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14 Smith et al. 2005 ACC/AHA/SCAI Practice Guidelines ACC - www.acc.org AHA - www.americanheart.org SCAI - www.scai.org Table 5. Studies Comparing Balloon Angioplasty with Stents for Native Coronary Artery Lesions Follow-Up, n, Stent/ Angiographic Restenosis, % TVR, % Study (Ref) Year mo Angioplasty Stent Angioplasty P value Stent Angioplasty P value Death, % Stent Angioplasty P value STRESS (83) 1994 6 205/202 31.6 42.1 0.046 10.2 15.4 0.06 1.5 1.5 NS BENESTENT (80,107) 1996 7/12* 259/257 22 32 0.02 10 21 0.001 1.2 0.8 NS Versaci et al. (108) 1997 12 60/60 19 40 0.02 6.6 22 NA NA NA NA STRESS II (109) 1998 12 100/89 NA NA NA 10 20 NA 17|| 34|| NA BENESTENT II (88) 1998 6 413/410 16 31 Less than 8† 13.7 0.02 0.001 0.2% 0.5% NS OCBAS (110) 1998 7 57/59 18.8 16.6 NA 17.5 9.2 NA 0 1.6 NS EPISTENT (111,112)‡ 1998 6 794/796 NA NA NA 8.7 15.4 Less than 0.001 0.5 1.8 0.02 START (113) 1999 6/48§ 229/223 22 37 Less than 12 24.6 Less than 0.002 0.002 2.7 2.4 NS OPUS (114) 2000 6 479 (Overall) NA NA NA 3.0 10.1 0.003 0.4 1.2 NS mo indicates months; NA, data not reported for that category, NS, not significant; and TVR, target vessel revascularization. Data are for lesions in coronary arteries with vessel diameter greater than or equal to 3.0 mm. *6-7 months angiographic follow-up and 12 months clinical follow-up. †Any repeat procedure. ‡Stent plus abciximab versus percutaneous transluminal angioplasty plus abciximab. §6 months angiographic follow-up and 48 months clinical follow-up. ||End point of death/any MI/CABG/target lesion percutaneous transluminal angioplasty. Modified with permission from Al SJ et al. JAMA 2000;284:1828-36 (106).
ACC - www.acc.org AHA - www.americanheart.org SCAI - www.scai.org Table 6. Lesion Classification System Smith et al. 2005 ACC/AHA/SCAI Practice Guidelines 15 Descriptions of a High-Risk Lesion (Type C Lesion) Diffuse (length greater than 2 cm) Excessive tortuosity of proximal segment Extremely angulated segments, greater than 90° Total occlusions more than 3 months old and/or bridging collaterals* Inability to protect major side branches Degenerated vein grafts with friable lesions* *The high risk with these criteria is for technical failure and increased restenosis, not for acute complications. interleukin-6 and other cytokines, have also been shown to be predictive of outcome (137). The BARI trial found that patients with diabetes and multivessel CAD had an increased periprocedural risk of ischemic complications and increased 5-year mortality compared with patients without diabetes or patients with diabetes undergoing bypass surgery using internal mammary artery (IMA) grafts (10,42). Patients with impaired renal function, especially those with diabetes, are at increased risk for contrast nephropathy (138) and increased 30-day and 1-year mortality (139,140). Renal insufficiency is a strong predictor of outcome in both primary and elective PCI (141-143). Increased risk for death or severe compromise in LV function may occur in association with a complication involving a vessel that also supplies collateral flow to viable myocardium. Certain variables were used to prospectively identify patients at risk for significant cardiovascular compromise during PTCA (144,145). These resulted in a Table 7. SCAI Lesion Classification System: Characteristics of Class I-IV Lesions Type I lesions (highest success expected, lowest risk) (1) Does not meet criteria for C lesion (2) Patent Type II lesions (1) Meets any of these criteria for ACC/AHA C lesion Diffuse (greater than 2 cm length) Excessive tortuosity of proximal segment Extremely angulated segments, greater than 90° Inability to protect major side branches Degenerated vein grafts with friable lesions (2) Patent Type III lesions (1) Does not meet criteria for C lesion (2) Occluded Type IV lesions (1) Meets any of the criteria for ACC/AHA C lesion Diffuse (greater than 2 cm length) Excessive tortuosity of proximal segment Extremely angulated segments, greater than 90° Inability to protect major side branches Degenerated vein grafts with friable lesions Occluded for more than 3 months (2) Occluded Reprinted from Krone et al. Evaluation of the American College of Cardiology/American Heart Association and the Society for Coronary Angiography and Interventions lesion classification system in the current “stent era” of coronary interventions (from the ACC- National Cardiovascular Data Registry ® ). Am J Cardiol 2003;92:394 (Appendix B) (132). composite 4-variable scoring system, prospectively validated to be both sensitive and specific in predicting cardiovascular collapse for failed PTCA, which includes: 1) percentage of myocardium at risk (e.g., greater than 50% viable myocardium at risk and LV ejection fraction of less than 25%), 2) preangioplasty percent diameter stenosis, 3) multivessel CAD, and 4) diffuse disease in the dilated segment (124) or a high myocardial jeopardy score (125). Patients with higher preprocedural jeopardy scores were shown to have a greater likelihood of cardiovascular collapse when abrupt vessel closure occurred during PTCA (144). 3.5.1.2. Left Main CAD CABG has long been considered the “gold standard” for revascularization of lesions in the unprotected left main (ULM) coronary artery (146). With the advent of newer technology utilizing BMS and DES, experience has been gained in performing PCI in ULM coronary artery lesions. Some studies have demonstrated that stenting of the ULM is feasible and appears to be a promising strategy in selected patients (147-152). Patients treated for ULM disease have varied from those presenting with stable angina to those with MI and shock. However, despite the feasibility and high procedural success rate of ULM PCI in the pre-DES era, there are reports of an unacceptably high incidence of long-term adverse events (153-155). This may be attributed to the inclusion of high-risk patients, such as those not considered good surgical candidates. The experience with BMS for ULM PCI in the multicenter ULTIMA (Unprotected Left Main Trunk Intervention Multicenter Assessment) registry suggested a high early mortality (2% per month among hospital survivors over the first 6 months after hospital discharge), and careful surveillance with coronary angiography was recommended (153) (see Section 6.3.4). Patients presenting with MI, ULM occlusion, and cardiogenic shock have lower successful PCI rates (69.7% vs 100%, P equals 0.040), higher in-hospital mortality (71.4% vs 10%, P equals 0.0008), and higher 1-year mortality rates (P equals 0.0064) than stable MI patients regardless of performance of primary PCI with stents (155). More recently, published studies of left main PCI using DES have reported 6-month or 1-year death rates ranging from 0% to 14% (Table 8) (147-150,152-161). Furthermore, ISR appears to be improved with the use of DES versus BMS. One of the larger studies performed to date showed that the 6-month angiographic restenosis rate was signifi-
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