Relationship between Percutaneous Transluminal Coronary Angioplasty Volume and Immediate Outcome 2000 2
. 1999 10. 1999 12
Relationship between Percutaneous Transluminal Coronary Angioplasty Volume and Immediate Outcome by Young-Ho Khang A thesis submitted in partial fulfillment of the requirement for the degree of Doctor of Philosophy in Medicine (Health Policy and Management) in Seoul National University, Seoul, Korea December, 1999 Doctoral Committee : Professor Lee, Young-Woo Chairman Associate Professor Kim, Yong-Ik Vice Chairman Associate Professor Oh, Byung-Hee Associate Professor Park, Byung-Joo Associate Professor Ahn, Hyeong-Sik
(percutaneous transluminal coronary angioplasty, PTCA) 1977.,, PTCA. PTCA.,, PTCA. PTCA PTCA.,., PTCA., - (volume-outcome relationship) (practice-makes-perfect hypothesis, ) (selective-referral pattern hypothesis, ) PTCA. 1997 10 12 3 400 25 60 1,379 PTCA, 1,317 ( 95.5%). (, -coronary artery bypass graft, CABG-, ), - i -
,. 25 200 14 (56%), 60 75 39 (63%). 1,317 70%, CABG 2.7%. PTCA 54%. 20 (1.5%), 26 (2.0%). 3 (20%, 50% ) 84 6.4%( 93.6%).,,.,, 200 200 399 (P=0.023). 200, 200 399, 400 (X 2 tr en d = 16.168, P=0.0001). ( ) PTCA (transfer) PTCA -,.,.. - ii -
,., PTCA.. : Percutaneous Transluminal Coronary Angioplasty, Volume, Outcome, Risk Adjustment, Quality of Care : 98801-801 - iii -
List of T ables Table 1. The studies supporting volume-outcome relationship of percutaneous transluminal coronary angioplasty (PTCA) and their volume/outcome variables 7 Table 2. Recommendations for clinical competence in percutaneous transluminal coronary angioplasty minimum recommended number of cases per year 9 Table 3. Hospital percutaneous transluminal coronary angioplasty (PTCA) volumes during the study period, their volumes and proportions surveyed, and their volumes except repeated PTCAs 18 Table 4. Confounding variables: demographic, preprocedural, and procedural characteristics of patients and their past medical histories, comorbidity, and diagnosis 20 Table 5. Determination criteria of modified ACC/AHA legion type 22 Table 6. Beds, ownership, and education affiliation of hospitals, their number of operator, and their percutaneous transluminal coronary angioplasty (PTCA) volume attempt in 1997 29 Table 7. Operators' intervention career, their experience trained at other countries, and their percutaneous transluminal coronary angioplasty (PTCA) volume attempt in 1997 30 Table 8a. Univariate analysis of demographic, preprocedural, and procedural characteristics of patients and their past medical histories, comorbidity, diagnosis, and outcomes : Results based on total samples and on samples repeated PTCAs excluded 33 Table 8b. Univariate analysis of demographic, preprocedural, and procedural characteristics of patients and their past medical histories, comorbidity, diagnosis, and outcomes : Results based on total samples and on samples repeated PTCAs excluded 34 Table 9. Number of involved vessels and their proportion of total samples and of samples repeated PTCAs excluded 35 Table 10. Comparison of patient characteristics by hospitals or operators volume 37 - iv -
Table 11. Unadjusted comparison of outcome by hospital or operator volume 38 Table 12. Unadjusted comparison of intervention failure rate and major adverse outcome rate by patients' characteristics 40 Table 13. Hospital volume and the variables associated with intervention failure (Analysis of Maximum Likelihood Estimates) 44 Table 14. Hospital volume and other significant risk factors associated with major adverse outcome (Analysis of Maximum Likelihood Estimates) 45 Table 15. Operator volume and the variables associated with intervention failure (Analysis of Maximum Likelihood Estimates) 46 Table 16. Operator volume and other significant risk factors associated with major adverse outcome (Analysis of Maximum Likelihood Estimates) 47 Table 17. Variables associated with intervention failure or major adverse outcome in the logistic regression analysis and their distribution by hospital volume 51 Table 18. Outcomes by hospital volume among myocardial infarction patients who were transferred from the healthcare facilities where PTCA was not available 52 Table 19. PTCA outcome indicators and their results of other studies in Korea 61 Table 20. Risk factor profiles affecting outcomes of percutaneous transluminal coronary angioplasty by sex 65 Table 21. Comparisons of major risk factors affecting outcomes of percutaneous transluminal coronary angioplasty by smoking history 67 Table 22. Comparison of PTCA clinical outcomes by hospital's number of operator 69 - v -
List of Figures Figure 1. Weighted kappa values of inter-observer reliability tests by modified ACC/AHA lesion type (A, B1, B2, C). 26 Figure 2. Kappa values of inter-observer reliability tests by lesion type C. 27 Figure 3. Increases of percutaneous transluminal coronary angioplasty operators by year in Korea. 30 Figure 4. Distribution of intervention failure rate and major adverse outcome rate by hospital volumes. 50 - vi -
List of Abbreviations 95% CI : Confidence interval ACC : American College of Cardiology AHA : American Heart Association AMI : Acute myocardial infarction ANOVA : Analysis of variance ARF : Acute renal failure BMI : Body mass index CABG : Coronary artery bypass graft COPD : Chronic obstructive pulmonary disease CRF : Chronic renal failure MI : Myocardial infarction PTCA : Percutaneous transluminal coronary angioplasty - vii -
1. 1 2. 6 ) PTCA - 6 ) 8 ) 9 ) - 10 ) 10 ) - 11 3. 15 1) 15 ) 15 ) 17 2) 19 ) 19 ( ) : 19 ( ) : 19 ( ) 20 ( ) 23 ) 24 ) 24 4. 26 1) 26 ) 26 - viii -
) 28 2) PTCA 29 ) PTCA 29 ) 31 ( ) 31 ( ) 32 ( ) 35 3) - 36 ) 36 ( ) 36 ( ) 38 ( ) 39 ) : 42 ( ) 42 ( ) 43 ( ) 46 4) :, 48 5) 50 6) 51 5. 54 1) 54 ) 54 ) : 57 ) 59 2) 60 ) PTCA 60 ) 63 ( ) 63 ( ) 66 ) - 68 ) 69 - ix -
) - 70 3), 72 ) 72 ) 73 ) 74 6. 76 78 - x -
1. PTCA 1977 Andreas R. Grüentzig (Grüentzig 1978),. PTCA (ideal lesion : proximal, non-calcified, discrete, and concentric lesion) ( 1992; 1995)., PTCA,. 63% 9.2% (,, ) (Dorros et al. 1983), 1% (Ellis et al. 1997; Hannan et al. 1997). PTCA., PTCA., 10 2 ( 1998)., 1997 2,.,,,. (OECD) 21, 10-1 -
