ACC/AHA Guidelines for Percutaneous Coronary Intervention Revised 6/01, JACC Ryan Tsuda, MD Ryan Tsuda, MD

ACC/AHA Guidelines for ACC/AHA Guidelines for Percutaneous Coronary Percutaneous Coronary

InterventionIntervention Revised 6/01, JACCRevised 6/01, JACC

Ryan Tsuda, MDRyan Tsuda, MD

Historical Timeline of Cardiac Historical Timeline of Cardiac CatheterizationCatheterization

► 1844 Claude Bernard catheterizes both the 1844 Claude Bernard catheterizes both the right and left ventricles of a horse via the right and left ventricles of a horse via the jugular vein and carotid artery.jugular vein and carotid artery.

► 1929 Werner Forssmann credited with 1929 Werner Forssmann credited with being the first person to catheterize a being the first person to catheterize a living person, himself.living person, himself. At age 25, while At age 25, while receiving clinical instruction in surgery at receiving clinical instruction in surgery at Eberswalde, near Berlin, he passed a catheter Eberswalde, near Berlin, he passed a catheter 65 cm through one of his left antecubital 65 cm through one of his left antecubital veins, guiding it by fluoroscopy until it veins, guiding it by fluoroscopy until it entered his right atrium. He then walked to entered his right atrium. He then walked to the radiology department (upstairs), where the radiology department (upstairs), where the catheter was documented with a cxr.the catheter was documented with a cxr.

Historical Timeline of Cardiac Historical Timeline of Cardiac CatheterizationCatheterization

► 1930 Klein reports 11 right-sided heart 1930 Klein reports 11 right-sided heart catheterizations, and 2 measurements of CO using the catheterizations, and 2 measurements of CO using the Fick equation.Fick equation.

► 1932 Padillo et al also reports successful right heart 1932 Padillo et al also reports successful right heart catheterization with CO measurement.catheterization with CO measurement.

► 1940-1950s Andre Cournand and Dickinson Richards 1940-1950s Andre Cournand and Dickinson Richards report a large series of investigations of right heart report a large series of investigations of right heart physiology in humans.physiology in humans.

► 1947 Dexter reports his studies on congenital heart 1947 Dexter reports his studies on congenital heart disease. Reports the first catheterization of the distal disease. Reports the first catheterization of the distal pulmonary artery.pulmonary artery.

► 1953 Seldinger develops his percutaneous technique 1953 Seldinger develops his percutaneous technique of vascular access.of vascular access.

► 1959 Sones selective coronary arteriography. 1959 Sones selective coronary arteriography. ► 1977 Gruntzig introduces the technique of PTCA. 1977 Gruntzig introduces the technique of PTCA.

ACC/AHA Style ClassificationACC/AHA Style Classification► Class I: Conditions for which there is evidence for Class I: Conditions for which there is evidence for and/or general agreement that the and/or general agreement that the procedure or treatment is useful and effective.procedure or treatment is useful and effective.► Class II: Conditions for which there is conflicting evidence Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment. usefulness/efficacy of a procedure or treatment. Class IIa: Weight of evidence/opinion is Class IIa: Weight of evidence/opinion is

in favor of usefulness/efficacy.in favor of usefulness/efficacy. Class IIb: Usefulness/efficacy is less wellClass IIb: Usefulness/efficacy is less well established by evidence/opinion. established by evidence/opinion.

► Class III: Conditions for which there is evidence and/or Class III: Conditions for which there is evidence and/or general agreement that the general agreement that the procedure/treatment is not useful/effective, and procedure/treatment is not useful/effective, and in some cases may be harmful.in some cases may be harmful.

Level of EvidenceLevel of Evidence

►A: Data derived from multiple A: Data derived from multiple randomized randomized

clinical trials.clinical trials.►B: Data derived from a single B: Data derived from a single

randomized randomized

trial or nonrandomized studies.trial or nonrandomized studies.►C: Consensus opinion of experts.C: Consensus opinion of experts.

Recommendations for PCI Institutional Recommendations for PCI Institutional and Operator Volumes at Centers With and Operator Volumes at Centers With

Onsite Cardiac SurgeryOnsite Cardiac Surgery* Cited 11 studies which identified procedural volumes * Cited 11 studies which identified procedural volumes

as a determining factor for frequency of as a determining factor for frequency of complications with PCI.complications with PCI.

