • B. Kurt - Dr. Pohl foundation professorship "Preventional Cardiology", Center for Internal Medicine, University Hospital Giessen-Marburg, Germany
  • M. Hahmann - Koordinierungszentrum fuer klinische Studien (KKS) of the Philipps-University, Marburg, Germany
  • A. Sattler - Dr. Pohl foundation professorship "Preventional Cardiology", Center for Internal Medicine, University Hospital Giessen-Marburg, Germany
  • D. Leussler - Kardiologieplattform Hessen eG (KPH), Marburg, Germany
  • J. R. Schaefer - Dr. Pohl foundation professorship "Preventional Cardiology", Center for Internal Medicine, University Hospital Giessen-Marburg, Germany

Deutsche Gesellschaft für Arterioskleroseforschung e.V.. 24. Jahrestagung der Deutschen Gesellschaft für Arterioskleroseforschung. Blaubeuren, 18.-20.03.2010. Düsseldorf: German Medical Science GMS Publishing House; 2011. Doc10dgaf21

DOI: 10.3205/10dgaf21, URN: urn:nbn:de:0183-10dgaf219

Veröffentlicht: 23. März 2011

© 2011 Foerster et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Abstract

The objective of this registry is to survey data about the situation and quality of medical care for patients receiving an outpatient percutaneous coronary intervention (PCI) in the state of Hessia. The so called “MAIN-Registry” (Management of ambulatory percutaneous coronary interventions in Hessia) is a prospective study where data of 551 outpatient PCI-patients were collected by the attending or PCI-performing cardiologist via questionnaires. After three, six, nine, and twelve months after the initial PCI, a total of four questionnaires were completed. These questionnaires included information about the patient status as well as LDL-cholesterol, blood pressure and HbA1c-values. In addition, the accompanying medication was registered. In this interim analysis, 97% of all patients received a dual platelet aggregation inhibition (ASS and Clopidogrel) after PCI. After three, six, nine, and twelve months 58%, 50%, 48% and 35% of the patients still received Clopidogrel. In 88% of all patients a stent was implanted of which 42% were DES (Drug eluting stents). The LDL-cholesterol target value of <100 mg/dl was achieved by 85% of the patients. Furthermore, 55% reached the lower LDL-target level of <70 mg/dl. In 62% Statins were prescribed, 7% received Statins plus Ezetimibe. After twelve months 89% of the patients reached blood pressure values below 140/90 mmHg, 76% of the diabetic patients reached HbA1c-values below 6.5%.

Our results show that a consequent implementation of the guidelines of the German Cardiac Society results in an increased quality of medical care in Hessia. The desired target values are reached in a higher percentage rate as in comparison to other medical care registries (e.g. Euroaspire, DUTY, 4E).


Introduction

The percutaneous coronary intervention (PCI) is one of the most important therapeutic procedures of the acute coronary syndrome (ACS). In order to improve the long-term outcome due to ACS after having received PCI, Clopidogrel therapy should be administered nine to twelve months after the implantation of bare metal stents (BMS) or drug eluting stents (DES). PCIs that were not carried out in an acute event, after having implanted a BMS, Clopidogrel therapy is recommended for at least four weeks. Additionally, patients with cardiovascular risk factors benefit from a cholesterol lowering therapy with Statins. Nonetheless, the optimal medical care after PCI is not ubiquitarily provided. The objective of this registry is to survey data about the situation and quality of medical care in patients receiving an outpatient PCI in the state of Hessia. The data of such registries enable us to increase the actual quality of medical care in daily practice.


Methods

In this prospective registry, data of 551 outpatient PCI-patients were collected. Altogether, 28 cardiological practices participated in the MAIN-Registry. The patients that were included in this registry were members of the BKK health insurance (Betriebskrankenkassen) who consented to their participation. All of them had to undergo an outpatient PCI. The data were collected by the attending or PCI-performing cardiologist via questionnaires. After three, six, nine, and twelve months after the initial PCI, a total of four questionnaires were completed, which included information about the patient status, possible occurred complications, LDL-cholesterol, blood pressure and HbA1c-values and the accompanying medication. The data were documented in Microsoft ACCESS, the statistical analysis was performed by the KKS (Center for Coordination of clinical studies) Marburg via SAS. This project was approved by the Ethics Committee of the Philipps-University of Marburg.


Results

A total of 551 patients out of 28 cardiological practices participated in this registry. The average age was 65 years with a minimum of 33 and a maximum of 91 years. 72% (n=394) of the collective was male. The risk factor profile proved to be manifold (Figure 1 [Fig. 1]). The majority of patients suffered from arterial hypertension (60%, n=333) and hyperlipidemia (49%, n=270). 14% (n=79) of the patients had received an earlier PCI before participating in this study.

Unstable angina pectoris was the reason for intervention in 50% (n=270) of all cases, whereas stable angina pectoris occurred in 33% (n=174). 14% (n=77) suffered from a non-ST-elevation myocardial infarction (NSTEMI) and 10% (n=55) a ST-elevating myocardial infarction (STEMI). In 94% (n=518) stents were implanted in native coronary vessels, in 5% (n=28) in bypass-grafts and in 1% (n=5) in both, in bypass and in the native blood vessels. 44% (n=240) of the patients had a 2-vessel coronary artery disease, 28% had a 1- (n=153) or 3-vessel coronary artery disease (n=153). In single cases a combination of a main coronary vessel stenosis in combination with a 2- (n=1) or 3- vessel disease (n=3) was manifested.