1997 ( 1998),. PTCA. PTCA. PTCA, (1999), (. 1986; 1991;. 1992; 1993;. 1994; 1994; 1994; 1995). (1998) (technology assessment in healthcare) PTCA, (4 ), (ecologic fallacy). ( 1997), 1983, 1997 30 58 5,000. PTCA 2 1,088, ACC/AHA 200 ( 17 ) ( 1997). PTCA - 2 -
,,,. (high volumes lead to better results)' (Luft 1980; Luft et al. 1990), -,.,. Luft (1979),, (coronary artery bypass graft, CABG), Showstack (1987), Hannan (1991). Hannan (1989) CABG,,, Hosenpud (1994), Lavernia Guzman(1995), Hamilton Hamilton(1997), Begg (1998), Hannan (1998), Witt (1998) (palatoplasty), Norton (1998), Birkmeyer (1999) (pancreaticoduodenectomy), Sollano (1999) -. Shortell LoGerfo(1981), Thiemann (1999), Maerki (1986),,,. Farley Ozminkowski(1992), Jones Rowan(1995).. Mayfield (1990), - 3 -
. Sollno (1990) CABG. Wen (1996) (elective) -,. Kelly Hellinger(1986),. -.,. 1950 (maternity unit) (Phillips and Luft 1997),,, (accreditation),. American College of Cardiology( ACC) American Heart Association( AHA) (percutaneous transluminal coronary angioplasty, PTCA) CABG (Ryan et al, 1988; Ryan et al. 1990; Kirklin et al. 1991; Ryan et al. 1993). - (Hosenpud et al. 1994; Anthony 1988; McGregor and Pelletier 1978)., Croke(1991),., - 4 -
.,., -...,, PTCA.,,. -., PTCA., - ( ) ( ) PTCA. - 5 -
2. PTCA -. ) PTCA - PTCA -,,. Dorros (1983), Jacob (1986), Hamad (1988), Ritchie (1993), Jollis (1994), Ellis (1997) ( 1).,,,, 34 PTCA O'Neil (1996),. (low volume), (simple lesion), (Hamad et al. 1988). - 6 -
Table 1. The studies supporting volume-outcome relationship of percutaneous transluminal coronary angioplasty (PTCA) and their volume/outcome variables Studies Volume variables Outcome variables Ellis et al. 1997 physician volume composite outcome (mortality, Q-wave infarction, ( 75 vs 75) emergency bypass surgery) Jollis et al. 1997 hospital/physician vol. mortality, bypass surgery ( 200 vs 200 / 75 vs 75) Hannan et al. 1997 hospital/physician vol. mortality, bypass surgery ( 600 vs 600 / 75 vs 75) Ellis et al. 1996 physician volume death, Q-wave infarction, bypass surgery, ( 75 vs 75) procedural success Kimmel et al. 1995a hospital volume emergency bypass surgery, MI *, in-hospital mortality ( 400 vs 400) Phillips et al. 1995 hospital volume adverse outcome (CABG * after PTCA), mortality, ( 200 vs 200, length of stay, charges 400 vs 400) Shook et al. 1995 physician volume emergency CABG after PTCA, in-hospital mortality, ( 50 vs 50) in-hospital morbidity(ventricular fibrillation, CABG during same hospitalization), length of stay, hospital costs Jollis et al. 1994 hospital volume short-term mortality, CABG after PTCA ( 100 vs 100) Ritchie et al. 1993 hospital volume CABG during the same hospitalization, death ( 200 vs 200) Hamad et al. 1988 physician volume success rate ( 100 vs 100) Jacob et al. 1986 physician volume success rate ( 2 vs 2 per month) Kelsey et al. 1984 physician volume angiographic success rate, clinical success rate, ( 50 vs 50) * MI : myocardial infarction, CABG : coronary artery bypass graft. complications (MI, death, emergency CABG) - 7 -
) -.,. Luft (1979), Kimmel (1995a).. PTCA Ritchie (1993), Jollis (1994) - (Kimmel et al. 1995a). Omoigui (1996) Topol (1995),,,. Meier (1984) (patient selection),., (heterogeneity). - 8 -
) -,., (cut-off point). ( 2). ACC/AHA (Ryan et al. 1990; Ryan et al. 1993) 200, 75, (Croke 1991)., Ritchie (1993), Jollis (1994) ACC/AHA, Kimmel (1995a) 200 400. Shook (1996) - (dose-effect response). Table 2. Recommendations for clinical competence in percutaneous transluminal coronary angioplasty minimum recommended number of cases per year * Training Practicing Total number Cases Number of Cases per year of cases as primary operator to maintain competency Bethesda Conference(1985) * 125 75 - The Society for Cardiac Angiography(1988) 125 75 50 ACC/AHA(1988) 125 75 52 ACP/ACC/AHA(1990) 125 75 75 ACC/AHA(1993) 125 75 75 * Seventeenth Bethesda Conference 1986. The Society for Cardiac Angiography 1988. Ryan et al. 1990. Ryan et al. 1990. Ryan et al. 1993. - 9 -
) - -,. PTCA Kimmel (1995a), Phillips (1995), Jollis (1994), Ritchie (1993), Ellis (1997), Ellis (1996), Shook (1995), Hamad (1988), Jacob (1986), Kelsey (1984). PTCA, Kelly Hellinger(1986), -.,.,,,. ).,. (success rate), - 10 -
(intermediate outcome indicator). - PTCA, Ritchie (1993), Kimmel (1995a), Ellis (1997) CABG, Kelsey (1984), Jacob (1986), Hamad (1988), Ellis (1996) PTCA. Phillips (1995), Shook (1996).,, CABG, ( ) (adverse outcome composite outcome) (Kelsey et al. 1984; Kimmel et al. 1995a; Ellis et al. 1996; Ellis et al. 1997), ( 1). ) - -. -.. (Luft 1980; Luft et al. 1987; Luft et al. 1990; Jones et al. 1995).,. (learning curve), (experience - 11 -
curve).,, (Wright 1936; Lieberman 1984). 37 Lieberman (1984). (learning-by-doing) (Luft et al. 1979)., (Meier et al. 1984).. Ikhena (1999), Shackford (1999), Soot (1999), Rege Joehl(1999). - (Luft et al. 1987). Flood (1984c), Luft (1987). CABG (Luft et al. 1987; Farley et al. 1992), PTCA. Phillips (1995) PTCA. - 12 -
, PTCA,. Jollis (1994) PTCA -, (1), (2),, (3). Kimmel (1995a) PTCA -., PTCA (acute vessel closure),,,,,,,. PTCA.,,,., (Luft et al. 1987). - 13 -
PTCA - (Jolis et al. 1994; Kimmel et al. 1995a; Phillips et al. 1995),. - 14 -
3. 1) ). PTCA 25. 1997 10 1 1997 12 31 3 PTCA, PTCA (PTCA, ). PTCA., 25 13 21, 34. (pretest)., ACC/AHA (modified ACC/AHA legion type), (cath sheet),. (admission note), (discharge summary), (progress note),, (nursing chart) - 15 -
.,. CABG,. (echocardiography) Q CK-MB (3 ). PTCA,,,,,., 24 CABG,,. PTCA 1997 (junior staff), 2 ( : / ).. (lipid battery), (ejection fraction)., 3, 3.., MIBG scan,. - 16 -
1, 1997. ) 25, 60.,. PTCA (,, ) 1997 3 1,379 ( 3). 6, 200. 1,379 1,317 95.5%. 62 29 W, 1 PTCA (fail). 62 19 F, 1 PTCA, PTCA. 14, 1 PTCA, 6, 7 ( 200 1, 6 ). - 17 -