* * Kimmel, et al…JAMA 1995Kimmel, et al…JAMA 1995...Using data from the ...Using data from the Society of Cardiac Angiography and Interventions, Society of Cardiac Angiography and Interventions, found that an found that an inverse relationship existed inverse relationship existed between the number of angioplasty procedures between the number of angioplasty procedures performed at a hospital and the rate of major performed at a hospital and the rate of major complications.complications. These results were risk stratified These results were risk stratified and independent of patient risk profile. and independent of patient risk profile. Significantly Significantly fewer complications occurred in labs fewer complications occurred in labs performing >400 angioplasty procedures/year.performing >400 angioplasty procedures/year. Conversely, low volume hospitals were associated Conversely, low volume hospitals were associated with higher rates of emergent CABG surgery and with higher rates of emergent CABG surgery and death. death. Improved outcomes were identified with Improved outcomes were identified with a threshold volume of 75 Medicare a threshold volume of 75 Medicare angioplasties per physician and 200 Medicare angioplasties per physician and 200 Medicare angioplasties per hospital.angioplasties per hospital.


Onsite Cardiac SurgeryOnsite Cardiac Surgery

Class I:Class I: PCI done by operators with acceptable volume (>75) at PCI done by operators with acceptable volume (>75) at

high volume centers (>400). (Level of evidence: B)high volume centers (>400). (Level of evidence: B)

Class IIa:Class IIa: 1. PCI done by operators with acceptable volume (>75) at 1. PCI done by operators with acceptable volume (>75) at low volume centers (200-400). (Level of evidence: C)low volume centers (200-400). (Level of evidence: C) 2. PCI done by low volume operators (<75) at high-volume 2. PCI done by low volume operators (<75) at high-volume

centers (>400). Note: Ideally, operators with an annual centers (>400). Note: Ideally, operators with an annual procedure volume <75 should only work at institutions procedure volume <75 should only work at institutions with an activity level of >600 procedures/year. with an activity level of >600 procedures/year.

(Level of evidence: C)(Level of evidence: C)


Onsite Cardiac SurgeryOnsite Cardiac SurgeryClass III:Class III:

PCI done by low-volume operators (<75) at PCI done by low-volume operators (<75) at low-volume centers (200-400). Note: An low-volume centers (200-400). Note: An institution with a volume <200 institution with a volume <200 procedures/year, unless in a region that is procedures/year, unless in a region that is underserved because of the geography, underserved because of the geography, should carefully consider whether it should should carefully consider whether it should continue to offer service. continue to offer service.


Recommendations for PCI With Recommendations for PCI With and Without On-Site Cardiac and Without On-Site Cardiac

SurgerySurgery• Primary PCI in the early phase of an acute Primary PCI in the early phase of an acute

MI can be difficult, and requires even more MI can be difficult, and requires even more skill and experience than routine PCI.skill and experience than routine PCI.

• The need for an experienced operator and The need for an experienced operator and experienced lab technical support with experienced lab technical support with availability of a broad range of catheters, availability of a broad range of catheters, guidewires, stents, IABPs, etc…guidewires, stents, IABPs, etc…

• Thrombolysis is still an acceptable form Thrombolysis is still an acceptable form of therapy and is preferable to acute of therapy and is preferable to acute PCI by an inexperienced team.PCI by an inexperienced team.


SurgerySurgery Class I:Class I:

1. Patients undergoing elective PCI in 1. Patients undergoing elective PCI in facilities with on-site cardiac surgery. facilities with on-site cardiac surgery.

(Level of evidence: B)(Level of evidence: B)

2. Patients undergoing primary PCI in 2. Patients undergoing primary PCI in facilities with on-site cardiac surgery. facilities with on-site cardiac surgery.



SurgerySurgery► Class IIb:Class IIb: Patients undergoing primary PCI in facilities without Patients undergoing primary PCI in facilities without

on-site cardiac surgery, but with a proven plan for on-site cardiac surgery, but with a proven plan for rapid access (within 1 h) to a cardiac surgery rapid access (within 1 h) to a cardiac surgery operating room in a nearby facility with appropriate operating room in a nearby facility with appropriate hemodynamic support capability for transfer. The hemodynamic support capability for transfer. The procedure should be limited to patients with ST-procedure should be limited to patients with ST-segment elevation MI or new LBBB on ECG, and done segment elevation MI or new LBBB on ECG, and done in a timely fashion (balloon inflation within 90 +/- 30 in a timely fashion (balloon inflation within 90 +/- 30 min. of admission) by persons skilled in the procedure min. of admission) by persons skilled in the procedure (>75 PCIs/year) and only at facilities performing a (>75 PCIs/year) and only at facilities performing a minimum of 36 primary PCI procedures per year. minimum of 36 primary PCI procedures per year.