In our interim analysis, 97% of all patients received a dual platelet aggregation inhibition (ASS and Clopidogrel) immediately after PCI. After three, six, nine, and twelve months 58% (n=310), 50% (n=268), 48% (n=250) and 35% (n=176) of the patients still received Clopidogrel. In addition to Clopidogrel, 96% (n=528) of the patients received ASS after 3 months, 93% after 6 (n=501) and 9 months (n=481) and 92% still received ASS after 12 months (n=469).

In 88% (n=483) a stent was implanted, 42% of those were DES (n=251, BMS n=353). The average stent dimensions were 2.97 x 14.9 mm in BMS, and 2.86 x 16.8 mm in DES. Patients, who had a DES implanted, received Clopidogrel for nine months on average. In patients who received a BMS, Clopidogrel was discontinued in most cases to the first follow-up after three months.

The LDL-cholesterol target value of <100 mg/dl was achieved by 85% (n=431) of all patients, whereas 55% (n=278) reached the LDL-value <70 mg/dl after twelve months. In 62% (n=315) Statins were prescribed, 7% received Statins plus Ezetimibe (n=37). After twelve months 89% (n=452) of the patients reached blood pressure values below 140/90 mmHg. 28% (n=156) of all patients suffered from diabetes mellitus. Interestingly, 76% (n=110) of these patients with diabetes reached HbA1c-values below 6.5%.

Over the course of the registry, 11% (n=63) had to undergo another coronary angiography. In 9% (n=52) the target vessel had to be intervened once more. 4% (n=22) received an aortocoronary bypass (ACB)-operation and 3% (n=14) suffered from a myocardial infarction, 2% (n=11) from an apoplexy and 1% (n=4) suffered from a gastrointestinal bleeding. During the observation, 3% (n=19) of the patients died and 7% (n=39) were lost to follow-up. The complications that occurred during the observation are summarized in Figure 2 [Fig. 2]. In the deceased patient group, a correlation between the different stent types and the dual platelet aggregation inhibition could not be observed. The patients that died during the study observation showed an increased risk profile with a higher rate of acute myocardial infarctions as reason for intervention, and a decreased left ventricular pump function.


Discussion

Despite all efforts, the quality of care in coronary artery disease (CAD) – patients is still not ideal. Within the scope of the 4E-registry, it could be revealed that 79% of the patients did not reach the LDL-cholesterol target value of <100 mg/dl [1], [2]. Without doubt, big registries are able to improve the current situation of the quality of care [3] and therefore, new registries are designed and released to survey the quality management of medical care in an outpatient setting (LIMA-Registry, [4]). In order to gain insight into the current situation of medical care in outpatient PCI-patients, we performed the MAIN-Registry (Management of ambulatory percutaneous coronary interventions in Hessen) in cooperation with the Kardiologieplattform Hessen. In doing so, we found out that PCIs, which were carried out in an outpatient setting, are correlated with a low rate of complications. Remarkably, the target values of blood pressure, diabetes adjustment and LDL-cholesterol were reached in a high percentage of all patients. The results in this study exceeded the target values of the 4E-Registry. In this study, only 21% of the patients reached LDL target values of <100 mg/dl in contrast to the MAIN-Registry where 85% attained that value.

All in all, the medical care of CAD-patients in Hessia by outpatient cardiologists takes place on a high level and the relevant target values are commonly reached. Our results show that a consequent implementation of the guidelines of the German Cardiac Society results in an increased quality of medical care. Certainly, not every patient reaches the optimal values so there is still need for further improvement.


Acknowledgement

Sanofi-Aventis Germany supplied an unrestricted research grant for the MAIN-Registry to the KPH.


References

1.
Assmann G, Schulte H, Cullen P, Neiss A, Bestehorn K. Treatment of hyperlipidemia in primary practise in Germany: sub-group analyses from the 4E-registry with particular emphasis on men and women with diabetes mellitus. Exp Clin Endocrinol Diabetes. 2007 Feb;115(2):85-91. DOI: 10.1055/s-2007-955094 Externer Link
2.
Assmann G, Benecke H, Neiss A, Cullen P, Schulte H, Bestehorn K. Gap between guidelines and practice: attainment of treatment targets in patients with primary hypercholesterolemia starting statin therapy. Results of the 4E-Registry (Efficacy Calculation and Measurement of Cardiovascular and Cerebrovascular Events Including Physicians' Experience and Evaluation). Eur J Cardiovasc Prev Rehabil. 2006 Oct;13(5):776-83. DOI: 10.1097/01.hjr.0000189805.76482.6e Externer Link
3.
Schaefer JR, Simon B, Soufi M, Sattler A, Noll B, Herzum M, Maisch B. Strategies to optimize CAD prevention in modern cardiology. The "Marburg CAD Prevention Project". Herz. 2000 Mar;25(2):113-6.
4.
Bestehorn K, Schaefer J, Gitt AK, Jannowitz C, Karmann B, Sonntag F, Weizel A. LIMA-register: rationale, aims and design. MMW Fortschr Med. 2008 Sep 18;150 Suppl 3:135-41.