Table 3. Hospital percutaneous transluminal coronary angioplasty (PTCA) volumes during the study period, their volumes and proportions surveyed, and their volumes except repeated PTCAs Hos- Total Surveyed 1st PTCAs * Hos- Total Surveyed 1st PTCAs * pital volume volume (%) volume (% ) pital volume volume (%) volume (% ) A 40 40 (100) 33 ( 83) B 52 52 (100) 40 ( 77) C 34 33 ( 97) 31 ( 94) D 63 63 (100) 55 ( 87) E 21 20 ( 95) 20 (100) F 132 113 ( 86) 89 ( 79) G 9 9 (100) 9 (100) H 84 80 ( 95) 72 ( 90) I 14 14 (100) 13 ( 93) J 19 19 (100) 13 ( 68) K 39 39 (100) 38 ( 97) L 42 42 (100) 36 ( 86) M 117 116 ( 99) 86 ( 74) N 86 86 (100) 70 ( 81) O 18 18 (100) 17 ( 94) P 201 196 ( 98) 156 ( 80) Q 2 2 (100) 2 (100) R 64 64 (100) 52 ( 81) S 93 91 ( 98) 70 ( 77) T 19 19 (100) 16 ( 84) U 51 51 (100) 41 ( 80) V 9 9 (100) 9 (100) W 134 105 ( 78) 80 ( 76) X 30 30 (100) 28 ( 93) Y 6 6 (100) 6 (100) * Refers to the hospital volumes when repeated PTCAs were excluded. Refers to the first PTCAs' proportion of the surveyed volume by hospital. Total 1,379 1,317 (96) 1,082 ( 82) - 18 -
2) ) ( ) : - ACC/AHA 200 75 (Ryan et al. 1990; Ryan et al. 1993). 400 (Kimmel et al. 1995a), 50 Shook (1996), Society for Cardiac Angiography (1988) 400, 50. ( ) :. (major adverse outcome), 24, 24 CABG. 1, 0. Ellis (1997), Ellis (1996), Kimmel (1995b), Kelsey (1984) CABG,., Ellis (1990), Hamad (1988), (1994) (,, CABG) 20% 50%. ( = 1, = 0 ). - 19 -
PTCA PTCA. PTCA (successful) (fail). " " " ". ( ) - ( 4). Table 4. Confounding variables: demographic, preprocedural, and procedural characteristics of patients and their past medical histories, comorbidity, and diagnosis Demographic risk factors age, sex, body mass index Preprocedural risk factors resting heart rate, ejection fraction, lipid battery (total cholesterol, TG, HDL) Past medical histories and comorbidity hypertension, diabetes mellitus, congestive heart failure, stroke valvular disease (aortic valve disease or mitral valve disease) smoking (current smokers, former smokers, non-smokers) respiratory disease (COPD * or asthma), renal disease (ARF * or CRF * or dialysis) previous PTCA * (or with stent), previous CABG * Diagnosis acute myocardial infarction within 24 hours before coronary angioplasty myocardial infarction within 1-14 days before coronary angioplasty Procedural risk factors number of vessels involved, number of stents, Type C lesion (modified ACC/AHA lesion type) * COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, PTCA : percutaneous transluminal coronary angioplasty, CABG : coronary artery bypass graft.,, (body mass index) - 20 -
.. (Ellis et al. 1997; Jollis et al. 1994; Ritchie et al. 1993) PTCA,.,,., 3. 100, 30% 50% ( 50% = 0, 49% 30% = 1, 29% = 2 ).. Ellis (1990) ACC/AHA. (chronic obstructive pulmonary disease, COPD), (acute renal failure, ARF) (chronic renal failure) (dialysis).. Phillips (1995), Kimmel (1995b) 24 1 14. Kimmel (1995b) 24, 1 14,.,. Q - 21 -
CK-MB fraction 3.,, (worst lesion type). 50%. (proximal), (middle), (distal) ( left circumflex artery ), 50%. 5 ACC/AHA. Table 5. Determination criteria of modified ACC/AHA legion type 1. Type A lesions (minimally complex) discrete (length < 10mm) readily accessible smooth contour less than totally occlusive no major side branch involvement concentric nonangulated segment ( <45 ) little or no calcification not ostial in location absence of thrombus 2. Type B lesions (moderately complex) : Type B1 - one, Type B2 - two or more tubular (length 10 to 20mm) eccentric moderate tortuosity of proximal segment irregular contour moderately angulated segment ( >45, <90 ) moderate or heavy calcification total occlusions <3 month old ostial in location some thrombus present bifurcation lesions requiring double guide wires 3. Type C lesions (severe complex) diffuse (length > 2cm) excessive tortuosity of proximal segment extremely angulated segments > 90 total occlusions > 3 month and/or bridging collaterals inability to protect major side branches degenerated vein grafts with friable lesions - 22 -
( ) -. Phillips (1995),., Luft (1987), Showstack (1987) CABG. Phillips (1995) PTCA (transfer). PTCA, -., -, PTCA,., PTCA. PTCA ( 1997) PTCA, PTCA 3 PTCA. - 23 -
) ( )..,. 5 ( 2, 3 ) PTCA 110 (inter-observer reliability)..,. (intra-observer reliability), 13,. ),,. ACC/AHA 200 ( 199 = 1, 200 = 0 ), 75 ( 74 = 1, 75 = 0 ), ( = 1, = 0 ) ( = 1, = 0 ). - 24 -
20% (stepwise logistic regression). P 0.2,, (dummy variable)... PTCA, PTCA -. -. Windows PC-SAS ver. 6.12, 5%. - 25 -
4. 1) ) 5 ( 200 2, 3 ) 110 ( 1,317 8.4%). 1 ( ), 1 ( ), 1 ( ) 3.., 4 (A = 1', B1 = '2', B2 = '3', C = '4') C (lesion type C). Cath sheet N=110 0.652 Low volume Fellow 0.651 0.733 0.621 0.685 High volume Fellow 0.694 High volume Resident Figure 1. Weighted kappa values of inter-observer reliability tests by modified ACC/AHA lesion type (A, B1, B2, C). 110 4-26 -
0.621 0.733. 3 4 110 46.4%., 3 2. Cath sheet N=110 0.705 Low volume Fellow 0.677 0.804 0.705 0.776 High volume Fellow 0.776 High volume Resident Figure 2. Kappa values of inter-observer reliability tests by lesion type C. ' C', 0.677 0.804. ' C' 4 110 81.8%.,. - 27 -
) (intra-observer reliability). 13 13.,,, (N = 115) 2, (N = 25) (N = 39) 1 2. 115 (A, B1, B2, C) 0.746. 30%, 30% 49%, 50%, 25 1 (96%). 39 89.7% 10% ( : 80% 70% 90% ), 7.7% 15% 20%, 50% ( : 60% 40%). - 28 -
2) PT CA ) PTCA 25 1997 200 14, 200 399 5, 400 6. 400., 5 (20%). 72%. PTCA 2 15 60%. Table 6. Beds, ownership, and education affiliation of hospitals, their number of operator, and their percutaneous transluminal coronary angioplasty (PTCA) volume attempt in 1997 Hospital characteristics Number Percent Number of total hospitals 25 100.0 PTCA volume attempted in 1997 199 14 56.0 200-399 5 20.0 400 6 24.0 Hospital beds, beds 400-699 8 32.0 700-999 13 52.0 1,000 4 16.0 Ownership public 5 20.0 private 20 80.0 Educational affiliation * yes 18 72.0 no 7 28.0 Number of operator, persons 1 4 16.0 2 11 44.0 3 7 28.0 4 2 8.0 5 1 4.0 * Refers to whether a hospital is affiliated with medical school. 60, 1997 75 63.3%. 5 56.7%, 2-29 -
. 45%. Table 7. Operators' intervention career, their experience trained at other countries, and their percutaneous transluminal coronary angioplasty (PTCA) volume attempt in 1997 Operator characteristics Number Percent PTCA volume attempted in 1997 49 28 46.7 50-74 11 18.3 75-99 6 10.0 100-199 5 8.3 200 10 16.7 Intervention career, years 2 16 26.7 3-5 18 30.3 6 26 43.3 Training at other countries yes 33 55.0 no 27 45.0, 3. 1980. Figure 3. Increases of percutaneous transluminal coronary angioplasty operators by year in Korea. - 30 -