Recommendations for PCI With and Recommendations for PCI With and Without On-Site Cardiac SurgeryWithout On-Site Cardiac Surgery

*Based on Class IIb recommendations, if patient is not having active life-threatening ischemia, better to arrange transfer of care, rather than attempt PCI in a hospital without on-site cardiac surgery.

TIMITIMITIMI 0: Refers to the absence of any antegrade flow beyond a TIMI 0: Refers to the absence of any antegrade flow beyond a

coronary coronary occlusion.occlusion.

TIMI 1: Flow is faint antegrade coronary flow beyond the occlusion, TIMI 1: Flow is faint antegrade coronary flow beyond the occlusion, although filling of the distal coronary bed is incomplete.although filling of the distal coronary bed is incomplete.

TIMI 2: Flow is delayed or sluggish antegrade flow with complete TIMI 2: Flow is delayed or sluggish antegrade flow with complete filling filling

of the distal territory.of the distal territory.

TIMI 3: Flow is normal flow which fills the distal coronary bed TIMI 3: Flow is normal flow which fills the distal coronary bed completely.completely.

*The outcome after thrombolytic therapy in patients with an STEMI is related to the *The outcome after thrombolytic therapy in patients with an STEMI is related to the degree degree

to which flow has been restored in the infarct-related artery. The TIMI classification to which flow has been restored in the infarct-related artery. The TIMI classification is is

commonly used. It characterizes coronary blood flow in the infarct-related artery, commonly used. It characterizes coronary blood flow in the infarct-related artery, which is which is

usually measured at 60 to 90 minutes after the administration of thrombolytic usually measured at 60 to 90 minutes after the administration of thrombolytic therapy: therapy:


SurgerySurgery► Class III:Class III: 1. Patients undergoing elective PCI in facilities 1. Patients undergoing elective PCI in facilities without on-site cardiac surgery. without on-site cardiac surgery. (Level of evidence: C)(Level of evidence: C) 2. Patients undergoing primary PCI in facilities without on-2. Patients undergoing primary PCI in facilities without on- site cardiac surgery and without a proven plan for site cardiac surgery and without a proven plan for

rapid rapid access (within 1 h) to a cardiac surgery operating room access (within 1 h) to a cardiac surgery operating room in a nearby facility with appropriate hemodynamic in a nearby facility with appropriate hemodynamic support capability for transfer or when performed by support capability for transfer or when performed by lower skilled operators (<75 PCIs/year) in a facility lower skilled operators (<75 PCIs/year) in a facility performing <36 primary PCI procedures/year. performing <36 primary PCI procedures/year. (Level of evidence: C)(Level of evidence: C)

Recommendations for PCI in Recommendations for PCI in Asymptomatic or Class I Angina PatientsAsymptomatic or Class I Angina Patients

• In the previous (1993) guidelines, specific In the previous (1993) guidelines, specific recommendations were made separately for recommendations were made separately for patients with single vs. multi-vessel disease.patients with single vs. multi-vessel disease.

• PCI techniques have improved such that, less PCI techniques have improved such that, less emphasis is given to the number of diseased emphasis is given to the number of diseased coronaries requiring PCI. More emphasis is coronaries requiring PCI. More emphasis is given to the patients clinical condition, given to the patients clinical condition, specific coronary lesion morphology and specific coronary lesion morphology and anatomy, LV function, and associated medical anatomy, LV function, and associated medical co-morbidities.co-morbidities.

• The CCS Class of Angina (I to IV) is used to The CCS Class of Angina (I to IV) is used to define severity of symptoms. define severity of symptoms.

Canadian Cardiovascular Society


► Class I:Class I:

Patients who do not have treated diabetes Patients who do not have treated diabetes with asymptomatic ischemia or mild angina with asymptomatic ischemia or mild angina with 1 or more significant lesions in 1 or 2 with 1 or more significant lesions in 1 or 2 coronary arteries suitable for PCI with a high coronary arteries suitable for PCI with a high likelihood of success and a low risk of likelihood of success and a low risk of morbidity and mortality. The vessels to be morbidity and mortality. The vessels to be dilated must subtend a large area of viable dilated must subtend a large area of viable myocardium. myocardium.



*Davies RF, et al…Circulation 1997…Asymptomatic Cardiac Ischemia Pilot (ACIP) study. *Davies RF, et al…Circulation 1997…Asymptomatic Cardiac Ischemia Pilot (ACIP) study. Two year outcomes of patients treated medically vs. revascularization. Two year outcomes of patients treated medically vs. revascularization.