) ( ) 1997 10 12 3 25 PTCA (N= 1,379) 1,317. 69.2%, 60 37.2%, 59.7 9.9 (28 94 ). 70.6 13.6, 100 (sinus tachycardia) 4.3%. (N= 1,317) 1,092 (82.9%), MIBG scan, 195 (14.8%), 1,287 56.8 12.0%. 30% 16.6%, 30 49% 18.9%. 43.9%, 23.4%, 4.0%, 3.8%. 2.4%,, 1.7%. PTCA 17.8%, CABG 2.7%.,, 24 8.1%, 14 24 9.0%., (single vessel disease) 54.7%, (double vessel disease) 31.5%, (triple vessel disease) 13.7%. PTCA 1 53.7%. lesion type 28.2% type C lesion. - 31 -
1,317 20 1.5%,, CABG, 24 2.0%. (20%, 50% ) 84 6.4%( 93.6%). ( ) 1,317 PTCA 1,082 82.2%.,,,,. 2.7% CABG 1.8%. 24 8.1% 9.0%, 14 24 9.0% 10.3%. 2.2%, 6.7%. - 32 -
Table 8a. Univariate analysis of demographic, preprocedural, and procedural characteristics of patients and their past medical histories, comorbidity, diagnosis, and outcomes : Results based on total samples and on samples repeated PTCAs excluded All surveyed Repeated PTCAs excluded Patient characteristics Number % or No. of Number % or No. of mean sd missing mean sd missing Sex Female 406 30.8-337 31.1 - Age, years 49 211 16.0-178 16.5-50-59 403 30.6 329 30.4 60-69 490 37.2 402 37.2 70 213 16.2 173 16.0 Mean SD 1,317 59.7 9.9-1,082 59.6 9.9 - Body mass index (kg/m 2 ) 1,078 24.6 2.9 238 869 24.6 2.9 213 Resting heart rate 100 56 4.3 8 51 4.7 6 Mean SD 1,309 70.6 13.6 8 1,076 70.9 13.9 6 Ejection fraction, % 50 830 64.5 30 665 62.9 25 30-49 243 18.9 217 20.5 30 214 16.6 175 16.6 Mean SD 1,287 56.8 12.0 30 1,057 56.5 12.1 25 Total cholesterol Mean SD 1,274 197 39 43 1,046 198 39 36 Triglyceride Mean SD 1,208 164 112 109 994 165 115 88 HDL Mean SD 1,189 43 21 128 978 43 22 104 Hypertension 578 43.9-476 44.0 - Diabetes mellitus 308 23.4-243 22.5 - Congestive heart failure 53 4.0-43 4.0 - Valvular disease (aortic or mitral) 50 3.8-40 3.7 - Stroke 74 5.6-65 6.0 - Respiratory disease (COPD or asthma) 31 2.4-25 2.3 - Smoking current smokers 572 43.4-495 45.7 - former smokers 211 16.0 150 13.9 nonsmokers 534 40.5 437 40.4 Kidney disease (ARF or CRF or dialysis) 23 1.7-20 1.8 - Previous PTCA (or with stent) 235 17.8 - Previous CABG 35 2.7-20 1.8 - Diagnosis MI (within previous 1-14 days) 118 9.0-111 10.3 - AMI (within 24 hours before PTCA) * 107 8.1-97 9.0 - * Determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). Refers to the vessels involved more than 50% or over. Refers to at least one complication of death during same hospitalization after intervention or emergency CABG or acute myocardial infarction performed or occurred within 24 hours after PTCA. Defined as the case of the final result 50% diameter stenosis or the failure in 20% reduction of diameter stenosis or having any major adverse outcome described above. COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, CABG : coronary artery bypass graft, MI : myocardial infarction. - 33 -
Table 8b. Univariate analysis of demographic, preprocedural, and procedural characteristics of patients and their past medical histories, comorbidity, diagnosis, and outcomes : Results based on total samples and on samples repeated PTCAs excluded All surveyed Repeated PTCAs excluded Patient characteristics Number % or No. of Number % or No. of mean sd missing mean sd missing Involved vessels single 721 54.7-587 54.3 - double 415 31.5 336 31.1 triple 181 13.7 159 14.7 Number of stents 0 610 46.3-480 44.4-1 615 46.7 528 48.8 2 83 6.3 68 6.3 3 9 0.7 6 0.6 Worst lesion type A 150 11.4-125 11.6 - B1 454 34.5 375 34.7 B2 338 25.7 285 26.3 C 375 28.5 297 27.4 Major adverse outcome 26 2.0-24 2.2 - death during same hospitalization 20 1.5-19 1.8 - emergency CABG after PTCA 5 0.4-4 0.4 - AMI within 24 hours after PTCA 4 0.3-3 0.3 - Intervention failure 84 6.4-72 6.7 - * Determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). Refers to the vessels involved more than 50% or over. Refers to at least one complication of death during same hospitalization after intervention or emergency CABG or acute myocardial infarction performed or occurred within 24 hours after PTCA. Defined as the case of the final result 50% diameter stenosis or the failure in 20% reduction of diameter stenosis or having any major adverse outcome described above. COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, CABG : coronary artery bypass graft, MI : myocardial infarction. - 34 -
( ) 50% 9. Table 9. Number of involved vessels * repeated PTCAs excluded and their proportion of total samples and of samples Vessels All surveyed Repeated PTCAs excluded (N=1,317) (N=1,082) No. of vessels % No. of vessels % Left main coronary artery 22 1.7 19 1.8 Left anterior descending 963 73.1 787 72.7 Left anterior descending, proximal 461 35.0 368 34.0 Left anterior descending, middle 577 43.8 475 43.9 Left anterior descending, distal 98 7.4 81 7.5 Left circumflex 531 40.3 447 41.3 Left circumflex, proximal 223 16.9 186 17.2 Left circumflex, distal 345 26.2 291 26.9 Right coronary 595 45.2 497 45.9 Right coronary, proximal 211 16.0 177 16.4 Right coronary, middle 223 16.9 186 17.2 Right coronary, distal 261 19.8 216 20.0 * Refers to the vessels involved more than 50% or over. (left main coronary artery) 50% 1.7%, (left anterior descending artery) 73.1%. 40.3%, (right coronary artery) 45.2% 50%.,, 43.8%. PTCA ( 9). - 35 -
3) - ) ( ) ( 200, 75 ) 10.,,,,., (55.6 11.7%) (59.0 13.0%) (P<0.001)., 100 (p=0.047). T-,. (P=0.011), (P<0.01). (P=0.002). CABG (P=0.012). 24 (P=0.016) 1 14 (P=0.051), 1 14 (P=0.001). 50%,. 1 (P=0.001). - 36 -