I


►Class IIa:Class IIa:

The same clinical and anatomic The same clinical and anatomic requirements for Class I, except the requirements for Class I, except the myocardial area at risk is of moderate myocardial area at risk is of moderate size or the patient has treated size or the patient has treated diabetes. diabetes.

(Level of evidence: (Level of evidence: B)B)


► Class IIb:Class IIb: Patients with asymptomatic ischemia or mild Patients with asymptomatic ischemia or mild

angina with 3+ coronary arteries suitable for PCI angina with 3+ coronary arteries suitable for PCI with a high likelihood of success and a low risk of with a high likelihood of success and a low risk of morbidity and mortality. The vessels to be morbidity and mortality. The vessels to be dilated must subtend at least a moderate area of dilated must subtend at least a moderate area of viable myocardium. In the physician’s judgment, viable myocardium. In the physician’s judgment, there should be evidence of myocardial ischemia there should be evidence of myocardial ischemia by ECG exercise testing, stress nuclear imaging, by ECG exercise testing, stress nuclear imaging, stress echocardiography or ambulatory ECG stress echocardiography or ambulatory ECG monitoring, or intra-coronary physiologic monitoring, or intra-coronary physiologic measurements.measurements.


Recommendations for PCI in Recommendations for PCI in Asymptomatic or Class I Angina PatientsAsymptomatic or Class I Angina PatientsI & II


► Class III:Class III: Patients with asymptomatic ischemia or mild angina who do Patients with asymptomatic ischemia or mild angina who do

not meet the criteria as listed under Class I or Class II and who not meet the criteria as listed under Class I or Class II and who have:have:

a. Only a small area of viable myocardiuma. Only a small area of viable myocardium at risk.at risk. b. No objective evidence of ischemia.b. No objective evidence of ischemia. c. Lesions that have a low likelihood of c. Lesions that have a low likelihood of successful dilation.successful dilation. d. Mild symptoms that are unlikely to be due to d. Mild symptoms that are unlikely to be due to myocardial ischemia.myocardial ischemia. e. Factors associated with increased risk of morbidity ande. Factors associated with increased risk of morbidity and mortality.mortality. f. Left main disease.f. Left main disease. g. Insignificant disease < 50%g. Insignificant disease < 50% (Level of evidence: (Level of evidence:

C) C)

Recommendations for Patients with Moderate or Severe Recommendations for Patients with Moderate or Severe Symptoms (Angina Class II to IV, Unstable Angina or Non ST Symptoms (Angina Class II to IV, Unstable Angina or Non ST

Elevation MI) With Single or Multi-vessel Coronary Disease on Elevation MI) With Single or Multi-vessel Coronary Disease on Medical Therapy.Medical Therapy.

*

The Treat Angina with Aggrastat and The Treat Angina with Aggrastat and Determine the Cost of Therapy with an Determine the Cost of Therapy with an

Invasive or Conservative Strategy (TACTICS) Invasive or Conservative Strategy (TACTICS) TrialTrial

* Randomized 2220 patients to an early invasive * Randomized 2220 patients to an early invasive strategy (cath and pci 4-48 h after randomization) or strategy (cath and pci 4-48 h after randomization) or to a conservative strategy (revascularization to a conservative strategy (revascularization reserved for patients who develop recurrent ischemia reserved for patients who develop recurrent ischemia after medical stabilization).after medical stabilization).

* All patients treated with aspirin, heparin, b-blockers, * All patients treated with aspirin, heparin, b-blockers, lipid therapy, and tirofiban.lipid therapy, and tirofiban.

* Composite primary end point (death, MI, re-* Composite primary end point (death, MI, re-hospitalization for worsening chest pain) at 6 months, hospitalization for worsening chest pain) at 6 months, was significantly lower in patients assigned to the was significantly lower in patients assigned to the invasive strategy (15.9% vs 19.4% in patients invasive strategy (15.9% vs 19.4% in patients assigned to conservative therapy; p=0.0025)assigned to conservative therapy; p=0.0025)

* Rate of death or MI was also significantly reduced at 6 * Rate of death or MI was also significantly reduced at 6 months in the invasive strategy arm (7.3% vs 9.5% in months in the invasive strategy arm (7.3% vs 9.5% in patients assigned to conservative therapy; p<0.05).patients assigned to conservative therapy; p<0.05).

Recommendations for Patients with Recommendations for Patients with Moderate or Severe Symptoms (Angina Moderate or Severe Symptoms (Angina Class II to IV, Unstable Angina or Non ST Class II to IV, Unstable Angina or Non ST Elevation MI) With Single or Multi-vessel Elevation MI) With Single or Multi-vessel Coronary Disease on Medical Therapy.Coronary Disease on Medical Therapy.

► Class I:Class I: Patients with 1 or more significant lesions in Patients with 1 or more significant lesions in

1 or more coronary arteries suitable for PCI 1 or more coronary arteries suitable for PCI with a high likelihood of success and low risk with a high likelihood of success and low risk of morbidity or mortality. The vessel(s) to of morbidity or mortality. The vessel(s) to be dilated must subtend a moderate or large be dilated must subtend a moderate or large area of viable myocardium and have high area of viable myocardium and have high risk.risk.



► Class IIa:Class IIa: Patients with focal saphenous vein graft lesions or multiple Patients with focal saphenous vein graft lesions or multiple

stenoses who are poor candidates for re-operative surgery. stenoses who are poor candidates for re-operative surgery.

(Level of evidence: C)(Level of evidence: C) Class IIb:Class IIb: Patient has 1 or more lesions to be dilated with reduced Patient has 1 or more lesions to be dilated with reduced

likelihood of success or the vessel(s) subtend a less than likelihood of success or the vessel(s) subtend a less than moderate area of viable myocardium. Patients with 2 or 3 moderate area of viable myocardium. Patients with 2 or 3 vessel disease, with significant proximal LAD CAD and vessel disease, with significant proximal LAD CAD and treated diabetes or abnormal LV function. treated diabetes or abnormal LV function.



► Class III:Class III: 1. Patient has no evidence of myocardial injury or ischemia on 1. Patient has no evidence of myocardial injury or ischemia on

objective testing and has not had a trial of medical therapy, or hasobjective testing and has not had a trial of medical therapy, or has a. Only a small area of myocardium at a. Only a small area of myocardium at riskrisk b. All lesions or the culprit lesion to be dilated b. All lesions or the culprit lesion to be dilated with morphology with a low likelihood of success.with morphology with a low likelihood of success. c. A high risk of procedure-related morbidity or mortality.c. A high risk of procedure-related morbidity or mortality. (Level of evidence: C)(Level of evidence: C) 2. Patients with insignificant coronary stenoses (e.g., < 2. Patients with insignificant coronary stenoses (e.g., <

50%).50%). (Level of evidence: (Level of evidence:

C)C) 3. Patients with significant left main CAD who are candidates for 3. Patients with significant left main CAD who are candidates for

CABG.CABG. (Level of evidence: B)(Level of evidence: B)

Recommendations for Primary Recommendations for Primary PCI for Acute Transmural MI PCI for Acute Transmural MI Patients as an Alternative to Patients as an Alternative to

ThrombolysisThrombolysis► Class I:Class I: 1. As an alternative to thrombolytic therapy in patients with AMI 1. As an alternative to thrombolytic therapy in patients with AMI

and ST segment elevation or new or presumed new left bundle and ST segment elevation or new or presumed new left bundle branch block who can undergo angioplasty of the infarct artery branch block who can undergo angioplasty of the infarct artery < 12 hrs. from the onset of ischemic symptoms or > 12 hrs. if < 12 hrs. from the onset of ischemic symptoms or > 12 hrs. if symptoms persist, if performed in a timely fashion by individuals symptoms persist, if performed in a timely fashion by individuals skilled in the procedure and supported by experienced skilled in the procedure and supported by experienced personnel in an appropriate laboratory environment. personnel in an appropriate laboratory environment. (Level of evidence: A) (Level of evidence: A)

2. In patients who are within 36 hrs. of an acute ST elevation/Q-2. In patients who are within 36 hrs. of an acute ST elevation/Q-wave or new left bundle branch block MI who develop wave or new left bundle branch block MI who develop cardiogenic shock, are < 75 years of age, and revascularization cardiogenic shock, are < 75 years of age, and revascularization can be performed within 18 h of the onset of shock by can be performed within 18 h of the onset of shock by individuals skilled in the procedure in an appropriate laboratory individuals skilled in the procedure in an appropriate laboratory environment. (Level of evidence: A)environment. (Level of evidence: A)

**Performance standard: balloon inflation within 90 +/- 30 min. of hospital Performance standard: balloon inflation within 90 +/- 30 min. of hospital admission. Individuals who perform >75 PCI procedures/year. Centers admission. Individuals who perform >75 PCI procedures/year. Centers

that that perform > 200 PCI procedures/year and have cardiac surgical capability. perform > 200 PCI procedures/year and have cardiac surgical capability.