Table 10. Comparison of patient characteristics by hospitals or operators volume Patient characteristics Hospital volume Operator volume 199 200 P value 74 75 P value N=278 N=804 N=365 N=717 Female, % 31.3 31.1 0.950 34.0 29.7 0.152 Age, years 49 16.9 16.3 0.992 16.4 16.5 0.589 50-59 29.9 30.6 29.0 31.1 60-69 37.4 37.1 36.4 37.5 70 15.8 16.0 18.1 14.9 59.5 10.0 59.7 9.9 0.868 59.8 10.2 59.5 9.8 0.606 Body mass index (kg/m 2 ) 24.6 3.2 24.6 2.8 0.981 24.5 3.0 24.6 2.9 0.552 Resting heart rate 100 2.6 5.5 0.047 4.7 4.8 0.962 69.8 12.2 71.3 14.4 0.089 70.8 12.5 71.0 14.6 0.800 Ejection fraction 50 67.8 61.2 0.026 59.5 64.6 0.011 30-50 14.8 22.5 19.1 21.3 30 17.4 16.3 21.4 14.1 59.0 13.0 55.6 11.7 <0.001 56.0 12.7 56.7 11.8 0.343 Total cholesterol 199 35 197 40 0.508 200 38 197 39 0.314 Triglyceride 171 142 163 104 0.403 167 134 164 103 0.759 HDL 41 20 44 22 0.061 42 14 43 24 0.181 Hypertension 45.7 43.4 0.510 45.8 43.1 0.405 Diabetes mellitus 22.3 22.5 0.942 25.2 21.1 0.122 Congestive heart failure 5.8 3.4 0.078 6.0 2.9 0.011 Valvular disease (aortic or mitral) 6.5 2.7 0.004 7.4 1.8 0.001 Stroke 5.8 6.1 0.837 5.2 6.4 0.428 Respiratory disease (COPD or asthma) 4.7 1.5 0.002 3.3 1.8 0.127 Kidney disease (ARF /CRF /dialysis) 2.2 1.7 0.656 2.2 1.7 0.550 Smoking current smokers 41.0 40.2 0.040 42.3 39.3 0.610 former smokers 18.0 12.4 13.4 14.1 non-smokers 41.0 47.4 44.1 46.6 Previous CABG 1.4 2.0 0.556 3.3 1.1 0.012 Diagnosis others 87.4 78.5 0.005 84.4 78.9 0.005 MI (1-14 days) 7.2 11.3 6.0 12.4 AMI (within 24hrs) * 5.4 10.2 9.6 8.7 Involved vessels single 57.9 53.0 0.267 54.0 54.4 0.355 double 29.9 31.5 29.3 31.9 triple 12.2 15.5 16.7 13.7 Number of stents 0 58.6 39.4 0.001 53.4 39.8 0.001 1 39.9 51.9 43.3 51.6 2 1.4 8.0 3.3 7.8 3 0.0 0.7 0.0 0.8 Lesion type C 23.4 28.9 0.078 21.1 30.7 0.001 * Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). Refers to the vessels involved more than 50% or over. Two-tailed Fisher's exact test. COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, CABG : coronary artery bypass graft, MI : myocardial infarction. - 37 -
' C', (P=0.078), (P=0.001). ( ),. 200, (P=0.001), 75 ( 11). Table 11. Unadjusted comparison of outcome by hospital or operator volume Patient outcome Hospital volume Operator volume 199 200 P value 74 75 P value N=278 N=804 N=365 N=717 Major adverse outcome * 3.6 1.7 0.070 1.9 2.4 0.632 death during same hospitalization 2.2 1.6 0.597 1.1 2.1 0.238 AMI within 24 hours after PTCA 0.7 0.1 0.164 0.3 0.3 1.000 emergency CABG after PTCA 0.7 0.3 0.273 0.6 0.3 0.607 Intervention failure 11.9 4.9 0.001 7.7 6.1 0.338 * Refers to at least one complication of death during same hospitalization after intervention or emergency CABG within 24 hours after PTCA or acute myocardial infarction within 24 hours after PTCA. Defined as the case of the final result 50% diameter stenosis or the failure in 20% reduction of diameter stenosis or having any major adverse outcome described above. Two-tailed Fisher's exact test. CABG : coronary artery bypass graft. - 38 -
( ). (P=0.044).. 10 (X 2 tr en d = 11.544, P=0.0007), (X 2 tr en d =8.880, P=0.0029). (N=72) 63.2 9.1 (N= 1,010) (59.4 9.9 ) (P=0.0016), (N=24) (66.2 10.1 ) (N= 1,058) (59.5 9.9 ) (P=0.0011). 100 (Fisher's exact test, P<0.05). (total cholesterol), (triglyceride), (HDL, high density lipoprotein) 0.2. (X 2 tr en d = 10.398, P=0.0013), (X 2 tr en d =22.694, P=0.0001). (N=71) 49.8 15.5% (N=986) 57.0 11.7% (P<0.001), (N=24) 43.4 15.0% (N= 1,033) 56.8 11.9% (P<0.001).,,, CABG, 0.2. - 39 -
Table 12. Unadjusted comparison of intervention failure rate and major adverse outcome rate by patients' characteristics Characteristics Intervention failure * Major adverse outcome Rate P value Rate P value Gender Male 5.9 0.142 1.6 0.044 Female 8.3 3.6 Age, years 49 2.3 0.001 0.6 0.003 50-59 5.2 1.2 60-69 8.5 2.7 70 9.8 4.6 Resting heart rate 99 6.1 0.014 1.8 0.001 100 15.7 11.8 Ejection fraction, % 50 4.7 0.001 0.6 0.001 30-49 9.7 3.7 30 10.9 6.9 Hypertension No 6.6 0.936 2.5 0.517 Yes 6.7 1.9 Diabetes mellitus No 6.6 0.808 2.2 0.763 Yes 7.0 2.5 Congestive heart failure No 6.3 0.020 1.9 0.013 Yes 16.3 9.3 Valvular disease No 6.6 0.745 2.2 0.599 (aortic or mitral) Yes 7.5 2.5 Stroke No 6.5 0.435 2.3 1.000 Yes 9.2 1.5 Respiratory disease No 6.4 0.079 2.1 0.104 (COPD ** or asthma) Yes 16.0 8.0 Kidney disease No 6.5 0.143 2.1 0.070 (ARF ** or CRF ** or dialysis) Yes 15.0 10.0 Smoking current smokers 5.1 0.141 1.2 0.029 former smokers 8.7 1.3 non-smokers 7.8 3.7 Previous CABG ** No 6.2 0.001 2.1 0.070 Yes 30.0 10.0 Diagnosis others 5.7 0.001 1.1 0.001 MI within 1-14 days 5.4 3.6 AMI within 24 hours 16.5 10.3 Involved vessels single 6.1 0.285 2.6 0.603 double 6.6 2.1 triple 8.8 1.3 Lesion type C No 4.2 0.001 1.4 0.003 Yes 13.1 4.4 * Defined as the case of the final result 50% diameter stenosis or the failure in 20% reduction of diameter stenosis or having any major adverse outcome described below. Refers to at least one complication of death during same hospitalization after PTCA or emergency CABG within 24 hours after PTCA or acute myocardial infarction within 24 hours after PTCA. Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). Refers to the vessels involved more than 50% or over. Likelihood ratio test for trend. Two-tailed Fisher's exact test. ** COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, CABG : coronary artery bypass graft, MI : myocardial infarction. - 40 -
P 0.052, ( ) (P=0.008). 24 (P=0.001). 24 1 14 ( = 0, 1 14 = 1, 24 = 2 ), (X 2 tr en d =22.161, P=0.0001).. ACC/AHA C, (P<0.01). - 41 -
) : ( ),. 0.2 ( 12). 0.2.,,.. 0.2 (25 ) (6 ), 0, 1,051., 3 ( 49 = 0, 50-59 = 1, 60 = 2 ), 2 ( 50 = 0, 50 = 1 ). 12 4, 3., (current smoker = 0, former smoker or non-smoker = 1),, (current smoker or former smoker = 0, non-smoker = 1). - 42 -
, 24, ( = 0, 1 14 = 1, 24 = 2 ). 4 (A, B1, B2, C)., ' C' ' C'.,. ( ) 1, 0, (200 = 1, 200 = 0 ) (por = 3.692, 95% CI : 2.131-6.398). 60 (95% CI : 1.515-12.787), 100 (95% CI : 1.155-7.197), 50% (95% CI : 1.174-3.449), CABG (95% CI : 1.668-20.382), 24 (95% CI : 1.489-5.821), C (95% CI : 2.025-5.813) ( 13). - 43 -