*Weaver, et al…Meta-analysis of primary coronary angioplasty and intravenous thrombolytic therapy for acute MI. JAMA 1997.


ThrombolysisThrombolysis

►Class IIa:Class IIa:

As a reperfusion strategy in candidates As a reperfusion strategy in candidates who have a contraindication to who have a contraindication to thrombolytic therapy. (Level thrombolytic therapy. (Level of evidence: C)of evidence: C)

Recommendations for Primary PCI for Acute Transmural MI Patients as Recommendations for Primary PCI for Acute Transmural MI Patients as an Alternative to Thrombolysisan Alternative to Thrombolysis


ThrombolysisThrombolysis► Class III:Class III: 1. Elective PCI of a non-infarct related artery at the time of acute 1. Elective PCI of a non-infarct related artery at the time of acute

MI. MI. (Level of evidence: C) (Level of evidence: C) 2. In patients with acute MI who:2. In patients with acute MI who: a. have received fibrinolytic therapy a. have received fibrinolytic therapy within 12 h and have no symptoms of within 12 h and have no symptoms of myocardial ischemia.myocardial ischemia. b. are eligible for thrombolytic therapy and are b. are eligible for thrombolytic therapy and are undergoing primary angioplasty by an undergoing primary angioplasty by an inexperienced operator (individual who performsinexperienced operator (individual who performs < 75 PCI procedures/year).< 75 PCI procedures/year). c. are beyond 12 h after onset of symptoms and have no c. are beyond 12 h after onset of symptoms and have no

evidenceevidence of myocardial ischemia. of myocardial ischemia. (Level of evidence: C) (Level of evidence: C)

Recommendations for PCI After Recommendations for PCI After ThrombolysisThrombolysis

Class I:Class I:Objective evidence for recurrent Objective evidence for recurrent infarction or ischemia (rescue PCI). infarction or ischemia (rescue PCI).


*RESCUE trial randomized 151 anterior wall MI patients with *RESCUE trial randomized 151 anterior wall MI patients with 0/1 TIMI flow (mean = 4.5 hrs.) after initial thrombolysis to 0/1 TIMI flow (mean = 4.5 hrs.) after initial thrombolysis to PCI vs. conservative management. The PCI group PCI vs. conservative management. The PCI group demonstrated a reduction in rates of combined death and demonstrated a reduction in rates of combined death and CHF maintained up to 1 year. (6% in PCI group vs. 17% in CHF maintained up to 1 year. (6% in PCI group vs. 17% in conservative management group) conservative management group)


Class IIa:Class IIa:Cardiogenic Shock or hemodynamic instability. Cardiogenic Shock or hemodynamic instability.

(Level of evidence: B)(Level of evidence: B) *SHOCK…Hochman et al…NEJM 1999*SHOCK…Hochman et al…NEJM 1999 302 patients with AMI and cardiogenic shock randomly assigned to emergency 302 patients with AMI and cardiogenic shock randomly assigned to emergency

revascularization by coronary angioplasty (60%) or bypass surgery (40%) within revascularization by coronary angioplasty (60%) or bypass surgery (40%) within 6 hours or to initial medical stabilization. The 30 day mortality was significantly 6 hours or to initial medical stabilization. The 30 day mortality was significantly lower (p < 0.01) for patients < 75 years old treated with ERV (41.1% mortality) lower (p < 0.01) for patients < 75 years old treated with ERV (41.1% mortality) compared to IMS (56.8% mortality). By contrast, mortality among patients >75 compared to IMS (56.8% mortality). By contrast, mortality among patients >75 years was worse for those treated with ERV. Overall 30 day mortality was years was worse for those treated with ERV. Overall 30 day mortality was comparable in both groups (ERV 47% vs IMS 56%, p=0.11). Revascularization comparable in both groups (ERV 47% vs IMS 56%, p=0.11). Revascularization did reduce mortality at 6 months (ERV 50% vs. IMS 63%, p=0.027).did reduce mortality at 6 months (ERV 50% vs. IMS 63%, p=0.027).


*SWIFT study (BMJ 1991): *SWIFT study (BMJ 1991): Examined 800 patients with AMI randomly assigned to Examined 800 patients with AMI randomly assigned to

PCI within 2-7 days after thrombolysis or to conservative PCI within 2-7 days after thrombolysis or to conservative management with intervention for spontaneous or management with intervention for spontaneous or provocable ischemia. There was no difference in the two provocable ischemia. There was no difference in the two treatment strategies regarding LV function, incidence of treatment strategies regarding LV function, incidence of reinfarction, in-hospital survival, or 1 year survival rate.reinfarction, in-hospital survival, or 1 year survival rate.

*TIMI Phase II trial (NEJM 1989):*TIMI Phase II trial (NEJM 1989): 3262 patients randomized to angioplasty within 18-48 h 3262 patients randomized to angioplasty within 18-48 h

vs. conservative management after acute infarct and vs. conservative management after acute infarct and receiving t-pa. The two groups had similar mortality at 6 receiving t-pa. The two groups had similar mortality at 6 weeks (5.2% vs. 4.7%), incidence of nonfatal reinfarction weeks (5.2% vs. 4.7%), incidence of nonfatal reinfarction (6.4% vs. 5.8%), and LV ejection fraction (0.5% vs 0.5%). (6.4% vs. 5.8%), and LV ejection fraction (0.5% vs 0.5%). The 1 and 3 year survival rates, anginal class, and The 1 and 3 year survival rates, anginal class, and frequency of bypass surgery were also similar between frequency of bypass surgery were also similar between the two groups. the two groups.

IIb-2


Class IIb:Class IIb: 1. Recurrent angina without objective evidence of 1. Recurrent angina without objective evidence of ischemia/infarction. (Level of evidence: ischemia/infarction. (Level of evidence:

C)C) 2. Angioplasty of the infarct-related artery 2. Angioplasty of the infarct-related artery

stenoses stenoses within hours to days (48 h) following successfulwithin hours to days (48 h) following successful thrombolytic therapy in asymptomatic patientsthrombolytic therapy in asymptomatic patients without clinical and/or inducible evidence of without clinical and/or inducible evidence of

ischemia. ischemia. (Level of evidence: (Level of evidence:

B) B)


► TAMI-6 study (Topol, et al…Circulation 1992)TAMI-6 study (Topol, et al…Circulation 1992) Angioplasty of a persistently occluded Angioplasty of a persistently occluded

infarct artery 7-48 hrs. after symptom onset infarct artery 7-48 hrs. after symptom onset demonstrated that the infarct-related artery demonstrated that the infarct-related artery patency was similar in aggressive vs. patency was similar in aggressive vs. conservatively treated groups at 6 month conservatively treated groups at 6 month follow-up. There was a higher incidence of follow-up. There was a higher incidence of infarct-related artery patency in patients infarct-related artery patency in patients who did not receive angioplasty, as well as a who did not receive angioplasty, as well as a high incidence of re-occlusion in those who high incidence of re-occlusion in those who did.did.

III


►Class III:Class III:

1. Routine PCI within 48 h following failed1. Routine PCI within 48 h following failed

thrombolysis. (Level of evidence: B)thrombolysis. (Level of evidence: B)

2. Routine PCI of the infarct-artery 2. Routine PCI of the infarct-artery

stenoses immediately after stenoses immediately after thrombolyticthrombolytic

therapy. (Level of evidence: A) therapy. (Level of evidence: A)

Recommendations for PCI During Recommendations for PCI During Subsequent Hospital Management After Subsequent Hospital Management After Acute Therapy for AMI Including Primary Acute Therapy for AMI Including Primary

PCIPCI

► Class I:Class I:

1. Spontaneous or provocable myocardial1. Spontaneous or provocable myocardial

ischemia during recovery from ischemia during recovery from

infarction. (Level of evidence: C)infarction. (Level of evidence: C)

2. Persistent hemodynamic instability.2. Persistent hemodynamic instability.



PCIPCI

► Class IIa:Class IIa: Patients with LV ejection fraction < 40%, CHF, or serious ventricular Patients with LV ejection fraction < 40%, CHF, or serious ventricular arrythmias. (Level of evidence: C)arrythmias. (Level of evidence: C)

Class IIb:Class IIb: 1. Coronary angiography and angioplasty for an occluded infarct- 1. Coronary angiography and angioplasty for an occluded infarct- related artery in an otherwise stable patient to revascularize that related artery in an otherwise stable patient to revascularize that

artery artery (open artery hypothesis). (Level of evidence: C)(open artery hypothesis). (Level of evidence: C) 2. All patients after a non Q wave MI.2. All patients after a non Q wave MI. (Level of evidence: C)(Level of evidence: C) 3. Clinical HF during the acute episode, but subsequent3. Clinical HF during the acute episode, but subsequent demonstration of preserved LV function (LVEF > 40%).demonstration of preserved LV function (LVEF > 40%). (Level of evidence: C)(Level of evidence: C)


PCIPCI

Class III:Class III:

PCI of the infarct-related artery within 48PCI of the infarct-related artery within 48

to 72 h after thrombolytic therapy withoutto 72 h after thrombolytic therapy without

evidence of spontaneous or provocableevidence of spontaneous or provocable

ischemia. (Level of evidence: ischemia. (Level of evidence: C)C)

Recommendations for PCI With Recommendations for PCI With Prior CABGPrior CABG

*Ischemic symptoms recur in 4-8% of *Ischemic symptoms recur in 4-8% of patients/year following CABG. patients/year following CABG.