Table 13. Hospital volume and the variables associated with intervention failure (Analysis of Maximum Likelihood Estimates) * Variables Number (%) por 95% CI Hospital volume High, 200 784 (74.6) 1.000 Low, 199 267 (25.4) 3.692 2.131-6.398 Age, years 49 174 (16.6) 1.000 50-59 322 (30.6) 2.307 0.739-7.203 60 555 (52.8) 4.401 1.515-12.787 Resting heart rate 99 1002 (95.3) 1.000 100 49 ( 4.7) 2.884 1.155-7.197 Ejection fraction, % 50 661 (62.9) 1.000 50 390 (37.1) 2.012 1.174-3.449 Previous CABG No 1032 (98.2) 1.000 Yes 19 ( 1.8) 5.830 1.668-20.382 Diagnosis Others 954 (90.8) 1.000 AMI, within 24 hours 97 ( 9.2) 2.944 1.489-5.821 Lesion type C No 762 (72.5) 1.000 Yes 289 (27.5) 3.431 2.025-5.813 * Missing values (N=31) were excluded. Chi-square for Covariates : 83.936 with 8 DF (P=0.0001). Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). por : prevalence odds ratio, CI : confidence interval, CABG : coronary artery bypass graft. (, CABG, ), (200 = 1, 200 = 0 ) (por = 3.136, 95% CI : 1.184-8.305). 100 (95% CI : 2.217-27.124), 30% (95% CI : 2.402-27.537), (95% CI : 1.053-7.263), 1 14 (95% CI : 1.050-16.659) 24 (95% CI : 2.692-22.320), C (95% CI : 1.259-8.026). - 44 -
Table 14. Hospital volume and other significant risk factors associated with major adverse outcome (Analysis of Maximum Likelihood Estimates) * Variables Number (%) por 95% CI Hospital volume High, 200 784 (74.6) 1.000 Low, 199 267 (25.4) 3.136 1.184-8.305 Age, years 49 174 (16.6) 1.000 50-59 322 (30.6) 1.389 0.133-14.467 60-69 388 (36.9) 5.918 0.659-53.173 70 167 (15.9) 6.808 0.687-67.439 Resting heart rate 99 1,002 (95.3) 1.000 100 49 ( 4.7) 7.754 2.217-27.124 Ejection fraction, % 50 661 (62.9) 1.000 30-49 216 (20.5) 2.625 0.676-10.191 30 174 (16.6) 8.133 2.402-27.537 Congestive heart failure No 1,008 (95.9) 1.000 Yes 43 ( 4.1) 2.762 0.709-10.766 Renal disease No 1,031 (98.1) 1.000 (ARF or CRF or dialysis) Yes 20 ( 1.9) 5.027 0.810-31.199 Smoking history Yes 631 (60.0) 1.000 (current or former) No 420 (40.0) 2.765 1.053-7.263 Diagnosis others 844 (80.3) 1.000 MI, within 1-14 days 110 (10.5) 4.183 1.050-16.659 AMI, within 24 hours 97 ( 9.2) 7.752 2.692-22.320 Lesion type C No 762 (72.5) 1.000 Yes 289 (27.5) 3.178 1.259-8.026 * Missing values (N=31) were excluded. Chi-square for Covariates : 78.510 with 13 DF (P=0.0001). Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). por : prevalence odds ratio, CI : confidence interval, ARF : acute renal failure, CRF : chronic renal failure. - 45 -
( ) 1, 0, (75 = 1, 75 = 0 ) (por = 1.198, 95% CI : 0.695-2.064). Table 15. Operator volume and the variables associated with intervention failure (Analysis of Maximum Likelihood Estimates) * Variables Number (%) por 95% CI Operator volume High, 75 698 (66.4) 1.000 Low, 74 353 (33.6) 1.198 0.695-2.064 Age, years 49 174 (16.6) 1.000 50-59 322 (30.6) 2.121 0.680-6.615 60 555 (52.8) 3.954 1.362-11.476 Resting heart rate 99 1,002 (95.3) 1.000 100 49 ( 4.7) 2.217 0.918-5.351 Ejection fraction, % 50 661 (62.9) 1.000 50 390 (37.1) 1.788 1.041-3.070 Congestive heart failure No 1,008 (95.9) 1.000 Yes 43 ( 4.1) 1.932 0.765-4.878 Respiratory disease No 1,027 (97.7) 1.000 (COPD or asthma) Yes 24 ( 2.3) 2.931 0.893-9.620 Previous CABG No 1,032 (98.2) 1.000 Yes 19 ( 1.8) 4.666 1.426-15.273 Diagnosis Others 954 (90.8) 1.000 AMI, within 24 hours 97 ( 9.2) 2.581 1.340-4.970 Lesion type C No 762 (72.5) 1.000 Yes 289 (27.5) 3.311 1.963-5.584 * Missing values (N=31) were excluded. Chi-square for Covariates : 68.075 with 10 DF (P=0.0001). Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). por : prevalence odds ratio, CI : confidence interval, COPD : chronic obstructive pulmonary disease, CABG : coronary artery bypass graft. - 46 -
(, CABG, ), (75 = 1, 75 = 0 ) (por = 0.536, 95% CI : 0.185-1.555). Table 16. Operator volume and other significant risk factors associated with major adverse outcome (Analysis of Maximum Likelihood Estimates) * Variables Number (%) por 95% CI Operator volume High, 75 698 (66.4) 1.000 Low, 74 353 (33.6) 0.536 0.185-1.555 Age, years 49 174 (16.6) 1.000 50-59 322 (30.6) 1.103 0.103-11.851 60-69 388 (36.9) 4.777 0.530-43.050 70 167 (15.9) 5.737 0.579-56.805 Resting heart rate 99 1,002 (95.3) 1.000 100 49 ( 4.7) 5.990 1.797-19.970 Ejection fraction, % 50 661 (62.9) 1.000 30-49 216 (20.5) 2.733 0.708-10.557 30 174 (16.6) 9.931 2.831-34.831 Congestive heart failure No 1,008 (95.9) 1.000 Yes 43 ( 4.1) 2.735 0.673-11.118 Respiratory disease No 1,027 (97.7) 1.000 (COPD or asthma) Yes 24 ( 2.3) 3.269 0.534-20.020 Renal disease No 1,031 (98.1) 1.000 (ARF or CRF or dialysis) Yes 20 ( 1.9) 6.318 0.943-42.346 Smoking history Yes 631 (60.0) 1.000 (current or former) No 420 (40.0) 2.426 0.912-6.450 Previous CABG No 1,032 (98.2) 1.000 Yes 19 ( 1.8) 8.179 0.920-72.694 Diagnosis Others 844 (80.3) 1.000 MI, within 1-14 days 110 (10.5) 4.104 1.018-16.540 AMI, within 24 hours 97 ( 9.2) 7.159 2.463-20.814 Lesion type C No 762 (72.5) 1.000 Yes 289 (27.5) 2.880 1.114-7.446 * Missing values (N=31) were excluded. Chi-square for Covariates : 78.357 with 15 DF (P=0.0001). Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). por : prevalence odds ratio, CI : confidence interval, COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, CABG : coronary artery bypass graft. - 47 -
4) :,,.,. G(X ) = L og ( P 1 - P ) = 0 + i X i + j X j + + p X p --------------------- ( 1) PTCA, -, PTCA.,., ' C',., 0.2. 0.2.,,.. - 48 -
0.2 (30 ) (8 ), 1,279. P 0.05. L og ( P f ail 1 - P f ail ) = 4.3072 0.7881 * AGE50 1.2615 * AGE60 0.8921 * HR100 0.7555 * EF50 1.2508 * R_DIS 1.4029 * P_CABG 0.8614 * AMI Pfa il : probability of intervention failure AGE50 AGE60 : '1' = 50 patient age < 60, '0' = otherwise : '1' = 60 patient age, '0' = otherwise HR100 EF50 : '1' = 100 heart rate, '0' = otherwise : '1' = ejection fraction < 50, '0' = otherwise R_DIS : '1' = respiratory diseases such as chronic obstructive pulmonary disease or asthma, '0' = otherwise P_CABG AMI : '1' = history of previous coronary artery bypass graft, '0' = otherwise : '1' = acute myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). '0' = otherwise L og ( P compl. 1 - P com pl. ) = 7.1938 0.8210 * SEX 1.3845 * AGE60 1.5030 * AGE70 1.7194 * HR100 1.2719 * EF50 2.1700 * EF30 1.5733 * R_DIS 1.9503 * P_CABG 1.4980 * MI_14 1.8383 * AMI Pco m p l. : probability of major adverse outcome (complication) such as death during same hospitalization, emergency CABG within 24 hours after PTCA, and acute myocardial infarction within 24 hours after PTCA. SEX : '1' = female, '0' = male AGE60 : '1' = 60 patient age < 70, '0' = otherwise AGE70 : '1' = 70 patient age, '0' = otherwise HR100 : '1' = 100 heart rate, '0' = otherwise EF50 : '1' = 30 ejection fraction < 50, '0' = otherwise EF30 : '1' = ejection fraction < 30, '0' = otherwise R_DIS : '1' = respiratory diseases such as chronic obstructive pulmonary disease or asthma, '0' = otherwise P_CABG : '1' = history of previous coronary artery bypass graft, '0' = otherwise MI_14 : '1' = myocardial infarction occurred between 1 day and 14 days before PTCA '0' = otherwise AMI : '1' = acute myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). '0' = otherwise - 49 -