*Recurrence of symptoms can be attributed to *Recurrence of symptoms can be attributed to progression of native vessel coronary disease progression of native vessel coronary disease (5%/year) and bypass conduit occlusion, (5%/year) and bypass conduit occlusion, particularly SVG failure (7% in week 1; 15-particularly SVG failure (7% in week 1; 15-20% in first year; 1-2%/yr during the first 5-6 20% in first year; 1-2%/yr during the first 5-6 years, and 3-5%/yr in years 6-10 postop). years, and 3-5%/yr in years 6-10 postop).

*At 10 years postop, approximately half of all *At 10 years postop, approximately half of all SVG conduits are occluded and only half of SVG conduits are occluded and only half of the remaining patent grafts are free of the remaining patent grafts are free of significant disease.significant disease.


Class I:Class I: Patients with early ischemia (usually within 30 days) after CABG. Patients with early ischemia (usually within 30 days) after CABG. (Level of evidence: B)(Level of evidence: B)

Class IIa:Class IIa: 1. Patients with ischemia occurring 1 to 3 years post-operatively 1. Patients with ischemia occurring 1 to 3 years post-operatively

and and preserved LV function with discrete lesions in graft conduits. preserved LV function with discrete lesions in graft conduits. (Level of evidence: B)(Level of evidence: B) 2. Disabling angina secondary to new disease in a native coronary 2. Disabling angina secondary to new disease in a native coronary

circulation. (If angina is not typical, the objective evidence of circulation. (If angina is not typical, the objective evidence of ischemia should be obtained). (Level of evidence: B)ischemia should be obtained). (Level of evidence: B) 3. Patients with diseased vein grafts > 3 years following CABG.3. Patients with diseased vein grafts > 3 years following CABG. (Level of evidence: B) (Level of evidence: B)


Class III:Class III:

1. PCI to chronic total vein graft occlusions.1. PCI to chronic total vein graft occlusions.


2. Patients with multivessel disease, failure 2. Patients with multivessel disease, failure

or multiple SVGs, and impaired LV or multiple SVGs, and impaired LV

function. (Level of evidence: B)function. (Level of evidence: B)


• Patients with prior bypass surgery who Patients with prior bypass surgery who undergo successful PCI have a long-term undergo successful PCI have a long-term outcome that is dependent on patient age, the outcome that is dependent on patient age, the degree of LV dysfunction, and the presence of degree of LV dysfunction, and the presence of multi-vessel coronary atherosclerosis. multi-vessel coronary atherosclerosis.

• The best long-term results are observed after The best long-term results are observed after re-canalization of distal anastomotic stenoses re-canalization of distal anastomotic stenoses (both svg and ima) occurring within 1 year of (both svg and ima) occurring within 1 year of operation. operation.

• Conversely, event-free survival is less Conversely, event-free survival is less favorable following angioplasty of totally favorable following angioplasty of totally occluded SVGs, ostial vein graft stenoses, or occluded SVGs, ostial vein graft stenoses, or grafts with diffuse or multicentric disease. grafts with diffuse or multicentric disease.

*Werner Forssmann, amidst criticisms over the inherent recklessness of his experiments, turns his attention to other endeavors. Eventually pursued a career as a Urologist. Ultimately, he did receive (shared with Cournand and Richards) the Nobel Prize in Medicine in 1956.

ReferencesReferences

►ACC/AHA Guidelines for Percutaneous ACC/AHA Guidelines for Percutaneous Coronary Intervention. JACC, June Coronary Intervention. JACC, June 2001. (Revision of the 1993 PTCA 2001. (Revision of the 1993 PTCA Guidelines)Guidelines)

►Baim, Grossman. Grossman’s Cardiac Baim, Grossman. Grossman’s Cardiac Catheterization, Angiography, and Catheterization, Angiography, and Intervention, 6Intervention, 6thth Edition. 2000. pp 1-5. Edition. 2000. pp 1-5.

►Up To DateUp To Date

Documents

ACC/AHA Guidelines for Percutaneous Coronary Intervention Revised 6/01, JACC Ryan Tsuda, MD Ryan Tsuda, MD