5), -,, 200, 20 0 399, 400..,, 200 200 399 (P=0.023). 200, 200 399, 400 (X 2 tr en d = 16.168, P=0.0001) 200 200 399 (P=0.208), (X 2 tr en d =2.629, P=0.105). 200 200 399, 200 200, ACC/AHA 200. P=0.023 P=0.181 P=0.208 P=0.873 Figure 4. Distribution of intervention failure rate and major adverse outcome rate by hospital volumes. - 50 -
6) - PTCA,. ( ). Jollis (1994), Phillips (1995),. PTCA,. Table 17. Variables associated with intervention failure or major adverse outcome in the logistic regression analysis and their distribution by hospital volume Outcome associated with variables Low High in the logistic regression analysis 199 200 P value N=804 N=278 Age, 60 years Intervention failure * 53.2 53.1 0.971 Resting heart rate, 100 Intervention failure, adverse outcome 2.6 5.5 0.047 Ejection fraction, 50% Intervention failure 32.2 38.8 0.055 Ejection fraction, 30% Adverse outcome 17.4 16.3 0.700 Previous CABG Intervention failure 1.4 2.0 0.556 Diagnosis, MI (1-14 days) Adverse outcome 7.2 11.3 0.051 Diagnosis, AMI (within 24hrs) Intervention failure, adverse outcome 5.4 10.2 0.016 Lesion type C Intervention failure, adverse outcome 23.4 28.9 0.078 * Defined as the case of the final result 50% diameter stenosis or the failure in 20% reduction of diameter stenosis or having any major adverse outcome described below. Refers to at least one complication of death during same hospitalization after intervention or emergency CABG or acute myocardial infarction performed or occurred within 24 hours after PTCA. CABG : coronary artery bypass graft. Refers to the myocardial infarction occurred within 1-14 days before PTCA. Determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave). - 51 -
17 ( 13, 14) (odds ratio)... Table 18. Outcomes by hospital volume among myocardial infarction patients who were transferred from the healthcare facilities where PTCA was not available Intervention failure Major adverse outcome Success Failure No Yes Acute myocardial infarction occurred within 24 hours before PTCA High volume (N=81), 200 71 (87.7) 10 (12.3) 76 (93.8) 5 ( 6.2) Low volume (N=13), 199 10 (76.9) 3 (23.1) 11 (84.6) 2 (15.4) P value P=0.381 * P=0.248 * Myocardial infarction occurred within 14days before PTCA High volume (N=173), 200 157 (90.8) 16 ( 9.2) 164 (94.8) 9 ( 5.2) Low volume (N=35), 199 29 (82.9) 6 (17.1) 30 (85.7) 5 (14.3) P value P=0.223 * P=0.065 * * Two-tailed Fisher's exact test. Determined by cardiac enzymes (CM-MB fraction 3 fold increase) or electrocardiographic changes (new Q-wave)., PTCA. 24 14,. - - 52 -
,,. - 53 -
5. 1) ),.. (gold standard)... 5 110. 3 A, B1, B2, C ( ) 0.621 0.733. 4 110 46.4%. ' C', 0.677 0.804. 110 81.8%., 2.. 5, (1) - 54 -
, (2). 3.. PTCA., Ellis (1990) 58%, 1 (level) 35%, 2 7%. Ellis (1990).. 4 0.75, ' C' 3 0.75. 0.75 (. 1996), 4 ' C' -..,. 2.2%(24 ), CABG,,. - 55 -
PTCA PTCA. 2 23 95%. PTCA,,, 6 ( 200 ). " " " ". 6,.,., 1,317 1,092 (82.9%), MIBG scan. 30%, 30% 49%, 50%, 25 1 (96%).., 39 lesion 89.7% 10% ( : 80% 70% 90% ), 7.7% 15% 20%, 50% ( : 60% 40%). PTCA. 1997, 2 ( : / ) - 56 -
,.. ( 75 ) ( 75 ),.. ) :., 25 13 21 34.. (, ),.,,. /, /. - 57 -
.. (bifurcation, thrombus, angulation ), ' C'.., (information bias)..,., -., (score-carding),, -. - 58 -
). (thrombolytics), (bifurcation), (angulation), (thrombus),...,,... - 59 -
2) ) PTCA 1997 ACC/AHA 200 25 56%, ACC/AHA 75 60 63.3%. ACC/AHA, PTCA. 3 25 1,317 PTCA 20 1.5%,, CABG, 24 2.0%. 3 (20%, 50% ) 84 6.4%( 93.6%)., 10. (1986), 1983 1985 PTCA 73%,, (1992) 1986 1991 90%. 93.6% (1999) 94.8%, (1999) 1. - 60 -
, (1986), 3.0%, 9.0% 1 2%, 0 2%. 1.5%, 2.2%, Ellis (1997) (1993 1994, 1.3%, 4.5%),. (1992) (steerable guide wire, low profile balloon ). Table 19. PTCA outcome indicators and their results of other studies in Korea Study Study period No. of Outcome indicators Results sample (1994) 1992-1994 303 success rate 91.7% emergency CABG * 0.7% mortality 1.3% (1994) 1989-1993 516 success rate 90.0% AMI * 1.7% (1992) 1986-1991 250 success rate 90.0% ventricular fibrillation or arrythmia 2.1% (1991) 1983-1989 164 success rate 82.5% (without AMI) AMI 3.8% emergency CABG 1.7% mortality(ventricular fibrillation) 0.5% (1986) 1983-1985 33 success rate 73.0% AMI 9.0% death 3.0% * AMI : acute myocardial infarction, CABG : coronary artery bypass graft. PTCA (. 1999). 1998 11 5 11 519, - 61 -
59.8 10.1(32 87 ), 32.4% 30.2%., PTCA 36.0%, 17.9%, 43.7% 23.0%., (1999) 65.7%,, 25.4%, 8.9%, 54.7%, 31.5%, 13.7%., 50%, (1999). (1999) PTCA 15.2%, CABG 2.1%, 17.8%, 2.7%. PTCA (. 1999) 575 61.7%, 1), 53.4%. PTCA 200,, 10 1 61.6% PTCA. 1). PTCA 575 1.1,. - 62 -
) ( ) 3 25 PTCA, 30%. PTCA, (1986) 21%, (1991) 22%, (1992) 30.3%, (1994) 28.1%, (1999).. PTCA, PTCA (P=0.048)., 20%., (sex bias in the delivery of medical care)., (Hussain et al. 1997). (Tobin et al. 1987; Khan et al. 1990; Ayanian & Epstein 1991; Steingart et al. 1991). Tobin (1987), Khan (1990) CABG. Tobin (1987) (radionuclide scan) 4% CABG, 40% - 63 -
CABG, CABG (underuse). Khan (1990) CABG. Ayanian Epstein(1991),. Steingart (1991). PTCA (Holmes et al. 1988; Kelsey et al. 1993; Hussain et al. 1997), Kelsey (1993) PTCA,..,,, CABG ( 20). Hussain (1997) PTCA., 1980 (Hussain et al. 1997). - 64 -
Table 20. Risk factor profiles affecting outcomes of percutaneous transluminal coronary angioplasty by sex Characteristics Male (N=745) Female (N=337) P value Age, years 49 21.2 5.9 0.001 50-59 34.0 22.6 60-69 33.7 44.8 70 11.1 26.7 Mean SD 57.6 9.7 64.1 8.9 0.001 Resting heart rate 100 4.6 5.1 0.706 Ejection fraction, % 50 61.7 65.6 0.436 30-49 21.5 18.4 30 16.8 16.0 Congestive heart failure 3.5 5.0 0.225 Respiratory disease (COPD * or asthma) 1.9 3.3 0.160 Kidney disease (ARF * or CRF * or dialysis) 1.9 1.8 0.911 Previous CABG * 1.5 2.7 0.177 AMI within 24 hours 8.7 9.5 0.681 Lesion type C 27.5 27.3 0.941 * COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, CABG : coronary artery bypass graft. Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes(cm-mb fraction 3 fold increase) or electrocardiographic changes(new Q-wave)...,. - 65 -
( ) (current smoker vs former/non smoker) P 0.052, (current/former smoker vs nonsmoker) (P=0.008). (Doyle et al. 1964; Doll & Peto 1976), (procoagulant effect) PTCA (Quillen et al. 1993; Hung et al. 1995), (Barbash et al. 1993; Gomez et al. 1993; Zijlstra et al. 1993; Barbash et al. 1995a; Barbash et al. 1995b; Grines et al. 1995; Gottlieb et al. 1996). (smoker's paradox),. (1), (2), (3) (sudden death), (4) (Barbash et al. 1995a). PTCA, PTCA Hasdai (1999),,,.., ( 21), (P=0.001), - 66 -
(ANOVA),, (P<0.001). CABG,, (X 2 tr en d = 17.066, P=0.0001). Table 21. Comparisons of major risk factors affecting outcomes of percutaneous transluminal coronary angioplasty by smoking history Characteristics Current smokers Former smokers Non-smokers P value (N=495) (N=150) (N=437) Female, % 7.9 10.0 64.8 0.001 Age, years 49 24.9 14.0 7.8 50-59 33.3 28.7 27.7 60-69 33.3 42.0 39.8 70 8.5 15.3 24.7 Mean SD * 56.7 9.5 60.0 9.9 62.8 9.4 0.001 Resting heart rate 100 4.9 5.3 4.4 0.885 Ejection fraction, % 50 60.1 63.5 65.9 30-49 23.1 21.6 17.2 30 16.7 14.9 16.9 Mean SD 55.8 12.0 57.0 12.7 57.2 12.0 0.184 Congestive heart failure 3.8 4.0 4.1 0.976 Respiratory diseases 1.6 3.3 2.8 0.163 (COPD * or asthma) Kidney diseases 1.2 2.0 2.5 0.138 (ARF * or CRF * or dialysis) Previous CABG * 0.2 2.0 3.7 0.001 AMI within 24 hours 10.9 4.7 8.2 0.051 Lesion type C 25.6 27.3 29.5 0.419 * COPD : chronic obstructive pulmonary disease, ARF : acute renal failure, CRF : chronic renal failure, CABG : coronary artery bypass graft, SD : standard deviation. Defined as the case of the myocardial infarction occurred within 24 hours before PTCA and determined by cardiac enzymes(cm-mb fraction 3 fold increase) or electrocardiographic changes(new Q-wave). chi-square test comparing current smokers, former smokers, and non-smokers, ANOVA test, chi-square test comparing current smokers and former/non smokers as two groups, chi-square test for trend comparing current smokers, former smokers, and non-smokers as three group., P 0.052, P 0.008,. 14 (por = 2.765, 95% CI : 1.053-7.263), - 67 -
(95% CI : 0.962-9.570). ) - 200, 75. Kelly Hellinger(1986)., ( 14)..., 2... ( 75 ) ( 75 ),.,. PTCA, - 68 -
.,, 1 2 3. Table 22. Comparison of PTCA clinical outcomes by hospital's number of operator No. of operator, 2 No. of operator, >3 P value (N=430) (N=652) Intervention failure * 10.5 4.1 0.001 Major adverse outcome 4.0 1.1 0.002 * Defined as the case of the final result 50% diameter stenosis or the failure in 20% reduction of diameter stenosis or having any major adverse outcome described below. At least one complication of death during same hospitalization after intervention or emergency CABG within 24 hours after PTCA or acute myocardial infarction within 24 hours after PTCA. ) 200, 200 399, 400, 200 200 399 (P=0.023), 200, 200 399, 400 (X 2 tr e n d = 16.168, P=0.0001). 200 200 399 (P=0.208), 200 200., ACC/AHA - 69 -
. 200, 400.,. 200 400 100.. ) - '.,., -,.. -,. - ( ), PTCA - 70 -
14.,..,.,,.. Hannan (1997) (longitudinal data).. - 71 -
3), ).,. PTCA,.,.,., 25.., (, 24, 24 CABG). 2.2%., -. (1), (2),., - 72 -
.,....,.,, (Hannan 1999). ),, PTCA PTCA. (1999), PTCA,,, PTCA. - - 73 -
. -,. )., -.. PTCA.,., -. Hannan (1997).,.., -.,. ( : 2 PTCA, PTCA ), - 74 -
( : ), ( : ). - 75 -
6. (percutaneous transluminal coronary angioplasty, PTCA) 1977.,,,, PTCA. 25 3 (1997 10 12 ) PTCA ( 1,317, 95.5%),. 200, 75, PTCA (volume-outcome relationship). (,, ).,.., 200 200 399. PTCA -,., PTCA. - 76 -
, (low volume) (high volume).. PTCA,. - 77 -
,,,,,,,. Coronary Artery Stenting.. 1996; 26(3): 614-622.,,,,,,,. (Coronary Angioplasty). 1994; 24(3): 448-457.. - -. 1998.,,,,,,,,,,. Palmaz-Schatz Stenting.. 1997;27(1):56-64.,,,,,,,,,.. 1992; 22(6): 912-921..., 1994..,. 1997.,,.., 1996. pp143-144.,,. [ ]. 1999... 1995; 38(6): 766-774..., 1994.., 1993.,,,,,,,,,.. 1993; 23(6): 837-842. - 78 -
,,,,,,. (PTCA). 1986; 3: 317-329... 1992; 22(6): 905-911..., 1995..., 1991.. 1997 ( )., 1998. pp20-46 Anthony C. Federal financing of transplantation. Transplant Proc 1988;20(suppl):1047-1050. Ayanian JZ, Epstein AM. Differences in the use of procedures between women and men hospitalized for coronary heart disease. N Engl J Med 1991; 325 : 221-5. Barbash GI, Reiner J, White HD, Wilcox RG, Armstrong PW, Sadowski Z, Morris D, Aylward P, Woodlief LH, Topol EJ, Califf RM, Ross AM. Evaluation of paradoxic beneficial effects of smoking in patients receiving thrombolytic therapy for acute myocardial infarction: mechanism of the "smoker's paradox" from the GUSTO- Trial, with angiographic insights. J Am Coll Cardiol 1995a; 26: 1222-1229. Barbash GI, White HD, Diaz MR, Hampton JR, Heikkila J, Kristinsson A, Moulopoulos S, Paolasso EAC, Van Der Werf, Pehrsson K, Sandoe E, Simes J, Wilcox RG, Verstraete M, Von Der Lippe G, Van De Werf. Acute myocardial infarction in the young - the role of smoking. Eur Heart J 1995b; 16: 313-316. Barbash GI, White HD, Modan M, Diaz R, Hampton JR, Heikkila J, Kristinsson A, Moulopoulos S, Paolasso EAC, Van der Werf T, Pehrsson K, Sandoe E, Simes J, Wilcox RG, Verstraete M, Von Der Lippe G, Van De Verf F. Significance of smoking in patients receiving thrombolytic therapy for acute myocardial infarction: experience gleaned from the international tissue plasminogen activator/streptokinase mortality trial. Circulation 1993; 87: 53-58. Begg CB, Cramer LD, Hoskins WJ, Brennan MF. Impact of hospital on operative mortality for major cancer surgery. JAMA 1998; 280(20): 1747-1751. Birkmeyer JD, Finlayson SR, Tosteson AN, Sharp SM, Warshaw AL, Fisher ES. Effect of hospital volume on in-hospital mortality with pancreaticoduodenectomy. Surgery 1999; 125(3): 250-256. Croke RP. Case volume and clinical competence.[letter] Circulation 1991; 83(1): 354. - 79 -